Cancer drugs, survival, and ethics

BMJ (Online)

Volumn 355, Issue , 2016, Pages

  Wise, Peter H ^a  

^a CHARING CROSS HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL STUDY; COST BENEFIT ANALYSIS; DRUG APPROVAL; DRUG COST; DRUG INDUSTRY; HUMAN; INFORMED CONSENT; MEDICAL ETHICS; METASTASIS; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SURVIVAL RATE; SURVIVAL TIME;

EID: 84995451012     PISSN: 09598146     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.i5792     Document Type: Article

References (41)

1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin 2015;65:5-29. doi:10.3322/caac.21254 pmid:25559415.
2. Masters GA, Krilov L, Bailey HH et al. Clinical cancer advances 2015: annual report on progress against cancer from the American Society of Clinical Oncology. JCO, 2014.
3. Morgan G, Ward R, Barton M. The contribution of cytotoxic chemotherapy to 5-year survival in adult malignancies. Clin Oncol (R Coll Radiol) 2004;16:549-60. doi:10.1016/j. clon.2004.06.007 pmid:15630849.
4. Apolone G, Joppi R, Bertele V, et al. Ten years of marketing approvals of cancer drugs in Europe. Br J Cancer 2005;93:504-9. doi:10.1038/sj.bjc.6602750 pmid:16136026.
5. Fojo T, Mailankody S, Lo A. Unintended consequences of expensive cancer therapeutics-the pursuit of marginal indications and a me-too mentality that stifles innovation and creativity: the John Conley Lecture. JAMA Otolaryngol Head Neck Surg 2014;140:1225-36. doi:10.1001/jamaoto.2014.1570 pmid:25068501.
6. Hiom SC. Diagnosing cancer earlier: reviewing the evidence for improving cancer survival. Br J Cancer 2015;112(Suppl 1):S1-5. doi:10.1038/bjc.2015.23 pmid:25734391.
7. Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA 2004;291:2720-6. doi:10.1001/jama.291.22.2720 .
8. Constantino T. Global market for cancer treatments grows to $107 billion in 2015. 2 Jun 2016. htps:/www.imshealth.com/en/about-us/news/ims-health-study-global-market-for-cancer-treatments-grows-to-107-bilion-in-2015-fueled-by-record-level-of-innovation.
9. Nurgat ZA, Craig W, Campbell NC, Bissett JD, Cassidy J, Nicolson MC. Patient motivations surrounding participation in phase I and phase II clinical trials of cancer chemotherapy. Br J Cancer 2005;92:1001-5. doi:10.1038/sj.bjc.6602423 pmid:15770219.
10. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004;363:263-70. doi:10.1016/S0140-6736(03)15383-4 pmid:14751698.
11. Van Huijstee M, Schipper I. Ethical concerns. In: Putting contract research organisations on the radar. Social Sciences Research Network, 2011: 55-72.
12. Prasad V, Kim C, Burotto M, et al. The strength of association between surrogate endpoints and survival in oncology. JAMA Intern Med 2015;175:1389-98. doi:10.1001/jamainternmed. 2015.2829 pmid:26098871.
13. Wilson MK, Collyar D, Chingos DT, et al. Outcomes and endpoints in cancer trials: bridging the divide. Lancet Oncol 2015;16:e43-52. doi:10.1016/S1470-2045(14)70380-8 .
14. Kim C, Prasad V. Strength of validation for surrogate end points used in the US Food and Drug Administration's approval of oncology drugs. Mayo Clin Proc 2016;91:713-25. doi: 10.1016/j.mayocp.2016.02.012.
15. Nabors LB. The role of bevacizumab in glioblastoma. J Natl Compr Canc Netw 2014;12:1201-2.pmid:25190689.
16. Johnson JR, Ning Y-M, Farrell A, Justice R, Keegan P, Pazdur R. Accelerated approval of oncology products: the food and drug administration experience. J Natl Cancer Inst 2011;103:636-44. doi:10.1093/jnci/djr062 pmid:21422403.
17. Wise P, Drury M. Pharmaceutical trials in general practice: the first 100 protocols. An audit by the clinical research ethics committee of the Royal College of General Practitioners. BMJ 1996;313:1245-8. doi:10.1136/bmj.313.7067.1245 pmid:8939118.
18. Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category-implications for patients. N Engl J Med 2014;370:1252-8. doi:10.1056/NEJMhle1311493 .
19. Joly F, Vardy J, Pintilie M, Tannock IF. Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Ann Oncol 2007;18:1935-42. doi:10.1093/ annonc/mdm121 pmid:17698837.
20. English V, Sommerville A, Brannan S. Medical ethics today. Blackwell, 2012.
