Abstract
1126 Background: In N0531 (Roy et al, Ann Oncol 2009) NP+G was effective and tolerable in MBC, with complete + partial response rate (CR+PR) 50%, proportion with 6-month progression free survival (6-mo PFS) 60%, median PFS 7.9 mo, 14% with grade (gr) 4 adverse events (AE). N0735 studied addition of B to NP+G to improve response rate and PFS without reducing tolerability. Methods: Single stage phase II study enrolled pts with measurable MBC eligible for 1st line chemotherapy (chemo). Pts received NP 125 mg/m2 followed by G 1000 mg/m2 days 1 and 8; followed by B 15 mg/kg day 1 of 21 day cycles. Dose modifications allowed for NP and G. Primary endpoint was proportion of pts with PFS 6 months from registration. 47 evaluable pts required to test null hypothesis that 6-mo PFS was at most 60% against alternative of at least 77.5%. Results: 48 evaluable pts enrolled 11/08 - 3/10. Median age 56 (27-77). 30 pts (63%) ER- and 25 (52%) PgR-positive, 2 (4%) HER2 positive. 29 (60%) had prior neoadjuvant or adjuvant chemo. Median follow-up 10.6 mos (5-19.6). Median of 9.5 cycles completed (1-27). 39 pts discontinued, due to progression (36%), pt refusal (26%), adverse events (31%), alternate therapy (3%). 6-mo PFS was 81% (95% CI: 67-91%). Confirmed CR+PR was 69% (95% CI: 54-81%): 2 CR, 31 PR. Median duration of response was 9.9 mos (95% CI: 7.3-12.6). Median PFS was 11.7 mos (95% CI: 8.9-13.1); median overall survival (OS) was not reached. 12-mo OS rate was 84% (95% CI: 73-97%). Gr 4 AE occurred in 18 pts (38%), gr 3/4 AE in 43 (90%). Most common gr 3/4 AEs: neutropenia (71%), fatigue (21%), thrombocytopenia (19%), anemia (15%), leukopenia (10%), dyspnea (10%). Four pts had gr 3 neuropathy. Conclusions: The combination of NP+G+B is active in patients with MBC, and met study’s prespecified endpoint (6-mo PFS >60%) to warrant further study of this regimen. Toxicities were manageable, permitting long duration therapy to achieve high response and PFS rates. This regimen should be further evaluated in phase III trials comparing regimens of chemotherapy + targeted agents in MBC.
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