Phase III Multicenter Trial of Doxorubicin Plus Cyclophosphamide Followed by Paclitaxel Compared With Doxorubicin Plus Paclitaxel Followed by Weekly Paclitaxel As Adjuvant Therapy for Women With High-Risk Breast Cancer
| Autor: | John D. Hainsworth, John Pippen, Neil Senzer, Lina Asmar, John Sandbach, F. Anthony Greco, Svetislava J. Vukelja, Scot Sedlacek, David M. Loesch, Kristi J. McIntyre, Manuel Modiano, Kristi A. Boehm, Feng Zhan, Howard A. Burris, Deborah Lindquist, Frankie A. Holmes, Nicholas J. Robert, Stephen E. Jones, Joanne L. Blum |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Cancer Research medicine.medical_specialty Paclitaxel medicine.medical_treatment Urology Breast Neoplasms Adenocarcinoma Young Adult chemistry.chemical_compound Breast cancer Risk Factors Multicenter trial Antineoplastic Combined Chemotherapy Protocols Adjuvant therapy medicine Humans Cyclophosphamide Survival rate Aged Neoplasm Staging Aged 80 and over Chemotherapy Performance status business.industry Middle Aged medicine.disease Surgery Survival Rate Treatment Outcome Oncology chemistry Doxorubicin Lymphatic Metastasis Female Breast disease business |
| Zdroj: | Journal of Clinical Oncology. 28:2958-2965 |
| ISSN: | 1527-7755 0732-183X |
| DOI: | 10.1200/jco.2009.24.1000 |
| Popis: | Purpose This study compared disease-free survival (DFS) obtained with two different regimens of adjuvant therapy in high-risk breast cancer. Methods Women (who had performance status [PS] of 0 to 1) with operable, histologically confirmed, stage I to III adenocarcinoma of the breast were eligible. Patients had undergone primary surgery with no residual tumor. Treatments were as follows: arm 1 was doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks for four cycles followed by paclitaxel 175 mg/m2 every 3 weeks for four cycles (ie, AC-P); and arm 2 was doxorubicin 50 mg/m2 plus paclitaxel 200 mg/m2 every 3 weeks for four cycles followed by paclitaxel 80 mg/m2 weekly for 12 weeks. Results Overall, 1,830 patients were enrolled and 1,801 were treated: arm 1 (n = 906; AC→P) and arm 2 (n = 895; AP-WP). Overall, patients had a PS of 0 (88%), had estrogen receptor and progesterone receptor–positive disease (52%), had one to three positive nodes (46%), and were postmenopausal (57%); the median age was 52 years. Currently, 1,640 patients (90%) are alive. The 6-year DFS was 79% to 80% in both groups. Disease relapse was the cause of death for 83 patients in arm 1 and in 66 patients of arm 2. Overall 6-year survival rates were 82% and 87% in arms 1 and 2, respectively. Reasons for patients being taken off study treatment included toxicity (13% in arm 1 v 20% in arm 2), progressive disease or recurrence (7% v 5%), and consent withdrawn (9% v 8%), respectively. The most frequent toxicities were hematologic, including neutropenia and leukopenia followed by neuropathy, myalgia, nausea, fatigue, headache, arthralgia, and vomiting. Conclusion The results indicate that the AP-WP regimen is an equally effective and tolerable option for the adjuvant treatment of patients with high-risk breast cancer. The substitution of paclitaxel for cyclophosphamide results in comparable effectiveness of the regimen. |
| Databáze: | OpenAIRE |
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