Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.07.048
Purpose/Objective(s)
To assess the impact of cisplatin cycles on both overall survival (OS) and disease-free survival (DFS) in locally advanced cervical cancer (LACC) patients undergoing concurrent chemoradiotherapy (CCRT), and to build a nomogram-based prognostic stratification to identify LACC patients who might benefit from ≥ 5 cycles of cisplatin.
Materials/Methods
A total of 918 patients with LACC who underwent CCRT at our hospital were retrospectively enrolled. The difference in survival outcomes between the < 5 cycles and ≥ 5 cycles groups were compared using the paired Log-rank test. Subgroup analysis was further conducted to explore the survival differences between the ≥ 5 cycles and < 5 cycles groups in different subpopulations, including age, histology, tumor size, squamous cell carcinoma antigen (SCC Ag), and Federation International of Gynecology and Obstetrics (FIGO) stage. Univariate and multivariate Cox regression analyses were performed in the < 5 cycles group to identify independent risk factors, and a nomogram was developed accordingly. The patients were divided into two risk subgroups according to the total points derived from the nomogram, and the survival outcomes between the < 5 cycles and ≥ 5 cycles groups were compared in each risk strata.
Results
The 5-year OS and DFS were 76.7% (95% CI = 74.3–79.9%) and 86.1% (95% CI = 84.6–87.6%) (P = 0.002) and 68.7% (95% CI = 66.1%–71.3%) and 78.3% (95% CI = 76.6%–80.0%) (P = 0.0016) for the < 5 and ≥ 5 cycles groups, respectively. In subgroup analysis, the survival benefit of ≥ 5 cycles could be maintained in patients with squamous disease (P = 0.0031 in OS; P = 0.0019 in DFS), patients with SCC > 1.5 ng/mL (P = 0.0096 in OS; P = 0.019 in DFS), patients with tumor size > 4 cm (P = 0.0036 in OS; P = 0.0011 in DFS), and patients with stage I/II disease (P = 0.0041 in OS; P = 0.014 in DFS). A nomogram incorporating size, SCCAg, and FIGO stage was constructed, and patients were divided into two risk groups (low-risk: total points < 101; high-risk: total points ≥ 101). Receiving ≥ 5 cycles showed superiority in OS (P = 0.0025) and DFS (P = 0.008) over < 5 cycles in the low-risk subgroup; however, this survival benefit could not be maintained in the high-risk subgroup (P = 0.130 in OS; P = 0.093 in DFS).
Conclusion
Receiving ≥ 5 cycles of cisplatin improved OS and DFS in LACC patients who received CCRT when compared with < 5 cycles. A nomogram was constructed and the newly defined low-risk patients might gain significant OS and DFS benefit from receiving ≥ 5 cycles.
目的评估顺铂周期对接受同期化放疗（CCRT）的局部晚期宫颈癌（LACC）患者总生存期（OS）和无病生存期（DFS）的影响，并建立基于提名图的预后分层，以识别可能从≥5个顺铂周期中获益的LACC患者。采用配对Log-rank检验比较了< 5个周期组和≥5个周期组之间生存结果的差异。进一步进行亚组分析，探讨≥5周期组和< 5周期组在不同亚人群中的生存差异，包括年龄、组织学、肿瘤大小、鳞状细胞癌抗原（SCC Ag）和国际妇产科联盟（FIGO）分期。在< 5周期组中进行了单变量和多变量Cox回归分析，以确定独立的风险因素，并制定了相应的提名图。根据提名图得出的总积分将患者分为两个风险亚组，并比较了每个风险分层中< 5周期组和≥5周期组的生存结果。结果 5周期组和≥5周期组的5年OS和DFS分别为76.7%（95% CI = 74.3-79.9%）和86.1%（95% CI = 84.6-87.6%）（P = 0.002）和68.7%（95% CI = 66.1%-71.3%）和78.3%（95% CI = 76.6%-80.0%）（P = 0.0016）。在亚组分析中，鳞状病患者（OS中P = 0.0031；DFS中P = 0.0019）、SCC > 1.5 ng/mL患者（OS中P = 0.0096 in OS; P = 0.019 in DFS）、肿瘤大小> 4 cm的患者（P = 0.0036 in OS; P = 0.0011 in DFS）和I/II期患者（P = 0.0041 in OS; P = 0.014 in DFS）。结合肿瘤大小、SCCAg和FIGO分期构建了一个提名图，并将患者分为两个风险组（低风险：总分< 101；高风险：总分≥101）。与< 5个周期相比，接受≥5个周期顺铂治疗的低危亚组患者的OS（P = 0.0025）和DFS（P = 0.008）均优于< 5个周期；但在高危亚组中，这种生存获益无法保持（OS中的P = 0.130；DFS中的P = 0.093）。我们构建了一个提名图，新定义的低危患者接受≥5个周期的顺铂治疗可显著改善其OS和DFS。
{"title":"Effect of Cisplatin Cycles on Prognosis for Locally Advanced Cervical Cancer Patients Treated with Concurrent Chemoradiotherapy: A Long-Term Follow-Up, Large Cohort Study","authors":"","doi":"10.1016/j.ijrobp.2024.07.048","DOIUrl":"10.1016/j.ijrobp.2024.07.048","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>To assess the impact of cisplatin cycles on both overall survival (OS) and disease-free survival (DFS) in locally advanced cervical cancer (LACC) patients undergoing concurrent chemoradiotherapy (CCRT), and to build a nomogram-based prognostic stratification to identify LACC patients who might benefit from ≥ 5 cycles of cisplatin.</div></div><div><h3>Materials/Methods</h3><div>A total of 918 patients with LACC who underwent CCRT at our hospital were retrospectively enrolled. The difference in survival outcomes between the < 5 cycles and ≥ 5 cycles groups were compared using the paired Log-rank test. Subgroup analysis was further conducted to explore the survival differences between the ≥ 5 cycles and < 5 cycles groups in different subpopulations, including age, histology, tumor size, squamous cell carcinoma antigen (SCC Ag), and Federation International of Gynecology and Obstetrics (FIGO) stage. Univariate and multivariate Cox regression analyses were performed in the < 5 cycles group to identify independent risk factors, and a nomogram was developed accordingly. The patients were divided into two risk subgroups according to the total points derived from the nomogram, and the survival outcomes between the < 5 cycles and ≥ 5 cycles groups were compared in each risk strata.</div></div><div><h3>Results</h3><div>The 5-year OS and DFS were 76.7% (95% CI = 74.3–79.9%) and 86.1% (95% CI = 84.6–87.6%) (<em>P</em> = 0.002) and 68.7% (95% CI = 66.1%–71.3%) and 78.3% (95% CI = 76.6%–80.0%) (<em>P</em> = 0.0016) for the < 5 and ≥ 5 cycles groups, respectively. In subgroup analysis, the survival benefit of ≥ 5 cycles could be maintained in patients with squamous disease (<em>P</em> = 0.0031 in OS; <em>P</em> = 0.0019 in DFS), patients with SCC > 1.5 ng/mL (<em>P</em> = 0.0096 in OS; <em>P</em> = 0.019 in DFS), patients with tumor size > 4 cm (<em>P</em> = 0.0036 in OS; <em>P</em> = 0.0011 in DFS), and patients with stage I/II disease (<em>P</em> = 0.0041 in OS; <em>P</em> = 0.014 in DFS). A nomogram incorporating size, SCCAg, and FIGO stage was constructed, and patients were divided into two risk groups (low-risk: total points < 101; high-risk: total points ≥ 101). Receiving ≥ 5 cycles showed superiority in OS (<em>P</em> = 0.0025) and DFS (<em>P</em> = 0.008) over < 5 cycles in the low-risk subgroup; however, this survival benefit could not be maintained in the high-risk subgroup (<em>P</em> = 0.130 in OS; <em>P</em> = 0.093 in DFS).</div></div><div><h3>Conclusion</h3><div>Receiving ≥ 5 cycles of cisplatin improved OS and DFS in LACC patients who received CCRT when compared with < 5 cycles. A nomogram was constructed and the newly defined low-risk patients might gain significant OS and DFS benefit from receiving ≥ 5 cycles.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.07.072
Purpose/Objective(s)
To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.
