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Showing content from https://pubmed.ncbi.nlm.nih.gov/25981812/ below:

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

Clinical Trial

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 Suresh Senan², Marinus A Paul³, Reza J Mehran⁴, Alexander V Louie², Peter Balter⁵, Harry J M Groen⁶, Stephen E McRae⁷, Joachim Widder⁸, Lei Feng⁹, Ben E E M van den Borne¹⁰, Mark F Munsell⁹, Coen Hurkmans¹¹, Donald A Berry⁹, Erik van Werkhoven¹², John J Kresl¹³, Anne-Marie Dingemans¹⁴, Omar Dawood¹⁵, Cornelis J A Haasbeek², Larry S Carpenter¹⁶, Katrien De Jaeger¹¹, Ritsuko Komaki¹⁷, Ben J Slotman², Egbert F Smit¹⁸, Jack A Roth⁴

Affiliations

¹ Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: jychang@mdanderson.org.
² Department of Radiation Oncology, VU University Medical Center, Amsterdam, Netherlands.
³ Department of Cardiothoracic Surgery, VU University Medical Center, Amsterdam, Netherlands.
⁴ Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.
⁷ Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁸ Department of Radiation Oncology, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.
⁹ Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁰ Department of Pulmonary Diseases, Catharina Hospital, Eindhoven, Netherlands.
¹¹ Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands.
¹² Department of Biometrics, Netherlands Cancer Institute, Amsterdam, Netherlands.
¹³ Phoenix CyberKnife and Radiation Oncology Center, Phoenix, AZ, USA.
¹⁴ Department of Pulmonary Diseases, Maastricht University Medical Center, Netherlands.
¹⁵ Kona Medical, Bellevue, WA, USA.
¹⁶ Department of Radiation Oncology, CHI St Luke's Health, Houston, TX, USA.
¹⁷ Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁸ Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, Netherlands.

PMID: 25981812
PMCID: PMC4489408
DOI: 10.1016/S1470-2045(15)70168-3

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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.

doi: 10.1016/S1470-2045(15)70168-3. Epub 2015 May 13. Authors Joe Y Chang¹, Suresh Senan², Marinus A Paul³, Reza J Mehran⁴, Alexander V Louie², Peter Balter⁵, Harry J M Groen⁶, Stephen E McRae⁷, Joachim Widder⁸, Lei Feng⁹, Ben E E M van den Borne¹⁰, Mark F Munsell⁹, Coen Hurkmans¹¹, Donald A Berry⁹, Erik van Werkhoven¹², John J Kresl¹³, Anne-Marie Dingemans¹⁴, Omar Dawood¹⁵, Cornelis J A Haasbeek², Larry S Carpenter¹⁶, Katrien De Jaeger¹¹, Ritsuko Komaki¹⁷, Ben J Slotman², Egbert F Smit¹⁸, Jack A Roth⁴ Affiliations

¹ Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: jychang@mdanderson.org.
² Department of Radiation Oncology, VU University Medical Center, Amsterdam, Netherlands.
³ Department of Cardiothoracic Surgery, VU University Medical Center, Amsterdam, Netherlands.
⁴ Department of Thoracic and Cardiovascular Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Radiation Physics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.
⁷ Department of Interventional Radiology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁸ Department of Radiation Oncology, University of Groningen and University Medical Center Groningen, Groningen, Netherlands.
⁹ Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁰ Department of Pulmonary Diseases, Catharina Hospital, Eindhoven, Netherlands.
¹¹ Department of Radiation Oncology, Catharina Hospital, Eindhoven, Netherlands.
¹² Department of Biometrics, Netherlands Cancer Institute, Amsterdam, Netherlands.
¹³ Phoenix CyberKnife and Radiation Oncology Center, Phoenix, AZ, USA.
¹⁴ Department of Pulmonary Diseases, Maastricht University Medical Center, Netherlands.
¹⁵ Kona Medical, Bellevue, WA, USA.
¹⁶ Department of Radiation Oncology, CHI St Luke's Health, Houston, TX, USA.
¹⁷ Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
¹⁸ Department of Pulmonary Diseases, VU University Medical Center, Amsterdam, Netherlands.

PMID: 25981812
PMCID: PMC4489408
DOI: 10.1016/S1470-2045(15)70168-3

Item in Clipboard

Erratum in

Correction to Lancet Oncol 2015; 16: 634, 637.
[No authors listed] [No authors listed] Lancet Oncol. 2015 Sep;16(9):e427. doi: 10.1016/S1470-2045(15)00238-7. Lancet Oncol. 2015. PMID: 26370351 No abstract available.

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. Study design for STARS and…

Figure 1. Study design for STARS and ROSEL trials

SABR=stereotactic ablative radiotherapy.

Figure 1. Study design for STARS and ROSEL trials

SABR=stereotactic ablative radiotherapy.

Figure 2. Overall survival (A) and recurrence-free…

Figure 2. Overall survival (A) and recurrence-free survival (B)

One patient died and five had…

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. Freedom from local (A), regional…

Figure 3. Freedom from local (A), regional (B), and distant (C) recurrence

In the SABR…

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.

Comment in

SABR in early operable lung cancer: time for evidence.
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