PURPOSE:Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0-120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC). METHODS: This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data. RESULTS: A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 receiveddoxorubicin/cyclophosphamide chemotherapyfor breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8-84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1-63.9 %) of patients in the OAD arm achieved an overall CR. CONCLUSIONS: While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.
RCT Entities:
PURPOSE:Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0-120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC). METHODS: This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data. RESULTS: A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 received doxorubicin/cyclophosphamide chemotherapy for breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8-84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1-63.9 %) of patients in the OAD arm achieved an overall CR. CONCLUSIONS: While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.
Authors: Ethan Basch; Ann Alexis Prestrud; Paul J Hesketh; Mark G Kris; Petra C Feyer; Mark R Somerfield; Maurice Chesney; Rebecca Anne Clark-Snow; Anne Marie Flaherty; Barbara Freundlich; Gary Morrow; Kamakshi V Rao; Rowena N Schwartz; Gary H Lyman Journal: J Clin Oncol Date: 2011-09-26 Impact factor: 44.544
Authors: M S Aapro; S M Grunberg; G M Manikhas; G Olivares; T Suarez; S A Tjulandin; L F Bertoli; F Yunus; B Morrica; F Lordick; A Macciocchi Journal: Ann Oncol Date: 2006-06-09 Impact factor: 32.976
Authors: Ronald Chow; David G Warr; Rudolph M Navari; May Tsao; Marko Popovic; Leonard Chiu; Milica Milakovic; Henry Lam; Carlo DeAngelis Journal: Support Care Cancer Date: 2018-05-23 Impact factor: 3.603
Authors: Marko Popovic; David G Warr; Carlo Deangelis; May Tsao; Kelvin K W Chan; Michael Poon; Cheryl Yip; Natalie Pulenzas; Henry Lam; Liying Zhang; Edward Chow Journal: Support Care Cancer Date: 2014-03-04 Impact factor: 3.603