Randomized Phase II Trial of Nivolumab Versus Nivolumab and Ipilimumab for Recurrent or Persistent Ovarian Cancer: An NRG Oncology Study
Autor: | Heather A. Lankes, Sudarshan K. Sharma, Carol Aghajanian, Cara Mathews, Daniel J. Powell, Dmitriy Zamarin, Andrea R. Hagemann, Oliver Zivanovic, Camille C. Gunderson, Emily M. Ko, Samir N. Khleif, Robert A. Burger, Michael W. Sill, Michael Feldman |
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Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Oncology Adult Cancer Research medicine.medical_specialty Time Factors Programmed Cell Death 1 Receptor Ipilimumab Carcinoma Ovarian Epithelial law.invention 03 medical and health sciences 0302 clinical medicine Antineoplastic Agents Immunological Randomized controlled trial law Internal medicine Antineoplastic Combined Chemotherapy Protocols Carcinoma medicine Humans Progression-free survival Immune Checkpoint Inhibitors Aged Aged 80 and over Ovarian Neoplasms Errata business.industry ORIGINAL REPORTS Middle Aged medicine.disease Progression-Free Survival United States Blockade Clinical trial 030104 developmental biology Nivolumab 030220 oncology & carcinogenesis Female Neoplasm Recurrence Local business Ovarian cancer medicine.drug |
Zdroj: | J Clin Oncol |
ISSN: | 1527-7755 |
Popis: | PURPOSE Single-agent PD-1 blockade exhibits limited efficacy in epithelial ovarian cancer (EOC). We evaluated ipilimumab plus nivolumab compared with nivolumab alone in women with persistent or recurrent EOC. METHODS Eligibility criteria included measurable disease, 1-3 prior regimens, and platinum-free interval (PFI) < 12 months. Participants were randomly allocated to intravenous nivolumab (every 2 weeks) or induction with nivolumab plus ipilimumab for 4 doses (every 3 weeks), followed by every-2-week maintenance nivolumab for a maximum of 42 doses. The primary null hypothesis was equal probability of objective response within 6 months of random allocation in each arm. RESULTS One hundred patients were allocated to receive either nivolumab (n = 49), or nivolumab plus ipilimumab (n = 51), with PFI of < 6 months in 62%. Six (12.2%) responses occurred within 6 months in the nivolumab group and 16 (31.4%) in the nivolumab plus ipilimumab group (odds ratio, 3.28; 85% CI, 1.54 to infinity; P = .034). The median progression-free survival (PFS) was 2 and 3.9 months in the nivolumab and nivolumab plus ipilimumab groups, respectively, with a PFI-stratified hazard ratio of 0.53 (95% CI, 0.34 to 0.82); the respective hazard ratio for death was 0.79 (95% CI, 0.44 to 1.42). Grade ≥ 3 related adverse events occurred in 33% of patients in the nivolumab group and 49% in the combination group, with no treatment-related deaths. PD-L1 expression was not significantly associated with response in either treatment group. CONCLUSION Compared with nivolumab alone, the combination of nivolumab and ipilimumab in EOC resulted in superior response rate and longer, albeit limited, PFS, with toxicity of the combination regimen comparable to prior reports. Additional combination studies to enhance durability of the dual regimen are warranted. |
Databáze: | OpenAIRE |
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