Materials/Methods
This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
Results
The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; P = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; P = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; P = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; P < 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (P < 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; P = 0.08), but the difference was not significant.
Conclusion
The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.
材料/方法这项随机临床试验在2011年10月1日至2019年12月31日期间招募了患者。接受D2胃切除术的病理确诊胃癌患者（任何T期，N+，M0）被随机（1:1）分配接受术后化放疗（CRT）或辅助化疗。辅助化疗组的干预措施为8个周期的SOX（S-1+奥沙利铂）化疗。放疗在4-6个周期的SOX化疗后进行。在S-1化疗的同时，采用调强放射治疗（IMRT）技术，在5周内进行25次1.8 Gy的分次放疗，每次45 Gy。主要终点是3年无病生存期（DFS）。急性毒性反应根据《不良事件通用术语标准》4.0版进行评估和分级。结果由于患者入组缓慢，该试验于2022年6月结束。共有308名患者（中位数[IQR]年龄，58[23-74]岁；221[71.8%]名男性和87[28.8%]名女性）入组，其中157名患者被随机分配到辅助化疗组，151名患者被随机分配到辅助化放疗组。121名患者（46.5%）为III期患者。对照组的三年 DFS 为 67.2%，实验组为 67.5%（危险比 [HR] = 1.08；95% CI = 0.69-1.70；P = 0.74）。在总生存率（HR = 0.81；95% CI = 0.49-1.33；P = 0.40）或局部复发率（HR = 1.58；95% CI = 0.66-3.82；P = 0.31）方面，组间无明显差异。在对患者淋巴结阳性数目和淋巴结转移位置进行分析后，我们将pN分期≥N2且有腹膜外淋巴结转移的患者定义为高危组，其余患者定义为低危组。高危组和低危组的三年 DFS 分别为 59.8% 和 76.2%（HR = 2.05; 95% CI = 1.30-3.25; P <0.05）。对于高危患者，辅助化疗组和辅助化放疗组的三年DFS分别为54.0%和71.2%（P <0.05）。辅助化疗组的3级和4级急性毒性反应多于化放疗组（42例[26.8%] vs 18例[17.5%]；P = 0.08），但差异不显著。
{"title":"Long-Term Prognostic Analysis of Chemoradiotherapy vs. Chemotherapy after D2 Resection for High-Risk Gastric Cancer: Results from a Prospective Randomized Control Study","authors":"","doi":"10.1016/j.ijrobp.2024.07.072","DOIUrl":"10.1016/j.ijrobp.2024.07.072","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>To explore the prognosis value of postoperative chemoradiotherapy in patients with D2-resected, high-risk, node-positive gastric cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized clinical trial enrolled patients between October 1, 2011, and December 31, 2019. Patients with pathologically confirmed gastric cancer (stage any T, N+, M0) who underwent D2 gastrectomy were randomized (1:1) to receive postoperative chemoradiotherapy (CRT) or adjuvant chemotherapy. The interventions of the adjuvant chemotherapy group were 8 cycles of SOX (S-1+Oxaliplatin) chemotherapy. The radiotherapy was given after 4-6 cycles of SOX chemotherapy. Radiotherapy (RT) comprised 45 Gy in 25 fractions of 1.8 Gy over 5 weeks by the intensity modulated radiation therapy (IMRT) technique concurrently with S-1 chemotherapy. The primary endpoint was 3-year disease-free survival (DFS). Acute toxic effects were assessed and graded according to the Common Terminology Criteria for Adverse Events version 4.0.</div></div><div><h3>Results</h3><div>The trial closed in June 2022 due to slow patient enrollment. A total of 308 patients (median [IQR] age, 58 [23-74] years; 221 [71.8%] men and 87 [28.8%] women) were enrolled, including 157 patients randomized to the adjuvant chemotherapy group and 151 patients to the adjuvant chemoradiotherapy group. One hundred and twenty-one (46.5%) patients had stage III disease. Three-year DFS was 67.2% for the control arm and 67.5% for the experimental arm (hazard ratio [HR] = 1.08; 95% CI = 0.69-1.70; <em>P</em> = 0.74). There was no significant difference between groups in overall survival (HR = 0.81; 95% CI = 0.49-1.33; <em>P</em> = 0.40) or local recurrence (HR = 1.58; 95% CI = 0.66-3.82; <em>P</em> = 0.31). After analyzing the number of positive lymph nodes and the location of lymph node metastasis in the patients, we defined pN staging ≥ N2 patients with extra-perigastric lymph node metastasis as the high-risk group and the remaining patients as the low-risk group. The three-year DFS for the high-risk group and the low-risk group was 59.8% and 76.2%, respectively (HR = 2.05; 95% CI = 1.30-3.25; <em>P</em> < 0.05). For high-risk patients, the three-year DFS in the adjuvant chemotherapy and adjuvant chemoradiotherapy group were 54.0% and 71.2%, respectively (<em>P</em> < 0.05). More grade 3 and 4 acute toxic effects were observed in the adjuvant chemotherapy group than in the chemoradiotherapy group (42 patients [26.8%] vs 18 patients [17.5%]; <em>P</em> = 0.08), but the difference was not significant.</div></div><div><h3>Conclusion</h3><div>The result of the subgroup analysis from the randomized clinical trial found that high-risk patients could benefit from the adjuvant chemoradiotherapy.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142359567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.08.018
<div><h3>Purpose/Objective(s)</h3><div>Adjuvant chemotherapy and chemoradiotherapy are both mainstream treatment modalities for gastric cancer, but whether to administer radiotherapy after gastric cancer D2 radical resection has been a focal point of discussion in recent years. This study compared the efficacy of chemotherapy alone and radiochemotherapy for adjuvant treatment in patients with stage T4 or positive lymph nodes after D2 resection.</div></div><div><h3>Materials/Methods</h3><div>Researchers randomly assigned patients in a 1:1 ratio to either the concurrent chemoradiotherapy arm (SOXRT) or the chemotherapy-alone arm (SOX). In the SOXRT arm, patients received one cycle of induction chemotherapy with the SOX regimen 21 days before starting radiotherapy; the radiotherapy was at a total dose of 50.4Gy in 28 fractions, 1.8Gy per day, 5 fractions per week, simultaneously with concurrent chemotherapy with S-1 at a dose of 50 mg, bid. Three to four weeks after the completion of radiotherapy, three cycles of chemotherapy with the SOX regimen were administered, with the same dosage as the induction chemotherapy. The SOX arm received a total of six cycles of chemotherapy with the SOX regimen. The specific dosages for the SOX regimen were: S-1 30-40mg/m2 bid on days 1-14, and oxaliplatin 130mg/m2 on day 1, every 3 weeks. The primary endpoint of the study was disease-free survival (DFS). The double significance level is 0.05. Assuming that higher DFS can be achieved with simultaneous radiotherapy, the sample size needed for this project is 516 patients. Assuming that 20% of the patients need to be excluded from the statistics, the total number of patients that need to be enrolled in this project is 620.</div></div><div><h3>Results</h3><div>A total of 620 patients were randomized up to 16 August 2022. Patients had a median age of 54 years, 64% were male, 43% were stage T4 patients, and 72% were stage III (the eighth edition of the Cancer Staging Manual of AJCC). The baseline patient characteristics were balanced across treatment arms. The median DFS follow-up period was 64 months, with 263 DFS events observed. The 3-year DFS rates were 71.7% and 71.4%, and the 5-year DFS was 60.2% and 59.2% in the SOXRT and SOX arms, respectively. The median overall survival (OS) follow-up period was 69 months, with 188 OS events observed. The 3-year OS rates were 81.1% and 79.8%, and 5-year OS survival rates were 74.9% and 73.2% in the SOXRT and SOX arms, respectively. There was no statistically significant difference between the SOX arm and the SOXRT arm in both DFS (HR 0.930; P=0.56) and OS (HR 1.003; P=0.99). The incidence of adverse events in each treatment arm was as expected, and overall it was well tolerated with manageable toxicity.</div></div><div><h3>Conclusion</h3><div>In T4 or lymph node-positive GC patients with D2 resection, the addition of radiation therapy to the postoperative adjuvant SOX regimen did not significantly improves the DFS or OS after D
{"title":"A Multicenter Phase III Randomized Clinical Trial Comparing the Efficacy of an Adjuvant SOX Chemotherapy Regimen with SOX Combined with a Simultaneous Radiotherapy Regimen after D2 Radical Resection for Gastric Cancer","authors":"","doi":"10.1016/j.ijrobp.2024.08.018","DOIUrl":"10.1016/j.ijrobp.2024.08.018","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Adjuvant chemotherapy and chemoradiotherapy are both mainstream treatment modalities for gastric cancer, but whether to administer radiotherapy after gastric cancer D2 radical resection has been a focal point of discussion in recent years. This study compared the efficacy of chemotherapy alone and radiochemotherapy for adjuvant treatment in patients with stage T4 or positive lymph nodes after D2 resection.</div></div><div><h3>Materials/Methods</h3><div>Researchers randomly assigned patients in a 1:1 ratio to either the concurrent chemoradiotherapy arm (SOXRT) or the chemotherapy-alone arm (SOX). In the SOXRT arm, patients received one cycle of induction chemotherapy with the SOX regimen 21 days before starting radiotherapy; the radiotherapy was at a total dose of 50.4Gy in 28 fractions, 1.8Gy per day, 5 fractions per week, simultaneously with concurrent chemotherapy with S-1 at a dose of 50 mg, bid. Three to four weeks after the completion of radiotherapy, three cycles of chemotherapy with the SOX regimen were administered, with the same dosage as the induction chemotherapy. The SOX arm received a total of six cycles of chemotherapy with the SOX regimen. The specific dosages for the SOX regimen were: S-1 30-40mg/m2 bid on days 1-14, and oxaliplatin 130mg/m2 on day 1, every 3 weeks. The primary endpoint of the study was disease-free survival (DFS). The double significance level is 0.05. Assuming that higher DFS can be achieved with simultaneous radiotherapy, the sample size needed for this project is 516 patients. Assuming that 20% of the patients need to be excluded from the statistics, the total number of patients that need to be enrolled in this project is 620.</div></div><div><h3>Results</h3><div>A total of 620 patients were randomized up to 16 August 2022. Patients had a median age of 54 years, 64% were male, 43% were stage T4 patients, and 72% were stage III (the eighth edition of the Cancer Staging Manual of AJCC). The baseline patient characteristics were balanced across treatment arms. The median DFS follow-up period was 64 months, with 263 DFS events observed. The 3-year DFS rates were 71.7% and 71.4%, and the 5-year DFS was 60.2% and 59.2% in the SOXRT and SOX arms, respectively. The median overall survival (OS) follow-up period was 69 months, with 188 OS events observed. The 3-year OS rates were 81.1% and 79.8%, and 5-year OS survival rates were 74.9% and 73.2% in the SOXRT and SOX arms, respectively. There was no statistically significant difference between the SOX arm and the SOXRT arm in both DFS (HR 0.930; P=0.56) and OS (HR 1.003; P=0.99). The incidence of adverse events in each treatment arm was as expected, and overall it was well tolerated with manageable toxicity.</div></div><div><h3>Conclusion</h3><div>In T4 or lymph node-positive GC patients with D2 resection, the addition of radiation therapy to the postoperative adjuvant SOX regimen did not significantly improves the DFS or OS after D","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358686","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.07.049
<div><h3>Purpose/Objective(s)</h3><div>Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.</div></div><div><h3>Materials/Methods</h3><div>This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m<sup>2</sup> Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).</div></div><div><h3>Results</h3><div>Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, <em>P</em> = 0.001), DFS (92.2% vs 55.5%, <em>P</em> = 0.003), and OS (98.0% vs 77.8%, <em>P</em> = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.</div></div><div><h3>Conclusion</h3><div>Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstr
