Dynamic modeling in ovarian cancer: An original approach linking early changes in modeled longitudinal CA-125 kinetics and survival to help decisions in early drug development

Gynecologic Oncology

Volumn 133, Issue 3, 2014, Pages 460-466

  Wilbaux, Mélanie ^a   Hénin, Emilie ^a   Oza, Amit ^b   Colomban, Olivier ^a   Pujade Lauraine, Eric ^c   Freyer, Gilles ^a,d   Tod, Michel ^a   You, Benoit ^a,d  

^a UNIVERSITÉ CLAUDE BERNARD LYON 1   (France)

^b PRINCESS MARGARET HOSPITAL   (Canada)

^c HÔTEL DIEU   (France)

^d HOSPICES CIVILS DE LYON   (France)

Author keywords

CA 125; Drug development; Ovarian cancer; Progression free survival

Indexed keywords

CA 125 ANTIGEN; CARBOPLATIN; DOXORUBICIN; PACLITAXEL;

ADULT; AGED; CANCER COMBINATION CHEMOTHERAPY; CANCER PROGNOSIS; CANCER RECURRENCE; CANCER SIZE; CANCER SURVIVAL; CONFERENCE PAPER; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; MATHEMATICAL MODEL; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; OVARY CANCER; PHASE 3 CLINICAL TRIAL; PREDICTION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL;

CA-125; DRUG DEVELOPMENT; OVARIAN CANCER; PROGRESSION-FREE SURVIVAL;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CA-125 ANTIGEN; CARBOPLATIN; DISEASE-FREE SURVIVAL; DOXORUBICIN; DRUG DISCOVERY; FEMALE; HUMANS; KINETICS; MIDDLE AGED; MODELS, STATISTICAL; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PACLITAXEL; POLYETHYLENE GLYCOLS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84901647383     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2014.04.003     Document Type: Conference Paper

References (30)

