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Everolimus plus paclitaxel failed to improve pathological complete response rate

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San Antonio Breast Cancer Symposium

SAN ANTONIO — Adding everolimus to 12 weeks of paclitaxel as neoadjuvant therapy did not improve the rate of pathological complete response in patients with breast cancer who did not respond to treatment with epirubicin/cyclophosphamide with or without bevacizumab, according to a presentation here.

Jens Huober, MD, PhD, of the University of Tübingen, Germany, presented results of the study, which evaluated paclitaxel with or without everolimus (Afinitor, Zortress; Novartis) in patients who did not respond to treatment on the GeparQuinto study. The 395 patients in this study had unilateral or bilateral breast carcinoma, were HER-2–negative, had breast lesions 2 cm or larger by palpation or 1 cm or larger by ultrasound. None of the patients had responded to epirubicin/cyclophosphamide with or without bevacizumab (Avastin, Genentech).

“In vitro synergistic reactions with everolimus and several chemotherapeutic drugs, including paclitaxel, were observed previously,” Huober said. “Additional neoadjuvant treatment strategies are needed for patients without early clinical response.”

The pathological complete response rate was not significantly different between those who received paclitaxel plus everolimus and those who received only paclitaxel, Huober said. The pathological complete response rate was 5.6% for those who received paclitaxel only vs. 3.6% for those who received the combination. The clinical complete response rate was 62.1% in those who received paclitaxel only vs. 52.2% for those who received the combination, but this was not significant. Also, the toxicity was higher in patients who received the combination therapy.

“DFS and OS have to be awaited because pathological complete response might not be the appropriate endpoint,” Huober said. “A large biomarker program is ongoing to identify predictive markers.”

Disclosure: Dr. Huober received research/grant funding from GlaxoSmithKline, is a consultant for Novartis, Roche, Amgen and GlaxoSmithKline, and receives other financial/material support from Novartis and Roche.

Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.

The GeparQuinto trial was an interesting trial that was designed to look at what we can do for patients who are currently not responding to therapy. This was a study that compared epirubicin plus cyclophosphamide, with or without bevacizumab. In this trial, patients who did not respond to this treatment were randomly assigned to switch over to paclitaxel with or without everolimus. It was designed to look at the complete pathological response rate, and there was no statistical difference in this rate between the groups. One thing we have to be mindful of is that even though this was a negative study in terms of complete pathological response rate, we also know from the GeparTrio study that the complete pathological response rate in patients who don’t respond to therapy is going to be low and may not necessarily predict long-term outcome. In another study, researchers didn’t use everolimus, but they did use alternate chemotherapy, and in the end, patients did have a better DFS when they were crossed over to a different chemotherapy. This trial had a similar design, but instead, the patients crossed over to a biological therapy. Even though the complete pathological response rate was not different, we’re going to have to wait and see what the DFS is. We’re finding out that with neoadjuvant therapy, complete pathological response rate can predict long-term outcome in certain conditions, but not in all conditions. We are going to wait and see if everolimus has a role in this setting.

Debasish "Debu" Tripathy, MD
HemOnc Today Editorial Board member

For more information:

• Huober J. #S3-6. Presented at: the 2011 CTRC-AACR San Antonio Breast Cancer Symposium; Dec. 6-11, 2011; San Antonio.

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