Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials
Open accessAbstract
Background The standard of care for operable, stage I, non-small-cell lung cancer (NSCLC) is lobectomy with mediastinal lymph node dissection or sampling. Stereotactic ablative radiotherapy (SABR) for inoperable stage I NSCLC has shown promising results, but two independent, randomised, phase 3 trials of SABR in patients with operable stage I NSCLC (STARS and ROSEL) closed early due to slow accrual. We aimed to assess overall survival for SABR versus surgery by pooling data from these trials.Methods Eligible patients in the STARS and ROSEL studies were those with clinical T1-2a (<4 cm), N0M0, operable NSCLC. Patients were randomly assigned in a 1:1 ratio to SABR or lobectomy with mediastinal lymph node dissection or sampling. We did a pooled analysis in the intention-to-treat population using overall survival as the primary endpoint. Both trials are registered with ClinicalTrials.gov (STARS: NCT00840749; ROSEL: NCT00687986).Findings 58 patients were enrolled and randomly assigned (31 to SABR and 27 to surgery). Median follow-up was 40·2 months (IQR 23·0-47·3) for the SABR group and 35·4 months (18·9-40·7) for the surgery group. Six patients in the surgery group died compared with one patient in the SABR group. Estimated overall survival at 3 years was 95% (95% CI 85-100) in the SABR group compared with 79% (64-97) in the surgery group (hazard ratio [HR] 0·14 [95% CI 0·017-1·190], log-rank p=0·037). Recurrence-free survival at 3 years was 86% (95% CI 74-100) in the SABR group and 80% (65-97) in the surgery group (HR 0·69 [95% CI 0·21-2·29], log-rank p=0·54). In the surgery group, one patient had regional nodal recurrence and two had distant metastases; in the SABR group, one patient had local recurrence, four had regional nodal recurrence, and one had distant metastases. Three (10%) patients in the SABR group had grade 3 treatment-related adverse events (three [10%] chest wall pain, two [6%] dyspnoea or cough, and one [3%] fatigue and rib fracture). No patients given SABR had grade 4 events or treatment-related death. In the surgery group, one (4%) patient died of surgical complications and 12 (44%) patients had grade 3-4 treatment-related adverse events. Grade 3 events occurring in more than one patient in the surgery group were dyspnoea (four [15%] patients), chest pain (four [15%] patients), and lung infections (two [7%]).Interpretation SABR could be an option for treating operable stage I NSCLC. Because of the small patient sample size and short follow-up, additional randomised studies comparing SABR with surgery in operable patients are warranted.Funding Accuray Inc, Netherlands Organisation for Health Research and Development, NCI Cancer Center Support, NCI Clinical and Translational Science Award.
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In low-risk early prostate cancer, RT may be postponed for 3-6 months while pursuing active surveillance or initial ADT.
“RT can be delayed by 3–6 months for patients with early prostate cancer in case of low-risk disease while aiming for either active surveillance or upfront androgen deprivation therapy (ADT) [65,66];”
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- Authors
- Chang, J. Y., Senan, S., Paul, M. A., Mehran, R. J., Louie, A. V., Balter, P., Groen, H. J. M., McRae, S. E., Widder, J., Feng, L., van den Borne, B. E. E. M., Munsell, M. F., Hurkmans, C., Berry, D. A., van Werkhoven, E., Kresl, J. J., Dingemans, A.-M., Dawood, O., Haasbeek, C. J. A., Carpenter, L. S., De Jaeger, K., Komaki, R., Slotman, B. J., Smit, E. F., & Roth, J. A.
- Affiliations
- The University of Texas MD Anderson Cancer Center (US)
- Amsterdam UMC Location Vrije Universiteit Amsterdam (NL)
- University Medical Center Groningen (NL)
- Catharina Ziekenhuis (NL)
- Maastricht University Medical Centre (NL)
- Kona Medical (United States) (US)
- Corresponding author
- Chang, Joe Y
- ORCID
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2015-06
- Volume
- 16
- Issue
- 6
- Pages
- 630-637
- ISSN
- 1470-2045 (ISSN-L)
- PMC
- PMC4489408
- OpenAlex
- W2098354451
- Cited by
- 1,462
- References
- 27
- Citations by year
- 2026: 46 · 2025: 81 · 2024: 106 · 2023: 102 · 2022: 130 · 2021: 107 · 2020: 132 · 2019: 154 · 2018: 199 · 2017: 185 · 2016: 151 · 2015: 68
- FWCI
- 158.99
- Type
- journal article
- Language
- en
- Update notices
- erratum (2015-09-01)
- Open access
- green
- pure.amsterdamumc.nl
- Licence
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Pure Amsterdam UMC (publishedVersion, other-oa)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (publishedVersion)
- PubMed Central (acceptedVersion)
- Research Publications (Maastricht University) (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Funders
- Netherlands Organisation for Health Research and Development (80-82310-98-08005)
- NCI Cancer Center Support (Core) (Grant CA016672)
- NCI Clinical and Translational Science Award (UL1 RR024148)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Physical Sciences › Physics and Astronomy › Radiation › Advanced Radiotherapy Techniques
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Keywords
- stereotactic body radiotherapy, lobectomy, stage I non-small cell lung cancer, mediastinal lymph node dissection, overall survival, recurrence-free survival, pooled analysis, surgical versus radiotherapy comparison, early-stage lung cancer surgery, regional nodal recurrence, quality of life
- MeSH terms
- Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Follow-Up Studies, Humans, Lymph Nodes, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Netherlands, Radiosurgery, Treatment Outcome, Anterior Temporal Lobectomy
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