دورية أكاديمية
Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer
| العنوان: | Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer |
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| المؤلفون: | Moore, Kathleen N., Angelergues, Antoine, Konecny, Gottfried E., García, Yolanda, Banerjee, Susana, Lorusso, Domenica, Lee, Jung-Yun, Moroney, John W., Colombo, Nicoletta, Roszak, Andrzej, Tromp, Jacqueline, Myers, Tashanna, Lee, Jeong-Won, Beiner, Mario, Cosgrove, Casey M., Cibula, David, Martin, Lainie P., Sabatier, Renaud, Buscema, Joseph, Estévez-García, Purificación, Coffman, Lan, Nicum, Shibani, Duska, Linda R., Pignata, Sandro, Gálvez, Fernando, Wang, Yuemei, Method, Michael, Berkenblit, Anna, Bello Roufai, Diana, Gorp, Toon Van, Gynecologic Oncology Group Partners, European Network of Gynaecological Oncological Trial Groups |
| بيانات النشر: | Massachusetts Medical Society |
| سنة النشر: | 2023 |
| المجموعة: | Digital.CSIC (Consejo Superior de Investigaciones Científicas / Spanish National Research Council) |
| الوصف: | [BACKGROUND] Mirvetuximab soravtansine-gynx (MIRV), a first-in-class antibody–drug conjugate targeting folate receptor α (FRα), is approved for the treatment of platinum-resistant ovarian cancer in the United States. ; [METHODS] We conducted a phase 3, global, confirmatory, open-label, randomized, controlled trial to compare the efficacy and safety of MIRV with the investigator’s choice of chemotherapy in the treatment of platinum-resistant, high-grade serous ovarian cancer. Participants who had previously received one to three lines of therapy and had high FRα tumor expression (≥75% of cells with ≥2+ staining intensity) were randomly assigned in a 1:1 ratio to receive MIRV (6 mg per kilogram of adjusted ideal body weight every 3 weeks) or chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan). The primary end point was investigator-assessed progression-free survival; key secondary analytic end points included objective response, overall survival, and participant-reported outcomes. ; [RESULTS] A total of 453 participants underwent randomization; 227 were assigned to the MIRV group and 226 to the chemotherapy group. The median progression-free survival was 5.62 months (95% confidence interval [CI], 4.34 to 5.95) with MIRV and 3.98 months (95% CI, 2.86 to 4.47) with chemotherapy (P<0.001). An objective response occurred in 42.3% of the participants in the MIRV group and in 15.9% of those in the chemotherapy group (odds ratio, 3.81; 95% CI, 2.44 to 5.94; P<0.001). Overall survival was significantly longer with MIRV than with chemotherapy (median, 16.46 months vs. 12.75 months; hazard ratio for death, 0.67; 95% CI, 0.50 to 0.89; P=0.005). During the treatment period, fewer adverse events of grade 3 or higher occurred with MIRV than with chemotherapy (41.7% vs. 54.1%), as did serious adverse events of any grade (23.9% vs. 32.9%) and events leading to discontinuation (9.2% vs. 15.9%). ; [CONCLUSIONS] Among participants with platinum-resistant, FRα-positive ovarian cancer, treatment with MIRV ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0028-4793 1533-4406 |
| العلاقة: | http://dx.doi.org/10.1056/NEJMoa2309169Test; Sí; The New England Journal of Medicine 389(23): 2162-2174 (2023); http://hdl.handle.net/10261/353608Test |
| DOI: | 10.1056/NEJMoa2309169 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa2309169Test http://hdl.handle.net/10261/353608Test |
| حقوق: | none |
| رقم الانضمام: | edsbas.85EF1A6E |
| قاعدة البيانات: | BASE |
| تدمد: | 00284793 15334406 |
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| DOI: | 10.1056/NEJMoa2309169 |