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Referencias

Belgium 1966 {published and unpublished data}

van Houtte P, Rocmans P, Smets P, Goffin JC, Lustman‐Marecal J, Vanderhoeft P, et al. Postoperative radiation therapy in lung cancer: a controlled trial after resection of curative design. International Journal of Radiation, Oncology, Biology and Physics 1980;6:983‐6. CENTRAL

CAMS 1981 {published and unpublished data}

Feng QF, Wang M, Wang LJ, Yang ZY, Zhang YG, Zhang DW, et al. A study of postoperative radiotherapy in patients with non‐small cell lung cancer: a randomized trial. International Journal of Radiation Oncology, Biology, Physics 2000;47(4):925‐9. CENTRAL

EORTC 08861 {unpublished data only}

EORTC 08861(unpublished). Phase III randomised trial of adjuvant radiotherapy vs no adjuvant therapy with completely resected non‐small cell lung cancer. CENTRAL

GETCB 04CB86 {published and unpublished data}

Dautzenberg B, Arriagada R, Chammard AB, Jarema A, Mezzetti M, Mattson K, et al. for the Groupe d'Etude et de Traitement des Cancers Bronchiques. A controlled study of postoperative radiotherapy for patients with completely resected nonsmall cell lung carcinoma. Cancer1999; Vol. 86, issue 2:265‐273. CENTRAL

GETCB 05CB88 {published and unpublished data}

Dautzenberg B, Arriagada R, Chammard AB, Jarema A, Mezzetti M, Mattson K, et al. for the Groupe d'Etude et de Traitement des Cancer Bronchiques. A controlled study of postoperative radiotherapy for patients with completely resected nonsmall cell lung carcinoma. Cancer 1999;86(2):265‐73; Vol. 86, issue 2:265‐273. CENTRAL

Italy 2002 {published and unpublished data}

Trodella L, Granone P, Valente S, Valentini V, Balducci M, Mantini G, et al. Adjuvant radiotherapy in non‐small cell lung cancer with pathological stage I: definitive results of a phase III randomised trial. Radiotherapy and Oncology 2002;62:11‐9. CENTRAL

Korea 2007 {published and unpublished data}

Park JH. Postoperative adjuvant therapy for stage IIIa non‐small cell lung cancer. Journal of Thoracic Oncology 2007;2 (8 Suppl 4):S651. CENTRAL

LCSG 773 {published and unpublished data}

Lung Cancer Study Group. Effects of postoperative mediastinal radiation on completely resected stage II and stage III epidermoid cancer of the lung. New England Journal of Medicine 1986;315(22):1377‐81. CENTRAL

Lille 1985 {published and unpublished data}

Lafitte JJ, Ribet ME, Prévost BM, Gosselin BH, Copin M‐C, Brichet AH. Post‐irradiation for T2 N0 M0 non‐small cell carcinoma: a prospective randomized study. Annals of Thoracic Surgery 1996;62:830‐4. CENTRAL

MRC LU11 {published and unpublished data}

Stephens RJ, Girling DJ, Bleehen NM, Moghissi K, Yosef HMA, Machin D. The role of post‐operative radiotherapy in non‐small cell lung cancer: a multicentre randomised trial in patients with pathologically staged T1‐2, N1‐2, M0 disease. British Journal of Cancer 1996;74:632‐9. CENTRAL

Slovenia 1988 {published and unpublished data}

Debevec M, Bitenc M, Vidmar S, Rott T, Orel J, Strojan P, et al. Post‐operative radiotherapy for radically resected N2 non‐small cell lung cancer: randomised clinical study 1988‐92. Lung Cancer 1996;14:99‐107. CENTRAL

Austria 1996 {published data only}

Mayer R, Smolle‐Juettner F‐M, Szolar D, Stuecklschweiger GF, Quehenberger F, Friehs G, et al. Postoperative radiotherapy in radically resected non‐small cell lung cancer. Chest 1997;112:954‐9. CENTRAL

Dymek 2003 {published data only}

Dymek P, Kowalska T, Reinfuss M, Walasek T, Zareba‐Szlubowska M, Mitus J, et al. The efficacy of adjuvant thoracic radiation therapy in NSCLC patients with ipsilateral mediastinal/hilar lymph node involvement [Ocena skutecznosci pooperacyjnej teleradioterapii chorych na NDRP zoperowanych miejscowo doszczetnie z obecnoscia przerzutow w usunietych wezlach chlonnych srodpiersia albo wneki (kontrolowane doswiadczenie kliniczne)]. Pneumonol Alergol Pol 2003;71(11‐12):496‐503. CENTRAL

