Phase II multicenter trial of albumin-bound paclitaxel and capecitabine in first-line treatment of patients with metastatic breast cancer.

Capecitabine, a tumor-activated oral fluoropyrimidine, and albumin-bound paclitaxel (ab-paclitaxel) have substantial single-agent activity in patients with metastatic breast cancer (MBC). Taxane and antimetabolite doublets have improved efficacy compared with single agents. This phase II open-label trial was designed to test the safety and efficacy of capecitabine and ab-paclitaxel in previously untreated MBC. Patients received capecitabine (825 mg/m(2) orally twice daily, approximately 12 hours apart, on days 1 to 15) and ab-paclitaxel (125 mg/m(2) intravenously on days 1 and 8 of each cycle with no premedication) every 3 weeks. The primary endpoint was overall objective response rate (ORR), with evaluation performed after every 2 cycles. Entry criteria included measurable MBC, human epidermal growth factor receptor 2 (HER2) negativity, Eastern Cooperative Oncology Group (ECOG) performance status 0-2, no previous chemotherapy for metastatic disease, and > 6 months since adjuvant fluoropyrimidine or paclitaxel treatment. Fifty patients received at least 1 dose of study drug, with 46 patients evaluable for efficacy evaluation. Three hundred seventy-four cycles of therapy were delivered. Eighty percent of patients completed 8 cycles. The ORR was 61% (complete response [CR], 4%; partial response [PR], 57%), and 7 patients had sustained (≥ 24 weeks) stable disease for a clinical benefit rate of 76.1%. The median progression-free survival (PFS) was 10.6 months, and the median overall survival was 19.9 months. The most common adverse events (AEs) that were ≥ grade 3 were pain, hand-foot syndrome, and neutropenia. The combination of weekly ab-paclitaxel plus daily capecitabine orally at these doses and scheduling was well tolerated and showed substantial efficacy.

Schwartzberg LS ，Arena FP ，Mintzer DM ，Epperson AL ，Walker MS ... -  《-》

Phase II trial of capecitabine and weekly paclitaxel as first-line therapy for metastatic breast cancer.

Blum JL ，Dees EC ，Chacko A ，Doane L ，Ethirajan S ，Hopkins J ，McMahon R ，Merten S ，Negron A ，Neubauer M ，Ilegbodu D ，Boehm KA ，Asmar L ，O'Shaughnessy JA ... -  《-》

Phase II trial of capecitabine and weekly paclitaxel in patients with metastatic breast cancer previously treated with every-3-week taxane therapy.

Blum JL ，Dees EC ，Vukelja SJ ，Amare M ，Gill DP ，McMahon RT ，Ilegbodu D ，Asmar L ，O'Shaughnessy JA ... -  《Clinical Breast Cancer》

Paclitaxel and bevacizumab with or without capecitabine as first-line treatment for HER2-negative locally recurrent or metastatic breast cancer: a multicentre, open-label, randomised phase 2 trial.

Lam SW ，de Groot SM ，Honkoop AH ，Jager A ，ten Tije AJ ，Bos MM ，Linn SC ，van den Bosch J ，Kroep JR ，Braun JJ ，van Tinteren H ，Boven E ，Dutch Breast Cancer Research Group ... -  《-》

Capecitabine plus paclitaxel as front-line combination therapy for metastatic breast cancer: a multicenter phase II study.

Gradishar WJ ，Meza LA ，Amin B ，Samid D ，Hill T ，Chen YM ，Lower EE ，Marcom PK ... -  《-》