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PURPOSE: Real-world evidence on locally advanced or metastatic urothelial carcinoma (la/mUC) management in Spain is limited. This study describes patient characteristics, treatment patterns, survival, and health care resource utilization (HCRU) in this population. METHODS/PATIENTS: This retrospective observational study included all adults with a first diagnosis/record of la/mUC (index date) from January 2015 to June 2020 at nine university hospitals in Spain. Data were collected up to December 31, 2020 (end of study), death, or loss to follow-up. Patient characteristics, treatment patterns, median overall survival (OS) and progression-free survival (PFS) from index date (Kaplan-Meier estimates), and disease-specific HCRU were described. RESULTS: Among 829 patients, median age at diagnosis was 71 years; 70.2% had ≥ 1 comorbidity, and 52.5% were eligible for cisplatin. Median follow-up was 12.7 months. Most (84.7%) patients received first-line systemic treatment; of these, 46.9% (n = 329) received second-line and 16.6% (n = 116) received third-line therapy. Chemotherapy was the most common treatment in all lines of therapy, followed by programmed cell death protein 1/ligand 1 inhibitors. Median (95% confidence interval) OS and PFS were 18.8 (17.5-21.5) and 9.9 (8.9-10.5) months, respectively. Most patients required ≥ 1 outpatient visit (71.8%), inpatient admission (56.6%), or emergency department visit (56.5%). CONCLUSIONS: Therapeutic patterns were consistent with Spanish guideline recommendations. Chemotherapy had a role in first-line treatment of la/mUC in Spain during the study period. However, the disease burden remains high, and new first-line treatments recommended in the latest European guidelines should be made available to patients in Spain.
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Cisplatin has been one of the principal chemotherapy agents for the last 30 years and is still used widely in the treatment of testicular, ovarian, lung, head and neck, bladder and several other tumours. Resistance to chemotherapeutic agents is a major obstacle for successful treatment. Treatment effect on germ cell tumours (GCTs) is more successful than in adults suffering from almost any other solid tumour, but resistance still appears in 20% of patients with metastatic disease. However, because of the young age of patients and few data regarding the process of becoming resistant, this situation is still a challenge. In this review we are going to analyse the published literature on cisplatin resistance in GCTs and explain the initiatives that the Spanish Germ Cell Cancer Group (GG) is taking to try to elucidate the molecular mechanisms behind this process.
Assuntos
Cisplatino/uso terapêutico , Resistencia a Medicamentos Antineoplásicos/genética , Neoplasias Embrionárias de Células Germinativas/tratamento farmacológico , Neoplasias Embrionárias de Células Germinativas/genética , Adulto , Animais , Antineoplásicos/farmacologia , Antineoplásicos/uso terapêutico , Cisplatino/farmacologia , Modelos Animais de Doenças , Humanos , Modelos Biológicos , Neoplasias Embrionárias de Células Germinativas/patologia , Transdução de Sinais/efeitos dos fármacos , Transdução de Sinais/genéticaRESUMO
INTRODUCTION: Sunitinib is a multiselective oral inhibitor of several tyrosine-kinase receptors that has demonstrated its efficacy in patients with metastatic and/or unresectable gastrointestinal stroma tumours (GIST) who were resistant to or intolerant to previous treatment with imatinib. The purpose of this study is to assess the cost-effectiveness of sunitinib vs. best supportive care (BSC) in GIST as a second- line treatment, from the perspective of the Spanish National Health System. MATERIALS AND METHODS: A Markov model was used to assess the cost effectiveness of sunitinib (50 mg/day, 4 weeks "on" and 2 weeks "off") vs. BSC in GIST as a second-line treatment. Transition probabilities between the three health states considered in the model (progression-free survival (PFS), progression and death) were obtained from a clinical trial [Demetri et al. (2006) Lancet 368:1329-1338]. Health resource data (drugs, medical visits, laboratory and radiology tests, palliative care and adverse events) were obtained from an expert panel. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: Projected PFS years, life years (LY) and quality of life adjusted years (QALYs) were higher for sunitinib compared with BSC: 0.50 vs. 0.24, 1.59 vs. 0.88 and 1.00 vs. 0.55. Mean costs per patient were 23,259 euros with sunitinib and 1,622 euros with BSC. The incremental cost-effectiveness ratios (ICERs) obtained were: 4,090 euros/month PFS, 30,242 euros/LY and 49,090 euros/QALY gained. The most influential variables for the results were the efficacy and unit cost of sunitinib. CONCLUSIONS: According to the efficiency thresholds for oncology patients in developed countries, sunitinib is considered cost-effective vs. BSC with acceptable costs per LY and QALY gained.