Sequential capecitabine-based treatment of patients with metastatic colorectal cancer (MCRC) combined with oxaliplatin first-line: A retrospective analysis

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Abstract
3631 Background: A favorable outcome of first-line therapy of capecitabine (XEL) and oxaliplatin (XELOX) was recently documented for patients with MCRC. Retrospectively, we analyzed MCRC patients treated with sequential therapy of XELOX, XEL+irinotecan, and XEL+mitomycin in progressive disease (PD). Methods: Inclusion criteria: 18–75 yrs of age, serum creatinine < 1.5 mg/dL, informed consent. Therapy was capecitabine-based with 1,000 mg/m2 bid from day1–14 (XEL), first-line with oxaliplatin 130 mg/m2 (XELOX), d1 q3 wks for max of 6 cycles, if progress or toxicity, a second-line therapy with XEL and irinotecan 250 mg/m2 (XELIRI), d1 q3 wks for max of 6 cycles, if progress or toxicity, a third-line therapy with XEL and mitomycin 10 mg/m2 (XELMIC), d1 q3 wks for 6 cycles. CT scans performed every 12 wks to assess response according to the RECIST criteria. Primary objectives were the number of responses, time-to-progression (TTP), and overall survival. Secondary objectives were NCI-CTC Grad 3+4 toxicity. Results: All 16 pts, median age 61.2 yrs underwent prior tumor surgery. Sites of metastases were: liver (63%), lung (47%), peritoneum (33%), local (20%), others (33%). 7 pts (44%) received prior adjuvant chemotherapy. After a median of 5 cycles XELOX (range: 2–10) 1 CR (6%), 8 PR (50%), 3 SD (19%) and 4 PD (25%) were observed. In 1 pt XELOX dosage was reduced to 50% because of diarrhea. Median time of response was 13.1 wks (range: 0–26) with a median TTP (Kaplan-Meier estimation, 9 events, 7 censored) of 26 wks. 13 pts actually receive second-line XELIRI and 2 pts FOLFIRI. After 6 cycles of XELIRI, 4 pts have a PD and 1 pt a SD, yet receiving XELMIC. 3 pts died in week 29, 34 and 60 due to concomitant diseases. After a median of 33.4 wks (range: 20–60), 13 pts (81%) are still alive and median survival has not been reached yet. Grade 3 + 4 toxicity were: 6 diarrhea, 1 neutropenia, 1 hand-and-foot syndrome. Conclusions: First-line XELOX is safe and effective in MCRC with an overall response of 56% and a TTP of 28 weeks. Toxicities rarely occurred and are manageable with standard supportive care. No significant financial relationships to disclose.

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