Abstract
Objectives
More than half of cases of gastric cancer (GC) are diagnosed in elderly patients (≥70 years). 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 70 years or older were randomized 1:1 to receive X monotherapy (capecitabine 1000 mg/m2 bid po on days one to fourteen) or XELOX (X plus oxaliplatin 110 mg/m2 iv on D1). Treatment was repeated every 21 days 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 11.1 months for XELOX arm and 6.3 months 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 (7.1 months) than with X (2.6 months).
Conclusion
Platinum-based combination chemotherapy was associated with survival benefit, as compared
with X monotherapy in elderly patients with GC.
Keywords
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Article info
Publication history
Published online: January 23, 2017
Accepted:
January 13,
2017
Received in revised form:
November 15,
2016
Received:
October 9,
2016
Identification
Copyright
© 2017 Elsevier Ltd. All rights reserved.
