title: Safety and efficacy of aprepitant, ramosetron, and dexamethasone for chemotherapy-induced nausea and vomiting in patients with ovarian cancer treated with paclitaxel/carboplatin.
abstract: OBJECTIVE
  Women with ovarian carcinoma that are treated with paclitaxel/carboplatin are particularly susceptible to chemotherapy-induced nausea and vomiting (CINV). The current study evaluated the new combination (aprepitant/ramosetron/dexamethasone, 20 mg) in ovarian cancer patients receiving multiple cycles of paclitaxel/carboplatin.
  
  
  METHODS
  This is a prospective non-randomized single site study. Patients received the following regimen for the prevention of CINV-day 1, 125 mg aprepitant, 0.6 mg ramosetron, and 20 mg dexamethasone before chemotherapy; and days 2-3, 80 mg aprepitant each day. The primary end point was the proportion of patients with complete response (CR) during the 120 h following the first chemotherapy cycle. Toxicity assessments were conducted using the NCI-CTC investigator guide (version 3.0).
  
  
  RESULTS
  Of the 89 patients enrolled, 85 patients were evaluable for efficacy and toxicity, and 68 (80 %) completed all 6 cycles. In cycle 1, the percentage of patients who achieved CR in the acute, delayed, and overall phases was 98.8 %, 89.4 %, and 89.4 %, respectively. Of the 460 cycles, adverse events, drug-related adverse events, and serious adverse events occurred in 179 (38.9 %), 35 (7.6 %), and 10 cycles (2.2 %), respectively. The most common adverse event was constipation (12.4 %) and headache (11.1 %). None of the patients discontinued the study because of adverse events.
  
  
  CONCLUSIONS
  The combination of aprepitant, ramosetron, and high-dose dexamethasone demonstrated efficacy for CINV prevention in ovarian cancer patients receiving paclitaxel and carboplatin.
authors: Department of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong, Kangnam-Ku, Seoul, 135-710, South Korea.
authors: Chel Hun
authors: CH
authors: Choi
authors: Min Kyu
authors: MK
authors: Kim
authors: Jin-Young
authors: JY
authors: Park
authors: Aera
authors: A
authors: Yoon
authors: Ha-Jeong
authors: HJ
authors: Kim
authors: Yoo-Young
authors: YY
authors: Lee
authors: Tae-Joong
authors: TJ
authors: Kim
authors: Jeong-Won
authors: JW
authors: Lee
authors: Byoung-Gie
authors: BG
authors: Kim
authors: Duk-Soo
authors: DS
authors: Bae
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use; D009325:Nausea / Q000139:chemically induced* / Q000188:drug therapy / Q000517:prevention & control*; D010051:Ovarian Neoplasms / Q000139:chemically induced / Q000188:drug therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011446:Prospective Studies; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D001562:Benzimidazoles; D009025:Morpholines; D000077608:Aprepitant; D003907:Dexamethasone; C071315:ramosetron; D016190:Carboplatin; D017239:Paclitaxel