European Journal of Cancer
Volume 44, Issue 11 , Pages 1536-1540 , July 2008

90-Days mortality rate in patients treated within the context of a phase-I trial: How should we identify patients who should not go on trial?

  • Hendrik-Tobias Arkenau

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • H.T.A. and D.O. contributed equally.
    • Corresponding Author InformationCorresponding authors: Tel.: +44 (0) 208 6426011; fax: +44 (0) 208 6427979.
    • ,
  • David Olmos

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • H.T.A. and D.O. contributed equally.
    • Corresponding Author InformationCorresponding authors: Tel.: +44 (0) 208 6426011; fax: +44 (0) 208 6427979.
    • ,
  • Joo Ern Ang

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • ,
  • Jorge Barriuso

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • ,
  • Vasilios Karavasilis

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • ,
  • Sue Ashley

      Affiliations

    • Department of Computing and Statistics, Royal Marsden Hospital, United Kingdom
    • ,
  • Johann de Bono

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • ,
  • Ian Judson

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom
    • ,
  • Stan Kaye

      Affiliations

    • Drug Development Unit, Royal Marsden Hospital and Institute of Cancer Research, Downs Road, SM2 5PT Sutton, United Kingdom

Received 7 April 2008 ,Accepted 24 April 2008.

References 

  1. Roberts TG, Goulart BH, Squitieri L, et al. Trends in the risk and benefits to patients with cancer participating in phase-I clinical trials. JAMA. 2004;292:2130–2140
  2. Horstmann E, McCabe MS, Grochow L, et al. Risks and benefits of phase-1 oncology trials, 1991 through 2002. New Engl J Med. 2005;352:895–904
  3. Sekine I, Yamamoto N, Kunitoh H, et al. Relationship between objective responses in phase-I trials and potential efficacy of non-specific cytotoxic investigational new drugs. Ann Oncol. 2002;13:1300–1306
  4. Arkenau HT, Olmos D, Ang JE, de Bono J, Judson I, Kaye S. Clinical outcome and prognostic factors for patients treated within the context of a phase-I study: The Royal Marsden Hospital experience. Br J Cancer. 2008;98:1029–1033
  5. Bachelot T, Ray-Coquard I, Catimel G, et al. Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase-I clinical trials. Ann Oncol. 2000;11:151–156
  6. Han C, Braybrooke JP, Deplanque G, et al. Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents. Br J Cancer. 2003;89:1166–1171
  7. Yamamoto N, Tamura T, Fukuoka M, Saijo N. Survival and prognostic factors in lung cancer patients treated in phase-I trials: Japanese experience. Int J Oncol. 1999;15:737–774
  8. Arkenau HT, Barriuso J, Olmos D et al. Prospective validation of a prognostic score to improve patient selection for phase-I trials. In: Proc. ASCO; 2008 [abstr 2508].
  9. Seidenfeld J, Horstmann E, Emanuel EJ, Grady C. Participants in phase-I oncology research trials: are they vulnerable?. Arch Intern Med. 2008;168:16–20
  10. Connors T. Anticancer drug development: the way forward. Oncologist. 1996;1:180–181
  11. Penel N, Vanseymortier M, Bonneterre ME, et al. Prognostic factors among cancer patients with good performance status screened for phase I trials. Invest New Drugs. 2008;26(1):53–58

☆ Part of this work has been accepted as oral presentation for the 2008 Annual Meeting of American Society of Clinical Oncology.

PII: S0959-8049(08)00330-4

doi: 10.1016/j.ejca.2008.04.017

European Journal of Cancer
Volume 44, Issue 11 , Pages 1536-1540 , July 2008

Article Tools

* Image Usage & Resolution