Ethics of mandatory research biopsy for correlative end points within clinical trials in oncology

Journal of Clinical Oncology

Volumn 28, Issue 15, 2010, Pages 2635-2640

  Peppercorn, Jeffrey ^a   Shapira, Iuliana ^a   Collyar, Deborah ^a   Deshields, Teresa ^a   Lin, Nancy ^a   Krop, Ian ^a   Grunwald, Hans ^a   Friedman, Paula ^a   Partridge, Ann H ^a   Schilsky, Richard L ^a   Bertagnolli, Monica M ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER;

CANCER TISSUE; CLINICAL ASSESSMENT; CLINICAL DECISION MAKING; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; ONCOLOGY; PRACTICE GUIDELINE; PRIORITY JOURNAL; RESEARCH; REVIEW; TUMOR BIOPSY; ADULT; ARTICLE; BIOASSAY; BIOPSY; CLINICAL TRIAL; ETHICS; MANDATORY TESTING; METHODOLOGY;

ADULT; BIOPSY; CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; MANDATORY TESTING; MEDICAL ONCOLOGY;

EID: 77956406352     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2009.27.2443     Document Type: Review

References (47)

1. Jemal A, Siegel R, Ward E, et al: Cancer statistics, 2008. CA Cancer J Clin 58:71-96, 2008
2. O'Brien SG, Guilhot F, Larson RA, et al: Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 348:994-1004, 2003 (Pubitemid 36302244)
3. Slamon DJ, Leyland-Jones B, Shak S, et al: Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 344:783-792, 2001 (Pubitemid 32222155)
4. Karapetis CS, Khambata-Ford S, Jonker DJ, et al: K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 359:1757-1765, 2008
5. Allegra CJ, Jessup JM, Somerfield MR, et al: American Society of Clinical Oncology provisional clinical opinion: Testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. J Clin Oncol 27:2091-2096, 2009
6. Radich JP, Zelenetz AD, Chan WC, et al: NCCN task force report: Molecular markers in leukemias and lymphomas. J Natl Compr Canc Netw 7:S1-S34, 2009 (suppl 4)
7. Simon G, Sharma A, Li X, et al: Feasibility and efficacy of molecular analysis-directed individualized therapy in advanced non-small-cell lung cancer. J Clin Oncol 25:2741-2746, 2007 (Pubitemid 47123182)
8. Heinrich MC, Maki RG, Corless CL, et al: Primary and secondary kinase genotypes correlate with the biological and clinical activity of sunitinib in imatinib-resistant gastrointestinal stromal tumor. J Clin Oncol 26:5352-5359, 2008
9. Yao JC, Phan AT, Chang DZ, et al: Efficacy of RAD001 (everolimus) and octreotide LAR in advanced low- to intermediate-grade neuroendocrine tumors: Results of a phase II study. J Clin Oncol 26:4311-4318, 2008
10. Curigliano G, Pelosi G, De Pas T, et al: Absence of epidermal growth factor receptor gene mutations in patients with hormone refractory prostate cancer not responding to gefitinib. Prostate 67:603-604, 2007 (Pubitemid 46685279)
11. Buchholz TA, Stivers DN, Stec J, et al: Global gene expression changes during neoadjuvant chemotherapy for human breast cancer. Cancer J 8:461-468, 2002
12. Arce C, Perez-Plasencia C, Gonzalez-Fierro A, et al: A proof-of-principle study of epigenetic therapy added to neoadjuvant doxorubicin cyclophosphamide for locally advanced breast cancer. PLoS One 1:e98, 2006
13. Sequist LV, Lynch TJ: EGFR tyrosine kinase inhibitors in lung cancer: An evolving story. Annu Rev Med 59:429-442, 2008 (Pubitemid 351287947)
14. Peppercorn J, Perou CM, Carey LA: Molecular subtypes in breast cancer evaluation and management: Divide and conquer. Cancer Invest 26:1-10, 2008
15. Lenz G, Wright GW, Emre NC, et al: Molecular subtypes of diffuse large B-cell lymphoma arise by distinct genetic pathways. Proc Natl Acad Sci U S A 105:13520-13525, 2008
16. Berns K, Horlings HM, Hennessy BT, et al: A functional genetic approach identifies the PI3K pathway as a major determinant of trastuzumab resistance in breast cancer. Cancer Cell 12:395-402, 2007 (Pubitemid 47539306)
17. Pusztai L, Broglio K, Andre F, et al: Effect of molecular disease subsets on disease-free survival in randomized adjuvant chemotherapy trials for estrogen receptor-positive breast cancer. J Clin Oncol 26:4679-4683, 2008
18. Lynch TJ, Bell DW, Sordella R, et al: Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 350:2129-2139, 2004 (Pubitemid 38637993)
19. Mandrekar SJ, Sargent DJ: Clinical trial designs for predictive biomarker validation: Theoretical considerations and practical challenges. J Clin Oncol 27:4027-4034, 2009
20. Krop IE, Winer EP: Ten years of HER2-directed therapy: Still questions after all these years. Breast Cancer Res Treat 113:207-209, 2009
