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Assessing off-time is important for researchers as well as clinicians, who monitor off-time for needed changes in medication schedule, dose, or additional treatments needed [ 14, 16].
At the end of the CACZ885D2306 study (July 2010), all patients continued treatment with canakinumab in an open fashion with the last schedule (dose and frequency) used during the trial.
Dose reduction during subsequent cycles is relatively common with either schedule: dose reduction occurred in 34% of patients receiving BSA-adjusted dosing with capecitabine in the phase III trials compared with a similar percentage (38%) in our study of fixed-dose capecitabine (Cassidy et al, 2002).
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Drug schedule, dose-reduction policy and timing of radiological assessments were left to the discretion of the attending doctors in accordance with current local practice guidelines.
The patient age groups < 60 years and 60 to 64 years performed similarly, whereas patients older than 64 years had the highest incidences of dose delays (20%) and hospitalizations (50%) with the combination dose-dense schedule (dose-dense doxorubicin/docetaxel).
Overall among taxane schedules, the incidences of dose delays (13.8%) and of hospitalization (25%) were markedly higher with the sequence dose-dense schedule (dose-dense epirubicin/dose-dense paclitaxel regimen) versus other taxane schedules.
In a phase I trial using a 2-week on/2-week off dosing schedule, dose-limiting skin rash and diarrhoea was encountered at 900 mg (Hoekstra et al, 2002).
Regarding the WBI schedule, doses higher than 10 × 3 Gy resulted in better overall survival than standard doses of 10 × 3 Gy and 5 × 4 Gy.
The first patient was lost to follow-up after cataract surgery in the study eye that was performed after receiving the second scheduled dose of sirolimus.
The patient required GLM every 3 weeks in order to control ocular inflammation that developed prior to the next scheduled dose.
NIH Director Francis Collins has granted exceptions to those whose conditions could be severely compromised if they failed to receive their next scheduled dose.
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