Capecitabine plus irinotecan (CAPIRI) as first-line treatment for patients (pts) with metastatic colorectal cancer (MCRC)

• Published in: Journal of clinical oncology Vol. 24; no. 18_suppl; p. 13573
• Main Authors: Laudani, A., Agostara, B., Savio, G., Leonardi, V., Salvagno, L., Palmisano, V., Usset, A.
• Format: Journal Article
• Language: English
• Published: 20.06.2006
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/jco.2006.24.18_suppl.13573

Abstract only 13573 Background: Twice-daily oral capecitabine mimics 5-FU infusion and has superior efficacy, improved safety and convenience compared with 5-FU/LV in MCRC and early-stage colon cancer. Preclinical and phase I/II clinical data suggest supra-additive efficacy of X + irinotecan and no significant pharmacokinetic interactions. We evaluated the efficacy and safety of X plus weekly irinotecan (CAPIRI) in 3-week cycles as first-line treatment for MCRC. Methods: Pts with no prior treatment for MCRC received irinotecan 80 mg/m 2 i.v. infusion on d1&8 + capecitabine 1000 mg/m 2 orally bid d1–14, q3w. Results: Baseline characteristics of the 39 enrolled pts (22 men/17 women) were: median age 59.9 years (range 38–76), ECOG PS 0–1, colon cancer (n=25), rectal cancer (n=14), metastatic sites (liver 74%, pelvis 20%, nodes 23%, lung 18%, peritoneum 10%, primary tumor 20%). Previous treatments were as follows: adjuvant chemotherapy (36%), radiotherapy (5%), neoadjuvant chemotherapy (3%). Pts received a total of 199 cycles (mean 5.1 per pt, range 1–13). All 39 pts were evaluable for safety and 38 for efficacy. The most common treatment-related grade 3/4 adverse events were nausea/vomiting (23% of pts), diarrhea (10%), and leucopenia (5%). The overall response rate was 45%, including 3 complete and 14 partial responses. A further 8 pts (21%) had stable disease. The duration of response in pts with a complete response was >10 months. Conclusions: These early findings indicate that this combination is effective and well tolerated as first-line treatment for MCRC. Replacing 5-FU with capecitabine in XELIRI offers benefits to the pt in terms of efficacy, safety, convenience, reduced discomfort and avoidance of central venous access compared with infusional 5-FU/LV-based regimens (IFL and FOLFIRI). No significant financial relationships to disclose.