6/30/23, 2:24 AM Twice-daily RT for SCLC Pathway Feedback Search Clinical Topics Home Studies Twice-daily RT for SCLC Twice-daily RT for SCLC Disease Small cell lung cancer Trial question Is twice-daily thoracic radiotherapy superior to once daily thoracic radiotherapy in patients with limited small cell lung cancer receiving cisplatin plus etoposide? Study design Multi-center Open label RCT Population Characteristics of study participants 41.0% female N = 417 59.0% male 417 patients (173 female, 244 male) Inclusion criteria: patients with limited small cell lung cancer receiving four 21-day cycles of cisplatin plus etoposide Key exclusion criteria: pleural effusion on chest films, contralateral hilar or supraclavicular adenopathy, symptomatic cardiac disease, myocardial infarction within the previous six months, prior cancer or prior treatment with either chemotherapy or radiotherapy Interventions N=211 twice-daily thoracic radiotherapy (total of 45 Gy of concurrent thoracic radiotherapy given twice-daily over a three-week period) https://web.pathway.md/studies/recZ62VhVUcFp1HP5 1/2 6/30/23, 2:24 AM Twice-daily RT for SCLC Pathway N=206 once daily thoracic radiotherapy (total of 45 Gy of concurrent thoracic radiotherapy given once daily over a period of five weeks) Primary outcome Median survival at a follow-up of 8 years 23.0 months 23 19 17.3 months 11.5 months 5.8 months Significant increase 0.0 months Twice-daily thoracic radiotherapy Once daily thoracic radiotherapy Significant increase in median survival at a follow-up of 8 years (23 months vs. 19 months; HR 1.2, 95% CI 1 to 1.6) Secondary outcomes No significant difference in failure-free survival at 2 years (29% vs. 24%; AD 5%, 95% CI -0.96 to 10.96) No significant difference in complete response rate (56% vs. 49%; AD 7%, 95% CI -4.38 to 18.38) Significant decrease in simultaneous local and distal treatment failure (6% vs. 23%; ARD -17, 95% CI -29.94 to -4.06) Safety outcomes No significant difference in hospitalization of the patient or perforation of the esophagus. Significant difference in grade 3 esophagitis (27% vs. 11% patients). Conclusion In patients with limited small cell lung cancer receiving four 21-day cycles of cisplatin plus etoposide, twice-daily thoracic radiotherapy was superior to once daily thoracic radiotherapy with respect to median survival at a follow-up of 8 years. Reference Turrisi AT rd, Kim K, Blum R et al. Twice-daily compared with once-daily thoracic radiotherapy in limited small-cell lung cancer treated concurrently with cisplatin and etoposide. N Engl J Med. 1999 Jan 28;340(4):265-71. Open reference URL https://web.pathway.md/studies/recZ62VhVUcFp1HP5 2/2