Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC) Versus FAC Followed by Weekly Paclitaxel As Adjuvant Therapy for High-Risk, Node-Negative Breast Cancer: Results From the GEICAM/2003-02 Study

被引：46

作者：

Martin, Miguel ^{[1
]}

Ruiz, Amparo ^{[7
]}

Ruiz Borrego, Manuel ^{[9
]}

Barnadas, Agusti ^{[11
]}

Gonzalez, Sonia ^{[12
]}

Calvo, Lourdes ^{[17
]}

Margeli Vila, Mireia ^{[13
]}

Anton, Antonio ^{[18
]}

Rodriguez-Lescure, Alvaro ^{[20
]}

Angel Segui-Palmer, Miguel ^{[14
]}

Munoz-Mateu, Montserrat ^{[15
]}

Dorca Ribugent, Joan ^{[21
]}

Manuel Lopez-Vega, Jose ^{[22
]}

Jara, Carlos ^{[2
]}

Espinosa, Enrique ^{[3
]}

Mendiola Fernandez, Cesar ^{[4
]}

Andres, Raquel ^{[19
]}

Ribelles, Nuria ^{[23
]}

Plazaola, Arrate

Sanchez-Rovira, Pedro ^{[26
]}

Salvador Bofill, Javier ^{[10
]}

Crespo, Carmen ^{[5
]}

Carabantes, Francisco J. ^{[24
]}

Servitja, Sonia ^{[16
]}

Ignacio Chacon, Jose ^{[27
]}

Rodriguez, Cesar A. ^{[28
]}

Hernando, Blanca ^{[29
]}

Alvarez, Isabel ^{[25
]}

Carrasco, Eva ^{[6
]}

Lluch, Ana ^{[8
]}

机构：

[1] Univ Complutense, Inst Invest Sanitaria Gregorio Maranon, Madrid 28009, Spain

[2] Fdn Hosp Alcorcon, Madrid, Spain

[3] Hosp Univ la Paz, Madrid, Spain

[4] Hosp Univ 12 Octubre, Madrid, Spain

[5] Hosp Univ Ramon & Cajal, Madrid, Spain

[6] Spanish Breast Canc Res Grp GEICAM Headquarter, Madrid, Spain

[7] Inst Valenciano Oncol, Valencia, Spain

[8] Hosp Clin Univ, Valencia, Spain

[9] Hosp Univ Virgen del Rocio, Seville, Spain

[10] Hosp Valme, Seville, Spain

[11] Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, E-08193 Barcelona, Spain

[12] Hosp Mutua Terrassa, Barcelona, Spain

[13] Hosp Badalona Germans Trias & Pujol, Barcelona, Spain

[14] Corporacion Sanitaria Parc Tauli, Catalonia, Spain

[15] Hosp Clin Barcelona, Barcelona, Spain

[16] Hosp del Mar, Barcelona, Spain

[17] Complejo Hosp Univ A Coruna, La Coruna, Spain

[18] Hosp Univ Miguel Servet, Zaragoza, Spain

[19] Hosp Univ Lozano Blesa, Zaragoza, Spain

[20] Hosp Gen Elche, Alicante, Spain

[21] Inst Catalan Oncol, Girona, Spain

[22] Hosp Univ Marques Valdecilla, Santander, Spain

[23] Hosp Univ Virgen de la Victoria, Malaga, Spain

[24] Hosp Reg Univ Carlos Haya, Malaga, Spain

[25] Hosp Univ Donostia, San Sebastian, Spain

[26] Complejo Hosp Jaen, Jaen, Spain

[27] Hosp Univ Virgen de la Salud, Toledo, OH USA

[28] Hosp Univ Salamanca, Salamanca, Spain

[29] Hosp Univ Burgos, Burgos, Spain

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2013年 / 31卷 / 20期

关键词：

POSITIVE AXILLARY NODES; PLUS CYCLOPHOSPHAMIDE; CHEMOTHERAPY; DOCETAXEL; TRIAL; EPIRUBICIN; BENEFIT;

D O I：

10.1200/JCO.2012.46.9841

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Adding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reported so far showed a docetaxel benefit but significant toxicity. Here we tested the efficacy and safety of weekly paclitaxel (wP) in node-negative patients, which is yet to be established. Patients and Methods Patients with BC having T1-T3/N0 tumors and at least one high-risk factor for recurrence (according to St. Gallen 1998 criteria) were eligible. After primary surgery, 1,925 patients were randomly assigned to receive fluorouracil, doxorubicin, and cyclophosphamide (FAC) X 6 or FAC X 4 followed by wP X 8 (FAC-wP). The primary end point was disease-free survival (DFS) after a median follow-up of 5 years. Secondary end points included toxicity and overall survival. Results After a median follow-up of 63.3 months, 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free (hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04). Thirty-one patients receiving FAC-wP versus 40 patients receiving FAC died (one and seven from cardiovascular diseases, respectively; HR, 0.79; 95% CI, 0.49 to 1.26; log-rank P = .31). The most relevant grade 3 and 4 adverse events in the FAC-wP versus the FAC arm were febrile neutropenia (2.7% v 3.6%), fatigue (7.9% v 3.4%), and sensory neuropathy (5.5% v 0%). Conclusion For patients with high-risk node-negative BC, the adjuvant FAC-wP regimen was associated with a small but significant improvement in DFS compared with FAC therapy, in addition to manageable toxicity, especially regarding long-term cardiac effects. (C) 2013 by American Society of Clinical Oncology

引用

页码：2593 / +

页数：8

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