A RANDOMIZED TRIAL OF 3 OR 6 COURSES OF ETOPOSIDE CYCLOPHOSPHAMIDE METHOTREXATE AND VINCRISTINE OR 6 COURSES OF ETOPOSIDE AND IFOSFAMIDE INSMALL-CELL LUNG-CANCER (SCLC) .2. QUALITY-OF-LIFE

A total of 458 eligible patients, from 21 centres, with microscopicall y confirmed SCLC were allocated at random to three chemotherapy regime ns, each given at 3-week intervals. In two regimens, etoposide, cyclop hosphamide, methotrexate and vincristine were given for a total of eit her three courses (ECMV3) or six courses (ECMV6). In the third regimen , etoposide and ifosfamide were given for six courses (EI6). Patients with limited disease also received radiotherapy to the primary site af ter the third course of chemotherapy in all three groups. As reported by clinicians, 59% of the ECMV3, 67% of the ECMV6 and 63% of the E16 p atients experienced moderate or severe adverse reactions to their chem otherapy. The major symptoms of disease, cough, haemoptysis, chest pai n, anorexia, and dysphagia, were palliated in 63% or more of patients and the median duration of palliation was 63% or more of survival, the results being similar in the three groups. Among patients with poor o verall condition, physical activity and breathlessness on admission, t he proportions who improved were higher in the E16 group but the diffe rences were small. In all three groups, levels of anxiety fell substan tially during treatment. Levels of depression were lower and showed li ttle change. As assessed by patients using a daily diary card, the pat terns of nausea, vomiting, activity and mood. associated with courses of chemotherapy were very similar in the three groups. In the E16 grou p there was less dysphagia and better overall condition between course s, but these advantages need to be weighed against the inconvenience o f the 24-h infusions required, compared with the 30-min infusions of t he other two regimens. As reported in the companion paper (MRC Lung Ca ncer Working Party, 1993a) there was no statistically significant surv ival advantage to any of the three regimens, although the results do n ot exclude the possibility of a minor survival advantage with the two six-course regimens. In conclusion, there was no major clinical gain f rom continuing chemotherapy beyond three courses or from using the ifo sfamide regimen.