Retrospective study of the efficacy and safety of neoadjuvant docetaxel, carboplatin, trastuzumab/pertuzumab (TCH-P) in nonmetastatic HER2-positive breast cancer

• DOI: 10.1007/s10549-016-3866-0
• Publication Date: 2016-06-20T08:31:17Z
• Authors: Shruti R. Tiwari; Prasun Mishra; Paola Raska; Benjamin Calhoun; Jame Abraham; Halle Moore; G. Thomas Budd; Alicia Fanning; Stephanie Valente; Robyn Stewart; Stephen R. Grobmyer; Alberto J. Montero
• Keywords: Receptor, ErbB-2; Breast Neoplasms; Docetaxel; Middle Aged; Trastuzumab; Antibodies, Monoclonal, Humanized; Survival Analysis; Disease-Free Survival; Neoadjuvant Therapy; Carboplatin; 3. Good health; 03 medical and health sciences; Treatment Outcome; 0302 clinical medicine; Antineoplastic Combined Chemotherapy Protocols; Humans; Female; Taxoids; Registries; Retrospective Studies

Pertuzumab is FDA approved in the preoperative setting in combination with trastuzumab and chemotherapy, in women with nonmetastatic HER2 + breast cancer. The TRYPHAENA trial (n = 77) reported a pathologic complete response rate (pCR), i.e., ypT0ypN0, of 52 % in patients treated with neoadjuvant (docetaxel, carboplatin, trastuzumab, & pertuzumab) TCH-P. Aside from this study, there is limited information regarding the safety and efficacy of TCH-P in the neoadjuvant setting. Our goal was to evaluate the safety and efficacy of neoadjuvant TCH-P in a non-clinical trial setting.Cancer data registry was utilized to identify patients with HER2 + nonmetastatic breast cancer that received neoadjuvant TCH-P. pCR was defined as the absence of invasive or noninvasive cancer in breast and lymph nodes, i.e., ypT0ypN0.70 patients with a median age of 52 years met our inclusion criteria. Clinical staging was I-8.5 %; II-68.5 %; and III-22.8 %. 60 % of patients had hormone receptor (HR)-positive tumors. 23 % (16/71) of patients required dose reduction for rash, diarrhea, neuropathy, or thrombocytopenia. Overall, no patients developed grade 3-4 left ventricular systolic dysfunction(LVSD); an asymptomatic reduction in LVEF of >10 % was observed in three patients. The overall observed pCR rate was 53 %. As expected, the pCR rate was higher in patients with HR-negative breast cancer than for patients with HR+ disease: 69 % (20/29) vs. 42 % (17/41), respectively. The axillary downstaging rate was approximately 53 % (19/36).Neoadjuvant TCH-P, in a nonclinical trial setting, was associated with a pCR rate of 53 % similar the reported rate in TRYPHAENA. Toxicity was manageable, with no patients experiencing symptomatic heart failure.