A critical review of the analytical approaches for circulating tumor biomarker kinetics during treatment

Annals of Oncology

Volumn 25, Issue 1, 2014, Pages 41-56

  Almufti, R ^a,b   Wilbaux, M ^c,d   Oza, A ^e   Henin, E ^c,d   Freyer, G ^a,c,d   Tod, M ^c,d   Colomban, O ^c,d   You, B ^a,c,d  

^a CENTRE HOSPITALIER LYON SUD   (France)

^b Ministry of Education Saudi Arabia   (Saudi Arabia)

^c UNIVERSITÉ LYON 1   (France)

^d UNIVERSITÉ DE LYON   (France)

^e PRINCESS MARGARET HOSPITAL   (Canada)

Author keywords

Kinetics; Predictive factor; Prostate adenoma; Prostate cancer; Tumor biomarkers

Indexed keywords

CA 125 ANTIGEN; CA 15-3 ANTIGEN; CA 19-9 ANTIGEN; CARCINOEMBRYONIC ANTIGEN; CHORIONIC GONADOTROPIN; CIRCULATING TUMOR BIOMARKER; PROSTATE SPECIFIC ANTIGEN; TUMOR MARKER; UNCLASSIFIED DRUG;

ANALYTIC METHOD; ANALYTICAL PARAMETERS; AREA UNDER THE CURVE; BASELINE CONCENTRATION; CANCER CHEMOTHERAPY; CANCER PROGNOSIS; CHEMICAL ANALYSIS; CIRCULATING TUMOR CELL; CUT OFF AT TIME T; EMPIRICAL MODEL; HALF LIFE TIME; HUMAN; INTERINDIVIDUAL VARIABILITY; INTRAINDIVIDUAL VARIABILITY; MATHEMATICAL MODEL; MECHANISTIC MODEL; NADIR VALUE; NON LINEAR EFFECT MODEL; NORMAL VALUE; POPULATION KINETICS APPROACH; PREDICTIVE VALUE; PRIORITY JOURNAL; REFERENCE VALUE; REVIEW; STANDARDIZATION; TIME SERIES ANALYSIS; TIME TO EVENT APPROACH; TIME TO NADIR; TIME TO NORMALIZATION; TREATMENT RESPONSE; TUMOR BIOMARKER KINETIC ANALYSIS;

KINETICS; PREDICTIVE FACTOR; PROSTATE ADENOMA; PROSTATE CANCER; TUMOR BIOMARKERS;

ADENOMA; AREA UNDER CURVE; HUMANS; KINETICS; MALE; MODELS, BIOLOGICAL; PROSTATIC NEOPLASMS; TUMOR MARKERS, BIOLOGICAL;

EID: 84894154060     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdt382     Document Type: Review

References (187)

1. Sturgeon C. Practice guidelines for tumor marker use in the clinic. Clin Chem 2002; 48: 1151-1159.
2. Sturgeon CM, Duffy MJ, Stenman UH et al. National Academy of Clinical Biochemistry laboratory medicine practice guidelines for use of tumor markers in testicular, prostate, colorectal, breast, and ovarian cancers. Clin Chem 2008; 54: e11-e79.
3. McDermott U, Downing JR, Stratton MR. Genomics and the continuum of cancer care. N Engl J Med 2011; 364: 340-350.
4. Olmos D, Brewer D, Clark J et al. Prognostic value of blood mRNA expression signatures in castration-resistant prostate cancer: a prospective, two-stage study. Lancet Oncol 2012; 13: 1114-1124.
5. Ligthart ST, Coumans FA, Attard G et al. Unbiased and automated identification of a circulating tumour cell definition that associates with overall survival. PLoS One 2011; 6: e27419.
6. Scher H, Heller G, Molina A et al. Evaluation of circulating tumor cell (CTC) enumeration as an efficacy response biomarker of overall survival (OS) in metastatic castration-resistant prostate cancer (mCRPC): Planned final analysis (FA) of COU-AA-301, a randomized double-blind, placebo-controlled phase III study of abiraterone acetate (AA) plus low-dose prednisone (P) post docetaxel. Proceedings of 2011 American Society Clinical Oncology Annual Meeting. Abs. LBA4517^.
7. Danila DC, Fleisher M, Scher HI. Circulating tumor cells as biomarkers in prostate cancer. Clin Cancer Res 2011; 17: 3903-3912.
8. Diehl F, Schmidt K, Choti MA et al. Circulating mutant DNA to assess tumor dynamics. Nat Med 2008; 14: 985-990.
9. Park YJ, Youk EG, Choi HS et al. Experience of 1446 rectal cancer patients in Korea and analysis of prognostic factors. Int J Colorectal Dis 1999; 14: 101-106.
10. Wang WS, Lin JK, Chiou TJ et al. Preoperative carcinoembryonic antigen level as an independent prognostic factor in colorectal cancer: Taiwan experience 2. Jpn J Clin Oncol 2000; 30: 12-16.
11. Paramasivam S, Tripcony L, Crandon A et al. Prognostic importance of preoperative CA-125 in International Federation of Gynecology and Obstetrics stage I epithelial ovarian cancer: an Australian multicenter study. J Clin Oncol 2005; 23: 5938-5942.
12. Vorgias G, Iavazzo C, Savvopoulos P et al. Can the preoperative Ca-125 level predict optimal cytoreduction in patients with advanced ovarian carcinoma? A single institution cohort study. Gynecol Oncol 2009; 112: 11-15.
13. Zorn KK, Tian C, McGuire WP et al. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer 2009; 115: 1028-1035.
14. Jeng KS, Sheen IS, Tsai YC. Does the presence of circulating hepatocellular carcinoma cells indicate a risk of recurrence after resection? Am J Gastroenterol 2004; 99: 1503-1509.
15. Voorzanger-Rousselot N, Garnero P. Biochemical markers in oncology. Part I: molecular basis. Part II: clinical uses. Cancer Treat Rev 2007; 33: 230-283.
16. Clinical practice guidelines for the use of tumor markers in breast and colorectal cancer. Adopted on May 17, 1996 by the American Society of Clinical Oncology J Clin Oncol 1996; 14: 2843-2877.
17. Gion M, Boracchi P, Dittadi R et al. Prognostic role of serum CA15.3 in 362 node-negative breast cancers. An old player for a new game 5. Eur J Cancer 2002; 38: 1181-1188.
18. Uehara M, Kinoshita T, Hojo T et al. Long-term prognostic study of carcinoembryonic antigen (CEA) and carbohydrate antigen 15-3 (CA 15-3) in breast cancer. Int J Clin Oncol 2008; 13: 447-451.
19. Kattan MW, Wheeler TM, Scardino PT. Postoperative nomogram for disease recurrence after radical prostatectomy for prostate cancer. J Clin Oncol 1999; 17: 1499-1507.
20. Lilja H, Ulmert D, Vickers AJ. Prostate-specific antigen and prostate cancer: prediction, detection and monitoring. Nat Rev Cancer 2008; 8: 268-278.
21. Han M, Partin AW, Zahurak M et al. Biochemical (prostate specific antigen) recurrence probability following radical prostatectomy for clinically localized prostate cancer. J Urol 2003; 169: 517-523.
22. Eche N, Pichon MF, Quillien V et al. [Standards, options and recommendations for tumor markers in colorectal cancer]. Bull Cancer 2001; 88: 1177-1206.
23. Kouri M, Nordling S, Kuusela P et al. Poor prognosis associated with elevated serum CA 19-9 level in advanced colorectal carcinoma, independent of DNA ploidy or SPF 1. Eur J Cancer 1993; 29A: 1691-1696.
24. Hess V, Glimelius B, Grawe P et al. CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial 1. Lancet Oncol 2008; 9: 132-138.
25. Steinberg W. The clinical utility of the CA 19-9 tumor-associated antigen 2. Am J Gastroenterol 1990; 85: 350-355.
26. Reni M, Cereda S, Balzano G et al. Carbohydrate antigen 19-9 change during chemotherapy for advanced pancreatic adenocarcinoma. Cancer 2009; 115: 2630-2639.
27. Boeck S, Haas M, Laubender RP et al. Application of a time-varying covariate model to the analysis of CA 19-9 as serum biomarker in patients with advanced pancreatic cancer. Clin Cancer Res 16: 986-994.
28. International Germ Cell Consensus Classification: a prognostic factor-based staging system for metastatic germ cell cancers. International Germ Cell Cancer Collaborative Group. J Clin Oncol 1997; 15: 594-603.
29. FIGO staging for gestational trophoblastic neoplasia 2000. FIGO Oncology Committee. Int J Gynaecol Obstet 2002; 77: 285-287.
30. Fitzpatrick JM, Banu E, Oudard S. Prostate-specific antigen kinetics in localized and advanced prostate cancer. BJU Int 2009; 103: 578-587.
