PURPOSE: Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial for maintaining the quality of life of cancer patients. Female patients have been underrepresented in previous clinical studies of aprepitant or palonosetron. We performed a prospective multicenter study to investigate the efficacy and safety of triple therapy comprising these two agents and dexamethasone in female cancer patients receiving chemotherapy that included cisplatin (≥ 50 mg/m(2)). METHODS: Aprepitant was administered at a dose of 125 mg before chemotherapy on day 1 and at 80 mg on days 2 and 3. Palonosetron (0.75 mg) was given before chemotherapy on day 1. Dexamethasone was administered at a dose of 9.9 mg before chemotherapy on day 1 and at 6.6 mg on days 2-4. The primary endpoint was the the proportion of patients with a complete response (CR no vomiting and no use of rescue medication) throughout the overall period (0-120 h post-chemotherapy). RESULTS: Ninety-six women (median age 55 years) were enrolled. The overall CR rate was 54.2 %. CR was obtained during the acute phase (0-24 h post-chemotherapy) and the delayed phase (24-120 h post-chemotherapy) in 87.5 and 56.3 % of the patients, respectively. The most common adverse reactions were constipation and fatigue (reported by three patients each). CONCLUSIONS: Exhibition of a favorable overall CR rate over existing two-drug combinations suggests that the triple therapy regimen used in the present study is effective and tolerable in patients with gynecological malignancies receiving cisplatin-based chemotherapy. Female patients may have a higher risk of developing CINV.
PURPOSE: Prevention of chemotherapy-induced nausea and vomiting (CINV) is crucial for maintaining the quality of life of cancerpatients. Female patients have been underrepresented in previous clinical studies of aprepitant or palonosetron. We performed a prospective multicenter study to investigate the efficacy and safety of triple therapy comprising these two agents and dexamethasone in female cancerpatients receiving chemotherapy that included cisplatin (≥ 50 mg/m(2)). METHODS: Aprepitant was administered at a dose of 125 mg before chemotherapy on day 1 and at 80 mg on days 2 and 3. Palonosetron (0.75 mg) was given before chemotherapy on day 1. Dexamethasone was administered at a dose of 9.9 mg before chemotherapy on day 1 and at 6.6 mg on days 2-4. The primary endpoint was the the proportion of patients with a complete response (CR no vomiting and no use of rescue medication) throughout the overall period (0-120 h post-chemotherapy). RESULTS: Ninety-six women (median age 55 years) were enrolled. The overall CR rate was 54.2 %. CR was obtained during the acute phase (0-24 h post-chemotherapy) and the delayed phase (24-120 h post-chemotherapy) in 87.5 and 56.3 % of the patients, respectively. The most common adverse reactions were constipation and fatigue (reported by three patients each). CONCLUSIONS: Exhibition of a favorable overall CR rate over existing two-drug combinations suggests that the triple therapy regimen used in the present study is effective and tolerable in patients with gynecological malignancies receiving cisplatin-based chemotherapy. Female patients may have a higher risk of developing CINV.
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Authors: Sant P Chawla; Steven M Grunberg; Richard J Gralla; Paul J Hesketh; Cindy Rittenberg; Mary E Elmer; Carrie Schmidt; Arlene Taylor; Alexandra D Carides; Judith K Evans; Kevin J Horgan Journal: Cancer Date: 2003-05-01 Impact factor: 6.860
Authors: Paul J Hesketh; Steven M Grunberg; Richard J Gralla; David G Warr; Fausto Roila; Ronald de Wit; Sant P Chawla; Alexandra D Carides; Juliana Ianus; Mary E Elmer; Judith K Evans; Klaus Beck; Scott Reines; Kevin J Horgan Journal: J Clin Oncol Date: 2003-10-14 Impact factor: 44.544
Authors: Su-Er W Huskey; Brian J Dean; Ray Bakhtiar; Rosa I Sanchez; F David Tattersall; Wayne Rycroft; Richard Hargreaves; Alan P Watt; Gary G Chicchi; Carolann Keohane; Donald F Hora; Shuet-Hing L Chiu Journal: Drug Metab Dispos Date: 2003-06 Impact factor: 3.922
Authors: H J Schmoll; M S Aapro; S Poli-Bigelli; H-K Kim; K Park; K Jordan; J von Pawel; H Giezek; T Ahmed; C Y Chan Journal: Ann Oncol Date: 2006-03-08 Impact factor: 32.976