{"title":"A Phase II Trial of Camrelizumab in Combination with Concurrent Chemoradiotherapy as First-Line Treatment for Betel Nut-Related Locally Advanced Oral Squamous Cell Carcinoma","authors":"","doi":"10.1016/j.ijrobp.2024.07.049","DOIUrl":"10.1016/j.ijrobp.2024.07.049","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Betel nut chewing is an established cause of oral cancer. We hypothesized that patients with nonoperative betel nut-related locally advanced oral squamous cell carcinoma (LAOSCC) can benefit from the addition of concurrent and adjuvant camrelizumab to cisplatin-based concurrent chemoradiotherapy (CCRT) as first-line treatment. The purpose of this single arm, phase 2 trial was to evaluate the efficacy and safety of CCRT plus concurrent and adjuvant camrelizumab as first-line treatment for patients with nonoperative betel nut-related LAOSCC.</div></div><div><h3>Materials/Methods</h3><div>This study was an open-label, single-arm phase 2 trial. A total of 60 patients with betel nut-related (consumption of at least 10 betel nuts per day for more than 5 years), nonoperative, stage III to IVB oral squamous cell carcinoma (OSCC) were enrolled. All patient were treated with CCRT plus concurrent and adjuvant camrelizumab as first-line treatment. The concurrent head and neck irradiation using intensity-modulated radiation therapy (IMRT) was administered at a dose of 70 Gy in 35 fractions. Cisplatin was administered at a dosage of 100mg /m<sup>2</sup> Q3W, concurrently with radiotherapy. Camrelizumab (200 mg on days 1, 22, and 43) was given concurrently to CCRT, and this was followed by adjuvant doses of 200 mg every 3-weeks for 1 year or until disease progression, the occurrence of unacceptable adverse events (AEs), withdrawal of consent or investigator’s decision. The primary endpoint was disease-free survival (DFS). Secondary outcomes were treatment response, overall survival (OS), local recurrence-free survival (LRFS), local regional recurrence-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related toxicity. This trial is registered with chictr.org.cn (ChiCTR2200056298).</div></div><div><h3>Results</h3><div>Median follow-up duration was 12 months. The objective response rate (ORR), complete response (CR) rate and partial response (PR) rate were 100%, 88.3%, and 11.7%, respectively. The 1-year DFS, OS, LRFS, LRRFS, and DMFS were 86.7%, 95.0%, 91.7%, 88.3%, and 86.7%, respectively. Compared to patients with a PD-L1 combined positive score (CPS) of < 1, those with a CPS ≥1 have significant higher CR rate (94.1% vs 55.5%, <em>P</em> = 0.001), DFS (92.2% vs 55.5%, <em>P</em> = 0.003), and OS (98.0% vs 77.8%, <em>P</em> = 0.011). The common (incidence ≥ 10%) severe (≥ grade 3) toxic effects included oral mucositis (65.0%), decreased lymphocyte count (36.6%), dysphagia (23.3%), nausea (16.6%), hyponatremia (13.3%), weight loss (11.6%), vomiting (11.6%), and radiation dermatitis (10.0%). The incidence of reactive capillary endothelial proliferation (RCEP) was 6.7%, all of which are grades 1-2. No grade 5 toxicities were observed.</div></div><div><h3>Conclusion</h3><div>Cisplatin-based concurrent chemoradiotherapy plus concurrent and adjuvant camrelizumab as first-line treatment has demonstr","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358678","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.07.022
Purpose/Objective(s)
Commercial devices capable of delivering FLASH radiotherapy are being introduced into radiobiology research. There is a critical necessity for a unified dosimetric protocol to ensure dosimetric consistency across institutes. This work introduces a collaborative, multi-institutional dosimetry protocol designed to validate and standardize dosimetry across two research facilities using FLASH intraoperative systems.
Materials/Methods
Two independent institutes used the same collimator design (4x4 cm2) and same beam parameters to deliver 12 or 14 Gy with FLASH or conventional (CONV) dose rates. For dosimetry, replicates of a realistic anatomy 3D-printed mouse phantom with coronal or sagittal division allowing insertions of radiochromic films, and a set of films (sourced from a singular source) were sent from Institute 1 to Institute 2. The institutes independently calibrated the target doses for FLASH using films from the phantom against the associated measurements from the embedded toroid of the system, and for CONV against the total number of MU. Ultimately, 80 experimental toroid measurements for FLASH (40 per target dose) were acquired in 4 days, with 5 set of films per modality per day of measurement. The films were returned to Institute 1 for analysis and the experimental values for FLASH and CONV were calculated.
Results
For 12 Gy target dose, the toroid-derived FLASH doses combined for Institute 1 vs Institute 2 were 11.85 ± 0.11 Gy vs 12.32 ± 0.16 Gy, for 14 Gy were 14.12 ± 0.07 Gy vs 14.09 ± 0.01 Gy. for CONV 11.74 ± 0.23 Gy vs 12.19 ± 0.20 Gy and for 14 Gy were 13.86 ± 0.21 Gy vs 14.47 ± 0.31 Gy.
Conclusion
The differences between measured and target doses, as well as between FLASH and CONV doses, were within 3%, and the inter-institutional dose differences were under 5%. Enhancing the protocol could entail incorporating an extra calibration step before the experimental dates to fine tune dose alignment between institutions. The success of the collaborative, multi-institutional dosimetry protocol, using realistic anatomy 3D-printed mouse phantom, is evidenced by the demonstrated consistency in preclinical radiobiological experiments across distinct research facilities.
