Pathologic response rate (pCR) and near-pathologic response rate (near-pCR) with docetaxel-carboplatin (TCarb) in early triple-negative breast cancer.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 277-277 ◽  
Author(s):  
P. Kern ◽  
H. C. Kolberg ◽  
A. Kalisch ◽  
C. Liedtke ◽  
F. Otterbach ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clin Oncol ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Response Rate ◽  
Pathological Complete Response ◽  
Complete Response ◽  
Pathologic Response ◽  
Term Survival ◽  
Pathologic Response Rate

277 Background: Triple-negative breast cancer (TNBC) is associated with a poor prognosis unless a pathological complete response is achieved (Liedtke C et al. 2008: J Clin Oncol 26:1275-1281) or almost achieved (Symmans WF. 2007: J Clin Oncol 25:4414-4422). Sensitivity to platin compounds has been demonstrated in BRCA1-positive settings (Byrski T et al. 2010: J Clin Oncol 20:28:375-9; Silver DP. 2010: J Clin Oncol 28:1145-1153) with only limited numbers of patients (Byrski T et al. 2010: J Clin Oncol 20:28:375-9) or in sporadic breast cancer with heterogeneous cohorts (Sikov WM et al 2009: J Clin Oncol 27:4693-4700; Chang HR et al. 2010: Cancer 15; 116:4227-4237). Methods: This pivotal trial was to assess the efficacy of platinum and taxane-based combination therapy without the use of anthracyclines. 27 patients with primary TNBC (majority of them cT2, two cT3 and one cT4a) had to be unsuitable for standard anthracycline-based chemotherapy. They received 6 cycles, respectively in two cases only 5 cycles, of carboplatin AUC 6 and docetaxel 75 mg/m2 q3w. The primary endpoint was the pCR-rate, secondary endpoint toxicity. Results: 20 out of 27 (74%) patients had pathological complete response (52%) or near-complete response (22%)—ypT1mic and ypT1a—both being associated with a good prognosis. Seven remaining patients had still good partial response, leaving only low residual cancer burden, which was defined as ypT1. Treatment was well-tolerated: grade III and IV toxicities were neutropenia, thrombopenia, oedema, nausea, joint pain, nail changes, fatigue, hypertension, and alopecia. Conclusions: These results show a high efficacy of carboplatin AUC6 and docetaxel 75 mg/m2 q3w and good feasibility as primary chemotherapy for TNBC with a pCR- and near-pCR-rate of 74% and total response rate of 100%. The incorporation of anthracyclines and parp-inhibitors into further trial designs could enhance the efficacy of these compounds. The omission of exposure to anthracyclines in patients with considerable heart disease risks seems to be feasible with a good pCR-rate, the latter being a surrogate-marker for long-term survival.

Updated results of neoadjuvant chemotherapy with carboplatin AUC 6 and docetaxel 75 mg/m2 in triple-negative breast cancer (TNBC).

2013 ◽  
Vol 31 (26_suppl) ◽  
pp. 149-149 ◽  
Author(s):  
Peter Kern ◽  
Hans C. Kolberg ◽  
Anne Kalisch ◽  
Rainer Kimmig ◽  
Dirk Pott ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Side Effects ◽  
Triple Negative Breast Cancer ◽  
Survival Data ◽  
Triple Negative ◽  
Pathological Complete Response ◽  
Surrogate Marker ◽  
Complete Response ◽  
Term Survival ◽  
Carboplatin Auc

149 Background: Triple-negative breast cancer (TNBC) is associated with a poor prognosis unless a pathological complete response (pCR) is achieved or almost achieved (near-pCR). Treatment of TNBC remains a challenge as some patients fail to respond to the use of standard anthracyclin-based chemotherapy regimens. Phenotypic and molecular similarities between TNBC and BRCA1-associated breast cancer suggest that TNBC may share the same sensitivity to platinum analogues as tumors associated with BRCA1. Methods: 30 patients with primary, unilateral, non-metastasized TNBC (majority of them cT1 or cT2, two cT4) had to be unsuitable for standard anthracycline-based chemotherapy. They received 6 cycles, respectively in two case sonly 5 cycles, of carboplatin AUC 6 and docetaxel 75 mg/m² q3w. Adverse effects were recorded according to CTCAE V4.07. Primary endpoint was pathological complete response (pCR) and near-pCR, secondary endpoint toxicity. Results: 70% (21/30) of patients had either a pathological complete response (55%; 15/27) or a near-complete response (20%; 6/30) - defined as pT1mic and ypT1a - both being associated with a good prognosis. Eight remaining patients had still good partial response, leaving only low residual cancer burden, which was specified as ypT1, in contrast only one ypT4 tumor. Treatment was well tolerated - grade IV toxicities were predominantly hematological side effects (especially concerning neutropenia) and in 2 cases grade IV edema and joint pain. Carboplatin dose reduction (to an AUC of 5) was required in 5 cases (because of limited renal function, hematological side effects or patient’s age). Conclusions: Our results demonstrate a high-anti-tumour activity of docetaxel 75mg/m² in combination with carboplatin AUC 6, promising high rates of tumour regression and pathological complete remission. The omission of exposure to anthracyclines in patients with considerable heart disease risks seems to be feasible with a good pCR-rate, the latter being a surrogate-marker for long-term survival. Survival data of this trial are currently being updated and will be presented on the Breast Cancer Symposium.

scholarly journals A Prospective, Single-Arm, Phase II Trial of Apatinib Combined With Nab-Paclitaxel and Carboplatin for The Neoadjuvant Treatment of Triple-Negative Breast Cancer

2021 ◽  
Author(s):  
Tianyu Zeng ◽  
Jue Wang ◽  
Wei Li ◽  
Yiqi Yang ◽  
Fan Yang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Phase Ii ◽  
Triple Negative Breast Cancer ◽  
Triple Negative ◽  
Response Rate ◽  
Pathological Complete Response ◽  
Locally Advanced ◽  
Complete Response ◽  
Axillary Lymph

Abstract Background: Pathological complete response (pCR) is essential for improvements of prognosis in triple-negative breast cancer (TNBC). We evaluated the efficacy of apatinib combined with nab-paclitaxel and carboplatin in patients in this phase II clinical trial.Methods: Women with hormone receptor- and human epidermal growth factor receptor 2 (HER2)- negative, stage II/III breast cancer received six cycles of 75 mg/m2 docetaxel, carboplatin (AUC = 5) and 15 mg/kg bevacizumab every 21 days. The primary end point was pathological complete response (pCR) in the primary breast and axillary lymph nodes (ALN).Results: Thirty-two patients were recruited into the clinical trial, the vast majority of the patients had stage III tumors (65.6%) and the median longest tumor size was 3.5 cm. The pCR rate was 43.8% (n = 14); clinical response rate 93.8% (n = 30); complete response rate 21.9% (n = 7); partial response rate 71.9% (n = 23); stable disease 6.2% (n = 2). After surgery, 7 (63.6%) of the 11 patients without axillary lymph node metastasis achieved a pCR. The median target lesions in breast reduced to 1.2 cm after the third cycle treatment and 0.9cm after the last cycle. Most frequent grade 3/4 adverse events were thrombopenia (40.6%, n = 13) and neutropenia (25%, n = 8). Conclusions: Neoadjuvant apatinib, combined with albumin paclitaxel and carboplatin resulted in an encouraging pCR rate in locally advanced breast cancer and no major safety concerns during the therapy.Clinical trial registration: NCT03650738

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