英文原文：Celgene's Abraxane Increases Survival In Advanced Pancreatic Cancer
Celgene International Sàrl, a subsidiary of Celgene Corp. (CELG: Quote), announced that its phase III clinical trial of abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve 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=0.000015)].
In the MPACT or Metastatic Pancreatic Adenocarcinoma Clinical Trial study, ABRAXANE plus gemcitabine demonstrated a 59% increase in one-year survival (35% vs. 22%, p=0.0002) and demonstrated double the rate of survival at two years (9% vs. 4%, p=0.02) as compared to gemcitabine alone.
Abraxane plus gemcitabine 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 (PFS) of 5.5 vs. 3.7 months (HR 0.69, P=0.000024) and an overall response rate (ORR) of 23% compared to 7% (response rate ratio of 3.19, p=1.1 x 10-10).
Another endpoint assessed included time to treatment failure, which was significantly improved with the Abraxane combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P<0.0001)].
The most common grade = 3 treatment-related adverse events in the study for ABRAXANE plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%).
In the Abraxane 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).
The company said it plans to submit dossiers for registration in the US and Europe during the first half of 2013 followed by submissions in other countries/regions during the second half of 2013.
These results are from an investigational phase III study. Abraxane is not currently approved for the treatment of advanced pancreatic cancer.
Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types. Across all patients with pancreatic cancer, relative 5-year survival is 6% and is less than 2% for those with advanced disease. There are two main types of pancreatic cancer - adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors.
In October 2012, Abraxane was approved by the U.S. Food and Drug Administration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
关键词：Celgene,Braxane,转移性胰腺癌
