Our previous non-randomized study indicated that patients receiving first-line treatment of XELOX followed by capecitabine as maintaining therapy had significantly prolonged median time to progression. Therefore, we initiated this randomized study to evaluate the efficacy and safety of maintenance therapy with capecitabine after induction of XELOX (or FOLFOX) in first-line treatment of mCRC.
In this multi-center, randomized phase III study, patients were received 18-24 weeks of XELOX or FOLFOX. Following the chemotherapy, patients who achieved controlled disease (CR, PR or SD) were randomized 1:1 to receive maintenance therapy of capecitabine (1,000 mg/m2 twice a day from days 1–14, every 3 weeks) or only observation until disease progression. The primary endpoint was PFS; the secondary endpoint was overall survival (OS).
The intent-to-treat population comprised of 274 patients (capecitabine maintenance, n= 136; observation, n = 138). There were no significant differences in baseline characteristics between capecitabine maintenance group and observation group. The median follow-up was 29.0 months (range, 0–62.5 months). Median PFS in capecitabine maintenance group was significantly longer than observation group (10.43 [95% confidence interval (CI) 9.70 to 12.23] vs. 7.82 [95% CI 7.00 to 8.60] months; p < 0.0001). The secondary endpoint of median OS in capecitabine maintenance group was longer than observation group, but not statistically significant (23.17 vs. 19.73 months; p = 0.2548). There was no significant difference between XELOX or FOLFOX and the relevant observation group with respect to OS. Similar safety profiles were observed in both arms. The most common grade 3 or 4 toxicities in capecitabine maintenance versus observation were neutropenia, hand–foot syndrome, and mucositis.
Maintenance therapy with single agent capecitabine after induction of XELOX or FOLFOX seems beneficial in mCRC, demonstrating a prolonged PFS with acceptable toxicities.
Clinical trial identification
All authors have declared no conflicts of interest.