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).

METHODS:

A total of 43 patients aged ≥70 years received oxaliplatin 85 mg/m(2) together with 6S-leucovorin 200 mg/m(2) on day 1, followed by a 46-h infusion of 5-fluorouracil 2,400 mg/m(2), 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).

• Authors: Vincenzo Catalano, Renato Bisonni, Francesco Graziano, Paolo Giordani, Paolo Alessandroni, Anna Maria Baldelli, Virginia Casadei, David Rossi, Stefano Luzi Fedeli, Silvia D'Emidio, Lucio Giustini, Giammaria Fiorentini
• Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association (Gastric Cancer) Vol. 16 Issue 3 Pg. 411-9 (Jul 2013) ISSN: 1436-3305 [Electronic] Japan
• PMID: 23065042 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)

Chemical References

• Organoplatinum Compounds
• Leucovorin
• Fluorouracil

Topics

• Age Factors
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Disease-Free Survival
• Female
• Fluorouracil (adverse effects, therapeutic use)
• Humans
• Leucovorin (adverse effects, therapeutic use)
• Male
• Neoplasm Metastasis
• Organoplatinum Compounds (adverse effects, therapeutic use)
• Stomach Neoplasms (drug therapy, pathology)
• Survival Rate
• Treatment Outcome