European Journal of Cancer最新文献

Shared decision-making supported by outcome information regarding surveillance after curative treatment for breast cancer: Results of the SHOUT-BC study 乳腺癌根治性治疗后监测结果信息支持的共同决策：SHOUT-BC研究的结果

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115107

Background

Integrating outcome information into the process of shared decision-making (SDM) about post-treatment surveillance can enhance its effectiveness. The Breast Cancer Surveillance Decision Aid (BCS-PtDA) integrates risk estimations of patients’ risks for recurrences as well as outcome information on fear of cancer recurrence (FCR). The SHOUT-BC study aimed to evaluate the effectiveness of the implementation of the BCS-PtDA. Patients’ satisfaction with the BCS-PtDA was also evaluated.

Methods

As described in a previously published protocol paper, the study employed a Prospective multiple interrupted time series (ITS) design in which the BCS-PtDA was implemented stepwise into the care pathways of eight Dutch hospitals.

Results

A total of 507 participants completed a questionnaire after their first surveillance consultation which usually takes place approximately one year after surgery. ITS analysis per hospital and subsequent meta-analysis over hospital effects indicated a significant increase in patient-reported SDM from pre- to post-implementation (overall estimated effect: 27.14, 95 % CI: 22.71 to 31.87, p < .0001). Moreover, post-implementation participants (n = 225) reported a more active role in decision-making, decreased decisional conflict, and increased knowledge on the aim and methods of surveillance. Furthermore, a decrease in FCR was seen post-implementation. The self-reported intensity of surveillance schedules decreased slightly and the BCS-PtDA received highly positive evaluations.

Discussion

The implementation of the BCS-PtDA, which integrates outcome information, led to increased patient-reported SDM and an improved quality of decision-making. The BCS-PtDA was evaluated highly positively by participants. Further research should address optimisation of the implementation.

背景将结果信息纳入有关治疗后监测的共同决策（SDM）过程可提高其有效性。乳腺癌监测决策辅助工具（BCS-PtDA）整合了对患者复发风险的估计以及对癌症复发恐惧（FCR）的结果信息。SHOUT-BC研究旨在评估BCS-PtDA的实施效果。结果共有 507 名参与者在首次监测咨询（通常在术后一年左右）后填写了调查问卷。每家医院的 ITS 分析和随后的医院效应荟萃分析表明，从实施前到实施后，患者报告的 SDM 显著增加（总体估计效应：27.14，95 % CI：22.71 至 31.87，p < .0001）。此外，实施后的参与者（n = 225）表示在决策中扮演了更积极的角色，减少了决策冲突，增加了对监测目的和方法的了解。此外，FCR 在实施后也有所下降。讨论整合了结果信息的 BCS-PtDA 的实施增加了患者报告的 SDM，提高了决策质量。参与者对 BCS-PtDA 的评价非常积极。进一步的研究应解决实施过程中的优化问题。

{"title":"Shared decision-making supported by outcome information regarding surveillance after curative treatment for breast cancer: Results of the SHOUT-BC study","authors":"","doi":"10.1016/j.ejca.2024.115107","DOIUrl":"10.1016/j.ejca.2024.115107","url":null,"abstract":"<div><h3>Background</h3><div>Integrating outcome information into the process of shared decision-making (SDM) about post-treatment surveillance can enhance its effectiveness. The Breast Cancer Surveillance Decision Aid (BCS-PtDA) integrates risk estimations of patients’ risks for recurrences as well as outcome information on fear of cancer recurrence (FCR). The SHOUT-BC study aimed to evaluate the effectiveness of the implementation of the BCS-PtDA. Patients’ satisfaction with the BCS-PtDA was also evaluated.</div></div><div><h3>Methods</h3><div>As described in a previously published protocol paper, the study employed a Prospective multiple interrupted time series (ITS) design in which the BCS-PtDA was implemented stepwise into the care pathways of eight Dutch hospitals.</div></div><div><h3>Results</h3><div>A total of 507 participants completed a questionnaire after their first surveillance consultation which usually takes place approximately one year after surgery. ITS analysis per hospital and subsequent meta-analysis over hospital effects indicated a significant increase in patient-reported SDM from pre- to post-implementation (overall estimated effect: 27.14, 95 % CI: 22.71 to 31.87, <em>p</em> < .0001). Moreover, post-implementation participants (<em>n</em> = 225) reported a more active role in decision-making, decreased decisional conflict, and increased knowledge on the aim and methods of surveillance. Furthermore, a decrease in FCR was seen post-implementation. The self-reported intensity of surveillance schedules decreased slightly and the BCS-PtDA received highly positive evaluations.</div></div><div><h3>Discussion</h3><div>The implementation of the BCS-PtDA, which integrates outcome information, led to increased patient-reported SDM and an improved quality of decision-making. The BCS-PtDA was evaluated highly positively by participants. Further research should address optimisation of the implementation.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587305","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial 中药（健皮布散）与 II 期和 III 期结肠癌患者辅助化疗的完成率：随机临床试验

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115109

Purpose

Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients.

