Results of an Open-Label Study to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated with Carboplatin-Containing Chemotherapy in Patients with Ovarian Cancer, Primary Peritoneal, or Fallopian Tube Carcinoma (Stage I-IV) or Papillary Serous Cancer of the Uterus

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Abstract

Purpose:

Aprepitant might offer an advantage in preventing acute/delayed chemotherapy-induced nausea and vomiting (CINV). This study integrated palonosetron and dexamethasone into the regimen to determine the efficacy and safety of this combination.

Patients and Methods:

Fifty patients were enrolled; 49 were evaluable. Main inclusion criteria were (1) diagnosis of ovarian (OV), primary peritoneal (PP), or fallopian tube (FT) carcinoma (stage I-IV) or papillary serous cancer of the uterus (UPSC); (2) patients naive to emetogenic chemotherapy Hesketh ≥ level 4; (3) scheduled to receive paclitaxel 175 mg/m2 intravenously (I.V.) and carboplatin AUC 6 I.V.; able to read/understand the Functional Living Index-Emesis questionnaire.

Results:

Median age was 61 years, 60% had Eastern Cooperative Oncology Group performance status of 0, 86% had previous surgery (74% OV, 12% PP, 8% UPSC, and 6% FT). The metastases rate was 30%; 21% were visceral metastasis. Eighty-six percent of patients reported no vomiting or use of rescue medications during cycle 1 (95% and 100% in cycles 2-3 and 4-6, respectively) and were deemed as complete responders. Grade 3/4 treatment-related adverse events limited to neutropenia (6%). Grade 1/2 toxicities > 5% included nausea (12%), alopecia, constipation, arthralgia (8% each), and anemia (6%). Some toxicities might have been related to chemotherapy and were not related to the aprepitant, palonosetron, or dexamethasone.

Conclusion:

The addition of aprepitant to palonosetron and dexamethasone appears to be very well tolerated. This combination is effective in the prevention of chemotherapy-induced nausea and vomiting when used with emetogenic therapy (paclitaxel and carboplatin).

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