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.

Abstract

BACKGROUND:

Inflammatory breast cancer (IBC) is a rare and highly aggressive disease. A neoadjuvant regimen with chemotherapy and an antiangiogenic strategy was investigated.

PATIENTS AND METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

• Authors: Antonella Palazzo, Silvia Dellapasqua, Elisabetta Munzone, Vincenzo Bagnardi, Manuelita Mazza, Giuseppe Cancello, Raffaella Ghisini, Monica Iorfida, Emilia Montagna, Aaron Goldhirsch, Marco Colleoni
• Journal: Clinical breast cancer (Clin Breast Cancer) Vol. 18 Issue 4 Pg. 328-335 (08 2018) ISSN: 1938-0666 [Electronic] United States
• PMID: 29486983 (Publication Type: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Antineoplastic Agents
• Antineoplastic Agents, Immunological
• Biomarkers, Tumor
• Bevacizumab

Topics

• Angiogenesis Inhibitors (administration & dosage, adverse effects)
• Antineoplastic Agents (administration & dosage, adverse effects)
• Antineoplastic Agents, Immunological (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Bevacizumab (administration & dosage, adverse effects)
• Biomarkers, Tumor (metabolism)
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Inflammatory Breast Neoplasms (drug therapy, mortality, pathology)
• Middle Aged
• Neoadjuvant Therapy (adverse effects, methods)
• Survival Analysis
• Treatment Outcome