Patients and methods

This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III).

Results

A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients.

Conclusion

JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.

目的许多癌症患者表示有兴趣在化疗期间使用中药，但对中药的益处和风险却知之甚少。这项多中心、III 期、随机、安慰剂对照试验纳入了术后计划接受 CAPOX（卡培他滨和奥沙利铂）化疗的 II 期（高复发风险）和 III 期结肠癌患者。患者按 1:1 随机分配接受 JPBS 或安慰剂治疗。主要结果是计划化疗周期的完成率。次要结果包括相对剂量强度（RDI）、化疗引起的毒性反应、生活质量（通过埃德蒙顿症状评估系统ESAS测量）、不良事件（AEs）和严重不良事件（SAEs）。按照年龄（65/≤65岁）和TNM分期（II/III期）进行了预定义的亚组分析。JPBS 组的化疗完成率明显高于安慰剂组（63.0% 对 47.6%，P = 0.003）。JPBS 组的奥沙利铂 RDI 也更高（P = 0.049）。亚组分析显示，JPBS 显著提高了 II 期患者（73.0% 对 42.4%，P = 0.001）和年轻患者（66.9% 对 48.8%，P = 0.004）的手术完成率。JPBS减少了≥2级呕吐（3.8% vs. 6.4%，P = 0.007），但增加了≥2级血小板减少（16.2% vs. 12.4%，P = 0.012）。结论JPBS提高了II期和年轻结肠癌患者的化疗完成率，同时不影响耐受性。需要进一步研究其机制和长期效果。

{"title":"Chinese herbal medicine (JianPi-BuShen) and completion rate of adjuvant chemotherapy for patients with stage II and III colon cancer: A randomized clinical trial","authors":"","doi":"10.1016/j.ejca.2024.115109","DOIUrl":"10.1016/j.ejca.2024.115109","url":null,"abstract":"<div><h3>Purpose</h3><div>Many cancer patients express interest in using herbal medicine during chemotherapy, but little is known about its benefits and risks. This study aimed to evaluate the effects of the Chinese herbal medicine JianPi-BuShen formula (JPBS) on adjuvant chemotherapy completion in colon cancer patients.</div></div><div><h3>Patients and methods</h3><div>This multi-center, phase III, randomized, placebo-controlled trial included patients with stage II (high risk for recurrence) and stage III colon cancer following surgery, planning to receive CAPOX (capecitabine and oxaliplatin) chemotherapy. Patients were randomized 1:1 to receive either JPBS or a placebo. The primary outcome was the completion rate of planned chemotherapy cycles. Secondary outcomes included relative dose intensity (RDI), chemotherapy-induced toxicities, quality of life (measured by the Edmonton Symptom Assessment System - ESAS), adverse events (AEs), and serious AEs (SAEs). Predefined subgroup analyses were performed by age (>65/≤65) and TNM stage (II/III).</div></div><div><h3>Results</h3><div>A total of 376 participants were analyzed, with a median age of 60.3 years; 56.9 % were male, and 67.6 % had stage III disease. Chemotherapy completion was significantly higher in the JPBS group than in the placebo group (63.0 % vs. 47.6 %, P = 0.003). Oxaliplatin RDI was also higher in the JPBS group (P = 0.049). Subgroup analyses showed JPBS significantly improved completion rates for stage II patients (73.0 % vs. 42.4 %, P = 0.001) and younger patients (66.9 % vs. 48.8 %, P = 0.004). JPBS reduced grade ≥ 2 vomiting (3.8 % vs. 6.4 %, P = 0.007) but increased grade ≥ 2 thrombocytopenia (16.2 % vs. 12.4 %, P = 0.012). Quality of life improved in stage II and younger patients.</div></div><div><h3>Conclusion</h3><div>JPBS improved chemotherapy completion rates in stage II and younger colon cancer patients without compromising tolerability. Further research is needed to explore its mechanisms and long-term effects.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593314","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}

引用次数: 0

Updated survival outcome of regorafenib, ipilimumab, and nivolumab in refractory microsatellite stable non-liver metastatic colorectal cancer: A phase I nonrandomized clinical trial regorafenib、ipilimumab和nivolumab治疗难治性微卫星稳定型非肝转移性结直肠癌的最新生存结果：一期非随机临床试验

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-11-02 DOI: 10.1016/j.ejca.2024.115111

Background

Combination regorafenib, ipilimumab, and nivolumab (RIN) was evaluated in a phase 1 nonrandomized study (NCT04362839) of refractory microsatellite stable (MSS) metastatic colorectal cancer. Promising antitumor activity was previously reported in the non-liver metastatic (NLM) population. This updated analysis describes long-term survival outcomes in the NLM cohort and highlights durable remissions with potential cure following completion of RIN therapy.