21. QuintilesIMS Institute. Global oncology trend report. 2016. http://www.imshealth.com/en/ thought-leadership/quintilesims-institute/reports/global-oncology-trend-report-a-reviewof- 2015-and-outlook-to-2020
22. Abraham J. The pharmaceutical industry as a political player. Lancet 2002;360:1498-502. doi:10.1016/S0140-6736(02)11477-2 pmid:12433532.
23. Bien J, Prasad V. Future jobs of FDA's haematology-oncology reviewers. BMJ 2016;354:i5055. doi:10.1136/bmj.i5055 pmid:27677772.
24. NICE/NHS. Proposals for a new Cancer Drugs Fund (CDF) operating model. 2015. https: //www.engage.england.nhs.uk/consultation/cdf-consultation
25. Cherny NI, Sullivan R, Dafni U, et al. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Ann Oncol 2015;26:1547-73. doi:10.1093/annonc/mdv249 pmid:26026162.
26. Shulman LN, Wagner CM, Barr R, et al. Proposing essential medicines to treat cancer: methodologies, processes and outcomes. J Clin Oncol 2016;34:69-75. doi:10.1200/JCO. 2015.61.8736 pmid:26578613.
27. Zafar SY, Peppercorn JM, Schrag D, et al. The financial toxicity of cancer treatment: a pilot study assessing out-of-pocket expenses and the insured cancer patient's experience. Oncologist 2013;18:381-90. doi:10.1634/theoncologist.2012-0279 pmid:23442307.
28. Weingart SN, Flug J, Brouillard D, et al. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ 2007;334:407. doi:10.1136/bmj.39069.489757.55 .
29. Chan JK, Kiet TK, Monk BJ, et al. Applications for oncologic drugs: a descriptive analysis of the oncologic drugs advisory committee reviews. Oncologist 2014;19:299-304. doi:10. 1634/theoncologist.2013-0276 pmid:24599479.
30. Wallington M, Saxon EB, Bomb M, et al. 30-day mortality after systemic anticancer treatment for breast and lung cancer in England: a population-based, observational study. Lancet Oncol 2016;17:1203-16. doi:10.1016/S1470-2045(16)30383-7 pmid:27599138.
31. Wright AA, Zhang B, Keating NL, Weeks JC, Prigerson HG. Associations between palliative chemotherapy and adult cancer patients' end of life care and place of death: prospective cohort study. BMJ 2014;348:g1219. doi:10.1136/bmj.g1219 pmid:24594868.
32. Higginson IJ, Sen-Gupta GJ. Place of care in advanced cancer: a qualitative systematic literature review of patient preferences. J Palliat Med 2000;3:287-300. doi:10.1089/jpm. 2000.3.287 pmid:15859670.
33. Gattellari M, Voigt KJ, Butow PN, Tattersall MH. When the treatment goal is not cure: are cancer patients equipped to make informed decisions?J Clin Oncol 2002;20:503-13. doi: 10.1200/JCO.20.2.503 pmid:11786580.
34. Weeks JC, Catalano PJ, Cronin A, et al. Patients' expectations about effects of chemotherapy for advanced cancer. N Engl J Med 2012;367:1616-25. doi:10.1056/ NEJMoa1204410 pmid:23094723.
35. Audrey S, Abel J, Blazeby JM, Falk S, Campbell R. What oncologists tell patients about survival benefits of palliative chemotherapy and implications for informed consent: qualitative study. BMJ 2008;337:a752. doi:10.1136/bmj.a752 pmid:18669570.
36. Koedoot CG, Oort FJ, de Haan RJ, Bakker PJ, de Graeff A, de Haes JC. The content and amount of information given by medical oncologists when telling patients with advanced cancer what their treatment options are. palliative chemotherapy and watchful-waiting. Eur J Cancer 2004;40:225-35. doi:10.1016/j.ejca.2003.10.008 pmid:14728937.
37. Malin JL, Weeks JC, Potosky AL, Hornbrook MC, Keating NL. Medical oncologists' perceptions of financial incentives in cancer care. J Clin Oncol 2013;31:530-5. doi:10. 1200/JCO.2012.43.6063 pmid:23269996.
38. Bauman JR, Temel JS. The integration of early palliative care with oncology care: the time has come for a new tradition. J Natl Compr Canc Netw 2014;12:1763-71, quiz 1771.pmid:25505216.
39. Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ 2012;184:533-40. doi:10.1503/cmaj.112120 pmid:22392947.
40. Pardon K, Deschepper R, Vander Stichele R, et al. Are patients' preferences for information and participation in medical decision-making being met' Interview study with lung cancer patients. Palliat Med 2011;25:62-70. doi:10.1177/0269216310373169 pmid:20621948.
41. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 2014;32:1277-80. doi:10.1200/JCO.2013.53.8009 pmid:24638016.