In a pooled analysis of data from clinical trials in the ACCENT/IDEA databases reported in the Journal of Clinical Oncology, Claire Gallois, MD, and colleagues found that patients aged ≥ 70 years receiving oxaliplatin-based adjuvant chemotherapy for stage III colon cancer had a similar time to disease recurrence compared with younger patients and a generally similar safety profile.
Claire Gallois, MD
Study Details
The analysis involved data from 12 randomized trials in the ACCENT and IDEA databases in which at least one treatment group received 3 to 6 months of adjuvant modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) or capecitabine and oxaliplatin (CAPOX).
Key Findings
A total of 17, 909 patients were included in the analysis, including 4,340 patients (24.2%) aged ≥ 70 years. Median follow-up was 75.8 months.
In multivariable analysis, time to disease recurrence did not differ significantly between older vs younger patients in the overall population (hazard ratio [HR] = 1.05, 95% confidence interval [CI] = 0.98–1.12, P = .18) or among those receiving 6-month regimens (HR = 1.02, 95% CI = 0.94–1.12, P = .61) or 3-month regimens (HR = 1.10, 95% CI = 0.98–1.23, P = .10). In the overall population, older patients had significantly poorer disease-free survival (HR = 1.20, 95% CI = 1.13–1.28, P < .001), overall survival (HR = 1.44, 95% CI = 1.34–1.54, P < .001), survival after recurrence (HR = 1.35, 95% CI = 1.24–1.47, P < .001), and cancer-specific survival (HR = 1.18, 95% CI = 1.07–1.30, P ≤ .001).
Early treatment discontinuation was more frequent in older patients (22.0% vs 15.5%, P < .001). Among patients treated with mFOLFOX6, no significant differences in grade ≥ 3 adverse events were observed between older vs younger patients, except for thrombocytopenia (2.4% vs 1.7%, P = .04). Among patients treated with CAPOX, grade ≥ 3 adverse events were similar for older vs younger patients, except for significantly higher rates of diarrhea (14.2% vs 11.2%, P = .01) and neutropenia (12.1% vs 9.6%, P = .04) among older patients.
The investigators concluded, “In patients [aged] ≥ 70 years with stage III colon cancer fit enough to be enrolled in clinical trials, oxaliplatin-based adjuvant chemotherapy was well tolerated and led to similar time to recurrence with younger patients, suggesting similar efficacy. Time to recurrence may be a more appropriate endpoint for efficacy in this patient population.”
Demetris Papamichae, MD, of the Department of Medical Oncology, Bank of Cyprus Oncology Centre, Nicosia, Cyprus, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the European Society for Medical Oncology. For full disclosures of the study authors, visit ascopubs.org.
