Pembrolizumab in combination with bevacizumab and pegylated liposomal doxorubicin in patients with platinum-resistant epithelial ovarian cancer
| العنوان: | Pembrolizumab in combination with bevacizumab and pegylated liposomal doxorubicin in patients with platinum-resistant epithelial ovarian cancer |
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| المؤلفون: | Benoit You, Fanny Pommeret, François Ghiringhelli, Aurélien Marabelle, Corinne Balleyguier, Rastilav Bahleda, Christophe Massard, Judith Michels, Caroline Brard, Jean-Sebastien Frenel, Anne Floquet, Sophie Broutin, Emeline Colomba, Lauriane Eberst, Alexandra Leary, Patricia Pautier, Catherine Genestie |
| المصدر: | Journal of Clinical Oncology. 39:5522-5522 |
| بيانات النشر: | American Society of Clinical Oncology (ASCO), 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Cancer Research, medicine.medical_specialty, Bevacizumab, business.industry, Pembrolizumab, medicine.disease, Pegylated Liposomal Doxorubicin, Unmet needs, Internal medicine, medicine, In patient, Epithelial ovarian cancer, business, Ovarian cancer, medicine.drug, Platinum resistant |
| الوصف: | 5522 Background: There is a medical unmet need for effective treatments in platinum resistant ovarian cancer patients. We assessed the safety and efficacy of a combination of pembrolizumab with bevacizumab and pegylated liposomal doxorubicin (PLD). Methods: This is an open-label phase 1b trial in patients ECOG 0 or 1 with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The safety of the dual combinations of pembrolizumab with bevacizumab or with PLD were previously evaluated in 6 patients respectively. In the absence of dose limiting toxicities (DLT) the triple combination was evaluated at a maximum tolerated dose (MTD)-1 for PLD in 3 patients and in the absence of DLT at MTD. The sample size was calculated according to the modified toxicity probability interval design. The primary evaluation criteria was the safety, the secondary endpoint was the outcome. Pharmacokinetics of the flat dose of bevacizumab will be evaluated. Results: 22 patients were enrolled from September 2019 until June 2020 in six French centers. 3 initial patients have been treated at 20mg/m2 of PLD (MTD-1) and 19 patients were treated at the dose of 30mg/m2 of PLD (MTD) combined with 200mg of pembrolizumab until progression, unacceptable toxicity, or withdrawal of consent and 400mg of bevacizumab for a total of six cycles. The patients’ characteristics are reported in the table. No DLT occurred. Grade 3 palmar-plantar erythrodysesthesia were reported in 4 patients. The recommended phase II dose of PLD was 30mg/m2 in combination with pembrolizumab and bevacizumab. For patients treated at MTD, the overall response rate was 32% (6 partial responses) with 74% of clinical benefit with a durable response in 10 patients (53%). Median number of cycles was 7.5 (2 to not reached). Two patients are still on treatment. Correlative studies are ongoing. Conclusions: The combination was well tolerated and demonstrated clinical benefit in 74% platinum resistant ovarian cancer patients with durable response (>6 months) in 53% of patients. Clinical trial information: NCT03596281. [Table: see text] |
| تدمد: | 1527-7755 0732-183X 0359-6281 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::953ea5ba944def8f29c7c0c1c461171b https://doi.org/10.1200/jco.2021.39.15_suppl.5522 |
| رقم الأكسشن: | edsair.doi...........953ea5ba944def8f29c7c0c1c461171b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15277755 0732183X 03596281 |
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