Prophylactic growth factor (GF) support with adjuvant docetaxel, doxorubicin, and cyclophosphamide (TAC) for node-negative breast cancer (BC): An interim safety analysis of the GEICAM 9805 study

• DOI: 10.1200/jco.2004.22.90140.620
• Publication Date: 2017-04-05T03:17:42Z
• Authors: M. Martin; A. Lluch; M. A. Seguí; A. Antón; A. Ruiz; M. Ramos; A. Rodríguez-Lescure; E. Adrover
• Keywords: Interim analysis; Interim

620 Background: For patients (pts) with node-positive BC, TAC confers signficant disease-free and overall survival benefits vs FAC (5-fluorouracil, doxorubicin, cyclophosphamide), but a higher rate of febrile neutropenia (Martin, SABCS 2003 ab 43). In our study for node-negative we performed an interim safety analysis to assess the impact GF support on incidence TAC-related adverse events. Methods: Following surgery, operable, high-risk (St Gallen, 1998), 18–70 yr old, KPS ≥ 80%, adequate hematologic organ function were randomized (F 500 mg/m2, A 50 C mg/m2) or (T 75 day 1 every 3 wk 6 cycles. After enrollment 224 pts, was amended require prophylactic G-CSF pts subsequently treated TAC, not FAC. The present assessed (FN; fever grade 2 gr 4 neutropenia) other 3/4 toxicities in TAC. Results: At cut-off date this analysis, 448 had been enrolled: 124 received (111 prior amendment) (109 without mandatory [TAC-G]; 115 [TAC+G]). receiving FAC, FN (% pts) 1.3% (0.9% pre-, 1.7% post-amendment); events observed 26.7% (27% 26.5% post-amendment). Among rates 23.8% TAC-G (95% CI: 15.9–31.9%) 3.5% TAC+G (1.0–8.7%); 50.4% (41.1–59.8%) 20% (12.7–27.3%). relative dose intensities TAC+G, respectively, T: 92% 96%, A: 93% 97%, C: 97%. Conclusion: Within limitations non-randomized comparison, use beginning first cycle substantially reduces enables maintenance chemotherapy intensity women early stage breast cancer. event is similar that Author Disclosure Employment Leadership Consultant Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis