Tolerability of pemetrexed and oxaliplatin in the treatment of stage III colon cancer during raltitrexed shortage

2020 ◽  
pp. 107815522093416
Author(s):  
Jasmine Giani ◽  
Michael B Sawyer ◽  
Carole Chambers
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Clinical Trials ◽  
Case Report ◽  
Adverse Events ◽  
Phase I ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
Colorectal Cancer Treatment ◽  
Phase I And Ii

Colorectal cancer is one of the most common malignancies diagnosed in Canada. Currently, adjuvant colorectal cancer treatment primarily includes chemotherapeutic regimens such as FOLFOX6 (5-fluorouracil, leucovorin, oxaliplatin) or CAPOX (capecitabine, oxaliplatin), as well as alternative regimens such as TOMOX (raltitrexed, oxaliplatin). However, the prevalence of drug shortages in today’s society may make these preferred regimens inaccessible. The purpose of this case report is to highlight the tolerability of an alternative adjuvant regimen (pemetrexed plus oxaliplatin) that has undergone both phase I and II clinical trials for the treatment of colorectal cancer. The patient presented in this case report is a 57-year-old female diagnosed with Stage III colon cancer. This patient received seven cycles of pemetrexed plus oxaliplatin and experienced several adverse events, with the majority of them being mild in nature including fatigue and cold dysesthesia. However, the patient also experienced progressive neuropathy which required a dose reduction and subsequent discontinuation of oxaliplatin. Overall, pemetrexed and oxaliplatin’s tolerability seems comparable to other regimens used to treat colorectal cancer and could potentially be an option to consider in the future for alternative treatment of colorectal cancer pending further trials.

Stage III Colon Cancer: What Works, What Doesn't and Why, and What's Next

2012 ◽  
pp. 223-230
Author(s):  
Thierry André ◽  
Bert H. O'Neil ◽  
Jeffrey A. Meyerhardt
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Clinical Trials ◽  
Complementary Therapies ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
The Past ◽  
What Works ◽  
Metastatic Setting ◽  
Diet And Exercise

Overview: Adjuvant treatment for patients with stage III colon cancer, one of the most common malignancies, is an important issue in oncology. The use of adjuvant chemotherapy in this setting has undoubtedly improved prognosis. This article describes the development of adjuvant therapy and progress in the past decade as well as failures in multiple agents that have demonstrated efficacy in the metastatic setting. Finally, the current clinical trials will be reviewed, as well as complementary therapies including diet and exercise for survivors of colorectal cancer.

Clinical trials versus clinical practice in colorectal cancer: Equivalent populations?

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 802-802
Author(s):  
Alejandra Magdaleno Cremades ◽  
María del Carmen Ors Castaño ◽  
María Ballester Espinosa ◽  
Marta Llopis Cuquerella ◽  
María del Rocío Ramirez Belloch ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Clinical Trials ◽  
Clinical Practice ◽  
Adjuvant Treatment ◽  
Combination Treatment ◽  
Primary Tumor ◽  
Stage Iv ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

802 Background: Clinical trials are criticized due to inclusion of selected populations. The aim of this analysis is to compare populations included in clinical trials which justify treatment recommendations in stage III and IV colorectal cancer (CRC) to patient populations in our area. Methods: Data related to age, sex, primary tumor and stage of CRC patients consecutively diagnosed in Vega Baja Hospital and Elche University General Hospital were collected. Also data regarding the same variables were collected from the publications of clinical trials which justify adjuvant treatment in stage III colon cancer and combination treatment with chemotherapy and targeted therapies in stage IV CRC. Results: We analyzed 249 patients with stage III colon cancer and 237 patients with stage IV CRC from our area. In our experience, 56.6% of stage III colon cancer were males, and median age was 66.2 years (23 - 91), with 41.8% ≥ 70 years. In clinical trials supporting adjuvant treatment 54 - 56.1% of patients were males, and median age was 59 - 61 years (19-83), with 14 - 21.7% ≥ 70 years. In our experience 64.4% of stage IV CRC patients were males, and median age was 67.2 years (38-89), 76.4% primary tumor in colon. In clinical trials supporting combination treatment with chemotherapy and targeted therapies 60-67% of patients were males, and median age was 59.2 – 62 years, primary tumor in colon 57.9 – 81% (Table). Conclusions: Patient populations included in clinical trials which support standard treatment in CRC are younger to those in our area. This fact, added to the restrictions based on inclusion and exclusion criteria of clinical trials, justify the qualification of “selected” to these populations not being representative of our clinical practice. [Table: see text]

