000150081 001__ 150081 000150081 005__ 20250203110526.0 000150081 0247_ $$2doi$$a10.1200/JCO.2008.21.6531 000150081 0248_ $$2sideral$$a142408 000150081 037__ $$aART-2009-142408 000150081 041__ $$aeng 000150081 100__ $$aWardley, Andrew M. 000150081 245__ $$aRandomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in <i>HER2</i>-Positive Metastatic Breast Cancer 000150081 260__ $$c2009 000150081 5203_ $$aPurpose To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. Patients and Methods Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m2 in HTX arm, 100 mg/m2 in HT arm, every 3 weeks) with or without X (950 mg/m2 twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. Conclusion HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids. 000150081 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/ 000150081 590__ $$a17.793$$b2009 000150081 591__ $$aONCOLOGY$$b4 / 164 = 0.024$$c2009$$dQ1$$eT1 000150081 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000150081 700__ $$aPivot, Xavier 000150081 700__ $$aMorales-Vasquez, Flavia 000150081 700__ $$aZetina, Luis M. 000150081 700__ $$ade Fátima Dias Gaui, Maria 000150081 700__ $$aReyes, Douglas Otero 000150081 700__ $$aJassem, Jacek 000150081 700__ $$aBarton, Claire 000150081 700__ $$aButton, Peter 000150081 700__ $$aHersberger, Veronica 000150081 700__ $$0(orcid)0000-0002-9159-4988$$aAntón Torres, Antonio$$uUniversidad de Zaragoza 000150081 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000150081 773__ $$g28, 6 (2009), 976-983$$pJ. clin. oncol.$$tJOURNAL OF CLINICAL ONCOLOGY$$x0732-183X 000150081 8564_ $$s281881$$uhttps://zaguan.unizar.es/record/150081/files/texto_completo.pdf$$yVersión publicada 000150081 8564_ $$s2928862$$uhttps://zaguan.unizar.es/record/150081/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000150081 909CO $$ooai:zaguan.unizar.es:150081$$particulos$$pdriver 000150081 951__ $$a2025-02-03-11:02:18 000150081 980__ $$aARTICLE