Characteristics and outcomes of patients with advanced non-small-cell lung cancer who declined to participate in randomised clinical chemotherapy trials

British Journal of Cancer

Volumn 100, Issue 7, 2009, Pages 1037-1042

  Tanai, C ^a   Nokihara, H ^a   Yamamoto, S ^b   Kunitoh, H ^a   Yamamoto, N ^a   Sekine, I ^a   Ohe, Y ^a   Tamura, T ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

^b NATIONAL CANCER CENTER   (Japan)

Author keywords

Lung cancer; Randomised clinical trial; Trial effect; Trial participation

Indexed keywords

CARBOPLATIN; CISPLATIN; GEFITINIB; GEMCITABINE; IRINOTECAN; NAVELBINE; PACLITAXEL; PLATINUM;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CONFOUNDING VARIABLE; CONTROLLED STUDY; DOCTOR PATIENT RELATION; FEMALE; HAZARD RATIO; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MEDICAL RECORD REVIEW; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT COMPLIANCE; PHYSICIAN; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SURVIVAL TIME; TREATMENT OUTCOME; TREATMENT RESPONSE;

ADULT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; PATIENT PARTICIPATION; PROPORTIONAL HAZARDS MODELS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RETROSPECTIVE STUDIES; TREATMENT OUTCOME;

EID: 63949087993     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6604982     Document Type: Article

References (24)

1. Albrecht TL, Eggly SS, Gleason MEJ, Harper FWK, Foster TS, Peterson AM, Orom H, Penner LA, Ruckdeschel JC (2008) Influence of clinical communication on patients' decision making on participation in clinical trials. J Clin Oncol 26: 2666- 2673
2. Braunholtz DA, Edwards SJL, Lilford RJ (2001) Are randomized clinical trials good for us (in the short term)? Evidence for a 'trial effect'. J Clin Epidemiol 54: 217-224
3. Burgers JA, Arance A, Ashcroft L, Hodgetts J, Lomax L, Thatcher N (2002) Identical chemotherapy schedules given on and off trial protocol in small cell lung cancer response and survival results. Br J Cancer 87: 562-566
4. Corrie P, Shaw J, Harris R (2003) Rate limiting factors in recruitment of patients to clinical trials in cancer research: descriptive study. BMJ 327: 320-321
5. Davis S, Wright P, Schulman SF, Hill LD, Pinkham RD, Johnson LP, Jones TW, Kellogg HB, Radke HM, Sikkema WW, Jolly PC, Hammar SP (1985) Participants in prospective, randomized clinical trials for resected nonsmall cell lung cancer have improved survival compared with nonparticipants in such trials. Cancer 56: 1710- 1718
6. Ellis PM, Butow PN, Tattersall MHN, Dunn SM, Houssami N (2001) Randomized clinical trials in oncology: understanding and attitudes predict willingness to participate. J Clin Oncol 19: 3554-3561
7. Fallowfield LJ, Jenkins V, Brennan C, Sawtell M, Moynihan C, Souhami RL (1998) Attitudes of patients to randomised clinical trials of cancer therapy. Eur J Cancer 34: 1554-1559
8. Go RS, Frisby KA, Lee JA, Mathiason MA, Meyer CM, Ostern JL, Walther SM, Schroeder JE, Meyer LA, Umberger KE (2006) Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer 106: 426-433
9. Ho J, Pond GR, Newman C, Maclean M, Chen EX, Oza AM, Siu LL (2006) Barriers in phase I cancer clinical trials referrals and enrollment: fiveyear experience at the Princess Margaret Hospital. BMC Cancer 6: 263
10. Jenkins V, Fallowfield L (2000) Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer 82: 1783-1788
11. Kelly K, Crowley J, Bunn PA, Presant CA, Grevstad PK, Moinpour CM, Ramsey SD, Wozniak AJ, Weiss GR, Moore DF, Israel VK, Livingston RB, Gandara DR (2001) Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small cell lung cancer: a Southwest Oncology Group Trial. J Clin Oncol 19: 3210-3218
12. Lara PN, Higdon R, Lim N, Kwan K, Tanaka M, Lau DHM, Wun T, Welborn J, Meyers FJ, Christensen S, O'Donnell R, Richman C, Scudder SA, Tuscano J, Gandara DR, Lam KS (2001) Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol 19: 1728- 1733
13. Link MP, Goorin AM, Miser AW, Green AA, Pratt CB, Belasco JB, Pritchard J, Malpas JS, Baker AR, Kirkpatrick JA, Ayala AG, Shuster JJ, Abelson HT, Simone JV, Vietti TJ (1986) The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med 314: 1600- 1606
14. Madsen SM, Holm S, Davidsen B, Munkholm P, Schlichting P, Riis P (2000) Ethical aspects of clinical trials: the attitudes of participants in two non-cancer trials. J Intern Med 248: 463-474
15. Madsen SM, Mirza MR, Holm S, Hilsted KL, Kampmann K, Riis P (2002) Attitudes towards clinical research amongst participants and nonparticipants. J Intern Med 251: 156-168
16. Nokihara H, Ohe Y, Yamada K, Kawaishi M, Kato T, Yamamoto N, Sekine I, Kunitoh H, Saijo N, Tamura T (2008) Randomized phase II study of sequential carboplatin/paclitaxel (CP) and gefitinib (G) in chemotherapy- naïve patients with advanced non-small-cell lung cancer (NSCLC): final results. J Clin Oncol 26: 441s (Suppl; abstr 8069)
17. Ohe Y, Ohashi Y, Kubota K, Tamura T, Nakagawa K, Negoro S, Nishiwaki Y, Saijo N, Ariyoshi Y, Fukuoka M (2007) Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-smallcell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol 18: 317-323
18. Peppercorn JM, Weeks JC, Cook EF, Joffe S (2004) Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 363: 263-270
19. Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH (2002) Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 346: 92-98
20. Schmoor C, Olschewski M, Schumacher M (1996) Randomized and nonrandomized patients in clinical trials: experiences with comprehensive cohort studies. Stat Med 15: 263- 271
21. Stryker JE, Wray RJ, Emmons KM, Winer E, Demetri G (2006) Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret. Patient Educ Couns 63: 104-109
22. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Glabbeke MV, Oosterom AT, Christian MC, Gwyther SG (2000) New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 92: 205-216
23. West J, Wright J, Tuffnell D, Jankowicz D, West R (2005) Do clinical trials improve quality of care? A comparison of clinical processes and outcomes in patients in a clinical trial and similar patients outside a trial where both groups are managed according to a strict protocol. Qual Saf Health Care 14: 175 -178
24. Wright JR, Whelan TJ, Schiff S, Dubois S, Crooks D, Haines PT, DeRosa D, Roberts RS, Gafni A, Pritchard K, Levine MN (2004) Why cancer patients enter randomized clinical trials: exploring the factors that influence their decision. J Clin Oncol 22: 4312-4318