Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14 Journal Article
| Authors: | Brown, J.; Miller, A.; Holman, L. L.; Backes, F.; Nagel, C.; Bender, D.; Miller, D. S.; Powell, M. A.; Westin, S. N.; Bonebrake, A.; Muller, C. Y.; Secord, A. A.; Crane, E.; Schorge, J.; Tew, W. P.; Sood, A. K.; Bookman, M. A.; Aghajanian, C.; Gershenson, D. M. |
| Article Title: | Results of a randomized phase II trial of paclitaxel and carboplatin versus bleomycin, etoposide and cisplatin for newly diagnosed and recurrent Chemonaive stromal ovarian tumors: An NRG oncology/gynecologic oncology group study14 |
| Abstract: | Objectives: To assess the efficacy and toxicity of paclitaxel and carboplatin (PC) compared to bleomycin, etoposide, and cisplatin (BEP) for treatment of newly diagnosed Stage IIA-IV or recurrent chemotherapy-naive ovarian sex cord-stromal tumors (SCST). Methods: This phase II noninferiority trial randomly assigned patients to receive PC (6 cycles P 175 mg/m2 and C AUC = 6 IV every 3 weeks), or BEP (4 cycles B 20 units/m2 IV push day 1, E 75 mg/m2 IV days 1–5, and cisplatin 20 mg/m2 IV days 1–5 every 3 weeks). The primary endpoint was progression- free survival (PFS). This trial is registered with ClinicalTrials.gov, NCT01042522. Results: At the interim analysis, 63 patients (31 PC and 32 B.P. had accrued between Feb 8, 2010 and Apr 30, 2020. Median age was 48 years. 87% had granulosa cell tumors. 37% had measurable disease. The DSMB closed accrual early for futility of PC arm. The futility analysis was supported by an estimated HR = 1.11 [95% CI: 0.57 to 2.13] which exceeded the pre-determined threshold for non-inferiority (1.10). Median PFS was 27.7 months [11.2 to 41.0] for PC and 19.7 months for BEP [95% CI: 10.4–52.7]. PC patients had fewer grade 3 or higher adverse events (PC 77% vs BEP 90%). Conclusions: The study met its pre-specified criterion for stopping early for futility and so failed to demonstrate non-inferiority of PC versus BEP in ovarian SCSTs, in a non-inferiority test with a hazard ratio margin of 1.1. Both PC and BEP may be considered in patients with advanced/recurrent SCST. © 2024 Elsevier Inc. |
| Keywords: | adult; controlled study; treatment response; major clinical study; overall survival; drug tolerability; fatigue; cancer recurrence; cisplatin; area under the curve; cancer combination chemotherapy; drug efficacy; hypertension; side effect; treatment duration; paclitaxel; comparative study; cancer staging; follow up; ovarian cancer; carboplatin; progression free survival; computer assisted tomography; infection; multiple cycle treatment; neutrophil count; phase 2 clinical trial; anemia; etoposide; nausea; randomized controlled trial; histology; hyperglycemia; cause of death; multicenter study; thromboembolism; granulosa cell tumor; bleomycin; drug toxicity; metabolic disorder; adverse drug reaction; leukocyte; lymphocyte count; vascular disease; study design; response evaluation criteria in solid tumors; Common Terminology Criteria for Adverse Events; nutritional disorder; androblastoma; intention to treat analysis; human; female; article; sex cord-stromal tumor; infestation; non-inferiority trial; alternative hypothesis; ovarian sex cord stromal tumor |
| Journal Title: | Gynecologic Oncology |
| Volume: | 190 |
| ISSN: | 0090-8258 |
| Publisher: | Elsevier Inc. |
| Date Published: | 2024-11-01 |
| Start Page: | 283 |
| End Page: | 290 |
| Language: | English |
| DOI: | 10.1016/j.ygyno.2024.09.002 |
| PROVIDER: | scopus |
| PUBMED: | 39265466 |
| DOI/URL: | |
| Notes: | Article -- Source: Scopus |
