Phase II multi-institutional prospective trial of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer
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ORIGINAL ARTICLE
Phase II multi‑institutional prospective trial of nab‑paclitaxel as second‑line chemotherapy for advanced gastric cancer refractory to fluoropyrimidine with modified dose reduction criteria (CCOG1303) Daisuke Kobayashi1 · Yoshinari Mochizuki2 · Koji Torii3 · Shin Takeda4 · Yoshihisa Kawase5 · Kiyoshi Ishigure6 · Hitoshi Teramoto7 · Masahiko Ando8 · Yasuhiro Kodera1 Received: 30 October 2019 / Accepted: 11 June 2020 © Japan Society of Clinical Oncology 2020
Abstract Background The aim of this study was to explore the efficacy and safety of nab-paclitaxel as second-line chemotherapy for advanced gastric cancer with modified dose reduction criteria by which the doses were manipulated earlier. Methods Gastric cancer patients who developed progression during the fluoropyrimidine-containing first-line chemotherapy were assigned to receive nab-paclitaxel (260 mg/m2) by triweekly administration. Dose reduction was regulated according to predefined toxicity criteria which included neutropenia less than 1000/mm3 and/or peripheral sensory neuropathy of grade 2 or more. The primary endpoint was progression-free survival. Results A total of 50 patients were enrolled, 47 of whom were eligible for efficacy analyses. The median number of treatment cycles and relative dose intensity given per patient was four (range 1–25), and 90% (range 60–100). Of total administration throughout the trial of 280 cycles, dose reduction was required in 50 cycles. The median progression-free survival was 3.5 months (95% confidence interval 2.5–4.4) that met the primary endpoint. The median overall survival was 9.0 months (95% confidence interval 6.8–11.8), overall response rate was 16% (95% confidence interval 2–30), and disease control rate was 72% (95% confidence interval 54–90). The median time to treatment failure was 3.5 months (95% confidence interval 2.5–4.4). Adverse events of grade 3 or worse included neutropenia in 49%, and peripheral sensory neuropathy in 11%. Febrile neutropenia occurred only in one patient (2%). Conclusion The modified dose reduction criteria for triweekly administration of nab-paclitaxel resulted in decreased incidence of severe peripheral sensory neuropathy without decline in efficacy. Keywords Gastric cancer · Nab-paclitaxel · Peripheral sensory neuropathy * Daisuke Kobayashi [email protected]‑u.ac.jp 1
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine, 65 Tsurumai‑cho, Showa‑ku, Nagoya 466‑8550, Japan
2
Department of Surgery, Komaki City Hospital, Komaki, Japan
3
Department of Surgery, Meitetsu Hospital, Nagoya, Japan
4
Department of Surgery, National Hospital Organization Nagoya Medical Center, Nagoya, Japan
5
Department of Surgery, Tosei General Hospital, Seto, Japan
6
Department of Surgery, Konan Kosei Hospital, Konan, Japan
7
Department of Surgery, Yokkaichi Municipal Hospital, Yokkaichi, Japan
8
Center for Advanced Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan
Introduction Gastric cancer is the
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