TRABECTEDIN FOR METASTATIC SOFT TISSUE SARCOMA – A RETROSPECTIVE ANALYSIS

AR Gaspar, PF Tavares, J Casanova. Centro Hospitalar e Universitário de Coimbra, UTAL – Bone and Soft Tissue Sarcoma Unit, Coimbra, Portugal

Background: soft tissue sarcomas (STSs) are rare tumours arising from connective tissues characterised by high morphologic and biologic heterogeneity, as well as by limited responsiveness to cytotoxic chemotherapeutic agents. Trabectedin was approved in 2007 for patients with advanced STS after failure of anthracyclines and ifosfamide, or for patients unsuited to receive these agents.

Purpose: to obtain basic epidemiological information on patients with soft tissue sarcomas, standard treatment procedures and results of trabectedin treatment in clinical practise.

Materials and methods: this retrospective study analysed 31 STS patients treated with trabectedin between January 2009 and September 2012. A retrospective cohort study of all patients with a diagnosis of STS treated with trabectedin 1.5 mg/m2, D1, 24 hours’ continuous IV infusion, every 3 weeks. Toxicity was evaluated using Common Terminology Criteria for Adverse Events (CTCAE). Progression-free survival curves (PFS) and Overall Survival (a 95% confi dence interval was used) were estimated by using the Kaplan-Meier method.

Results: median age at the initiation of trabectedin therapy was 52 years (18–79 years). Leiomyosarcoma was the most frequent tumour (25.8%) and liposarcoma occurred in 16.2% of the patients. Median number of cycles administered was 6.7 (2–16 cycles). Thrombocytopenia, leukopenia (16.1% of patients), asthenia (12.9%) and elevation of liver transaminases (9.7% of patients) were the most frequent adverse effects. Nine patients achieved a partial remission (PR) and in 3 the disease stabilised (SD). Median overall survival (95% CI) was 6.0 months (0.8; 36.1), median progression-free survival (PFS) (95% CI) was 11.48 months. PFS for all patients was 90.3% at three months and 79.0% at six months.

Conclusions: our results indicate that trabectedin shows promise as an effective and tolerable new drug for the treatment of patients with STS.

No conflict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238

IPILIMUMAB FOR ADVANCED MELANOMA: DRUG USE REVIEW

AR Rubio Salvador, J Medina Martínez, JM Martínez Sesmero, P Moya Gómez, MA Cruz Mora, JI Chacón López-Muñiz, JJ Cía Lecumberri.

Hospital Virgen de la Salud, Pharmacy, Toledo, Spain; Hospital Virgen de la Salud, Oncology, Toledo, Spain

Background: ipilimumab is a recombinant, fully human monoclonal antibody (IgG1) which blocks the inhibitory effects of cytotoxic T-lymphocyte antigen 4 (CTLA4), a negative regulator of T-cell activation. It has been approved for the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic treatment for advanced disease.

Purpose: to review the effectiveness and safety profi le of ipilimumab in the treatment of adult patients with advanced melanoma.

Materials and methods: medical record review and retrospective analysis (January 2011 to September 2012) of prescriptions recorded in the Integral Oncology Patient Information System (ONCOBASS) in a teaching general hospital. Previous drug use, dose, line of chemotherapy, number of cycles administered, objective response rate and toxicity were analysed.

Results: a total of 5 patients with metastatic melanoma were prescribed ipilimumab (2 male, 3 female), median age 45 (36–60). The 4 cycles of treatment planned were completed by 3 patients, 1 continues in active treatment at the moment of fi nishing this study and the other one has been lost to follow-up due to change of hospital. In the group of four patients who received treatment, 2 were prescribed ipilimumab as a second line after failure of a temozolomide- based regimen, and 2 were prescribed ipilimumab as third line after two regimens based on immunotherapy, temozolomide or vemurafenib. After completing the 4 cycles planned, 1 patient maintained complete response (16 months) and 1 patient showed stable disease (maintained for 5 months), and the other one is in evaluation. No patients suffered grade 3–4 toxicity and the treatment was well tolerated.

Conclusions: ipilimumab has shown effectiveness and safety in the treatment of unresectable or metastatic melanoma in patients who have failed or do not tolerate other systemic treatment for advanced disease in our patients, although data from more patients and longer-term studies are required.

No confl ict of interest.

Eur J Hosp Pharm 2013;20(Suppl 1):A1–238