Margot Lehman1, Anne Bernard2, Adrienne See3, Madeleine King4, Michael Michael5. 1. Department of Radiation Oncology, Princess Alexandra Hospital (Ipswich Road), Brisbane, Australia; School of Medicine, University of Queensland, Brisbane, Australia. Electronic address: margot.lehman@health.qld.gov.au. 2. QCIF Facility for Advanced Bioinformatics, Institute for Molecular Bioscience, The University of Queensland, QLD, Australia. 3. Cancer Trials Unit, Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia. 4. The University of Sydney, Faculty of Science, School of Psychology, Sydney Quality of Life Office, Sydney, Australia. 5. The Sir Peter MacCallum Department of Oncology, Melbourne, Australia; The University of Melbourne, Melbourne, Australia.
Abstract
PURPOSE: We compared intrathoracic symptom response rate, quality of life (QOL) and toxicity in patients with non-small cell lung cancer (NSCLC) not suitable for radical chemo-radiation therapy, experiencing symptoms from intrathoracic disease, who were randomized to receive palliative radiation therapy (PRT36/12) or concurrent chemotherapy and PRT (C-PRT40/20). METHODS AND MATERIALS: We included patients with stage III or IV NSCLC, with a Eastern Cooperative Oncology Group Performance status 0 to 1, who were experiencing at least one of the following: dyspnea, cough, hemoptysis, or chest pain. The primary outcome was a change in intrathoracic response rate from baseline to 6 weeks post completion of therapy using (1) a composite measure, the Intrathoracic Symptom Burden Index(ISBI), and (2) individual symptom scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire - Lung Cancer 13 item (QLQ-LC 13) instruments. RESULTS:Seventy-six patients were recruited with 68 eligible for analysis. In addition, 42.6% and 57.4% had stage III and IV disease, respectively. The Intrathoracic Symptom Burden Index was significantly lower at 6 weeks posttreatment than at baseline (adjusted mean difference -8.77, standard error 2.67; 95% confidence interval, -13.97% to -3.58%; P < .01) for the entire cohort with no difference between trial arms (P = .34). Both treatments provided effective palliation of individual symptoms with no significant difference between trial arms. QOL during treatment was significantly better for patients receiving C-PRT(40/20). There was no difference between arms in overall QOL between baseline and 6 weeks posttreatment. There was no difference in toxicity between treatment arms during treatment nor between baseline and 6 weeks posttreatment. There was no difference in progression-free survival. A nonstatistically significant 3-month improvement in median survival favored C-PRT(40/20). CONCLUSION:PRT(36/12) and C-PRT(40/20) provide effective symptom palliation in patients with stage III NSCLC not suitable for radical chemo-radiation therapy and in patients with stage IV disease. Chemotherapy added to PRT(40/20) does not provide superior symptomatic relief in this patient cohort.
RCT Entities:
PURPOSE: We compared intrathoracic symptom response rate, quality of life (QOL) and toxicity in patients with non-small cell lung cancer (NSCLC) not suitable for radical chemo-radiation therapy, experiencing symptoms from intrathoracic disease, who were randomized to receive palliative radiation therapy (PRT36/12) or concurrent chemotherapy and PRT (C-PRT40/20). METHODS AND MATERIALS: We included patients with stage III or IV NSCLC, with a Eastern Cooperative Oncology Group Performance status 0 to 1, who were experiencing at least one of the following: dyspnea, cough, hemoptysis, or chest pain. The primary outcome was a change in intrathoracic response rate from baseline to 6 weeks post completion of therapy using (1) a composite measure, the Intrathoracic Symptom Burden Index(ISBI), and (2) individual symptom scores measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and Quality of Life Questionnaire - Lung Cancer 13 item (QLQ-LC 13) instruments. RESULTS: Seventy-six patients were recruited with 68 eligible for analysis. In addition, 42.6% and 57.4% had stage III and IV disease, respectively. The Intrathoracic Symptom Burden Index was significantly lower at 6 weeks posttreatment than at baseline (adjusted mean difference -8.77, standard error 2.67; 95% confidence interval, -13.97% to -3.58%; P < .01) for the entire cohort with no difference between trial arms (P = .34). Both treatments provided effective palliation of individual symptoms with no significant difference between trial arms. QOL during treatment was significantly better for patients receiving C-PRT(40/20). There was no difference between arms in overall QOL between baseline and 6 weeks posttreatment. There was no difference in toxicity between treatment arms during treatment nor between baseline and 6 weeks posttreatment. There was no difference in progression-free survival. A nonstatistically significant 3-month improvement in median survival favored C-PRT(40/20). CONCLUSION:PRT(36/12) and C-PRT(40/20) provide effective symptom palliation in patients with stage III NSCLC not suitable for radical chemo-radiation therapy and in patients with stage IV disease. Chemotherapy added to PRT(40/20) does not provide superior symptomatic relief in this patient cohort.
Authors: Alexander Fabian; Justus Domschikowski; Anne Letsch; Claudia Schmalz; Sandra Freitag-Wolf; Juergen Dunst; David Krug Journal: JAMA Netw Open Date: 2022-09-01