Pub Date : 2025-06-01Epub Date: 2025-02-01DOI: 10.1016/j.clcc.2025.01.005
Hong'en Xu , Jie Zhuang , Chenyu Zhang , Weixuan Huang , Bingchen Chen , Bo'an Zheng , Tao Song
Objective
To assess the impact of external iliac lymph node (N1b) metastasis on anal carcinoma (AC) staging and refine the Tumor-Node-Metastasis (TNM) system without modifying existing criteria.
Methods
This retrospective study was performed utilizing the data of 3,815 patients with AC included in the Surveillance, Epidemiology, and End Results (SEER) registry from 2018 to 2021. We compared the TNM8th and 9th editions with our proposed system, focusing on overall survival (OS) and cancer-specific survival (CSS). The Kaplan–Meier survival analysis and time-dependent C-index measures were employed to evaluate the 3 staging systems.
Results
The SEER registry identified only 42 patients with solitary N1b metastasis, with lymph node (LN) metastasis rates rising with higher T stages. No significant survival differences were found among N1a to N1c subgroups, yet N1a showed better OS and CSS than N1b+c (hazard ratio [HR] = 1.306, 95% confidence interval (CI): 1.011–1.687, P = .041 for OS; HR = 1.432, 95% CI: 1.088–1.886, P = .011 for CSS). The proposed TNM system, reclassifying T 1N1M0 as stage I and defining T3-T4 with LN status as stages IIIA and IIIB, showed marginally improved predictive accuracy (C-index: 0.684 vs. 0.683 for OS; 0.635 vs. 0.634 for CSS).
Conclusions
N1b metastasis minimally affects AC staging. We introduce a simplified TNM system for clinical use:
M Staging: Distant metastasis presence as M1.
T Staging: T1 as stage I, T2 as stage II, T3-T4 as stage III.
N Staging: N status noncontributory for stage I; N negative as stage A (IIA or IIIA), N positive as stage B (IIB or IIIB).
目的评估髂外淋巴结(N1b)转移对肛门癌(AC)分期的影响,并在不修改现有标准的情况下完善肿瘤-结节-转移(TNM)系统:这项回顾性研究利用了2018年至2021年纳入监测、流行病学和最终结果(SEER)登记册的3815名肛门癌患者的数据。我们将 TNM 第 8 版和第 9 版与我们提出的系统进行了比较,重点关注总生存期(OS)和癌症特异性生存期(CSS)。我们采用卡普兰-梅耶生存分析和时间依赖性C指数来评估这3种分期系统:SEER登记系统仅发现42例N1b单发转移患者,淋巴结(LN)转移率随着T分期的升高而升高。从N1a到N1c亚组之间没有发现明显的生存差异,但N1a的OS和CSS均优于N1b+c(OS的危险比[HR] = 1.306,95%置信区间(CI):1.011-1.687,P = .041;CSS的危险比[HR] = 1.432,95%置信区间(CI):1.088-1.886,P = .011)。拟议的TNM系统将T 1N1M0重新分类为I期,将T3-T4的LN状态定义为IIIA和IIIB期,其预测准确性略有提高(C指数:OS为0.684 vs. 0.683;CSS为0.635 vs. 0.634):结论:N1b 转移对 AC 分期的影响很小。结论:N1b 转移对 AC 分期的影响极小,我们将简化的 TNM 系统引入临床:M分期:远处转移灶作为 M1。T分期:T1 为 I 期,T2 为 II 期,T3-T4 为 III 期。N 分期:N 状态不影响 I 期;N 阴性为 A 期(IIA 或 IIIA),N 阳性为 B 期(IIB 或 IIIB)。
{"title":"Prognostic Value of External Iliac Lymph Node (N1b) Metastasis in Anal Carcinoma and Validation of a New Stage Grouping System","authors":"Hong'en Xu , Jie Zhuang , Chenyu Zhang , Weixuan Huang , Bingchen Chen , Bo'an Zheng , Tao Song","doi":"10.1016/j.clcc.2025.01.005","DOIUrl":"10.1016/j.clcc.2025.01.005","url":null,"abstract":"<div><h3>Objective</h3><div>To assess the impact of external iliac lymph node (N1b) metastasis on anal carcinoma (AC) staging and refine the Tumor-Node-Metastasis (TNM) system without modifying existing criteria.</div></div><div><h3>Methods</h3><div>This retrospective study was performed utilizing the data of 3,815 patients with AC included in the Surveillance, Epidemiology, and End Results (SEER) registry from 2018 to 2021. We compared the TNM8th and 9th editions with our proposed system, focusing on overall survival (OS) and cancer-specific survival (CSS). The Kaplan–Meier survival analysis and time-dependent C-index measures were employed to evaluate the 3 staging systems.</div></div><div><h3>Results</h3><div>The SEER registry identified only 42 patients with solitary N1b metastasis, with lymph node (LN) metastasis rates rising with higher T stages. No significant survival differences were found among N1a to N1c subgroups, yet N1a showed better OS and CSS than N1b+<em>c</em> (hazard ratio [HR] = 1.306, 95% confidence interval (CI): 1.011–1.687, <em>P</em> = .041 for OS; HR = 1.432, 95% CI: 1.088–1.886, <em>P</em> = .011 for CSS). The proposed TNM system, reclassifying T 1N1M0 as stage I and defining T3-T4 with LN status as stages IIIA and IIIB, showed marginally improved predictive accuracy (C-index: 0.684 vs. 0.683 for OS; 0.635 vs. 0.634 for CSS).</div></div><div><h3>Conclusions</h3><div>N1b metastasis minimally affects AC staging. We introduce a simplified TNM system for clinical use:</div><div>M Staging: Distant metastasis presence as M1.</div><div>T Staging: T1 as stage I, T2 as stage II, T3-T4 as stage III.</div><div>N Staging: N status noncontributory for stage I; N negative as stage A (IIA or IIIA), N positive as stage B (IIB or IIIB).</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 248-255.e2"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476958","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-02-03DOI: 10.1016/j.clcc.2025.01.006
C. Zwarthoed , C. Jaraudias , L. Evesque , D. Baron , E. François , D. Chardin , L. Marie , D. Mitrea , Y. Château , J. Gal , C. Bailleux
Background
The aim of this post hoc study was to assess the prognostic value of 18F-FDG PET/CT quantitative parameters recorded before and after treatment for anal canal neoplasm for the disease free survival.