Methods

Between May 2020 and January 2022, 39 patients with refractory MSS metastatic colorectal cancer were enrolled. Patients received RIN until progression, unacceptable toxicity, or completion at two years. The primary endpoint was recommended phase 2 dose (RP2D) selection. Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) at the RP2D level.

Results

22 patients with refractory non-liver metastatic MSS colorectal cancer were treated at the RP2D of RIN. ORR was 36.4 % (8/22 patients), and median PFS was 5.0 months (95 % CI: 3–9). After a median follow-up of 42 months, the 1-, 2-, and 3-year PFS rates were 24.1 %, 24.1 %, and 19.3 % by RECIST. The median OS was 27.5 months (95 % CI: 14.0 to NE). At data cutoff, 6 patients had ongoing clinical benefit, including 3 responders who remain disease-free > 18 months after treatment completion.

Conclusion

With extended follow-up, RIN combination therapy demonstrated durable clinical benefit in a subset of patients with NLM MSS metastatic colorectal cancer, including potential cure in 3 responders who remain disease-free > 18 months after treatment completion.

背景在一项针对难治性微卫星稳定（MSS）转移性结直肠癌的1期非随机研究（NCT04362839）中，对瑞戈非尼、伊匹单抗和尼伐单抗（RIN）的组合进行了评估。此前曾有报道称，该药在非肝转移（NLM）人群中具有良好的抗肿瘤活性。本更新分析描述了 NLM 组群的长期生存结果，并强调了完成 RIN 治疗后可能治愈的持久缓解。方法在 2020 年 5 月至 2022 年 1 月期间，39 例难治性 MSS 转移性结直肠癌患者入组。患者接受 RIN 治疗，直到病情进展、出现不可接受的毒性或两年后治疗结束。主要终点是推荐的二期剂量（RP2D）选择。结果22名难治性非肝转移MSS结直肠癌患者接受了RIN的RP2D治疗。ORR为36.4%（8/22例患者），中位PFS为5.0个月（95% CI：3-9个月）。中位随访 42 个月后，根据 RECIST 标准，1 年、2 年和 3 年的 PFS 分别为 24.1%、24.1% 和 19.3%。中位 OS 为 27.5 个月（95 % CI：14.0 至 NE）。结论随着随访时间的延长，RIN联合疗法在NLM MSS转移性结直肠癌患者中显示出持久的临床疗效，包括3名在治疗结束后18个月仍无疾病的应答者。

{"title":"Updated survival outcome of regorafenib, ipilimumab, and nivolumab in refractory microsatellite stable non-liver metastatic colorectal cancer: A phase I nonrandomized clinical trial","authors":"","doi":"10.1016/j.ejca.2024.115111","DOIUrl":"10.1016/j.ejca.2024.115111","url":null,"abstract":"<div><h3>Background</h3><div>Combination regorafenib, ipilimumab, and nivolumab (RIN) was evaluated in a phase 1 nonrandomized study (NCT04362839) of refractory microsatellite stable (MSS) metastatic colorectal cancer. Promising antitumor activity was previously reported in the non-liver metastatic (NLM) population. This updated analysis describes long-term survival outcomes in the NLM cohort and highlights durable remissions with potential cure following completion of RIN therapy.</div></div><div><h3>Methods</h3><div>Between May 2020 and January 2022, 39 patients with refractory MSS metastatic colorectal cancer were enrolled. Patients received RIN until progression, unacceptable toxicity, or completion at two years. The primary endpoint was recommended phase 2 dose (RP2D) selection. Secondary endpoints were safety, overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) at the RP2D level.</div></div><div><h3>Results</h3><div>22 patients with refractory non-liver metastatic MSS colorectal cancer were treated at the RP2D of RIN. ORR was 36.4 % (8/22 patients), and median PFS was 5.0 months (95 % CI: 3–9). After a median follow-up of 42 months, the 1-, 2-, and 3-year PFS rates were 24.1 %, 24.1 %, and 19.3 % by RECIST. The median OS was 27.5 months (95 % CI: 14.0 to NE). At data cutoff, 6 patients had ongoing clinical benefit, including 3 responders who remain disease-free > 18 months after treatment completion.</div></div><div><h3>Conclusion</h3><div>With extended follow-up, RIN combination therapy demonstrated durable clinical benefit in a subset of patients with NLM MSS metastatic colorectal cancer, including potential cure in 3 responders who remain disease-free > 18 months after treatment completion.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-11-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142587306","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}

引用次数: 0

Epidemiology of men with synchronous metastatic prostate cancer diagnosis – A nationwide 26-year temporal analysis 同步转移性前列腺癌男性患者的流行病学--26 年全国时间分析

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-11-01 DOI: 10.1016/j.ejca.2024.115110

Background

Evolving imaging modalities, increased awareness, and prostate-specific antigen testing in men with synchronous metastatic prostate cancer (mHSPC) are expected to have prolonged survival. Here we analyze trends in survival among men diagnosed with synchronous metastatic prostate cancer in Denmark.

