Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.

Authors

Bernardo Rapoport

Bernardo Leon Rapoport

The Medical Oncology Centre of Rosebank, Johannesburg, South Africa

Bernardo Leon Rapoport , Lee Steven Schwartzberg , Sujata Arora , Daniel Powers , Karin Jordan , Rudolph M. Navari

Organizations

The Medical Oncology Centre of Rosebank, Johannesburg, South Africa, The West Clinic, Memphis, TN, TESARO, Inc., Waltham, MA, Martin-Luther-University Halle-Wittenberg, Halle, Germany, Indiana University School of Medicine South Bend, South Bend, IN

Research Funding

Pharmaceutical/Biotech Company

Background: Rolapitant, a long-acting neurokinin-1 receptor antagonist, protected against CINV in patients receiving highly or moderately emetogenic chemotherapy (HEC or MEC). Methods: In 3 double-blind phase 3 studies, patients were randomized to receive oral rolapitant 180 mg or placebo before administration of HEC or MEC. All patients received a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone. In a post hoc analysis of 3 pooled studies (2 HEC and 1 MEC), we assessed the efficacy and safety of rolapitant in patients with gynecologic (ovarian, uterine, or cervical) cancer. Endpoints included complete response (CR; no emesis and no use of rescue medication), no emesis, no nausea (maximum visual analogue scale [VAS] < 5 mm), and complete protection (CP; no emesis, no use of rescue medication, and no significant nausea [maximum VAS < 25 mm]) in the overall (0–120 h), acute ( ≤ 24 h), and delayed ( > 24–120 h) phases. Results: Of 203 patients with gynecologic cancer, 55% received cisplatin-based HEC and 45% received MEC (98% of whom received carboplatin-based therapy). In the overall and delayed phases, improved rates of CR, no emesis, no nausea, and CP were observed with rolapitant compared with control (Table). The overall incidence of treatment-emergent adverse events was similar in the rolapitant and control groups (46% vs 54%). Conclusions: Rolapitant protected against overall and delayed CINV in patients with gynecologic cancer receiving HEC or MEC. Clinical trial information: NCT01500226, NCT01499849, NCT01500213

Endpoint, %Pooled HEC/MEC
Rolapitant (n = 107)Control
(n = 96)
Odds Ratio
(95% Confidence Interval)
Overall phase (0–120 h)
CR79642.1 (1.1–3.9)
No emesis83692.2 (1.2–4.4)
No nausea60402.3 (1.3–4.0)
CP74562.2 (1.2–4.0)
Acute phase ( ≤ 24 h)
CR92822.3 (1.0–5.5)
No emesis92842.0 (0.8–4.8)
No nausea76681.5 (0.8–2.7)
CP85781.6 (0.8–3.3)
Delayed phase ( > 24–120 h)
CR79652.1 (1.1–4.0)
No emesis84712.2 (1.1–4.3)
No nausea62432.2 (1.2–3.8)
CP75572.2 (1.2–4.0)

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Abstract Details

Meeting

2016 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Patient and Survivor Care

Track

Patient and Survivor Care

Sub Track

Palliative Care and Symptom Management

Clinical Trial Registration Number

NCT01500226, NCT01499849, NCT01500213

Citation

J Clin Oncol 34, 2016 (suppl; abstr 10122)

DOI

10.1200/JCO.2016.34.15_suppl.10122

Abstract #

10122

Poster Bd #

110

Abstract Disclosures

Similar Abstracts

Abstract

2016 Palliative and Supportive Care in Oncology Symposium

Rolapitant for control of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic cancer.

First Author: Bernardo Leon Rapoport

First Author: Rudolph M. Navari