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Clinical Trial
. 2015 Jun;16(6):630-7.
doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13.

Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials

Joe Y Chang  1 , Suresh Senan  2 , Marinus A Paul  3 , Reza J Mehran  4 , Alexander V Louie  2 , Peter Balter  5 , Harry J M Groen  6 , Stephen E McRae  7 , Joachim Widder  8 , Lei Feng  9 , Ben E E M van den Borne  10 , Mark F Munsell  9 , Coen Hurkmans  11 , Donald A Berry  9 , Erik van Werkhoven  12 , John J Kresl  13 , Anne-Marie Dingemans  14 , Omar Dawood  15 , Cornelis J A Haasbeek  2 , Larry S Carpenter  16 , Katrien De Jaeger  11 , Ritsuko Komaki  17 , Ben J Slotman  2 , Egbert F Smit  18 , Jack A Roth  4
Affiliations
Clinical Trial

Stereotactic ablative radiotherapy versus lobectomy for operable stage I non-small-cell lung cancer: a pooled analysis of two randomised trials

Joe Y Chang et al. Lancet Oncol. 2015 Jun.

Erratum in

Abstract

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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Figures

Figure 1
Figure 1. Study design for STARS and ROSEL trials
SABR=stereotactic ablative radiotherapy.
Figure 2
Figure 2. Overall survival (A) and recurrence-free survival (B)
One patient died and five had recurrence in the SABR group compared with six and six patients, respectively, in the surgery group. SABR=stereotactic ablative radiotherapy. HR=hazard ratio.
Figure 3
Figure 3. Freedom from local (A), regional (B), and distant (C) recurrence
In the SABR group, one patient had local recurrence, four had regional nodal recurrence, and one had distant metastases. In the surgery group, one patient had regional nodal recurrence and two had distant metastases. SABR=stereotactic ablative radiotherapy. HR=hazard ratio.
See this image and copyright information in PMC

Comment in

References

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