A multi-center, open-label, randomized phase III trial of first-line chemotherapy with capecitabine monotherapy versus capecitabine plus oxaliplatin in elderly patients with advanced gastric cancer.

Abstract

OBJECTIVES:

More than half of cases of gastric cancer (GC) are diagnosed in elderly patients (≥70years). While doublet combination with fluoropyrimidines and platinum is currently considered standard first-line chemotherapy in advanced GC, the main goal of chemotherapy remains palliation.

MATERIALS AND METHODS:

In a multi-center phase III trial, patients with chemotherapy-naïve, metastatic GC, aged 70years or older were randomized 1:1 to receive X monotherapy (capecitabine 1000mg/m2 bid po on days one to fourteen) or XELOX (X plus oxaliplatin 110mg/m2 iv on D1). Treatment was repeated every 21days until disease progression, unacceptable toxicity, or withdrawal. Primary endpoint was overall survival (OS).

RESULTS:

In total, 50 patients with a median age of 77 (range, 70 to 84) were enrolled (X, n=26; XELOX, n=24). No treatment-related serious adverse events or unexpected toxicities were observed. The most frequently observed toxicities were nausea and hand-foot syndrome, with fatigue and peripheral neuropathy more common in XELOX than in X patients. Median OS was 11.1months for XELOX arm and 6.3months for X arm (HR 0.58, 95% CI 0.30-1.12, P=0.108). Although the difference was not significant, on the basis of evidence of superiority of XELOX seen in the first interim analysis, an independent data monitoring committee recommended early stopping of the trial. PFS was significantly longer (HR 0.32, 95% CI 0.17-0.61, P<0.001) with XELOX (7.1months) than with X (2.6months).

CONCLUSION:

Platinum-based combination chemotherapy was associated with survival benefit, as compared with X monotherapy in elderly patients with GC.

• Authors: In Gyu Hwang, Jun Ho Ji, Jung Hun Kang, Hyo Rak Lee, Hui-Young Lee, Kyong-Choun Chi, Suk Won Park, Su Jin Lee, Seung Tae Kim, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang
• Journal: Journal of geriatric oncology (J Geriatr Oncol) Vol. 8 Issue 3 Pg. 170-175 (May 2017) ISSN: 1879-4076 [Electronic] Netherlands
• PMID: 28119041 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2017 Elsevier Inc. All rights reserved.

Chemical References

• Antimetabolites, Antineoplastic
• Oxaloacetates
• Deoxycytidine
• Capecitabine
• Fluorouracil

Topics

• Aged
• Aged, 80 and over
• Antimetabolites, Antineoplastic (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Capecitabine (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Administration Schedule
• Female
• Fluorouracil (administration & dosage, adverse effects, analogs & derivatives)
• Humans
• Kaplan-Meier Estimate
• Male
• Oxaloacetates
• Quality of Life
• Stomach Neoplasms (drug therapy, mortality, pathology)