000150077 001__ 150077
000150077 005__ 20250131200705.0
000150077 0248_ $$2sideral$$a64244
000150077 037__ $$aART-2009-64244
000150077 041__ $$aeng
000150077 100__ $$aChan, S.
000150077 245__ $$aPhase III Study of Gemcitabine Plus Docetaxel Compared with Capecitabine Plus Docetaxel for Anthracycline-Pretreated Patients with Metastatic Breast Cancer
000150077 260__ $$c2009
000150077 5203_ $$aPurpose Patients with metastatic breast cancer who are pretreated with anthracyclines frequently receive taxane-based combinations. This phase III study compared the efficacy and safety of gemcitabine- docetaxel (GD) with capecitabine-docetaxel (CD) in advanced breast cancer. Patients and Methods Patients were randomly assigned to GD (G 1,000 mg/m2 days 1 and 8; D 75 mg/m2 day 1) or CD (C 1,250 mg/m2 twice daily days 1 through 14; D 75 mg/m2 day 1) every 21 days. Comparison of progression-free survival (PFS) was the primary objective. Results Patient characteristics were balanced between arms (N ! 305). Median PFS was 8.05 months (95% CI, 6.60 to 8.71) for GD and 7.98 (95% CI, 6.93 to 8.77) for CD (log-rank P ! .121). Overall response rate (ORR) was 32% in both arms, and overall survival (OS) was not different between arms (P ! .983). Time to treatment failure (TTF; defined as discontinuation, progressive disease, death as a result of any cause, or the start of a new anticancer therapy) was superior in the GD arm (P ! .059). Hematologic toxicity was similar in both arms, except for grades 3 to 4 leukopenia (GD, 78%; CD, 66%; P ! .025) and transfusions (GD, 17%; CD, 7%; P ! .0051). Grades 3 to 4 diarrhea, mucositis, and hand-and-foot syndrome were significantly higher in the CD arm. Fewer patients in the GD arm discontinued because of drug-related adverse events (13% v 27% in CD; P ! .002). Conclusion No difference was observed between GD and CD arms in PFS, ORR, and OS. TTF was longer in the GD arm. These findings, combined with a nonhematologic toxicity profile that favors GD over approved doses of CD, suggest that gemcitabine may be a better option than capecitabine in combination with docetaxel in this clinical setting.
000150077 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000150077 590__ $$a17.793$$b2009
000150077 591__ $$aONCOLOGY$$b4 / 164 = 0.024$$c2009$$dQ1$$eT1
000150077 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000150077 700__ $$aRomieu, G.
000150077 700__ $$aHuober, J.
000150077 700__ $$aDelozier, T.
000150077 700__ $$aTubiana-Hulin, M.
000150077 700__ $$aSchneeweiss, A.
000150077 700__ $$aLluch, A.
000150077 700__ $$aLlombart, A.
000150077 700__ $$aDu Bois, A.
000150077 700__ $$aKreienberg, R.
000150077 700__ $$aMayordomo, J. I.$$uUniversidad de Zaragoza
000150077 700__ $$0(orcid)0000-0002-9159-4988$$aAnton, A.$$uUniversidad de Zaragoza
000150077 700__ $$aHarrison, M.
000150077 700__ $$aJones, A.
000150077 700__ $$aCarrasco, E.
000150077 700__ $$aVaury, A. T.
000150077 700__ $$aFrimodt-Moller, B.
000150077 700__ $$aFumoleau, P.
000150077 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000150077 773__ $$g27, 11 (2009), 1753-1760$$pJ. clin. oncol.$$tJOURNAL OF CLINICAL ONCOLOGY$$x0732-183X
000150077 8564_ $$s170815$$uhttps://zaguan.unizar.es/record/150077/files/texto_completo.pdf$$yVersión publicada
000150077 8564_ $$s3001074$$uhttps://zaguan.unizar.es/record/150077/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000150077 909CO $$ooai:zaguan.unizar.es:150077$$particulos$$pdriver
000150077 951__ $$a2025-01-31-20:06:36
000150077 980__ $$aARTICLE