Navari and the nausea trial: olanzapine, 2016

2016

The fourth drug: The single clinical result in this section that changed practice worldwide was run from the medical school's South Bend chair. Rudolph M. Navari — director and assistant dean of the IU School of Medicine—South Bend and, with Stack, first co-director of the Harper Institute — had spent his research career on the nausea and vomiting that chemotherapy causes, and on the antipsychotic olanzapine's action across the receptors that drive it. The test was a randomized, double-blind, phase 3 trial across forty-six American sites, funded by the National Cancer Institute, comparing olanzapine against placebo on top of the standard three-drug antiemetic regimen in patients receiving highly emetogenic chemotherapy for the first time. The New England Journal of Medicine published it on 14 July 2016 under Navari's first authorship and his South Bend affiliation, and the numbers are the journal's: of 380 evaluable patients, the proportion with no chemotherapy-induced nausea at all was seventy-four percent on olanzapine against forty-five on placebo in the first twenty-four hours, forty-two against twenty-five across the following four days, and thirty-seven against twenty-two over the whole five days; complete response — no vomiting and no rescue medication — ran eighty-six against sixty-five, sixty-seven against fifty-two, and sixty-four against forty-one in the same periods. Navari stated the result's claim himself, and it is printed as his: olanzapine, he told Medscape at publication, was "the first medication to demonstrate the prevention of nausea post-chemotherapy" — the earlier drugs had prevented vomiting while nausea, the symptom patients dread most, went largely unaddressed. The four-drug regimen the trial tested passed into the standard antiemetic practice its design proposed, and its first author's address on the paper is this city's.

Sources:

1. Navari RM et al., "Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting," New England Journal of Medicine 375 (14 July 2016): 134–142 — the trial itself: the first author's affiliation given as Indiana University School of Medicine—South Bend; 380 evaluable patients; the no-nausea proportions of 74 vs. 45, 42 vs. 25 and 37 vs. 22 percent; the complete-response proportions of 86 vs. 65, 67 vs. 52 and 64 vs. 41 percent; National Cancer Institute funding, ClinicalTrials.gov NCT02116530.
2. The ASCO Post (25 September 2016) — 401 patients enrolled at forty-six academic and community facilities; the trial's regimen and results as summarized for the oncology profession.
3. Medscape Medical News (July 2016) — Navari, identified as of the Indiana University School of Medicine—South Bend: "Olanzapine is the first medication to demonstrate the prevention of nausea post-chemotherapy," carried as his statement.