31. Pierga JY, Hajage D, Bachelot T et al. High independent prognostic and predictive value of circulating tumor cells compared with serum tumor markers in a large prospective trial in first-line chemotherapy for metastatic breast cancer patients. Ann Oncol 2012; 23: 618-624.
32. Wallwiener M, Hartkopf AD, Baccelli I et al. The prognostic impact of circulating tumor cells in subtypes of metastatic breast cancer. Breast Cancer Res Treat 2012.
33. Fasching PA, Gumbrecht W, Fehm TN et al. 4EVER: assessment of circulating tumor cells with a novel, filtration-based method, in a phase IIIb multicenter study for postmenopausal, HER2-negative, estrogen receptor-positive, advanced breast cancer patients. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 591.
34. Igawa S, Sasaki J, Masuda N. Circulating tumor cells as a prognostic factor in patients with small cell lung cancer. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 7592.
35. Grande E, Casanovas O, Earl J et al. sVEGFR2 and circulating tumor cells to predict for the efficacy of pazopanib in neuroendocrine tumors (NETs): PAZONET subgroup analysis. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 4140.
36. Coumans FA, Ligthart ST, Terstappen LW. Interpretation of changes in circulating tumor cell counts. Transl Oncol 2012; 5: 486-491.
37. Khan MS, Kirkwood A, Tsigani T et al. Circulating tumor cells as prognostic markers in neuroendocrine tumors. J Clin Oncol 2013; 31: 365-372.
38. Khoja L, Lorigan P, Zhou C et al. Biomarker utility of circulating tumor cells in metastatic cutaneous melanoma. J Invest Dermatol 2013; 133: 1582-1590.
39. Aggarwal C, Meropol NJ, Punt CJ et al. Relationship among circulating tumor cells, CEA and overall survival in patients with metastatic colorectal cancer. Ann Oncol 2013; 24: 420-428.
40. Bidard FC, Huguet F, Louvet C et al. Circulating tumor cells in locally advanced pancreatic adenocarcinoma: the ancillary CirCe 07 study to the LAP 07 trial. Ann Oncol 2013.
41. Olmos D, Arkenau HT, Ang JE et al. Circulating tumour cell (CTC) counts as intermediate end points in castration-resistant prostate cancer (CRPC): a singlecentre experience. Ann Oncol 2009; 20: 27-33.
42. Tie J, Kinde I, Wong H et al. Massively parallel sequencing (MPS) of circulating DNA in patients with metastatic colorectal cancer (mCRC): prognostic significance and early changes during chemotherapy (CT). In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 11015.
43. Schadendorf D, Flaherty K, Hersey P et al. Tumor-specific circulating cell-free DNA (cfDNA) to predict clinical outcome in BRAF V600 mutation-positive melanoma patients (pts) treated with the MEK inhibitor trametinib (T) or chemotherapy (C). In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 9020.
44. Von Bubnoff N, Kerle I, Specht K et al. Detection of mutant-free circulating tumor DNA in the plasma of patients with gastrointestinal stromal tumor (GIST) harboring activating mutations of C-Kit or PDGFRA. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 10508.
45. Szpechcinski A, Chorostowska-Wynimko J, Kupis W et al. Quantitative analysis of free-circulating DNA in plasma of patients with resectable NSCLC. Expert Opin Biol Ther 2012; 12(Suppl 1): S3-S9.
46. Philipp AB, Stieber P, Nagel D et al. Prognostic role of methylated free circulating DNA in colorectal cancer. Int J Cancer 131: 2308-2319.
47. Tian C, Markman M, Zaino R et al. CA-125 change after chemotherapy in prediction of treatment outcome among advanced mucinous and clear cell epithelial ovarian cancers: a Gynecologic Oncology Group study. Cancer 2009; 115: 1395-1403.
48. Rocconi RP, Matthews KS, Kemper MK et al. The timing of normalization of CA-125 levels during primary chemotherapy is predictive of survival in patients with epithelial ovarian cancer. Gynecol Oncol 2009; 114: 242-245.
49. Wong C, Dai ZM, Lele SB et al. Comparison of CA 125 after three courses of chemotherapy and results of second-look surgery. Eur J Gynaecol Oncol 2000; 21: 70-73.
50. Le T, Faught W, Hopkins L et al. Importance of CA125 normalization during neoadjuvant chemotherapy followed by planned delayed surgical debulking in patients with epithelial ovarian cancer. J Obstet Gynaecol Can 2008; 30: 665-670.
51. Tate S, Hirai Y, Takeshima N et al. CA125 regression during neoadjuvant chemotherapy as an independent prognostic factor for survival in patients with advanced ovarian serous adenocarcinoma. Gynecol Oncol 2005; 96: 143-149.
52. Hoskins PJ, Le N, Correa R. CA 125 normalization with chemotherapy is independently predictive of survival in advanced endometrial cancer. Gynecol Oncol 2010.
53. Vizcarra E, Lluch A, Cibrian R et al. Value of CA 15.3 in breast cancer and comparison with CEA and TPA: a study of specificity in disease-free follow-up patients and sensitivity in patients at diagnosis of the first metastasis. Breast Cancer Res Treat 1996; 37: 209-216.
54. Spiridonidis CH, Laufman LR, Stydnicki KA et al. Decline of posttreatment tumor marker levels after therapy of nonsmall cell lung cancer. A useful outcome predictor. Cancer 1995; 75: 1586-1593.
55. Seckl MJ, Sebire NJ, Berkowitz RS. Gestational trophoblastic disease. Lancet 2010; 376: 717-729.
