Low-dose olanzapine has ‘practice-defining implications’ for controlling CINV
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Key takeaways:
- Low-dose olanzapine appeared noninferior to standard dose for controlling chemotherapy-induced nausea and vomiting.
- The low dose appeared superior with regard to daytime somnolence.
SAN ANTONIO — Low-dose olanzapine appeared noninferior to the standard dose for controlling chemotherapy-induced nausea and vomiting without requiring delayed steroids among patients with solid tumors, according to study results.
A 2.5-mg dose also appeared superior to the standard 10-mg dose with regard to daytime somnolence among individuals receiving highly emetogenic chemotherapy, findings presented at San Antonio Breast Cancer Symposium showed.
“[This] has practice-defining implications and can benefit patients globally with a low-cost, sustainable intervention,” Jyoti Bajpai, MD, DM, professor in the department of medical oncology at Tata Memorial Centre in India, said during a presentation.
Background and methods
Chemotherapy-induced nausea and vomiting (CINV) is a common major adverse event associated with cancer treatment.
Olanzapine — an antipsychotic used to treat schizophrenia and bipolar disorder — has demonstrated effectiveness for treating nausea and vomiting associated with highly emetogenic chemotherapy. It typically is administered in a 10-mg dose, but significant daytime somnolence has limited the agent’s use.
Bajpai and colleagues conducted the randomized phase 3 OLAnzaPiNE trial to evaluate low-dose olanzapine for adults with solid tumors undergoing treatment with anthracycline-cyclophosphamide and high-dose cisplatin chemotherapy.
Researchers randomly assigned 267 study participants to low-dose olanzapine at 2.5 mg (n = 132) or the standard dose (n = 135) until day 4, with a triple antiemetics regimen in both treatment arms.
Trial participants maintained daily records of nausea, emetic episodes and rescue medication use, grading severity on a four-category scale.
Complete control rate — defined as the proportion of trial participants with no emetic episodes, no use of rescue medications, and no or mild nausea assessed in overall study phase (0 to 120 hours) — served as the primary objective.
Secondary objectives included complete response rate, time to treatment failure and incidence of significant daytime somnolence, as well as a comparison of complete control rates between groups in the acute phase (0 to 24 hours) and delayed phase (25 to 120 hours).
Results, next steps
Researchers reported complete control rates in the overall phase of 44.7% in the low-dose cohort and 43.7% in the standard-dose cohort.
Results showed no significant difference in complete control rates between the low-dose and standard groups in the acute phase (50% vs. 48.9%) or the delayed phase (50.8% vs. 58.5%).
Researchers reported similar complete response rates in the low-dose and standard cohorts in the acute phase (56.1% vs. 57%), delayed phase (55.3% vs. 63%) and overall phase (50.8% vs. 51.1%).
Total control rates between the low-dose and standard cohorts also appeared comparable in the acute phase (25% vs. 23%); delayed phase (20.5% vs. 22%) and overall phase (13.6% vs. 15.6%).
Trial participants assigned the low dose reported significantly less daytime somnolence than those assigned the standard dose (65.2% vs. 89.6%).
Researchers acknowledged potential study limitations, including the fact men accounted for only 4.5% of the study population, and that the majority of the cohort consisted of women with breast cancer who received anthracycline-based chemotherapy. They also noted the open-label nature of the study could lead to ascertainment bias.
However, the results highlight the potential for low-dose olanzapine to be an effective option for this patient population, Bajpai said.
“Daily low-dose olanzapine is noninferior to its 10 mg dose, in combination with standard triple antiemetics, in controlling CINV without the requirement of delayed steroids and is superior with respect to daytime somnolence in patients receiving [highly emetogenic chemotherapy],” Bajpai said. “This merits its consideration as an antiemetic regimen of choice for highly emetogenic chemotherapy.”
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Bajpai J, et al. Abstract RF01-08. Presented at: San Antonio Breast Cancer Symposium; Dec. 5-9, 2023; San Antonio.
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