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High-Dose Versus Standard-Dose Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC : Final Survival Data, Long-Term Toxicity, and Relapse Patterns in a Randomized, Open-Label, Phase II Trial

Grønberg, Bjørn Henning ; Killingberg, Kristin Toftaker ; Fløtten, Øystein ; Bjaanæs, Maria Moksnes ; Brustugun, Odd Terje ; Madebo, Tesfaye ; Langer, Seppo Wang ; Risumlund, Signe Lenora ; Schytte, Tine and Helbekkmo, Nina , et al. (2025) In Journal of Thoracic Oncology 20(8). p.1108-1119
Abstract

Introduction: Chemoradiotherapy is standard treatment for limited-stage SCLC. However, most patients relapse and there is a need for better treatment. We investigated whether twice-daily thoracic radiotherapy (TRT) of 60 Gy/40 fractions improves survival compared with the established schedule of 45 Gy/30 fractions. Here, we report final survival data and long-term toxicity. Methods: Randomized, open-label, phase II trial. Eligible patients had performance status of 0 to 2, were above or equal to 18 years of age, underwent 18F-fluorodeoxyglucose positron emission tomography computed tomography and brain magnetic resonance imaging for staging, and were randomized 1:1 to TRT of 60 or 45 Gy. Patients were to receive four courses... (More)

Introduction: Chemoradiotherapy is standard treatment for limited-stage SCLC. However, most patients relapse and there is a need for better treatment. We investigated whether twice-daily thoracic radiotherapy (TRT) of 60 Gy/40 fractions improves survival compared with the established schedule of 45 Gy/30 fractions. Here, we report final survival data and long-term toxicity. Methods: Randomized, open-label, phase II trial. Eligible patients had performance status of 0 to 2, were above or equal to 18 years of age, underwent 18F-fluorodeoxyglucose positron emission tomography computed tomography and brain magnetic resonance imaging for staging, and were randomized 1:1 to TRT of 60 or 45 Gy. Patients were to receive four courses of platinum and etoposide chemotherapy, and responders were offered prophylactic cranial irradiation. Results: A total of 170 patients were randomized (60 Gy: n = 89, 45 Gy: n = 81). Median age was 65 years, 31% above or equal to 70 years, 57% women, 89% had performance status of 0 to 1, 83% stage III disease, median planning target volume was 305 cm3, and 67% were treated with three-dimensional conformal radiotherapy. Median overall survival in the 60 Gy group was significantly longer (43.5 versus 22.5 mo, hazard ratio 0.68, 95% confidence interval 0.48–0.98, p = 0.037). The 60 Gy group did not experience more acute grades 3 to 4 esophagitis (60 Gy: 21%, 45 Gy: 18%, p = 0.83) or pneumonitis (60 Gy: 3%, 45 Gy: 0%, p = 0.39). Two patients, both in the 60 Gy group, developed esophageal strictures, whereas 11 patients (60 Gy: n = 5, 45 Gy: n = 6) developed severe long-term eating and swallowing dysfunction. Conclusion: Twice-daily TRT of 60 Gy/40 fractions was well tolerated and prolonged survival compared with 45 Gy/30 fractions in patients with limited-stage SCLC. This trial is registered at ClinicalTrials.gov: NCT02041845.

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organization
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type
Contribution to journal
publication status
published
subject
keywords
Accelerated, Chemoradiotherapy, Dose escalation, LS SCLC, Radiotoxicity, Twice daily RT
in
Journal of Thoracic Oncology
volume
20
issue
8
pages
12 pages
publisher
Elsevier
external identifiers
  • pmid:40258573
  • scopus:105006655744
ISSN
1556-0864
DOI
10.1016/j.jtho.2025.04.007
language
English
LU publication?
yes
id
c0a2cfbc-d5f4-45ad-8a8e-a7ab0562626f
date added to LUP
2025-09-26 10:56:07
date last changed
2025-12-05 14:01:38
@article{c0a2cfbc-d5f4-45ad-8a8e-a7ab0562626f,
  abstract     = {{<p>Introduction: Chemoradiotherapy is standard treatment for limited-stage SCLC. However, most patients relapse and there is a need for better treatment. We investigated whether twice-daily thoracic radiotherapy (TRT) of 60 Gy/40 fractions improves survival compared with the established schedule of 45 Gy/30 fractions. Here, we report final survival data and long-term toxicity. Methods: Randomized, open-label, phase II trial. Eligible patients had performance status of 0 to 2, were above or equal to 18 years of age, underwent <sup>18</sup>F-fluorodeoxyglucose positron emission tomography computed tomography and brain magnetic resonance imaging for staging, and were randomized 1:1 to TRT of 60 or 45 Gy. Patients were to receive four courses of platinum and etoposide chemotherapy, and responders were offered prophylactic cranial irradiation. Results: A total of 170 patients were randomized (60 Gy: n = 89, 45 Gy: n = 81). Median age was 65 years, 31% above or equal to 70 years, 57% women, 89% had performance status of 0 to 1, 83% stage III disease, median planning target volume was 305 cm<sup>3</sup>, and 67% were treated with three-dimensional conformal radiotherapy. Median overall survival in the 60 Gy group was significantly longer (43.5 versus 22.5 mo, hazard ratio 0.68, 95% confidence interval 0.48–0.98, p = 0.037). The 60 Gy group did not experience more acute grades 3 to 4 esophagitis (60 Gy: 21%, 45 Gy: 18%, p = 0.83) or pneumonitis (60 Gy: 3%, 45 Gy: 0%, p = 0.39). Two patients, both in the 60 Gy group, developed esophageal strictures, whereas 11 patients (60 Gy: n = 5, 45 Gy: n = 6) developed severe long-term eating and swallowing dysfunction. Conclusion: Twice-daily TRT of 60 Gy/40 fractions was well tolerated and prolonged survival compared with 45 Gy/30 fractions in patients with limited-stage SCLC. This trial is registered at ClinicalTrials.gov: NCT02041845.</p>}},
  author       = {{Grønberg, Bjørn Henning and Killingberg, Kristin Toftaker and Fløtten, Øystein and Bjaanæs, Maria Moksnes and Brustugun, Odd Terje and Madebo, Tesfaye and Langer, Seppo Wang and Risumlund, Signe Lenora and Schytte, Tine and Helbekkmo, Nina and Neumann, Kirill and Yksnøy, Øyvind and Engleson, Jens and Fluge, Sverre and Naustdal, Thor and Giske, Liv Ellen and Nyman, Jan and Tsakonas, Georgios and Halvorsen, Tarje Onsøien}},
  issn         = {{1556-0864}},
  keywords     = {{Accelerated; Chemoradiotherapy; Dose escalation; LS SCLC; Radiotoxicity; Twice daily RT}},
  language     = {{eng}},
  number       = {{8}},
  pages        = {{1108--1119}},
  publisher    = {{Elsevier}},
  series       = {{Journal of Thoracic Oncology}},
  title        = {{High-Dose Versus Standard-Dose Twice-Daily Thoracic Radiotherapy in Limited-Stage SCLC : Final Survival Data, Long-Term Toxicity, and Relapse Patterns in a Randomized, Open-Label, Phase II Trial}},
  url          = {{http://dx.doi.org/10.1016/j.jtho.2025.04.007}},
  doi          = {{10.1016/j.jtho.2025.04.007}},
  volume       = {{20}},
  year         = {{2025}},
}