56. Rose PG, Baker S, Fournier L et al. Serum squamous cell carcinoma antigen levels in invasive cervical cancer: prediction of response and recurrence. Am J Obstet Gynecol 1993; 168: 942-946.
57. Serrano MJ, Rovira PS, Martinez-Zubiaurre I et al. Dynamics of circulating tumor cells in early breast cancer under neoadjuvant therapy. Exp Ther Med 2012; 4: 43-48.
58. Riedinger JM, Wafflart J, Ricolleau G et al. CA 125 half-life and CA 125 nadir during induction chemotherapy are independent predictors of epithelial ovarian cancer outcome: results of a French multicentric study. Ann Oncol 2006; 17: 1234-1238.
59. Kang S, Seo SS, Park SY. Nadir CA-125 level is an independent prognostic factor in advanced epithelial ovarian cancer. J Surg Oncol 2009; 100: 244-247.
60. Prat A, Parera M, Peralta S et al. Nadir CA-125 concentration in the normal range as an independent prognostic factor for optimally treated advanced epithelial ovarian cancer. Ann Oncol 2008; 19: 327-331.
61. Liu PY, Alberts DS, Monk BJ et al. An early signal of CA-125 progression for ovarian cancer patients receiving maintenance treatment after complete clinical response to primary therapy. J Clin Oncol 2007; 25: 3615-3620.
62. Critz FA, Levinson AK, Williams WH et al. The PSA nadir that indicates potential cure after radiotherapy for prostate cancer. Urology 1997; 49: 322-326.
63. Ogawa K, Nakamura K, Sasaki T et al. Postoperative radiotherapy for localized prostate cancer: clinical significance of nadir prostate-specific antigen value within 12 months. Anticancer Res 2009; 29: 4605-4613.
64. Critz FA, Williams WH, Holladay CT et al. Post-treatment PSA < or = 0.2 ng/mL defines disease freedom after radiotherapy for prostate cancer using modern techniques. Urology 1999; 54: 968-971.
65. Doyle KL, Roach M, Weinberg V et al. What does the post radiotherapy prostate specific antigen (PSA) nadir tell us about progression-free-survival in patients with localized cancer. Int J Radiat Oncol Biol Phys 51.
66. Buyyounouski MK. Radiotherapy: PSA nadir predicts long-term mortality. Nat Rev Clin Oncol 2010; 7: 188-190.
67. Moreira DM, Presti JC, Jr, Aronson WJ et al. Postoperative prostate-specific antigen nadir improves accuracy for predicting biochemical recurrence after radical prostatectomy: results from the Shared Equal Access Regional Cancer Hospital (SEARCH) and Duke Prostate Center databases. Int J Urol 2010.
68. Stephenson AJ, Kattan MW, Eastham JA et al. Defining biochemical recurrence of prostate cancer after radical prostatectomy: a proposal for a standardized definition. J Clin Oncol 2006; 24: 3973-3978.
69. Hong SK, Park HZ, Lee WK et al. Prognostic significance of undetectable ultrasensitive prostate-specific antigen nadir after radical prostatectomy. Urology 2010; 76: 723-727.
70. Hori S, Jabbar T, Kachroo N et al. Outcomes and predictive factors for biochemical relapse following primary androgen deprivation therapy in men with bone scan negative prostate cancer. J Cancer Res Clin Oncol 2010.
71. Alexander A, Crook J, Jones S et al. Is biochemical response more important than duration of neoadjuvant hormone therapy before radiotherapy for clinically localized prostate cancer? An analysis of the 3- versus 8-month randomized trial. Int J Radiat Oncol Biol Phys 2010; 76: 23-30.
72. Morote J, Trilla E, Esquena S et al. Nadir prostate-specific antigen best predicts the progression to androgen-independent prostate cancer. Int J Cancer 2004; 108: 877-881.
73. Soga N, Arima K, Sugimura Y. Undetectable level of prostate specific antigen (PSA) nadir predicts PSA biochemical failure in local prostate cancer with delayed-combined androgen blockade. Jpn J Clin Oncol 2008; 38: 617-622.
74. Lin GW, Yao XD, Zhang SL et al. Prostate-specific antigen half-life: a new predictor of progression-free survival and overall survival in Chinese prostate cancer patients. Asian J Androl 2009; 11: 443-450.
75. D'Amico AV, Chen MH, de Castro M et al. Surrogate endpoints for prostate cancer-specific mortality after radiotherapy and androgen suppression therapy in men with localised or locally advanced prostate cancer: an analysis of two randomised trials. Lancet Oncol 13: 189-195.
76. Freedland SJ, Sutter ME, Dorey F et al. Defining the ideal cutpoint for determining PSA recurrence after radical prostatectomy. Prostate-specific antigen. Urology 2003; 61: 365-369.
77. Krivak TC, Tian C, Rose GS et al. A Gynecologic Oncology Group Study of serum CA-125 levels in patients with stage III optimally debulked ovarian cancer treated with intraperitoneal compared to intravenous chemotherapy: an analysis of patients enrolled in GOG 172. Gynecol Oncol 2009; 115: 81-85.
78. Kondo N, Murakami Y, Uemura K et al. Prognostic impact of perioperative serum CA 19-9 levels in patients with resectable pancreatic cancer. Ann Surg Oncol 2010; 17: 2321-2329.
79. Berger AC, Garcia M, Jr, Hoffman JP et al. Postresection CA 19-9 predicts overall survival in patients with pancreatic cancer treated with adjuvant chemoradiation: a prospective validation by RTOG 9704. J Clin Oncol 2008; 26: 5918-5922.
80. You B, Pollet-Villard M, Fronton L et al. Predictive values of hCG clearance for risk of methotrexate resistance in low-risk gestational trophoblastic neoplasias. Ann Oncol 2010; 21: 1643-1650.
81. van Trommel NE, Massuger LF, Schijf CP et al. Early identification of resistance to first-line single-agent methotrexate in patients with persistent trophoblastic disease. J Clin Oncol 2006; 24: 52-58. Volume 2
82. Kerkmeijer LG, Thomas CM, Harvey R et al. External validation of serum hCG cutoff levels for prediction of resistance to single-agent chemotherapy in patients with persistent trophoblastic disease. Br J Cancer 2009; 100: 979-984.
83. Savage P, Seckl M, Short D. Practical issues in the management of low-risk gestational trophoblast tumors. J Reprod Med 2008; 53: 774-780.
84. Micha JP, Goldstein BH, Rettenmaier MA et al. Clinical utility of CA-125 for maintenance therapy in the treatment of advanced stage ovarian carcinoma. Int J Gynecol Cancer 2009; 19: 239-241.
85. Scher HI, Smith MR, Sweeney C et al. An exploratory analysis of bone scan lesion area (BSLA), circulating tumor cell (CTC) change, pain reduction, and overall survival (OS) in patients (pts) with castration-resistant prostate cancer (CRPC) treated with cabozantinib (cabo): updated results of a phase II nonrandomized expansion (NRE) cohort. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 5026.
86. Tinhofer I, Konschak R, Stromberger C et al. Postoperative detection of circulating EGFR transcripts as a surrogate marker for circulating tumor cells to predict tumor recurrence after adjuvant radio(chemo-)therapy in locally advanced squamous cell carcinoma of the head and neck (LASCCHN). In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 6014.
87. Sakamori Y, Hak Kim Y, Yoshioka H et al. Circulating tumor cells as a prognostic marker in metastatic non-small-cell lung cancer patients receiving chemotherapy. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 11041.
88. Budd GT, Cristofanilli M, Ellis MJ et al. Circulating tumor cells versus imaging- predicting overall survival in metastatic breast cancer. Clin Cancer Res 2006; 12: 6403-6409.
89. Hayes DF, Cristofanilli M, Budd GT et al. Circulating tumor cells at each follow-up time point during therapy of metastatic breast cancer patients predict progression-free and overall survival. Clin Cancer Res 2006; 12: 4218-4224.
90. Sturgeon CM, Lai LC, Duffy MJ. Serum tumour markers: how to order and interpret them. BMJ 2009; 339: b3527.
91. Rustin GJ, Nelstrop AE, McClean P et al. Defining response of ovarian carcinoma to initial chemotherapy according to serum CA 125. J Clin Oncol 1996; 14: 1545-1551.
92. Bhoola SM, Coleman RL, Herzog T et al. Retrospective analysis of weekly topotecan as salvage therapy in relapsed ovarian cancer. Gynecol Oncol 2004; 95: 564-569.
93. Bodnar L, Wcislo G, Nasilowska A et al. Salvage therapy with topotecan in heavily pretreated ovarian cancer patients. J Cancer Res Clin Oncol 2009; 135: 815-821.
94. Riedinger JM, Bonnetain F, Basuyau JP et al. Change in CA 125 levels after the first cycle of induction chemotherapy is an independent predictor of epithelial ovarian tumour outcome. Ann Oncol 2007; 18: 881-885.
95. Kurebayashi J, Nishimura R, Tanaka K et al. Significance of serum tumor markers in monitoring advanced breast cancer patients treated with systemic therapy: a prospective study. Breast Cancer 2004; 11: 389-395.
96. Cheung KL, Evans AJ, Robertson JF. The use of blood tumour markers in the monitoring of metastatic breast cancer unassessable for response to systemic therapy. Breast Cancer Res Treat 2001; 67: 273-278.
97. Robertson JF, Pearson D, Price MR et al. Objective measurement of therapeutic response in breast cancer using tumour markers. Br J Cancer 1991; 64: 757-763.
98. Ziske C, Schlie C, Gorschluter M et al. Prognostic value of CA 19-9 levels in patients with inoperable adenocarcinoma of the pancreas treated with gemcitabine. Br J Cancer 2003; 89: 1413-1417.
99. Haas M, Laubender RP, Stieber P et al. Prognostic relevance of CA 19-9, CEA, CRP, and LDH kinetics in patients treated with palliative second-line therapy for advanced pancreatic cancer. Tumour Biol 31: 351-357.
100. Kelly WK, Scher HI, Mazumdar M et al. Prostate-specific antigen as a measure of disease outcome in metastatic hormone-refractory prostate cancer. J Clin Oncol 1993; 11: 607-615.
101. Scher HI, Kelly WM, Zhang ZF et al. Post-therapy serum prostate-specific antigen level and survival in patients with androgen-independent prostate cancer. J Natl Cancer Inst 1999; 91: 244-251.
102. Smith DC, Dunn RL, Strawderman MS et al. Change in serum prostate-specific antigen as a marker of response to cytotoxic therapy for hormone-refractory prostate cancer. J Clin Oncol 1998; 16: 1835-1843.
103. Bubley GJ, Carducci M, Dahut W et al. Eligibility and response guidelines for phase II clinical trials in androgen-independent prostate cancer: recommendations from the Prostate-Specific Antigen Working Group. J Clin Oncol 1999; 17: 3461-3467.
104. Scher HI, Halabi S, Tannock I et al. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: recommendations of the Prostate Cancer Clinical Trials Working Group. J Clin Oncol 2008; 26: 1148-1159.
105. Caffo O, Sava T, Comploj E et al. Estramustine plus docetaxel as second-line therapy in patients with hormone-refractory prostate cancer resistant to docetaxel alone. Urol Oncol 2010; 28: 152-156.
106. Di Lorenzo G, Buonerba C, Faiella A et al. Phase II study of docetaxel retreatment in docetaxel-pretreated castration-resistant prostate cancer. BJU Int 2010.
107. Ferrero JM, Foa C, Thezenas S et al. A weekly schedule of docetaxel for metastatic hormone-refractory prostate cancer. Oncology 2004; 66: 281-287.