Materials and Methods
Consecutive, previously untreated patients with histologically proved anal cancer, with 18F-FDG PET/CT pre- and 2 months post treatment were included. The following criteria were analyzed: baseline primary tumor lesion glycolysis (TLG), metabolic tumor volume (MTV), standardized tumor volume (SUV) max and mean, SUV normalized by lean body mass (SUL) max, mean and peak, variations between pre- and post-treatment examinations for SUVmax (Delta SUVmax), TLG (Delta TLG), MTV (Delta MTV), as well as post-treatment SULpeak and SUVmax for the primary tumor, and baseline sum of lesions TLG and MTV.
Results
About 78 consecutive patients were included in this study. Median follow-up was 49 months. Baseline TLG, SUVmax, SULpeak, SULmax, sum of lesions for TLG and MTV, Delta SUVmax, and post-therapeutic SULpeak and SUVmax for the primary tumor, were statistically significant for disease free survival.
Conclusion
Pretherapeutic 18F-FDG PET/CT has a statistically significant prognostic value. The wide variability of results published in literature compels us to specifically explore the interest of uptake variations between pre- and post-treatment examinations.
{"title":"Prognostic Values of Pre- and Post-Therapeutic FDG-PET in Anal Canal Cancer: Analysis of a Prospective Study","authors":"C. Zwarthoed , C. Jaraudias , L. Evesque , D. Baron , E. François , D. Chardin , L. Marie , D. Mitrea , Y. Château , J. Gal , C. Bailleux","doi":"10.1016/j.clcc.2025.01.006","DOIUrl":"10.1016/j.clcc.2025.01.006","url":null,"abstract":"<div><h3>Background</h3><div>The aim of this post hoc study was to assess the prognostic value of 18F-FDG PET/CT quantitative parameters recorded before and after treatment for anal canal neoplasm for the disease free survival.</div></div><div><h3>Materials and Methods</h3><div>Consecutive, previously untreated patients with histologically proved anal cancer, with 18F-FDG PET/CT pre- and 2 months post treatment were included. The following criteria were analyzed: baseline primary tumor lesion glycolysis (TLG), metabolic tumor volume (MTV), standardized tumor volume (SUV) max and mean, SUV normalized by lean body mass (SUL) max, mean and peak, variations between pre- and post-treatment examinations for SUVmax (Delta SUVmax), TLG (Delta TLG), MTV (Delta MTV), as well as post-treatment SULpeak and SUVmax for the primary tumor, and baseline sum of lesions TLG and MTV.</div></div><div><h3>Results</h3><div>About 78 consecutive patients were included in this study. Median follow-up was 49 months. Baseline TLG, SUVmax, SULpeak, SULmax, sum of lesions for TLG and MTV, Delta SUVmax, and post-therapeutic SULpeak and SUVmax for the primary tumor, were statistically significant for disease free survival.</div></div><div><h3>Conclusion</h3><div>Pretherapeutic 18F-FDG PET/CT has a statistically significant prognostic value. The wide variability of results published in literature compels us to specifically explore the interest of uptake variations between pre- and post-treatment examinations.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 256-263.e8"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143485064","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-11-22DOI: 10.1016/j.clcc.2024.11.002
Marjan Khan , Abdullah Chandasir , Abdul Qahar Khan Yasinzai , Jaylyn Robinson , Israr Khan , Zulfiqar Haider Jogezai , Agha Wali , Hritvik Jain , Asif Iqbal , Amir Humza Sohail , Asad Ullah
Background
There is controversy and limited data the management of rectosigmoid junction cancer (RSJC), especially the role of radiation. We aim to investigate the role of preoperative and postoperative radiation in RSJC and whether this cancer should be treated as a colon cancer or as a rectal cancer.
Methods
The data were extracted from the Surveillance, Epidemiology, and End Results (SEER) database and identified from 2000 to 2018.
Results
Of the 50,779 patients, 87% were ≥50 years old, 56.2% were male, 80.8% were White. Regarding tumor characteristics, 76% were Grade II, while 22.7% had distant-stage. 16.4% of patients were treated with multimodal therapy (surgery with chemoradiation), 47.9% surgery alone, 6.5% of patients received preoperative radiation, and 9.9% received postoperative radiation. Regarding prognostic significance of pre-operative and postoperative radiation factors, we evaluated factors, such as age, gender, race, tumor size, histologic variants of adenocarcinoma, and tumor grade. Patients with distant-staged tumors who received preoperative radiation had lower mortality compared to those who received postoperative radiation (95% CI, 0.73 – 0.97, (hazard ratio (HR) = 0.85, p = 0.04). There were no survival differences for localized or regional disease regarding pre and postoperative radiation, or when sub-stratifying for any other significant demographic or tumor characteristics.
Conclusion
Surgery with adjuvant chemoradiation had the best prognosis for all demographic and tumor characteristics. Preoperative radiation had a good prognosis only in distant disease. However, further randomized evidence is required to demonstrate the efficacy of pre-and post-operative radiation in rectosigmoid junction cancer.
