QUALITY-OF-LIFE AND SURVIVAL IN PATIENTS WITH ADVANCED NONSMALL CELL LUNG-CANCER RECEIVING SUPPORTIVE CARE PLUS CHEMOTHERAPY WITH CARBOPLATIN AND ETOPOSIDE OR SUPPORTIVE CARE ONLY - A MULTICENTER RANDOMIZED PHASE-III TRIAL

The aim of the present trial was to evaluate the effects of chemothera py on the quality of Life and survival of patients with advanced non-s mall cell lung cancer (NSCLC) (stage IIIB or IV). In a controlled mult icentre trial, patients were randomised to receive supportive care onl y or supportive care plus chemotherapy. Chemotherapy consisted of intr avenous (i.v.) carboplatin 300 mg/m(2) on day 1 and etoposide 120 mg/m (2) orally on days 1-5 every 4 weeks for a maximum of eight courses. Q uality of life was measured at randomisation and prior to each treatme nt course and at corresponding 4-week intervals in the control arm, us ing the EORTC QLQ-C30 + LC13 questionnaire. 48 patients were randomise d (supportive care 26, chemotherapy 22), being eligible for comparativ e analyses. Another 102 patients, 97 of which received chemotherapy, w ere subsequently included in the study on an individual treatment pref erence basis. Data from these patients were used for confirmative purp oses. Patients in the chemotherapy group reported better overall physi cal functioning and symptom control compared with the supportive care group. Group differences were smaller within the psychosocial domain, although trends were seen in favour of the chemotherapy group. No sign ificant differences were seen in favour of the supportive care group, except for hair loss. Median survival times were 29 weeks in the chemo therapy group versus 11 weeks in the supportive care group, and 1-year survival rates were 28% versus 8%. Quality of life and survival outco mes were similar in the randomised and non-randomised patients receivi ng chemotherapy. No treatment-related deaths occurred. In conclusion, treatment with carboplatin and etoposide can improve both the quality of Life and the survival of patients with advanced NSCLC. (C) 1998 Els evier Science Ltd. All rights reserved.