A phase II study of modified FOLFOX as first-line chemotherapy for metastatic gastric cancer in elderly patients with associated diseases

Abstract

Background Elderly patients are generally underrepresented in the study populations of combination chemotherapy trials. This study evaluates the efficacy and safety of a modified FOLFOX regimen in elderly patients with metastatic gastric cancer and presenting associated disease(s). , every 2 weeks. Assessment of response was performed every four cycles according to RECIST criteria. Results Median patient age was 74 years (range, 70-83 years). Overall response rate was 34.9 % [95 % confidence interval (CI), 20.6-49.1, with 3 complete responses and 12 partial responses. Grade 3 neutropenia occurred in 4 patients (9.3 %), fatigue in 3 patients (7.0 %), and vomiting in 2 patients (4.6 %). Grade 2 and 3 peripheral neuropathy was observed in 5 patients (11.6 %) and 1 patient (2.3 %), respectively. No treatment-related death was observed. Median progression-free and overall survival were 6.8 and 10.5 months, respectively. Conclusions This modified FOLFOX regimen is an active and well-tolerated treatment for elderly patients with metastatic gastric cancer and also represents a good therapeutic option in patients with associated disease(s).

Feasibility of Modified FOLFOX in Elderly Patients Aged ≥80 Years with Metastatic Gastric Cancer or Colorectal Cancer

“…After failure of modified FOL-FOX, the elderly patients in our study less frequently received second-line chemotherapy than did those in other studies [18,19,21] . Elderly patients over 80 years of age could be more fragile when they encountered symptoms of disease progression and chemotherapy-related toxicity.…”

“…Modified FOLFOX regimens have been widely used as the first-line treatment in elderly patients with metastatic CRC. Studies on modified FOLFOX evaluated clinical outcomes in elderly patients with metastatic GC or CRC [18][19][20][21] . These study populations consisted mainly of patients between 65 and 75 years of age, though some studies included a very small proportion of patients over 80 years of age.…”

Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

“…Regimens that have been specifically addressed in phase II trials in elderly patients with comparable survival results include capecitabine and oxaliplatin, FOLFOX (leucovorin, 5-FU and oxaliplatin), single-agent capecitabine and S1 (in Asian patients) [III, B] [66][67][68]. A phase II trial investigated the miniDOX (docetaxel, oxaliplatin and capecitabine) regimen in primarily older patients and also recruited patients with other poor prognostic markers (PS2, weight loss 10%-25%).…”

Clinical significance of chemotherapy for geriatric patients with advanced or recurrent gastric cancer

“…Previous studies have indicated the superiority of systemic chemotherapy compared to best supportive care (BSC) in patients with advanced or recurrent GC (3)(4)(5) and several phase III trials investigating systemic chemotherapy in advanced GC patients have been conducted (6)(7)(8)(9)(10)(11). Recently, several clinical trials assessed the tolerability or efficacy of systemic chemotherapy, including adjuvant chemotherapy, in geriatric patients with advanced or recurrent GC and demonstrated its feasibility (12)(13)(14)(15)(16)(17). However, the effect of systemic chemotherapy in the prognosis of geriatric patients with advanced or recurrent GC remains unclear.…”