Treatment with unfunded drugs in oncology: The impact of access programmes and clinical trials

Internal Medicine Journal

Volumn 43, Issue 1, 2013, Pages 23-31

  Tie, J ^a,b,c   Gibbs, P ^a,b,c,d  

^a ROYAL MELBOURNE HOSPITAL   (Australia)

^b Western Hospital   (Australia)

^c LUDWIG INSTITUTE FOR CANCER RESEARCH   (Australia)

^d BioGrid Australia   (Australia)

Author keywords

Access programme; Cetuximab; Clinical trial; Colorectal cancer; Unfunded drug

Indexed keywords

CAPECITABINE; CETUXIMAB; FLUOROURACIL; IRINOTECAN; OXALIPLATIN;

ADULT; AGED; ARTICLE; AUSTRALIA; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; COLORECTAL CANCER; DESCRIPTIVE RESEARCH; FEMALE; HEALTH CARE ACCESS; HEALTH CARE COST; HEALTH CARE UTILIZATION; HEALTH PROGRAM; HUMAN; INTERIM ACCESS PROGRAM; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PRIORITY JOURNAL; RETROSPECTIVE STUDY; SOCIAL STATUS;

ADOLESCENT; ADULT; AGE DISTRIBUTION; AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AUSTRALIA; CAMPTOTHECIN; CLINICAL TRIALS AS TOPIC; COLORECTAL NEOPLASMS; COMPASSIONATE USE TRIALS; COST SHARING; DRUG INDUSTRY; FEMALE; HEALTH SERVICES ACCESSIBILITY; HUMANS; MALE; MIDDLE AGED; NEOPLASM PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; RETROSPECTIVE STUDIES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84872544143     PISSN: 14440903     EISSN: 14455994     Source Type: Journal    
DOI: 10.1111/j.1445-5994.2012.02750.x     Document Type: Article

References (23)

1. AIHW (Australian Institute of Health and Welfare) and AACR (Australasian Association of Cancer Registries). Cancer in Australia: an overview, 2008. Cancer series no. 46. Cat no. CAN 42. Canberra: AIHW; 2008.
2. Meyerhardt JA, Mayer RJ. Systemic therapy for colorectal cancer. N Engl J Med 2005; 352: 476-487.
3. Ananda S. The impact of screening on new diagnoses of colorectal cancer. Clinical Oncological Society of Australia 36th annual scientific meeting. Vol. 5 (Suppl 2). Gold coast, Australia: Wiley-Blackwell, 2009; A105 (abs#09).
4. Schrag D. The price tag on progress - chemotherapy for colorectal cancer. N Engl J Med 2004; 351: 317-319.
5. Van Cutsem E, Kohne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A etal. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med 2009; 360: 1408-1417.
6. Sobrero AF, Maurel J, Fehrenbacher L, Scheithauer W, Abubakr YA, Lutz MP etal. EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26: 2311-2319.
7. Jonker DJ, O'Callaghan CJ, Karapetis CS, Zalcberg JR, Tu D, Au HJ etal. Cetuximab for the treatment of colorectal cancer. N Engl J Med 2007; 357: 2040-2048.
8. Bokemeyer C, Bondarenko I, Makhson A, Hartmann JT, Aparicio J, de Braud F etal. Fluorouracil, leucovorin, and oxaliplatin with and without cetuximab in the first-line treatment of metastatic colorectal cancer. J Clin Oncol 2009; 27: 663-671.
9. Cunningham D, Humblet Y, Siena S, Khayat D, Bleiberg H, Santoro A etal. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med 2004; 351: 337-345.
10. Karapetis CS, Khambata-Ford S, Jonker DJ, O'Callaghan CJ, Tu D, Tebbutt NC etal. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 2008; 359: 1757-1765.
11. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L etal. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000; 92: 205-216.
12. Australian Bureau of Statistics. Australian Demographic Statistics, 3010.0. 2009 Dec [cited 2009 Oct 15]. Available from URL: http://www.abs.gov.au.
13. Koczwara B, Barton M, Blinman P, Crossing S, Grimison P, Walpole E etal. The shortage of medical oncologists and low chemotherapy utilization in Australia [Abstract]. J Clin Oncol 2010; 28(Suppl): 6104.
14. Australian Bureau of Statistics. Census of Population and Housing: SocioEconomic Indexes for Areas (SEIFA). 2006 Available from URL: http://www.abs.gov.au/AUSSTATS/abs.nsf/Lookup/2033.0.55.001Main+Features12006?OpenDocument.
15. Australian Bureau of Statistics. Regional Population Growth, Australia, 2008-09. Cat. no. 3218.0 Available from URL: http://www.abs.gov.au/Ausstats/abs.nsf/mf/3218.0.
16. Thomson J, Schofield P, Mileshkin L, Agalianos E, Savulescu J, Zalcberg J etal. Do oncologists discuss expensive anti-cancer drugs with their patients? Ann Oncol 2006; 17: 702-708.
17. Siu J, Shapiro J, Jonker D, Karapetis C, Zalcberg J, Simes J etal. Phase III randomized trial of cetuximab (CET) plus either brivanib alaninate (BRIV) or placebo in patients (pts) with metastatic (MET) chemotherapy refractory K-RAS wild-type (WT) colorectal carcinoma (CRC): The NCIC Clinical Trials Group and AGITG CO.20 trial. J Clin Oncol 2012; 30(Suppl 4): abstract 386.
18. Australian Institute of Health and Welfare (AIHW). ACIM (Australian Cancer Incidence and Mortality) Books. Canberra: AIHW; 2011. [cited 2011 Jul 20]. Available from URL: http://www.aihw.gov.au/cancer/data/acim_books/index.cfm.
19. Heong V, Ananda S, Tie J, Gibbs P. Guesstimates are not good enough for determining what is happening in routine care. Br J Cancer 2010; 103: 1885-1886. Author reply 87-8.
20. Mileshkin L, Schofield PE, Jefford M, Agalianos E, Levine M, Herschtal A etal. To tell or not to tell: the community wants to know about expensive anticancer drugs as a potential treatment option. J Clin Oncol 2009; 27: 5830-5837.
21. Field KM, Kosmider S, Jefford M, Jennens R, Green M, Gibbs P. Chemotherapy treatments for metastatic colorectal cancer: is evidence-based medicine in practice? J Oncol Pract 2008; 4: 271-276.
22. Souglakos J, Philips J, Wang R, Marwah S, Silver M, Tzardi M etal. Prognostic and predictive value of common mutations for treatment response and survival in patients with metastatic colorectal cancer. Br J Cancer 2009; 101: 465-472.
23. De Roock W, Claes B, Bernasconi D, De Schutter J, Biesmans B, Fountzilas G etal. Effects of KRAS, BRAF, NRAS, and PIK3CA mutations on the efficacy of cetuximab plus chemotherapy in chemotherapy-refractory metastatic colorectal cancer: a retrospective consortium analysis. Lancet Oncol 2010; 11: 753-762.