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Paclitaxel tops newer drugs in comparative breast cancer study

Surprise result shows it bests Celgene's Abraxane and BMS' Ixempra

Patients with metastatic breast cancer fared at least as well on a paclitaxel-based regimen as those take one of two newer, more expensive drugs, according to a new study, although questions have been raised about the design of the trial.

The study found that first-line treatment with paclitaxel resulted in progression-free survival (PFS) of 10.6 months, compared to 9.2 months with Celgene's Abraxane (nanoparticle albumin-bound [nab]paclitaxel) and 7.6 months with Bristol-Myers Squibb's Ixempra (ixabepilone) in the cohort of chemotherapy-naïve patients. All the drugs were given on top of background treatment with Roche's Avastin (bevacizumab).

Paclitaxel also had the lowest overall toxicity, according to the 799-patient study, which was presented at the American Society of Clinical Oncology (ASCO) meeting in Chicago by Hope Rugo of the University of California San Francisco.

The Ixempra arm of the trial was stopped prematurely in June 2011 after an interim analysis, and the study continued as a two-horse race, according to Rugo. Last November, another interim analysis showed superiority for paclitaxel over Abraxane and the trial was closed.

"Ixabepilone was significantly inferior to paclitaxel [and] nab-paclitaxel was not superior to paclitaxel in this comparison," said Rugo at a press conference to publicise the findings.

The findings have yet to be subjected to extensive peer review, but if backed up could have profound implications as paclitaxel is available generically at a much lower cost than the rival products.

Criticism has been levelled at the design of the study, however, as the dose of nab-paclitaxel used was higher than that approved for use in clinical practice and this may have worsened its adverse event profile relative to paclitaxel.

"This study does not impact the body of breast cancer data for nab-paclitaxel monotherapy, which has demonstrated significantly superior efficacy, including an overall survival benefit and an acceptable safety profile in the definitive, randomised phase III clinical study of a head-to-head comparison with paclitaxel monotherapy," said Celgene in a statement.

Another complicating factor was the use of Avastin as background therapy, given that the US FDA revoked Roche's fast-track approval in metastatic breast cancer in 2010, after the trial was already underway.

Celgene has predicted blockbuster sales for Abraxane, which is approved in a number of other indications aside from breast cancer, and recorded more than $100m in sales in the first quarter of 2011. Ixempra sales were recorded as $117m in 2010 as a whole but revenues were not broken down in BMS' 2011 financial statements.

6th June 2012

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