A patient-specific analysis was performed in a single centre retrospective analysis, which enrolled 420 patients treated within 16 phase I trials over a 10-year period.
Most of the large multicentre 'phase III' trials over the past 15 years have been negative, with no significant differences shown between treatment and placebo groups, even when powered adequately [ 55].
These results are in keeping with the aforementioned published analysis comprising more than 460 phase I trials over a 12-year period, which found an RR of 17.8% for patients who received a chemotherapy-based regimen compared to 4.4% for patients who received non-cytotoxic agents.
Regarding the latter, a phase I trial with an over 7-week protracted schedule of TMZ, showed an acceptable tolerance at a daily dose of 75 mg m−2 day−1 (Brock et al, 1998), while increasing two-fold the systemic exposure as compared to the 200 mg m−2 day−1 × 5 per 28-day schedule.
Therefore, to address this question, we retrospectively reviewed the course of patients from the point of referral to trial entry or non-entry at the Princess Margaret Hospital (PMH) phase I trials clinic over the past 5 years.
No grade 4 or 5 toxic effects or treatment-related grade 3 toxic effects were observed [ 28]. Lee et al. from the Princess Margaret Hospital conducted phase I/II trial using 6 fractions over weeks of SBRT in 68 patients with liver metastases of varying sizes (up to 3090 mL) to evaluate the safety of SBRT for larger liver metastases [ 26].
When analyzed by the year of accrual, the proportions of patients who entered into a phase I trial did not differ significantly over time.
Firstly, this is the largest evaluation of the risks of non-oncology phase I trials, covering 394 trials with over 11 000 participants who received the study drugs; seven times larger than any previous assessment.
A total of 70 patients with MBC who participated in 30 different phase I trials at the RMH over 7 years between October 2002 and October 2009 were analysed.
With the trial over, I started seeing a counsellor to help me cope with my grief and I also applied to do a creative writing master's degree at Exeter University.
