A phase II study of ziv-aflibercept (Z) + FOLFIRI in Japanese patients (pts) with metastatic colorectal cancer (mCRC)

• Published in: Journal of clinical oncology Vol. 35; no. 4_suppl; p. 707
• Main Authors: Satoh, Taroh, Denda, Tadamichi, Hamaguchi, Tetsuya, Sugimoto, Naotoshi, Ura, Takashi, Yamazaki, Kentaro, Fujii, Hirofumi, Kajiwara, Takeshi, Nakajima, Takako Eguchi, Takahashi, Shin, Otsu, Satoshi, Komatsu, Yoshito, Sasaki, Toru, Sunaga, Yoshinori, Yoshino, Takayuki
• Format: Journal Article
• Language: English
• Published: 01.02.2017
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2017.35.4_suppl.707

Abstract only 707 Background: VEGF promotes tumor angiogenesis and metastasis. Z blocks the activity of VEGF-A/-B, and placental growth factor and was shown in the VELOUR phase III study (NCT00561470) outside of Japan to significantly improve overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) in mCRC pts as a second-line treatment given with FOLFIRI. Goals of the current open-label, multicenter phase II study were to assess the efficacy and safety of Z + FOLFIRI in a post-oxaliplatin setting in mCRC pts in Japan. Methods: Pts received Z (4 mg/kg) + FOLFIRI (400 mg/m 2 bolus 5-fluorouracil [FU]; 2400 mg/m 2 continuous infusion 5-FU; 200 mg/m 2 levofolinate; 180 mg/m 2 irinotecan) every 2 weeks until progression, unacceptable toxicity, or study withdrawal. Primary endpoint: ORR (required 60 pts in order to obtain a 95% CI width of 16–20%, assuming an ORR of 10–20%). Secondary endpoints: PFS, OS, and safety. Tumors were assessed by independent reviewers every 6 ± 1 weeks until progression. Results: Study enrolled 62 pts; 50 pts (83.3%) had received prior bevacizumab. Of 60 pts evaluable for response, 5 had a partial response and none had a complete response, resulting in an ORR of 8.3% (95% CI: 1.3–15.3%). The median PFS was 5.42 months (95% CI: 4.140–6.702), and the median OS was 15.59 months (range 11.20–19.81). Forty-one pts (66.1%) died due to progression; none died due to study treatment. Pts underwent a median of 8 treatment cycles (range 1–31) lasting a median of 21.8 weeks (range 2–73). The median relative dose intensity was 0.99 (range 0.2–1.0) for Z, 0.87 (range 0.4–1.0) for irinotecan, and 0.96 (range 0.7–1.0) for 5-FU. All pts had ≥1 treatment emergent adverse event (TEAE; see table). Conclusions: The ORR was 8.3% (95% CI: 1.3–15.3%), and the median OS was 15.59 months. The safety profile was consistent with that reported previously. Registered as NCT01882868. Clinical trial information: NCT01882868. [Table: see text]