Abstract
1152 Background: We recently published data on 41 patients (pts) treated with DalCMP (JCO 2009). We have now accrued additional pts to further compare responses in pts treated or not with prior anthracycline (A) and taxane (T) based regimens. Methods: Pts with measurable MBC received daily sc dalteparin (5,000UI), po cyclophosphamide (50mg), twice weekly po methothrexate (2.5mg BID) and daily po prednisone (5mg). Primary study endpoint was clinical benefit rate (CBR) (i.e., complete response [CR] + partial response [PR] + prolonged stable disease for ≥ 24 weeks [pSD]). Secondary endpoints included time to progression (TTP), duration of response (DOR), and overall survival (OS). Pts were in group 1 (no prior chemotherapy for metastatic disease) or group 2 (prior A and T for metastatic disease, or prior adjuvant A and T if relapse < 1 year, or prior adjuvant A and prior T for metastatic disease). Adverse events were assessed by common toxicity criteria version 2 (CTCAE). Kaplan-Meier methods and log rank test were used for time to event outcomes. Exact confidence intervals (CI) and Fisher's Exact test were used for proportions. Results: Between Oct 2003 and Sept 2008, 92 eligible pts were recruited from two cancer centers in Ontario, Canada, 44 in group 1 and 48 in group 2. There were 2 cases of grade (G) 4 toxicity (anemia, leukopenia). G3 toxicity included transient elevation of liver transaminases in 21 pts and fatigue in 7. Efficacy results are shown in the Table. Conclusions: Metronomic DalCMP is safe, well tolerated, and clinically active in MBC. Group 1 (no prior A/T) n=44 Group 2 (prior A/T) n=48 p value Response CR- 1 (2.2%) CR- none 0.15 PR-5 (11.4%) PR-3 (6.2%) D-14 (31.8%) SD-8 (16.7%) pSD-5 (11.4%) SD-5 (10.4%) D-19 (43.2%) PD-32 (66.7%) CBR (%) 25 (CI 95%: 13.2-40.3) 16.7 (CI 95%: 7.5-30.2) 0.44 TTP (median, wks) 15.7 (CI 95%: 7.4-22.1) 7.8 (CI 95%: 7.0-14.7) 0.16 OS (median, wks) 73.5 (CI 95%: 48.0- 86.8) 31.7 (CI 95%: 26.4- 57.0) 0.051 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer
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