背景:关于直肠乙状结肠结癌(RSJC)的治疗,特别是放射治疗的作用存在争议和有限的资料。我们的目的是探讨术前和术后放疗在RSJC中的作用,以及这种癌症是否应该作为结肠癌或直肠癌治疗。方法:数据从监测、流行病学和最终结果(SEER)数据库中提取,并从2000年至2018年进行识别。结果:50779例患者中,≥50岁的占87%,男性56.2%,白人80.8%。在肿瘤特征方面,76%为II级,22.7%为远处分期。16.4%的患者接受多模式治疗(手术加放化疗),47.9%的患者单独手术,6.5%的患者术前接受放疗,9.9%的患者术后接受放疗。关于术前和术后放疗因素的预后意义,我们评估了年龄、性别、种族、肿瘤大小、腺癌的组织学变异和肿瘤分级等因素。远处分期肿瘤患者术前接受放疗的死亡率低于术后接受放疗的患者(95% CI, 0.73 - 0.97,风险比(HR) = 0.85, p = 0.04)。对于局部或区域性疾病,在术前和术后放疗,或根据其他重要的人口统计学或肿瘤特征进行亚分层时,生存率没有差异。结论:手术配合放化疗在所有人口统计学和肿瘤特征方面预后最好。术前放疗仅对远处病变预后良好。然而,需要进一步的随机证据来证明术前和术后放射治疗直肠乙状结肠结癌的疗效。
{"title":"Rectosigmoid Junction Cancer; The Role of Preoperative and Postoperative Radiation With Novel Nomogram in Predicting Survival in the United States","authors":"Marjan Khan , Abdullah Chandasir , Abdul Qahar Khan Yasinzai , Jaylyn Robinson , Israr Khan , Zulfiqar Haider Jogezai , Agha Wali , Hritvik Jain , Asif Iqbal , Amir Humza Sohail , Asad Ullah","doi":"10.1016/j.clcc.2024.11.002","DOIUrl":"10.1016/j.clcc.2024.11.002","url":null,"abstract":"<div><h3>Background</h3><div>There is controversy and limited data the management of rectosigmoid junction cancer (RSJC), especially the role of radiation. We aim to investigate the role of preoperative and postoperative radiation in RSJC and whether this cancer should be treated as a colon cancer or as a rectal cancer.</div></div><div><h3>Methods</h3><div>The data were extracted from the Surveillance, Epidemiology, and End Results (SEER) database and identified from 2000 to 2018.</div></div><div><h3>Results</h3><div>Of the 50,779 patients, 87% were ≥50 years old, 56.2% were male, 80.8% were White. Regarding tumor characteristics, 76% were Grade II, while 22.7% had distant-stage. 16.4% of patients were treated with multimodal therapy (surgery with chemoradiation), 47.9% surgery alone, 6.5% of patients received preoperative radiation, and 9.9% received postoperative radiation. Regarding prognostic significance of pre-operative and postoperative radiation factors, we evaluated factors, such as age, gender, race, tumor size, histologic variants of adenocarcinoma, and tumor grade. Patients with distant-staged tumors who received preoperative radiation had lower mortality compared to those who received postoperative radiation (95% CI, 0.73 – 0.97, (hazard ratio (HR) = 0.85, p = 0.04). There were no survival differences for localized or regional disease regarding pre and postoperative radiation, or when sub-stratifying for any other significant demographic or tumor characteristics.</div></div><div><h3>Conclusion</h3><div>Surgery with adjuvant chemoradiation had the best prognosis for all demographic and tumor characteristics. Preoperative radiation had a good prognosis only in distant disease. However, further randomized evidence is required to demonstrate the efficacy of pre-and post-operative radiation in rectosigmoid junction cancer.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 135-142"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142848697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-03-01DOI: 10.1016/j.clcc.2025.02.006
Kim van den Berg , Felice N van Erning , Jacobus WA Burger , Irene EG van Hellemond , Jeanine ML Roodhart , Miriam Koopman , Harm JT Rutten , Geert-Jan Creemers
Background
A 3-month adjuvant treatment regimen with capecitabine and oxaliplatin (CAPOX) for high-risk stage II (T4N0) and stage III (node-positive) colon cancer was implemented in the Netherlands in 2017. The IDEA trial showed a clinically irrelevant difference in long-term outcomes in combination with a substantial decrease in toxicity in comparison with a 6-month regimen. A significantly increased dose intensity was observed in the 3-month arm, which might be essential to achieve optimal long-term outcomes. Hence, the aim of the present study was to evaluate if a similar dose intensity could be achieved in patients treated with adjuvant CAPOX for 3 months in daily practice.
Materials and Methods
Patients scheduled for 3 months of adjuvant CAPOX for high-risk stage II or stage III colon cancer were selected from the Netherlands Cancer Registry. The number of administered cycles and the daily cumulative dose of capecitabine and oxaliplatin were extracted from the medical files. Relative dose intensity (RDI) was determined by comparing the administered dose intensity with the standard dose intensity.
Results
In total, 802 (80.0%) of the 1002 patients completed 4 cycles of CAPOX. The overall mean RDI of adjuvant treatment was 82.9% for capecitabine, and 83.8% for oxaliplatin, based on the combination of dose reductions and omitting cycles.
Conclusion
One out of 5 patients did not complete 4 cycles of CAPOX. The administered dose of capecitabine and oxaliplatin in the first year after the update of the guideline was lower than the advised dose for the 3-month CAPOX regimen, and the administered dose in the IDEA study. The impact on long-term oncological outcomes should be awaited.