LCSG 841 {unpublished data only}

Lung Cancer Study Group (Unpublished). Phase III randomised study of post‐op radiotherapy vs no radiotherapy following resection of non‐small cell lung cancer. CENTRAL

Lung ART‐IGR 2006/1202 {unpublished data only}

LUNG ART‐IGR 2006/1202 (ongoing). Phase III study comparing post‐operative conformal radiotherapy to no post‐operative radiotherapy in patients with completely resected non‐small cell lung cancer and mediastinal N2 involvement. NCT00410683 . CENTRAL

American Cancer Society 2007

American Cancer Society. Cancer Facts and Figures 2007. Atlanta: American Cancer Society, 2007.

Billiet 2014

Billiet C, Dealuwe H, Peeters S, Vansteenkiste J, Dooms C, Haustermans K, et al. Corrigendum to "Modern post‐operative radiotherapy for stage III non‐small cell lung cancer may improve local control and survival: A meta‐analysis". Radiotherapy and Oncology 2014;113(2):300‐1.

Datta 2003

Datta D, Lahiri B. Preoperative evaluation of patients undergoing lung resection surgery. Chest 2003;123:2096‐103.

Dickersin 1995

Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews. In: Chalmers I, Altman DG editor(s). Systematic Reviews. London: BMJ Publishing Group, 1995:17‐36.

Fisher 2011

Fisher DJ, Copas AJ, Tierney JF, Parmar MKB. A critical review of methods for the assessment of patient‐level interactions in individual patient data (IPD) meta‐analysis of randomised trials, and guidance for practitioners. Journal of Clinical Epidemiology 2011;64:949‐67.

Higgins 2002

Higgins JPT, Thompson SG. Quantifying heterogeneity in a meta‐analysis. Statistics in Medicine 2002;21:1539‐58.

Higgins 2011

Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Handbook for Systematic Reviews of Interventions ‐ Version 5.0.1 [updated in September 2011]. The Cochrane Collaboration, 2011. www.cochrane‐handbook.org.

Jemal 2011

Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA: A Cancer Journal for Clinicians 2011;61:69‐90.

Kaplan 1958

Kaplan EL, Meier P. Nonparametric estimation from incomplete observation. Journal of the American Statistical Association 1958;53:457‐81.

Lefebvre 2001

Lefebvre C, Clarke MJ. Identifying randomised trials. In: Egger M, Smith GD, Altman DG editor(s). Systematic Reviews in Healthcare. 2nd Edition. London: BMJ Publishing Group, 2001:69‐87.

Lefebvre 2008

Lefebvre C, Manheimer E, Glanville J, on behalf of the Cochrane Information Retrieval Methods Group. Searching for studies. In: Higgins JPT, Green S editor(s). Cochrane Handbook for Systematic Reviews of Interventions. Chichester: John Wiley & Sons Ltd, 2008:95‐150.

Mountain 1987

Mountain CF. The new international staging system for lung cancer. Surgical Clinics of North America 1987;67(5):925‐35.

Mountain 1997

Mountain CF. Revisions in the International System for Staging Lung Cancer. Chest 1997;111(6):1710‐7.

NSCLCCG 1995

Non‐small Cell Lung Cancer Collaborative Group. Chemotherapy in non‐small cell lung cancer: a meta‐analysis using updated data on individual patients from 52 randomised clinical trials. British Medical Journal 1995;311(7010):899‐909.

Parmar 1995

Parmar MKB, Machin D. Survival Analysis: A Practical Approach. London: John Wiley & Sons Ltd, 1995.

Patel 2014

Patel SH, Ma Y, Wernicke AG, Nori D, Chao KSC, Parashar B. Evidence supporting contemporary post‐operative radiation therapy (PORT) using linear accelerators in N2 lung cancer. Lung Cancer 2014;84:156‐60.

RevMan 2014 [Computer program]

The Cochrane Collaboration. Review Manager (RevMan). Version 5.3.5. Copenhagen: The Nordic Cochrane Centre. The Cochrane Collaboration, 2014.

