Quality of life assessment in advanced non-small-cell lung cancer patientsundergoing an accelerated radiotherapy regimen: Report of ECOG study 4593

Purpose: To prospectively evaluate the quality of life (QOL) before, at com pletion, and after therapy for patients receiving an accelerated fractionat ion schedule of radiotherapy for advanced, unresectable non-small-cell lung cancer in a Phase II multi-institutional trial. Methods and Materials: The Functional Assessment of Cancer Therapy-Lung (FA CT-L) patient questionnaire was use to score the QOL in patients enrolled i n the Eastern Cooperative Oncology Group Phase II trial (ECOG 4593) of hype rfractionated accelerated radiotherapy in non-small-cell lung cancer. Radio therapy (total dose 57.6 Gy in 36 fractions) was delivered during 15 days, with three radiation fractions given each treatment day. The protocol was a ctivated in 1993, and 30 patients had accrued by November 1995. The FACT-L questionnaire was administered at study entry (baseline), on the last day o f radiotherapy (assessment 2), and 4 weeks after therapy (assessment 3). Th e FACT-L includes scores for physical, functional, emotional, and social we ll-being (33 items), and a subscale of lung cancer symptoms (10 additional items). The summation of the physical, functional, and lung cancer symptom subscales (21 items) constitutes the Trial Outcome Index (TOI), considered the most clinically relevant outcome measure in lung cancer treatment trial s. Results: The FACT-L completion rates at the designated study time points we re as follows: baseline, 30 of 30 assessment 2, 29 (97%) of 30; and assessm ent 3, 24 (80%) of 30. At treatment completion, statistically significant d eclines in QOL scores were noted, compared with baseline for physical and f unctional well-being. Emotional well-being scores improved at both assessme nt 2 and assessment 3. The physical and functional scores returned approxim ately to baseline values at assessment 3. The change in TOI score was evalu ated as a function of the clinical response to treatment, toxicity grade, a nd survival; no clear association was noted. A trend for the largest decrea se in QOL was noted for patient groups with shorter survival times. The mea n change in the TOI score from baseline to assessment 3 was -8.96 for patie nts surviving < 52 weeks vs. -0.95 for those surviving > 52 weeks. Conclusions: The FACT-L questionnaire can be successfully administered to n on-small-cell lung cancer patients enrolled in a prospective Phase II trial of accelerated radiation fractionation. The decrement in physical and func tional QOL during treatment returned to baseline level at 4 weeks after tre atment. Emotional well-being improved at all time points. A trend was noted for shorter survival times in patients with the largest negative change in TOI score. These data suggest that the clinical use of hyperfractionated a ccelerated radiotherapy did not cause a significant, long-term decrease in the QOL of the treated patients, and that it is feasible to perform a QOL s tudy of patients enrolled in such a trial. (C) 2001 Elsevier Science Inc.