Clinical efficacy and safety of early adjuvant chemotherapy for stage III colon cancer: Short-term outcomes of a multicenter, randomized, open-label, phase 3 trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3598-3598
Author(s):  
Jun Seok Park ◽  
Soo Yeun Park ◽  
Gyu-Seog Choi ◽  
Hye Jin Kim ◽  
Jong Gwang Kim ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Surgical Complication ◽  
Phase Iii ◽  
Stage Iii ◽  
Survival Outcomes ◽  
Stage Iii Colon Cancer

3598 Background: Adjuvant chemotherapy (AC) is recommended to commence within 8 weeks since after surgical resection of stage II or III colon cancer. Results of many retrospective studies showed inferior survival outcomes following delay of AC delay. Moreover, preclinical studies showed that the progression of disseminated cancer cells is profound during the postoperative period. This study is the first prospective trial to evaluate early (≤ 14 days postoperative) AC for patients (pts) with stage III colon cancer. Methods: This study is a prospective, multicenter, randomized phase III trial. Pts with pathological stage III colon cancer were enrolled and randomized 1:1 to early AC (starting AC ≤ 14 days after surgery) or conventional AC (starting AC > 14 days after surgery). Pts were recommended to receive 12 cycles of FOLFOX-6 for AC. The primary endpoint was disease-free survival. The secondary endpoints were overall survival, adverse events, surgical complication during AC, and patient-reported outcomes (quality of life) during 1 year after surgery. Herein, safety data, chemotherapy delivery, and quality of life are presented. Results: This study randomized 443 pts either early AC arm (221pts) or early AC arm (222 pts) to the during September 2011 to March 2020. 380 pts who received at least one cycle of FOLFOX-6 were included in the safety analysis (192 and 188 in the early and conventional AC arms, respectively). The baseline characteristics of the two groups were well-balanced except for the interval from the surgery to the initial AC. The early and conventional AC arms started their first chemotherapy at median of 13 (4-43 days) and 29 (17-53 days) after surgery (p < 0.001), respectively. No significant differences were seen in the median chemotherapy cycles, AC completion, and relative oxaliplatin dose intensity between groups. AC Completion without any change of dose or schedule delay was seen in 18% and 20% in early and conventional AC arms respectively, while dose reduction or delay was 65% and 61%, respectively. Toxicities of grade 3 or more were seen in 28% in both groups. One patient in the early AC arm underwent an emergent operation for anastomotic leakage on the second day of 5-fluorouracil infusion (postoperative day 14). However, the surgical complication was not seen in any other patient. The scores of the European Organization for Research and Treatment of Cancer Quality of Life core 30 questionnaire were similar in both arms at baseline (before starting AC), and 1 month, 3 months, 6 months, and 12 months after surgery. Conclusions: Early AC was safe and did not increase either chemotherapy-related adverse events or surgery-related complications during treatment. Moreover early AC did not reduce the quality of life of the pts during 1 year after surgery. This study continues to follow-up the patients for survival outcomes. Clinical trial information: NCT01460589.