{"title":"Multi-Institutional Standardized Dosimetry Protocol for Preclinical Radiobiological Experiments","authors":"","doi":"10.1016/j.ijrobp.2024.07.022","DOIUrl":"10.1016/j.ijrobp.2024.07.022","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Commercial devices capable of delivering FLASH radiotherapy are being introduced into radiobiology research. There is a critical necessity for a unified dosimetric protocol to ensure dosimetric consistency across institutes. This work introduces a collaborative, multi-institutional dosimetry protocol designed to validate and standardize dosimetry across two research facilities using FLASH intraoperative systems.</div></div><div><h3>Materials/Methods</h3><div>Two independent institutes used the same collimator design (4x4 cm<sup>2</sup>) and same beam parameters to deliver 12 or 14 Gy with FLASH or conventional (CONV) dose rates. For dosimetry, replicates of a realistic anatomy 3D-printed mouse phantom with coronal or sagittal division allowing insertions of radiochromic films, and a set of films (sourced from a singular source) were sent from Institute 1 to Institute 2. The institutes independently calibrated the target doses for FLASH using films from the phantom against the associated measurements from the embedded toroid of the system, and for CONV against the total number of MU. Ultimately, 80 experimental toroid measurements for FLASH (40 per target dose) were acquired in 4 days, with 5 set of films per modality per day of measurement. The films were returned to Institute 1 for analysis and the experimental values for FLASH and CONV were calculated.</div></div><div><h3>Results</h3><div>For 12 Gy target dose, the toroid-derived FLASH doses combined for Institute 1 vs Institute 2 were 11.85 ± 0.11 Gy vs 12.32 ± 0.16 Gy, for 14 Gy were 14.12 ± 0.07 Gy vs 14.09 ± 0.01 Gy. for CONV 11.74 ± 0.23 Gy vs 12.19 ± 0.20 Gy and for 14 Gy were 13.86 ± 0.21 Gy vs 14.47 ± 0.31 Gy.</div></div><div><h3>Conclusion</h3><div>The differences between measured and target doses, as well as between FLASH and CONV doses, were within 3%, and the inter-institutional dose differences were under 5%. Enhancing the protocol could entail incorporating an extra calibration step before the experimental dates to fine tune dose alignment between institutions. The success of the collaborative, multi-institutional dosimetry protocol, using realistic anatomy 3D-printed mouse phantom, is evidenced by the demonstrated consistency in preclinical radiobiological experiments across distinct research facilities.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.08.014
<div><h3>Purpose/Objective(s)</h3><div>NRG-HN005 was a phase II/III randomized study comparing each of two experimental arm(s) against a control arm from RTOG 1016, in patients with p16+, non-smoking associated, locoregionally advanced oropharyngeal cancer. The phase II primary endpoint was non-inferiority (NI) of progression-free survival (PFS). The phase III trial would have included the experimental arm(s) found to be NI in phase II, with co-primary endpoints of NI PFS and superior quality of life.</div></div><div><h3>Materials/Methods</h3><div>Eligible patients had p16+ stage T1-2N1M0 or T3N0-N1M0 (AJCC 8<sup>th</sup> edition) oropharyngeal squamous cell carcinoma and ≤10 pack-year smoking history. Patients were stratified by Zubrod performance status and randomized (1:1:1) to 70 Gy of intensity modulated radiation therapy (IMRT) over 6 weeks + Cisplatin at 100 mg/m<sup>2</sup> every 3 weeks (Arm 1) vs 60 Gy IMRT over 6 weeks + Cisplatin at 100 mg/m<sup>2</sup> every 3 weeks (Arm 2) vs 60 Gy IMRT over 5 weeks with nivolumab (Arm 3). For trial design, the assumed 9-month PFS was 96.5% and the lower threshold for Arms 2 and 3 was 91.8% (absolute NI margin 4.7%), for a hazard ratio (HR) boundary HR < 2.4 required for noninferiority. With one-sided type I error rate of 10% per test and 80% power, a log-rank test required 22 events from 266 patients per comparison (requiring 133 patients per arm and a total sample size of 399). In phase II, a futility analysis would be triggered for each comparison after 50% of the PFS events (11/22) had been reported. If the observed HR exceeded the NI margin, accrual would be discontinued. All randomized patients were included in analysis.</div></div><div><h3>Results</h3><div>Phase II accrued from 7/10/19 to 11/8/23. Accrual was suspended from 2/3/23 to 5/25/23, to discontinue Arm 2, after which randomization continued (1:1) to Arms 1 and 3 to complete the new phase II sample size of 382 patients. The median age was 60 years, 90.6% were male, 87.5% were White, and 84.9% had stage I disease. The first futility analysis was conducted after 11 PFS events (Arm 1: 2, Arm 2: 9) were reported, at a median follow-up of 1.1 years. The estimated HR was 4.34 (1-sided 90% upper confidence limit 11.83). The second futility analysis was triggered after 11 PFS events (Arm 1: 2, Arm 3: 9) were reported, at a median follow-up of 1.7 years. The estimated HR was 4.51 (1-sided 90% upper confidence limit 12.29). Accrual would have stopped but phase II had already completed. At present (median follow-up 2.2 years), 2-year PFS estimates are 98.1% (95% CI 95.4, 100) for Arm 1, 88.6% (95% CI 82.4, 94.7) for Arm 2, and 90.3% (95% CI 84.5, 96.1) for Arm 3. The 2-year overall survival estimates are 99.0% (95% CI 97.0, 100), 98.0% (95% CI 95.2, 100), and 96.1% (95% CI 92.3, 99.9), respectively.</div></div><div><h3>Conclusion</h3><div>The failure of the experimental arms to satisfy non-inferiority is due in part to the highly favorable ou
