Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

doi:10.1016/S1470-2045(13)70334-6

Review

. 2014 Jan;15(1):e42-50.

doi: 10.1016/S1470-2045(13)70334-6.

Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

Collaborators, Affiliations

Collaborators

University of Texas MD Anderson Lung Cancer Collaborative Group:
John Heymach, George Blumenschein, James D Cox, Wayne Hofstetter, Bingliang Fang, Frank Fossella, Bonnie Glisson, Waun Ki Hong, Kathryn Gold, Faye Johnson, Merrill S Kies, Zhongxing Liao, Steven Lin, Ritsuko Komaki, Reza Mehran, Michael O'Reilly, Vali Papadimitrakopulou, Katherine Pisters, David Rice, Jack Roth, Pierre Saintigny, Boris Sepesi, George Simon, Anne Tsao, Garrett L Walsh, James Welsh, Ara Vaporciyan

Affiliations

¹ Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
² Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
³ Thoracic Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
⁴ Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Thoracic and Cardiovascular Surgery, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
⁷ Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: krism@mskcc.org.

PMID: 24384493
PMCID: PMC4734624
DOI: 10.1016/S1470-2045(13)70334-6

Review

Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

Matthew D Hellmann et al. Lancet Oncol. 2014 Jan.

. 2014 Jan;15(1):e42-50.

doi: 10.1016/S1470-2045(13)70334-6.

Collaborators

University of Texas MD Anderson Lung Cancer Collaborative Group:
John Heymach, George Blumenschein, James D Cox, Wayne Hofstetter, Bingliang Fang, Frank Fossella, Bonnie Glisson, Waun Ki Hong, Kathryn Gold, Faye Johnson, Merrill S Kies, Zhongxing Liao, Steven Lin, Ritsuko Komaki, Reza Mehran, Michael O'Reilly, Vali Papadimitrakopulou, Katherine Pisters, David Rice, Jack Roth, Pierre Saintigny, Boris Sepesi, George Simon, Anne Tsao, Garrett L Walsh, James Welsh, Ara Vaporciyan

Affiliations

¹ Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
² Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
³ Thoracic Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
⁴ Department of Pathology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁵ Department of Thoracic and Cardiovascular Surgery, Division of Surgery, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
⁶ Department of Pathology, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
⁷ Thoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. Electronic address: krism@mskcc.org.

PMID: 24384493
PMCID: PMC4734624
DOI: 10.1016/S1470-2045(13)70334-6

Abstract

Improvements in outcomes for patients with resectable lung cancers have plateaued. Clinical trials of resectable non-small-cell lung cancers with overall survival as the primary endpoint require a decade or longer to complete, are expensive, and limit innovation. A surrogate for survival, such as pathological response to neoadjuvant chemotherapy, has the potential to improve the efficiency of trials and expedite advances. 10% or less residual viable tumour after neoadjuvant chemotherapy, termed here major pathological response, meets criteria for a surrogate; major pathological response strongly associates with improved survival, is reflective of treatment effect, and captures the magnitude of the treatment benefit on survival. We support the incorporation of major pathological response as a surrogate endpoint for survival in future neoadjuvant trials of resectable lung cancers. Additional prospective studies are needed to confirm the validity and reproducibility of major pathological response within individual histological and molecular subgroups and with new drugs.

PubMed Disclaimer

Figures

**Figure 1**
Methods for assessment of % viable residual tumor

See this image and copyright information in PMC

Comment in

Pathological complete response as a surrogate endpoint after neoadjuvant therapy for lung cancer.
Huynh C, Sorin M, Rayes R, Fiset PO, Walsh LA, Spicer JD. Huynh C, et al. Lancet Oncol. 2021 Aug;22(8):1056-1058. doi: 10.1016/S1470-2045(21)00405-8. Lancet Oncol. 2021. PMID: 34339641 No abstract available.

