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ASCO Proceedings BREAST CANCER—TRIPLE-NEGATIVE/CYTOTOXICS/LOCAL THERAPY LBA1000 Oral Abstract Session, Tue, 9:45 AM-12:45 PM NSABP B-38: Definitive analysis of a randomized adjuvant trial comparing dose- dense (DD) AC followed by paclitaxel (P) plus gemcitabine (G) with DD AC followed by P and with docetaxel, doxorubicin, and cyclophosphamide (TAC) in women with operable, node-positive breast cancer. Sandra M. Swain, Gong Tang, Charles E. Geyer, Priya Rastogi, James Norman Atkins, Paul P. Donnellan, Louis Fehrenbacher, Catherine A. Azar, Andre Robidoux, Jonathan Polikoff, Adam Brufsky, David D. Biggs, Edward A. Levine, John L. Zapas, Louise Provencher, Edith A. Perez, Soonmyung Paik, Joseph P. Costantino, Eleftherios P. Mamounas, Norman Wolmark; National Surgical Adjuvant Breast and Bowel Project and Washington Cancer Institute, MedStar Washington Hospital Center, Washington, DC; NSABP Biostatistical Center and University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and University of Texas, Southwestern Medical Center, Dallas, TX; National Surgical Adjuvant Breast and Bowel Project and University of Pittsburgh Cancer Institute, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and SCCC-CCOP, Goldboro, NC; All Ireland Cooperative Oncology Research Group and University Hospital Galway, Galway, Ireland; National Surgical Adjuvant Breast and Bowel Project and Kaiser Permanente Northern California, Vallejo, CA; National Surgical Adjuvant Breast and Bowel Project and Kaiser Permanente, Denver, CO; National Surgical Adjuvant Breast and Bowel Project and Centre Hospitalier de l’Universite de Montreal, Montreal, QC, Canada; National Surgical Breast and Bowel Project and Kaiser Permanente Southern California, San Diego, CA; National Surgical Adjuvant Breast and Bowel Project and University of Pittsburgh, Magee-Womens Hospital, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and Helen F. Graham Cancer Center, Christiana Care Health System, Newark, DE; National Surgical Adjuvant Breast and Bowel Project and Surgical Oncology Service, Wake Forest University, Winston-Salem, NC; National Surgical Adjuvant Breast and Bowel Project and Medstar Franklin Square Medical Center, Baltimore, MD; National Surgical Adjuvant Breast and Bowel Project and Centre Hospitalier Affilié Universitaire de Québec, Hopital du St-Sacrement, Quebec City, QC, Canada; National Surgical Adjuvant Breast and Bowel Project and Mayo Clinic, Jacksonville, FL; National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project Biostatistical Center and University of Pittsburgh Graduate School of Public Health, Department of Biostatistics, Pittsburgh, PA; National Surgical Adjuvant Breast and Bowel Project and Aultman Hospital, Canton, OH; National Surgical Adjuvant Breast and Bowel Project and Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Monday, June 4, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News. © 2012 American Society of Clinical Oncology. Reprinted with permission. BREAST CANCER—TRIPLE-NEGATIVE/CYTOTOXICS/LOCAL THERAPY 1001 Oral Abstract Session, Tue, 9:45 AM-12:45 PM Randomized phase III study of adjuvant chemotherapy for high-risk, node-negative breast cancer (BC) comparing FAC with FAC followed by weekly paclitaxel: First efficacy analysis of the GEICAM/2003-02 trial. Miguel Martin, Ana Lluch, Amparo Ruiz, Manuel Ruiz Borrego, Agust Barnadas, Sonia Gonzalez, Lourdes Calvo, Mireia Margeli Vila, Antonio Anton, Alvaro Rodriguez-Lescure, Miguel Angel Seguí-Palmer, Montserrat Munoz-Mateu, Joan Dorca Ribugent, Jose Manuel Lopez-Vega, Cesar Mendiola Fernandez, Raquel Andres, Arrate Plazaola, Cesar Rodriguez, Maria Isabel Casas, Eva Maria Carrasco, Spanish Breast Cancer Research Group GEICAM; Hospital General Universitario Gregorio Marañón, Madrid, Spain; H C U de Valencia, Valencia, Spain; Instituto Valenciano de Oncologia, Valencia, Spain; Hospital Universitario Virgen del Rocio, Seville, Spain; Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; Hosp Mutua Terrassa, Barcelona, Spain; CHU de A Coruña, A Coruna, Spain; Hospital Univerditari Germans Trias i Pujol, Barcelona, Spain; Hospital Universitario Miguel Servet, Zaragoza, Spain; Hospital General de Elche, Alicante, Spain; Corporació Sanita`ria Parc Taulí, Sabadell, Spain; Hospital Clinico de Barcelona, Barcelona, Spain; Institut Catala d’Oncologia, Gerona, Spain; Hospital Universitario Marques de Valdecilla, Cantabria, Spain; Hospital Universitario Doce de Octubre, Madrid, Spain; H Lozano