Systematic Literature Reviews (SLRs) Of Clinical Outcomes And Patient-Reported Outcomes Of Recommended Treatments For Patients With Platinum-Resistant Ovarian Cancer (PROC)
Author(s)
Zhiyuan Chen, MSc1, Thomas Macmillan, MSc2, Lei Chen, PhD, MD3, Thomas J. Herzog, PhD4;
1Cytel Inc., Toronto, ON, Canada, 2Cytel Inc., London, United Kingdom, 3Mural Oncology Inc., Waltham, MA, USA, 4University of Cincinnati, Cincinnati, OH, USA
1Cytel Inc., Toronto, ON, Canada, 2Cytel Inc., London, United Kingdom, 3Mural Oncology Inc., Waltham, MA, USA, 4University of Cincinnati, Cincinnati, OH, USA
OBJECTIVES: To understand the evidence landscape for patients with PROC, defined as relapse ≤6 months after platinum-based chemotherapy (CT).
METHODS: Two SLRs were conducted on clinical efficacy and safety in randomized clinical trials (RCTs) and patient-reported outcomes in health-related quality of life (HRQoL) studies. This report focuses on non-CT regimens recommended by the National Comprehensive Cancer Network (NCCN).
RESULTS: Among the 66 included RCTs, eight studies compared five recommended regimens against CT: mirvetuximab soravtansine (MIRV), bevacizumab (BEV) + CT, rucaparib, tamoxifen and olaparib. In patients with ≤2 prior lines of therapy [LOTs] (AURELIA), BEV + CT demonstrated significantly prolonged PFS, and higher objective response rate (ORR) vs. CT, though OS was similar. In patients who had 1-3 prior LOTs, MIRV prolonged OS and PFS significantly compared with CT in patients with high-FRα-expressing tumors (MIRASOL). MIRV also demonstrated non-significant PFS and OS benefit (vs CT) in the high-FRα subgroup, with similar survival observed in overall FRα-expressing patients (1-3 prior LOTs) (FORWARD I). MIRV was associated with a higher rate of Grade 3+ ocular toxicities compared with CT (blurred vision, keratopathy and dry eye). No significant survival benefit was identified from trials of tamoxifen (in patients with mainly 1-2 prior LOTs), rucaparib (BRCA mutation, 2-5 prior LOTs) or olaparib (majority ≤4 prior LOTs). The median OS and PFS for patients with PROC remains short in interventional settings (7.4-22.2 and 1.9-6.7 months, respectively). Of 38 included HRQoL studies, HRQoL of BEV and MIRV were superior to CT, especially for gastrointestinal and ovarian symptoms. For other identified regimens, patients generally reported similar or better HRQoL compared with CT.
CONCLUSIONS: Compared with CT, only MIRV (in FRα high tumors) and BEV ± CT demonstrated both OS and HRQoL improvement in PROC patients, with mOS remaining short. There is a substantial unmet need for clinically efficacious and tolerable treatments for PROC.
METHODS: Two SLRs were conducted on clinical efficacy and safety in randomized clinical trials (RCTs) and patient-reported outcomes in health-related quality of life (HRQoL) studies. This report focuses on non-CT regimens recommended by the National Comprehensive Cancer Network (NCCN).
RESULTS: Among the 66 included RCTs, eight studies compared five recommended regimens against CT: mirvetuximab soravtansine (MIRV), bevacizumab (BEV) + CT, rucaparib, tamoxifen and olaparib. In patients with ≤2 prior lines of therapy [LOTs] (AURELIA), BEV + CT demonstrated significantly prolonged PFS, and higher objective response rate (ORR) vs. CT, though OS was similar. In patients who had 1-3 prior LOTs, MIRV prolonged OS and PFS significantly compared with CT in patients with high-FRα-expressing tumors (MIRASOL). MIRV also demonstrated non-significant PFS and OS benefit (vs CT) in the high-FRα subgroup, with similar survival observed in overall FRα-expressing patients (1-3 prior LOTs) (FORWARD I). MIRV was associated with a higher rate of Grade 3+ ocular toxicities compared with CT (blurred vision, keratopathy and dry eye). No significant survival benefit was identified from trials of tamoxifen (in patients with mainly 1-2 prior LOTs), rucaparib (BRCA mutation, 2-5 prior LOTs) or olaparib (majority ≤4 prior LOTs). The median OS and PFS for patients with PROC remains short in interventional settings (7.4-22.2 and 1.9-6.7 months, respectively). Of 38 included HRQoL studies, HRQoL of BEV and MIRV were superior to CT, especially for gastrointestinal and ovarian symptoms. For other identified regimens, patients generally reported similar or better HRQoL compared with CT.
CONCLUSIONS: Compared with CT, only MIRV (in FRα high tumors) and BEV ± CT demonstrated both OS and HRQoL improvement in PROC patients, with mOS remaining short. There is a substantial unmet need for clinically efficacious and tolerable treatments for PROC.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO24
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Oncology, SDC: Rare & Orphan Diseases