Methods

Here, we included all men diagnosed with mHSPC (N = 12,017) in Denmark between January 1st, 1995, and December 31st, 2021. Men were followed until December 31st, 2022. Median time to death was calculated by the Kaplan Meier method and the 3-year risk of prostate cancer death per calendar year was estimated by the Aalen-Johansen estimator from time of diagnosis.

Findings

Median follow-up was 9 years (IQR: 4–15), from 2015 59 % of the men with mHSPC had treatment beyond androgen depletion therapy. Median survival increased from 1.7 years (IQR: 1·3–2·0) to 3.8 years (IQR: 3·3–4·2) in men diagnosed in 1995 and 2018, respectively (p < 0·001), after which median survival was not reached. The prostate cancer-specific mortality three years after diagnosis decreased from 66 % (95 %CI: 60–72) in 1995 to 28 % (95 %CI: 25–32) in 2019 (p < 0·001). From the period 1995–1999 to 2015–2021 median overall survival increased from 1·7 years (IQR: 0·8–3·7) to 4·5 years (IQR: 2·4-not reached; p < 0·001) in men age < 65 years and from 1·5 years (IQR: 0·7–2·9) to 3·1 years (IQR: 1·6–5·7; p < 0.001) in men older than 74 years at diagnosis.

Interpretation

The improved survival suggests that, among other contributing factors, implementing novel therapies has likely been efficacious outside the clinical trial setting. Still, most men diagnosed with synchronous metastatic prostate cancer will die of prostate cancer. As such the need for life-prolonging and age-tailored treatment trials remains evident.

背景同步转移性前列腺癌（mHSPC）男性患者的成像模式不断发展、认知度提高以及前列腺特异性抗原检测有望延长患者的生存期。在此，我们分析了丹麦确诊为同步转移性前列腺癌的男性患者的生存趋势。方法我们纳入了1995年1月1日至2021年12月31日期间丹麦确诊为mHSPC的所有男性患者（N = 12,017）。随访至 2022 年 12 月 31 日。中位死亡时间用卡普兰-梅耶尔法计算，前列腺癌每日历年的3年死亡风险用Aalen-Johansen估算器估算，从诊断时间算起。1995年和2018年确诊的男性中位生存期分别从1.7年（IQR：1-3-2-0）增至3.8年（IQR：3-3-4-2）（p <0-001），之后未达到中位生存期。确诊三年后的前列腺癌特异性死亡率从 1995 年的 66 %（95 %CI：60-72）降至 2019 年的 28 %（95 %CI：25-32）（p < 0-001）。从1995-1999年到2015-2021年，65岁男性的中位总生存期从1-7年（IQR：0-8-3-7）延长至4-5年（IQR：2-4-未达到；p< 0-001），74岁以上男性的中位总生存期从1-5年（IQR：0-7-2-9）延长至3-1年（IQR：1-6-5-7；p< 0.001）。释义生存期的延长表明，除其他因素外，新型疗法的实施很可能在临床试验环境之外具有疗效。不过，大多数确诊为同步转移性前列腺癌的男性将死于前列腺癌。因此，延长生命和针对不同年龄段进行治疗试验的必要性仍然是显而易见的。