21. Dowlati A, Haaga J, Remick SC, et al: Sequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation. Clin Cancer Res 7:2971-2976, 2001 (Pubitemid 32963813)
22. Banerji U, de Bono J, Judson I, et al: Biomarkers in early clinical trials: The committed and the skeptics. Clin Cancer Res 14:2512, 2008 (Pubitemid 351551090)
23. Cannistra SA: Performance of biopsies in clinical research. J Clin Oncol 25:1454-1455, 2007
24. Anderson BD, Adamson PC, Weiner SL, et al: Tissue collection for correlative studies in childhood cancer clinical trials: Ethical considerations and special imperatives. J Clin Oncol 22:4846-4850, 2004
25. Helft PR, Daugherty CK: Are we taking without giving in return? The ethics of research-related biopsies and the benefits of clinical trial participation. J Clin Oncol 24:4793-4795, 2006 (Pubitemid 46630904)
26. Brown AP, Wendler DS, Camphausen KA, et al: Performing nondiagnostic research biopsies in irradiated tissue: A review of scientific, clinical, and ethical considerations. J Clin Oncol 26:3987-3994, 2008
27. Joffe S, Cook EF, Cleary PD, et al: Quality of informed consent: A new measure of understanding among research subjects. J Natl Cancer Inst 93:139-147, 2001 (Pubitemid 32111992)
28. Daugherty C, Ratain MJ, Grochowski E, et al: Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol 13:1062-1072, 1995
29. Joffe S, Cook E, Clark J, et al: Altruism among participants in cancer clinical trials. Proc Am Soc Clin Oncol 22:523, 2003 (abstr 2103)
30. Wright JR, Whelan TJ, Schiff S, et al: Why cancer patients enter randomized clinical trials: Exploring the factors that influence their decision. J Clin Oncol 22:4312-4318, 2004 (Pubitemid 41185152)
31. Nurgat ZA, Craig W, Campbell NC, et al: Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer 92:1001-1005, 2005 (Pubitemid 40546660)
32. Gelber RD, Goldhirsch A: Can a clinical trial be the treatment of choice for patients with cancer? J Natl Cancer Inst 80:886-887, 1988
33. Emanuel EJ, Wendler D, Grady C: What makes clinical research ethical? JAMA 283:2701-2711, 2000
34. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research: the Belmont Report: Ethical principles and guidelines for the protection of humans subjects of research. U.S. Government Printing Office, DHEW Publication No. (OS) 78-0013 and (OS) 78-0014, 1979
35. World Medical Association: Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects. 59th WMA General Assembly. Seoul, Korea, 2008
36. Yao MD, von Rosenvinge EC, Groden C, et al: Multiple endoscopic biopsies in research subjects: Safety results from a National Institutes of Health series. Gastrointest Endosc 69:906-910, 2009
37. Elston WJ, Whittaker AJ, Khan LN, et al: Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. Eur Respir J 24:375-377, 2004 (Pubitemid 39232258)
38. Eichler K, Hempel S, Wilby J, et al: Diagnostic value of systematic biopsy methods in the investigation of prostate cancer: A systematic review. J Urol 175:1605-1612, 2006
39. Agulnik M, Oza AM, Pond GR, et al: Impact and perceptions of mandatory tumor biopsies for correlative studies in clinical trials of novel anticancer agents. J Clin Oncol 24:4801-4807, 2006 (Pubitemid 46655611)
40. Djulbegovic B, Lacevic M, Cantor A, et al: The uncertainty principle and industry-sponsored research. Lancet 356:635-638, 2000 (Pubitemid 30627590)
41. Gish RG, Porta C, Lazar L, et al: Phase III randomized controlled trial comparing the survival of patients with unresectable hepatocellular carcinoma treated with nolatrexed or doxorubicin. J Clin Oncol 25:3069-3075, 2007
42. Deenik W, van der Holt B, Verhoef GE, et al: High-vs low-dose cytarabine combined with interferon alfa in patients with first chronic phase chronic myeloid leukemia. A prospective randomized phase III study. Ann Hematol 86:117-125, 2007 (Pubitemid 44964003)
43. Muss HB, Berry DA, Cirrincione CT, et al: Adjuvant chemotherapy in older women with early-stage breast cancer. N Engl J Med 360:2055-2065, 2009
44. Rettig RAJP, Farquhar CM, Aubry WM: False Hope: Bone Marrow Transplantation for Breast Cancer. New York, NY, Oxford University Press, 2007
45. Davé UP, Jenkins NA, Copeland NG: Gene therapy insertional mutagenesis insights. Science 303:333, 2004 (Pubitemid 38095765)
46. Abigail Alliance v. Von Eschenbach. US Court of Appeals, No. 04-5350, 2007
47. Henderson GE, Churchill LR, Davis AM, et al: Clinical trials and medical care: Defining the therapeutic misconception. PLoS Med 4:e324, 2007