TESARO, Inc., Waltham, MA
Daniel Powers, Paul Joseph Hesketh, Lee Steven Schwartzberg, Manuel R. Modiano, Sujata Arora, Ian D. Schnadig
Background: Rolapitant, a novel NK-1 receptor antagonist, showed efficacy in CINV prevention in patients (pts) receiving MEC (anthracycline/cyclophosphamide (AC) and other regimens) in a global phase 3 trial. Recent anti-emetic guidelines consider AC based regimens to be highly emetogenic. In this post hoc analysis, the efficacy and safety of rolapitant was assessed in Cycle 1 in pts receiving non-AC MEC, and in the subset of pts receiving carboplatin-based MEC. Methods: In a double-blind, active-controlled study, pts were randomized to oral rolapitant 180 mg or placebo 1–2 hours before MEC. All pts received granisetron 2 mg oral on days 1-3 and oral dexamethasone 20 mg on day 1. Complete response (CR = no emesis + no use of rescue medication), no emesis, and no nausea were assessed in overall (0-120 h), acute (0-24 h), and delayed ( > 24-120 h) phases. Results: CR was significantly (P < 0.01) higher with rolapitant than active control in overall and delayed phases in the carboplatin subset and in all 3 phases in the non-AC population (Table). No emesis rates were significantly (p < 0.05) higher with rolapitant in the carboplatin subset in the overall phase. No nausea rates were significantly (P < 0.05) higher with rolapitant in the overall and delayed phases in carboplatin-based MEC. Incidences of treatment-related AEs in Cycle 1 with rolapitant vs. active control were 11.3% vs. 6.7% in the carboplatin-based subset. Most common AEs with rolapitant and active control were constipation, fatigue, and headache. Conclusions: Rolapitant was superior to active control in preventing CINV in pts receiving non-AC MEC, including in the subgroup receiving carboplatin. Rolapitant was well tolerated with low incidence of AEs. Clinical trial information: NCT01500226
Complete Response Rates (%) | Carboplatin (N = 401) | Non-AC (N = 629) | ||
---|---|---|---|---|
Rolapitant (N = 192) | Active Control (N = 209) | Rolapitant (N = 322) | Active Control (N = 307) | |
Delayed Phase (> 24–120 h) | 82.3% | 65.6% | 76.1% | 63.8% |
p-valuea | < 0.001 | < 0.001 | ||
Acute Phase (0–24 h) | 91.7% | 88.0% | 90.7% | 84.4% |
p-valuea | 0.231 | 0.016 | ||
Overall Phase (0–120 h) | 80.2% | 64.6% | 74.8% | 61.2% |
p-valuea | < 0.001 | < 0.001 |
aunstratified CMH test
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Abstract Disclosures
2015 ASCO Annual Meeting
First Author: Paul Joseph Hesketh
2022 ASCO Annual Meeting
First Author: Camilla Vieira de Reboucas
2014 ASCO Annual Meeting
First Author: Laszlo Urban
2023 ASCO Annual Meeting
First Author: Venkatraman Radhakrishnan