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Meta-Analysis
. 2015 Mar 2;2015(3):CD011430.
doi: 10.1002/14651858.CD011430.

Adjuvant chemotherapy for resected early-stage non-small cell lung cancer

Sarah Burdett  1 , Jean Pierre Pignon, Jayne Tierney, Helene Tribodet, Lesley Stewart, Cecile Le Pechoux, Anne Aupérin, Thierry Le Chevalier, Richard J Stephens, Rodrigo Arriagada, Julian P T Higgins, David H Johnson, Jan Van Meerbeeck, Mahesh K B Parmar, Robert L Souhami, Bengt Bergman, Jean-Yves Douillard, Ariane Dunant, Chiaki Endo, David Girling, Harubumi Kato, Steven M Keller, Hideki Kimura, Aija Knuuttila, Ken Kodama, Ritsuko Komaki, Mark G Kris, Thomas Lad, Tommaso Mineo, Steven Piantadosi, Rafael Rosell, Giorgio Scagliotti, Lesley K Seymour, Frances A Shepherd, Richard Sylvester, Hirohito Tada, Fumihiro Tanaka, Valter Torri, David Waller, Ying Liang; Non‐Small Cell Lung Cancer Collaborative Group
Collaborators, Affiliations
Meta-Analysis

Adjuvant chemotherapy for resected early-stage non-small cell lung cancer

Sarah Burdett et al. Cochrane Database Syst Rev. .

Abstract

Background: To evaluate the effects of administering chemotherapy following surgery, or following surgery plus radiotherapy (known as adjuvant chemotherapy) in patients with early stage non-small cell lung cancer (NSCLC),we performed two systematic reviews and meta-analyses of all randomised controlled trials using individual participant data. Results were first published in The Lancet in 2010.

Objectives: To compare, in terms of overall survival, time to locoregional recurrence, time to distant recurrence and recurrence-free survival:A. Surgery versus surgery plus adjuvant chemotherapyB. Surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapyin patients with histologically diagnosed early stage NSCLC.(2)To investigate whether or not predefined patient subgroups benefit more or less from cisplatin-based chemotherapy in terms of survival.

Search methods: We supplemented MEDLINE and CANCERLIT searches (1995 to December 2013) with information from trial registers, handsearching relevant meeting proceedings and by discussion with trialists and organisations.

Selection criteria: We included trials of a) surgery versus surgery plus adjuvant chemotherapy; and b) surgery plus radiotherapy versus surgery plus radiotherapy plus adjuvant chemotherapy, provided that they randomised NSCLC patients using a method which precluded prior knowledge of treatment assignment.

Data collection and analysis: We carried out a quantitative meta-analysis using updated information from individual participants from all randomised trials. Data from all patients were sought from those responsible for the trial. We obtained updated individual participant data (IPD) on survival, and date of last follow-up, as well as details of treatment allocated, date of randomisation, age, sex, histological cell type, stage, and performance status. To avoid potential bias, we requested information for all randomised patients, including those excluded from the investigators' original analyses. We conducted all analyses on intention-to-treat on the endpoint of survival. For trials using cisplatin-based regimens, we carried out subgroup analyses by age, sex, histological cell type, tumour stage, and performance status.

Main results: We identified 35 trials evaluating surgery plus adjuvant chemotherapy versus surgery alone. IPD were available for 26 of these trials and our analyses are based on 8447 participants (3323 deaths) in 34 trial comparisons. There was clear evidence of a benefit of adding chemotherapy after surgery (hazard ratio (HR)= 0.86, 95% confidence interval (CI)= 0.81 to 0.92, p< 0.0001), with an absolute increase in survival of 4% at five years.We identified 15 trials evaluating surgery plus radiotherapy plus chemotherapy versus surgery plus radiotherapy alone. IPD were available for 12 of these trials and our analyses are based on 2660 participants (1909 deaths) in 13 trial comparisons. There was also evidence of a benefit of adding chemotherapy to surgery plus radiotherapy (HR= 0.88, 95% CI= 0.81 to 0.97, p= 0.009). This represents an absolute improvement in survival of 4% at five years.For both meta-analyses, we found similar benefits for recurrence outcomes and there was little variation in effect according to the type of chemotherapy, other trial characteristics or patient subgroup.We did not undertake analysis of the effects of adjuvant chemotherapy on quality of life and adverse events. Quality of life information was not routinely collected during the trials, but where toxicity was assessed and mentioned in the publications, it was thought to be manageable. We considered the risk of bias in the included trials to be low.

Authors' conclusions: Results from 47 trial comparisons and 11,107 patients demonstrate the clear benefit of adjuvant chemotherapy for these patients, irrespective of whether chemotherapy was given in addition to surgery or surgery plus radiotherapy. This is the most up-to-date and complete systematic review and individual participant data (IPD) meta-analysis that has been carried out.

PubMed Disclaimer

Conflict of interest statement

There is no known conflict of interest.

