Olanzapine for CINV Prophylaxis
Trial question
What is the role of addition of olanzapine to a moderately emetogenic chemotherapy regimen in patients with solid malignant tumors?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 560
560 patients (201 female, 359 male)
Inclusion criteria: patients with solid malignant tumors who were receiving moderately emetogenic chemotherapy regimens containing oxaliplatin, carboplatin, or irinotecan
Key exclusion criteria: emesis or clinically significant nausea in the 24 hours preceding the first dose of study medication; uncontrolled comorbidities; known hypersensitivity or contraindication to the trial drugs; receipt of treatment that may have influenced medications used in the study
Interventions
N=282 olanzapine (olanzapine 10 mg qHS in addition to palonosetron, dexamethasone, and aprepitant)
N=278 usual care (dexamethasone, aprepitant, and palonosetron)
Primary outcome
Complete response
91
82
91.0 %
68.3 %
45.5 %
22.8 %
0.0 %
Olanzapine
Usual
care
Significant
increase ▲
NNT = 11
Significant increase in complete response (91% vs. 82%; AD 9%, 95% CI 2.72 to 15.28)
Secondary outcomes
Significant increase in complete response during later period (92% vs. 83%; AD 9%, 95% CI 3.66 to 14.34)
Significant increase in nausea control (96% vs. 87%; AD 9%, 95% CI 3.66 to 14.34)
Significant increase in chemotherapy-induced nausea and vomiting control (96% vs. 91%; AD 5%, 95% CI 0.78 to 9.22)
Conclusion
In patients with solid malignant tumors who were receiving moderately emetogenic chemotherapy regimens containing oxaliplatin, carboplatin, or irinotecan, olanzapine was superior to usual care with respect to complete response.
Reference
Vikas Ostwal, Anant Ramaswamy, Sarika Mandavkar et al. Olanzapine as Antiemetic Prophylaxis in Moderately Emetogenic Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2426076.
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