• Kenjiro Aogi, Hiroshi Sakai, Hirohisa Yoshizawa, Norikazu Masuda, Nobuyuki Katakami, Yasuhiro Yanagita, Kenichi Inoue, Masaru Kuranami, Mitsuhiro Mizutani, and Noriyuki Masuda.
• Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Ko, Minami-Umemoto, Matsuyama, Ehime 791-0280, Japan. kaogi@shikoku-cc.go.jp
• Support Care Cancer. 2012 Jul 1;20(7):1507-14.

PurposePrevention of chemotherapy-induced nausea and vomiting (CINV) is of great importance for the completion of multiple cycles of cancer chemotherapy. Palonosetron is a second-generation 5-HT(3) receptor antagonist with proven efficacy for both acute and delayed CINV. This study was designed to assess the safety and efficacy of 0.75 mg palonosetron in repeated cycles of highly emetogenic chemotherapy or anthracycline-cyclophosphamide combination (AC/EC).MethodsWe gave 0.75 mg palonosetron to 538 patients 30 min prior to ≥ 50 mg/m(2) cisplatin or AC/EC on day 1. Prophylactic dexamethasone was administered on days 1-3. The primary endpoint was the incidence rate of adverse events (AEs). The secondary endpoint was complete response rate (CR, defined as no emesis and no rescue medication) throughout the study period.ResultsTreatment-related AEs were seen in 44% (237 of 538 patients). Serious AEs were seen in 4% (23 of 538 patients), all considered unrelated or unlikely to be related to palonosetron. Only one patient discontinued the study due to a treatment-related AE. No trend toward worsening of AEs was observed in subsequent cycles of chemotherapy. Complete response rates were maintained throughout repeated cycles.ConclusionThe extraordinary safety profile and maintenance of efficacy of 0.75 mg palonosetron combined with dexamethasone were demonstrated throughout repeated chemotherapy cycles.

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