Skip to main content
Top
Published in: BMC Cancer 1/2014

Open Access 01-12-2014 | Research article

Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study

Authors: Anne-Claire Toffart, Denis Moro-Sibilot, Sébastien Couraud, Patrick Merle, Maurice Perol, Nicolas Girard, Pierre-Jean Souquet, Bénédicte Mastroianni, Gilbert R Ferretti, Philippe Romand, Patrick Chatellain, Aurélien Vesin, Elisabeth Brambilla, Christian Brambilla, Jean-François Timsit

Published in: BMC Cancer | Issue 1/2014

Login to get access

Abstract

Background

Response Evaluation Criteria in Solid Tumors (RECIST) are widely used to assess the effect of chemotherapy in patients with cancer. We hypothesised that the change in unidimensional tumour size handled as a continuous variable was more reliable than RECIST in predicting overall survival (OS).

Methods

The prospective Pharmacogenoscan study enrolled consecutive patients with non-small-cell lung cancer (NSCLC) at any stage seen between 2005 and 2010 at six hospitals in France, given chemotherapy. After exclusion of patients without RECIST or continuous-scale tumour size data and of those with early death, 464 patients were left for the survival analyses. Cox models were built to assess relationships between RECIST 1.1 categories or change in continuous-scale tumour size and OS. The best model was defined as the model minimising the Akaike Information Criterion (AIC).

Results

OS was 14.2 months (IQR, 7.3-28.9 months). According to RECIST 1.1, 146 (31%) patients had a partial or complete response, 245 (53%) stable disease, and73 (16%) disease progression. RECIST 1.1 predicted better OS than continuous-scale tumour in early (<6 months) predicted survival analyses (p = 0.03) but the accuracy of the two response evaluation methods was similar in late (≥6 months) predicted survival analyses (p = 0.15).

Conclusion

In this large observational study, change in continuous-scale tumour size did not perform better than RECIST 1.1 in predicting survival of patients given chemotherapy to treat NSCLC.

Trial registration

Appendix
Available only for authorised users
Literature
1.
go back to reference Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000, 92 (3): 205-216. 10.1093/jnci/92.3.205.CrossRefPubMed Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG: New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000, 92 (3): 205-216. 10.1093/jnci/92.3.205.CrossRefPubMed
2.
go back to reference Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009, 45 (2): 228-247. 10.1016/j.ejca.2008.10.026.CrossRefPubMed Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009, 45 (2): 228-247. 10.1016/j.ejca.2008.10.026.CrossRefPubMed
3.
go back to reference James K, Eisenhauer E, Christian M, Terenziani M, Vena D, Muldal A, Therasse P: Measuring response in solid tumors: unidimensional versus bidimensional measurement. J Natl Cancer Inst. 1999, 91 (6): 523-528. 10.1093/jnci/91.6.523.CrossRefPubMed James K, Eisenhauer E, Christian M, Terenziani M, Vena D, Muldal A, Therasse P: Measuring response in solid tumors: unidimensional versus bidimensional measurement. J Natl Cancer Inst. 1999, 91 (6): 523-528. 10.1093/jnci/91.6.523.CrossRefPubMed
4.
go back to reference Buyse M, Thirion P, Carlson RW, Burzykowski T, Molenberghs G, Piedbois P: Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer Lancet. 2000, 356 (9227): 373-378.PubMed Buyse M, Thirion P, Carlson RW, Burzykowski T, Molenberghs G, Piedbois P: Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer Lancet. 2000, 356 (9227): 373-378.PubMed
5.
go back to reference Paesmans M, Sculier JP, Libert P, Bureau G, Dabouis G, Thiriaux J, Michel J, Van Cutsem O, Sergysels R, Mommen P, Klastersky J: Response to chemotherapy has predictive value for further survival of patients with advanced non-small cell lung cancer: 10 years experience of the European Lung Cancer Working Party. Eur J Cancer. 1997, 33 (14): 2326-2332. 10.1016/S0959-8049(97)00325-0.CrossRefPubMed Paesmans M, Sculier JP, Libert P, Bureau G, Dabouis G, Thiriaux J, Michel J, Van Cutsem O, Sergysels R, Mommen P, Klastersky J: Response to chemotherapy has predictive value for further survival of patients with advanced non-small cell lung cancer: 10 years experience of the European Lung Cancer Working Party. Eur J Cancer. 1997, 33 (14): 2326-2332. 10.1016/S0959-8049(97)00325-0.CrossRefPubMed
6.
go back to reference Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O'Dwyer PJ: Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006, 24 (16): 2505-2512. 10.1200/JCO.2005.03.6723.CrossRefPubMed Ratain MJ, Eisen T, Stadler WM, Flaherty KT, Kaye SB, Rosner GL, Gore M, Desai AA, Patnaik A, Xiong HQ, Rowinsky E, Abbruzzese JL, Xia C, Simantov R, Schwartz B, O'Dwyer PJ: Phase II placebo-controlled randomized discontinuation trial of sorafenib in patients with metastatic renal cell carcinoma. J Clin Oncol. 2006, 24 (16): 2505-2512. 10.1200/JCO.2005.03.6723.CrossRefPubMed
7.
go back to reference Jain RK, Lee JJ, Ng C, Hong D, Gong J, Naing A, Wheler J, Kurzrock R: Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies. J Clin Oncol. 2012, 30 (21): 2684-2690. 10.1200/JCO.2011.36.4752.CrossRefPubMedPubMedCentral Jain RK, Lee JJ, Ng C, Hong D, Gong J, Naing A, Wheler J, Kurzrock R: Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies. J Clin Oncol. 2012, 30 (21): 2684-2690. 10.1200/JCO.2011.36.4752.CrossRefPubMedPubMedCentral
8.
go back to reference Karrison TG, Maitland ML, Stadler WM, Ratain MJ: Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst. 2007, 99 (19): 1455-1461. 10.1093/jnci/djm158.CrossRefPubMed Karrison TG, Maitland ML, Stadler WM, Ratain MJ: Design of phase II cancer trials using a continuous endpoint of change in tumor size: application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst. 2007, 99 (19): 1455-1461. 10.1093/jnci/djm158.CrossRefPubMed
9.
go back to reference Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R: Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol. 2009, 27 (25): 4103-4108. 10.1200/JCO.2008.21.0807.CrossRefPubMed Claret L, Girard P, Hoff PM, Van Cutsem E, Zuideveld KP, Jorga K, Fagerberg J, Bruno R: Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol. 2009, 27 (25): 4103-4108. 10.1200/JCO.2008.21.0807.CrossRefPubMed
10.
go back to reference Van Hazel GA, Tu D, Tebbutt NC, Jonker DJ, Price TJ, O'Callaghan C, Zalcberg JR, Taylor M, Strickland AH, Tomiak AT, Yip D, Simes J, Yadav SK, Links M, Burnell MJ, Jefford M, Karapetis CS: Early change in tumor size from waterfall plot analysis and RECIST response as predictor of overall survival (OS) in advanced, chemotherapy-refractory colorectal cancer (ACRC): NCIC CTG/AGITG CO.17 study. J Clin Oncol. 2011, 29: suppl; abstr 3602 Van Hazel GA, Tu D, Tebbutt NC, Jonker DJ, Price TJ, O'Callaghan C, Zalcberg JR, Taylor M, Strickland AH, Tomiak AT, Yip D, Simes J, Yadav SK, Links M, Burnell MJ, Jefford M, Karapetis CS: Early change in tumor size from waterfall plot analysis and RECIST response as predictor of overall survival (OS) in advanced, chemotherapy-refractory colorectal cancer (ACRC): NCIC CTG/AGITG CO.17 study. J Clin Oncol. 2011, 29: suppl; abstr 3602
11.
go back to reference Sobin LH, Wittekind C: TNM Classification of Malignant Tumours,Sixth Edition. 2002, New York: John Wiley & Sons Sobin LH, Wittekind C: TNM Classification of Malignant Tumours,Sixth Edition. 2002, New York: John Wiley & Sons
12.
go back to reference Groome PA, Bolejack V, Crowley JJ, Kennedy C, Krasnik M, Sobin LH, Goldstraw P: The IASLC Lung Cancer Staging Project: validation of the proposals for revision of the T, N, and M descriptors and consequent stage groupings in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol. 2007, 2 (8): 694-705. 10.1097/JTO.0b013e31812d05d5.CrossRefPubMed Groome PA, Bolejack V, Crowley JJ, Kennedy C, Krasnik M, Sobin LH, Goldstraw P: The IASLC Lung Cancer Staging Project: validation of the proposals for revision of the T, N, and M descriptors and consequent stage groupings in the forthcoming (seventh) edition of the TNM classification of malignant tumours. J Thorac Oncol. 2007, 2 (8): 694-705. 10.1097/JTO.0b013e31812d05d5.CrossRefPubMed
13.
go back to reference Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982, 5 (6): 649-655. 10.1097/00000421-198212000-00014.CrossRefPubMed Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP: Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982, 5 (6): 649-655. 10.1097/00000421-198212000-00014.CrossRefPubMed
14.
go back to reference Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response. J Clin Oncol. 1983, 1 (11): 710-719.PubMed Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response. J Clin Oncol. 1983, 1 (11): 710-719.PubMed
15.
go back to reference Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables. J Clin Oncol. 2008, 26 (24): 3913-3915. 10.1200/JCO.2008.16.1000.CrossRefPubMed Anderson JR, Cain KC, Gelber RD: Analysis of survival by tumor response and other comparisons of time-to-event by outcome variables. J Clin Oncol. 2008, 26 (24): 3913-3915. 10.1200/JCO.2008.16.1000.CrossRefPubMed
16.
go back to reference Bogaerts J, Ford R, Sargent D, Schwartz LH, Rubinstein L, Lacombe D, Eisenhauer E, Verweij J, Therasse P, Party RW: Individual patient data analysis to assess modifications to the RECIST criteria. Eur J Cancer. 2009, 45 (2): 248-260. 10.1016/j.ejca.2008.10.027.CrossRefPubMed Bogaerts J, Ford R, Sargent D, Schwartz LH, Rubinstein L, Lacombe D, Eisenhauer E, Verweij J, Therasse P, Party RW: Individual patient data analysis to assess modifications to the RECIST criteria. Eur J Cancer. 2009, 45 (2): 248-260. 10.1016/j.ejca.2008.10.027.CrossRefPubMed
17.
go back to reference Akaike H: A new look at the statistical model identification. IEEE Trans Automat Control. 1974, AC-19: 716-723.CrossRef Akaike H: A new look at the statistical model identification. IEEE Trans Automat Control. 1974, AC-19: 716-723.CrossRef
18.
go back to reference Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V: Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011, 173 (6): 676-682. 10.1093/aje/kwq433.CrossRefPubMed Quan H, Li B, Couris CM, Fushimi K, Graham P, Hider P, Januel JM, Sundararajan V: Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge abstracts using data from 6 countries. Am J Epidemiol. 2011, 173 (6): 676-682. 10.1093/aje/kwq433.CrossRefPubMed
19.
go back to reference Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ: Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011, 16 (6): 859-867. 10.1634/theoncologist.2011-0064.CrossRefPubMedPubMedCentral Heun JM, Grothey A, Branda ME, Goldberg RM, Sargent DJ: Tumor status at 12 weeks predicts survival in advanced colorectal cancer: findings from NCCTG N9741. Oncologist. 2011, 16 (6): 859-867. 10.1634/theoncologist.2011-0064.CrossRefPubMedPubMedCentral
20.
go back to reference Erasmus JJ, Gladish GW, Broemeling L, Sabloff BS, Truong MT, Herbst RS, Munden RF: Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: implications for assessment of tumor response. J Clin Oncol. 2003, 21 (13): 2574-2582. 10.1200/JCO.2003.01.144.CrossRefPubMed Erasmus JJ, Gladish GW, Broemeling L, Sabloff BS, Truong MT, Herbst RS, Munden RF: Interobserver and intraobserver variability in measurement of non-small-cell carcinoma lung lesions: implications for assessment of tumor response. J Clin Oncol. 2003, 21 (13): 2574-2582. 10.1200/JCO.2003.01.144.CrossRefPubMed
21.
go back to reference Belton AL, Saini S, Liebermann K, Boland GW, Halpern EF: Tumour size measurement in an oncology clinical trial: comparison between off-site and on-site measurements. Clin Radiol. 2003, 58 (4): 311-314. 10.1016/S0009-9260(02)00577-9.CrossRefPubMed Belton AL, Saini S, Liebermann K, Boland GW, Halpern EF: Tumour size measurement in an oncology clinical trial: comparison between off-site and on-site measurements. Clin Radiol. 2003, 58 (4): 311-314. 10.1016/S0009-9260(02)00577-9.CrossRefPubMed
22.
go back to reference Oxnard GR, Zhao B, Sima CS, Ginsberg MS, James LP, Lefkowitz RA, Guo P, Kris MG, Schwartz LH, Riely GJ: Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes. J Clin Oncol. 2011, 29 (23): 3114-3119. 10.1200/JCO.2010.33.7071.CrossRefPubMedPubMedCentral Oxnard GR, Zhao B, Sima CS, Ginsberg MS, James LP, Lefkowitz RA, Guo P, Kris MG, Schwartz LH, Riely GJ: Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes. J Clin Oncol. 2011, 29 (23): 3114-3119. 10.1200/JCO.2010.33.7071.CrossRefPubMedPubMedCentral
23.
go back to reference Moertel CG, Hanley JA: The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer. 1976, 38 (1): 388-394. 10.1002/1097-0142(197607)38:1<388::AID-CNCR2820380156>3.0.CO;2-A.CrossRefPubMed Moertel CG, Hanley JA: The effect of measuring error on the results of therapeutic trials in advanced cancer. Cancer. 1976, 38 (1): 388-394. 10.1002/1097-0142(197607)38:1<388::AID-CNCR2820380156>3.0.CO;2-A.CrossRefPubMed
24.
go back to reference Andoh H, McNulty NJ, Lewis PJ: Improving accuracy in reporting CT scans of oncology patients: assessing the effect of education and feedback interventions on the application of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Acad Radiol. 2013, 20 (3): 351-357. 10.1016/j.acra.2012.12.002.CrossRefPubMed Andoh H, McNulty NJ, Lewis PJ: Improving accuracy in reporting CT scans of oncology patients: assessing the effect of education and feedback interventions on the application of the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Acad Radiol. 2013, 20 (3): 351-357. 10.1016/j.acra.2012.12.002.CrossRefPubMed
25.
go back to reference Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ: Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008, 26 (2): 183-189. 10.1200/JCO.2007.13.8099.CrossRefPubMed Grothey A, Hedrick EE, Mass RD, Sarkar S, Suzuki S, Ramanathan RK, Hurwitz HI, Goldberg RM, Sargent DJ: Response-independent survival benefit in metastatic colorectal cancer: a comparative analysis of N9741 and AVF2107. J Clin Oncol. 2008, 26 (2): 183-189. 10.1200/JCO.2007.13.8099.CrossRefPubMed
26.
go back to reference Lara PN, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR: Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008, 26 (3): 463-467. 10.1200/JCO.2007.13.0344.CrossRefPubMed Lara PN, Redman MW, Kelly K, Edelman MJ, Williamson SK, Crowley JJ, Gandara DR: Disease control rate at 8 weeks predicts clinical benefit in advanced non-small-cell lung cancer: results from Southwest Oncology Group randomized trials. J Clin Oncol. 2008, 26 (3): 463-467. 10.1200/JCO.2007.13.0344.CrossRefPubMed
27.
go back to reference Mandrekar SJ, An MW, Meyers J, Grothey A, Bogaerts J, Sargent DJ: Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse. J Clin Oncol. 2014, 32 (8): 841-850. 10.1200/JCO.2013.52.3019.CrossRefPubMedPubMedCentral Mandrekar SJ, An MW, Meyers J, Grothey A, Bogaerts J, Sargent DJ: Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse. J Clin Oncol. 2014, 32 (8): 841-850. 10.1200/JCO.2013.52.3019.CrossRefPubMedPubMedCentral
Metadata
Title
Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study
Authors
Anne-Claire Toffart
Denis Moro-Sibilot
Sébastien Couraud
Patrick Merle
Maurice Perol
Nicolas Girard
Pierre-Jean Souquet
Bénédicte Mastroianni
Gilbert R Ferretti
Philippe Romand
Patrick Chatellain
Aurélien Vesin
Elisabeth Brambilla
Christian Brambilla
Jean-François Timsit
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2014
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-14-989

Other articles of this Issue 1/2014

BMC Cancer 1/2014 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine