Phase II Trial of Bevacizumab Plus Weekly Paclitaxel, Carboplatin, and Metronomic Cyclophosphamide With or Without Trastuzumab and Endocrine Therapy as Preoperative Treatment of Inflammatory Breast Cancer

Inflammatory breast cancer is a rare and highly aggressive disease. We investigated in a phase II study a neoadjuvant regimen with chemotherapy and an antiangiogenic strategy. The pathologic complete remission (pCR) rate was 29% and was significantly greater in patients with HER2+ tumors (57%). The...

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Published in:Clinical breast cancer 2018-08, Vol.18 (4), p.328-335
Main Authors: Palazzo, Antonella, Dellapasqua, Silvia, Munzone, Elisabetta, Bagnardi, Vincenzo, Mazza, Manuelita, Cancello, Giuseppe, Ghisini, Raffaella, Iorfida, Monica, Montagna, Emilia, Goldhirsch, Aaron, Colleoni, Marco
Format: Article
Language:English
Subjects:
Angiogenesis Inhibitors - administration & dosage
Angiogenesis Inhibitors - adverse effects
Antiangiogenesis
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents, Immunological - administration & dosage
Antineoplastic Agents, Immunological - adverse effects
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Bevacizumab - administration & dosage
Bevacizumab - adverse effects
Biomarkers, Tumor - metabolism
Drug Administration Schedule
Female
Follow-Up Studies
Humans
IBC
Inflammatory Breast Neoplasms - drug therapy
Inflammatory Breast Neoplasms - mortality
Inflammatory Breast Neoplasms - pathology
Metronomic chemotherapy
Middle Aged
Neoadjuvant chemotherapy
Neoadjuvant Therapy - adverse effects
Neoadjuvant Therapy - methods
Outcome
Survival Analysis
Treatment Outcome
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Summary:Inflammatory breast cancer is a rare and highly aggressive disease. We investigated in a phase II study a neoadjuvant regimen with chemotherapy and an antiangiogenic strategy. The pathologic complete remission (pCR) rate was 29% and was significantly greater in patients with HER2+ tumors (57%). The achievement of a pCR was associated with longer disease-free and overall survival. The investigated regimen was effective and well tolerated. The antiangiogenic strategy warrants further studies in this setting. Inflammatory breast cancer (IBC) is a rare and highly aggressive disease. A neoadjuvant regimen with chemotherapy and an antiangiogenic strategy was investigated. Patients with primary or recurrent IBC who were candidates for neoadjuvant treatment received weekly carboplatin and paclitaxel plus bevacizumab every 3 weeks and oral metronomic cyclophosphamide for 6 months. Trastuzumab was added for patients with HER2+ tumors and endocrine therapy was added for patients with estrogen receptor and/or progesterone receptor ≥ 10% tumors. Oral metronomic capecitabine and cyclophosphamide was continued for 6 months after surgery in those patients with a response. The primary efficacy endpoints were pathologic complete remission (pCR) and the objective response. From July 2010 to December 2013, 34 patients with IBC were included. The surrogate intrinsic tumor subtypes were as follows: luminal B-like (HER2−), 10 (29%); luminal B-like (HER2+), 8 (24%); HER2+ (nonluminal), 6 (18%); and triple negative, 10 (29%). An objective response was obtained in 30 patients (88%; 95% confidence interval, 73%-97%) and a pCR in 10 patients (29%; 95% confidence interval, 15%-48%). The proportion of pCR was significantly greater in the patients with HER2+ tumors (57%) than in patients with triple-negative (20%) or luminal B-like (HER2−) tumors (0%; P = .019). After a median follow-up of 4.4 years, the 5-year disease-free survival and overall survival was 58% and 72%, respectively. The achievement of pCR was associated with longer disease-free (P = .12) and overall (P = .029) survival. In patients with IBC, neoadjuvant treatment with the investigated regimen was successful and well tolerated. Further studies evaluating the potential benefit of an antiangiogenic strategy in this setting are awaited.
ISSN:1526-8209
1938-0666
DOI:10.1016/j.clbc.2018.01.010