{"title":"Epidemiology of men with synchronous metastatic prostate cancer diagnosis – A nationwide 26-year temporal analysis","authors":"","doi":"10.1016/j.ejca.2024.115110","DOIUrl":"10.1016/j.ejca.2024.115110","url":null,"abstract":"<div><h3>Background</h3><div>Evolving imaging modalities, increased awareness, and prostate-specific antigen testing in men with synchronous metastatic prostate cancer (mHSPC) are expected to have prolonged survival. Here we analyze trends in survival among men diagnosed with synchronous metastatic prostate cancer in Denmark.</div></div><div><h3>Methods</h3><div>Here, we included all men diagnosed with mHSPC (N = 12,017) in Denmark between January 1st, 1995, and December 31st, 2021. Men were followed until December 31st, 2022. Median time to death was calculated by the Kaplan Meier method and the 3-year risk of prostate cancer death per calendar year was estimated by the Aalen-Johansen estimator from time of diagnosis.</div></div><div><h3>Findings</h3><div>Median follow-up was 9 years (IQR: 4–15), from 2015 59 % of the men with mHSPC had treatment beyond androgen depletion therapy. Median survival increased from 1.7 years (IQR: 1·3–2·0) to 3.8 years (IQR: 3·3–4·2) in men diagnosed in 1995 and 2018, respectively (p < 0·001), after which median survival was not reached. The prostate cancer-specific mortality three years after diagnosis decreased from 66 % (95 %CI: 60–72) in 1995 to 28 % (95 %CI: 25–32) in 2019 (p < 0·001). From the period 1995–1999 to 2015–2021 median overall survival increased from 1·7 years (IQR: 0·8–3·7) to 4·5 years (IQR: 2·4-not reached; p < 0·001) in men age < 65 years and from 1·5 years (IQR: 0·7–2·9) to 3·1 years (IQR: 1·6–5·7; p < 0.001) in men older than 74 years at diagnosis.</div></div><div><h3>Interpretation</h3><div>The improved survival suggests that, among other contributing factors, implementing novel therapies has likely been efficacious outside the clinical trial setting. Still, most men diagnosed with synchronous metastatic prostate cancer will die of prostate cancer. As such the need for life-prolonging and age-tailored treatment trials remains evident.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142593610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Corrigendum to “Letter re: High serum sodium predicts immunotherapy response in metastatic renal cell and urothelial carcinoma” [Eur J Cancer, 207, August 2024, 114173] 更正："关于高血清钠可预测转移性肾细胞癌和尿路上皮癌的免疫疗法反应的信函"[《欧洲癌症杂志》，207 年 8 月 2024 日，114173]。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-30 DOI: 10.1016/j.ejca.2024.115101

引用次数: 0

Corrigendum to “Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations” [Eur J Cancer 207 (2024) 114158] 来自 GEOMETRY mono-1 试验的卡马替尼治疗与 SOC 在携带 METex14 跳过突变的德国局部晚期或转移性 NSCLC 患者中的间接比较 "的更正 [Eur J Cancer 207 (2024) 114158]。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-30 DOI: 10.1016/j.ejca.2024.115074

引用次数: 0

Immune checkpoint inhibitors for patients with metastatic triple-negative inflammatory breast cancer (INCORPORATE): An international cohort study 针对转移性三阴性炎性乳腺癌患者的免疫检查点抑制剂（INCORPORATE）：一项国际队列研究

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-28 DOI: 10.1016/j.ejca.2024.115097

Background

Inflammatory breast cancer (IBC) is the most aggressive clinical presentation of breast cancer, recapitulating a specific biology with more immune-vulnerability than non-IBC. Patients with metastatic, triple-negative IBC (mTN-IBC) receive immune checkpoint inhibitors (ICIs) and chemotherapy, similarly to patients with triple-negative non-IBC. However, the benefit derived from ICI incorporation in this rare type of breast cancer is unknown.

Methods

We conducted a multicenter, international, retrospective, cohort study to evaluate the activity of ICIs in patients with metastatic, triple-negative, primary IBC, who received ICIs plus first line chemotherapy from January 2015 to April 2023. A sample size of 42 patients allowed to detect an increase in 6-months real-world progression-free survival (rwPFS) rate from 40 % with only chemotherapy to 60 % with ICI and chemotherapy.

Results

41 patients from eight international IBC referral centers were included (61 % with primary, de novo mTN-IBC, 61 % with visceral disease). All received ICIs plus first line chemotherapy and 24 % underwent breast surgery and/or locoregional radiotherapy. After a median follow-up of 19.3 months, the 6-months rwPFS rate was 30 % (95 % Confidence Interval [CI], 17–45 %), the median rwPFS was 3.3 months (95 % CI: 2.2–5.4), the median overall survival was 15.7 months (95 % CI: 6.8–16.3).

Conclusions

This one-sample analysis showed a poor outcome of patients with mTN-IBC, despite the treatment with ICI, in contrast with the expected benefit based on preclinical evidence of immune-vulnerability of IBC. These results suggest the need to further investigate the role of immunotherapy in this aggressive and rare type of breast cancer presentation.

背景炎性乳腺癌（IBC）是临床表现最具侵袭性的乳腺癌，与非 IBC 相比，它再现了一种免疫脆弱性更强的特殊生物学特性。转移性三阴性IBC（mTN-IBC）患者接受免疫检查点抑制剂（ICIs）和化疗的情况与三阴性非IBC患者类似。方法我们开展了一项多中心、国际性、回顾性队列研究，以评估2015年1月至2023年4月期间接受ICIs加一线化疗的转移性三阴性原发性IBC患者中ICIs的活性。42例患者的样本量可以检测到6个月真实世界无进展生存期（rwPFS）率从仅接受化疗的40%提高到接受ICI和化疗的60%。结果纳入了来自8个国际IBC转诊中心的41例患者（61%为原发性、新发mTN-IBC，61%为内脏疾病）。所有患者都接受了 ICIs 和一线化疗，24% 的患者接受了乳腺手术和/或局部放疗。中位随访时间为 19.3 个月，6 个月 rwPFS 率为 30%（95% 置信区间 [CI]，17-45%），中位 rwPFS 为 3.3 个月（95% CI：2.2-5.4），中位总生存期为 15.7 个月（95% CI：6.8-16.3）。结论这项单样本分析显示，尽管接受了 ICI 治疗，但 mTN-IBC 患者的预后不佳，这与基于 IBC 免疫易感性临床前证据的预期获益形成了鲜明对比。这些结果表明，有必要进一步研究免疫疗法在这种侵袭性罕见乳腺癌中的作用。

