A prospective study of XELIRI plus bevacizumab as the first-line therapy in Japanese patients with unresectable or recurrent colorectal cancer (KSCC1101).

Abstract

752 Background: XELIRI plus bevacizumab (Bev) might be one of the standard therapies for metastatic colorectal cancer (mCRC). However, there was no clinical practice data in Japan. This study was designed to evaluate the efficacy and safety of XELIRI plus Bev in clinical practice in Japanese mCRC patients (pts.). Methods: This was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated mCRC; presence of measurable lesions; age ≥20 years; ECOG performance status (PS) of 0–2; and adequate organ function. Pts received Bev 7.5 mg/kg day 1 and XELIRI (irinotecan 200 mg/m2 day 1 plus capecitabine 800 mg/m2 bid d1-14) q3w. This schedule was repeated until unacceptable toxicity or disease progression occurred. The primary endpoint was RECIST-confirmed objective response rate (ORR). A sample size of 35 was planned for a threshold ORR of 30% and expected value of 53%, with one-sided alpha of 0.05 and beta of approximately 0.2. Results: A total of 36 pts (male/female, 23/13; median age, 65.0 years (range 44.0-80.0); PS 0/1/2, 31/5/0) were enrolled in this study from July 2011 to September 2012. One patient did not fulfill the eligibility criteria and one withdrew the informed consent before the start of protocol treatment. Thirty-four pts were assessed for response; CR 0, PR 18, SD 9, PD 4, and NE 3. The confirmed ORR was 52.9% (90% CI, 37.7-67.8%). Median PFS was 9.6 months (95% CI, 5.1-11.1 months) and mOS was 23.0 months (95% CI, 11.3-NE months). mTTF was 5.3 months (95% CI, 3.2-8.3 months). The most common grade 3/4 adverse events were neutropenia 31.4%, anemia 20.0%, thrombocytopenia 5.7%, hyponatremia 20.0%, anorexia 20.0%, diarrhea 22.8%, fatigue 0.0%, hypertension 2.9%, hand-foot syndrome 0.0%, and bleeding 0.0%. Conclusions: First-line treatment of XELIRI + Bev showed a promising response rate and an acceptable tolerability profile in the clinical practice in Japanese mCRC pts. Clinical trial information: UMIN000006070.