CAN CANADA SUSTAIN PAEDIATRIC PHASE I TRIALS? A NATIONAL SURVEY OF CANCER RELAPSE IN CHILDREN
Main Article Content
Keywords
Neoplasms, recurrence, paediatrics, Canada, phase I clinical trials
Abstract
Background
Paediatric phase I trials are critical to the evaluation of new agents using standardized methodology. However a large proportion of paediatric patients in Canada do not have access to phase I therapy.
Objectives
A National Paediatric Cancer Relapse Survey was conducted to collect preliminary data to evaluate the feasibility of multi-centre paediatric phase I trials within Canada.
Methods
A survey consisting of 20 individual questions was sent out to all of the 17 paediatric oncology centres in
Canada.
Results
Fifteen centres (88%) responded to the survey. 1027 children are diagnosed with cancer each year in Canada while 241 present with recurrent cancer. Of the 85 patients who are considered to be eligible for phase I study each year, only 53% were referred for phase I therapy. Two centres have more than 10 eligible patients a year, while the remaining 13 centres have less than 10 eligible patients each year.
Conclusions
We estimate that 20% of the eligible patients could be accrued to phase I trials and Canada may provide sufficient patient number, i.e. 25 to 30 solid tumour patients every 2 years, to allow one multi-centre paediatric phase I trial to be completed over a 2-year period.
References
2. Mertens AC, Yasui Y, Neglia JP, et al. Late mortality experience in five-year survivors of childhood and adolescent cancer: the Childhood Cancer Survivor Study. J Clin Oncol 2001;19(13):3163-72.
3. Pratt CB. The conduct of phase I-II clinical trials in children with cancer. Med Pediatr Oncol
1991;19(4):304-9.
4. Smith M, Bernstein M, Bleyer WA, et al. Conduct of phase I trials in children with cancer. J Clin Oncol 1998;16(3):966-78.
5. Health Canada. Cancer surveillance on-line. Cancer incidence by age group. http://dsol- smed.hc-sc.gc.ca/dsol-smed/cgi- in/cancerchart2?DATA_TYPE=D&AGE_GROU PS=T%3BU%3BV%3BW&CAUSE2=019&YEA R2=00&AREA2=00&SEX2=3&CAGE2=View+C hart&SCALE=LINEAR (May 18, 2004).
6. Health Canada. Cancer surveillance on-line.Cancer mortality by age group. http://dsol- smed.hc-sc.gc.ca/dsol-smed/cgi- bin/cancerchart2?DATA_TYPE=D&AGE_GROU PS=T%3BU%3BV%3BW&CAUSE2=019&YEA R2=00&AREA2=00&SEX2=3&DATA_SET=M ORT&CAGE2=View+Chart&SCALE=LINEAR (May 18, 2004).
7. National Childhood Cancer Foundation. Childhood cancer treatment and research centers. http://www.nccf.org/help/references.asp?cat=13&c atName=CHILDHOOD%20CANCER%20TREATMENT%20AND%20RESEARCH%20CENTERS#results (May 18, 2004).
8. Estlin EJ, Cotterill S, Pratt CB, Pearson AD, Bernstein M. Phase I trials in pediatric oncology: perceptions of pediatricians from the United Kingdom Children's Cancer Study Group and the Pediatric Oncology Group. J Clin Oncol 2000;18(9):1900-5.
9. Shah S, Weitman S, Langevin AM, Bernstein M, Furman W, Pratt C. Phase I therapy trials in children with cancer. J Pediatr Hematol Oncol
1998;20(5):431-8.
10. Langevin AM, Weitman SD, Kuhn JG, et al. Phase I trial of rebeccamycin analog (NSC #655649) in children with refractory solid tumors: a pediatric oncology group study. J Pediatr Hematol Oncol 2003;25(7):526-33.
11. Wells RJ, Reid JM, Ames MM, et al. Phase I trial of cisplatin and topotecan in children with recurrent solid tumors: Children's Cancer Group Study 0942. J Pediatr Hematol Oncol 2002;24(2):89-93.
12. Health Canada. Cancer surveillance on-line.Cancer incidence by site. http://dsol-http://dsol-smed.hc-sc.gc.ca/dsol-smed/cgi-bin/cancerchart2?DATA_TYPE=D_HBAR1 &CAUSE=ALL&YEAR=00&AREA=00&A GE=T&SEX=2&CCAUSE1=View+Chart (May 18, 2004).