ObjectiveTo determine the efficacy of the thrombopoietin receptor agonist romiplostim for the prevention of temozolomide-induced thrombocytopenia in newly diagnosed glioblastoma.MethodsIn the PLATUM phase II open-label, multicenter, single-arm trial, patients diagnosed with Common Terminology Criteria for Adverse Events grade 3 or 4 thrombocytopenia during chemoradiotherapy received weekly subcutaneous romiplostim injections. PLATUM aimed at demonstrating that the percentage of thrombocytopenic patients treated with romiplostim able to complete 6 cycles of maintenance temozolomide chemotherapy exceeded 10% (p0 = 0.10; pA = 0.35). Using type I error equal to 0.05% and 95% power, 31 patients had to be recruited. According to a Fleming 2-step design with a preplanned interim analysis after recruitment of 20 patients (step 1), the trial was terminated early for success.ResultsTwenty patients were enrolled in step 1. Median age was 61 years (range 33–73). Twelve patients received 6 temozolomide cycles, corresponding to a success rate of 60% (95% confidence interval 36%–81%). Four patients discontinued temozolomide because they did not respond to romiplostim, 2 for progression, and 2 for adverse events unrelated to romiplostim.ConclusionThe thrombopoietin receptor agonist romiplostim improves exposure to chemotherapy in patients with glioblastoma experiencing temozolomide-induced thrombocytopenia.Clinicaltrials.gov identifierNCT02227576.Classification of evidenceThis study provides Class IV evidence that for patients with glioblastoma and thrombocytopenia, romiplostim is effective for the secondary prophylaxis of temozolomide-induced thrombocytopenia.

Objective: To evaluate, using indicators, the impact of an oncology-monitoring program on activity and organizational fluidity in a Cytotoxic Preparation Unit (CPU) and clinical departments. To identify positive and negative points of this program. Method: Collection of clinical and biological data between two injections by calling up the patient two days prior chemotherapy is performed by a specialist nurse of an outsourced medical call center. Data security is guaranteed by a licensed healthcare data host. After medical and pharmaceutical validation, early preparations (D-1) for expensive and non-expensive molecules are performed. Results: The program started in February 2016. After 4 months, 430 patients were included into the program. 23 patients on average are called per day related to 1860 completed clinical questionnaires (87 %). 47 % of files are complete at D-2 (biological and clinical data). The early preparation rate of expensive drugs, zero before the program, has reached 37 % at 4 months. The destroyed preparation rate because of non-administration decreased from 5 % to 2 %. Discussion: Preliminary results show a significant patient compliance, feasibility of early preparation of expensive and non-expensive chemotherapy. These are preliminary results of a one year study. They will be completed by an evaluation of patients' and health professionals' satisfaction, reduction of waiting time, optimization of operations for clinical departments and CPU. The D-2 biological data collection is the significant difficulty and limits efficiency of this program. A reorganization of professional practices and a strong doctor /pharmacist collaboration are essential for better patient care pathway.