{"title":"Treatment Adherence to Adjuvant Chemotherapy According to the New Standard 3-month CAPOX Regimen in High-risk Stage II and Stage III Colon Cancer: A Population-based Evaluation in The Netherlands","authors":"Kim van den Berg , Felice N van Erning , Jacobus WA Burger , Irene EG van Hellemond , Jeanine ML Roodhart , Miriam Koopman , Harm JT Rutten , Geert-Jan Creemers","doi":"10.1016/j.clcc.2025.02.006","DOIUrl":"10.1016/j.clcc.2025.02.006","url":null,"abstract":"<div><h3>Background</h3><div>A 3-month adjuvant treatment regimen with capecitabine and oxaliplatin (CAPOX) for high-risk stage II (T4N0) and stage III (node-positive) colon cancer was implemented in the Netherlands in 2017. The IDEA trial showed a clinically irrelevant difference in long-term outcomes in combination with a substantial decrease in toxicity in comparison with a 6-month regimen. A significantly increased dose intensity was observed in the 3-month arm, which might be essential to achieve optimal long-term outcomes. Hence, the aim of the present study was to evaluate if a similar dose intensity could be achieved in patients treated with adjuvant CAPOX for 3 months in daily practice.</div></div><div><h3>Materials and Methods</h3><div>Patients scheduled for 3 months of adjuvant CAPOX for high-risk stage II or stage III colon cancer were selected from the Netherlands Cancer Registry. The number of administered cycles and the daily cumulative dose of capecitabine and oxaliplatin were extracted from the medical files. Relative dose intensity (RDI) was determined by comparing the administered dose intensity with the standard dose intensity.</div></div><div><h3>Results</h3><div>In total, 802 (80.0%) of the 1002 patients completed 4 cycles of CAPOX. The overall mean RDI of adjuvant treatment was 82.9% for capecitabine, and 83.8% for oxaliplatin, based on the combination of dose reductions and omitting cycles.</div></div><div><h3>Conclusion</h3><div>One out of 5 patients did not complete 4 cycles of CAPOX. The administered dose of capecitabine and oxaliplatin in the first year after the update of the guideline was lower than the advised dose for the 3-month CAPOX regimen, and the administered dose in the IDEA study. The impact on long-term oncological outcomes should be awaited.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 300-309"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-01-21DOI: 10.1016/j.clcc.2025.01.001
Céline Lugnier , Sarah Förster , Sabine Sommerlatte , Olaf Schoffer , Jens Christmann , Anna-Lena Kraeft , Tobias Terzer , Eleni Kourti , Oliver Overheu , Elena Schlageter , Ira Ekmekciu , Waldemar Uhl , Christoph Biermann , Lothar Müller , Marianne Sinn , Stefan Kasper-Virchow , Dominik Modest , Volker Heinemann , Jochen Schmitt , Jan Schildmann , Anke Reinacher-Schick
Background
Colorectal cancer (CRC) remains a leading cause of death despite notable advancements through guideline-based management. We present data on changes of CRC care during the COVID-19 pandemic in Germany.
Methods
Retrospective data from 22 AIO CCs and an academic Institute of Pathology compared the first (fw, 03-05.2020) and second wave (sw, 11-12.2020) of the pandemic with corresponding 2019 periods. Parameters were: number of cases diagnosed, age, sex, tumor stage, surgical procedures, quality criteria of CRC care (presentation in multidisciplinary tumor boards (MTB), psychological or social consultation), number of precancerous and malignant colorectal lesions (CRL). Data points were compared as mean values with confidence intervals estimated according to Clopper and Pearson (1934). Hypothesis tests were conducted using Poisson regression models that included interaction terms (year*sex or year*age over70). Statistical significance was considered at P < .05.
Results
A total of 4316 cases diagnosed (AIO CC) revealed a substantial reduction (fw -20.58%; sw -23.48%). Hypothesis test showed a significant decline in incidence due to the fw and sw of the pandemic. Quality criteria of cancer care remained stable except for trial participation. Analysis from 60,695 CRL detected a decrease in precancerous (fw: -16 %/sw: -4 %) and malignant (fw: -18 %) lesions while malignant CRL increased in the sw (+8 %). Hypothesis test revealed a significant decline only for the fw 2020 and detected age > 70 as independent risk factor in both waves.
Conclusion
We detected substantial alterations in cancer care during the pandemic, including detected precancerous CRL. CCs showed high resilience in quality criteria for CRC care.
{"title":"Significant Alterations of Colorectal Cancer Care in the COVID-19 Pandemic With High Adherence to Quality Criteria in German Cancer Centers (CC) ‒ Data From the AIO CancerCOVID Consortium (AIO-YMO/KRK 520/ass)","authors":"Céline Lugnier , Sarah Förster , Sabine Sommerlatte , Olaf Schoffer , Jens Christmann , Anna-Lena Kraeft , Tobias Terzer , Eleni Kourti , Oliver Overheu , Elena Schlageter , Ira Ekmekciu , Waldemar Uhl , Christoph Biermann , Lothar Müller , Marianne Sinn , Stefan Kasper-Virchow , Dominik Modest , Volker Heinemann , Jochen Schmitt , Jan Schildmann , Anke Reinacher-Schick","doi":"10.1016/j.clcc.2025.01.001","DOIUrl":"10.1016/j.clcc.2025.01.001","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) remains a leading cause of death despite notable advancements through guideline-based management. We present data on changes of CRC care during the COVID-19 pandemic in Germany.</div></div><div><h3>Methods</h3><div>Retrospective data from 22 AIO CCs and an academic Institute of Pathology compared the first (fw, 03-05.2020) and second wave (sw, 11-12.2020) of the pandemic with corresponding 2019 periods. Parameters were: number of cases diagnosed, age, sex, tumor stage, surgical procedures, quality criteria of CRC care (presentation in multidisciplinary tumor boards (MTB), psychological or social consultation), number of precancerous and malignant colorectal lesions (CRL). Data points were compared as mean values with confidence intervals estimated according to Clopper and Pearson (1934). Hypothesis tests were conducted using Poisson regression models that included interaction terms (year*sex or year*age over70). Statistical significance was considered at <em>P < .</em>05.</div></div><div><h3>Results</h3><div>A total of 4316 cases diagnosed (AIO CC) revealed a substantial reduction (fw -20.58%; sw -23.48%). Hypothesis test showed a significant decline in incidence due to the fw and sw of the pandemic. Quality criteria of cancer care remained stable except for trial participation. Analysis from 60,695 CRL detected a decrease in precancerous (fw: -16 %/sw: -4 %) and malignant (fw: -18 %) lesions while malignant CRL increased in the sw (+8 %). Hypothesis test revealed a significant decline only for the fw 2020 and detected age > 70 as independent risk factor in both waves.</div></div><div><h3>Conclusion</h3><div>We detected substantial alterations in cancer care during the pandemic, including detected precancerous CRL. CCs showed high resilience in quality criteria for CRC care.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 218-230"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143451119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-11-29DOI: 10.1016/j.clcc.2024.11.001
Carl Pinter , Shubham Sharma , Aunum Abid , Osama Ahmed , Duc Le , Rani Kanthan , Selliah C Kanthan , Dilip Gill , Haji Chalchal , Shahid Ahmed
Background
In this large population-based cohort study, we examined the prognostic significance of various clinical, pathological, and contextual variables for their correlation with survival in elderly patients with stage III colon cancer.
