Unidad de Investigación Clínica de Cáncer de Pulmón H12O-CNIO. /CNIO
The randomised, phase-3 trial enrolled more than 500 patients. The clinical trial has involved 209 institutions from 23 countries
The Lung Cancer Clinical Research Unit of the Spanish National Cancer Research Centre (CNIO) and the Medical Oncology Service at 12 de Octubre University Hospital has coordinated a randomised, phase-3 clinical trial that assessed chemotherapy in combination with immunotherapy (durvalumab) in patients with extensive-stage small-cell lung cancer (ES-SCLC). ES-SCLC is a very aggressive type of cancer that accounts for 15 to 20 per cent of all lung cancers and, in the majority of cases, is the result of smoking.
The Caspian study, published in the prestigious science journal The Lancet, is an international multi-site trial carried out on 537 patients with ES-SCLC in 209 centres across 23 countries, including 10 Spain-based institutions.
Patients were randomly assigned to three treatment groups. The control group received up to six standard chemotherapy cycles of platinum-etoposide; another group was given the PD-L1 inhibitor durvalumab plus platinum-etoposide; and the third group received durvalumab plus another immunotherapy drug, tremelimumab, plus platinum-etoposide.
The initial assessment of the study was carried out by an independent monitoring committee, whose members determined that chemotherapy plus durvalumab significantly improved overall survival in patients with ES-SCLC, with a 27 per cent lower chance of death and a median overall survival of 10.3 to 13 months.
Further efficacy indicators, such as quality of life, response rate and duration, and progression-free survival, also improved. As to the side effects, the safety profile of chemotherapy-immunotherapy treatment was as expected and was easily manageable on the whole.
The preliminary conclusions of Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): A randomised, controlled, open-label, phase 3 trial were presented at the presidential symposium of the World Conference on Lung Cancer and at the ESMO Congress, held in Barcelona in September this year. The study confirmed the efficacy of PD-L1 inhibitors in combination with chemotherapy in a clinical context where little progress had been made over the previous decades.
Durvalumab plus platinum-etoposide versus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer (CASPIAN): a randomised, controlled, open-label, phase 3 trial. Luis Paz-Ares et al (The Lancet, 2019). DOI: https://doi.org/10.1016/S0140-6736(19)32222-6