{"title":"Immune checkpoint inhibitors for patients with metastatic triple-negative inflammatory breast cancer (INCORPORATE): An international cohort study","authors":"","doi":"10.1016/j.ejca.2024.115097","DOIUrl":"10.1016/j.ejca.2024.115097","url":null,"abstract":"<div><h3>Background</h3><div>Inflammatory breast cancer (IBC) is the most aggressive clinical presentation of breast cancer, recapitulating a specific biology with more immune-vulnerability than non-IBC. Patients with metastatic, triple-negative IBC (mTN-IBC) receive immune checkpoint inhibitors (ICIs) and chemotherapy, similarly to patients with triple-negative non-IBC. However, the benefit derived from ICI incorporation in this rare type of breast cancer is unknown.</div></div><div><h3>Methods</h3><div>We conducted a multicenter, international, retrospective, cohort study to evaluate the activity of ICIs in patients with metastatic, triple-negative, primary IBC, who received ICIs plus first line chemotherapy from January 2015 to April 2023. A sample size of 42 patients allowed to detect an increase in 6-months real-world progression-free survival (rwPFS) rate from 40 % with only chemotherapy to 60 % with ICI and chemotherapy.</div></div><div><h3>Results</h3><div>41 patients from eight international IBC referral centers were included (61 % with primary, <em>de novo</em> mTN-IBC, 61 % with visceral disease). All received ICIs plus first line chemotherapy and 24 % underwent breast surgery and/or locoregional radiotherapy. After a median follow-up of 19.3 months, the 6-months rwPFS rate was 30 % (95 % Confidence Interval [CI], 17–45 %), the median rwPFS was 3.3 months (95 % CI: 2.2–5.4), the median overall survival was 15.7 months (95 % CI: 6.8–16.3).</div></div><div><h3>Conclusions</h3><div>This one-sample analysis showed a poor outcome of patients with mTN-IBC, despite the treatment with ICI, in contrast with the expected benefit based on preclinical evidence of immune-vulnerability of IBC. These results suggest the need to further investigate the role of immunotherapy in this aggressive and rare type of breast cancer presentation.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561157","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}

引用次数: 0

Letter Re: Indirect comparison of capmatinib treatment from GEOMETRY mono-1 trial to SOC in German patients with locally advanced or metastatic NSCLC harboring METex14 skipping mutations. 关于德国携带 METex14 跳过突变的局部晚期或转移性 NSCLC 患者中，GEOMETRY mono-1 试验中的卡马替尼治疗与 SOC 的间接比较。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-28 DOI: 10.1016/j.ejca.2024.115085

Claudio Sini, Alessandro Di Federico, Paolo Bironzo, Andrea De Giglio, Francesco Gelsomino

引用次数: 0

Feasibility analysis of using patient-derived tumour organoids for treatment decision guidance in locally advanced head and neck squamous cell carcinoma 在局部晚期头颈部鳞状细胞癌治疗决策指导中使用患者衍生肿瘤器官组织的可行性分析。

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-28 DOI: 10.1016/j.ejca.2024.115100

Background

Current treatment for head and neck squamous cell carcinoma (HNSCC) involves surgery, radiotherapy, and chemotherapy. Despite aggressive multimodal approaches, tumour recurrence occurs in 40–60 % of cases, leading to poor survival outcomes. HNSCC lacks common genetic drivers for tailored therapies, and reliable biomarkers for treatment selection are scarce. We investigated the procedural requirements for incorporating drug- and radiosensitivity screens in patient-derived organoids (PDOs) within a clinical trial framework.

Patients and methods

Fresh tumour samples (N = 198) from 186 HNSCC patients were included. Success rates of organoid establishment were correlated with clinical and procedural parameters. Timelines for establishment of PDO cultures were determined, and their long-term growth potential assessed by serial passaging. Additionally, we conducted whole exome sequencing on matched tumour-organoid pairs. Three PDO models were employed to establish radiosensitivity assays.

Results

In total, PDO models displaying histomorphological features and genomic alterations of parental tumours were successfully established for 35 % of patient tumours. Success rates rose to 77 % for samples with a tumour cell content of 30 % or higher. Advanced patient age, prior radiotherapy, and delays in tissue processing were identified as negative predictors for engraftment. The estimated time interval needed for screens was compatible with PDO-guided selection of curative-intent radiotherapy regimens.

