Quality of life of inoperable non-small cell lung carcinoma. A randomized phase II clinical study comparing radiotherapy alone and combined radio-chemotherapy.

Eighty one patients with inoperable non-small cell lung carcinoma (NSCLC) were entered in a randomized phase II trial comparing split-dose irradiation alone to combined treatment radiotherapy and polychemotherapy (C.A.P. + V.D.S.). The quality of life and the survival of the patients were studied. We have defined three classes of quality of life responses based on the time elapsed before the performance status index drops. A higher quality of life failure rate was observed in the combined treatment group (p non-significant) but the time elapsed before the Karnofsky index drops is longer in the combined treatment group for the quality of life "no change" subgroup (p = 0.15). Survival and quality adjusted survival are similar in both treatment groups. The same conclusion holds for retrospective stratified treatment groups. The results of the study are presented according to the decision tree theory. We conclude that as far as the quality of life is concerned, polychemotherapy combined with the particular split-dose irradiation schedule used is an effective treatment of inoperable NSCLC. Its efficiency is comparable to, but not better than, the same radiotherapy schedule alone taken as a reference baseline.

RCT Entities:   Population Interventions Outcomes