International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2025
A phase 2 study of pembrolizumab and weekly paclitaxel for platinum-resistant epithelial ovarian cancer.
СтатьяКлиническое исследование II фазыМногоцентровое исследованиеПоддержка исследования: вне правительства СШАПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Wenham Robert M, Buras Andrea L, Gordon Sarah W, Whiting Junmin, Fridley Brooke L, Dorman Denise, Apte Sachin M, Chon Hye Sook, Shahzad Mian M, Randall Leslie M, Havrilesky Laura J, Davidson Brittany A, Secord Angeles Alvarez
Аннотация
OBJECTIVE: Weekly dose-dense paclitaxel may have immunomodulatory effects, enhancing immune responses via cytotoxic T-cell infiltration. Therefore, we assessed the combination of weekly dose-dense paclitaxel with pembrolizumab in patients with platinum-resistant ovarian cancer that persisted or recurred within 6 months of previous platinum chemotherapy.
METHODS: A multi-center open-label, single-arm study was conducted and participants received weekly intravenous paclitaxel 80 mg/m2 and every 3-week intravenous pembrolizumab 200 mg until progression or toxicity. The primary objectives were to determine the progression-free survival at 6 months and safety. Secondary analyses included objective response rate, disease control rate, duration of response, median progression-free survival, and overall survival. All patients receiving any drug were included in the toxicity evaluation. Exploratory analysis of programmed cell death ligand 1 in archival tissue was performed.
RESULTS: Of the 42 patients enrolled, 37 had Response Evaluation Criteria in Solid Tumors (RECIST)-evaluable disease, and 41 were assessable in the intention-to-treat analysis. In the RECIST-evaluable cohort, the progression-free survival at 6 months was 58.6% (95% confidence interval 41.0 to 72.7), the overall response rate was 51.4% (range; 34.4-68.1), disease control rate was 86.5% (range; 75.5-97.5), and the median progression-free survival was 7.23 (range; 4.54-11.00) months. In the intention-to-treat analysis, the progression-free survival at 6 months was 55.3% (range; 38.8-69.1), overall response rate was 46.3% (range; 30.7-62.6), disease control rate was 78.0% (range; 62.4-89.4), and median progression-free survival was 6.87 (range; 4.37-8.9) months. The median duration of response for responders was 8.8 (range; 4.4-13.0) months. The median overall survival for the RECIST-evaluable and intention-to-treat groups were 26.3 (13.4 to not reached) and 25.9 (range; 13.3-27.1) months, respectively. Most common adverse events were anemia (69.1%), fatigue (52.4%), lab abnormalities (50.0%), decreased neutrophils (23.8%), and edema (47.6%).
CONCLUSIONS: The combination of weekly dose-dense paclitaxel and pembrolizumab demonstrated promising activity and was well tolerated, although edema may be increased.
METHODS: A multi-center open-label, single-arm study was conducted and participants received weekly intravenous paclitaxel 80 mg/m2 and every 3-week intravenous pembrolizumab 200 mg until progression or toxicity. The primary objectives were to determine the progression-free survival at 6 months and safety. Secondary analyses included objective response rate, disease control rate, duration of response, median progression-free survival, and overall survival. All patients receiving any drug were included in the toxicity evaluation. Exploratory analysis of programmed cell death ligand 1 in archival tissue was performed.
RESULTS: Of the 42 patients enrolled, 37 had Response Evaluation Criteria in Solid Tumors (RECIST)-evaluable disease, and 41 were assessable in the intention-to-treat analysis. In the RECIST-evaluable cohort, the progression-free survival at 6 months was 58.6% (95% confidence interval 41.0 to 72.7), the overall response rate was 51.4% (range; 34.4-68.1), disease control rate was 86.5% (range; 75.5-97.5), and the median progression-free survival was 7.23 (range; 4.54-11.00) months. In the intention-to-treat analysis, the progression-free survival at 6 months was 55.3% (range; 38.8-69.1), overall response rate was 46.3% (range; 30.7-62.6), disease control rate was 78.0% (range; 62.4-89.4), and median progression-free survival was 6.87 (range; 4.37-8.9) months. The median duration of response for responders was 8.8 (range; 4.4-13.0) months. The median overall survival for the RECIST-evaluable and intention-to-treat groups were 26.3 (13.4 to not reached) and 25.9 (range; 13.3-27.1) months, respectively. Most common adverse events were anemia (69.1%), fatigue (52.4%), lab abnormalities (50.0%), decreased neutrophils (23.8%), and edema (47.6%).
CONCLUSIONS: The combination of weekly dose-dense paclitaxel and pembrolizumab demonstrated promising activity and was well tolerated, although edema may be increased.