title: 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.
abstract: OBJECTIVE
  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/m/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/m.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.
authors.affiliation: Departments of *Reproductive Medicine †Radiology, Graduate School of Medicine, Chiba University, Chiba, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Mitsuhashi
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Usui
authors.forename: Kyoko
authors.initials: K
authors.lastname: Nishikimi
authors.forename: Noriko
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Shinsuke
authors.initials: S
authors.lastname: Hanawa
authors.forename: Shinichi
authors.initials: S
authors.lastname: Tate
authors.forename: Miho
authors.initials: M
authors.lastname: Watanabe-Nemoto
authors.forename: Takashi
authors.initials: T
authors.lastname: Uno
authors.forename: Makio
authors.initials: M
authors.lastname: Shozu
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D059248:Chemoradiotherapy / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D003907:Dexamethasone / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage*; D008875:Middle Aged; D009325:Nausea / Q000209:etiology* / Q000517:prevention & control*; D000077924:Palonosetron; D011446:Prospective Studies; D011812:Quinuclidines / Q000008:administration & dosage*; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000628:therapy*; D014839:Vomiting / Q000209:etiology* / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D007546:Isoquinolines; D011812:Quinuclidines; D000077924:Palonosetron; D003907:Dexamethasone; D002945:Cisplatin