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Outcome of patients with sarcoma and other mesenchymal tumours participating in phase I trials: a subset analysis of a European Phase I database

Lookup NU author(s): Professor Ruth Plummer


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Although sarcomas account for only 1% of all solid tumours, patients with sarcomas comprise a larger proportion of patients entering phase I trials, due to the limited number of registered or active drugs for these diseases. To help in patient selection, we evaluated the utility of the predictive Royal Marsden Score which had been derived in carcinoma patients. In addition, we analysed efficacy and toxicity regarding the sarcoma population enrolled in phase I trials.We used data from a European Database comprising 2182 patients treated in phase I trials in 14 European institutions between 2005 and 2007.One hundred and seventy-eight patients diagnosed with advanced sarcoma or other mesenchymal tumours were identified and accounted for 217 phase I trial participations during the study period. Histological type, class of drug, number of metastatic sites, high serum lactate dehydrogenase activity (LDH), low albumin and high white blood cell count were independent prognostic factors. Poor performance status (PS), liver metastases and high leucocyte count were associated with increased risk of early death. The class of drug used was the strongest predictor of progression-free survival (PFS) duration, inhibitors of angiogenesis and histone deacetylase giving the best results. Poor PS, high serum LDH and low lymphocyte count correlated with shorter PFS. In this heterogeneous population, PFS with investigational agents appeared comparable with that previously published for patients receiving standard treatments beyond first line.Prognostic factors in sarcoma patients do not differ from a broader phase I population. Efficacy measures suggest that some patients with sarcoma derive benefit from therapy in this setting which could therefore be considered for patients with no remaining standard therapeutic option.

Publication metadata

Author(s): Cassier PA, Polivka V, Judson I, Soria JC, Penel N, Marsoni S, Verweij J, Schellens JH, Morales-Barrera R, Schoffski P, Voest EE, Gomez-Roca C, Evans TRJ, Plummer R, Gallerani E, Kaye SB, Olmos D

Publication type: Article

Publication status: Published

Journal: Annals of Oncology

Year: 2014

Volume: 25

Issue: 6

Pages: 1222-1228

Print publication date: 01/06/2014

Online publication date: 07/03/2014

Acceptance date: 27/02/2014

ISSN (print): 0923-7534

ISSN (electronic): 1569-8041

Publisher: Oxford University Press


DOI: 10.1093/annonc/mdu108


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Funder referenceFunder name
Fondation de France
2010, 12, 430Federation Nationale des Centres de Lutte Contre le Cancer (FNCLCC, French Federation of Cancer Centers)