Retrospective study of the efficacy and safety of neoadjuvant docetaxel, carboplatin, trastuzumab/pertuzumab (TCH-P) in nonmetastatic HER2-positive breast cancer.
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.
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Shruti R
SR
Tiwari
Department of Medicine, University Hospitals Case Medical Center, 11100 Euclid Avenue, Cleveland, OH, 44106, USA.
Prasun
P
Mishra
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Paola
P
Raska
Department of Anatomic Pathology, Cleveland Clinic Main Campus, Mail Code L25, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Benjamin
B
Calhoun
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Jame
J
Abraham
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Halle
H
Moore
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
G Thomas
GT
Budd
Department of General Surgery/Breast Services, Cleveland Clinic Main Campus, Mail Code A81, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Alicia
A
Fanning
Department of General Surgery/Breast Services, Cleveland Clinic Main Campus, Mail Code A81, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Stephanie
S
Valente
Department of General Surgery/Breast Services, Cleveland Clinic Main Campus, Mail Code A81, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Robyn
R
Stewart
Department of General Surgery/Breast Services, Cleveland Clinic Main Campus, Mail Code A81, 9500 Euclid Avenue, Cleveland, OH, 44195, USA.
Stephen R
SR
Grobmyer
Department of Hematology Oncology, Cleveland Clinic Taussig Cancer Institute, Mail Code R35, 9500 Euclid Avenue, Cleveland, OH, 44195, USA. montero2@ccf.org.
Alberto J
AJ
Montero
D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000009:adverse effects / Q000379:methods*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012042:Registries; D012189:Retrospective Studies; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000068878:Trastuzumab / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; D000077143:Docetaxel; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab; C508053:ERBB2 protein, human; C485206:pertuzumab
Breast cancer; HER 2 positive; Neoadjuvant therapy; Pathologic complete response; Pertuzumab