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]

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.

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.

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.

Cost-effectiveness of adjuvant capecitabine, Mayo Clinic and de Gramont regimens for stage III colon cancer in the French setting

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 13506-13506
Author(s):  
P. R. Dufour ◽  
J. Douillard ◽  
M. Ychou ◽  
J. Seitz ◽  
G. Perrocheau ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Clinical Trials ◽  
Cost Effectiveness ◽  
Adjuvant Treatment ◽  
Mayo Clinic ◽  
Stage Iii ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Stage Iii Colon Cancer ◽  
The Cost

13506 Background: The oral fluoropyrimidine capecitabine is as effective but better tolerated than i.v. 5-FU/LV as first-line treatment in patients (pts) with metastatic colorectal cancer. Costs associated with the administration route could vary widely according to national rules and medical practice. We compared costs and outcomes of capecitabine, the Mayo Clinic, and de Gramont regimens as adjuvant treatment for stage III colon cancer. Methods: We assessed the cost-effectiveness of the three regimens using the third-party payer perspective, time horizon and efficacy/safety data (adjusted for indirect comparisons) from two published clinical trials [Twelves et al. N Engl J Med 2005; Andre et al. J Clin Oncol 2003]. The costs of chemotherapy and the treatment of side effects were estimated from the clinical trials and expert opinion. We applied French standard costs to resources consumed and evaluated cost-effectiveness using relapse-free survival (RFS), defined in X-ACT study, as an efficacy indicator. One-way sensitivity analyses were performed varying the cost estimates for each treatment. Results: Capecitabine-treated pts had a mean life duration increase without treatment failure of 1.3 months vs. Mayo (see table). De Gramont was considered as effective as Mayo. In the base-case analysis capecitabine appeared to be dominant, more effective and less costly than either Mayo Clinic or de Gramont. In the sensitivity analyses, capecitabine remained dominant except for the minimum costs scenario vs. de Gramont. In this case, the cost-effectiveness ratio was estimated at 8997.55€ per year without relapse. Conclusions: As adjuvant treatment for colon cancer, capecitabine decreases medical resources consumed, mainly in hospitals. Its approval in this setting is expected to bring cost savings and better outcomes. [Table: see text] [Table: see text]

scholarly journals Cost-effectiveness of oxaliplatin and capecitabine in the adjuvant treatment of stage III colon cancer

2006 ◽  
Vol 95 (9) ◽  
pp. 1195-1201 ◽  
Author(s):  
S Eggington ◽  
P Tappenden ◽  
A Pandor ◽  
S Paisley ◽  
M Saunders ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Cost Effectiveness ◽  
Adjuvant Treatment ◽  
Stage Iii ◽  
Stage Iii Colon Cancer

Oxaliplatin, Fluorouracil, and Leucovorin as Adjuvant Treatment for Colon Cancer

2017 ◽  
Author(s):  
Kelly McLeon
Keyword(s):  
Colon Cancer ◽  
Adjuvant Treatment ◽  
Disease Free Survival ◽  
Stage Iii ◽  
Reference Standard ◽  
Free Survival ◽  
Stage Iii Colon Cancer ◽  
Study Intervention ◽  
Disease Free

The landmark MOSAIC trial examined whether the addition of oxaliplatin to a postoperative adjuvant treatment regimen of fluorouracil and leucovorin affected disease-free survival from colon cancer. The MOSAIC trial established the efficacy of FOLFOX over 5-FU/LV as adjuvant treatment for stage III colon cancer and established FOLFOX4 as the reference standard for adjuvant treatment for stage III disease. This chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case.

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