Study 3 (rolapitant, moderately emetogenic chemotherapy)
Study 3 showed that a long-lasting anti-sickness tablet, rolapitant, taken once before moderately strong chemotherapy kept more people free of vomiting and rescue medicine in the days after treatment than the usual anti-sickness pair alone; it was one of the three trials behind the US approval of Varubi.
Overview
Study 3 was a randomised, double-blind, active-controlled phase 3 trial of oral rolapitant versus placebo, each with granisetron and dexamethasone, in patients receiving moderately emetogenic chemotherapy or anthracycline plus cyclophosphamide regimens at 170 centres in 23 countries. Patients received a single 180 mg oral dose of rolapitant or matching placebo one to two hours before cycle 1. The primary endpoint was complete response, meaning no vomiting and no rescue medication, in the delayed phase from more than 24 hours to 120 hours after the start of chemotherapy.
In the Lancet Oncology 2015 report, 1,369 patients were randomly assigned (684 rolapitant, 685 active control) and 666 per arm formed the modified intention-to-treat efficacy population. Delayed-phase complete response was achieved by 475 patients (71 percent) on rolapitant versus 410 (62 percent) on active control (odds ratio 1.6, 95 percent CI 1.2 to 2.0; p = 0.0002). Adverse events were similar between arms; neutropenia was the most common grade 3 to 4 event in cycle 1 (5 percent versus 3 percent), and no serious adverse event was treatment related.
The US Varubi label names the same study Study 3 and analyses the same 666 patients per arm alongside the two cisplatin-based studies, Studies 1 and 2. ClinicalTrials.gov lists organisation id TS-P04834 as a completed phase 3 with an actual enrolment of 1,369, matching the paper. The programme treats chemotherapy-induced nausea and vomiting rather than a named cancer, so the record carries no cancer ids.
- 71 vs 62 out of 100 had no sign of cancer on scans or tests with Rolapitant 180 mg + granisetron + dexamethasone compared with Placebo + granisetron + dexamethasone (active control); 9 more per 100.
- Roughly one extra person helped for every 11 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- The p-value (0.0002) says a difference this large would rarely happen by chance; it does not say how large or how useful the difference is.
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
- These results apply to the people the trial enrolled: Cancer treated with moderately emetogenic chemotherapy or an anthracycline plus cyclophosphamide regimen: a single oral 180 mg dose of rolapitant versus placebo before cycle 1, both with granisetron and dexamethasone. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,369 enrolled.
475 of 666; odds ratio 1.6 (95% CI 1.2 to 2.0) vs active control · 410 of 666
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Complete response in the delayed phase (no emesis and no rescue medication, more than 24 to 120 hours), cycle 1primary | Rolapitant 180 mg + granisetron + dexamethasone | 666 | 71% | - | 0.0002 | link |
| Placebo + granisetron + dexamethasone (active control) | 666 | 62% |
Similar pages
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