TREATMENT-RELATED DEATHS IN SMALL-CELL LUNG-CANCER TRIALS - CAN PATIENTS AT RISK BE IDENTIFIED

Objectives: This paper investigates the problem of treatment-related d eaths in small cell lung cancer (SCLC). Design: To observe and define increased hazard levels, and to identify factors relating to these exc ess deaths. Setting: The United Kingdom. Subjects: A total of 2196 pat ients entered into the series of six randomised clinical trials in SCL C conducted by the Medical Research Council (MRC) Lung Cancer Working Party (LCWP). Results: In this large series of patients an increased r isk of death in the second week after commencing the first cycle of ch emotherapy was observed, suggesting that of the 10% of patients who di ed within 3 weeks of starting chemotherapy, half may have been treatme nt-related. Much less additional risk was associated with subsequent c ycles of chemotherapy, and no additional risk with either initial surg ery or radiotherapy. Radford et al. [Eur J Cancer 1993; 29A: 81-86] su ggested that the risk factors for death from sepsis were a Karnofsky P erformance (KP) score of less than or equal to 50 (translated as a WHO performance grade (PS) greater than or equal to 3), age > 50 years an d three or more drugs in the chemotherapy regimen utilised. Starting w ith this model we found that our data suggest it can be refined by omi tting age and including a white blood cell count greater than or equal to 10000/mm(3) (this variable was not tested by Radford), and changin g the other categories to WHO PS greater than or equal to 2 (KP less t han or equal to 70), and four or more drugs. Within our data this revi sed model identified a high risk group of patients with an excess deat h rate of more than 15% in the second week after starting chemotherapy . Radford et als' suggestion that high risk patients be given half dos es of drugs at the first cycle should be tested in a randomised clinic al trial.