Phase III trial evaluating weekly paclitaxel versus docetaxel in combination with capecitabine in operable breast cancer.

Abstract

PURPOSE:

We investigated whether capecitabine and docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC) or weekly paclitaxel (WP) followed by FEC would improve relapse-free survival (RFS) in operable breast cancer.

PATIENTS AND METHODS:

In this single-institution study, patients with clinical stages I to IIIC breast cancer were randomly assigned on a 1:1 basis to WP 80 mg/m(2) for 12 weeks followed by fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2), and cyclophosphamide 500 mg/m(2) (FEC-100) every 3 weeks for four cycles or docetaxel 75 mg/m(2) on day 1 and capecitabine (XT) 1,500 mg/m(2) on days 1 through 14 every 3 weeks for four cycles followed by FEC for four cycles and stratified by timing of chemotherapy (preoperative v adjuvant). Accrual was stopped short of 930 patients on the basis of a Bayesian predictive calculation that additional accrual would be unlikely to change the qualitative comparison of the two regimens.

RESULTS:

After enrollment of 601 patients and a median follow-up of 50 months, we observed no improvement in RFS between XT (87.5%; 95% CI, 82.7% to 91.1%) and WP (90.7%; 95% CI, 86.4% to 93.7%; P = .51). In the preoperative group, the pathologic complete response rate was 19.8% and 16.4% in the XT and WP arms, respectively (P = .45). Rates of breast-conserving surgery were similar between the two groups (P = .48). The XT arm had a significantly higher incidence of stomatitis (P < .001), hand-foot syndrome (P < .001), and neutropenic infection (P < .001).

CONCLUSION:

There was no difference in efficacy between WP and XT as used in this randomized phase III trial. XT was associated with higher GI, skin, and neutropenic-related toxicities.

• Authors: Catherine M Kelly, Marjorie C Green, Kristine Broglio, Eva S Thomas, Abenaa M Brewster, Vicente Valero, Nuhad K Ibrahim, Ana M Gonzalez-Angulo, Daniel J Booser, Ronald S Walters, Kelly K Hunt, Gabriel N Hortobagyi, Aman U Buzdar
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 30 Issue 9 Pg. 930-5 (Mar 20 2012) ISSN: 1527-7755 [Electronic] United States
• PMID: 22331946 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Taxoids
• Deoxycytidine
• Docetaxel
• Epirubicin
• Capecitabine
• Cyclophosphamide
• Paclitaxel
• Fluorouracil

Topics

• Adult
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Breast Neoplasms (drug therapy, mortality, surgery)
• Capecitabine
• Carcinoma, Intraductal, Noninfiltrating (drug therapy, mortality, surgery)
• Combined Modality Therapy
• Cyclophosphamide (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Docetaxel
• Epirubicin (administration & dosage)
• Female
• Fluorouracil (administration & dosage, analogs & derivatives)
• Follow-Up Studies
• Humans
• Middle Aged
• Paclitaxel (administration & dosage)
• Survival Rate
• Taxoids (administration & dosage)
• Treatment Outcome