A Randomised Phase III Trial of Palliative Radiotherapy (PRT) versus Concurrent Chemotherapy and PRT (C-PRT) in Patients with Good Performance Status, Locally Advanced or Metastatic NSCLC with symptoms due to intrathoracic disease who are not suitable for radical Chemo-radiotherapy: Results of the Trans-Tasman Radiation Oncology Group (TROG) 11.03 Trial
Mené sur 68 patients atteints d'un cancer du poumon non à petites cellules de stade III ou IV, présentant des symptômes de maladie intrathoracique (dyspnée, toux, hémoptysie ou douleur thoracique) et n'étant pas éligibles à une chimio-radiothérapie radicale, cet essai randomisé de phase III compare l'efficacité, du point de vue de l'évolution du taux de réponse intrathoracique entre le début et la fin du traitement (délai : 6 semaines), et la toxicité d'une radiothérapie palliative seule ou associée à une chimiothérapie
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-radiotherapy (C-RT), 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). Methods and Materials: We included patients with stage III or IV NSCLC, Eastern Co-operative Oncology Group (ECOG) Performance status 0-1, experiencing at least one of dyspnea, cough, hemoptysis or chest pain. The primary outcome was a change in intrathoracic response rate from baseline to six weeks post completion of therapy using (1) a composite measure, the Intrathoracic Symptom Burden Index (ISBI) and (2) individual symptom scores measured by the EORTC QLQ-C30 and QLQ-LC 13 instruments. Results: 76 patients were recruited with 68 eligible for analysis. 42.6% and 57.4% had stage III and IV disease respectively. The ISBI was significantly lower at 6 weeks post treatment than at baseline (adjusted mean difference -8.77, SE 2.67, 95%CI [-13.97, -3.58], p<0.01) for the entire cohort with no difference between trial arms (p=0.34). 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 post treatment. There was no difference in toxicity between treatment arms during treatment nor between baseline and 6 weeks post treatment. There was no difference in progression-free survival (PFS). A non-statistically significant 3month 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 C-RT and in patients with Stage IV disease. Chemotherapy added to PRT (40/20) does not provide superior symptomatic relief in this patient cohort .