1511P - Treatment Patterns in Patients with Metastatic Soft Tissue Sarcoma (STS). Results from an Exhaustive Cohort in Rhone-Alpes Region (France), the EMS (Medical Evaluation of Sarcoma) Study

Abstract

ABSTRACT Background Soft tissues sarcomas (STS) are rare malignant tumors. Few treatments are approved for metastatic STS and an extent off-label drugs use is expected. Based on a prospective study (EMS) of 888 patients newly diagnosed with a sarcoma between March 2005 and Feb 2007 in the Rhone-Alpes region of France, the treatment patterns of patients with metastatic STS were described. Methods 358 patients with subtypes corresponding to subtypes included in the phase III PALETTE trial were identified in the EMS study. Of these patients 19.3% (n = 69) had metastatic STS at diagnosis. Among the patients with localized STS, 26.2% (n = 76/289) had progressed following diagnosis leading to a total of 145 metastatic STS patients in the population. These patients were characterized and followed to determine treatment patterns. Results For first line (1L) metastatic patients, 25.4% (n = 35/138) of patients entered a clinical trial. 68.4% of patients received at least one off-label drug (table 1). Doxorubicin was the most common 1L therapy (63%). In the 2L, 25.8% of patients entered a clinical trial and 51.6% received at least one off-label drug. Doxorubicin was still the most common therapy (29%), but there was no clear standard of care. Median time to relapse was 250, 123 and 110 days, for 1, 2 and 3L. Median treatment free interval (TFI) between 1L and 2L was 89 days and reduced to 30 days between 2L and 3L. Conclusions STS is a rare and heterogeneous disease with a high use of unapproved treatments and short TFIs between two treatment lines. The lack of clear standard of care, particularly in patients receiving 2L therapy demonstrates important medical need for new agents in this therapeutic area Table 1: treatment mainly used at 1st and 2nd metastatic treatment lines, either given alone or in combination. 1st metastatic line 2nd metastatic line Therapeutic option N = 145, MD * = 7 N = 83, MD = 4 Systemic Treatment 95 (68.8%) 62 (78.5%) Drugs administered N = 95 N = 62 Doxorubicin 60 (63.2%) 18 (29.0%) Ifosfamide 28 (29.5%) Fully combined with Doxo 7 (11.3%) 42.8% combiend with Doxo Dacarbazine 18 (18.9%) 2 (3.2% fully combined with Doxo Docetaxel‡ 12 (12.6%) 14 (22.6%) Gemcitabine‡ 12 (12.6%) 14 (22.6%) of which >80% use was Gemcitabine-Docetaxel regimen Trabectedine 7 (7.4%)‡ 8 (12.9%) Ate least 1 off-label drug 65 (68.4%) 35 (56.5%) * MD: Missing Data‡: off-label use in STS treatment Disclosure B. Tehard: GlaxoSmithKline Employee GlaxoSmithKline funded the data analyses leading to resultst mentionned in this abstract. I. Ray-Coquard: Isabelle Ray-Coquard received fees and Grants from GSK GlaxoSmithKline funded the data analyses leading to resultst mentionned in this abstract. N. Ladarre: GlaxoSmithKline Employee GlaxoSmithKline funded the data analyses leading to resultst mentionned in this abstract. S. Manson: GlaxoSmithKline Employee GlaxoSmithKline funded the data analyses leading to resultst mentionned in this abstract. J. Blay: Jean-Yves Blay received fees from GSK GlaxoSmithKline funded the data analyses leading to resultst mentionned in this abstract. All other authors have declared no conflicts of interest.