Methods
Patients aged ≥ 70 years with stage III colon cancer, diagnosed in Saskatchewan during 2012-2018, were evaluated. A Cox proportional multivariate survival analysis was performed to determine factors correlated with overall survival (OS) and disease-free survival.
Results
Overall, 404 eligible patients with a median age of 79 years and a male-to-female ratio of 1:1 were identified. Among them, 48% were aged ≥ 80 years, 66% had ≥ 1 major comorbid illness, 46% had high-risk disease, and 50% had a node-positive to node-harvested (NPNH) ratio of > 0.1. Forty-three percent of patients received adjuvant chemotherapy. The 5-year disease-free survival with chemotherapy was 49% versus 30% without chemotherapy (P < .001). The 5-year OS with adjuvant chemotherapy was 64% versus 49% without chemotherapy (P < .001). On multivariate analysis a past history of cancer, hazard ratio (HR) 1.47 (95% CI, 1.12-1.94); presence of an ostomy, HR 1.53 (1.16-2.03); NPNH ratio > 0.1, HR 1.51 (1.15-1.98); grade III tumor, HR 1.54 (1.16-2.04); WHO performance status > 1, HR 1.42 (1.06-1.90); no adjuvant chemotherapy, HR 1.82 (1.32-2.50); high-risk stage III disease, HR 1.60 (1.22-2.11), and baseline carcinoembryonic antigen > 5, HR 1.98 (1.50-2.61) were independently correlated with OS.
Conclusions
This study highlights the prognostic importance of several factors in elderly patients with stage III colon cancer, particularly the benefit of adjuvant chemotherapy on survival. Key predictors of poorer OS include a past history of cancer, presence pf an ostomy, and a higher NPNH ratio. These findings emphasize the need for personalized treatment approaches to improve outcomes in this vulnerable population.
{"title":"Outcomes of Elderly Patients With Node-Positive Colon Cancer: A Multicenter Population-Based Cohort Study","authors":"Carl Pinter , Shubham Sharma , Aunum Abid , Osama Ahmed , Duc Le , Rani Kanthan , Selliah C Kanthan , Dilip Gill , Haji Chalchal , Shahid Ahmed","doi":"10.1016/j.clcc.2024.11.001","DOIUrl":"10.1016/j.clcc.2024.11.001","url":null,"abstract":"<div><h3>Background</h3><div>In this large population-based cohort study, we examined the prognostic significance of various clinical, pathological, and contextual variables for their correlation with survival in elderly patients with stage III colon cancer.</div></div><div><h3>Methods</h3><div>Patients aged ≥ 70 years with stage III colon cancer, diagnosed in Saskatchewan during 2012-2018, were evaluated. A Cox proportional multivariate survival analysis was performed to determine factors correlated with overall survival (OS) and disease-free survival.</div></div><div><h3>Results</h3><div>Overall, 404 eligible patients with a median age of 79 years and a male-to-female ratio of 1:1 were identified. Among them, 48% were aged ≥ 80 years, 66% had ≥ 1 major comorbid illness, 46% had high-risk disease, and 50% had a node-positive to node-harvested (NPNH) ratio of > 0.1. Forty-three percent of patients received adjuvant chemotherapy. The 5-year disease-free survival with chemotherapy was 49% versus 30% without chemotherapy (<em>P < .</em>001). The 5-year OS with adjuvant chemotherapy was 64% versus 49% without chemotherapy (<em>P < .</em>001). On multivariate analysis a past history of cancer, hazard ratio (HR) 1.47 (95% CI, 1.12-1.94); presence of an ostomy, HR 1.53 (1.16-2.03); NPNH ratio > 0.1, HR 1.51 (1.15-1.98); grade III tumor, HR 1.54 (1.16-2.04); WHO performance status > 1, HR 1.42 (1.06-1.90); no adjuvant chemotherapy, HR 1.82 (1.32-2.50); high-risk stage III disease, HR 1.60 (1.22-2.11), and baseline carcinoembryonic antigen > 5, HR 1.98 (1.50-2.61) were independently correlated with OS.</div></div><div><h3>Conclusions</h3><div>This study highlights the prognostic importance of several factors in elderly patients with stage III colon cancer, particularly the benefit of adjuvant chemotherapy on survival. Key predictors of poorer OS include a past history of cancer, presence pf an ostomy, and a higher NPNH ratio. These findings emphasize the need for personalized treatment approaches to improve outcomes in this vulnerable population.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 143-152"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142873654","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2025-02-28DOI: 10.1016/j.clcc.2025.02.004
Hyunwook Kim , Lingjie Shen , Jeongseok Jeon , Yoon Dae Han , Dai Hoon Han , Minsun Jung , Seo Jeong Shin , Seng Chan You , Nam Kyu Kim , Byung Soh Min , Hyuk Hur , Joong Bae Ahn , Sang Joon Shin , Anna Jacoba van Gestel , Felice N. van Erning , Gijs Geleijnse , Han Sang Kim
Background
Lymph node (LN) examination is important for staging colorectal cancer. Examining < 12 LN has been associated with a poor prognosis. However, surgical and pathological advances have led to increase examined LN, necessitating the reassessment of the best cutoff for prognosis.
Patients and Methods
We reviewed patients with stage II–III colon cancer from the Yonsei Cancer Center Registry (YCC) database and the Netherlands Cancer Registry (NCR). The optimal LN cutoff was determined by comparison with hazard ratio (HR) in 12 LN. We compared higher vs. lower LN cutoff effects on a 6-year overall survival (OS).
