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A multicenter, randomized trial of flat dosing versus intrapatient dose escalation of single-agent carboplatin as first-line chemotherapy for advanced ovarian cancer: an SGCTG (SCOTROC 4) and ANZGOG study on behalf of GCIG
Background
The aim of the study is to demonstrate that intrapatient dose escalation of carboplatin would improve the outcome in ovarian
cancer compared with flat dosing.
Patients and methods
Patients with untreated stage IC-IV ovarian cancer received six cycles
of carboplatin area under the curve 6 (AUC 6) 3 weekly
either with no dose modification except for
toxicity (Arm A) or with dose escalations in cycles 2–6 based on nadir
neutrophil
and platelet counts (Arm B). The primary
end-point was progression-free survival (PFS).
Conclusions
Intrapatient dose escalation of carboplatin based on nadir blood counts is feasible and safe. However, it provided no improvement in PFS or OS compared with flat dosing. Baseline neutrophils over-ride nadir counts in prognostic significance. These data may have wider implications particularly in respect of the management of chemotherapy-induced neutropenia.
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