{"title":"Interim Futility Results of NRG-HN005, A Randomized, Phase II/III Non-Inferiority Trial for Non-Smoking p16+ Oropharyngeal Cancer Patients","authors":"","doi":"10.1016/j.ijrobp.2024.08.014","DOIUrl":"10.1016/j.ijrobp.2024.08.014","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>NRG-HN005 was a phase II/III randomized study comparing each of two experimental arm(s) against a control arm from RTOG 1016, in patients with p16+, non-smoking associated, locoregionally advanced oropharyngeal cancer. The phase II primary endpoint was non-inferiority (NI) of progression-free survival (PFS). The phase III trial would have included the experimental arm(s) found to be NI in phase II, with co-primary endpoints of NI PFS and superior quality of life.</div></div><div><h3>Materials/Methods</h3><div>Eligible patients had p16+ stage T1-2N1M0 or T3N0-N1M0 (AJCC 8<sup>th</sup> edition) oropharyngeal squamous cell carcinoma and ≤10 pack-year smoking history. Patients were stratified by Zubrod performance status and randomized (1:1:1) to 70 Gy of intensity modulated radiation therapy (IMRT) over 6 weeks + Cisplatin at 100 mg/m<sup>2</sup> every 3 weeks (Arm 1) vs 60 Gy IMRT over 6 weeks + Cisplatin at 100 mg/m<sup>2</sup> every 3 weeks (Arm 2) vs 60 Gy IMRT over 5 weeks with nivolumab (Arm 3). For trial design, the assumed 9-month PFS was 96.5% and the lower threshold for Arms 2 and 3 was 91.8% (absolute NI margin 4.7%), for a hazard ratio (HR) boundary HR < 2.4 required for noninferiority. With one-sided type I error rate of 10% per test and 80% power, a log-rank test required 22 events from 266 patients per comparison (requiring 133 patients per arm and a total sample size of 399). In phase II, a futility analysis would be triggered for each comparison after 50% of the PFS events (11/22) had been reported. If the observed HR exceeded the NI margin, accrual would be discontinued. All randomized patients were included in analysis.</div></div><div><h3>Results</h3><div>Phase II accrued from 7/10/19 to 11/8/23. Accrual was suspended from 2/3/23 to 5/25/23, to discontinue Arm 2, after which randomization continued (1:1) to Arms 1 and 3 to complete the new phase II sample size of 382 patients. The median age was 60 years, 90.6% were male, 87.5% were White, and 84.9% had stage I disease. The first futility analysis was conducted after 11 PFS events (Arm 1: 2, Arm 2: 9) were reported, at a median follow-up of 1.1 years. The estimated HR was 4.34 (1-sided 90% upper confidence limit 11.83). The second futility analysis was triggered after 11 PFS events (Arm 1: 2, Arm 3: 9) were reported, at a median follow-up of 1.7 years. The estimated HR was 4.51 (1-sided 90% upper confidence limit 12.29). Accrual would have stopped but phase II had already completed. At present (median follow-up 2.2 years), 2-year PFS estimates are 98.1% (95% CI 95.4, 100) for Arm 1, 88.6% (95% CI 82.4, 94.7) for Arm 2, and 90.3% (95% CI 84.5, 96.1) for Arm 3. The 2-year overall survival estimates are 99.0% (95% CI 97.0, 100), 98.0% (95% CI 95.2, 100), and 96.1% (95% CI 92.3, 99.9), respectively.</div></div><div><h3>Conclusion</h3><div>The failure of the experimental arms to satisfy non-inferiority is due in part to the highly favorable ou","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358890","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.08.013
<div><h3>Purpose/Objective(s)</h3><div>Concurrent chemoradiation (cCRT) followed by prophylactic cranial irradiation (PCI) has been the standard of care for LS-SCLC for decades. NRG-LU005 (NCT03811002) tested the addition of atezo to cCRT in this open label, randomized phase III international trial. Here, results of the 2nd planned interim analysis are reported as recommended by the Data Monitoring Committee.</div></div><div><h3>Materials/Methods</h3><div>Patients (pts) with LS-SCLC, stage Tx-4, N0-3, M0 with ECOG performance status (PS) 0-2 were eligible. Pts received one cycle of chemotherapy (platinum/etoposide) prior to study registration and were randomized 1:1 to cCRT versus cCRT plus atezo, 1200 mg IV, every 3 weeks until investigator-assessed progression or intolerable side effects, for a maximum of 17 cycles. Pts were stratified by choice of chemotherapy (cisplatin vs. carboplatin), radiation fractionation schedule (66 Gy once daily vs. 45 Gy twice daily), sex, and PS (0/1 vs. 2). The primary endpoint was overall survival (OS). Secondary endpoints included investigator assessed progression-free survival (PFS), objective response rate (ORR), local control and distant-metastasis free survival (DMFS). PCI was recommended for pts achieving a complete or near-complete response. It was designed to detect an OS improvement with a hazard ratio (HR) of 0.71, at 1-sided alpha of 0.025 and 85% power.</div></div><div><h3>Results</h3><div>544 pts were randomized from May 2019 and December 2023. Baseline pt characteristics were well balanced. 47.2% of pts received twice daily radiation (BID). Median follow up was 21.0 months (mos) for all pts. The 1, 2 and 3-year OS rates were 82.6% (95% CI 77.2 - 86.9), 62.9% (95% CI 56.2 - 69.0) and 50.3% (95% CI 42.3 - 57.8) for cCRT, and 80.2% (95% CI 74.7 - 84.6), 58.6% (95% CI 52.1- 64.6) and 44.7% (95% CI 36.6 - 52.4) for atezo+cCRT. Median OS was 39.5 mos (95% CI 27.5 - Not reached) and 33.1 mos (95% CI 27.8 - 43.9) for cCRT and atezo+cCRT, respectively (HR= 1.11, 95% CI: 0.85-1.45). Median PFS was 11.5 mos (95% CI: 10.7- 13.4) and 12.0 mos (95% CI: 10.8-15.1) for cCRT and atezo+cCRT, respectively (HR=1.00, 95% CI: 0.80-1.25). Median DMFS was 13.2 mos (95% CI: 11.3-18.2) and 16.8 mos (95% CI: 12.0-23.5) for cCRT and atezo+cCRT, respectively (HR=0.95, 95% CI:0.75-1.21). Cumulative incidence of local failure at 24 mos was 14.4% (95% CI: 10.1 -19.5) and 13.1% (95% CI: 9.0 - 18.1) for cCRT and atezo+cCRT, respectively (HR=0.84, 95% CI: 0.50-1.40). Complete or partial response was achieved in 58.5% and 59.1% on cCRT and atezo+cCRT. Grade 3+ pneumonitis was 3.1% and 5.6% on cCRT and atezo+cCRT. There were no concerning safety signals for atezo +cCRT. Regardless of the receipt of atezo, pts treated with BID had higher survival (median OS 35.4 mos, 95% CI: 32.3 - not reached) than daily RT (median OS 28.3 mos 95% CI: 21.7 - 40.6; HR=1.44, 95% CI: 1.10-1.89).</div></div><div><h3>Conclusion</h3><div>Chemoradiation with
目的/目标数十年来，LS-SCLC 的标准治疗方法一直是同步化疗 (cCRT) 后进行预防性颅脑照射 (PCI)。NRG-LU005 (NCT03811002)在这项开放标签、随机III期国际试验中测试了在cCRT中添加阿替佐的效果。材料/方法符合条件的LS-SCLC患者（pts）为Tx-4期、N0-3期、M0期，ECOG表现状态（PS）为0-2。患者在研究注册前接受了一个周期的化疗（铂类/依托泊苷），并按1:1随机分配到cCRT与cCRT+阿替佐治疗，阿替佐1200毫克，静脉滴注，每3周一次，直到研究者评估为病情进展或出现不可耐受的副作用，最多17个周期。患者按化疗选择（顺铂与卡铂）、放射分次计划（66 Gy 每天一次与 45 Gy 每天两次）、性别和 PS（0/1 与 2）进行分层。主要终点是总生存期（OS）。次要终点包括研究者评估的无进展生存期（PFS）、客观反应率（ORR）、局部控制率和无远处转移生存期（DMFS）。对于获得完全或接近完全应答的患者，建议进行 PCI 治疗。在单侧α为0.025、功率为85%的条件下，该研究旨在检测OS改善情况，其危险比（HR）为0.71。患者的基线特征非常均衡。47.2%的患者接受了每天两次的放射治疗（BID）。所有患者的中位随访时间为 21.0 个月。cCRT的1年、2年和3年OS率分别为82.6%（95% CI 77.2 - 86.9）、62.9%（95% CI 56.2 - 69.0）和50.3%（95% CI 42.3 - 57.8）；atezo+cCRT的OS率分别为80.2%（95% CI 74.7 - 84.6）、58.6%（95% CI 52.1- 64.6）和44.7%（95% CI 36.6 - 52.4）。cCRT 和 atezo+cCRT 的中位 OS 分别为 39.5 个月（95% CI 27.5 - 未达到）和 33.1 个月（95% CI 27.8 - 43.9）（HR= 1.11，95% CI：0.85-1.45）。cCRT和阿替佐+cCRT的中位PFS分别为11.5个月（95% CI：10.7- 13.4）和12.0个月（95% CI：10.8-15.1）（HR=1.00，95% CI：0.80-1.25）。cCRT和阿替佐+cCRT的中位DMFS分别为13.2个月（95% CI：11.3-18.2）和16.8个月（95% CI：12.0-23.5）（HR=0.95，95% CI：0.75-1.21）。24个月时，cCRT和阿替佐+cCRT的局部失败累积发生率分别为14.4%（95% CI：10.1-19.5）和13.1%（95% CI：9.0-18.1）（HR=0.84，95% CI：0.50-1.40）。58.5%和59.1%的患者在cCRT和阿替佐+cCRT治疗中获得完全或部分应答。cCRT和阿特佐+cCRT中3级以上肺炎的比例分别为3.1%和5.6%。阿替佐+cCRT没有出现令人担忧的安全信号。无论是否接受阿替佐治疗，BID治疗的患者生存率（中位OS 35.4个月，95% CI：32.3 - 未达标）高于每日RT（中位OS 28.3个月，95% CI：21.7 - 40.6；HR=1.44，95% CI：1.10-1.89）。
