title: Long-term outcomes in stage IIIB breast cancer patients who achieved less than a pathological complete response (<pCR) after primary chemotherapy.
abstract: OBJECTIVE
  Pathological complete response (pCR) to primary chemotherapy is the main determinant for improved disease-free survival (DFS) and overall survival (OS). The primary endpoints of our study were the long-term DFS and OS rates in homogeneously treated stage IIIB breast cancer patients who failed to achieve a pCR (<pCR), in relation to residual tumor burden. The secondary endpoint was the prognostic relevance of hormone receptor (HR) and human epidermal growth factor receptor (HER)-2 status.
  
  
  METHODS
  We analyzed 58 of 74 consecutive stage IIIB patients treated between 1996 and 2001 who achieved <pCR following a primary cisplatin, epirubicin, and vinorelbine regimen for up to six cycles. At the time of patient accrual, trastuzumab was not available. After definitive surgery, pathological residual disease remained in 40 (69%) patients in both the breast and axilla, in 14 (24%) patients in only the breast, and in four (7%) patients in only the axilla.
  
  
  RESULTS
  Fifty-eight (78%) of 74 patients achieved <pCR and 16 (22%) had pCR both in the breast and axilla. After a median follow-up of 99 months (range, 72-134 months), in patients with <pCR the estimated 10-year DFS and OS rates were 37.6% and 50.3%, respectively, significantly worse than in the pCR group (p = .003 and p = .008, respectively). Patients with four or more axillary nodes involved had a significantly worse 10-year DFS rate (28.9% versus 62.7%; p = .036). Patients with HR(-) tumors had significantly lower 10-year DFS (17.3% versus 46.4%; p = .018) and OS (17.3% versus 70.2%; p = .002) rates. Overall, the triple-negative (TN) group showed only a marginally significantly worse OS rate (p = .048). HER-2 status alone, in the absence of trastuzumab, did not appear to significantly affect outcomes.
  
  
  CONCLUSIONS
  Our data suggest that, in stage IIIB patients who achieve <pCR, the number of residual nodes and HR(-) status are strong predictors of poor outcomes. After a long follow-up time, HER-2 expression does not appear to significantly affect DFS and OS. TN patients showed a trend toward early recurrence and death.
authors.affiliation: Department of Medical Oncology, Azienda Ospedaliero-Universitaria, Cagliari, Italy. mtionta@yahoo.it
authors.forename: Maria Teresa
authors.initials: MT
authors.lastname: Ionta
authors.forename: Francesco
authors.initials: F
authors.lastname: Atzori
authors.forename: Maria Cristina
authors.initials: MC
authors.lastname: Deidda
authors.forename: Valeria
authors.initials: V
authors.lastname: Pusceddu
authors.forename: Sergio
authors.initials: S
authors.lastname: Palmeri
authors.forename: Barbara
authors.initials: B
authors.lastname: Frau
authors.forename: Monica
authors.initials: M
authors.lastname: Murgia
authors.forename: Michela
authors.initials: M
authors.lastname: Barca
authors.forename: Luigi
authors.initials: L
authors.lastname: Minerba
authors.forename: Bruno
authors.initials: B
authors.lastname: Massidda
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000378:metabolism / Q000473:pathology* / Q000628:therapy*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008198:Lymph Nodes; D008207:Lymphatic Metastasis; D008408:Mastectomy; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011879:Radiotherapy Dosage; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases