German Breast Group Shows Superior Activity Of Abraxane In Breast Cancer
By Cyndi Root
Germany with support from industry partners Roche and Celgene, has announced that Abraxane (nab-paclitaxel) showed a clinical benefit in breast cancer patients. The association announced the trial results in a press release, stating that the agent offered a significant benefit to breast cancer patients when compared to paclitaxel. Michael Untch, MD, coordinating investigator, presented the details at the San Antonio Breast Cancer Symposium. He said, “The phase 3 study provided a head-to-head comparison of weekly nab-paclitaxel with weekly conventional paclitaxel followed by epirubicin/cyclophosphamide in both arms before surgery. Our findings clearly demonstrate nab-paclitaxel is superior to paclitaxel in achieving pCRs in early high risk breast cancer.”
Abraxane
Abraxane, nanoparticle albumin-bound (nab)-paclitaxel is Celgene’s encapsulated version of paclitaxel in nano-sized albumin protein shells. The formulation takes advantage of albumin’s transportation properties and offers higher dose intensity and a more targeted delivery of the payload at the tumor site. In 2013, the Food and Drug Administration (FDA) today approved Abraxane in combination with gemcitabine to treat metastatic pancreatic cancer. The agent was previously approved for the treatment of breast cancer and non-small lung cancer.
Nab-Paclitaxel Vs. Paclitaxel
The GBG and the German Gynecological Oncology Working Group-Breast (AGO-B) enrolled over 1,200 patients in its study comparing nab-paclitaxel vs. paclitaxel. The GeparSepto clinical trial was a Phase 3 study in neoadjuvant breast cancer. Investigators found statistically significant and clinically meaningful improvement in the pCR (pathological complete response) rate when chemotherapy was started with nab-paclitaxel. Dr. Sibylle Loibl, Co-Chair of GBG, stated that nab-paclitaxel doubled the pCR measurement and was associated with fewer incidents of local disease progression. The GBG has published a graphic-rich report on the study.
About the GBG
The German Breast Group, along with the AGO-B, has been conducting studies since 1998. The association has treated over 10,000 patients in the Gepardo trials and over 35,000 patients in all breast cancer trials. Celgene and Roche supply medicines for the GBH trials. Current trials include Genevieve, a cabazitaxel vs. paclitaxel study for triple negative or Luminal B/Her2 normal breast cancer patients, and the NeoPHOEBE study for Her2+ breast cancer patients treated with trastuzumab plus BKM 120.