Tedizolid has demonstrated its efficacy and safety in clinical trials; however, data concerning its tolerability in long-term treatments are scarce. The aim of the study was to assess the indications and to describe the long-term safety profile of tedizolid. A multicentric retrospective study of patients who received tedizolid for more than 6 days was conducted. Adverse events (AEs) were identified from patients’ medical records and laboratory data. The World Health Organization causality categories were used to discern AEs that were probably associated with tedizolid. Eighty-one patients, treated with tedizolid 200 mg once daily for a median (interquartile range [IQR]) duration of 28 (14 to 59) days, were included; 36 (44.4%) had previously received linezolid. The most common reasons for selecting tedizolid were to avoid linezolid potential toxicities or interactions (53.1%) or due to previous linezolid-related toxicities (27.2%). The most common indications were off-label, including prosthetic joint infections, osteomyelitis, and respiratory infections (77.8%). Overall, 9/81 patients (11.1%) experienced a probably associated AE. Two patients (2.5%) developed gastrointestinal disorders, 1 (1.2%) developed anemia, and 6 developed thrombocytopenia (7.4%) after a median (IQR) duration of treatment of 26.5 (17 to 58.5) days. Four (5%) patients discontinued tedizolid due to AEs. Among 23 patients with chronic renal failure (CRF), the rate of myelotoxicity was 17.4%, and only 8.7% had to stop tedizolid; 20 out of 22 with previous linezolid-associated toxicity had no AE. Long-term tedizolid treatments had good tolerance with rates of gastrointestinal AE and hematological toxicity lower than those reported with linezolid, particularly in patients with CRF and in those with a history of linezolid-associated toxicity.

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BackgroundThe MAPK-pathway is a signal transduction cascade involved in the uncontrolled proliferation of many cancers. Mutations that activate these pathways occur in more than 90% of melanomas. This has led to the development of dabrafenib and vemurafenib (target V600E/K BRAF), and trametinib and cobimetinib (target MEK1/2).PurposeTo describe our experience in terms of effectiveness and safety in the use of BRAF/MEK inhibitors in metastatic melanoma (MM) with an activated MAPK-pathway.Material and methodsRetrospective observational study including patients with MM who received treatment with dabrafenib, trametinib, vemurafenib and/or cobimetinib.Clinical data were collected from electronic patients’ medical records, from the treatment prescription until May 2017, including: age, sex, ECOG, prior immunotherapy and chemotherapy lines, toxicity and treatment discontinuation.Response was measured as the time period from the start of treatment to the date of documentation of progression or lost to follow-up (PFS).ResultsThis study comprised 62 BRAF mutated patients (48.39% males) with a median age of 55 years (18–89) and a medium ECOG of 1 (47%). 16.13% received prior immunotherapy.Forty-seven per cent of patients were treated with dabrafenib +trametinib, 16% with vemurafenib +cobimetinib, 13% with dabrafenib, 11% with vemurafenib and 13% were combinations.Sixty-eight per cent of BRAF/MEK inhibitors were prescribed as a first-line treatment, 26% as second line and 3% as a third or more lines.Adverse events (AE) reported were: skin disorders (80%), elevated liver enzymes (64%), asthaenia/myalgia (59%), gastrointestinal disorders (55%), fever (36%), anaemia/neutropenia (23%) and ocular disorders (22%). Most of the AE were classified as grade 1–2 according to the Common Terminology Criteria for Adverse Events version 4.0.Fifty-two per cent of treatment discontinuations were due to disease progression, 22.58% toxicity and 8.06% death.Data of median PFS are available for 54 patients: 5.8 months for dabrafenib, 5.4 months for dabrafenib +trametinib, 1.34 months for vemurafenib and 7.48 months for vemurafenib +cobimetinib. These results are inferior compared with the pivotal studies.ConclusionThe majority of BRAF-mutated patients in our hospital with MM began with BRAF/MEK inhibitors as first-line treatment. AE were frequent, but manageable. PFS was lower than the pivotal studies. However, we need information on more patients to confirm these results.No conflict of interest

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Introduction Cytarabine is one of the main chemotherapy drugs used to treat hematological malignancies. Neurotoxicity is an increasingly recognized adverse effect of high-dose cytarabine therapy and occurs in 10% to 25% of patients. There is very little experience with cytarabine retreatment following neurotoxicity. Case report We report a case of a man who was diagnosed with chemotherapy-induced cerebellar syndrome. He was treated with high doses of cytarabine. Management and outcome The patient was successfully retreated at full dose after experiencing cytarabine-induced cerebellar toxicity during the first cycle of a chemotherapy regimen. He did not develop any neurological complications and successfully underwent hematopoietic stem cell transplantation. He is currently in complete remission and free of disease. Discussion This original case report assesses the possibility of retreatment without the need for dose reduction.

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