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125 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
  1. J Brown1,
  2. A Miller2,
  3. K Moxley3,
  4. F Backes4,
  5. C Nagel5,
  6. D Bender6,
  7. D Miller7,
  8. M Powell8,
  9. S Westin9,
  10. A Bonebrake10,
  11. C Muller11,
  12. A Alvarez Secord12,
  13. E Crane1,
  14. J Schorge13,
  15. W Tew14,
  16. A Sood9 and
  17. C Aghajanian14
  1. 1Levine Cancer Institute at Atrium Health, USA
  2. 2NRG Oncology, USA
  3. 3University of Oklahoma, USA
  4. 4The Ohio State University, USA
  5. 5Case Western Reserve University, USA
  6. 6University of Iowa, USA
  7. 7University of Texas Southwestern Medical Center, USA
  8. 8Washington University, USA
  9. 9MD Anderson Cancer Center, USA
  10. 10Cancer Research for the Ozarks, USA
  11. 11University of New Mexico, USA
  12. 12Duke University, USA
  13. 13Tufts University, USA
  14. 14Memorial Sloan Kettering Cancer Center, USA


Objectives To determine the progression free survival (PFS) of paclitaxel and carboplatin (PC) versus 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 study was a phase II, open-label, noninferiority trial. Eligible women with SCST were equally randomized to 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 targeted 128 patient accrual and PFS hazard ratio (HR)=0.67 provided 85% power to exclude noninferiority margin HR=1.10.

Results 63 patients were accrued at the interim futility analysis (31 PC and 32 BEP). Median age was 48 years. 87% had granulosa cell tumors. 37% had measurable disease. The DSMB closed the study early for futility of PC. The futility analysis was supported by 21/16 PFS events on the PC/BEP arms respectively, with an estimated HR=1.12 [95% CI: 0.58 to 2.16]. Median PFS was 27.7 months [7.4 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%). Differences included infections (0 vs 10%), low neutrophil count (65% vs 84%), and low WBC (22 vs 40%). One death NOS occurred on PC.

Conclusions Compared to BEP, PC failed to improve PFS in ovarian SCSTs. PC showed a more favorable side effect profile.

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