Figures

1
1
For all chemotherapy groups, HR 0.86 (0.81 to 92); p< 0.0001 Forest plot of comparison: 1 surgery versus surgery + chemotherapy, outcome: 1.1 survival.
2
2
Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
3
3
Methodological quality summary: review authors' judgements about each methodological quality item for each included study.
4
4
Simple (non‐stratified Kaplan‐Meier curves for trials of Surgery (S) and chemotherapy (CT) versus surgery alone and for trials of surgery and chemotherapy and radiotherapy (RT) versus surgery and radiotherapy.
5
5
Exploratory analyses of the effect of surgery (S) and chemotherapy (CT) versus surgery on survival, by the use of tegafur plus uracil/tegafur.
6
6
The effect of surgery (S) and chemotherapy (CT) versus surgery on survival by patient subgroup.
7
7
Exploratory analyses of the effect of surgery (S) and chemotherapy (CT) versus surgery on survival, by use of tegafur plus uracil or tegafur and by stage and performance status.
8
8
Forest plot of comparison: 2 surgery + radiotherapy versus surgery + radiotherapy + chemotherapy, outcome: 2.1 Survival.
9
9
The effect of surgery (S) and radiotherapy (RT) and chemotherapy (CT) versus surgery and radiotherapy on survival by patient subgroup.
1.1
1.1. Analysis
Comparison 1 Surgery versus surgery + adjuvant chemotherapy, Outcome 1 Survival.
2.1
2.1. Analysis
Comparison 2 Surgery + radiotherapy versus surgery + radiotherapy + adjuvant chemotherapy, Outcome 1 Survival.
See this image and copyright information in PMC

References

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A06 ALPI1 {published and unpublished data}
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A07 IALT1 {published and unpublished data}
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A08 BLT1 {published and unpublished data}
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A09 JCOG 9304 {published and unpublished data}
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A10 ANITA1 {published and unpublished data}
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A11 JBR10 {published and unpublished data}
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A12 IALT2 {published and unpublished data}
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A13 BLT2 {published and unpublished data}
    1. Waller D, Peake MD, Stephens RJ, Gower NH, Milroy R, Parmar MKB, et al. Chemotherapy for patients with non‐small cell lung cancer: the surgical setting of the Big Lung Trial. European Journal of Cardio‐Thoracic Surgery 2004;26:173‐82. - PubMed
A14 CALGB 9633 {published and unpublished data}
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A16 FLCSG 1 {published and unpublished data}
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A18 BLT3 {published and unpublished data}
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A20 OLCSG1c {published and unpublished data}
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A25 ACTLC4a {published and unpublished data}
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A26 OLCSG2b {published and unpublished data}
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A27 OLCSG1b {published and unpublished data}
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A28 OLCSG1a {published and unpublished data}
    1. Sawamura K, Mori T, Doi O, Yasumitsu T, Kuwahara O, Kuwabara M, et al. A prospective randomized controlled study of the postoperative adjuvant therapy for non‐small cell lung cancer. Lung Cancer 1988;4:A166.
A29 WJSG2 (2+3) {published and unpublished data}
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A30 WJSG4 {published and unpublished data}
    1. Nakagawa M, Tanaka F, Tsubota N, Ohta M, Takao M, Wada H. A randomised phase III trial of adjuvant chemotherapy with UFT for completely resected pathological stage I non‐small cell lung cancer: the West Japan Study Group for Lung Cancer Surgery (WJSG) ‐ the 4th study. Annals of Oncology 2005;16:75‐80. - PubMed
A31 NJSGLCS {published and unpublished data}
    1. Endo C, Saitoi Y, Iwanawi H, Tsushima T, Imai T, Kawamura M, et al. A randomized trial of postoperative UFT in p stage I, II non‐small cell lung cancer: North‐East Japan Study Group for Lung Cancer Surgery. Lung Cancer 2003;40:181‐6. - PubMed
A32 OLCSG2a {published and unpublished data}
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A33 ACTLC4b {published and unpublished data}
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A34 JLCRG {published and unpublished data}
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B01 MSKCC 80‐53 {published and unpublished data}
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B02 GETCB 01CB82 {published and unpublished data}
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B03 EORTC 08861 {unpublished data only}
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B04 MDA DM 87045 {unpublished data only}
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B05 INT 0115 {published and unpublished data}
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B06 ALPI2 {published and unpublished data}
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B07 IALT3 {published and unpublished data}
    1. Arriagada R, Dunant A, Pignon J‐P, Bergman B, Chabowski M, Grunenwald D, et al. Long‐term results of the International Adjuvant Lung Cancer Trial evaluating adjuvant cisplatin‐based chemotherapy in resected lung cancer. Journal of Clinical Oncology 2010;28:35‐42. - PubMed
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B08 BLT4 {published and unpublished data}
    1. Waller D, Peake MD, Stephens RJ, Gower NH, Milroy R, Parmar MKB, et al. Chemotherapy for patients with non‐small cell lung cancer: the surgical setting of the Big Lung Trial. European Journal of Cardio‐Thoracic Surgery 2004;26:173‐82. - PubMed
B09 ANITA2 {published and unpublished data}
    1. Douillard JY, Rosell R, Lena M, Carpagnano F, Ramlau R, Gonzales‐Larriba JL, et al. Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB‐IIIA non‐small‐cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial. Lancet Oncology 2006;7:719‐27. - PubMed
B10 IALT4 {published and unpublished data}
    1. Arriagada R, Dunant A, Pignon J‐P, Bergman B, Chabowski M, Grunenwald D, et al. Long‐term results of the International Adjuvant Lung Cancer Trial evaluating adjuvant cisplatin‐based chemotherapy in resected lung cancer. Journal of Clinical Oncology 2010;28:35‐42. - PubMed
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B11 LCSG 791 {published and unpublished data}
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B12 FLCSG 3 {unpublished data only}
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B13 OLCSG1d {published and unpublished data}
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References to studies excluded from this review

Ayoub 1991 {published data only}
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Clerici 1991 {published data only}
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Ueda 2004 {published data only}
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References to studies awaiting assessment

NATCH 2010 {published data only}
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