Cited by

Surgical resection following chemoradiotherapy for thoracic SMARCA4-deficient undifferentiated tumor: a report of two cases.
Takei K, Isaka M, Wasa J, Kawata T, Masuda T, Katsumata S, Maeda K, Kojima H, Konno H, Ohde Y. Takei K, et al. Surg Case Rep. 2024 Nov 5;10(1):253. doi: 10.1186/s40792-024-02053-y. Surg Case Rep. 2024. PMID: 39497014
Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial).
Duan H, Shao C, Luo Z, Wang T, Tong L, Liu H, Yao X, Lei J, Zhao J, Gao Y, Jiang T, Yan X. Duan H, et al. Signal Transduct Target Ther. 2024 Oct 28;9(1):296. doi: 10.1038/s41392-024-01992-0. Signal Transduct Target Ther. 2024. PMID: 39465257 Free PMC article. Clinical Trial.
Comparison of neoadjuvant chemoimmunotherapy and neoadjuvant chemotherapy for resectable esophageal squamous cell carcinoma: a retrospective study with 3-year survival analysis.
Wang P, Chen Y, Lei M, He H, Zhang D, Lin J, Lin H, Wei W, Chen P, Zhuang F, Chen W, Zhou H, Gao P, Liu S, Wang F. Wang P, et al. J Cancer Res Clin Oncol. 2024 Oct 25;150(10):477. doi: 10.1007/s00432-024-06004-w. J Cancer Res Clin Oncol. 2024. PMID: 39455469 Free PMC article.
Comparative Efficacy and Safety of Neoadjuvant Immunotherapy with Nivolumab vs. Pembrolizumab in Resectable Non-Small Cell Lung Cancer: A Systematic Review.
Papaporfyriou A, Bartziokas K, Apessos I, Mueller J, Leivaditis V, Koletsis E, Grapatsas K. Papaporfyriou A, et al. Curr Oncol. 2024 Oct 18;31(10):6289-6299. doi: 10.3390/curroncol31100469. Curr Oncol. 2024. PMID: 39451773 Free PMC article. Review.
Peripheral NK cell count predicts response and prognosis in breast cancer patients underwent neoadjuvant chemotherapy.
Zhang C, Wu F, Lu X, Wang S, Wu M, Chen N, Fan S, Wei W. Zhang C, et al. Front Immunol. 2024 Sep 30;15:1437193. doi: 10.3389/fimmu.2024.1437193. eCollection 2024. Front Immunol. 2024. PMID: 39403373 Free PMC article.

See all "Cited by" articles

References

1. Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. The New England Journal of Medicine. 2004 Jan 22;350(4):351–60. PubMed PMID: 14736927. - PubMed
1. Douillard JY, Rosell R, De 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. The Lancet Oncology. 2006 Sep;7(9):719–27. PubMed PMID: 16945766. - PubMed
1. Mauguen A, Pignon JP, Burdett S, Domerg C, Fisher D, Paulus R, et al. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data. The Lancet Oncology. 2013 Jun;14(7):619–26. PubMed PMID: 23680111. - PMC - PubMed
1. Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. Journal of Clinical Oncology. 2011 Apr 10;29(11):1465–71. PubMed PMID: 21383294. - PubMed
1. Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012 Apr 4;307(13):1383–93. PubMed PMID: 22474202. - PMC - PubMed

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

Substances

Actions

Grants and funding

LinkOut - more resources

Full Text Sources
Other Literature Sources
Medical
- MedlinePlus Health Information

[1] Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. The New England Journal of Medicine. 2004 Jan 22;350(4):351–60. PubMed PMID: 14736927. - PubMed

[2] Arriagada R, Bergman B, Dunant A, Le Chevalier T, Pignon JP, Vansteenkiste J. Cisplatin-based adjuvant chemotherapy in patients with completely resected non-small-cell lung cancer. The New England Journal of Medicine. 2004 Jan 22;350(4):351–60. PubMed PMID: 14736927. - PubMed

[3] Douillard JY, Rosell R, De 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. The Lancet Oncology. 2006 Sep;7(9):719–27. PubMed PMID: 16945766. - PubMed

[4] Douillard JY, Rosell R, De 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. The Lancet Oncology. 2006 Sep;7(9):719–27. PubMed PMID: 16945766. - PubMed

[5] Mauguen A, Pignon JP, Burdett S, Domerg C, Fisher D, Paulus R, et al. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data. The Lancet Oncology. 2013 Jun;14(7):619–26. PubMed PMID: 23680111. - PMC - PubMed

[6] Mauguen A, Pignon JP, Burdett S, Domerg C, Fisher D, Paulus R, et al. Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data. The Lancet Oncology. 2013 Jun;14(7):619–26. PubMed PMID: 23680111. - PMC - PubMed

[7] Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. Journal of Clinical Oncology. 2011 Apr 10;29(11):1465–71. PubMed PMID: 21383294. - PubMed

[8] Haller DG, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, et al. Capecitabine plus oxaliplatin compared with fluorouracil and folinic acid as adjuvant therapy for stage III colon cancer. Journal of Clinical Oncology. 2011 Apr 10;29(11):1465–71. PubMed PMID: 21383294. - PubMed

[9] Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012 Apr 4;307(13):1383–93. PubMed PMID: 22474202. - PMC - PubMed

[10] Alberts SR, Sargent DJ, Nair S, Mahoney MR, Mooney M, Thibodeau SN, et al. Effect of oxaliplatin, fluorouracil, and leucovorin with or without cetuximab on survival among patients with resected stage III colon cancer: a randomized trial. JAMA. 2012 Apr 4;307(13):1383–93. PubMed PMID: 22474202. - PMC - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

Collaborators

Affiliations

Pathological response after neoadjuvant chemotherapy in resectable non-small-cell lung cancers: proposal for the use of major pathological response as a surrogate endpoint

Authors

Collaborators

Affiliations

Abstract

Figures

Comment in

Similar articles

Cited by

References

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Other Literature Sources

Medical