108. Fossa SD, Jacobsen AB, Ginman C et al. Weekly docetaxel and prednisolone versus prednisolone alone in androgen-independent prostate cancer: a randomized phase II study. Eur Urol 2007; 52: 1691-1698.
109. Nabhan C, Lestingi TM, Galvez A et al. Erlotinib has moderate single-agent activity in chemotherapy-naive castration-resistant prostate cancer: final results of a phase II trial. Urology 2009; 74: 665-671.
110. Small EJ, Fontana J, Tannir N et al. A phase II trial of gefitinib in patients with non-metastatic hormone-refractory prostate cancer. BJU Int 2007; 100: 765-769.
111. Rustin GJ, Quinn M, Thigpen T et al. Re: New guidelines to evaluate the response to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst 2004; 96:487-488.
112. Lee CK, Friedlander M, Brown C et al. Early Decline in Cancer Antigen 125 as a surrogate for progression-free survival in recurrent ovarian cancer. J Natl Cancer Inst. 2011; 103: 1338-1342.
113. Kim HS, Park YH, Park MJ et al. Clinical significance of a serum CA15-3 surge and the usefulness of CA15-3 kinetics in monitoring chemotherapy response in patients with metastatic breast cancer. Breast Cancer Res Treat 2009; 118: 89-97.
114. Buller RE, Vasilev S, DiSaia PJ. CA 125 kinetics: a cost-effective clinical tool to evaluate clinical trial outcomes in the 1990s. Am J Obstet Gynecol 1996; 174: 1241-1253; discussion 1253-1244.
115. Buller RE, Berman ML, Bloss JD et al. Serum CA125 regression in epithelial ovarian cancer: correlation with reassessment findings and survival. Gynecol Oncol 1992; 47: 87-92.
116. Carlsson A, Bazhenova L, Kolatkar A et al. Dynamic changes in circulating tumor cell levels as a prognostic marker in stage IV non-small cell lung cancer. In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 8109.
117. Oesterling JE, Chan DW, Epstein JI et al. Prostate specific antigen in the preoperative and postoperative evaluation of localized prostatic cancer treated with radical prostatectomy. J Urol 1988; 139: 766-772.
118. Haab F, Meulemans A, Boccon-Gibod L et al. Clearance of serum PSA after open surgery for benign prostatic hypertrophy, radical cystectomy, and radical prostatectomy. Prostate 1995; 26: 334-338.
119. Ravery V, Meulemans A, Boccon-Gibod L. Clearance of free and total serum PSA after prostatic surgery. Eur Urol 1998; 33: 251-254.
120. Vollmer RT, Humphrey PA. Tumor volume in prostate cancer and serum prostatespecific antigen. Analysis from a kinetic viewpoint. Am J Clin Pathol 2003; 119: 80-89.
121. Stamey TA, Kabalin JN, McNeal JE et al. Prostate specific antigen in the diagnosis and treatment of adenocarcinoma of the prostate. II. Radical prostatectomy treated patients. J Urol 1989; 141: 1076-1083.
122. van Straalen JP, Bossens MM, de Reijke TM et al. Biological half-life of prostatespecific antigen after radical prostatectomy. Eur J Clin Chem Clin Biochem 1994; 32: 53-55.
123. Lein M, Brux B, Jung K et al. Elimination of serum free and total prostate-specific antigen after radical retropubic prostatectomy. Eur J Clin Chem Clin Biochem 1997; 35: 591-595.
124. Brandle E, Hautmann O, Bachem M et al. Serum half-life time determination of free and total prostate-specific antigen following radical prostatectomy-a critical assessment. Urology 1999; 53: 722-730.
125. Gregorakis AK, Malovrouvas D, Stefanakis S et al. Free/Total PSA (F/T ratio) kinetics in patients with clinically localized prostate cancer undergoing radical prostatectomy. Clin Chim Acta 2005; 357: 196-201.
126. May M, Gunia S, Helke C et al. Is it possible to provide a prognosis after radical prostatectomy for prostate cancer by means of a PSA regression model? Int J Biol Markers 2005; 20: 112-118.
127. Motzer RJ, Mazumdar M, Bajorin DF et al. High-dose carboplatin, etoposide, and cyclophosphamide with autologous bone marrow transplantation in first-line therapy for patients with poor-risk germ cell tumors. J Clin Oncol 1997; 15: 2546-2552.
128. Motzer RJ, Mazumdar M, Gulati SC et al. Phase II trial of high-dose carboplatin and etoposide with autologous bone marrow transplantation in first-line therapy for patients with poor-risk germ cell tumors. J Natl Cancer Inst 1993; 85: 1828-1835.
129. Murphy BA, Motzer RJ, Mazumdar M et al. Serum tumor marker decline is an early predictor of treatment outcome in germ cell tumor patients treated with cisplatin and ifosfamide salvage chemotherapy. Cancer 1994; 73: 2520-2526.
130. Riedinger JM, Eche N, Basuyau JP et al. Prognostic value of serum CA 125 biexponential decrease during first line paclitaxel/platinum chemotherapy: a French multicentric study. Gynecol Oncol 2008; 109: 194-198.
131. Yuan SQ, Zhou ZW, Wan DS et al. The role of half-life of carcinoembryonic antigen (CEA) in prognosis prediction of colorectal cancer patients with preoperatively elevated CEA. Ai Zheng 2008; 27: 612-617.
132. Konishi F. CEA doubling time and CEA half-life in the prediction of recurrences after colorectal cancer surgery. Jpn J Clin Oncol 2002; 32: 41-42.
133. Choi JS, Min JS. Significance of postoperative serum level of carcinoembryonic antigen (CEA) and actual half life of CEA in colorectal cancer patients. Yonsei Med J 1997; 38: 1-7.
134. Banu E, Banu A, Medioni J et al. Serum PSA half-life as a predictor of survival for hormone-refractory prostate cancer patients: modelization using a standardized set of response criteria. Prostate 2007; 67: 1543-1549.
135. Toner GC, Geller NL, Tan C et al. Serum tumor marker half-life during chemotherapy allows early prediction of complete response and survival in nonseminomatous germ cell tumors 1. Cancer Res 1990; 50: 5904-5910.
136. Gadducci A, Cosio S, Fanucchi A et al. The predictive and prognostic value of serum CA 125 half-life during paclitaxel/platinum-based chemotherapy in patients with advanced ovarian carcinoma. Gynecol Oncol 2004; 93: 131-136.
137. Gadducci A, Zola P, Landoni F et al. Serum half-life of CA 125 during early chemotherapy as an independent prognostic variable for patients with advanced epithelial ovarian cancer: results of a multicentric Italian study. Gynecol Oncol 1995; 58: 42-47.
138. Hanninen M, Venner P, North S. A rapid PSA half-life following docetaxel chemotherapy is associated with improved survival in hormone refractory prostate cancer. Can Urol Assoc J 2009; 3: 369-374.
139. Mano A, Godinho I, Falcao AC. CA 125 half-life breakpoint between a "good" and "poor" prognosis in patients with ovarian cancer. Int J Gynaecol Obstet 2005; 88: 333-335.
140. Yedema CA, Kenemans P, Voorhorst F et al. CA 125 half-life in ovarian cancer: a multivariate survival analysis. Br J Cancer 1993; 67: 1361-1367.
141. Rapellino M, Piantino P, Pecchio F et al. Disappearance curves of tumor markers after radical surgery. Int J Biol Markers 1994; 9: 33-37.
142. Gerl A, Lamerz R, Clemm C et al. Does serum tumor marker half-life complement pretreatment risk stratification in metastatic nonseminomatous germ cell tumors? Clin Cancer Res 1996; 2: 1565-1570.
143. Lange PH, Vogelzang NJ, Goldman A et al. Marker half-life analysis as a prognostic tool in testicular cancer. J Urol 1982; 128: 708-711.
144. Inanc SE, Meral R, Darendeliler E et al. Prognostic significance of marker half-life during chemotherapy in non-seminomatous germ cell testicular tumors 1. Acta Oncol 1999; 38: 505-509.
145. Zagars GK, Pollack A. Kinetics of serum prostate-specific antigen after external beam radiation for clinically localized prostate cancer. Radiother Oncol 1997; 44: 213-221.
146. Vollmer RT, Montana GS. The dynamics of prostate-specific antigen after definitive radiation therapy for prostate cancer. Clin Cancer Res 1999; 5: 4119-4125.
147. Zagars GK, Pollack A. The fall and rise of prostate-specific antigen. Kinetics of serum prostate-specific antigen levels after radiation therapy for prostate cancer. Cancer 1993; 72: 832-842.
148. Fizazi K, Culine S, Kramar A et al. Early predicted time to normalization of tumor markers predicts outcome in poor-prognosis nonseminomatous germ cell tumors. J Clin Oncol 2004; 22: 3868-3876.
149. Mego M, Rejlekova K, Reckova M et al. Kinetics of tumor marker decline as an independent prognostic factor in patients with relapsed metastatic germ-cell tumors. Neoplasma 2009; 56: 398-403.
150. Tsuda H, Hashiguchi Y, Nakata S et al. The CA125 regression rate to predict overall survival differ between paclitaxel-containing regimen and nonpaclitaxel regimen in patients with advanced ovarian cancer. Int J Gynecol Cancer 2002; 12: 435-437.
151. Richardson DL, Seamon LG, Carlson MJ et al. CA125 decline in ovarian cancer patients treated with intravenous versus intraperitoneal platinum-based chemotherapy. Gynecol Oncol 2008; 111: 233-236.
152. Schmitz MD, Padula GD, Chun PY et al. Normalization of prostate specific antigen in patients treated with intensity modulated radiotherapy for clinically localized prostate cancer. Radiat Oncol 2010; 5: 80.
153. Aref I, Eapen L, Agboola O et al. The relationship between biochemical failure and time to nadir in patients treated with external beam therapy for T1-T3 prostate carcinoma. Radiother Oncol 1998; 48: 203-207.
154. Kestin LL, Vicini FA, Ziaja EL et al. Defining biochemical cure for prostate carcinoma patients treated with external beam radiation therapy. Cancer 1999; 86: 1557-1566.
155. Martinez AA, Kestin LL, Stromberg JS et al. Interim report of image-guided conformal high-dose-rate brachytherapy for patients with unfavorable prostate cancer: the William Beaumont phase II dose-escalating trial. Int J Radiat Oncol Biol Phys 2000; 47: 343-352.
156. Cavanaugh SX, Kupelian PA, Fuller CD et al. Early prostate-specific antigen (PSA) kinetics following prostate carcinoma radiotherapy: prognostic value of a timeand-PSA threshold model. Cancer 2004; 101: 96-105.
157. Sandler HM, Dunn RL, McLaughlin PW et al. Overall survival after prostatespecific-antigen-detected recurrence following conformal radiation therapy. Int J Radiat Oncol Biol Phys 2000; 48: 629-633.
158. Kavadi VS, Zagars GK, Pollack A. Serum prostate-specific antigen after radiation therapy for clinically localized prostate cancer: prognostic implications. Int J Radiat Oncol Biol Phys 1994; 30: 279-287.
159. Ellis RJ, Vertocnik A, Kim E et al. Four-year biochemical outcome after radioimmunoguided transperineal brachytherapy for patients with prostate adenocarcinoma. Int J Radiat Oncol Biol Phys 2003; 57: 362-370.
160. Ellis RJ, Vertocnik A, Sodee B et al. Combination conformal radiotherapy and radioimmunoguided transperineal 103Pd implantation for patients with intermediate and unfavorable risk prostate adenocarcinoma. Brachytherapy 2003; 2: 215-222.
