Early mortality and overall survival in oncology phase I trial participants: Can we improve patient selection?

BMC Cancer

Volumn 11, Issue , 2011, Pages

  Chau, Nicole G ^a   Florescu, Ana ^a   Chan, Kelvin K ^a   Wang, Lisa ^b   Chen, Eric X ^a   Bedard, Philippe ^a   Oza, Amit M ^a   Siu, Lillian L ^a  

^a UNIVERSITY OF TORONTO   (Canada)

^b UNIVERSITY HEALTH NETWORK   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

ALBUMIN; CYTOTOXIC AGENT; LACTATE DEHYDROGENASE; TUMOR MARKER; BIOLOGICAL MARKER;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE METASTASIS; CANCER CHEMOTHERAPY; CANCER MORTALITY; CANCER SURVIVAL; CONTROLLED STUDY; FEMALE; HEMATOLOGIC MALIGNANCY; HUMAN; INTERMETHOD COMPARISON; LIVER METASTASIS; LUNG METASTASIS; MAJOR CLINICAL STUDY; MALE; MOLECULARLY TARGETED THERAPY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PATIENT SELECTION; PHASE 1 CLINICAL TRIAL (TOPIC); PREDICTION; RETROSPECTIVE STUDY; RISK ASSESSMENT; RISK FACTOR; SCORING SYSTEM; SOLID TUMOR; SURVIVAL TIME; TOTAL QUALITY MANAGEMENT; METABOLISM; MIDDLE AGED; MORTALITY; NEOPLASM; PROGNOSIS; SURVIVAL; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; BIOLOGICAL MARKERS; CLINICAL TRIALS, PHASE I AS TOPIC; FEMALE; HUMANS; MALE; MIDDLE AGED; NEOPLASMS; PATIENT SELECTION; PROGNOSIS; RETROSPECTIVE STUDIES; SURVIVAL ANALYSIS; TREATMENT OUTCOME; YOUNG ADULT;

EID: 80053508337     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-11-426     Document Type: Article

References (21)

