Patupilone in patients with pretreated metastatic/locally recurrent colorectal cancer: results of the Phase II CINATRA trial.

Autor: Moorcraft SY; The Royal Marsden, Downs Road, Sutton, SM2 5PT, UK., Chau I, Peckitt C, Cunningham D, Rao S, Yim KL, Walther A, Jackson CG, Stamp G, Webb J, Smith G, Gillbanks A, Swanton C
Jazyk: angličtina
Zdroj: Investigational new drugs [Invest New Drugs] 2013 Oct; Vol. 31 (5), pp. 1339-44. Date of Electronic Publication: 2013 Jun 26.
DOI: 10.1007/s10637-013-9990-3
Abstrakt: Background: Phase I trials of the microtubule stabilising agent patupilone showed encouraging tumour control and response rates in patients with metastatic colorectal cancer.
Methods: Patients with metastatic or locally recurrent colorectal cancer who had progressed following treatment with oxaliplatin, irinotecan and fluoropyrimidines were treated with patupilone (8 mg/m(2) IV every 3 weeks) in combination with dexamethasone or prednisolone.
Results: The trial was closed early after 29 patients had been enrolled due to concerns about toxicity. 20 patients (71.4 %) experienced at least one grade 3-5 toxicity, most commonly diarrhoea (14 patients), dehydration (7 patients) and lethargy (6 patients). The 12 week progression-free survival rate was 16.7 % (95 % CI 6.1 %-36.5 %) in the 24 patients with a 12 week scan available or who had died prior to the 12 week scan. No complete or partial responses were seen by 12 weeks. The median progression-free survival was 2.6 months (95 % CI 2.3-2.9) and median overall survival was 6.1 months (95 % CI 3.7-8.4).
Conclusion: Patupilone given at a dose of 8 mg/m(2) IV over 20 min every 3 weeks was associated with high levels of toxicity and no significant evidence of efficacy in patients with pre-treated colorectal cancer.
Databáze: MEDLINE
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