Abstract | OBJECTIVE: METHODS: A multicenter, single-arm, open-label phase II trial was conducted to evaluate the safety and effectiveness of palonosetron in controlling CINV in patients with gynecologic cancer. Chemotherapy-naïve patients received intravenous palonosetron (0.75 mg/body) and dexamethasone before the infusion of carboplatin-based chemotherapy on day 1. Dexamethasone was administered (orally or intravenously) on days 2-3. The incidence and severity of CINV were evaluated using the patient-completed Multinational Association of Supportive Care in Cancer Antiemesis Tool and treatment diaries. The primary endpoint was the proportion of patients experiencing complete control (CC) of vomiting, with "no rescue antiemetic medication" and "no clinically significant nausea" or "only mild nausea" in the delayed phase (24-120 hours post-chemotherapy). Secondary endpoints were the proportion of patients with a complete response (CR: "no vomiting" and "no rescue antiemetic medication") in the acute (0-24 hours), delayed (24-120 hours), and overall (0-120 hours) phases, and CC in the acute and overall phases. RESULTS: Efficacy was assessable in 77 of 80 patients recruited. In the acute and delayed phases, the CR rates the primary endpoint, were 71.4% and 59.7% and the CC rates, the secondary endpoint, were 97.4% and 96.1%, respectively. CONCLUSION:
|
Authors | Shin Nishio, Satomi Aihara, Mototsugu Shimokawa, Akira Fujishita, Shuichi Taniguchi, Toru Hachisuga, Shintaro Yanazume, Hiroaki Kobayashi, Fumihiro Murakami, Fumitaka Numa, Kohei Kotera, Naofumi Okura, Naoyuki Toki, Masatoshi Yokoyama, Kimio Ushijima |
Journal | Journal of gynecologic oncology
(J Gynecol Oncol)
Vol. 29
Issue 5
Pg. e77
(Sep 2018)
ISSN: 2005-0399 [Electronic] Korea (South) |
PMID | 30022637
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
|
Copyright | Copyright © 2018. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology. |
Chemical References |
- Antiemetics
- Palonosetron
- Dexamethasone
- Carboplatin
|
Topics |
- Adult
- Aged
- Antiemetics
(administration & dosage, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects)
- Carboplatin
(adverse effects)
- Dexamethasone
(administration & dosage, therapeutic use)
- Drug Administration Schedule
- Drug Therapy, Combination
- Female
- Genital Neoplasms, Female
(drug therapy)
- Humans
- Middle Aged
- Nausea
(chemically induced, prevention & control)
- Palonosetron
(administration & dosage, therapeutic use)
- Severity of Illness Index
- Vomiting
(chemically induced, prevention & control)
|