1. Ho J, Pond G, Newman C, Maclean M, Chen E, Oza A, Siu L. Barriers in phase I cancer clinical trials referrals and enrollment: five-year experience at the Princess Margaret Hospital. BMC Cancer 2006, 6:263. 10.1186/1471-2407-6-263, 1636658, 17092349.
2. Karavasilis V, Digue L, Arkenau T, Eaton D, Stapleton S, de Bono J, Judson I, Kaye S. Identification of factors limiting patient recruitment into phase I trials: a study from the Royal Marsden Hospital. Eur J Cancer 2008, 44:978-982. 10.1016/j.ejca.2008.02.040, 18362066.
3. 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. 10.1038/sj.bjc.6604218, 2275488, 18349817.
4. Arkenau HT, Olmos D, Ang JE, Burriuso J, Karavasilis V, Ashley S, de Bono J, Judson I, Kaye S. 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?. Eur J Cancer 2008, 44:1536-1540. 10.1016/j.ejca.2008.04.017, 18550361.
5. Penel N, Delord JP, Bonneterre ME, Bachelot T, Ray-Coquard I, Blay JY, Pascal LB, Borel C, Filleron T, Adenis T, Bonneterre J. Development and validation of a model that predicts early death among cancer patients participating in phase I clinical trials investigating cytotoxics. Invest New Drugs 2009, 28:76-82.
6. Bachelot T, Ray-Coquard I, Catimel G, Ardiet C, Guastalia JP, Dumortier A, Chauvin F, Droz JP, Philip T, Clavel M. Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials. Ann Oncol 2000, 11:151-156. 10.1023/A:1008368319526, 10761748.
7. Horstmann E, McCabe MS, Grochow L, Yamamoto S, Rubinstein L, Budd T, Shoemaker D, Emanuel EJ, Grady C. Risks and benefits of phase I oncology trials, 1991 through 2002. N Engl J Med 2005, 352:895-904. 10.1056/NEJMsa042220, 15745980.
8. Italiano A, Massard C, Bahleda R, Vataire AL, Deutsch E, Magne N, Pignon JP, Vassal G, Amand JP, Soria JC. Treatment outcome and survival in participants of phase I oncology trials carried out from 2003 to 2006 at Institut Gustave Roussy. Ann Oncol 2008, 19:787-792.
9. Penel N, Vanseymortier M, Bonneterre ME, Clisant S, Dansin E, Vendel Y, Beuscart R, Bonneterre J. Prognostic factors among cancer patients with good performance status screened for phase I trials. Invest New Drugs 2008, 26:53-58. 10.1007/s10637-007-9088-x, 17891337.
10. Wheler J, Tsimberidou AM, Hong D, Naing A, Jackson T, Liu S, Feng L, Kurzrock R. Survival of patients in a Phase 1 Clinic: the M. D. Anderson Cancer Center experience. Cancer 2009, 115:1091-1099. 10.1002/cncr.24018, 19165805.
11. Arkenau HT, Barriuso J, Olmos D, Ang JE, de Bono J, Judson I, Kaye S. Prospective validation of a prognostic score to improve patient selection for oncology phase I trials. J Clin Oncol 2009, 27:2692-2696. 10.1200/JCO.2008.19.5081, 19332724.
12. Olmos D, Hern RA, Marsoni S, Tabernero J, Soria JC, Verweij J, Voest E, Schoffski P, Penel N, Schellens J, Brunetto A, Gianni L, Evans J, Wilson R, Sessa C, Plummer R, Kaye S. Multi-institutional prognostic factor analysis of patients (pts) enrolled in phase I (Ph I) oncology trials: Can pts selection be improved [abstract]?. J Clin Oncol (Meeting Abstracts) 2010, 28:s2518.
13. Pencina MJ, D'Agostino RB. Overall C as a measure of discrimination in survival analysis: model specific population value and confidence interval estimation. Stat Med 2004, 23:2109-2123. 10.1002/sim.1802, 15211606.
14. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000, 92:205-216. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada, 10.1093/jnci/92.3.205, 10655437.
15. Joffe S, Miller FG. Rethinking risk-benefit assessment for phase I cancer trials. J Clin Oncol 2006, 24:2987-2990. 10.1200/JCO.2005.04.9296, 16809725.
16. Markman M. Further evidence of clinical benefit associated with participation in phase I oncology trials. Br J Cancer 2008, 98:1021-1022. 10.1038/sj.bjc.6604206, 2275490, 18349816.
17. Seidenfeld J, Horstmann E, Emanuel EJ, Grady C. Participants in Phase 1 Oncology Research Trials: Are They Vulnerable?. Arch Intern Med 2008, 168:16-20. 10.1001/archinternmed.2007.6, 18195190.
18. Roberts TG, Goulart BH, Squitieri L, Stallings SC, Halpern EF, Chabner BA, Gazelle GS, Finkelstein SN, Clark JW. Trends in the risks and benefits to patients with cancer participating in phase 1 clinical trials. JAMA 2004, 292:2130-2140. 10.1001/jama.292.17.2130, 15523074.
19. Han C, Braybrooke JP, Deplanque G, Taylor M, Mackintosh D, Kaur K, Samouri K, Ganesan TS, Harris AL, Talbot DC. Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents. Br J Cancer 2003, 89:1166-1171. 10.1038/sj.bjc.6601218, 2394292, 14520440.
20. Postel-Vinay S, Arkenau HT, Olmos D, Ang J, Barriuso J, Ashley S, Banerji U, de Bono J, Judson I, Kaye S. Clinical benefit in Phase-I trials of novel molecularly targeted agents: does dose matter?. Br J Cancer 2009, 100:1373-1378. 10.1038/sj.bjc.6605030, 2694416, 19401696.
21. Vittinghoff E, McCulloch CE. Relaxing the rule of ten events per variable in logistic and Cox regression. Am J Epidemiol 2007, 165:710-718. 10.1093/aje/kwk052, 17182981.