MedicalResearch.com Interview with:
Corey Pelletier PhD
Director, Health Economics & Outcomes Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: In a phase III clinical trial, ABRAXANE demonstrated significant improvement in ORR vs paclitaxel in patients with metastatic breast cancer. Celgene initiated this study because limited data exist on the comparative effectiveness of ABRAXANE vs paclitaxel for patients with metastatic breast cancer, including HR+/HER2- and triple negative (TN) metastatic breast cancer (MBC), in a real-world setting. This study used a U.S. based electronic medical record (EMR) dataset to evaluate the real-world comparative effectiveness of second-line ABRAXANE vs paclitaxel in patients with MBC and included patients with HR+/HER2- or TN MBC. This study also assessed adverse events and use of supportive care in this patient population.
The median time to treatment discontinuation (TTD) for ABRAXANE vs paclitaxel was 4.50 vs 2.83 months (adjusted P<0.0001*) in all patients. Patients with HR+/HER2- or TN MBC had similar TTD. The median time to next treatment (TTNT) in all patients was 5.9 vs 4.2 months (adjusted P=0.2140*) for ABRAXANE vs paclitaxel, respectively. Patients receiving ABRAXANE had less fatigue, neuropathy, and anemia compared to patients receiving paclitaxel. Patients treated with ABRAXANE also used less antiemetics, and had fewer treatments for hydration or allergic reaction compared to those treated with paclitaxel. Patients treated with paclitaxel used less GCSF and had fewer treatments for bone loss compared to those treated with ABRAXANE.
*TTD and TTNT were adjusted for age, number of metastases, targeted agent use, adjunctive chemotherapy, HER2 status, TN status, and CCI score without age.
MedicalResearch.com: What should readers take away from your report?
Response: This study demonstrates the clinical effectiveness of ABRAXANE versus paclitaxel in a real-world setting. This real-world comparison reported that treatment with ABRAXANE resulted in significantly longer TTD and numerically longer TTNT compared to paclitaxel in patients with metastatic breast cancer. Though the database that was used did not have information on patient response rates or progression, the endpoints TTD and TTNT are commonly used endpoints in comparative effectiveness research to serve as proxies for progression.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: While this study demonstrates the clinical effectiveness of ABRAXANE compared to paclitaxel in a real-world setting, it evaluated a small patient sample size derived from the Navigating Cancer Database. This limitation could underestimate or overestimate the effect, as statistical tests typically require larger sample sizes to ensure a representative distribution of the population and for the findings to be generalizable. As a follow-up, additional analyses that are similar in methodology using EMR databases that can provide larger sample sizes are recommended to confirm the findings.
MedicalResearch.com: Is there anything else you would like to add?
Response: These findings provide one of the first results showing the benefit of ABRAXANE compared to paclitaxel in a real-world setting, and reinforce the efficacy of ABRAXANE seen in the registrational trials of patients with metastatic breast cancer. Additional real-world analyses evaluating this patient population using larger sample sizes will provide further confirmation of the efficacy and benefit of ABRAXANE in MBC patients.
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Citation: ESMO 2016 Abstract
C. Pelletier1, M. Parisi1, S. Glück2, Q. Ni1, F. Braiteh3 1 U.S. Health Economics and Outcomes Research, Celgene Corporation, Summit, NJ, USA, 2 Pancreatic Cancer and Immuno-Oncology, Celgene Corporation, Summit, NJ, USA, 3 Clinical Associate Professor of Medicine, Comprehensive Cancer Centers of Nevada, Las Vegas, NV, USA
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