High-dose hyperfractionated radiotherapy improves outcomes in small cell lung cancer
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- High-dose hyperfractionated radiotherapy improved PFS and OS.
- Researchers reported no additional toxicities with the high-dose hyperfractionated regimen.
High-dose hyperfractionated thoracic radiotherapy with concurrent chemotherapy improved outcomes for patients with limited-stage small cell lung cancer, according to randomized phase 3 study results presented at ASTRO Annual Meeting.
Researchers reported longer OS and PFS among patients who received the high-dose hyperfractionated regimen compared with standard radiotherapy, with no increase in toxicity.
“Higher-dose thoracic radiation therapy concurrently with chemotherapy is an alternative therapeutic option for patients with limited-stage small cell lung cancer, without prolonging overall treatment time,” Jiayi Yu, PhD, of Peking University Cancer Hospital and Institute in Beijing, said during a presentation.
Background and methods
Twice-daily thoracic radiation administered concurrently with chemotherapy has been standard treatment for limited-stage small cell lung cancer for the past 2 decades. However, prognosis for this patient population generally is poor, according to study background.
Prior studies that examined high-dose thoracic radiotherapy have yielded mixed results.
Yu and colleagues evaluated the safety and efficacy of high-dose hyperfractionated, twice-daily thoracic radiotherapy — 54 Gy in 30 fractions — compared with standard-dose thoracic radiotherapy, administered at 45 Gy in 30 fractions, administered with concurrent chemotherapy as first-line treatment for patients with limited-stage small cell lung cancer.
Researchers enrolled 224 treatment-naive adults (age range, 18 to 70 years) from 16 public hospitals in China.
All study participants had histologically or cytologically confirmed limited-stage small cell lung cancer and ECOG performance status of 0 or 1.
All patients received four courses of IV cisplatin (75 mg/m2 on day 1, or divided into 2 days of each cycle) or carboplatin (area under the curve, 5 mg/mL per min on day 1 of each cycle) and IV etoposide (100 mg/m2 on days 1-3 of each cycle).
Investigators randomly assigned patients to volumetric-modulated arc radiotherapy (VMAT) of 45 Gy in 30 fractions (n = 116) or the simultaneous integrated boost VMAT (SIB-VMAT) of 54 Gy in 30 fractions (n = 108) to the primary lung tumor and lymph node metastases. Radiotherapy began within 0 to 42 days of the first chemotherapy cycle.
All study participants received thoracic radiotherapy twice daily and 10 fractions per week.
Patients who exhibited response also received prophylactic cranial radiation totaling 25 Gy in 10 fractions.
OS served as the primary endpoint. Secondary endpoints included PFS, local PFS, metastases-free survival, disease control rate, acute and late toxicities, and health-related quality of life.
Results
Median follow-up was 45 months (interquartile range, 41-48).
Results showed longer median OS (62.4 months vs. 43.1 months; HR = 0.59; 0.42-0.94) and PFS (30.5 months vs. 16.7 months; HR = 0.77; 95% CI, 0.54-1.1) in the high-dose hyperfractionated group.
A higher percentage of patients assigned the high-dose hyperfractionated regimen remained alive at 2 years (77.7% vs. 53.4%).
A comparable percentage of patients in the high-dose hyperfractionated and standard radiotherapy groups experienced grade 3 or grade 4 neutropenia (44.4vs. 43.2%), febrile neutropenia (11.2% vs. 9.3%), thrombocytopenia (12.8% vs. 14.3%), anemia (9.3% vs. 7.6%), esophagitis (12.9% vs. 12.1%) or pneumonitis (4.6% vs. 6%).
Researchers reported one treatment-related death — due to myocardial infarction — in the high-dose hyperfractionated radiotherapy group.
Perspective
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Sameera Kumar, MD
This is an exciting study because the standard of care has remained hyperfractionated chemoradiotherapy to a dose of 45 Gy in 30 fractions for nearly 30 years. In this study, the group of patients randomly assigned to 54 Gy of twice-daily radiation in 30 fractions achieved longer OS and PFS without a significant increase in toxicity compared with those who received the standard treatment. These data support a phase 2 study by Grønberg and colleagues, which showed similar results. This is very interesting and important to oncologists, and it definitely warrants further exploration.
Reference:
Grønberg BH, et al. Acta Oncol. 2016;doi:10.3109/0284186X.2015.1092584.
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Yu J, et al. Abstract 1. Presented at: ASTRO Annual Meeting; Oct. 1-Oct.4, 2023; San Diego.
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