Optimal duration of adjuvant chemotherapy for high-risk node-negative (N–) breast cancer patients: 6-year results of the prospective randomised multicentre phase III UNICANCER-PACS 05 trial (UCBG-0106)

Publication date: July 2017
Source:European Journal of Cancer, Volume 79
Author(s): Pierre Kerbrat, Isabelle Desmoulins, Lise Roca, Christelle Levy, Alain Lortholary, Alain Marre, Rémy Delva, Maria Rios, Patrice Viens, Étienne Brain, Daniel Serin, Magali Edel, Marc Debled, Mario Campone, Marie-Ange Mourret-Reynier, Thomas Bachelot, Marie-Josèphe Foucher-Goudier, Bernard Asselain, Jérôme Lemonnier, Anne-Laure Martin, Henri Roché
PurposeOptimal duration of adjuvant chemotherapy in the treatment of early-stage breast cancer remained to be investigated rigorously for the standard regimens in widespread use in North America (doxorubicin/cyclophosphamide, AC) and Europe (5-fluorouracil/epirubicin/cyclophosphamide, FEC). Whether six cycles of FEC 100 present an advantage, or not, compared with only four cycles was tested directly in a phase III prospective multicentre trial.Patients and methodsBetween 2002 and 2006, 1515 women between 18 and 65°years of age, with node negative N(−) high-risk early-stage breast cancer, were included in the study following breast surgery and axillary lymph node dissection or procedure by sentinel node technique. Inclusion in the study required tumour size T ≥ 1 cm and at least one of the high-risk factors: T > 2 cm, negative oestrogen receptor/progesterone receptor (ER– and PR–), Scarff-Bloom-Richardson (SBR) grade II or III and age ≤ 35°years. Patients were randomly assigned to either six FEC 100 (Arm A) or four FEC 100 (Arm B). The trial was powered to detect an absolute difference ≥6% in disease-free survival (DFS) at 5°years.ResultsAt 6.1°years median follow-up, with 91 (12%) events recorded in Arm A versus 106 (14%) in Arm B, no statistically significant risk increase was associated with four versus six FEC 100: DFS (hazard ratio (HR) = 1.18; CI 95% [0.89–1.56], P = .24) and overall survival (OS) (HR = 1.39; CI 95% [0.91–2.13], P = .12).ConclusionDifferences in chemotherapy duration did not induce notably different outcomes in our cohort of high-risk patients.Clinical trial registry numberNCT00055679, Agence National de Sécurité du Médicament (ANSM) – France.



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