Comparison of quality of life in patients randomized to high-dose once daily (QD) thoracic radiotherapy (TRT) with standard twice daily (BID) TRT in limited stage small cell lung cancer (LS-SCLC) on CALGB 30610 (Alliance, Sub-study CALGB 70702).

Abstract

8504 Background: The CALGB 30610 trial demonstrated that 70Gy QD TRT was not associated with a superior overall survival compared to standard BID 45Gy TRT in limited stage small cell lung cancer. Since both arms appeared to provide similar clinical benefit, other factors such as quality of life may help oncologists decide on the best treatment approach for their patients. The present analysis was conducted to compare patients’ quality of life between these regimens in terms of their physical symptoms, physical functioning and psychological state. Methods: In the CALGB 30610 planned sub-study CALGB 70702, patients were administered the FACT-L, FACT Trial Outcome Index-Lung Cancer (FACT-L TOI), FACT-Esophageal Cancer Eating and Swallowing Indices, ECOG Acute Esophagitis Scale, Hospital Anxiety and Depression Scale (HADS), the EQ-5D at baseline and a single item assessing difficulty swallowing at baseline, 3, 5, 7, 12, 26, and 52 weeks after starting radiation therapy. Patients were also asked to assess treatment inconvenience at these time points. The primary endpoints of CALGB 70702 were FACT-L TOI and FACT eating and swallowing subscales at 12 weeks. Mean changes from baseline were compared between arms using general linear mixed models. Results: 417 patients consented to participate in the patient-reported outcomes substudy. The completion rate of the questionnaires was 87% at baseline and 71% at week 52. The FACT-L total score mean worsening was significantly less in the QD arm compared to the BID arm at week 3 (-1.0 vs -7.0; P=.003), and marginally less at week 5 (-5.3 vs -11.0; P=.06). The FACT-L TOI mean worsening was significantly less in the QD arm than in the BID arm at week 3 (-2.9 vs -7.6; P=.003) and greater at week 12 (-7.6 vs -2.8; P=.03). The QD arm also had a lesser EQ-5D index mean worsening at 3 weeks (-0.04 vs 0.03; P=.002). Mean increase in the acute esophagitis score (1.06 vs 2.89; P<.001) and difficulty swallowing (0.39 vs 1.14; P<.001) were significantly greater in the BID arm at week 3. Mean worsening in HADS anxiety was significantly less in the QD arm at week 5 (-1.99 vs -0.95; P=.03). There were no other significant differences at the remaining timepoints between the two arms. Across visits on the QD arm, patients felt that treatment was inconvenient at 26% (96/376) assessments, compared to 33% (116/352) in the BID arm (chi-sq P=.03). Conclusions: Both radiation regimens were well tolerated. However, the QD arm had better quality of life scores at week 3 and was perceived to be less inconvenient. Clinical trial information: NCT00632853.