Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer Journal Article
| Authors: | Pignata, S.; Bookman, M.; Sehouli, J.; Miller, A.; Penson, R. T.; Taskiran, C.; Anderson, C.; Hietanen, S.; Myers, T.; Madry, R.; Willmott, L.; Lortholary, A.; Thomes-Pepin, J.; Aghajanian, C.; McCourt, C.; Stuckey, A.; Wu, X.; Nishio, S.; Copeland, L. J.; He, Y.; Molinero, L.; Patel, S.; Lin, Y. G.; Khor, V. K.; Moore, K. N. |
| Article Title: | Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer |
| Abstract: | Objective: To determine the impact on overall survival (OS) and patient-reported outcomes (PROs) of combining atezolizumab with standard therapy for newly diagnosed stage III/IV ovarian cancer. Methods: The placebo-controlled double-blind randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial (NCT03038100) assigned eligible patients to 3-weekly atezolizumab 1200 mg or placebo for 22 cycles with platinum-based chemotherapy and bevacizumab. Coprimary endpoints were progression-free survival (already reported) and OS in the PD-L1-positive and intent-to-treat (ITT) populations, tested hierarchically. Prespecified PRO analyses focused on disease-related abdominal pain and bloating symptoms (European Organisation for Research and Treatment of Cancer QLQ-OV28), functioning, and health-related quality of life (HRQoL) (QLQ-C30). Results: After 38 months’ median follow-up, the OS hazard ratio in the PD-L1-positive population was 0.83 (95% CI, 0.66–1.06; p = 0.13); median OS was not estimable with atezolizumab versus 49.2 months with placebo. The hazard ratio for OS in the ITT population was 0.92 (95% CI, 0.78–1.09; median 50.5 versus 46.6 months, respectively). At week 9, similar proportions of patients in both arms of the neoadjuvant cohort showed ≥10-point improvement from baseline in abdominal pain and bloating, functioning, and HRQoL. In the primary surgery cohort, similar proportions of patients in each arm had improved, stable, or worsened physical and role function and HRQoL from baseline over time. Neither cohort showed differences between arms in treatment-related symptoms or overall side-effect bother. Conclusions: Incorporation of atezolizumab into standard therapy for newly diagnosed ovarian cancer does not significantly improve efficacy or impose additional treatment burden for patients. ClinicalTrials.gov registration: NCT03038100. © 2023 |
| Keywords: | adult; cancer chemotherapy; controlled study; major clinical study; overall survival; fatigue; bevacizumab; diarrhea; drug safety; hypertension; side effect; treatment duration; paclitaxel; follow up; ovarian cancer; carboplatin; progression free survival; quality of life; multiple cycle treatment; ovary cancer; randomized controlled trial; cohort analysis; abdominal pain; alanine aminotransferase blood level; aspartate aminotransferase blood level; febrile neutropenia; fever; rash; alanine aminotransferase; aspartate aminotransferase; maculopapular rash; multicenter study; nausea and vomiting; phase 3 clinical trial; hypothyroidism; patient-reported outcomes; double blind procedure; bloating; pd-l1; exploratory research; patient-reported outcome; immune checkpoint blockade; human; female; article; atezolizumab; european organization for research and treatment of cancer quality of life questionnaire core 30 |
| Journal Title: | Gynecologic Oncology |
| Volume: | 177 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2023-10-01 |
| Start Page: | 20 |
| End Page: | 31 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2023.06.018 |
| PUBMED: | 37625235 |
| PROVIDER: | scopus |
| PMCID: | PMC10986425 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PDF -- Source: Scopus |