Irinotecan Fluorouracil Plus Leucovorin Is Not Superior to Fluorouracil Plus Leucovorin Alone As Adjuvant Treatment for Stage III Colon Cancer: Results of CALGB 89803

2007 ◽  
Vol 25 (23) ◽  
pp. 3456-3461 ◽  
Author(s):  
Leonard B. Saltz ◽  
Donna Niedzwiecki ◽  
Donna Hollis ◽  
Richard M. Goldberg ◽  
Alexander Hantel ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Metastatic Colorectal Cancer ◽  
Adjuvant Treatment ◽  
Disease Free Survival ◽  
Patient Characteristics ◽  
Stage Iii ◽  
Stage Iii Colon Cancer ◽  
First Line Therapy ◽  
Weekly Bolus

Purpose Randomized studies have shown that irinotecan (CPT-11) extends survival in metastatic colorectal cancer patients when administered in second-line and when added to fluorouracil (FU) plus leucovorin (LV) in first-line therapy of metastatic colorectal cancer. When this study was initiated, FU plus LV was standard adjuvant treatment for stage III colon cancer. We evaluated the efficacy and safety of weekly bolus CPT-11 plus FU plus LV in the treatment of patients with completely resected stage III colon cancer. Methods A total of 1,264 patients were randomly assigned to receive either standard weekly bolus FU plus LV regimen or weekly bolus CPT-11 plus FU plus LV. The primary end points of the study were overall survival (OS) and disease-free survival (DFS). Results Treatment arms were well-balanced for patient characteristics and prognostic variables. There were no differences in either DFS or OS between the two treatment arms. Toxicity, including lethal toxicity, was significantly higher on the CPT-11 plus FU plus LV arm. Conclusion The addition of CPT-11 to weekly bolus FU plus LV did not result in improvement in DFS or OS in stage III disease, but did increase both lethal and nonlethal toxicity. This trial demonstrates that advances in the treatment of metastatic disease do not necessarily translate into advances in adjuvant treatment, and it reinforces the need for randomized controlled adjuvant studies.

scholarly journals Comparison of adverse events during 5-fluorouracil versus 5-fluorouracil/oxaliplatin adjuvant chemotherapy for stage III colon cancer

Cancer ◽  
2012 ◽  
Vol 118 (17) ◽  
pp. 4309-4320 ◽  
Author(s):  
Hanna K. Sanoff ◽  
William R. Carpenter ◽  
Janet Freburger ◽  
Ling Li ◽  
Kun Chen ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

scholarly journals Adverse Events in Elderly Patients on Adjuvant Therapy With UFT/LV OR S-1 For Stage III Colon Cancer: ACTS-CC Trial [TRICC0706]

2012 ◽  
Vol 23 ◽  
pp. ix197
Author(s):  
M. Ishiguro ◽  
H. Uetake ◽  
T. Ishikawa ◽  
Y. Kusunoki ◽  
F. Kinoshita ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Adjuvant Therapy ◽  
Adverse Events ◽  
Elderly Patients ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

scholarly journals Severe rhabdomyolysis related to oxaliplatin adjuvant therapy for colorectal cancer

2019 ◽  
Vol 12 (4) ◽  
pp. e228673 ◽  
Author(s):  
Ana Pissarra ◽  
Mariana Malheiro ◽  
Leonor Vasconcelos Matos ◽  
Ana Neto Plácido
Keyword(s):  
Colorectal Cancer ◽  
Colon Cancer ◽  
Adjuvant Chemotherapy ◽  
Stage Iii ◽  
Standard Chemotherapy ◽  
Postoperative Adjuvant Chemotherapy ◽  
Stage Iii Colon Cancer ◽  
Distal Muscle ◽  
Common Cancer ◽  
Resected Stage

Colorectal cancer is the third most common cancer in men and the second in women. The standard chemotherapy regiment in stage III colon cancer is based in oxaliplatin. The most common side effects include neutropenia, peripheral neuropathy, vomiting and diarrhoea. Rhabdomyolysis due to oxaliplatin is rare, and there are no established guidelines for managing this adverse event. This report describes a case of a 52-year-old man, with a resected stage III colon cancer that started postoperative adjuvant chemotherapy with capecitabine plus oxaliplatin. After the second cycle, the patient developed distal muscle pain and weakness, with a total inability to walk. Blood tests showed an elevated creatine kinase and renal injury. Severe drug-related rhabdomyolysis was diagnosed. The goal of this case report is to discuss the side effect of adjuvant chemotherapy, given its rarity and severity.

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