1. A. Jemal, F. Bray, M.M. Center, J. Ferlay, E. Ward, and D. Forman Global cancer statistics CA Cancer J Clin 61 2011 69 90
2. I. Kola, and J. Landis Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov 3 2004 711 715
3. E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, and R. Ford et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1) Eur J Cancer 45 2009 228 247
4. Y. Wang, C. Sung, C. Dartois, R. Ramchandani, B.P. Booth, and E. Rock et al. Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development Clin Pharmacol Ther 86 2009 167 174
5. L. Claret, P. Girard, P.M. Hoff, E. Van Cutsem, K.P. Zuideveld, and K. Jorga et al. Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics J Clin Oncol 27 2009 4103 4108
6. L. Claret, P. Girard, and J. O'Shaughnessy Model-based predictions of expected anti-tumor response and survival in phase III studies based on phase II data of an investigational agent J Clin Oncol 24 2006 307s [Suppl.; abstr 6025]
7. G.J. Rustin, M. Quinn, T. Thigpen, A. du Bois, E. Pujade-Lauraine, and A. Jakobsen et al. Re: new guidelines to evaluate the response to treatment in solid tumors (ovarian cancer) J Natl Cancer Inst 96 2004 487 488
8. C.K. Lee, M. Friedlander, C. Brown, V.J. Gebski, A. Georgoulopoulos, and I. Vergote et al. Early decline in cancer antigen 125 as a surrogate for progression-free survival in recurrent ovarian cancer J Natl Cancer Inst 103 2011 1338 1342
9. R. Almufti, M. Wilbaux, A. Oza, E. Henin, G. Freyer, M. Tod, O. Colomban, and B. You A critical review of the analytical approaches for circulating tumor biomarker kinetics during treatment Ann Oncol 25 2013 41 56
10. J.L. Xu, J. Commins, E. Partridge, T.L. Riley, P.C. Prorok, and C.C. Johnson et al. Longitudinal evaluation of CA-125 velocity and prediction of ovarian cancer Gynecol Oncol 125 2012 70 74
11. C.W. Drescher, C. Shah, J. Thorpe, K. O'Briant, G.L. Anderson, and C.D. Berg et al. Longitudinal screening algorithm that incorporates change over time in CA125 levels identifies ovarian cancer earlier than a single-threshold rule J Clin Oncol 31 2012 387 392
12. M. Wilbaux, E. Henin, A. Oza, O. Colomban, E. Pujade-Lauraine, G. Freyer, M. Tod, and B. You Prediction of tumour response induced by chemotherapy using modelling of CA-125 kinetics in recurrent ovarian cancer patients Br J Cancer 110 2014 1517 1524
13. E. Pujade-Lauraine, U. Wagner, E. Aavall-Lundqvist, V. Gebski, M. Heywood, and P.A. Vasey et al. Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse J Clin Oncol 28 2010 3323 3329
14. G.E.P. Box, and D.R. Cox An analysis of transformations J R Stat Soc Ser B Methodol 26 1964 211 252
15. E.L. Kaplan, and P. Meier Nonparametric estimation from incomplete observations J Am Stat Assoc 53 1958 457 481
16. D.R. Cox Regression models and life-tables J R Stat Soc Ser B Methodol 34 1972 187 220
17. D. Kleinbaum, and M. Klein Parametric survival models Survival analysis 2012 Springer New York 289 344
18. H. Akaike Information theory and an extension of the maximum likelihood principle Second international symposium on information theory 1973 Akademiai Kiado Budapest
19. S.L. Beal, L.B. Sheiner, A. Boeckmann, and R.J. Bauer NONMEM user's guides (1989-2009) 2009 Icon Development Solutions Ellicott City, MD, USA
20. L. Lindbom, J. Ribbing, and E.N. Jonsson Perl-speaks-NONMEM (PsN) - a Perl module for NONMEM related programming Comput Methods Programs Biomed 75 2004 85 94
21. R Development Core Team R: a language and environment for statistical computing 2010 R Foundation for Statistical Computing Vienna, Austria
22. E.A. Eisenhauer Optimal assessment of response in ovarian cancer Ann Oncol 22 Suppl. 8 2011 viii49 viii51
23. C.K. Lee, R.J. Simes, C. Brown, S. Lord, U. Wagner, and M. Plante et al. Prognostic nomogram to predict progression-free survival in patients with platinum-sensitive recurrent ovarian cancer Br J Cancer 105 2011 1144 1150
24. L. Lindbom, L. Claret, V. Andre, A. Cleverly, D. de Alwis, and R. Bruno A drug-independent tumor size reduction-survival model in advanced ovarian cancer to support early clinical development decisions 2009 ACOP
25. T.G. Karrison, M.L. Maitland, W.M. Stadler, and M.J. Ratain 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 99 2007 1455 1461
26. A. du Bois, J. Herrstedt, A.C. Hardy-Bessard, H.H. Muller, P. Harter, and G. Kristensen et al. Phase III trial of carboplatin plus paclitaxel with or without gemcitabine in first-line treatment of epithelial ovarian cancer J Clin Oncol 28 2010 4162 4169
27. A. du Bois, B. Weber, J. Rochon, W. Meier, A. Goupil, and S. Olbricht et al. Addition of epirubicin as a third drug to carboplatin-paclitaxel in first-line treatment of advanced ovarian cancer: a prospectively randomized gynecologic cancer intergroup trial by the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group and the Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens J Clin Oncol 24 2006 1127 1135
28. J. Pfisterer, B. Weber, A. Reuss, R. Kimmig, A. du Bois, and U. Wagner et al. Randomized phase III trial of topotecan following carboplatin and paclitaxel in first-line treatment of advanced ovarian cancer: a gynecologic cancer intergroup trial of the AGO-OVAR and GINECO J Natl Cancer Inst 98 2006 1036 1045
29. M. Buyse, D.J. Sargent, A. Grothey, A. Matheson, and A. de Gramont Biomarkers and surrogate end points - the challenge of statistical validation Nat Rev Clin Oncol 7 2010 309 317
30. Y. Yano, S.L. Beal, and L.B. Sheiner Evaluating pharmacokinetic/ pharmacodynamic models using the posterior predictive check J Pharmacokinet Pharmacodyn 28 2001 171 192