Results
From 2005 to 2015, the proportion with < 12 LN decreased significantly (P < .001). There was no significant association between 6-year OS and LN yield in all stages II–III patients (HR = 1.21, P = .116), stage II (HR = 1.39, P = .068), and stage III (HR = 1.18, P = .297) colon cancer based on the standard 12 LN examined, whereas the 20 LN cutoff examined was associated with a significant increase in 6-year OS in all patients (HR = 1.51, P < .001). Multivariate regression revealed a significant decrease in 6-year OS in stage II (HR = 1.39, P = .026) and stage III (HR = 1.47, P < .001) with < 20 LN yield. In the NCR, < 20 LN was associated with poorer 6-year OS in stage II–III patients (HR = 1.25, P < .001), stage II (HR = 1.43, P < .001), and stage III (HR = 1.13, P = .007).
Conclusion
Over the past decade, inadequate LN examinations have significantly decreased. Compared to < 12 LN, < 20 LN examined is more associated with a worse prognosis in patients who underwent surgery.
背景:淋巴结(LN)检查对结直肠癌的分期很重要。检查< 12 LN与预后不良有关。然而,手术和病理的进步导致检查的LN增加,需要重新评估预后的最佳界限。患者和方法:我们回顾了来自延世癌症中心登记处(YCC)数据库和荷兰癌症登记处(NCR)的II-III期结肠癌患者。通过与12例LN的风险比(HR)比较,确定最佳LN截止值。我们比较了较高和较低的LN截止效应对6年总生存期(OS)的影响。结果:2005 ~ 2015年,LN < 12的患者比例明显下降(P < 0.001)。在所有II-III期结肠癌患者(HR = 1.21, P = 0.116)、II期(HR = 1.39, P = 0.068)和III期(HR = 1.18, P = 0.297)中,基于标准12个LN检查的6年OS与所有患者的6年OS显著增加相关(HR = 1.51, P < .001)。多因素回归显示,6年OS在II期(HR = 1.39, P = 0.026)和III期(HR = 1.47, P < 0.001)显著降低,LN产率< 20。在NCR中,II-III期(HR = 1.25, P < .001)、II期(HR = 1.43, P < .001)和III期(HR = 1.13, P = .007)患者< 20 LN与较差的6年OS相关。结论:在过去的十年中,LN检查不充分的情况显著减少。与< 12 LN相比,接受手术的患者检查< 20 LN与较差的预后更相关。
{"title":"Number of Lymph Nodes Examined as a Prognosis Factor in Patients With Stage II or III Colon Cancer","authors":"Hyunwook Kim , Lingjie Shen , Jeongseok Jeon , Yoon Dae Han , Dai Hoon Han , Minsun Jung , Seo Jeong Shin , Seng Chan You , Nam Kyu Kim , Byung Soh Min , Hyuk Hur , Joong Bae Ahn , Sang Joon Shin , Anna Jacoba van Gestel , Felice N. van Erning , Gijs Geleijnse , Han Sang Kim","doi":"10.1016/j.clcc.2025.02.004","DOIUrl":"10.1016/j.clcc.2025.02.004","url":null,"abstract":"<div><h3>Background</h3><div>Lymph node (LN) examination is important for staging colorectal cancer. Examining < 12 LN has been associated with a poor prognosis. However, surgical and pathological advances have led to increase examined LN, necessitating the reassessment of the best cutoff for prognosis.</div></div><div><h3>Patients and Methods</h3><div>We reviewed patients with stage II–III colon cancer from the Yonsei Cancer Center Registry (YCC) database and the Netherlands Cancer Registry (NCR). The optimal LN cutoff was determined by comparison with hazard ratio (HR) in 12 LN. We compared higher vs. lower LN cutoff effects on a 6-year overall survival (OS).</div></div><div><h3>Results</h3><div>From 2005 to 2015, the proportion with < 12 LN decreased significantly (<em>P</em> < .001). There was no significant association between 6-year OS and LN yield in all stages II–III patients (HR = 1.21, <em>P</em> = .116), stage II (HR = 1.39, <em>P</em> = .068), and stage III (HR = 1.18, <em>P</em> = .297) colon cancer based on the standard 12 LN examined, whereas the 20 LN cutoff examined was associated with a significant increase in 6-year OS in all patients (HR = 1.51, <em>P</em> < .001). Multivariate regression revealed a significant decrease in 6-year OS in stage II (HR = 1.39, <em>P</em> = .026) and stage III (HR = 1.47, <em>P</em> < .001) with < 20 LN yield. In the NCR, < 20 LN was associated with poorer 6-year OS in stage II–III patients (HR = 1.25, <em>P</em> < .001), stage II (HR = 1.43, <em>P</em> < .001), and stage III (HR = 1.13, <em>P</em> = .007).</div></div><div><h3>Conclusion</h3><div>Over the past decade, inadequate LN examinations have significantly decreased. Compared to < 12 LN, < 20 LN examined is more associated with a worse prognosis in patients who underwent surgery.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 280-289.e4"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143694432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-12-04DOI: 10.1016/j.clcc.2024.11.005
Neal Bhutiani MD, PhD , Chung-Yuan Hu MPH, PhD , Bryan Palis MS , Joseph Cotler MA, PhD , Qian Shi PhD , M. Kay Washington MD , Richard M. Goldberg MD , Scott R. Steele MD, MBA , George J. Chang MD, MS, MHCM
Background
Current American Joint Committee on Cancer (AJCC) staging for colorectal cancer utilizes TNM framework groups disease based on extent and provides prognostic information, ideally with a hierarchical logic. We sought to evaluate survival as a function of stage within the 8th edition AJCC staging system for colon and rectal cancer.
Methods
Patients with primary colon or rectal cancer diagnosed 2010-2016 were identified from the National Cancer Database (NCDB). Survival curves were used to determine staging hierarchy for colon and rectal cancer. Multivariable modeling was used to identify relative contributions of variables (z-score) to survival, and hazard ratio (HR)-based groupings were constructed.
