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Nab-paclitaxel plus Gemcitabine Demonstrates Survival Advantage in Phase III Study of Patients with Advanced Pancreatic Cancer

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Key Points

  • Nab-paclitaxel plus gemcitabine demonstrated a 59% increase in 1-year survival and demonstrated double the rate of survival at 2 years.
  • The most common grade ≥ 3 treatment-related adverse events in the study for nab-paclitaxel plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs 27%), fatigue (17% vs 7%), and neuropathy (17% vs 1%).

Celgene International Sàrl announced on Tuesday that its phase III clinical trial of paclitaxel protein-bound particles for injectable suspension, albumin-bound (nab-paclitaxel, Abaraxane) in combination with gemcitabine in treatment-naive patients with metastatic pancreatic cancer demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone (median of 8.5 vs. 6.7 months; HR 0.72, P = .000015).

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, nab-paclitaxel plus gemcitabine demonstrated a 59% increase in 1-year survival (35% vs 22%, P = .0002) and demonstrated double the rate of survival at 2 years (9% vs 4%, P = .02) as compared to gemcitabine alone.

The combination also demonstrated a statistically significant improvement in key secondary endpoints compared to gemcitabine alone, including a 31% reduction in the risk of progression or death with a median progression-free survival of 5.5 vs 3.7 months (HR = 0.69, P = .000024) and an overall response rate of 23% compared to 7% (response rate ratio = 3.19, P = 1.1×10-10). Another endpoint assessed included time to treatment failure, which was significantly improved with the nab-paclitaxel combination compared to gemcitabine alone (median 5.1 vs. 3.6 months; HR = 0.70, P < .0001).

New Hope for Patients with Pancreatic Cancer

“The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is both deadly and incredibly difficult to treat with success,” said Daniel D. Von Hoff, MD, FACP, lead principal investigator of the MPACT study and Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-in-Chief for TGen. “The fact that [nab-paclitaxel] plus gemcitabine demonstrated an overall survival benefit, and also did so at 1 and 2 years, is a significant step forward in offering potential new hope for our patients.”

The most common grade ≥ 3 treatment-related adverse events in the study for nab-paclitaxel plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs 27%), fatigue (17% vs 7%), and neuropathy (17% vs 1%). In the nab-paclitaxel plus gemcitabine arm, the median time to neuropathy improvement was 29 days. There was no difference in serious life threatening toxicity (4% in each arm).

Further details of the study will be highlighted in a late-breaking oral presentation by Dr. Von Hoff on Friday, January 25th, at the 2013 Gastrointestinal Cancers Symposium in San Francisco.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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