Background Breast cancer with pathological non-complete response (non-pCR) after neoadjuvant chemotherapy (NAC) has a worse prognosis. Despite Neo-Bioscore has been validated as an independent prognostic model for breast cancer submitted to NAC, non-pCR carcinoma was not assessed in this setting. Methods This is a retrospective trial that included women with localized breast cancer who underwent NAC and had non-pCR carcinoma in surgical specimen between 01/01/2013 to 12/31/2015 with a three-year follow-up. Survival analysis was performed by Kaplan-Meier estimator and hazard ratio (HR) set by log-rank test for the primary and secondary endpoints, respectively Disease-Free Survival (DFS) and Overall Survival (OS). According to Neo-Bioscore, the proposed prognostic model named Clustered Neo-Bioscore was classified into low (0–3), low-intermediate (4–5), high-intermediate (6) and high (7) risk. The prognostic accuracy for recurrence risk was assessed by time-dependent receiver operating characteristic (time-ROC) methodology. Multivariate Cox regression assessed the menopausal status, histological grade, Ki-67, estrogen receptor, HER2, tumor subtype, pathological and clinical stages. Confidence interval at 95% (CI95%) and statistical significance at set 2-sided p -value less than 0.05 were adopted. Results Among the 310 women enrolled, 267 patients (86.2%) had non-pCR carcinoma presenting size T3/T4 (63.3%), node-positive axilla (74.9%), stage III (62.9%), Ki-67 ≥ 20% (71.9%) and non-luminal A (78.3%). Non-pCR carcinoma presented worse DFS-3y (HR = 3.88, CI95% = 1.18–11.95) but not OS-3y (HR = 2.73, CI95% = 0.66–11.40). Clustered Neo-Bioscore discerned the recurrence risk for non-pCR carcinoma: low (DFS-3y = 0.86; baseline), low-intermediate (DFS-3y = 0.70; HR = 2.61), high-intermediate (DFS-3y = 0.13, HR = 14.05), and high (DFS-3y = not achieved; HR = 22.19). The prognostic accuracy was similar between Clustered Neo-Bioscore and Neo-Bioscore (0.76 vs 0.78, p > 0.05). Triple-negative subtype (HR = 3.6, CI95% = 1.19–10.92) and pathological stages II (HR = 5.35, CI95% = 1.19–24.01) and III (HR = 6.56, CI95% = 1.29–33.32) were prognoses for low-intermediate risk, whereas pathological stage III (HR = 13.0, CI95% = 1.60–106.10) was prognosis for low risk. Conclusions Clustered Neo-Bioscore represents a novel prognostic model of non-pCR carcinoma undergoing NAC with a more simplified and appropriate score pattern in the assessment of prognostic factors. Electronic supplementary material The online version of this article (10.1186/s12885-019-5812-0) contains supplementary material, which is available to authorized users.

Objective: There is insufficient information on predictors of pathologic complete response (pCR) to neoadjuvant chemotherapy (NAC) in breast carcinoma that also presented clinical complete response (cCR) evaluated in breast, axilla and breast and axilla. Methods: This retrospective study included 310 women with breast carcinoma who received NAC from 1/1/13 to 12/31/15 with follow-up until 8/31/16. The factors analyzed to predict pCR and cCR were menopausal status, Ki67, estrogen receptor, histologic grade, molecular subtype, tumor size, axilla status, and stage. Results: The cCR/pCR rates were 53.2/16.5% (breast), 76.3/36.8% (axilla) and 50.6/13.9% (breast and axilla). Molecular subtype and HER2-positive were independent predictors to confirm pCR in women with cCR, mainly triple negative (TN) in breast (OR 22.81, 95% CI 7.13–72.96) and breast and axilla (OR 36.06, 95% CI 8.77–148.26), but not in axilla. Ki67 ≥50% expression was predictor of cCR in breast (OR 2.00, 95% CI 1.31–3.06) and breast and axilla (OR 1.67, 95% CI 1.10–1.45). Conclusion: TN subtype and HER2-positive were the main independent predictors of pCR in women who also had cCR to NAC in breast and breast and axilla, but none was predictor in axilla. The Ki67 ≥50% was the independent predictor of cCR in breast and breast and axilla.

Ao meu orientador, Prof. Dr. Luiz Carlos Zeferino, pela amizade, orientação e dedicação na realização desta tese, cujos valorosos ensinamentos sou eternamente grato. À Profa. Dra. Sophie Françoise Mauricette Derchain, pela amizade e pela revisão meticulosa na elaboração final desta tese. À colega Dra. Susana Oliveira Botelho Ramalho, pela amizade, apoio e companheirismo.Ao Prof. Luiz Carlos Teixeira, principal responsável pela minha especial e importante convivência no CAISM, sem a qual não poderia ter iniciada essa jornada.Aos funcionários do ambulatório de quimioterapia e da secretaria da divisão da oncologia, pela solicitude e disponibilidade. RESUMOIntrodução: As mulheres com carcinoma de mama podem apresentar diferentes respostas clínica e patológica a quimioterapia neoadjuvante (neoQT), com pior prognóstico para aquelas com resposta patológica não completa (nRPc). O Neo-Bioscore é o mais importante escore prognóstico da neoQT. O objetivo dessa tese foi analisar os fatores preditivos das respostas clínica e patológica completa (RCc e RPc) na mama e na axila, como também os fatores prognósticos das mulheres com carcinoma nRPc segundo um novo modelo de clusterização do Neo-Bioscore (Clustered Neo-Bioscore). Metodologia: Este é um estudo observacional longitudinal retrospectivo que incluiu mulheres com carcinoma de mama submetidas a neoQT de 01/02/13 a 31/12/15 com seguimento até 31/08/16. Os desfechos principais foram sobrevida livre de doença (SLD), sobrevida geral (SG), RCc e RPc na mama e axila. Os fatores analisados foram status menopausal, expressão do Ki67, receptor de estrógeno (RE), grau histológico, subtipo molecular, tamanho tumoral, status axilar e estádio.O Clustered Neo-Bioscore classificou as mulheres em risco baixo, intermediário-baixo, intermediário-alto e alto conforme os escores para SLD. A acurácia prognóstica do Clustered Neo-Bioscore foi avaliada pela pela curva ROC-tempo. A associação preditiva para a RCc e a RPc foi realizada pela regressão logística multinomial. A análise prognóstica das mulheres com carcinoma nRPc foi realizada por teste de Log-rank e Regressão de Cox. Adotou-se uma significância estatística do valor p < 0,05. Resultados: Um total de 310 mulheres submetidas a neoQT com um predomínio de carcinomas de tamanho T3/T4 (64%), estádio III (62%), axila positiva (74%), Ki67 ≥ 20% (74%) e não luminal A (81%). A porcentagem de RCc/RPc, em relação a nRCc/nRPc, foi 53,2%/16,5%, 76,3%/36,8% e 50,6%/13,9% respectivamente na mama, na axila e na mama mais axila. O carcinoma triplo negativo (TN) foi o principal preditor da RPc na mama (odd