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Biotech / Medical : Cell Therapeutics (CTIC) -- Ignore unavailable to you. Want to Upgrade?

To: tuck who wrote (591)	3/10/2005 4:33:56 PM
From: Rudy Saucillo	Respond to of 946

>>I'm not sure how common that doublet is now.<< From the literature it appears that paclitaxel and cisplatin (a platinum) is a fairly common doublet in front-line NSCLC, especially with brain mets. I can understand why front-line patients treated with docetaxel were excluded (for the same reasons that any patients previously treated with PEG paclitaxel were excluded). It wouldn't be ethical to randomize a patient who previously failed docetaxel to a docetaxel arm (and the FDA wouldn't see that patient as a representative comparator to patients in the PEG paclitaxel arm). That certainly increases the hurdle for Xyo, IMO. Let's hope the SPA revision to include non-inferiority as a primary endpoint is approved.

To: tuck who wrote (591)	3/10/2005 5:30:47 PM
From: olivier benrubi	Respond to of 946

Thanks. I should have read the protocols instead of just looking at the description of the trials :-( . It is indeed tricky to find comprehensive statistics on the treatment being used. Not sure if this is posted already somewhere mesothel.com "Treatment of advanced non-small-cell lung cancer patients with ECOG performance status 2: results of an European Experts Panel" Results and conclusions: On the basis of current evidence, chemotherapy treatment appears justified for patients with advanced NSCLC and PS2. Single-agent chemotherapy (gemcitabine, vinorelbine, taxanes) could be the preferred option, although carboplatin-based or low-dose cisplatin-based doublets may represent alternative options. Stronger evidence is expected from new clinical research specifically focused on PS2 patients. Single-agent chemotherapy should be the standard arm against which experimental treatments are tested in randomised trials dedicated to PS2 patients. High priority should be given to the evaluation of tolerability and efficacy of platinum-based combinations, and to the testing of new biological agents. Another research priority is the improvement of supportive care. Patients strongly need symptomatic improvement: end points such as symptom relief, clinical benefit and quality of life should have a central position in trials dedicated to PS2 NSCLC patients.