Schemper 1996

Schemper M, Smith TL. A note on quantifying follow‐up in studies of failure time. Controlled Clinical Trials 1996;17(4):343‐6.

Stata 2013 [Computer program]

StataCorp LP. StataCorp 2013. Stata Statistical Software: Release 13. College Station, TX: StataCorp LP, 2013.

Yusuf 1985

Yusuf S, Peto R, Lewis J, Collins R, Sleight P. Beta‐blockade during and after myocardial infarction: an overview of the randomised trials. Progress in Cardiovascular Diseases 1985;27(5):335‐71.

PORT 1998

PORT Meta‐analysis Trialists Group. Postoperative radiotherapy in non‐small‐cell lung cancer: systematic review and meta‐analysis of individual patient data from nine randomised controlled trials. Lancet 1998;352:257‐63.

PORT 2005

Burdett S, Stewart L, on behalf of the PORT Meta‐analysis Trialist Group. Postoperative radiotherapy in non‐small cell lung cancer: update of an individual patient data meta‐analysis. Lung Cancer 2005;47(1):81‐3.

PORT 2013

Burdett S, Rydzewska L, Tierney JF, Fisher DJ. A closer look at the effects of postoperative radiotherapy by stage and nodal status: updated results of an individual participant data meta‐analysis in non‐small‐cell lung cancer. Lung Cancer 2013;80:350‐2.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Belgium 1966

Methods

1966 to 1977

RCT

Participants

224 patients
Stages I, II, III

Trial data used in subgroup analyses for sex, age and histology

Interventions

Surgery + radiotherapy vs surgery alone
RT details
60 Gy in 30 fractions in 6 weeks
Prescription technique: isodose 90%
Machine used: Co60
Average field size (cm): 15 × 9
Clinical target volume: bronchial stump, hilum, mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

20 small cell participants excluded from meta‐analysis
Unable to supply data for 2 participants

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: "randomisation carried out via sealed envelope"

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely to be influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

CAMS 1981

Methods

1981 to 1995

RCT

Participants

317 patients
Stages II, III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
60 Gy in 30 fractions in 6 weeks
Prescription technique: at midplane
Machine used: Co60 and linac
Average field size (cm): 6 × 12
Clinical target volume: hilum, mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Abstract only

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: "randomisation carried out via sealed envelope"

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

EORTC 08861

Methods

1986 to 1990 RCT

Participants

106 patients
Stages II, III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
56 Gy in 28 fractions in 5.5 weeks
Prescription technique: central axis, at the midplane
Machine used: linac
Average field size (cm): 15 × 10
Clinical target volume: hilum, mediastinum
Technique: composite plans

Outcomes

Survival

Notes

Unpublished trial

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: unpublished trial; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Comment: unpublished, insufficient information provided, but collection of IPD and correspondence with those who supplied the data reassured that data were adequate

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

GETCB 04CB86

Methods

1986 to 1994

RCT

Participants

189 patients
Stages I, II, III

Trial data used in subgroup analyses for sex, age, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
60 Gy in 24 to 30 fractions in 6 weeks
Prescription technique: isocentre
Machine used: Co60 and linac (majority linac)
Average field size (cm): unavailable
Clinical target volume: bronchial stump, hilum, mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Same publication as GETCB 05CB88

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomly assigned by centralised telephone procedure"

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Comment: randomisation by central telephone call

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

GETCB 05CB88

Methods

1988 to 1994

RCT

Participants

539 patients
Stages I, II, III

Trial data used in subgroup analyses for sex, age, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
60 Gy in 24 to 30 fractions in 6 weeks
Prescription technique: isocentre
Machine used: Co60 and linac (majority linac)
Average field size (cm): unavailable
Clinical target volume: bronchial stump, hilum, mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Same publication as GETCB 04CB86

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomly assigned by centralised telephone procedure"

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Comment: randomisation by central telephone call

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

Italy 2002

Methods

1989 to 1997

RCT

Participants

104 patients
Stage I

Trial data used in subgroup analyses for age, sex, histology and stage

Interventions

Surgery + radiotherapy vs surgery alone
RT details
50.4 Gy in 1.8 Gy/d in 5 weeks and 3 days
Prescription technique: angled field technique machine used: linac
Average field size (cm): unavailable
Clinical target volume: bronchial stump, hilum, mediastinum
Technique: unavailable

