Adjuvant treatment in stage III colon cancer: Comparison of patients recruited into trials and those treated outside a clinical trial: analysis of recruitment, trial effect and inclusion of elderly patients

571 Background: Capecitabine was approved in Japan in 2007 for the adjuvant treatment of stage III colon cancer based on Japanese clinical trial data in advanced and recurrent colorectal and breast cancers as well as data from the Phase III X-ACT trial. For the current study, we aimed to clarify compliance and tolerability of adjuvant treatment with capecitabine in Japanese patients. The study was entered in the UMIN clinical trial registry (UMIN000001444) by the Kyushu Study Group of Clinical Cancer (KSCC). Ethical approval was granted by the institutional review board of each hospital involved. Methods: Based on completion rates from the X-ACT trial we enrolled 97 patients with R0 stage III colon cancer who had histologically confirmed disease and had undergone curative resection (3D2 lymph node dissection). Patients were given oral capecitabine therapy (2,500 mg/m2/day; days 1–14 q3w; eight cycles) within 8 weeks of surgery. The proportion of patients completing eight cycles of treatment per protocol was the primary endpoint, and adverse event (AE) rate was analyzed as a secondary endpoint. Results: Treatment completion in the total patient population was 66.0% (64/97 patients; 95% CI: 55.7–75.3%) and in the per protocol population (PPP) was 70.3% (64/91; 95% CI: 59.8–79.5%). AEs leading to treatment discontinuation included hand-foot syndrome (HFS; n=7), hematotoxicity (n=5) and increased hepatic activity (n=4). Grade 3/4 AEs of note included HFS (22.7%), neutropenia (7.2%), diarrhea (2.1%), and increased bilirubin (0.0%). Of note, any treatment delay >3 weeks in the current trial was considered a withdrawal. In the X-ACT trial, delays of any duration were permitted. Using the X-ACT criteria the completion rate for the PPP in this study was 80.2%, comparable to the figure reported in X-ACT. Conclusions: Our results confirm those of previous global phase III studies and show that capecitabine is well tolerated in both global and Japanese-only populations, with similar high completion rates in both. [Table: see text]

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Effect of PRM1201 Combined With Adjuvant Chemotherapy on Preventing Recurrence and Metastasis of Stage III Colon Cancer: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Frontiers in Oncology ◽

10.3389/fonc.2021.618793 ◽

2021 ◽

Vol 11 ◽

Author(s):

Ru Jia ◽

Ningning Liu ◽

Guoxiang Cai ◽

Yun Zhang ◽

Haijuan Xiao ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Colon Cancer ◽

Placebo Group ◽

Adjuvant Chemotherapy ◽

Adjuvant Treatment ◽

Stage Iii ◽

Stage Iii Colon Cancer ◽

Global Quality Of Life

BackgroundChemotherapy is the standard adjuvant treatment for colon cancer. Chinese herbal formula PRM1201 improves the efficacy of chemotherapy when used in combination with Cetuximab or Bevacizumab in patients with metastatic colorectal cancer. This study aims to explore the benefits of treatment with chemotherapy plus PRM1201 in the postoperative adjuvant setting.MethodsIn this parallel-group study, patients who had undergone curative resection for stage III colon cancer were randomly assigned to receive adjuvant chemotherapy (FOLFOX q2w for 6 months, or CapeOx q3w for 6 months) plus PRM1201 (chemo+PRM1201 group) or adjuvant chemotherapy plus placebo (chemo+placebo group). The primary endpoint was disease-free survival (DFS), and the secondary endpoints were quality of life (QOL) and toxicity.ResultsA total of 370 patients were randomly assigned to chemotherapy plus PRM1201 group (n = 184) and chemotherapy plus placebo group (n = 186). Up to October 30, 2019, 96 events of recurrence, metastasis, or death had been reported, of which 38 events were in the group of chemotherapy plus PRM1201 and 58 events in the chemo+placebo group. The 3-year DFS rate was 77.1 and 68.6% in the chemo+PRM1201 and chemo+placebo group, respectively (hazard ratio [HR], 0.63; 95% CI, 0.42 to 0.94). The QOL of patients in the chemo+PRM1201 group were significantly improved in terms of global quality of life, physical functioning, role functioning, emotional functioning, fatigue, and appetite loss. The incidence of grade 3 or 4 treatment-related adverse event (TRAEs) were similar between the two arms.ConclusionsChemotherapy in combination with PRM1201 improved the adjuvant treatment of colon cancer. PRM1201 can be recommended as an effective option in clinical practice.Clinical Trial RegistrationChinese Clinical Trials Registry, identifier ChiCTR-IOR-16007719.