{"title":"Concurrent Chemoradiation ± Atezolizumab (atezo) in Limited-Stage Small Cell Lung Cancer (LS-SCLC): Results of NRG Oncology/Alliance LU005","authors":"","doi":"10.1016/j.ijrobp.2024.08.013","DOIUrl":"10.1016/j.ijrobp.2024.08.013","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>Concurrent chemoradiation (cCRT) followed by prophylactic cranial irradiation (PCI) has been the standard of care for LS-SCLC for decades. NRG-LU005 (NCT03811002) tested the addition of atezo to cCRT in this open label, randomized phase III international trial. Here, results of the 2nd planned interim analysis are reported as recommended by the Data Monitoring Committee.</div></div><div><h3>Materials/Methods</h3><div>Patients (pts) with LS-SCLC, stage Tx-4, N0-3, M0 with ECOG performance status (PS) 0-2 were eligible. Pts received one cycle of chemotherapy (platinum/etoposide) prior to study registration and were randomized 1:1 to cCRT versus cCRT plus atezo, 1200 mg IV, every 3 weeks until investigator-assessed progression or intolerable side effects, for a maximum of 17 cycles. Pts were stratified by choice of chemotherapy (cisplatin vs. carboplatin), radiation fractionation schedule (66 Gy once daily vs. 45 Gy twice daily), sex, and PS (0/1 vs. 2). The primary endpoint was overall survival (OS). Secondary endpoints included investigator assessed progression-free survival (PFS), objective response rate (ORR), local control and distant-metastasis free survival (DMFS). PCI was recommended for pts achieving a complete or near-complete response. It was designed to detect an OS improvement with a hazard ratio (HR) of 0.71, at 1-sided alpha of 0.025 and 85% power.</div></div><div><h3>Results</h3><div>544 pts were randomized from May 2019 and December 2023. Baseline pt characteristics were well balanced. 47.2% of pts received twice daily radiation (BID). Median follow up was 21.0 months (mos) for all pts. The 1, 2 and 3-year OS rates were 82.6% (95% CI 77.2 - 86.9), 62.9% (95% CI 56.2 - 69.0) and 50.3% (95% CI 42.3 - 57.8) for cCRT, and 80.2% (95% CI 74.7 - 84.6), 58.6% (95% CI 52.1- 64.6) and 44.7% (95% CI 36.6 - 52.4) for atezo+cCRT. Median OS was 39.5 mos (95% CI 27.5 - Not reached) and 33.1 mos (95% CI 27.8 - 43.9) for cCRT and atezo+cCRT, respectively (HR= 1.11, 95% CI: 0.85-1.45). Median PFS was 11.5 mos (95% CI: 10.7- 13.4) and 12.0 mos (95% CI: 10.8-15.1) for cCRT and atezo+cCRT, respectively (HR=1.00, 95% CI: 0.80-1.25). Median DMFS was 13.2 mos (95% CI: 11.3-18.2) and 16.8 mos (95% CI: 12.0-23.5) for cCRT and atezo+cCRT, respectively (HR=0.95, 95% CI:0.75-1.21). Cumulative incidence of local failure at 24 mos was 14.4% (95% CI: 10.1 -19.5) and 13.1% (95% CI: 9.0 - 18.1) for cCRT and atezo+cCRT, respectively (HR=0.84, 95% CI: 0.50-1.40). Complete or partial response was achieved in 58.5% and 59.1% on cCRT and atezo+cCRT. Grade 3+ pneumonitis was 3.1% and 5.6% on cCRT and atezo+cCRT. There were no concerning safety signals for atezo +cCRT. Regardless of the receipt of atezo, pts treated with BID had higher survival (median OS 35.4 mos, 95% CI: 32.3 - not reached) than daily RT (median OS 28.3 mos 95% CI: 21.7 - 40.6; HR=1.44, 95% CI: 1.10-1.89).</div></div><div><h3>Conclusion</h3><div>Chemoradiation with ","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.06.029
{"title":"Tribute to Paul Harari","authors":"","doi":"10.1016/j.ijrobp.2024.06.029","DOIUrl":"10.1016/j.ijrobp.2024.06.029","url":null,"abstract":"","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358885","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/S0360-3016(24)03170-5
{"title":"ASTRO Past Gold Medal Award Recipients","authors":"","doi":"10.1016/S0360-3016(24)03170-5","DOIUrl":"10.1016/S0360-3016(24)03170-5","url":null,"abstract":"","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-10-01DOI: 10.1016/j.ijrobp.2024.07.025
Purpose/Objective(s)
About 40% of patients develop serious complications after esophageal cancer surgery, which affects the quality of life. Symptoms such as fatigue and appetite loss caused by radiotherapy can also negatively impact the quality of life. However, rehabilitation exercises have been proven to significantly improve the quality of life. This study aimed to compare the effects of nurse-led multimodal rehabilitation versus conventional rehabilitation on physical recovery during adjuvant radiotherapy for postoperative esophageal cancer.
Materials/Methods
This randomized controlled trial recruited 70 patients who were randomized into the control group (CG, N = 35) and the intervention group (IG, N = 35). The CG received conventional care, and the IG received nurse-led multimodal rehabilitation. The patient’s quality of life, dyspnea index, fatigue, sleep quality, nutrition, anxiety, and depression were recorded before the start of radiotherapy (T0), after completion of radiotherapy (T1), and 6 months (T2) and 12 months (T3) after completion of radiotherapy. Data were analyzed following intention-to-treat principles. Linear mixed models were used to assess the effects of multimodal rehabilitation over time.
Results
The IG significantly increased the global health scores compared to the CG at T1 (difference = 26.19; 95% CI = 17.14 to 35.24; P < 0.001), with differences remaining significant at T2 (difference = 21.43; 95% CI = 8.02 to 34.84; P = 0.002) and T3 (difference = 23.34; 95% CI = 7.31 to 39.36; P = 0.005). Compared with the CG, the weight of the IG was significantly higher at T1 (difference = 3.33; 95% CI = 0.89 to 5.77; P = 0.008), and the difference was still significant at T2 (difference = 3.13; 95% CI = 0.26 to 6.00; P = 0.033) and T3 (difference = 3.91; 95% CI = 0.64 to 7.19; P = 0.020). The fatigue score of the IG decreased significantly at T1(difference = -65.74; 95% CI = -90.74 to -40.75; P < 0.001), and the difference remained statistically significant at T2 (difference = -64.86; 95% CI = -96.98 to -32.74; P < 0.001) and T3 (difference = -48.80; 95% CI = -82.61 to -14.99; P = 0.005). The anxiety and depression status of the IG improved significantly at T1 (difference = -3.00; 95% CI = -4.99 to -1.01; P = 0.004) and (difference = -2.43; 95% CI = -4.48 to -0.38; P = 0.021), and the difference remained significant at T2 (difference = -3.63; 95% CI = -6.84 to -0.42; P = 0.027) and (difference = -3.66; 95% CI = -6.80 to -0.51; P = 0.023).
