000150080 001__ 150080 000150080 005__ 20250130223147.0 000150080 0247_ $$2doi$$a10.1200/JCO.2012.46.9841 000150080 0248_ $$2sideral$$a142409 000150080 037__ $$aART-2013-142409 000150080 041__ $$aeng 000150080 100__ $$aMartín, Miguel 000150080 245__ $$aFluorouracil, 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 000150080 260__ $$c2013 000150080 5203_ $$aPurpose 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) × 6 or FAC × 4 followed by wP × 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. 000150080 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/ 000150080 590__ $$a17.96$$b2013 000150080 591__ $$aONCOLOGY$$b5 / 203 = 0.025$$c2013$$dQ1$$eT1 000150080 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000150080 700__ $$aRuiz, Amparo 000150080 700__ $$aBorrego, Manuel Ruiz 000150080 700__ $$aBarnadas, Agustí 000150080 700__ $$aGonzález, Sonia 000150080 700__ $$aCalvo, Lourdes 000150080 700__ $$aVila, Mireia Margelí 000150080 700__ $$aAntón, Antonio 000150080 700__ $$aRodríguez-Lescure, Alvaro 000150080 700__ $$aSeguí-Palmer, Miguel Angel 000150080 700__ $$aMuñoz-Mateu, Montserrat 000150080 700__ $$aRibugent, Joan Dorca 000150080 700__ $$aLópez-Vega, José Manuel 000150080 700__ $$aJara, Carlos 000150080 700__ $$aEspinosa, Enrique 000150080 700__ $$aFernández, César Mendiola 000150080 700__ $$0(orcid)0000-0003-0123-4274$$aAndrés, Raquel$$uUniversidad de Zaragoza 000150080 700__ $$aRibelles, Nuria 000150080 700__ $$aPlazaola, Arrate 000150080 700__ $$aSánchez-Rovira, Pedro 000150080 700__ $$aBofill, Javier Salvador 000150080 700__ $$aCrespo, Carmen 000150080 700__ $$aCarabantes, Francisco J. 000150080 700__ $$aServitja, Sonia 000150080 700__ $$aChacón, José Ignacio 000150080 700__ $$aRodríguez, César A. 000150080 700__ $$aHernando, Blanca 000150080 700__ $$aÁlvarez, Isabel 000150080 700__ $$aCarrasco, Eva 000150080 700__ $$aLluch, Ana 000150080 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000150080 773__ $$g31, 20 (2013), 2593-2599$$pJ. clin. oncol.$$tJOURNAL OF CLINICAL ONCOLOGY$$x0732-183X 000150080 8564_ $$s167204$$uhttps://zaguan.unizar.es/record/150080/files/texto_completo.pdf$$yVersión publicada 000150080 8564_ $$s2801361$$uhttps://zaguan.unizar.es/record/150080/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000150080 909CO $$ooai:zaguan.unizar.es:150080$$particulos$$pdriver 000150080 951__ $$a2025-01-30-20:32:13 000150080 980__ $$aARTICLE