A Randomized Phase 3 Trial of Palliative Radiation Therapy Versus Concurrent Chemotherapy and Palliative Radiation Therapy in Patients With Good Performance Status, Locally Advanced, or Metastatic Non-Small Cell Lung Cancer With Symptoms due to Intrathoracic Disease Who are Not Suitable for Radical Chemo-radiation Therapy: Results of the Trans-Tasman Radiation Oncology Group 11.03 Trial.

Abstract

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 (PRT_36/12) or concurrent chemotherapy and PRT (C-PRT_40/20). 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. 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). 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.