Tolerability of Nab-Paclitaxel Plus Gemcitabine as Adjuvant Setting in Japanese Patients With Resected Pancreatic Cancer: Phase I Study.

Ueno, Makoto; Morinaga, Soichiro; Hashimoto, Yusuke; Umemoto, Kumiko; Sasahira, Naoki; Saiura, Akio; Seyama, Yasuji; Honda, Goro; Ioka, Tatsuya; Takahashi, Hidenori; Miyamoto, Atsushi; Nakamori, Shoji; Unno, Michiaki; Takadate, Tatsuyuki; Mizuno, Nobumasa; Shimizu, Yasuhiro; Ueno, Hideki; Sugiyama, Masanori; Fukutomi, Akira; Shimizu, Satoshi; Okusaka, Takuji; Furuse, Junji

OBJECTIVE The combination of gemcitabine plus nab-paclitaxel (GnP) has not been studied in Japanese patients with resectable pancreatic cancer (PC). This study aimed to assess the tolerability of adjuvant GnP in Japanese patients with resected PC. METHODS This was a Phase I, open-label, multicenter, single-arm study of patients with resected PC in Japan. Patients received 125 mg/m2 of nab-paclitaxel and 1000 mg/m2 of gemcitabine on days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles. The primary end point was tolerability, defined as the absence of specific grade 3 or higher treatment-related adverse events by the end of cycle 2. Secondary end points included safety, disease-free survival, and overall survival. RESULTS Forty-one patients were enrolled between June 2016 and February 2017 (median age, 68 years; 51% male; stage II, 95%). Gemcitabine plus nab-paclitaxel met the tolerability criteria in 39 of the 40 patients included in the tolerability analysis set (97.5%). The most common treatment-related adverse events were leukopenia, neutropenia, alopecia, and peripheral sensory neuropathy. After a follow-up of 30.1 months, median disease-free survival was 17.0 months and median overall survival was not reached. CONCLUSIONS These results show that adjuvant GnP is tolerable in Japanese patients with resected PC.Clinical Trial Registration No.: JapicCTI-163179.