2019 ASCO Annual Meeting!
Session: Symptoms and Survivorship
Type: Oral Abstract Session
Time: Monday June 3, 8:00 AM to 11:00 AM
A randomized, double-blind, placebo-controlled phase III trial evaluating olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin-based chemotherapy: J-FORCE Study.
Palliative Care and Symptom Management
Symptoms and Survivorship
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 11503)
Author(s): Hironobu Hashimoto, Masakazu Abe, Masahiko Nakao, Hideaki Mizutani, Yasuhiko Sakata, Yukiyoshi Fujita, Tomoyasu Nishimura, Katsuya Hirano, Hideaki Okada, Naoki Inui, Yukio Sakata, Hirotoshi Iihara, Sadamoto Zenda, Yosuke Uchitomi, Takuhiro Yamaguchi, Yukari Hoshina, Takako Yanai, Satoru Iwasa, Noboru Yamamoto, Yuichiro Ohe; Department of Pharmacy, National Cancer Center Hospital, Tokyo, Chuo-Ku, Japan; Department of Gynecologic Oncology,Shizuoka Cancer Center, Shizuoka, Japan; Department of Pharmacy, Osaka City General Hospital, Osaka, Japan; Saitama Cancer Center, Saitama, Japan; Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan; Gunma Prefectural Cancer Center, Gunma, Japan; Wakayama Medical University Hospital, Wakayama Prefecture, Japan; Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan; Kobe Minimally Invasive Cancer Center, Hyogo, Japan; Department of Clinical Pharmacology and Therapeutics, Hamamatsu University School of Medicine, Hamamatsu, Japan; Hakodate Municipal Hospital, Hokkaido, Japan; Gifu University Hospital, Gifu, Japan; Japan Supportive, Palliative and Psychosocial Oncology Group, Tokyo, Japan; Tohoku University Graduate School of Medicine, Sendai, Japan; National Cancer Center Hospital, Tokyo, Japan; Department of Pharmacy, National Cancer Center Hospital, Tokyo, Tokyo, Japan; Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan; Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
Background: Olanzapine (OLZ) 10 mg added to standard antiemetic therapy including aprepitant (APR), palonosetron (PALO), and dexamethasone (DEX) has been recommended for the prevention of chemotherapy-induced nausea and vomiting (CINV) caused by highly emetogenic chemotherapy (HEC). Guidelines suggest that a dose of 5 mg should be taken into consideration in patients at risk of sedation. OLZ 5 mg showed an equivalent activity and favorable toxicity to somnolence in several phase II studies. We conducted a randomized, double-blind, placebo-controlled phase III trial to evaluate OLZ 5 mg in addition to standard antiemetic therapy for the prevention of CINV in patients receiving cisplatin-based chemotherapy. Methods: Patients receiving cisplatin (≥ 50 mg/m2) were randomly assigned to either OLZ 5 mg or placebo on days 1–4, combined with APR, PALO and DEX. The primary endpoint was complete response (CR), defined as no vomiting and no rescue medications in the delayed phase (24–120 h). A total of 690 patients were required to detect a 10% increase in CR from 65% in the placebo to 75% in the OLZ, with a one-sided alpha of 2.5% and a power of 80%. Results: A total of 710 patients were enrolled (OLZ 356 and placebo 354). CR in the delayed phase was 79.1% (95% CI: 74.9–83.3) in the OLZ 5 mg and 65.8% (95% CI: 60.9–70.8) in the placebo (p< 0.001). Other efficacy results are summarized in Table. The most common treatment-related adverse events was somnolence (43.1% for OLZ vs. 33.0% for placebo). Conclusions: OLZ 5 mg combined with APR, PALO and DEX can be considered a new standard antiemetic therapy in patients receiving cisplatin-based chemotherapy. Clinical trial information: UMIN000024676.
|OLZ 5 mg (n = 354)||placebo (n = 351)|
|CR||Acute||94.9||92.6, 97.2||88.6||85.3, 91.9|
|Delayed||79.1||74.9, 83.3||65.8||60.9, 70.8|
|Overall||78.0||73.7, 82.3||63.5||58.5, 68.6|
|TC*||Acute||85.9||82.3, 89.5||80.6||76.5, 84.8|
|Delayed||60.2||55.1, 65.3||50.1||44.9, 55.4|
|Overall||58.8||53.6, 63.9||48.1||42.9, 53.4|
*TC (total control): no vomiting, nausea and rescue medications
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