Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (alliance) Journal Article
| Authors: | Shulman, L. N.; Berry, D. A.; Cirrincione, C. T.; Becker, H. P.; Perez, E. A.; O'Regan, R.; Martino, S.; Shapiro, C. L.; Schneider, C. J.; Kimmick, G.; Burstein, H. J.; Norton, L.; Muss, H.; Hudis, C. A.; Winer, E. P. |
| Article Title: | Comparison of doxorubicin and cyclophosphamide versus single-agent paclitaxel as adjuvant therapy for breast cancer in women with 0 to 3 positive axillary nodes: CALGB 40101 (alliance) |
| Abstract: | Purpose: Optimal adjuvant chemotherapy for early-stage breast cancer balances efficacy and toxicity. We sought to determine whether single-agent paclitaxel (T) was inferior to doxorubicin and cyclophosphamide (AC), when each was administered for four or six cycles of therapy, and whether it offered less toxicity. Patients and Methods: Patients with operable breast cancer with 0 to 3 positive nodes were enrolled onto the study to address the noninferiority of single-agent T to AC, defined as the one-sided 95% upper-bound CI (UCB) of hazard ratio (HR) of T versus AC less than 1.30 for the primary end point of relapse-free survival (RFS). As a 2 × 2 factorial design, duration of therapy was also addressed and was previously reported. Results: With 3,871 patients enrolled onto the trial, a median follow-up period of 6.1 years, and 437 RFS events, we achieved an HR of 1.26 (one sided 95% UCB, 1.48; favoring AC does not allow a conclusion of noninferiority of T with AC; UCB > 1.3). With 266 patient deaths, the HR for overall survival (OS) was 1.27 favoring AC (UCB, 1.56). The estimated absolute advantage of AC at 5 years is 3% for RFS (91 v 88%) and 1% for OS (95 v 94%). All nine treatment-related deaths were patients receiving AC and are included in the analyses of both RFS and OS. Hematologic toxicity was more common in patients treated with AC, and neuropathy was more common in patients treated with T. Conclusion: This trial did not show noninferiority of T to AC, a conclusion that is unlikely to change with additional events and follow-up. T was less toxic than AC. © 2014 by American Society of Clinical Oncology. |
| Keywords: | adult; cancer survival; acute granulocytic leukemia; major clinical study; overall survival; fatigue; neutropenia; doxorubicin; diarrhea; heart left ventricle failure; side effect; treatment duration; paclitaxel; cancer adjuvant therapy; neurotoxicity; follow up; multiple cycle treatment; sensory neuropathy; breast cancer; tumor volume; blood toxicity; thrombocytopenia; vomiting; epidermal growth factor receptor 2; cyclophosphamide; hemoglobin; hemoglobin blood level; arthralgia; febrile neutropenia; axillary lymph node; myelodysplastic syndrome; heart infarction; cardiotoxicity; tamoxifen; estrogen receptor; progesterone receptor; trastuzumab; motor neuropathy; recurrence free survival; randomized controlled trial (topic); factorial design; human; female; priority journal; article |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 32 |
| Issue: | 22 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2014-08-01 |
| Start Page: | 2311 |
| End Page: | 2317 |
| Language: | English |
| DOI: | 10.1200/jco.2013.53.7142 |
| PROVIDER: | scopus |
| PMCID: | PMC4105484 |
| PUBMED: | 24934787 |
| DOI/URL: | |
| Notes: | Cited By (since 1996):1 -- Export Date: 2 September 2014 -- CODEN: JCOND -- Source: Scopus |
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