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In case of dose reductions, dose re-escalation was not allowed.
Adverse events were the most common reason for dose reductions, dose interruptions, and cycle delays.
One possible explanation is that the higher incidence of some adverse events in the sunitinib arm required more dose reductions, dose interruptions, and cycle delays, leading to a shorter overall median duration of treatment in the sunitinib arm.
All other patients required dose reductions, dose delays or the chemotherapy was stopped early because of neutropenic sepsis (11 patients), mucositis (eight), line problems (six), personal reasons (three), progressive disease (two) and others (six), including Herpes zoster infection and a chest infection.
Factors previously reported to protect against CIN and FN in any cycle of chemotherapy, such as dose reductions, dose delays, or growth factor use before an event occurred, could not be investigated since the details, reasons, and timing information were not available and only 15 out of 994 patients received primary prophylaxis with GCSF, mainly due to reimbursement criteria.
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A total of 424 (29·5%) patients had at least one dose reduction (dose level −2 through −4), with 306 patients requiring one dose reduction, 89 patients requiring two dose reductions, 28 patients requiring three dose reductions, and one patient requiring four dose reductions (the first dose reduction level for this patient was 20 mg).
Overall, adverse events were reversible and manageable with dose reduction, dose delay or treatment interruption and with symptomatic treatment.
Dose reductions and dose delays up to 2 weeks were permitted to manage drug-related toxicities.
These advantages include increased accuracy, higher resolution, scan-time reduction, and dose reduction.
Dose reductions were not considered as dose-limiting toxicities.
Dose reductions were carried out and described previously. 2 No dose escalation was allowed after a dose reduction, and no dose reduction of rituximab was required.
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