Kerbrat Pierre, Desmoulins Isabelle, Roca Lise, Levy Christelle, Lortholary Alain, Marre Alain, Delva Rémy, Rios Maria, Viens Patrice, Brain Étienne, Serin Daniel, Edel Magali, Debled Marc, Campone Mario, Mourret-Reynier Marie-Ange, Bachelot Thomas, Foucher-Goudier Marie-Josèphe, Asselain Bernard, Lemonnier Jérôme, Martin Anne-Laure, Roché Henri
Centre Eugène Marquis, Rue de la Bataille Flandres-Dunkerque - CS 44229, 35042 Rennes Cedex, France.
Centre Georges-François Leclerc, 1 rue Professeur Marion BP 77990, 21079 Dijon, France.
Eur J Cancer. 2017 Jul;79:166-175. doi: 10.1016/j.ejca.2017.03.004. Epub 2017 May 11.
Optimal 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.
Between 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.
At 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).
Differences in chemotherapy duration did not induce notably different outcomes in our cohort of high-risk patients.
NCT00055679, Agence National de Sécurité du Médicament (ANSM) - France.
对于北美广泛使用的标准方案（多柔比星/环磷酰胺，AC）和欧洲的标准方案（5-氟尿嘧啶/表柔比星/环磷酰胺，FEC），早期乳腺癌辅助化疗的最佳疗程仍有待严格研究。在一项III期前瞻性多中心试验中，直接检验了与仅四个疗程相比，六个疗程的FEC 100方案是否具有优势。
2002年至2006年期间，1515名年龄在18至65岁之间、淋巴结阴性N（-）的高危早期乳腺癌女性，在接受乳房手术和腋窝淋巴结清扫或前哨淋巴结技术手术后被纳入研究。纳入研究要求肿瘤大小T≥1 cm且具备至少一项高危因素：T>2 cm、雌激素受体/孕激素受体阴性（ER-和PR-）、斯卡夫-布卢姆-理查森（SBR）分级为II级或III级以及年龄≤35岁。患者被随机分配至六个疗程的FEC 100组（A组）或四个疗程的FEC 100组（B组）。该试验旨在检测5年时无病生存率（DFS）的绝对差异≥6%。
在中位随访6.1年时，A组记录到91例（12%）事件，B组记录到106例（14%）事件，四个疗程与六个疗程的FEC 100方案相比，无统计学显著风险增加：DFS（风险比（HR）=1.18；95%置信区间[0.89 - 1.56]，P = 0.24）和总生存率（OS）（HR = 1.39；95%置信区间[0.91 - 2.13]，P = 0.12）。
在我们的高危患者队列中，化疗疗程的差异并未导致显著不同的结果。
NCT00055679，法国国家药品安全局（ANSM）。
