[1096] Phase II trial of nanoparticle albumin-bound paclitaxel (ABX) + capecitabine (XEL) in first line treatment of metastatic breast cancer (MBC): interim results.

Schwartzberg LS, Arena F, Mintzer D, Epperson A, Fu D, Fortner BV.. Accelerated Community Oncology Research Network, Memphis, TN

Background: ABX and XEL both have substantial single agent activity in MBC. Taxane and anti-metabolite doublets improve response rate and TTP compared to singlet therapy. ABX given weekly has an excellent safety and efficacy profile with maintenance of dose intensity. We designed this study to test the safety and efficacy of ABX + XEL given in a novel combination schedule.
Methods: This phase II, multicenter open label study utilized ABX 125 mg/m² IV on day 1, 8 and with no premeds and Xeloda 825 mg/m² PO BID days 1-14 on an every three week cycle. The primary endpoint is objective response rate, with evaluation performed after every 2 cycles. Entry criteria include measurable MBC by RECIST criteria, age >18, PS 0-2, no prior chemo for metastatic disease, > 6 months since adjuvant fluoropyrimidine and/or paclitaxel. Pts are eligible to continue therapy after 6 cycles at the discretion of the investigator if stable/responding.
Results: To date, 27 patients (pts) have entered on study; data from 21 pts are available for analysis. Median age is 59.9 (range 31.2 76.0). 45% received prior adjuvant anthracycline and 45% prior adjuvant taxane. Median number of metastatic sites is 2 (range 1 7), with most common sites of disease liver, 47.6%; bone, 47.6%; and lung, 28.6%. 76 cycles of therapy have been delivered. 2 pts required a dose reduction in XEL to 650 mg/m² and 4 pts had dose reduction in ABX to 100 mg/m². Three pts have had grade 3 non hematologic AEs: 2 hand-foot syndrome, and 1 fatigue. Hematologic AEs included 4 grade 3 neutropenia and 1 febrile neutropenia. The most common AEs of any grade were nausea (11), fatigue (8), hand-foot syndrome (7), and alopecia (6). The incidence of Grade 1-2 neuropathy was 14.3%. Of 20 pts available for analysis of response, the overall response rate is 25%: PR 15%, CR 10%. 12 pts have stable disease. 6 pts have completed 6+ cycles. 3 pts have disease progression. Discussion: The combination of weekly ABX plus daily XEL orally at these doses and scheduling is well tolerated and shows preliminary evidence of substantial efficacy. Updated results will be presented.

Thursday, December 14, 2006 5:00 PM

Poster Session I: Treatment: Chemotherapy – New Drugs and Formulations (5:00 PM-7:00 PM)