Results
Among 270,584 colon and 53,846 rectal cancer patients, AJCC summary staging was non-hierarchical (e.g. HR IIC=2.92, HR IIIA=0.85-1.31). Multivariable analysis demonstrated high T category (T4a, T4b) confers the greatest mortality (colon: T4a HR 2.76, T4b HR 3.04; rectum: T4a HR 3.29, T4b HR 3.73), while high T category as well as high N category (colon: T4a z=66.9, T4b z=64.6, N2b z=55.7; rectum: T4b z=31.1, N2b z=25.1) contributed substantially to the survival model. HR based TN groupings resulted in hierarchical stage organization.
Conclusions
Current AJCC stage groups for colorectal cancer are non-hierarchical. High T category has a greater impact on survival than N category for patients with early N disease, while high N category was more important for patients with early T disease. An organizational framework based on HR groupings is hierarchical and provides more accurate prognostic information.
{"title":"Lack of Hierarchical Survival Prognosis in AJCC Staging for Colon and Rectal Cancer—Implications for Future Summary Stage Classification","authors":"Neal Bhutiani MD, PhD , Chung-Yuan Hu MPH, PhD , Bryan Palis MS , Joseph Cotler MA, PhD , Qian Shi PhD , M. Kay Washington MD , Richard M. Goldberg MD , Scott R. Steele MD, MBA , George J. Chang MD, MS, MHCM","doi":"10.1016/j.clcc.2024.11.005","DOIUrl":"10.1016/j.clcc.2024.11.005","url":null,"abstract":"<div><h3>Background</h3><div>Current American Joint Committee on Cancer (AJCC) staging for colorectal cancer utilizes TNM framework groups disease based on extent and provides prognostic information, ideally with a hierarchical logic. We sought to evaluate survival as a function of stage within the 8<sup>th</sup> edition AJCC staging system for colon and rectal cancer.</div></div><div><h3>Methods</h3><div>Patients with primary colon or rectal cancer diagnosed 2010-2016 were identified from the National Cancer Database (NCDB). Survival curves were used to determine staging hierarchy for colon and rectal cancer. Multivariable modeling was used to identify relative contributions of variables (z-score) to survival, and hazard ratio (HR)-based groupings were constructed.</div></div><div><h3>Results</h3><div>Among 270,584 colon and 53,846 rectal cancer patients, AJCC summary staging was non-hierarchical (e.g. HR IIC=2.92, HR IIIA=0.85-1.31). Multivariable analysis demonstrated high T category (T4a, T4b) confers the greatest mortality (colon: T4a HR 2.76, T4b HR 3.04; rectum: T4a HR 3.29, T4b HR 3.73), while high T category as well as high N category (colon: T4a z=66.9, T4b z=64.6, N2b z=55.7; rectum: T4b z=31.1, N2b z=25.1) contributed substantially to the survival model. HR based TN groupings resulted in hierarchical stage organization.</div></div><div><h3>Conclusions</h3><div>Current AJCC stage groups for colorectal cancer are non-hierarchical. High T category has a greater impact on survival than N category for patients with early N disease, while high N category was more important for patients with early T disease. An organizational framework based on HR groupings is hierarchical and provides more accurate prognostic information.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 159-165.e2"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142901185","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-12-03DOI: 10.1016/j.clcc.2024.11.004
Julian Hamfjord , Tormod Kyrre Guren , Bengt Glimelius , Halfdan Sorbye , Per Pfeiffer , Olav Dajani , Ole Christian Lingjærde , Kjell Magne Tveit , Karen-Lise Garm Spindler , Niels Pallisgaard , Elin H. Kure
Introduction
Patients with metastatic colorectal cancer (mCRC) respond differently to first-line chemotherapy. Early identification of patients with limited or no clinical benefit could prompt a timelier introduction of second-line therapy and potentially lead to improved overall outcomes. Carcinoembryonic antigen (CEA) is currently the only blood-based marker in clinical use for disease control monitoring in mCRC. Circulating cell-free DNA (cfDNA), including circulating tumor DNA (ctDNA) could become a useful surrogate for oncological outcomes.
Materials and Methods
Forty patients with RAS-/BRAF-mutated mCRC from the prospective NORDIC-VII trial (NCT00145314) were included. An exploratory model system was made to describe the early on-treatment kinetics of CEA, cfDNA and ctDNA during first-line oxaliplatin-based chemotherapy, and investigate the associations with radiological response, progression-free survival (PFS) and overall survival (OS).
Results
Summary metrics were made, representing percentage change from treatment start to time-grid day 7 (P7), day 14 (P14), and day 49 (P49); slope from time-grid day 0 to 7 (S7), day 8 to 14 (S14), and day 15 to 49 (S49); and area under the curve from time-grid day 0 to 49 (AUC). Notably P49 and S49 for ctDNA and CEA were associated with radiological response and/or PFS. The early dynamics of the two markers differed substantially, with faster and more marked changes in ctDNA compared with CEA. Nine patients did not reach complete/near complete molecular ctDNA response close to first evaluation (∼week 8), a state associated with a short PFS (HR 2.72; 95% CI, 1.22-6.06; P = .01) and OS (HR 3.12; 95% CI, 1.35-7.23; P < .01). Contrary, twenty-two patients did not reach radiological response (i.e., complete or partial response) at first evaluation, but this was not associated with PFS (HR 1.21; 95% CI, 0.64-2.30; P = .55) nor OS (HR 1.37; 95% CI, 0.70-2.68; P = .37).
Conclusion
Early dynamics of ctDNA during first-line oxaliplatin-based chemotherapy hold prognostic value, supporting the idea of prospectively validating a ctDNA-RECIST framework in the early care pathway of mCRC patients.