Outcomes

Survival

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "by chance" using computer‐generated model

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Comment: computer‐generated randomisation, which was checked by an independent colleague

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

Korea 2007

Methods

1989 to 1998

RCT

Participants

111 patients
Stages II, III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
50.4 to 55.8 Gy in 1.8 to 2 Gy fractions, 5 times a week
Prescription technique: at midplane
Average field size: defined inferiorly by a point 5 cm below the carina and superiorly by the suprasternal notch
Clinical target volume: tumour bed, bronchial stump, ipsilateral hilum, vascular shadows of the bilateral mediastinum
Technique: combination of parallel opposed, and anterior and posterior oblique fields, or any combination chosen at the discretion of the chest radiation oncologist

Outcomes

Survival

Notes

Abstract only

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Comment: insufficient information provided in abstract, but collection of IPD and correspondence with those who supplied the data reassured that data were adequate

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

LCSG 773

Methods

1978 to 1985

RCT

Participants

230 patients
Stages II, III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
50 Gy in 25 to 27.5 fractions in 5 to 5.5 weeks
Prescription technique: central axis, at midplane
Machine used: Co60 and linac
Average field size (cm): unavailable
Clinical target volume: bronchial stump, hilum, mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "permuted block randomisation"

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: treatment assigned by central office

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

Lille 1985

Methods

1985 to 1991

RCT

Participants

163 patients
Stage I

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
45 to 60 Gy in 22.5 to 30 fractions in 6 weeks
Prescription technique: isodose 90%
Machine used: Co60 and linac
Average field size (cm): 12 × 12
Clinical target volume: hilum, upper mediastinum
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "randomised with a table of randomisation according to Snedecor and Cochran"

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: "randomised with a table of randomisation according to Snedecor and Cochran"; insufficient information provided

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely to be influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

MRC LU11

Methods

1986 to 1993

RCT

Participants

308 patients
Stages II, III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
40 Gy in 15 fractions in 3 weeks
Prescription technique: central axis, at midplane
Machine used: Co60 and linac
Average field size (cm): unavailable
Clinical target volume: hilum, mediastinum, supraclavicular fossae for upper lobes
Technique: spinal cord blocks, oblique fields, lateral fields

Outcomes

Survival

Notes

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: "treatment assigned by central office"

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

Slovenia 1988

Methods

1988 to 1992 RCT

Participants

74 patients
Stage III

Trial data used in subgroup analyses for sex, age, histology, stage and nodal status

Interventions

Surgery + radiotherapy vs surgery alone
RT details
30 Gy in 10 to 12 fractions in 2 weeks
Prescription technique: central axis, at the midplane
Machine used: linac
Average field size (cm): 9 × 12
Clinical target volume: hilum, mediastinum
Technique: oblique fields, lateral fields

Outcomes

Survival

Notes

Sealed envelope randomisation

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Comment: stated as randomised in paper; checks run on IPD suggest adequate sequence generation

Allocation concealment (selection bias)

Low risk

Quote: "randomisation carried out via sealed envelope"

Blinding (performance bias and detection bias)
All outcomes

Low risk

Comment: trial not blinded owing to the nature of the intervention; outcome not likely influenced by lack of blinding

Incomplete outcome data (attrition bias)
All outcomes

Low risk

Comment: individual participant data obtained and checked for all outcomes

Selective reporting (reporting bias)

Low risk

Comment: individual participant data obtained and checked for all outcomes

Other bias

Low risk

Comment: study apparently free of other sources of bias

All trials supplied individual participant data for analysis and therefore are defined as unpublished data, even though most are published.

IPD = individual participant data.
RCT = randomised controlled trial.
RT = radiotherapy.1G

Characteristics of excluded studies [ordered by study ID]

Study

Reason for exclusion

Austria 1996

Data unavailable/eligibility uncertain
Reported to be an RCT. Data provided by trialists, but anomalies evident between reported results and data received, and it was not clear if the trial was randomised. We were unable to resolve these problems with the trialists

Dymek 2003

Eligible
Data could not be obtained

LCSG 841

Eligible
Data could not be obtained (5 participants)

RCT = randomised controlled trial.

