Current Findings in Trial Evaluating Paclitaxel Substitution in Invasive Breast Cancer
Invasive ductal carcinoma (IDC) is the most common type of invasive breast cancer.
|The following article features coverage from the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas. Click here to read more of Oncology Nurse Advisor's conference coverage.|
An update on the ongoing survival analysis of the GeparSepto trial was presented at the 2017 San Antonio Breast Cancer Symposium (SABCS 2017). The GeparSepto trial findings show that substituting nab-paclitaxel (nP) for paclitaxel (P) followed by epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy significantly increased the rate of pathologic complete response from 29% to 38% in previously untreated patients with unilateral or bilateral primary invasive breast cancer. However, whether this effect will translate into a survival benefit is still unknown.
The trial included 1229 patients from 69 German centers, between July 2012 and December 2013. Patients randomly received either nP or P for 12 weeks followed by 4 cycles of conventionally dosed EC. The primary objective was to observe pathologic complete response. The secondary objective was to observe invasive disease-free survival and overall survival, overall and according to stratified subpopulations, measured amongst other time to event end points. After 248 events, an analysis of invasive disease-free survival will be performed. Other measures include quality of life focusing on peripheral sensory neuropathy (PNP), treatment of PNP, cardiac toxicity, detection of circulating tumor DNA at the time of surgery and during follow-up, and correlation of pathologic complete response with early relapses.
The researchers report that “expected long-term results will help to assess the overall benefit of nP in breast cancer and the surrogate value of pathological complete response for survival end points.” Follow-up is ongoing.
Schneeweiss A, Jackisch C, Schmatloch S, et al. Survival analysis of the prospectively randomized phase III GeparSepto trial comparing neoadjuvant chemotherapy with weekly nab-paclitaxel with solvent-based paclitaxel followed by anthracycline/cyclophosphamide for patients with early breast cancer – GBG69. Oral presentation at: 2017 San Antonio Breast Cancer Symposium; December 6-9, 2017; San Antonio, TX. Abstract GS3-05.