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Phase III Trial Evaluating the Addition of Paclitaxel to Doxorubicin Followed by Cyclophosphamide, Methotrexate, and Fluorouracil, As Adjuvant or Primary Systemic Therapy: European Cooperative Trial in Operable Breast Cancer
Open accessAbstract
Purpose: To evaluate the addition of paclitaxel to an anthracycline-based adjuvant regimen and to compare this combination with the same regimen given as primary systemic (neoadjuvant) therapy. Patients and Methods: A total of 1,355 women with operable breast cancer were randomly assigned to one of three treatments: surgery followed by adjuvant doxorubicin (75 mg/m 2) followed by cyclophosphamide, methotrexate, and fluorouracil (CMF; arm A); surgery followed by adjuvant paclitaxel (200 mg/m 2) plus doxorubicin (60 mg/m 2), followed by CMF (arm B); or paclitaxel (200 mg/m 2) plus doxorubicin (60 mg/m 2) followed by CMF followed by surgery (arm C). The two coprimary objectives were to assess the effects on relapse-free survival (RFS) of the addition of paclitaxel to postoperative chemotherapy (arm B v arm A) and primary chemotherapy versus adjuvant chemotherapy (arm B v arm C). Results: Doxorubicin plus paclitaxel followed by CMF was well-tolerated as adjuvant or as primary chemotherapy. The addition of paclitaxel to adjuvant doxorubicin followed by CMF significantly improved RFS compared with adjuvant doxorubicin alone followed by CMF (hazard ratio [HR], 0.73; P = .03). Distant RFS was similarly improved (HR, 0.70; P = .027). There was no significant difference in RFS when the paclitaxel/doxorubicin/CMF chemotherapy was given before surgery compared with the same regimen given after surgery (HR, 1.21; P = .18). However, the rate of breast-conserving surgery was significantly higher with preoperative chemotherapy (63% v 34%; P < .001). Conclusion: Incorporating paclitaxel into anthracycline-based adjuvant therapy resulted in a significant improvement in RFS and distant RFS. When given as primary systemic therapy, the paclitaxel-containing regimen allowed breast-sparing surgery in a significant percentage of patients.
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Rastogi, P., Anderson, S. J., Bear, H. D., Geyer, C. E., Kahlenberg, M. S., Robidoux, A., Margolese, R. G., Hoehn, J. L., Vogel, V. G., Dakhil, S. R., et al. (2008) · Journal of Clinical Oncology · doi:10.1200/jco.2007.15.0235 · Cited by 1,789
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Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
Cardoso, F., Kyriakides, S., Ohno, S., Penault-Llorca, F., Poortmans, P., Rubio, I. T., Zackrisson, S., & Senkus, E. (2019) · Annals of Oncology · doi:10.1093/annonc/mdz173 · Cited by 2,214
Gianni, L., Eiermann, W., Semiglazov, V., Manikhas, A., Lluch, A., Tjulandin, S., Zambetti, M., Vazquez, F., Byakhow, M., Lichinitser, M., et al. (2010) · The Lancet · doi:10.1016/s0140-6736(09)61964-4 · Cited by 1,255
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Metadata
- Authors
- Gianni, L., Baselga, J., Eiermann, W., Porta, V. G., Semiglazov, V., Lluch, A., Zambetti, M., Sabadell, D., Raab, G., Cussac, A. L., Bozhok, A., Martinez-Agulló, A., Greco, M., Byakhov, M., Lopez, J. J. L., Mansutti, M., Valagussa, P., & Bonadonna, G.
- Venue
- Journal of Clinical Oncology
- Published
- 2009-05-20
- Volume
- 27
- Issue
- 15
- Pages
- 2474-2481
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2156556190
- Cited by
- 220
- References
- 1
- FWCI
- 4.18
- Type
- journal article
- Language
- en
- Open access
- bronze
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- CoChat. (2026). Citation check: Phase III Trial Evaluating the Addition of Paclitaxel to Doxorubicin Followed by Cyclophosphamide, Methotrexate, and Fluorouracil, As Adjuvant or Primary Systemic Therapy: European Cooperative Trial in Operable Breast Cancer. https://app.cochat.ai/papers/10.1200/jco.2008.19.2567
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- Gianni, L., Baselga, J., Eiermann, W., Porta, V. G., Semiglazov, V., Lluch, A., Zambetti, M., Sabadell, D., Raab, G., Cussac, A. L., Bozhok, A., Martinez-Agulló, A., Greco, M., Byakhov, M., Lopez, J. J. L., Mansutti, M., Valagussa, P., & Bonadonna, G. (2009). Phase III Trial Evaluating the Addition of Paclitaxel to Doxorubicin Followed by Cyclophosphamide, Methotrexate, and Fluorouracil, As Adjuvant or Primary Systemic Therapy: European Cooperative Trial in Operable Breast Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2008.19.2567
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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