Characteristics of ongoing studies [ordered by study ID]

Lung ART‐IGR 2006/1202

Trial name or title

Essai de phase III comparant une radiothérapie médiastinale conformationnelle post‐opératoire à l’absence de radiothérapie après chirurgie complète chez des patients présentant un carcinome bronchique non à petites cellules (CBNPC) avec envahissement médiastinal N2

Methods

Phase III multi‐centric

Participants

Interventions

Outcomes

Evaluation de l’impact de la radiothérapie médiastinale conformationnelle sur la survie sans récidive comparé à l’absence de radiothérapie

Starting date

2006

Contact information

Docteur Cécile Le Péchoux ‐ [email protected]

Notes

Data and analyses

Open in table viewer
Comparison 1. Surgery + PORT versus surgery alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.18 [1.07, 1.31]

Analysis 1.1

Comparison 1 Surgery + PORT versus surgery alone, Outcome 1 Survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 1 Survival.

2 Local recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.12 [1.01, 1.23]

Analysis 1.2

Comparison 1 Surgery + PORT versus surgery alone, Outcome 2 Local recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 2 Local recurrence‐free survival.

3 Distant recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.13 [1.02, 1.24]

Analysis 1.3

Comparison 1 Surgery + PORT versus surgery alone, Outcome 3 Distant recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 3 Distant recurrence‐free survival.

4 Recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.10 [0.99, 1.21]

Analysis 1.4

Comparison 1 Surgery + PORT versus surgery alone, Outcome 4 Recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 4 Recurrence‐free survival.

5 RT delivery method Show forest plot

11

2343

Hazard Ratio (95% CI)

1.18 [1.07, 1.31]

Analysis 1.5

Comparison 1 Surgery + PORT versus surgery alone, Outcome 5 RT delivery method.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 5 RT delivery method.

5.1 Cobalt‐60 only

1

202

Hazard Ratio (95% CI)

1.48 [1.09, 2.02]

5.2 Cobalt‐60 and linac

6

1746

Hazard Ratio (95% CI)

1.18 [1.05, 1.33]

5.3 Linac only

4

395

Hazard Ratio (95% CI)

1.02 [0.80, 1.31]

6 RT dose Show forest plot

11

2343

Peto Odds Ratio (95% CI)

1.18 [1.07, 1.31]

Analysis 1.6

Comparison 1 Surgery + PORT versus surgery alone, Outcome 6 RT dose.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 6 RT dose.

6.1 < 45 Gy

2

382

Peto Odds Ratio (95% CI)

0.93 [0.75, 1.17]

6.2 ≥ 45 Gy

9

1961

Peto Odds Ratio (95% CI)

1.25 [1.12, 1.40]

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
Figuras y tablas -
Figure 2

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

Overall survival.
Figuras y tablas -
Figure 3

Overall survival.

PORT effect on overall survival by trial according to stage.
Figuras y tablas -
Figure 4

PORT effect on overall survival by trial according to stage.

Hazard ratio (HR) for the interaction between the effect of PORT on survival and (a) stage or (b) nodal status.
Figuras y tablas -
Figure 5

Hazard ratio (HR) for the interaction between the effect of PORT on survival and (a) stage or (b) nodal status.

Sensitivity analysis 1: only trials with all stage subgroups included.
Figuras y tablas -
Figure 6

Sensitivity analysis 1: only trials with all stage subgroups included.

Sensitivity analysis (2): only trials with stage II and III subgroups represented.
Figuras y tablas -
Figure 7

Sensitivity analysis (2): only trials with stage II and III subgroups represented.

PORT effect on overall survival by trial according to nodal status.
Figuras y tablas -
Figure 8

PORT effect on overall survival by trial according to nodal status.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 1 Survival.
Figuras y tablas -
Analysis 1.1

Comparison 1 Surgery + PORT versus surgery alone, Outcome 1 Survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 2 Local recurrence‐free survival.
Figuras y tablas -
Analysis 1.2

Comparison 1 Surgery + PORT versus surgery alone, Outcome 2 Local recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 3 Distant recurrence‐free survival.
Figuras y tablas -
Analysis 1.3

Comparison 1 Surgery + PORT versus surgery alone, Outcome 3 Distant recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 4 Recurrence‐free survival.
Figuras y tablas -
Analysis 1.4

Comparison 1 Surgery + PORT versus surgery alone, Outcome 4 Recurrence‐free survival.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 5 RT delivery method.
Figuras y tablas -
Analysis 1.5

Comparison 1 Surgery + PORT versus surgery alone, Outcome 5 RT delivery method.

