German Study Demonstrate Significant Pathological Complete Response for Abraxane® in Early Stage Breast Cancer

CancerConnect News: Doctors from Germany reported the results of a clinical trial at the San Antonio Breast Cancer Symposium (SABCS) demonstrating that Abraxane®(nab-paclitaxel) is superior to conventional solvent-based paclitaxel for the treatment of women with early high-risk breast cancer.

Nab-paclitaxel encapsulates paclitaxel in near-nano-sized albumin, protein shells. This takes advantage of the natural transport properties of albumin and allows for the delivery of more paclitaxel to the cancer compared to solvent based paclitaxel.

In this clinical study, 1,200 women with early-stage breast cancer were treated with neoadjuvant chemotherapy consisting of epirubicin and cyclosphamide and either solvent-based paclitaxel or Abraxane and directly compared. Neoadjuvant chemotherapy is administered prior to surgery with the goal of providing rapid treatment and decreasing the size of the cancer that needs to be surgically removed. The cancer removed during surgery can be measured to determine the effectiveness of the chemotherapy. If no cancer is found following neoadjuvant chemotherapy, it is referred to as a pathologic complete remission (pCR).

The study found that 38% of individuals treated with Abraxane achieved a pCR compared to only 29% of those treated with solvent-based paclitaxel. This 9% absolute improvement is impressive and clinically meaningful. The researchers also reported a superior effect of Abraxane in patients with triple-negative disease where the pCR almost doubled.

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Paclitaxel is a standard and widely used treatment for both metastatic and early-stage breast cancer. It is also associated with neuropathy and other troubling side effects. It would be a significant advance if improvements in patient outcomes could be achieved substituting Abraxane for solvent-based paclitaxel. Further analysis of this preliminary date presented at SABCS will be required to determine if there are differences in side effects between Abraxane and solvent-based paclitaxel. Moreover additional long-term follow up data will be required to determine if the improvements in pCR translate into a meaningful survival benefit.

Reference: Untch M, Jackisch C, Schneeweiß A, et al. A randomized phase III trial comparing neoadjuvant chemotherapy with weekly nanoparticle-based paclitaxel with solventbased paclitaxel followed by anthracyline/ cyclophosphamide for patients with early breast cancer (GeparSepto); GBG 69. Presented at the 2014 San Antonio Breast Cancer Symposium, December 9-13, 2014. San Antonio, Texas. Abstract S2-07.

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