BACKGROUND: The purpose was to investigate adjuvant marrow-supportive high-dose chemotherapy compared with an equitoxicity-tailored comparator arm. PATIENTS AND METHODS: Five hundred and twenty-five women below the age of 60 years with operated high-risk primary breast cancer were randomised to nine cycles of granulocyte colony-stimulating factor supported and individually tailored FEC (5-fluorouracil, epirubicin, cyclophosphamide), (n = 251) or standard FEC followed by marrow-supported high-dose therapy with CTCb (cyclophosphamide, thiotepa, carboplatin) therapy (n = 274), followed by locoregional radiotherapy and tamoxifen for 5 years. RESULTS: There were 104 breast cancer relapses in the tailored FEC group versus 139 in the CTCb group (double triangular method by Whitehead, P = 0.046), with a median follow-up of all included patients of 60.8 months. The event-free survival demonstrated 121 and 150 events in the tailored FEC- and CTCb group, respectively [P = 0.074, hazard ratio (HR) 0.804, 95% confidence interval (CI) 0.633-1.022]. Ten patients in the tailored FEC regimen developed acute myeloid leukaemia (AML)/myelodysplasia (MDS). One hundred deaths occurred in the tailored FEC group and 121 in the CTCb group (P = 0.287, HR 0.866, 95% CI 0.665-1.129). CONCLUSION: The update of this study shows an improved outcome linked to the tailored FEC treatment in relation to breast cancer relapse, but also an increased incidence of AML/MDS.
RCT Entities:
BACKGROUND: The purpose was to investigate adjuvant marrow-supportive high-dose chemotherapy compared with an equitoxicity-tailored comparator arm. PATIENTS AND METHODS: Five hundred and twenty-five women below the age of 60 years with operated high-risk primary breast cancer were randomised to nine cycles of granulocyte colony-stimulating factor supported and individually tailored FEC (5-fluorouracil, epirubicin, cyclophosphamide), (n = 251) or standard FEC followed by marrow-supported high-dose therapy with CTCb (cyclophosphamide, thiotepa, carboplatin) therapy (n = 274), followed by locoregional radiotherapy and tamoxifen for 5 years. RESULTS: There were 104 breast cancer relapses in the tailored FEC group versus 139 in the CTCb group (double triangular method by Whitehead, P = 0.046), with a median follow-up of all included patients of 60.8 months. The event-free survival demonstrated 121 and 150 events in the tailored FEC- and CTCb group, respectively [P = 0.074, hazard ratio (HR) 0.804, 95% confidence interval (CI) 0.633-1.022]. Ten patients in the tailored FEC regimen developed acute myeloid leukaemia (AML)/myelodysplasia (MDS). One hundred deaths occurred in the tailored FEC group and 121 in the CTCb group (P = 0.287, HR 0.866, 95% CI 0.665-1.129). CONCLUSION: The update of this study shows an improved outcome linked to the tailored FEC treatment in relation to breast cancer relapse, but also an increased incidence of AML/MDS.
Authors: A VanderWalde; W Ye; P Frankel; D Asuncion; L Leong; T Luu; R Morgan; P Twardowski; M Koczywas; R Pezner; I B Paz; K Margolin; J Wong; J H Doroshow; S Forman; S Shibata; G Somlo Journal: Biol Blood Marrow Transplant Date: 2012-02-02 Impact factor: 5.742
Authors: Hervé Bonnefoi; Martine Piccart; Jan Bogaerts; Louis Mauriac; Pierre Fumoleau; Etienne Brain; Thierry Petit; Philippe Rouanet; Jacek Jassem; Emmanuel Blot; Khalil Zaman; Tanja Cufer; Alain Lortholary; Elisabet Lidbrink; Sylvie André; Saskia Litière; Lissandra Dal Lago; Véronique Becette; David A Cameron; Jonas Bergh; Richard Iggo Journal: Lancet Oncol Date: 2011-05-11 Impact factor: 41.316
Authors: Donald A Berry; Naoto T Ueno; Marcella M Johnson; Xiudong Lei; Jean Caputo; Sjoerd Rodenhuis; William P Peters; Robert C Leonard; William E Barlow; Martin S Tallman; Jonas Bergh; Ulrike A Nitz; Alessandro M Gianni; Russell L Basser; Axel R Zander; R Charles Coombes; Henri Roché; Yutaka Tokuda; Elisabeth G E de Vries; Gabriel N Hortobagyi; John P Crown; Paolo Pedrazzoli; Marco Bregni; Taner Demirer Journal: J Clin Oncol Date: 2011-07-18 Impact factor: 44.544
Authors: Tessa G Steenbruggen; Lars C Steggink; Caroline M Seynaeve; Jacobus J M van der Hoeven; Maartje J Hooning; Agnes Jager; Inge R Konings; Judith R Kroep; Wim M Smit; Vivianne C G Tjan-Heijnen; Elsken van der Wall; Adriaan D Bins; Sabine C Linn; Michael Schaapveld; Judy N Jacobse; Flora E van Leeuwen; Carolien P Schröder; Harm van Tinteren; Elisabeth G E de Vries; Gabe S Sonke; Jourik A Gietema Journal: JAMA Oncol Date: 2020-04-01 Impact factor: 31.777
Authors: Steven A Eschrich; William J Fulp; Yudi Pawitan; John A Foekens; Marcel Smid; John W M Martens; Michelle Echevarria; Vidya Kamath; Ji-Hyun Lee; Eleanor E Harris; Jonas Bergh; Javier F Torres-Roca Journal: Clin Cancer Res Date: 2012-07-25 Impact factor: 12.531
Authors: Lorenzo Gianni; Shari Gelber; Alberto Ravaioli; Karen N Price; Ilaria Panzini; Manuela Fantini; Monica Castiglione-Gertsch; Olivia Pagani; Edda Simoncini; Richard D Gelber; Alan S Coates; Aron Goldhirsch Journal: Eur J Cancer Date: 2008-12-04 Impact factor: 9.162
Authors: Yee Chung Cheng; Yushu Shi; Mei-Jie Zhang; Ruta Brazauskas; Michael T Hemmer; Michael R Bishop; Yago Nieto; Edward Stadtmauer; Lois Ayash; Robert Peter Gale; Hillard Lazarus; Leona Holmberg; Michael Lill; Richard F Olsson; Baldeep Mona Wirk; Mukta Arora; Parameswaran Hari; Naoto Ueno Journal: J Cancer Date: 2017-03-25 Impact factor: 4.207