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Implementation Trial results With Docetaxel Closely Mirror What has been seen in past Phase 2 and 3 Trials: Presented at ERS

By Cameron Johnston

GLASGOW, SCOTLAND -- September 8, 2004 -- A large implementation study involving patients with non-small-cell lung cancer (NSCLC) who were treated with docetaxel suggests that investigators who have conducted previous phase 2 and 3 trials with the drug might have been too cautious in selecting patients for their research.

According to principal investigator Céline Mascaux, MD, research fellow at the Jules Bordet Institute, Brussels, Belgium, the previous phase 2 and 3 trials exclude large numbers of patients because they were deemed, for one reason or another, to be ineligible. "They are highly selective about the patients they use in these trials," she said in an interview.

However, in the latest study, patients were allowed to use docetaxel as long as their performance scores warranted it and they were healthy enough to tolerate the regimen. In the study, 27 patients who had previously failed a platinum-based therapy were compared against the selection criteria for 8 other phase 2 and 3 trials and they were classified as to whether they would have been eligible or ineligible for those studies.

Patients were then treated with either 75 of 100 mg/m² of docetaxel.

The study revealed that in this real-life situation, median survival time was more or less comparable to what was seen in the phase 2 and 3 studies (25 weeks), as was the objective response rate (7.4%). This indicates that many patients who were excluded from the original studies could have been treated because the response rates were similar, Dr. Mascaux said.

It is important to find that patients showed the same response in this study as what was seen in other studies because it indicates that many more patients may be candidates for docetaxel treatment, even if it is just as salvage therapy, she said. Also, it suggests that the recruitment criteria for many phase 2 and 3 studies are too strict and that patients are unfairly excluded, she added.

Dr. Mascaux said the argument between phase 2 and 3 studies and real-life implementation studies is not new, but these results demonstrate that as far as the Jules Bordet Institute is concerned, the outcomes in real-life studies are very close to what has been seen in previous clinical trials.

She added that implementation studies are now the norm at the Institute and that patients who are being treated for NSCLC will be selected on the basis of their Karnofsky performance scores, whether they are strong enough to tolerate any form of chemotherapy, and their own preference as to whether they want to undergo further therapy, given that they have already failed at least one course of a previous treatment.


[Presentation title: "Implementation Study: Role of Docetaxel After a First Line Cisplatinum Based Chemotherapy For Non-Small Cell Lung Cancer (NSCLC)." Poster 1945]

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