Conclusion
Nurse-led multimodal rehabilitation significantly improved the quality of life, sleep quality, nutrition, fatigue, anxiety, and depression status in patients undergoing postoperative radiotherapy for esophageal cancer.
目的/目标：约 40% 的患者在食道癌手术后会出现严重并发症，从而影响生活质量。放疗引起的疲劳和食欲不振等症状也会对生活质量产生负面影响。然而，康复锻炼已被证明能显著提高生活质量。本研究旨在比较护士指导的多模式康复训练与传统康复训练对食管癌术后辅助放疗期间身体恢复的影响。材料/方法本随机对照试验招募了 70 名患者，随机分为对照组（CG，35 人）和干预组（IG，35 人）。对照组接受常规治疗，干预组接受护士指导的多模式康复治疗。分别在放疗开始前（T0）、放疗结束后（T1）、放疗结束后 6 个月（T2）和 12 个月（T3）记录患者的生活质量、呼吸困难指数、疲劳、睡眠质量、营养、焦虑和抑郁情况。数据按照意向治疗原则进行分析。结果与CG相比，IG在T1显著提高了总体健康评分（差异=26.19；95% CI=17.14至35.24；P< 0.001），在T2（差异=21.43；95% CI=8.02至34.84；P=0.002）和T3（差异=23.34；95% CI=7.31至39.36；P=0.005）差异仍然显著。与 CG 相比，IG 的体重在 T1 阶段显著增加（差异 = 3.33；95% CI = 0.89 至 5.77；P = 0.008），在 T2 阶段（差异 = 3.13；95% CI = 0.26 至 6.00；P = 0.033）和 T3 阶段（差异 = 3.91；95% CI = 0.64 至 7.19；P = 0.020）差异仍然显著。IG 的疲劳评分在 T1（差异 = -65.74; 95% CI = -90.74 to -40.75; P <0.001）显著下降，在 T2（差异 = -64.86; 95% CI = -96.98 to -32.74; P <0.001）和 T3（差异 = -48.80; 95% CI = -82.61 to -14.99; P = 0.005）差异仍有统计学意义。IG 的焦虑和抑郁状况在 T1（差异 = -3.00；95% CI = -4.99～-1.01；P = 0.004）和（差异 = -2.43；95% CI = -4.48～-0.38；P = 0.021）时有明显改善，在 T2（差异 = -3.63；95% CI = -6.84～-0.42；P = 0.027）和（差异 = -3.66; 95% CI = -6.80 to -0.51; P = 0.023）.结论护士主导的多模式康复显著改善了食管癌术后放疗患者的生活质量、睡眠质量、营养、疲劳、焦虑和抑郁状况。
{"title":"Effectiveness of Nurse-Led Multimodal Rehabilitation for Patients Undergoing Postoperative Radiotherapy of Esophageal Cancer: A Randomized Controlled Trial","authors":"","doi":"10.1016/j.ijrobp.2024.07.025","DOIUrl":"10.1016/j.ijrobp.2024.07.025","url":null,"abstract":"<div><h3>Purpose/Objective(s)</h3><div>About 40% of patients develop serious complications after esophageal cancer surgery, which affects the quality of life. Symptoms such as fatigue and appetite loss caused by radiotherapy can also negatively impact the quality of life. However, rehabilitation exercises have been proven to significantly improve the quality of life. This study aimed to compare the effects of nurse-led multimodal rehabilitation versus conventional rehabilitation on physical recovery during adjuvant radiotherapy for postoperative esophageal cancer.</div></div><div><h3>Materials/Methods</h3><div>This randomized controlled trial recruited 70 patients who were randomized into the control group (CG, <em>N</em> = 35) and the intervention group (IG, <em>N</em> = 35). The CG received conventional care, and the IG received nurse-led multimodal rehabilitation. The patient’s quality of life, dyspnea index, fatigue, sleep quality, nutrition, anxiety, and depression were recorded before the start of radiotherapy (T0), after completion of radiotherapy (T1), and 6 months (T2) and 12 months (T3) after completion of radiotherapy. Data were analyzed following intention-to-treat principles. Linear mixed models were used to assess the effects of multimodal rehabilitation over time.</div></div><div><h3>Results</h3><div>The IG significantly increased the global health scores compared to the CG at T1 (difference = 26.19; 95% CI = 17.14 to 35.24; <em>P</em> < 0.001), with differences remaining significant at T2 (difference = 21.43; 95% CI = 8.02 to 34.84; <em>P</em> = 0.002) and T3 (difference = 23.34; 95% CI = 7.31 to 39.36; <em>P</em> = 0.005). Compared with the CG, the weight of the IG was significantly higher at T1 (difference = 3.33; 95% CI = 0.89 to 5.77; <em>P</em> = 0.008), and the difference was still significant at T2 (difference = 3.13; 95% CI = 0.26 to 6.00; <em>P</em> = 0.033) and T3 (difference = 3.91; 95% CI = 0.64 to 7.19; <em>P</em> = 0.020). The fatigue score of the IG decreased significantly at T1(difference = -65.74; 95% CI = -90.74 to -40.75; <em>P</em> < 0.001), and the difference remained statistically significant at T2 (difference = -64.86; 95% CI = -96.98 to -32.74; <em>P</em> < 0.001) and T3 (difference = -48.80; 95% CI = -82.61 to -14.99; <em>P</em> = 0.005). The anxiety and depression status of the IG improved significantly at T1 (difference = -3.00; 95% CI = -4.99 to -1.01; <em>P</em> = 0.004) and (difference = -2.43; 95% CI = -4.48 to -0.38; <em>P</em> = 0.021), and the difference remained significant at T2 (difference = -3.63; 95% CI = -6.84 to -0.42; <em>P</em> = 0.027) and (difference = -3.66; 95% CI = -6.80 to -0.51; <em>P</em> = 0.023).</div></div><div><h3>Conclusion</h3><div>Nurse-led multimodal rehabilitation significantly improved the quality of life, sleep quality, nutrition, fatigue, anxiety, and depression status in patients undergoing postoperative radiotherapy for esophageal cancer.</div></div>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":null,"pages":null},"PeriodicalIF":6.4,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142358923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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