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The Efficacy of Palonosetron Plus Dexamethasone in Preventing Chemoradiotherapy-induced Nausea and Emesis in Patients Receiving Daily Low-dose Cisplatin-based Concurrent Chemoradiotherapy for Uterine Cervical Cancer: A Phase II Study.

Mitsuhashi, Akira MD, PhD; Usui, Hirokazu MD, PhD; Nishikimi, Kyoko MD; Yamamoto, Noriko MD, PhD; Hanawa, Shinsuke MD; Tate, Shinichi MD, PhD; Watanabe-Nemoto, Miho MD, PhD; Uno, Takashi MD, PhD; Shozu, Makio MD, PhD
American Journal of Clinical Oncology:
doi: 10.1097/COC.0000000000000117
Original Article: PDF Only
Abstract

Objectives: The prevention of chemotherapy-induced and radiotherapy-induced emesis is recommended by several guidelines; however, there are no evidence-based recommendations for the use of antiemetics in concurrent chemoradiotherapy (CCRT). The aim of the present study was to evaluate the efficacy and safety of antiemetic therapy comprising palonosetron and dexamethasone during CCRT.

Methods: This is a nonrandomized, prospective, single-center, open phase II study.

Twenty-six consecutive patients with cervical carcinoma were treated with daily low-dose cisplatin (8 mg/m2/d)-based CCRT (2 Gy/d, 25 fractions, 5 times a week). All patients received 0.75 mg of palonosetron on day 1 of each week and 4 mg of oral dexamethasone daily. The primary endpoint was the percentage of patients achieving a complete response, which was defined as no emetic episodes and no antiemetic rescue medication during treatment.

Results: Planned daily low-dose cisplatin-based CCRT was successful without delay or interruption in 46% (12/26) of the patients. The mean dose of total cisplatin was 184 (range, 136 to 200) mg/m2.

No patient vomited during the treatment period. The complete response rate during CCRT was 100%. A total of 81% patients were completely free from nausea. All patients tolerated the combination of palonosetron and dexamethasone and completed the scheduled regimen. Five patients exhibited grade 1 Cushingoid features that resolved after treatment.

Conclusions: Antiemetic therapy comprising palonosetron and dexamethasone provided complete protection from nausea and vomiting in patients with cervical cancer receiving daily low-dose cisplatin-based CCRT.

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