Bevacizumab ‘No Clinical Benefit’ For HER2-Negative Inflammatory Breast Cancer

Inflammatory breast cancer research challenges the addition of bevacizumab to standard treatments for nonmetastatic, HER2-negative disease

medwireNews: Bevacizumab may not increase the likelihood of pathological complete response (pCR) in patients undergoing multidisciplinary treatment for nonmetastatic, HER2-negative inflammatory breast cancer, suggest phase II trial results.

The BEVERLY-1 investigators say in The Lancet Oncology that the primary endpoint of pCR was achieved by just 19 of 100 patients, giving a rate that is “inferior or equal to that which has been reported without bevacizumab.”

And the 3-year disease-free and overall survival rates of 57% and 75%, respectively, were “similar to results reported in the most recent clinical trial without bevacizumab and inferior to those reported for the HER2-positive patients in BEVERLY-2 who were treated with the same regimen plus trastuzumab ”, write François Bertucci, from Institut Paoli-Calmettes in Marseille, France, and co-authors.

The participants were assigned to receive four cycles of neoadjuvant fluorouracil , epirubicin , cyclophosphamide and bevacizumab, followed by four cycles of docetaxel and bevacizumab. Postoperative treatment included radiotherapy, hormone therapy where appropriate and bevacizumab.

The most common toxicities related to bevacizumab therapy included grade 1–2 hypertension and proteinuria, and grade 1–3 wound healing complications. One patient died from thrombotic microangiopathy after the first cycle of chemotherapy, and this was judged to be probably related to bevacizumab therapy.

Twelve patients discontinued neoadjuvant bevacizumab because of infection, haematological events, skin events, bleeding or allergy. A further 10 patients discontinued adjuvant bevacizumab, mostly due to proteinuria and infection, although wound healing complications, heart failure, thromboembolism and asthenia were each reported in one patient.

“The standard systemic treatment for these patients remains a taxane–anthracycline chemotherapy backbone in the neoadjuvant setting, and adjuvant hormone therapy in case of hormone receptor-positive disease”, the authors therefore conclude.

“Longer follow-up and correlative studies to identify predictors of benefit from bevacizumab are needed.”

In an accompanying comment, Massimo Cristofanilli, from Northwestern University in Chicago, Illinois, USA, says that despite the “disappointing results”, the BEVERLY-1 study’s enrolment of 100 patients over 20 months is “a remarkable achievement in view of the rarity of the disease and the challenges in diagnosis and referral.”

The results, alongside those of the BEVERLY-2 study in HER2-positive inflammatory breast cancer patients, “show that it is possible to design and complete prospective clinical trials for inflammatory breast cancer”, he emphasizes.

References

Bertucci F, Fekih M, Autret A, et al. Bevacizumab plus neoadjuvant chemotherapy in patients with HER2-negative inflammatory breast cancer (BEVERLY-1): a multicentre, single-arm, phase 2 study. Lancet Oncol 2016; Advance online publication 28 March. DOI: http://dx.doi.org/10.1016/S1470-2045(16)00011-5

Cristofanilli M. Inflammatory breast cancer: a new approach. Lancet Oncol 2016; Advance online publication 28 March. DOI: http://dx.doi.org/10.1016/S1470-2045(16)00064-4

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