Conclusions

Our findings suggest that with high-quality samples and efficient tissue processing, PDO screens can be successfully performed in 77 % of HNSCC patients. Given the procedural challenges involved, future clinical trials aiming to the utility of PDOs for guiding treatment decisions should consider implementing centralised PDO screening.

背景：目前治疗头颈部鳞状细胞癌（HNSCC）的方法包括手术、放疗和化疗。尽管采取了积极的多模式治疗方法，但仍有40-60%的病例出现肿瘤复发，导致患者生存率低下。HNSCC 缺乏可用于定制疗法的常见基因驱动因素，而用于治疗选择的可靠生物标志物也非常稀缺。我们研究了在临床试验框架内将药物和放射敏感性筛选纳入患者衍生有机体（PDOs）的程序要求：纳入了 186 名 HNSCC 患者的新鲜肿瘤样本（N = 198）。类器官建立的成功率与临床和程序参数相关。确定了PDO培养物的建立时间，并通过连续传代评估了其长期生长潜力。此外，我们还对匹配的肿瘤-类器官对进行了全外显子组测序。我们采用了三种 PDO 模型来建立放射敏感性测定：结果：总共有 35% 的患者肿瘤成功建立了显示亲代肿瘤组织形态学特征和基因组改变的 PDO 模型。肿瘤细胞含量达到或超过30%的样本的成功率上升到77%。高龄患者、曾接受过放疗和组织处理延迟被认为是影响移植的不利因素。筛查所需的估计时间间隔符合PDO指导下的治疗性放疗方案选择：我们的研究结果表明，通过高质量的样本和高效的组织处理，77% 的 HNSCC 患者可以成功进行 PDO 筛查。考虑到所涉及的程序挑战，未来旨在利用 PDO 指导治疗决策的临床试验应考虑实施集中式 PDO 筛查。

{"title":"Feasibility analysis of using patient-derived tumour organoids for treatment decision guidance in locally advanced head and neck squamous cell carcinoma","authors":"","doi":"10.1016/j.ejca.2024.115100","DOIUrl":"10.1016/j.ejca.2024.115100","url":null,"abstract":"<div><h3>Background</h3><div>Current treatment for head and neck squamous cell carcinoma (HNSCC) involves surgery, radiotherapy, and chemotherapy. Despite aggressive multimodal approaches, tumour recurrence occurs in 40–60 % of cases, leading to poor survival outcomes. HNSCC lacks common genetic drivers for tailored therapies, and reliable biomarkers for treatment selection are scarce. We investigated the procedural requirements for incorporating drug- and radiosensitivity screens in patient-derived organoids (PDOs) within a clinical trial framework.</div></div><div><h3>Patients and methods</h3><div>Fresh tumour samples (<em>N</em> = 198) from 186 HNSCC patients were included. Success rates of organoid establishment were correlated with clinical and procedural parameters. Timelines for establishment of PDO cultures were determined, and their long-term growth potential assessed by serial passaging. Additionally, we conducted whole exome sequencing on matched tumour-organoid pairs. Three PDO models were employed to establish radiosensitivity assays.</div></div><div><h3>Results</h3><div>In total, PDO models displaying histomorphological features and genomic alterations of parental tumours were successfully established for 35 % of patient tumours. Success rates rose to 77 % for samples with a tumour cell content of 30 % or higher. Advanced patient age, prior radiotherapy, and delays in tissue processing were identified as negative predictors for engraftment. The estimated time interval needed for screens was compatible with PDO-guided selection of curative-intent radiotherapy regimens.</div></div><div><h3>Conclusions</h3><div>Our findings suggest that with high-quality samples and efficient tissue processing, PDO screens can be successfully performed in 77 % of HNSCC patients. Given the procedural challenges involved, future clinical trials aiming to the utility of PDOs for guiding treatment decisions should consider implementing centralised PDO screening.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Liquid biopsy with plasma Epstein-Barr virus DNA characterizes biological relapse for the prediction of cancer recurrence in non-disseminated nasopharyngeal carcinoma 利用血浆 Epstein-Barr 病毒 DNA 进行液体活检可确定生物复发的特征，从而预测非扩散性鼻咽癌的复发情况

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer

Pub Date : 2024-10-26 DOI: 10.1016/j.ejca.2024.115098

Purpose

To investigate whether a bounce in plasma Epstein-Barr virus (EBV) DNA during posttreatment surveillance of nasopharyngeal carcinoma (NPC) informs the risk of clinical recurrence and its implication for early therapeutic intervention.

