期刊
CANCER
卷 110, 期 12, 页码 2666-2671出版社
JOHN WILEY & SONS INC
DOI: 10.1002/cncr.23091
关键词
elderly patients; FOLFOX; 5-fluorouracil; metastatic colorectal cancer; oxaliplatin
类别
BACKGROUND. Patients older than 75 years of age are usually excluded from metastatic colorectal cancer randomized studies. The OPTIMOX1 study evaluated FOLFOX7, a simplified (s) leucovorin (LV) and 5-fluorouracil (5FU) regimen (sLV5FU2) with high-dose oxaliplatin, in a new oxaliplatin stop-and-go strategy. An exploratory cohort of patients aged 76 to 80 years was included in the study. METHODS. in all, 620 previously untreated patients were randomized between FOLFOX4 until progression (arm A), or FOLFOX7 for 6 cycles, maintenance without oxaliplatin for 12 cycles, and reintroduction of FOLFOX7 (arm 13). RESULTS. A total of 37 patients aged 76 to 80 years were included, 20 in arm A and 17 in arm B. The overall response rate (ORR) was 59.4%, comparable to younger patients (59%). Median progression-free survival (PFS) was 9.0 months and median overall survival (OS) was 20.7 months. These results did not differ from that in younger patients <= 75 years in the OPTIMOX1 study with PFS 9.0 months (P=.63) and OS 20.2 months (P =.57). They experienced slightly more grade 3 of 4 toxicity than younger patients: 65% versus 48% (P =.06), mainly with more neutropenia (4 1 % vs 24%, P =.03) and neurotoxicity (22% vs 11 %, P =.06). Tolerability, however, was manageable and no toxic death occurred in this elderly population. CONCLUSIONS. The efficacy of FOLFOX-based treatment was maintained in patients >75 years with both FOLFOX regimens. The oxaliplatin stop-and-go management strategy performed well in this population.
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