161. Hanlon AL, Moore DF, Hanks GE. Modeling postradiation prostate specific antigen level kinetics: predictors of rising postnadir slope suggest cure in men who remain biochemically free of prostate carcinoma. Cancer 1998; 83: 130-134.
162. Ebert MA, Lamb DS, Joseph DJ et al. A methodology for the analysis of PSA response signatures. Radiother Oncol 98: 198-202.
163. Botteri E, Sandri MT, Bagnardi V et al. Modeling the relationship between circulating tumour cells number and prognosis of metastatic breast cancer. Breast Cancer Res Treat 2010; 122: 211-217.
164. Beal SL, Sheiner et al. NONMEM Users Guides. Icon Development Solutions. Ellicott City, Maryland, USA 2006.
165. Ette EI, Williams PJ. Population pharmacokinetics I: background, concepts, and models. Ann Pharmacother 2004; 38: 1702-1706.
166. Sheiner LB. The population approach to pharmacokinetic data analysis: rationale and standard data analysis methods. Drug Metab Rev. 1984; 15: 153-171.
167. Maillet D, Ruffion A, Perrin P et al. Independent confirmation of the strong early predictive value of modeled PSA kinetics in prostate cancer patients treated by radical prostatectomy: results of the prospective PSAMODEL study. In Proceedings of 2012 European Society of Medical Oncology Congress. Abs. 907.
168. You B, Fronton L, Boyle H et al. Predictive value of modeled AUC(AFP-hCG), a dynamic kinetic parameter characterizing serum tumor marker decline in patients with nonseminomatous germ cell tumor. Urology 2010; 76: 423-429 e422.
169. You B, Harvey R, Golfier F et al. Early prediction of treatment resistance in lowrisk gestational trophoblastic neoplasia using population kinetic modelling of hCG measurements. Br J Cancer 2013; in press.
170. You B, Deng W, Oza A et al. Validation of the predictive value of modeled hCG residual production "P" in low-risk gestational trophoblastic neoplasia (GTN) patients treated in GOG-174 phase III trial. In Proceedings of 2012 ASCO Annual Meeting. Abs. 5110.
171. Cappelli G. Mathematical model application to the kinetic study of tumor markers. Int J Biol Markers 1994; 9: 8-14.
172. You B, Colomban O, Heywood M et al. Mathematical modeling of CA125 kinetics in recurrent ovarian cancer (ROC) patients treated with chemotherapy and predictive value of early modeled kinetic parameters in CALYPSO trial: a GCIG study. In Proceedings of 2011 Annual Meeting of American Society of Clinical Oncology. Abs. 5065.
173. Wilbaux M, You B, Colomban O et al. Population K-PD modeling of CA125 and tumor size kinetics in relapsed ovarian cancer patients. In Proceedings of 2011 Annual Congress of Population Apprach Group in Europe. Abs. 2200. http://www. page-meeting.org/default.asp?abstract=2200.
174. Wilbaux M, Henin E, Colomban O et al. Benefit in progression-free survival (PFS) to expect based on CA125 reduction at week 6 in recurrent ovarian cancer (ROC) patients: CALYPSO phase III trial data (a GINECO-GCIG study). In Proceedings of 2013 American Society of Clinical Oncology Annual Meeting. Abs. 5547.
175. Wilbaux M, Henin E, Colomban O et al. A drug-independent model predicting Progression-Free Survival to support early drug development in recurrent ovarian cancer. In Proceedings of 2013 Annual Congress of Population Apprach Group in Europe. Abs. 2716. http://www.page-meeting.org/?abstract=2716.
176. Tanaka G, Hirata Y, Goldenberg SL et al. Mathematical modelling of prostate cancer growth and its application to hormone therapy. Philos Transact A Math Phys Eng Sci 2010; 368: 5029-5044.
177. Dancey JE, Dobbin KK, Groshen S et al. Guidelines for the development and incorporation of biomarker studies in early clinical trials of novel agents. Clin Cancer Res 2010; 16: 1745-1755.
178. Hirata Y, Akakura K, Higano CS et al. Quantitative mathematical modeling of PSA dynamics of prostate cancer patients treated with intermittent androgen suppression. J Mol Cell Biol 2012; 4: 127-132.
179. Drescher CW, Shah C, Thorpe J 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 2013; 31: 387-392.
180. Vollmer RT. Dissecting the dynamics of serum prostate-specific antigen. Am J Clin Pathol 2010; 133: 187-193.
181. McIntosh MW, Urban N. A parametric empirical Bayes method for cancer screening using longitudinal observations of a biomarker. Biostatistics 2003; 4: 27-40.
182. Ivy SP, Siu LL, Garrett-Mayer E et al. Approaches to phase 1 clinical trial design focused on safety, efficiency, and selected patient populations: a report from the clinical trial design task force of the national cancer institute investigational drug steering committee. Clin Cancer Res 2010; 16: 1726-1736.
183. Raimondi C, Gradilone A, Gazzaniga P. Controversies in circulating tumor cell count during therapy. Expert Rev Mol Diagn 2013; 13: 499-507.
184. Gazzaniga P, Raimondi C, Gradilone A et al. Circulating tumor cells in metastatic colorectal cancer: do we need an alternative cutoff? J Cancer Res Clin Oncol 2013; 139: 1411-1416.
185. McShane LM, Altman DG, Sauerbrei W et al. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005; 97: 1180-1184.
186. Frasci G, Conforti S, Zullo F et al. A risk model for ovarian carcinoma patients using CA 125: time to normalization renders second-look laparotomy redundant. Cancer 1996; 77: 1122-1130.
187. Mano A, Falcao A, Godinho I et al. CA-125 AUC as a new prognostic factor for patients with ovarian cancer. Gynecol Oncol 2005; 97: 529-534.