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Impact of laparoscopy on oncological outcomes after colectomy for stage III colon cancer: A post-hoc multivariate analysis from PETACC8 European randomized clinical trial

Digestive and Liver Disease ◽

10.1016/j.dld.2021.05.012 ◽

2021 ◽

Cited By ~ 1

Author(s):

Thibault Voron ◽

Mehdi Karoui ◽

Réa LoDico ◽

Karine Le Malicot ◽

Eloy Espin ◽

...

Keyword(s):

Clinical Trial ◽

Colon Cancer ◽

Multivariate Analysis ◽

Randomized Clinical Trial ◽

Stage Iii ◽

Stage Iii Colon Cancer ◽

Oncological Outcomes ◽

Post Hoc

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Decreasing Use of Chemotherapy in Older Patients With Stage III Colon Cancer Irrespective of Comorbidities

Journal of the National Comprehensive Cancer Network ◽

10.6004/jnccn.2019.7287 ◽

2019 ◽

Vol 17 (9) ◽

pp. 1089-1099 ◽

Cited By ~ 6

Author(s):

Viola Walter ◽

Daniel Boakye ◽

Janick Weberpals ◽

Lina Jansen ◽

Walter E. Haefeli ◽

...

Keyword(s):

Colon Cancer ◽

Elderly Patients ◽

Old Age ◽

Population Based ◽

Stage Iii ◽

Stage Iii Colon Cancer ◽

Patient Interviews ◽

Chemotherapy Administration ◽

Hospital Factors ◽

Chemotherapeutic Treatment

Background: Chemotherapy underuse in elderly patients (aged ≥75 years) with colon cancer has been reported in previous studies. However, these studies were mostly registry-based and limited in their potential to consider underlying reasons of such undertreatment. This study aimed to evaluate patient and hospital determinants of chemotherapeutic treatment in patients with stage III colon cancer, with a particular focus on age and underlying reasons for nontreatment of elderly patients. Methods: A total of 629 patients with stage III colon cancer who were diagnosed in 2003 through 2012 and recruited into a population-based study in the Rhine-Neckar region of Germany were included. Information on sociodemographic and lifestyle factors, comorbidities, and treatment was collected from patient interviews and physicians. Patient (with an emphasis on age) and hospital factors were evaluated for their associations with administration of adjuvant chemotherapy overall and of oxaliplatin specifically using multivariable logistic regression. Results: Administration of chemotherapy decreased from 94% in patients aged 30 to 64 years to 51% in those aged ≥75 years. A very strong decline in chemotherapy use with age persisted even after comprehensive adjustment for multiple patient factors—including comorbidities—and hospital factors and was also seen among patients without any major comorbidities. Between 2005 and 2008, and 2009 and 2012, chemotherapy administration in patients aged ≥75 years decreased from 60% to 41%. Among chemotherapy recipients, old age was also strongly associated with higher odds of nonadministration of oxaliplatin. The 2 most commonly reported reasons for chemotherapy nonreceipt among the study population were patient refusal (30%) and old age (24%). Conclusions: Age was the strongest predictor of chemotherapy underuse, irrespective of comorbidities and even in patients without comorbidities. Such underuse due just to older age in otherwise healthy patients deserves increased attention in clinical practice to ensure that elderly patients also get the best possible care. Patients’ refusal as the most frequent reason for chemotherapy nonreceipt also warrants further investigation to exclude misinformation as underlying cause.

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