Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial

Background: Inflammatory blood markers, such as neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR), have been reported as putative prognostic factors for survival and predictive factors for pathological complete response and toxicity in cancers, however with conflicting results. Methods: We retrospectively analyzed data of 280 patients with early breast cancer receiving neo-adjuvant chemotherapy between 2005 and 2013 in our center. Neutrophil count, lymphocyte count and platelet count before treatment were collected as well as data on pathological complete response, toxicity, recurrence and survival. Results: In multivariate analysis, high PLR was an independent prognostic factor for relapse-free survival (hazard ratio [HR] = 1.91; 95%CI = 1.15–3.16; p = 0.012) and for shorter overall survival (HR = 1.83; 95%CI = 1.03–3.24; p = 0.039). NLR was an independent predictive factor for febrile neutropenia (HR = 0.28; 95%CI = 0.13–0.58; p = 0.001). In triple negative breast cancer molecular subtype, low white blood cell count (<6.75 G/L) was predictive for a higher pathological complete response rate (odds ratio [OR] = 0.29; 95%CI = 0.14–0.61; p < 0.01). Conclusion: In the present study, PLR was found as an independent prognostic factor for survival, while NLR was an independent predictive factor for febrile neutropenia.

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Capecitabine in operable triple receptor–negative breast cancer: A subgroup analysis of a randomized phase III trial.

Journal of Clinical Oncology ◽

10.1200/jco.2011.29.27_suppl.292 ◽

2011 ◽

Vol 29 (27_suppl) ◽

pp. 292-292

Author(s):

C. M. Kelly ◽

M. C. Green ◽

K. Broglio ◽

L. Pusztai ◽

E. Thomas ◽

...

Keyword(s):

Breast Cancer ◽

Subgroup Analysis ◽

Triple Negative ◽

Pathological Complete Response ◽

Complete Response ◽

Phase Iii ◽

Relapse Free Survival ◽

Phase Iii Trial ◽

Free Survival

292 Background: Recent data suggest that patients with operable triple negative breast cancer (TNBC) may derive greater benefit from the addition of capecitabine to anthracycline-taxane regimens. Methods: We examined pathological complete response (pCR), relapse-free survival (RFS) and overall survival (OS) in patients with TNBC randomized to paclitaxel 80mg/m2 weekly (WP) x 12 followed by fluorouracil (500mg/m2), epirubicin (100mg/m2), cyclophosphamide (500mg/m2) every 3 weeks x 4 cycles (FEC) vs. docetaxel (75mg/m2) 3 weekly and capecitabine D1-14 (1500mg/m2 daily; DX) followed by FEC. Patients were stratified by timing of chemotherapy (preoperative vs. adjuvant). Results: 149 patients with TNBC comprising 25% of all patients randomized (N=601). Median age; 49 years (IQR; 41 to 55). The number and proportion of patients by stage were; I (n=32: 21.5%), IIA (n=72: 48.3%), IIB (n=34: 22.8%), IIIA (n=9: 6.0%) and IIIC (n=2; 1.3%). Preoperative therapy was administered to 58 patients (39%) and adjuvant to 91 (61%). There were 17 events (21%) in the DX arm and 10 events (15%) in the WP arm (P=0.36) including 11 distant recurrences in the DX arm and 9 in the WP arm (P=0.99). We observed a pCR in 11 patients (37%) and 10 (36%) in the DX and WP arms respectively (P=0.94). The odds ratio for pCR for patients with TNBC given DX vs. WP was 0.98 (95% CI; 0.33 to 2.80: P=0.94). At 50-months median follow-up the RFS and OS in patients with TNBC randomized to DX or WP was 77% (66 to 86%) and 83% (73 to 92%) (P=0.41) and 78% (67 to 87%) and 87% (77 to 95%) (P=0.16) respectively. RFS and OS for WP vs. DX for non-TNBC was 93% (87 to 95%) and 92% (88 to 96%) (p=0.91) and 96% (92 to 98%) and 97% (94 to 99%) for WP and DX respectively (P=0.39). Conclusions: In this unplanned subgroup analysis there was no difference in pCR, RFS or OS in patients with operable TNBC randomized to WP or DX however, power is limited and should be considered when interpreting these data.

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