The Medical Oncology Center of Rosebank, Johannesburg, South Africa
Bernardo Leon Rapoport, Lee Steven Schwartzberg, Martin Robert Chasen, Daniel Powers, Sujata Arora, Rudolph M. Navari, Ian D. Schnadig
Background: The long-acting neurokinin-1 receptor antagonist (NK-1 RA) rolapitant has demonstrated efficacy for CINV prevention in patients receiving HEC and MEC during Cycle 1. The efficacy and safety of rolapitant was examined during subsequent cycles 2–6 in a pooled analysis. Methods: In 4 double-blind, active-controlled studies, patients were randomized to oral rolapitant 180 mg or placebo 1–2 hours before chemotherapy. All patients received active control: 5HT3 receptor antagonist + oral dexamethasone. Patients completing Cycle 1 could receive the same anti-emetic treatment in subsequent cycles. On Days 6-8 of subsequent cycles, patients self-reported the incidence of emesis, or of nausea interfering with normal daily life following Day 1 of chemotherapy. Results: A greater proportion of patients on rolapitant than on active control reported no emesis or interfering nausea separately for each subsequent cycle. Results of individual studies and pooled analysis are shown in the Table. During cycles 2-6, the incidence of treatment-related adverse events (AEs) was similar for rolapitant (5.5%) and control (6.8%). The most common treatment-related AEs were similar in both arms: constipation (rolapitant: 1.2%; control: 0.8%) and fatigue (rolapitant: 1.3%; control: 1.8%). Conclusions: Rolapitant was superior to active control in reducing CINV when administered over multiple cycles of moderately or highly emetogenic chemotherapy, with no increase in toxicity. Clinical trial information: NCT00394966 - NCT01500213 - NCT01500226 - NCT01499849
Cycle | Patients with No Emesis or No Nausea Interfering with Normal Daily Life % (N)* | ||
---|---|---|---|
Rolapitant 200mg | Active Control | p-value** | |
2 | 75.7 (1006) | 70.1 (990) | 0.006 |
3 | 76.9 (834) | 67.9 (826) | < 0.001 |
4 | 78.6 (682) | 70.9 (687) | 0.001 |
5 | 84.7 (378) | 78.2 (362) | 0.021 |
6 | 84.0 (318) | 80.1 (312) | 0.209 |
*mITT population **CMH test adjusted for study and gender
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Abstract Disclosures
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First Author: Camilla Vieira de Reboucas
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First Author: Venkatraman Radhakrishnan