Gertraud Stocker1, Ulrich T Hacker2, Frédéric Fiteni3, Jestinah John Mahachie4, Arnaud D Roth5, Eric Van Cutsem6, Marc Peeters7, Florian Lordick2, Murielle Mauer4. 1. University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany. Electronic address: gertraud.stocker@medizin.uni-leipzig.de. 2. University Cancer Center Leipzig (UCCL), University Medicine Leipzig, Leipzig, Germany. 3. Medical Oncology Department, University Hospital of Nîmes, Nîmes, France; Unité de biométrie, Institut du Cancer de Montpellier, Montpellier, France. 4. EORTC Headquarters, Brussels, Belgium. 5. Oncosurgery Unit, Geneva University Hospital, Geneva, Switzerland. 6. Department of Gastroenterology and Digestive Oncology, University Hospitals and KU Leuven, Leuven, Belgium. 7. Department of Oncology, Antwerp University Hospital, Antwerp, Belgium.
Abstract
BACKGROUND: Dose reduction in obese cancer patients has been replaced by fully weight-based dosing recommendations. No data, however, are available on the effects of dose reduction in obese stage III colon cancer patients undergoing adjuvant chemotherapy. METHODS:Survival outcomes and toxicity data of obese (body mass index [BMI] ≥30 kg/m2), stage III colon cancer patients treated within the phase III PETACC 3 trial comparing leucovorin, 5-FU (LV5FU2) with LV5FU2 plus irinotecan were analysed retrospectively according to chemotherapy dosing at first infusion (i.e. fully weight-based dosed - versus dose-reduced group). Multivariate analyses on relapse free survival (RFS) and overall survival (OS) were conducted to adjust for baseline prognostic factors using Cox regression model. RESULTS: 13.4% (280 of 2094 patients) had a BMI ≥ 30 kg/m2, and 5.3% had both a BMI ≥ 30 kg/m2 and a body surface area (BSA) ≥2 m2. Dose reductions occurred in 16.1% of patients with a BMI ≥ 30 kg/m2 and 32.4% with BMI ≥ 30 kg/m2 and BSA ≥ 2 m2, respectively. In patients with BMI ≥ 30 kg/m2, multivariate analysis demonstrated a trend towards better RFS in the fully dosed compared to the dose-reduced group (Hazard ratio (HR): 0.69, 95% CI: 0.43-1.09; p = 0.11); however, there was no statistically significant difference in OS. In patients with BMI ≥ 30 kg/m2 and BSA ≥ 2 m2, multivariate analysis demonstrated better RFS in fully dosed compared with dose-reduced patients (HR: 0.48, 95% CI: 0.27-0.85; p = 0.01) and a strong trend towards better OS (HR: 0.53, 95% CI: 0.28-1.01; p = 0.052). This group comprised predominantly of men. CONCLUSIONS: Data support the recommendation of using fully dosed chemotherapy for the adjuvant treatment in obese patients with colon cancer.
RCT Entities:
BACKGROUND: Dose reduction in obese cancerpatients has been replaced by fully weight-based dosing recommendations. No data, however, are available on the effects of dose reduction in obese stage III colon cancerpatients undergoing adjuvant chemotherapy. METHODS: Survival outcomes and toxicity data of obese (body mass index [BMI] ≥30 kg/m2), stage III colon cancerpatients treated within the phase III PETACC 3 trial comparing leucovorin, 5-FU (LV5FU2) with LV5FU2 plus irinotecan were analysed retrospectively according to chemotherapy dosing at first infusion (i.e. fully weight-based dosed - versus dose-reduced group). Multivariate analyses on relapse free survival (RFS) and overall survival (OS) were conducted to adjust for baseline prognostic factors using Cox regression model. RESULTS: 13.4% (280 of 2094 patients) had a BMI ≥ 30 kg/m2, and 5.3% had both a BMI ≥ 30 kg/m2 and a body surface area (BSA) ≥2 m2. Dose reductions occurred in 16.1% of patients with a BMI ≥ 30 kg/m2 and 32.4% with BMI ≥ 30 kg/m2 and BSA ≥ 2 m2, respectively. In patients with BMI ≥ 30 kg/m2, multivariate analysis demonstrated a trend towards better RFS in the fully dosed compared to the dose-reduced group (Hazard ratio (HR): 0.69, 95% CI: 0.43-1.09; p = 0.11); however, there was no statistically significant difference in OS. In patients with BMI ≥ 30 kg/m2 and BSA ≥ 2 m2, multivariate analysis demonstrated better RFS in fully dosed compared with dose-reduced patients (HR: 0.48, 95% CI: 0.27-0.85; p = 0.01) and a strong trend towards better OS (HR: 0.53, 95% CI: 0.28-1.01; p = 0.052). This group comprised predominantly of men. CONCLUSIONS: Data support the recommendation of using fully dosed chemotherapy for the adjuvant treatment in obesepatients with colon cancer.
Authors: Sandrine Boulet; Moreno Ursino; Peter Thall; Bruno Landi; Céline Lepère; Simon Pernot; Anita Burgun; Julien Taieb; Aziz Zaanan; Sarah Zohar; Anne-Sophie Jannot Journal: Stat Methods Med Res Date: 2019-04-09 Impact factor: 2.494