Comparison 1 Surgery + PORT versus surgery alone, Outcome 6 RT dose.
Figuras y tablas -
Analysis 1.6

Comparison 1 Surgery + PORT versus surgery alone, Outcome 6 RT dose.

Table 1. Common meta‐analysis stage scale (original analyses ‐ based on TNM 4th edition)

T stage

N stage

M stage

Meta‐analysis stage

AJCC stage

0, 1, 2, X, iS

0

0

I

I

0, 1, 2, X, iS

1

0

II

II

Any

2, 3

0

III

III non‐metastatic

3, 4

Any

0

III

III non‐metastatic

Any

Any

1

IV

Any metastatic

AJCC = American Joint Committee on Cancer.

Figuras y tablas -
Table 1. Common meta‐analysis stage scale (original analyses ‐ based on TNM 4th edition)
Table 2. Common meta‐analysis stage scale (current analysis ‐ based on TNM 6th edition)

T stage

N stage

M stage

Meta‐analysis stage

1, 2

0

0

I

1, 2

1

0

II

3

0

0

II

1, 2

2

0

III

3

1, 2

0

III

Any

Any

1

IV

Figuras y tablas -
Table 2. Common meta‐analysis stage scale (current analysis ‐ based on TNM 6th edition)
Table 3. Characteristics of participants in PORT meta‐analysis

Characteristic

Postoperative RT

Surgery only

Total

AGE (data from 11 trials)

< 54 years

294

327

621

55 to 59 years

267

261

528

60 to 64 years

290

276

566

> 65 years

312

315

627

Unknown

0

1

1

SEX (data from 11 trials)

Male

988

992

1980

Female

175

187

362

Not recorded

0

1

1

HISTOLOGY (data from 9 trials)

Adenocarcinoma

195

218

413

Squamous

522

545

1067

Other

66

54

120

Unknown

380

363

743

META‐ANALYSIS STAGE (data from 11 trials)

I

328

338

666

II

353

366

719

III

463

455

918

IV

1

0

1

Unknown

18

21

39

WHO PERFORMANCE STATUS (data from 4 trials; not used)

Good (0, 1)

195

196

391

Poor (2, 3, 4)

77

83

160

Unknown

22

21

43

Figuras y tablas -
Table 3. Characteristics of participants in PORT meta‐analysis
Table 4. Changes in results over time

Trend or interaction

1998

Trend or interaction

2005

Trend or interaction

2010 'old' methods

Trend or interaction

2010 'new' methods

and TNM changes

Age

P = 0.34

P = 0.44

P = 0.32

P = 0.20

Sex

P = 0.94

P = 0.92

P = 0.84

P = 0.49

Histology

P = 0.75

P = 0.61

P = 0.42

P = 0.38

Stage

P = 0.0003

P = 0.003

P = 0.003

P = 0.12

Nodal status

P = 0.016

P = 0.02

P = 0.03

P = 0.39

Figuras y tablas -
Table 4. Changes in results over time
Comparison 1. Surgery + PORT versus surgery alone

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.18 [1.07, 1.31]

2 Local recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.12 [1.01, 1.23]

3 Distant recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.13 [1.02, 1.24]

4 Recurrence‐free survival Show forest plot

11

2343

Hazard Ratio (95% CI)

1.10 [0.99, 1.21]

5 RT delivery method Show forest plot

11

2343

Hazard Ratio (95% CI)

1.18 [1.07, 1.31]

5.1 Cobalt‐60 only

1

202

Hazard Ratio (95% CI)

1.48 [1.09, 2.02]

5.2 Cobalt‐60 and linac

6

1746

Hazard Ratio (95% CI)

1.18 [1.05, 1.33]

5.3 Linac only

4

395

Hazard Ratio (95% CI)

1.02 [0.80, 1.31]

6 RT dose Show forest plot

11

2343

Peto Odds Ratio (95% CI)

1.18 [1.07, 1.31]

6.1 < 45 Gy

2

382

Peto Odds Ratio (95% CI)

0.93 [0.75, 1.17]

6.2 ≥ 45 Gy

9

1961

Peto Odds Ratio (95% CI)

1.25 [1.12, 1.40]

Figuras y tablas -
Comparison 1. Surgery + PORT versus surgery alone