Phase III trial of induction gemcitabine (G) or paclitaxel (T) plus carboplatin (C) followed by elective T consolidation in advanced ovarian cancer (OC): Interim analysis of induction chemotherapy

• DOI: 10.1200/jco.2008.26.15_suppl.5536
• Publication Date: 2017-02-24T07:33:44Z
• Authors: A. N. Gordon; M. G. Teneriello; N. Spirtos; M. F. Janicek; T. Goss; Y. Wang; M. Orlando; C. K. Obasaju; J. F. Gill; D. F. Tai
• Keywords: Carboplatin; Interim analysis; Induction chemotherapy

5536 Background: Induction TC is a standard of care for advanced OC. GC approved use in recurrent platinum-sensitive Phase II trials show G + platinum to be active as first-line therapy Also, evidence suggests that 12-month T consolidation improves progression- free survival (PFS). This trial compared safety and efficacy induction regimens followed by elective consolidation. interim disclosure, permitted protocol, reports toxicity response results the first 449 pts randomized regimens. Methods: Pts enrolled with histologic diagnosis prior resection Stage Ic-IV epithelial ovarian, primary peritoneal, or fallopian tube carcinomas were two arms. arm was given 1,000 mg/m2 on Days 1, 8 plus C AUC 5 Day 1. 175 6 Up six 21-day cycles permitted. CR allowed 135 every 28 days up 12 months. Non-CR patients single-agent crossover (GC: 1; TC: 8) 21 until CR, PD, undue toxicity. Best assessed measurable disease RECIST; required normalized CA-125. The 2-sided Fisher's exact test determined p-values. Results: Enrollment stopped 2006 at 919 protocol modified allow PFS endpoint. Interim are summarized below. Demographics well balanced between Anemia, thrombocytopenia, platelet transfusions greater GC, while neuropathy severe alopecia TC. ORR DCR not statistically different Conclusions: Based upon this analysis, profiles each consistent clinical experience. Response rates comparable therapies. Parameter PC p- Value (enrolled pts) N=225 N=224 Median age (range) 60 (22–84) 61 (27–86) FIGO stage initial surgery, n (%) IC 11 (4.9%) (5.4%) 27 (12.0%) 22 (9.8%) III 153 (68.0%) 158 (70.5%) IV 34 (15.1%) 31 (13.8%) Zubrod performance status, 0 137 (60.9%) 134 (59.8%) 1 69 (30.7%) 79 (35.3%) 2 13 (5.8%) 7 (3.1%) Toxicity (pt-based), N=219 N=220 G3–4 Neutropenia 173 (79.0%) 181 (82.3%) 0.4001 Thrombocytopenia 143 (65.3%) 40 (18.2%) <0.0001 Anemia 52 (23.7%) 20 (9.1%) Fatigue 18 (8.2%) (5.0%) 0.1848 Nausea 9 (4.1%) (2.7%) 0.4460 Vomiting (3.2%) (2.3%) 0.5752 >G2 Neuropathy 24 (11.0%) 43 (19.5%) 0.0165 Febrile neutropenia (0.9%) 0.1752 Myalgia 4 (1.8%) 3 (1.4%) 0.7240 G2 Alopecia (36.1%) 110 (50.0%) 0.0038 RBC transfusion 15 (6.8%) 0.4274 Platelet (0.0%) 0.0073 response, N=66 N=58 Complete (CR) 30 (45.5%) 26 (44.8%) Partial (PR) (19.7%) (20.7%) Stable (SD) (7.6%) Progressive (PD) (6.9%) Unknown (CR+PR) (65.2%) 38 (65.5%) >0.999 (CR+PR+SD) 48 (72.7%) 46 (79.3%) 0.410 consolidation, (% enrolled) 111 (49.3%) (49.1%) Author Disclosure Employment Leadership Consultant Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Eli Lilly Company