FOLFOX4 as adjuvant therapy in elderly patients (pts) with colon cancer (CC): Subgroup analysis of the MOSAIC trial.
2010; Lippincott Williams & Wilkins; Volume: 28; Issue: 15_suppl Linguagem: Inglês
10.1200/jco.2010.28.15_suppl.3522
ISSN1527-7755
AutoresChristophe Tournigand, Thierry André, Jean‐Baptiste Bachet, Luís Teixeira, C. Boni, P. Clingan, Tamas Hickish, Josep Tabernero, Aimery de Gramont,
Tópico(s)Cancer Treatment and Pharmacology
Resumo3522 Background: In elderly CC pts, adjuvant 5FU-based chemotherapy increases overall survival (OS) and disease-free survival (DFS) (Sargent, NEJM 2001). FOLFOX4 improved DFS and OS in stage III (André, JCO 2009). In a pooled analysis of NSABP-C07 and MOSAIC trials, oxaliplatin/5FU-based chemotherapy was not superior to 5FU/LV in pts ≥ 70 years (Jackson Mc Cleary, ASCO 2009). Methods: We performed a subgroup analysis of pts aged ≥ 70 yrs in the MOSAIC trial, reviewing clinical characteristics, comorbidities according to Adult Comorbidity Evaluation-27, SAEs, 2nd cancer and cause of death. Results: 315 pts ≥ 70 yrs were randomized between FOLFOX4 (155 pts) and LV5FU2 (160 pts). Median follow-up was 6 yrs. DFS hazard ratio (HR) was 0.91; 95% confidence interval (CI) 0.62 to 1.34 and OS HR was 1.10; 95% CI 0.73 to 1.65. No imbalance was observed for initial characteristics. In the FOLFOX4 arm and the LV5FU2 arm, 59 and 66 pts were stage II, 38 and 42 high risk stage II (pT4 and/or < 12 lymph nodes), 96 and 94 pts were stage III, 24 and 29 N2, 85 and 93 pts had grade 1-2 comorbidities, including 74 and 75 pre-existing cardiovascular disease, respectively. 30 pts had a SAE (treatment related 9, cardiovascular 4 and other 19) with FOLFOX4 compared to 15 pts (treatment 3, cardiovascular 2, other 10) with LV5FU2 (p = 0.02). Less patients had surgery of metastases (9 vs. 22; p = 0.01) and irinotecan- or oxaliplatin-based therapy (16 vs. 30; p = 0.01) at relapse in the FOLFOX4 than in the LVFU2 arm. More deaths not CC-related occurred with FOLFOX4 than with LV5FU2 (22 vs. 11; p = 0.043), including second cancer deaths, 9 vs. 1 pts, respectively (p = 0.02). Conclusions: The DFS benefit of FOLFOX4 in elderly pts could be of less magnitude than in the younger population. Lack of OS benefit is not related to initial tumor characteristics or comorbidities, but to different management or outcome of relapses or second cancers. More pts died of second malignancy in FOLFOX4 arm. Higher occurrence of SAEs and difficulties in treatment of relapses argue to reduce the FOLFOX4 duration (IDEA study). An ongoing update and a 10-year follow up will allow the further evaluation of these findings. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Baxter International, Roche, sanofi-aventis Baxter International, Pfizer, Roche, sanofi-aventis sanofi-aventis Roche, sanofi-aventis
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