Blesa, Zaragoza, Spain; Onkologikoa, San Sebastián, Spain; Spanish Breast Cancer Research Group GEICAM, Madrid, Spain; Spanish Breast Cancer Research Group- GEICAM, Madrid, Spain; GEICAM, Madrid, Spain Background: Adjuvant weekly paclitaxel (wP) sequential to anthracyclines improves the outcome of operable node-positive BC patients (pts) [Sparano NEJM 2008, Martin BCRT 2009]; however, most BC pts are currently node-negative at diagnosis. The role of wP in these pts is not well established yet. Methods: Pts aged 18-70, with T1-T3/N0 operable BC and at least one high-risk St Gallen 1998 criteria (size Ͼ2 cm, hormone-receptor [HR] negative, grade 2/3, age Ͻ35 years,) were eligible. HER2ϩ pts were allowed, after 792 entered the trial, the study was amended to exclude them. Pts were stratified by site, menopausal status, nodal status diagnostic method (sentinel-node biopsy versus lymphadenectomy) and HR status and randomized to receive FAC x6 (500/50/500 mg/m2 every 3w) or FAC x4¡wP x8 (paclitaxel 100 mg/m2 weekly). The primary endpoint was DFS. The trial was designed to detect an absolute 5-y DFS increase of 5% (80% FAC, 85% FAC¡wP); a sample size of 1812 evaluable patients (906 per arm) was required to detect this difference (␣ϭ0.05, ␤ϭ 80%). Assuming a drop-out rate of 6%, 1929 pts were required. The first analysis of DFS was planned when a median follow-up of 5 years was reached. Results: Between September 2003 and October 2008, 1925 pts (FAC 974, FAC¡wP 951) were randomized. Patient characteristics were well balanced between arms, median age was 50, 73% of pts were HR positive and 9% HER2 positive. 97% of pts with FAC and 85% of pts with FAC¡wP completed all treatment as planned. The median dose intensity was 98% with FACx6, 99% with FACx4 and 98% with wP. The most frequent grade 3-4 toxicities (Ͼ3% in either arm) with FAC vs FAC¡wP were neutropenia (25% vs 22%) with 4% vs 3% of febrile neutropenia, fatigue (3% vs 8%), sensory neuropathy (0 vs 5%), and vomiting (4% in each arm). After a median follow-up of 5.3 years, the proportion of patients disease free is 93% and 90% with FAC¡wP and FAC (HR for relapse 0.732, 95% CI: 0.542 to 0.990; log-rank p-valueϭ0.0423). Conclusions: For pts with high-risk node-negative BC, adjuvant FAC¡wP was associated with a small but significant improvement in DFS compared with FAC, with manageable toxicity. © 2012 American Society of Clinical Oncology. Reprinted with permission. BREAST CANCER—TRIPLE-NEGATIVE/CYTOTOXICS/LOCAL THERAPY CRA1002 Oral Abstract Session, Tue, 9:45 AM-12:45 PM CALGB 40502/NCCTG N063H: Randomized phase III trial of weekly paclitaxel (P) compared to weekly nanoparticle albumin bound nab-paclitaxel (NP) or ixabepilone (Ix) with or without bevacizumab (B) as first-line therapy for locally recurrent or metastatic breast cancer (MBC). Hope S. Rugo, William Thomas Barry, Alvaro Moreno-Aspitia, Alan P. Lyss, Constance Cirrincione, Erica L. Mayer, Michael Naughton, Rachel M. Layman, Lisa A. Carey, Robert A. Somer, Edith A. Perez, Clifford Hudis, Eric P. Winer; University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA; Alliance Statistical Center, Duke University, Durham, NC; Mayo Clinic, Jacksonville, FL; Missouri Baptist Cancer Center, Heartland Cancer Research CCOP, St. Louis, MO; Dana-Farber Cancer Institute, Boston, MA; Washington University School of Medicine, St. Louis, MO; The Ohio State University, Columbus, OH; University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC; Cooper Cancer Institute, Voorhees, NJ; Memorial Sloan-Kettering Cancer Center, New York, NY The full, final text of this abstract will be available at abstract.asco.org at 12:01 AM (EDT) on Monday, June 4, 2012, and in the Annual Meeting Proceedings online supplement to the June 20, 2012, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Monday edition of ASCO Daily News. © 2012 American Society of Clinical Oncology. Reprinted with permission. BREAST CANCER—TRIPLE-NEGATIVE/CYTOTOXICS/LOCAL THERAPY 1003 Oral Abstract Session, Tue, 9:45 AM-12:45 PM A phase III, multicenter, randomized trial of maintenance versus observation after achieving clinical response in patients with metastatic breast cancer who received six cycles of gemcitabine plus paclitaxel as first-line chemotherapy (KCSG-BR 0702, NCT00561119). Young-Hyuck Im, Yeon Hee Park, Kyung Hae Jung, Seock-Ah Im, Joo Hyuk Sohn, Jungsil Ro, Sung-Bae Kim, Jin-Hee Ahn, Do Youn Oh, Sae-Won Han, Soohyeon Lee, In Hae Park, Keun-Seok Lee, Jee Hyun Kim, Seok Yun Kang, Moon Hee
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