Barriers to study enrollment in patients with advanced cancer referred to a phase I clinical trials unit

Oncologist

Volumn 18, Issue 12, 2013, Pages 1315-1320

  Siqing, Fu ^a   McQuinn, Lacey ^a   Naing, Aung ^a   Wheler, Jennifer J ^a   Janku, Filip ^a   Falchook, Gerald S ^a   Piha Paul, Sarina A ^a   Tu, Dennis ^a   Howard, Adrienne ^a   Tsimberidou, Apostolia ^a   Zinner, Ralph ^a   Hong, David S ^a   Kurzrock, Razelle ^b  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Barrier; Consults; Enrollment; New patients; Patient referral; Phase I trial

Indexed keywords

ADOLESCENT; ADULT; ADVANCED CANCER; AGED; ARTICLE; CANCER CENTER; COMORBIDITY; DEATH; DIGESTIVE SYSTEM CANCER; FEMALE; GYNECOLOGIC CANCER; HEALTH INSURANCE; HOSPICE CARE; HUMAN; MAJOR CLINICAL STUDY; MALE; OUTCOME ASSESSMENT; OUTCOME VARIABLE; PATIENT PARTICIPATION; PHASE 1 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RETROSPECTIVE STUDY; VERY ELDERLY;

BARRIER; CONSULTS; ENROLLMENT; NEW PATIENTS; PATIENT REFERRAL; PHASE I TRIAL;

ADOLESCENT; AGED; CLINICAL TRIALS, PHASE I AS TOPIC; FEMALE; HOSPICES; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PATIENT PARTICIPATION; REFERRAL AND CONSULTATION; RETROSPECTIVE STUDIES;

EID: 84890044052     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2013-0202     Document Type: Article

References (31)

1. Kurzrock R, Benjamin RS. Risks and benefits of phase 1 oncology trials, revisited. N Engl J Med 2005;352:930-932.
2. Wheler J, Tsimberidou AM, Hong D et al. Survival of 1,181 patients in a phase I clinic: The MD Anderson Clinical Center for targeted therapy experience. Clin Cancer Res 2012;18:2922-2929.
3. Fu S, Hong DS, Naing A et al. Outcome analyses after the first admission to an intensive care unit in patients with advanced cancer referred to a phase I clinical trials program. J Clin Oncol 2011;29:3547-3552.
4. Fu S, Barber FD, Naing A et al. Advance care planning in patients with cancer referred to a phase I clinical trials program: The MD Anderson Cancer Center experience. J Clin Oncol 2012;30:2891-2896.
5. Roberts TG, Jr. Goulart BH, Squitieri L et al. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004;292:2130-2140.
6. Horstmann E, McCabe MS, Grochow L et al. Risks and benefits of phase 1 oncology trials, 1991 through 2002. N Engl J Med 2005;352:895-904.
7. Tsimberidou AM, Iskander NG, Hong DS et al. Personalized medicine in a phase I clinical trials program: The MD anderson cancer center initiative. Clin Cancer Res 2012;18:6373-6383.
8. Catt S, Langridge C, Fallowfield L et al. Reasons given by patients for participating, or not, in phase 1 cancer trials. Eur J Cancer 2011;47:1490-1497.
9. Ho J, Pond GR, Newman C et al. Barriers in phase I cancer clinical trials referrals and enrollment: Fiveyear experience at the Princess Margaret Hospital. BMC Cancer 2006;6:263.
10. Horng S, Emanuel EJ, Wilfond B et al. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 2002;347:2134-2140.
11. Janku F, Wheler JJ, Westin SN et al. PI3K/AKT/ mTOR inhibitors in patients with breast and gynecologic malignancies harboring PIK3CA mutations. J Clin Oncol 2012;30:777-782.
12. Kwak EL, Bang YJ, Camidge DR et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-1703.
13. Flaherty KT, Infante JR, Daud A et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med 2012;367:1694-1703.
14. Chapman PB, Hauschild A, Robert C et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364: 2507-2516.
15. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: Race-, sex-, and agebased disparities. JAMA 2004;291:2720-2726.
16. Corrie P, Shaw J, Harris R. Rate limiting factors in recruitment of patients to clinical trials in cancer research: Descriptive study. BMJ 2003;327:320-321.
17. Lara PN, Jr. Higdon R, Lim N et al. Prospective evaluation of cancer clinical trial accrual patterns: Identifying potential barriers to enrollment. J Clin Oncol 2001;19:1728-1733.
18. Itoh K, Sasaki Y, Fujii H et al. Patients in phase I trials of anti-cancer agents in Japan: Motivation, comprehension and expectations. Br J Cancer 1997; 76:107-113.
19. Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials 2011;8:616-623.
20. Gross CP, Filardo G, Mayne ST et al. The impact of socioeconomic status and race on trial participation for older women with breast cancer. Cancer 2005;103:483-491.
21. Quinn GP, Koskan A, Wells KJ et al. Cancer patients' fears related to clinical trial participation: A qualitative study. J Cancer Educ 2012;27:257-262.
22. Meropol NJ, Buzaglo JS, Millard J et al. Barriers to clinical trial participation as perceived by oncologists and patients. J Natl Compr Canc Netw 2007;5: 655-664.
23. Brunetto A, Olmos D, Arkenau HT et al. Perceptions and referral trends into phase I oncology trials: Results of a clinical survey. J Oncol 2011:861401, 2011.
24. Simon MS, Du W, Flaherty L et al. Factors associated with breast cancer clinical trials participation and enrollment at a large academic medical center. J Clin Oncol 2004;22:2046-2052.
25. Pentz RD, White M, Harvey RD et al. Therapeutic misconception, misestimation, and optimism in participants enrolled in phase 1 trials. Cancer 2012; 118:4571-4578.
26. van der Biessen DA, Cranendonk MA, Schiavon G et al. Evaluation of patient enrollment in oncology phase I clinical trials. The Oncologist 2013;18:323-329.
27. Rouanne M, Massard C, Hollebecque A et al. Evaluation of sexuality, health-related quality-oflife and depression in advanced cancer patients: A prospective study in a phase I clinical trial unit of predominantly targeted anticancer drugs. Eur J Cancer 2013;49:431-438.
28. Kemeny MM, Peterson BL, Kornblith AB et al. Barriers to clinical trial participation by older women with breast cancer. J Clin Oncol 2003;21: 2268-2275.
29. Townsley CA, Selby R, Siu LL. Systematic review of barriers to the recruitment of older patients with cancer onto clinical trials. J Clin Oncol 2005;23: 3112-3124.
30. Aapro MS, Kohne CH, Cohen HJ et al. Never too old? Age should not be a barrier to enrollment in cancer clinical trials. The Oncologist 2005;10:198-204.
31. Rodon J, Perez J, Kurzrock R. Combining targeted therapies: Practical issues to consider at the bench and bedside. The Oncologist 2010;15:37-50.