Methods

950 non-disseminated NPC patients with completed remission in 3 months after treatment were retrospectively screened. Detectable EBV DNA with no evidence of clinical relapse during follow-up was deemed as DNA bounce. The diagnostic and prognostic performance of EBV DNA bounce was assessed for subsequent failures.

Results

Tumor recurrence occurred in 6.6 %, 10.1 % and 65.8 % in the group with persistently negative EBV DNA, single positive test and ≥ 2 positive tests, respectively. EBV DNA bounce over twice was associated with worse disease-free survival (DFS), locoregional recurrence-free survival (LRRFS), and distant metastasis-free survival (DMFS) than the other two groups. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy for the prediction of recurrence were 0.56, 0.95, 0.66, 0.93 and 0.90 using two positive tests, which were hence deemed as biological relapse. Serial cutoffs (EBV DNA 1 ≥ 40 copies/ml or EBV DNA 2 ≥100 copies/ml) further defined a high-risk subgroup with an eventual recurrence rate of 77.9 % and 3-year DFS of merely 20.5 %. Prophylactic medical intervention with capecitabine or S1 significantly improved the 3-year DFS when compared to those with observation.

Conclusions

The earliest two positive tests of EBV DNA represent a biomarker of biological relapse that allows early detection of clinical recurrence in EBV-related NPC. For high-risk biological relapse, preemptive intervention provides potential survival benefits.

目的研究在鼻咽癌（NPC）治疗后监测期间，血浆中爱泼斯坦-巴氏病毒（EBV）DNA的反弹是否能告知临床复发的风险及其对早期治疗干预的影响。可检测到 EBV DNA 且随访期间无临床复发证据的患者被视为 DNA 反弹。结果EBV DNA持续阴性组、单次检测阳性组和≥2次检测阳性组的肿瘤复发率分别为6.6%、10.1%和65.8%。与其他两组相比，EBV DNA反跳两次以上与更差的无病生存期（DFS）、无局部复发生存期（LRRFS）和无远处转移生存期（DMFS）相关。预测复发的灵敏度、特异性、阳性预测值（PPV）、阴性预测值（NPV）和准确度分别为 0.56、0.95、0.66、0.93 和 0.90（使用两次阳性测试，因此被视为生物学复发）。序列截断值（EBV DNA 1 ≥ 40拷贝/毫升或EBV DNA 2 ≥ 100拷贝/毫升）进一步定义了高风险亚组，其最终复发率为77.9%，3年DFS仅为20.5%。与观察组相比，使用卡培他滨或 S1 进行预防性医疗干预可显著改善 3 年 DFS。对于高风险的生物复发，先期干预可为患者带来潜在的生存益处。

{"title":"Liquid biopsy with plasma Epstein-Barr virus DNA characterizes biological relapse for the prediction of cancer recurrence in non-disseminated nasopharyngeal carcinoma","authors":"","doi":"10.1016/j.ejca.2024.115098","DOIUrl":"10.1016/j.ejca.2024.115098","url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate whether a bounce in plasma Epstein-Barr virus (EBV) DNA during posttreatment surveillance of nasopharyngeal carcinoma (NPC) informs the risk of clinical recurrence and its implication for early therapeutic intervention.</div></div><div><h3>Methods</h3><div>950 non-disseminated NPC patients with completed remission in 3 months after treatment were retrospectively screened. Detectable EBV DNA with no evidence of clinical relapse during follow-up was deemed as DNA bounce. The diagnostic and prognostic performance of EBV DNA bounce was assessed for subsequent failures.</div></div><div><h3>Results</h3><div>Tumor recurrence occurred in 6.6 %, 10.1 % and 65.8 % in the group with persistently negative EBV DNA, single positive test and ≥ 2 positive tests, respectively. EBV DNA bounce over twice was associated with worse disease-free survival (DFS), locoregional recurrence-free survival (LRRFS), and distant metastasis-free survival (DMFS) than the other two groups. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy for the prediction of recurrence were 0.56, 0.95, 0.66, 0.93 and 0.90 using two positive tests, which were hence deemed as biological relapse. Serial cutoffs (EBV DNA 1 ≥ 40 copies/ml or EBV DNA 2 ≥100 copies/ml) further defined a high-risk subgroup with an eventual recurrence rate of 77.9 % and 3-year DFS of merely 20.5 %. Prophylactic medical intervention with capecitabine or S1 significantly improved the 3-year DFS when compared to those with observation.</div></div><div><h3>Conclusions</h3><div>The earliest two positive tests of EBV DNA represent a biomarker of biological relapse that allows early detection of clinical recurrence in EBV-related NPC. For high-risk biological relapse, preemptive intervention provides potential survival benefits.</div></div>","PeriodicalId":11980,"journal":{"name":"European Journal of Cancer","volume":null,"pages":null},"PeriodicalIF":7.6,"publicationDate":"2024-10-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142561156","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}

引用次数: 0