{"title":"Exploring Early Kinetic Profiles of CEA, ctDNA and cfDNA in Patients With RAS-/BRAF-Mutated Metastatic Colorectal Cancer","authors":"Julian Hamfjord , Tormod Kyrre Guren , Bengt Glimelius , Halfdan Sorbye , Per Pfeiffer , Olav Dajani , Ole Christian Lingjærde , Kjell Magne Tveit , Karen-Lise Garm Spindler , Niels Pallisgaard , Elin H. Kure","doi":"10.1016/j.clcc.2024.11.004","DOIUrl":"10.1016/j.clcc.2024.11.004","url":null,"abstract":"<div><h3>Introduction</h3><div>Patients with metastatic colorectal cancer (mCRC) respond differently to first-line chemotherapy. Early identification of patients with limited or no clinical benefit could prompt a timelier introduction of second-line therapy and potentially lead to improved overall outcomes. Carcinoembryonic antigen (CEA) is currently the only blood-based marker in clinical use for disease control monitoring in mCRC. Circulating cell-free DNA (cfDNA), including circulating tumor DNA (ctDNA) could become a useful surrogate for oncological outcomes.</div></div><div><h3>Materials and Methods</h3><div>Forty patients with <em>RAS-</em>/<em>BRAF-</em>mutated mCRC from the prospective NORDIC-VII trial (NCT00145314) were included. An exploratory model system was made to describe the early on-treatment kinetics of CEA, cfDNA and ctDNA during first-line oxaliplatin-based chemotherapy, and investigate the associations with radiological response, progression-free survival (PFS) and overall survival (OS).</div></div><div><h3>Results</h3><div>Summary metrics were made, representing percentage change from treatment start to time-grid day 7 (P<sub>7</sub>), day 14 (P<sub>14</sub>), and day 49 (P<sub>49</sub>); slope from time-grid day 0 to 7 (S<sub>7</sub>), day 8 to 14 (S<sub>14</sub>), and day 15 to 49 (S<sub>49</sub>); and area under the curve from time-grid day 0 to 49 (AUC). Notably P<sub>49</sub> and S<sub>49</sub> for ctDNA and CEA were associated with radiological response and/or PFS. The early dynamics of the two markers differed substantially, with faster and more marked changes in ctDNA compared with CEA. Nine patients did not reach complete/near complete molecular ctDNA response close to first evaluation (∼week 8), a state associated with a short PFS (HR 2.72; 95% CI, 1.22-6.06; <em>P</em> = .01) and OS (HR 3.12; 95% CI, 1.35-7.23; <em>P</em> < .01). Contrary, twenty-two patients did not reach radiological response (i.e., complete or partial response) at first evaluation, but this was not associated with PFS (HR 1.21; 95% CI, 0.64-2.30; <em>P</em> = .55) nor OS (HR 1.37; 95% CI, 0.70-2.68; <em>P</em> = .37).</div></div><div><h3>Conclusion</h3><div>Early dynamics of ctDNA during first-line oxaliplatin-based chemotherapy hold prognostic value, supporting the idea of prospectively validating a ctDNA-RECIST framework in the early care pathway of mCRC patients.</div><div><strong>Trial registration:</strong> ClinicalTrials.gov, NCT00145314</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 153-158"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142916082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-06-01Epub Date: 2024-12-11DOI: 10.1016/j.clcc.2024.12.002
Julien Taieb , Marwan Fakih , Josep Tabernero , Fortunato Ciardiello , Eric Van Cutsem , Gemma Soler , Elizabeth Calleja , Valentine Barboux , Lucas Roby , Nadia Amellal , Gerald W. Prager
Background
The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).
Methods
Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan–Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.
Results
Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.
Conclusion
This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.
{"title":"Impact of Treatment With Trifluridine/Tipiracil in Combination With Bevacizumab on Health-Related Quality of Life and Performance Status in Refractory Metastatic Colorectal Cancer: An Analysis of the Phase III SUNLIGHT Trial","authors":"Julien Taieb , Marwan Fakih , Josep Tabernero , Fortunato Ciardiello , Eric Van Cutsem , Gemma Soler , Elizabeth Calleja , Valentine Barboux , Lucas Roby , Nadia Amellal , Gerald W. Prager","doi":"10.1016/j.clcc.2024.12.002","DOIUrl":"10.1016/j.clcc.2024.12.002","url":null,"abstract":"<div><h3>Background</h3><div>The efficacy of trifluridine/tipiracil (FTD/TPI) + bevacizumab compared to FTD/TPI for treatment of refractory metastatic colorectal cancer (mCRC) was demonstrated in the SUNLIGHT trial. This analysis of SUNLIGHT investigated the impact of treatment with FTD/TPI + bevacizumab on patient quality of life (QoL) and Eastern Cooperative Oncology Group performance status (ECOG PS).</div></div><div><h3>Methods</h3><div>Questionnaires (EORTC QLQ-C30 and EQ-5D-5L) and ECOG PS assessments were conducted at baseline and on Day 1 of each treatment cycle. Time to definitive deterioration (TTDD) of QoL and time to ECOG PS worsening between treatment arms was assessed. A repeated-measures mixed-effects model was used to compare changes in QoL and ECOG PS from baseline. Kaplan–Meier and Cox regression methods were used to assess TTDD of QoL, time to ECOG PS worsening to ≥ 2, and overall survival (OS) and progression-free survival (PFS) in patients maintaining an ECOG PS of 0-1.</div></div><div><h3>Results</h3><div>Both treatment arms showed similar QoL scores from baseline to cycle 6, with no clinically relevant change over time. Patients receiving FTD/TPI + bevacizumab had a longer TTDD of QoL than patients receiving FTD/TPI, as well as longer time to ECOG PS worsening. In patients with maintained ECOG PS, median OS and PFS was prolonged in the FTD/TPI + bevacizumab arm compared to the FTD/TPI arm.</div></div><div><h3>Conclusion</h3><div>This analysis of SUNLIGHT showed that patients treated with FTD/TPI + bevacizumab had no clinically relevant changes in QoL, and prolonged TTDD and time to ECOG PS worsening, compared to patients treated with FTD/TPI.</div></div>","PeriodicalId":10373,"journal":{"name":"Clinical colorectal cancer","volume":"24 2","pages":"Pages 180-187.e4"},"PeriodicalIF":3.3,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143018319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}