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Blogger's Note: ovarian cancer patients were included in this study
Rolapitant (VARUBI®
open access - Efficacy of the neurokinin-1 receptor antagonist rolapitant in preventing nausea and vomiting in patients receiving carboplatin-based chemotherapy
Study Design and Patients
A global, multicenter, randomized, parallel-group, double-blind, controlled phase 3 study (NCT01500226) was conducted in 23 countries in North America, Central and South America, Europe, Asia, and Africa.[12] The protocol was approved by institutional review boards at each study site, all patients provided written informed consent, and all investigators and site personnel were required to follow ethical principles outlined in the Declaration of Helsinki and consistent with the International Conference on Harmonisation Good Clinical Practice guidelines and applicable local laws and regulations.
Patients (see Table1)
Of the 1332 patients who composed
the modified intent-to-treat population for the phase 3 MEC trial, 401
received their first course of chemotherapy with a carboplatin-based
regimen and were included in the efficacy analysis for cycle 1. Baseline
and disease characteristics were similar for patients in the rolapitant
and control groups, as shown in Table 1.
The median age of the patients was 62 years, and more patients were
female (54.9%) than male (45.1%). The primary malignancy among patients
treated with carboplatin-based chemotherapy was lung cancer (52.1%);
other malignancies included ovarian, breast, and uterine cancer (13.7%,
13.7%, and 7.7%, respectively). The receipt of concomitant emetogenic
chemotherapy with a Hesketh level ≥ 3 was low and occurred in 15.7% of
the patients.
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