title: Is it important to adapt neoadjuvant chemotherapy to the visible clinical response? An open randomized phase II study comparing response-guided and standard treatments in HER2-negative operable breast cancer.
abstract: BACKGROUND
  Neoadjuvant treatment provides a unique opportunity to evaluate individual tumor sensitivity. This study evaluated whether a response-guided strategy could improve clinical outcome compared with a standard treatment.
  
  
  METHODS
  Overall, 264 previously untreated stage II-III operable breast cancer patients were randomized to receive either standard treatment (arm A, n = 131), consisting of fluorouracil, epirubicin, and cyclophosphamide (FEC100: 500, 100, and 500 mg/m(2), respectively, for 3 cycles) followed by docetaxel (100 mg/m(2) for 3 cycles), or adapted treatment (arm B, n = 133), beginning with 2 cycles of FEC100 and switching to docetaxel if tumor size decreased by <30% after 2 cycles or <50% after 4 cycles of FEC100 (ultrasound assessments according to World Health Organization criteria). Otherwise, FEC100 was given for six cycles before surgery. Intent-to-treat analysis was performed.
  
  
  RESULTS
  Similar results were observed for clinical response (objective response was 54% vs 56%, p = .18), breast conservation surgery (BCS; 67% vs 68%, p = .97), and pathological complete response rate (Chevallier classification: 14% vs 11%, p = .68; Statloff classification: 16% vs 13%, p = .82) between arms A and B. Similar toxicities were observed, even with unbalanced numbers of FEC100 and docetaxel courses.
  
  
  CONCLUSIONS
  Adapted and standard treatments had similar results in terms of tumor response, BCS rate, and tolerability. Further survival outcome data are expected.
authors: Centre Jean Perrin, Clermont-Ferrand, France; Clinical Investigation Center (CIC), Clermont-Ferrand, France; qiwang1219dav@yahoo.fr.
authors: Qian
authors: Q
authors: Wang-Lopez
authors: Centre Jean Perrin, Clermont-Ferrand, France;
authors: Marie-Ange
authors: MA
authors: Mouret-Reynier
authors: Institut Jean-Godinot, Reims, France;
authors: Aude-Marie
authors: AM
authors: Savoye
authors: Centre Jean Perrin, Clermont-Ferrand, France; ERTICA EA 4677, Research Team for Individualized Cancer Treatment, and.
authors: Catherine
authors: C
authors: Abrial
authors: Centre Jean Perrin, Clermont-Ferrand, France;
authors: Fabrice
authors: F
authors: Kwiatkowski
authors: Institut Jean-Godinot, Reims, France;
authors: Christian
authors: C
authors: Garbar
authors: Centre Jean Perrin, Clermont-Ferrand, France;
authors: Pascale
authors: P
authors: DuBray-Longeras
authors: Institut Jean-Godinot, Reims, France;
authors: Jean-Christophe
authors: JC
authors: Eymard
authors: Centre Jean Perrin, Clermont-Ferrand, France;
authors: Guillaume
authors: G
authors: Lebouedec
authors: Centre Jean Perrin, Clermont-Ferrand, France;
authors: Isabelle
authors: I
authors: Vanpraagh
authors: Centre Jean Perrin, Clermont-Ferrand, France; ERTICA EA 4677, Research Team for Individualized Cancer Treatment, and.
authors: Frederique
authors: F
authors: Penault-Llorca
authors: UMR 990 INSERM, University of Auvergne, Clermont-Ferrand, France.
authors: Philippe
authors: P
authors: Chollet
authors: Institut Jean-Godinot, Reims, France;
authors: Hervé
authors: H
authors: Cure
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D000077143:Docetaxel; D015251:Epirubicin; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids