A.R.CA.D publications

Peer-reviewed papers:

1. de Gramont, Haller DG, Sargent DJ, Tabernero J, Matheson A, Schilsky RL. Toward efficient trials in colorectal cancer: the ARCAD Clinical Trials Program. J ClinOncol. 2010 Feb 1; 28(4):527-30. Epub 2009 Oct 19. PMID:19841311. DOI:10.1200/JCO.2009.25.2544.

2. Buyse M, Sargent DJ, Grothey A, Matheson A, de Gramont A. Biomarkers and surrogate end points – the challenge of statistical validation. Nature Reviews Clinical Oncology 2010; 7:309-317. doi:10.1038/nrclinonc.2010.43

3.  Chibaudel B, Bonnetain F, Shi Q, Buyse M, Tournigand C, Sargent DJ, Allegra CJ, Goldberg RM, de Gramont A. Alternative end points to evaluate a therapeutic strategy in advanced colorectal cancer: evaluation of progression-free survival, duration of disease control, and time to failure of strategy–an Aide et RechercheenCancerologie Digestive Group Study. J ClinOncol. 2011 Nov 1; 29(31):4199-204. Epub 2011 Oct 03.  PMID:21969501. DOI:10.1200/JCO.2011.35.5867.

4. Sargent DJ, Buyse M, Matheson A, Goldberg RM, de Gramont, ARCAD Clinical. The ARCAD clinical trials program: an update and invitation. 2012; 17(2):188-91. Epub 2012 Feb 02.  PMID:22302228. PMCID:3286167. DOI:10.1634/theoncologist.2011-0332.

5.  Buyse M, Michiels S, Sargent DJ, Grothey A, Matheson A & de Gramont A. Integrating biomarkers in clinical trials. Expert Rev. 2011;11(2): 171–182

6. Lieu C, Renfro LA, de Gramont A, Maughan TS, Seymour MT, Saltz L, Goldberg RM, Sargent DJ, Eckhardt SG, Eng C. Association of age with survival in patients with metastatic colorectal cancer: analysis from the ARCAD clinical trials program.J ClinOncol. 2014 Sep 20;32(27):2975-2982. DOI: 10.1200/JCO.2013.54.9329

7. Shi Q, De Gramont A, Grothey A, Zalcberg J, Chibaudel B, Schmoll HJ, Seymour MT, Adams RA, Saltz L, Goldberg RM, Punt CJA, Douillard JY, Hoff PM, Hecht JR, Hurwitz H, Diaz-Rubio E, Porschen R, Tebbutt NC, Fuchs CS, Souglakos J, Falcone A, Tournigand C, Kabbinavar FF, Heinemann V, Van Cutsem E, Bokemeyer C, Buyse ME, Sargent DJ. Individual patient data analysis of progression-free survival versus overall survival as a first-line endpoint for metastatic colorectal cancer in modern randomized trials: Findings from the analysis and research in cancers of the digestive system database.J ClinOncol. Epub2014 Nov 10. DOI: 10.1200/JCO.2014.56.5887

8. de Gramont A, Watson S, Ellis LM, Rodón J, Tabernero J, de Gramont  A, Hamilton SR. Pragmatic issues in biomarker evaluation for targeted therapies in cancer. Nature Reviews Clinical Oncology 2015;12:197–212 doi:10.1038/nrclinonc.2014.202

9. Renfro LA, Loupakis F, Adams RA, Seymour MT, Heinemann V, Schmoll HJ, Douillard JY, Hurwitz H, Fuchs CS, Diaz-Rubio E, Porschen R, Tournigand C, Chibaudel B, Falcone A, Tebbutt NC, Punt CJ, Hecht JR, Bokemeyer C, Van Cutsem E, Goldberg RM, Saltz LB, de Gramont A, Sargent DJ, Lenz HJ.Body Mass Index Is Prognostic in Metastatic Colorectal Cancer: Pooled Analysis of Patients From First-Line Clinical Trials in the ARCAD Database. J ClinOncol. 2016 Jan 10;34(2):144-50. doi: 10.1200/JCO.2015.61.6441. Epub 2015 Oct 26.  PMID:  26503203

10. Franko J, Shi Q, Meyers JP, Maughan TS, Adams RA, Seymour MT, Saltz L, Punt CJA, Koopman M, Tournigand C, Tebbutt NC, Diaz-Rubio E, Souglakos J, Falcone Alfredo, Chibaudel B, Heinemann V, Moen J, De Gramount Aimery, Sargent DJ, Grothey A, for the Analysis and Research in Cancers of the Digestive System (ARCAD) group. Prognosis of patients with peritoneal metastatic colorectal cancer given systemic therapy: an analysis of individual patient data from prospective randomized trials from the analysis and research in cancers of the digestive system (ARCAD) database.Lancet Oncol 2016 Dec; 17 (12):1709-1719 Epub 2016 Oct 12 PMID: 27743922 DOI: 10.1016/S1470-2045(16)30500-9.

11. ARCAD Clinical Trials Program, Renfro LA, Goldberg RM, Grothey A, Sobrero A, Adams R, Seymour MT, Heinemann V, Schmoll HJ, Douillard JY, Hurwitz H, Fuchs CS, Diaz-Rubio E, Porschen R, Tournigand C, Chibaudel B, Hoff PM, Kabbinavar FF, Falcone A, Tebbutt NC, Punt CJA, Hecht JR, Souglakos J, Bokemeyer C, Van Cutsem E, Saltz L, de Gramont A, Sargent DJ. Clinical Calculator for Early Mortality in Metastatic Colorectal Cancer: An Analysis of Patients From 28 Clinical Trials in the Aide et RechercheenCancerologie Digestive Database. J ClinOncol 2017Jun 10; 35 (17):1929-1937 Epub 2017 Apr 17 PMID:28414610 DOI:10.1200/JCO.2016.71.5771

12. Bleiberg H, Decoster G, de Gramont A, Rougier P, Sobrero A, Benson A, Chibaudel B, Douillard JY, Eng C, Fuchs C, Fujii M, Labianca R, Larsen AK, Mithchell E, Schmool HJ, Sprumont D, Zalcberg J. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD group. Annals of Oncology 0:922-930, 2017 doi:10.1093/annonc/mdx050

13. Bonnetain F, Borg C, Adams RR, Ajani JA, Benson A, Bleiberg H, Chibaudel B, Diaz-Rubio E, Douillard JY, Fuchs CS, Giantonio BJ, Goldberg R, Heinemann V, Koopman M, Labianca R, Larsen AK, Maughan T, Mitchell E, Peeters M, Punt CJA, Schmoll HJ, Tournigand C, de Gramont A. How health-related quality of life assessment should be used in advanced colorectal cancer clinical trials. Ann Oncol. 2017 Apr 18

14. Sjoquist KM, Renfro LA, Simes RJ, Tebbutt NC, Clarke S, Seymour MT, Adams R, Maughan TS, Saltz L, Goldberg RM, Schmoll HJ, Van Cutsem E, Douillard JY, Hoff PM, Hecht JR, Tournigand C, Punt CJA, Koopman M, Hurwitz H, Heinemann V, Falcone A, Porschen R, Fuchs C, Diaz-Rubio E, Aranda E, Bokemeyer C, Souglakos I, Kabbinavar FF, Chibaudel B, Meyers JP, Sargent DJ, de Gramont A, Zalcberg JR, Fondation Aide et RechercheenCancerologie Digestive Group.  Personalizing Survival Predictions in Advanced Colorectal Cancer: The ARCAD Nomogram Project. J Natl Cancer Inst. 2017 Dec 18 [Epub ahead of print] PMID: 29267900 DOI: https://doi.org/1009310.1093/jnci/djx253

15. van Rooijen KL, Shi Q, Goey KKH, Meyers J, Heinemann V, Diaz-Rubio E, Aranda E, Falcone A, Green E, de Gramont A, Sargent DJ, Punt CJA, Koopman M. Prognostic value of primary tumour resection in synchronous metastatic colorectal cancer: Individual patient data analysis of first-line randomised trials from the ARCAD database. Eur J Cancer. 2018 Jan 17; 91:99-106 [Epub ahead of print] PMID: 29353165 DOI: 10.1016/j.ejca.2017.12.014

Letters:

1. Buyse M, Sargent DJ, Goldberg RM, de Gramont A, ARCAD Clinical Trials Program. The ARCAD advanced colorectal cancer database–open for business.  Ann Oncol. 2012 Jan; 23(1):281-2. Epub 2011 Nov 21.  PMID:22104572. DOI:10.1093/annonc/mdr547.

Abstracts:

1. Lieu C, Renfro L, De Gramont A, Maughan TS, Seymour MT, Saltz L, Goldberg RM, Sargent D, Eckhardt SG, Eng C. The impact of young age on survival in patients with metastatic colorectal cancer: analysis from the ARCAD clinical trials program.Eur J Cancer. 2013 Sep; 49:S483.

2. Sommeijer DW, Shi Q, Meyer J, Sjoquist KM, Hoff PM, Seymour MT, Cassidy J, Goldberg R, Douillard JY, Hecht JR, Hurwitz H, Tournigand C, Tebbutt NC, Aranda E, Souglakos J, Kabbinavar FF, Chibaudel B, De Gramont A, Sargent DJ, Zalcberg J. Prognostic value of early objective tumor response (EOTR) to first line systemic therapy in metastatic colorectal cancer (mCRC): individual patient data (IPD) meta-analysis of randomized trials from the ARCAD database. Journal Of Clinical Oncology (meeting abstract). 2013May

3. Shi Q, De Gramont A, Buyse ME, Grothey A, Schmoll HJ, Seymour MT, Adams RA, Saltz L, Goldberg RM, Punt CJA, Douillard JY, Hecht JR, Hurwitz H, Diaz-Rubio E, Porschen R, Tebbutt NC, Fuchs CS, Souglakos J, Falcone A, Sargent DJ. Individual patient data (IPD) analysis of progression-free survival (PFS) versus overall survival (OS) as an endpoint for metastatic colorectal cancer (mCRC) in modern trials: Findings from the 16,700 patients (pts) ARCAD database. J ClinOncol. 2013; 31. Abstract no. 3533.

4. Sommeijer DW, Shi Q, Saad ED, Coart E, Buyse ME, Burzykowski T, Meyers JP, Maughan T, Adams RA, Seymour MT, SaltzL, Goldberg RM, Douillard J-Y, Schmoll H-J, Punt CJA, Tournigand C, Chibaudel B, De Gramont A, Sargent DJ, Zalcberg JR, for the ARCAD group. Early predictors of prolonged overall survival (OS) in patients (pts) on first-line chemotherapy (CT) for metastatic colorectal cancer (mCRC): An ARCAD study with individual patient data (IPD) on 10,962 pts. ASCO 2014

5. Saad ED, Coart E, Sommeijer, Shi Q, Zalcberg JR, Burzykowski T, Meyers JP, Hoff PM, Hecht JR,Hurwitz H, Tol J, Tebbutt NC, Fuchs CS, Diaz-Rubio E, Souglakos J, Falcone A, Kabbinavar FF, Sargent DJ, De Gramont A, Buyse ME, for the ARCAD Group. Early predictors of improved long-term outcomes in first-line antiangiogenics plus chemotherapy (anti-ANG/CT) in metastatic colorectal cancer (mCRC): Analysis of individual patient (pt) data from the ARCAD database. ASCO 2014

6.Renfro LA, Loupakis F, Adams RA, Seymour MT, Schmoll H-J, Douillard J-Y, Hurwitz H, Fuchs CS, Diaz-Rubio E, Porschen R, Tournigand C, Falcone A, Tebbutt NC, Hecht JR, Punt CJA, Goldberg RM, Saltz L, De Gramont A, Sargent DJ, Lenz H-J, ARCAD Clinical Trials Program. Body mass index (BMI) as prognostic in metastatic colorectal cancer (mCRC): A pooled analysis of 21 first-line trials in the ARCAD database.ASCO 2014J ClinOncol 32:5s, 2014 (suppl; abstr 3537)

7.Sjoquist KM, Renfro LA, Simes J, Tebbutt NC, Clarke SJ, Meyers JP, Gonsalves WI, Adams R, Seymour MT, Saltz L, Schmoll H, Sargent DJ, De Gramont A, Zalcberg JR. Nomograms for overall survival (os) and progression-free survival (pfs) in metastatic colorectal cancer (mcrc): construction from 19,678 arcad patients. J ClinOncol. 2015 Jan 20; 33(3).

8. Sjoquist KM, Bokemeyer C, Renfro LA, Simes J, Tebbutt NC, Clarke SJ, Adams R, Punt CJA, Van Cutsem E, Douillard JY, Hecht JR, Heinemann V, Sougklakos I, Diaz-Rubio E, Porschen R, Meyers JP, Gonsalves WI, Sargent DJ, De Gramont A, Zalcberg JR. Calculators for overall survival (os) and progression-free survival (pfs) in metastatic colorectal cancer (mcrc): construction from 19,678 arcad patients. J ClinOncol. 2015 May 20; 33(15).

9. Coart E, Saad ED, Shi Q, Sommeijer DW, Zalcberg JR, Maughan T, Goldberg RM, Schmoll HJ, Punt CJA, Van Cutsem E, Douillard JY, Hoff PM, Tebbutt NC, Fuchs CS, Falcone A, Tournigand C, De Gramont A, Sargent DJ, Burzykowski T, Buyse ME. Trial-level association between response-based endpoints (rbes) and progression-free (pfs)/overall survival (os) in first-line therapy for metastatic colorectal cancer (mcrc) in the arcad database. J ClinOncol. 2015 Jan 20; 33(3).

10. Franko J, Shi Q, Meyers JP, Heinemann V, Falcone A, Tebbutt NC, Maughan T, Seymour M, Saltz L, Tournigand C, Diaz-Rubio E, Sougklakos I, Chibaudel B, Moen J, De Gramont A, Adams RA, Sargent DJ, Grothey A. Prognostic value of isolated peritoneal versus other metastatic sites in colorectal cancer (crc) patients treated by systemic chemotherapy: findings from 9,265 pts in the arcad database Journal Of Clinical Oncology 2016 Feb 1; 34 (4)

11. Koopman M, Shi Q, Goey KKH, Green E, Heinemann V, Diaz-Rubio E, Aranda E, Falcone A, De Gramont A, Sargent DJ, Punt CJA. Prognostic value of primary tumor resection in synchronous metastatic colorectal cancer (mcrc): individual patient data (ipd) analysis of first-line randomized trials from the arcad database Journal Of Clinical Oncology 2016 Feb 1; 34 (4)

12. Henriques J, Vernerey D, de Gramont A, Chibaudel B, Van Cutsem E, Falcone A, Goldberg RM, Shi Q, Bonnetain F, Shmueli E. Prognosis of lung metastases in patients with metastatic colorectal cancer: an arcadmeta analysis Annals Of Oncology 2016 Jun; 27:122

13. Salem ME, Yin J, Renfro LA, Weinberg BA, Maughan T, Adams R, Van E, Falcone A, Tebbutt NC, Seymour MT, Diaz-Rubio E, Aranda E, Bokemeyer C, Heinemann V, de A, Grothey A, Marshall J, Sargent DJ. Rectal versus left-sided colon cancers: clinicopatholigical differences observed in a pooled analysis of 4,182 patients enrolled to 8 clinical trials from the ARCAD Database J Clin Oncol.2017;35:(suppl 4S) Abstract no.675.

14.   Leal AD, Ou F-S, De Gramont A, Pederson L, Sobrero AF, Peeters M, Arnold D, Pitot HC, Rothenberg ML, Giantonio BJ, Van Cutsem E, Sargent DJ, and Grothey A. Outcomes in the second line treatment of metastatic colorectal cancer (mCRC): Findings from 6,462 patients (pts) in the ARCAD database.Journal of Clinical Oncology 2017 35:4_suppl, 757-757. DOI: 10.1200/JCO.2017.35.4_suppl.757

15. Zalcberg JR, Shi Q, Ferraro DA, Meyers JP, Saltz L, Goldberg R, Van Cutsem E, Hurwitz H, Fuchs C, Bokemeyer C, Sargent DJ, De Gramont A, Price TJ, and Adams R.Impact of overall severity of adverse events (AEs) on long term outcomes in metastatic colorectal cancer (mCRC) patients (pts) treated with first line systemic chemotherapy: Findings from 3,971 pts in the ARCAD database. J Clin Oncol.2017;35:no. 15_suppl (May 2017) 3582-3582.DOI: 10.1200/JCO.2017.35.15_suppl.3582

16. Ou F-S, Hubbard JM, Kasi PM, Dixon J, Van Cutsem E, Saltz L, Schmoll H-J, Punt CJA, Goldberg RM, Hoff P, Douillard J-Y, Hecht JR, Hurwitz H, Bokemeyer C, Fuchs C, Diaz-Rubio E, Sargent DJ, De Gramont A, Shi Q, Grothey A, and ARCAD. Heterogeneity in early lesion changes on treatment as a marker of poor prognosis in patients (pts) with metastatic colorectal cancer (mCRC) treated with first line systemic chemotherapy ± biologic: Findings from 9,092 pts in the ARCAD database.Journal of Clinical Oncology 2017 35:15_suppl, 3535-3535. DOI: 10.1200/JCO.2017.35.15_suppl.3535

17.  Leal AD, Ou F-S, Pederson L, Sobrero AF, RothenbergML, Van Cutsem E, Peeters M, Pitot HC, Punt CJA, Arnold D, Giantonio BJ, Tournigand C, Dawood S, De Gramont A, Sargent DJ, and Grothey A. Assessing outcome differences in the second line treatment of metastatic colorectal cancer (mCRC): An ARCAD analysis comparing sequence after first line trials (SAFL) and dedicated second line trials (DSLT). Journal of Clinical Oncology 2017 35:15_suppl, 3554-3554. DOI: 10.1200/JCO.2017.35.15_suppl.3554

18.  Ou FS, Lou Y, Van Cutsem E, Saltz L, Schmoll H-J, Goldberg RM, Hoff P, Douillard J-Y, Hecht JR, Hurwitz H, Cornelis Punt JA, Bokemeyer C, Fuchs CS, Diaz-Rubio E, Tebbut N, Falcone A, Kabbinavar FF, De Gramont A, Grothey A, Shi Q. Evaluation of lesion-based response at 12 weeks (LBR12) of treatment (Rx) in metastatic colorectal cancer (mCRC): Findings from 9,092 patients (pts) in the ARCAD database. J ClinOncol 36, 2018 (suppl 4S; abstr 612)

19. Danielle Angela Ferraro, John Raymond Zalcberg, Qian Shi, Jeffrey P. Meyers, Matthew T. Seymour, Leonard B. Saltz, Tim Maughan, Richard M. Goldberg, Eric Van Cutsem, Volker Heinemann, Herbert Hurwitz, Alfredo Falcone, Eduardo Diaz-Rubio, Benoist Chibaudel, Charles S. Fuchs, Rainer Porschen, Carsten Bokemeyer, Aimery De Gramont, Tim Price, Richard Adams. Associations of incidence of common adverse events (AEs) and survival outcomes in metastatic colorectal cancer (mCRC) patients (pts) treated with first line chemotherapy: Findings from 9,812 pts in the ARCAD database. J ClinOncol 36, 2018 (suppl 4S; abstr 612)