Background We describe the feasibility and safety of an oral administration schedule of hydration, alkalinization and leucovorin rescue with an ambulatory high-dose methotrexate regimen. Methods Single-centre prospective observational study conducted within a tertiary hospital where all patients have received systemic high-dose methotrexate (3.5 g/m2). Patients were instructed to keep an adequate ambulatory oral hydration and alkalinization to monitor urine pH and to adjust bicarbonate according to our institution's treatment protocol. High-dose methotrexate was infused over 4 h. Urine pH was checked before high-dose methotrexate administration, and for any value less than 7 a sodium bicarbonate bolus was given. Leucovorin at a standard dose was begun 24 h after high-dose methotrexate. methotrexate serum concentrations were monitored daily from 24 h after administration until clearance (level ≤ 0.1 µmol/L). Results From January 2016 to June 2018, 49 ambulatory high-dose methotrexate courses were given to 18 patients. No dose reduction was required afterwards. All patients completed succesfully the planned three doses in an outpatient basis, except four patients, one of them due to pneumonitis. Previous to methotrexate infusion, urinary pH > 7 was achieved in 35 (79.5%) cycles. Methotrexate clearance was achieved by 72 h in 35 courses (71.4%), and by 96 h in 100%. Neutropenia/trombocytopenia grades III/IV were observed in four cycles (8.16%) and two (4.08%) cycles, respectively. Around 20.40% were associated with stomatitis, 14.20% vomiting, 10.20% asthenia, 8.16% diarrhea and 6.12% with renal toxicity. Conclusions Ambulatory administration of high-dose methotrexate as CNS prophylaxis is safe and feasible following the described approach, allowing us to optimize healthcare resources.
BackgroundIn Spain, hospital medicines are assessed and selected by local Pharmacy and Therapeutics committees (PTCs). Of all the drugs assessed, cancer drugs are particularly important because of their budgetary impact and the sometimes arguable added value with respect to existing alternatives. This study analyzed the PTC drug selection process and the main objective was to evaluate the degree of compliance of prescriptions for oncology drugs with their criteria for use.MethodsThis was a retrospective observational study (May 2007 to April 2010) of PTC-assessed drugs. The variables measured to describe the committee’s activity were number of drugs assessed per year and number of drugs included in any of these settings: without restrictions, with criteria for use, and not included in formulary. These drugs were also analyzed by therapeutic group. To assess the degree of compliance of prescriptions, a score was calculated to determine whether prescriptions for bevacizumab, cetuximab, trastuzumab, and bortezomib were issued in accordance with PTC drug use criteria.ResultsThe PTC received requests for inclusion of 40 drugs, of which 32 were included in the hospital formulary (80.0%). Criteria for use were established for 28 (87.5%) of the drugs included. In total, 293 patients were treated with the four cancer drugs in eight different therapeutic indications. The average prescription compliance scores were as follows: bevacizumab, 83% for metastatic colorectal cancer, 100% for metastatic breast cancer, and 82.3% for non-small-cell lung cancer; cetuximab, 62.0% for colorectal cancer and 50% for head and neck cancer; trastuzumab, 95.1% for early breast cancer and 82.4% for metastatic breast cancer; and bortezomib, 63.7% for multiple myeloma.ConclusionThe degree of compliance with criteria for use of cancer drugs was reasonably high. PTC functions need to be changed so that they can carry out more innovative tasks, such as monitoring conditions for drug use.
Aim Assess the effectiveness and safety of nivolumab versus cetuximab in
patients with R/M HNSCC, as well as to analyze possible prognostic
factors for response to treatment with nivolumab. Methods We conducted
an observational, retrospective, descriptive study of patients with R/M
HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in
two periods of equivalent duration. Overall efficacy was measured in
progression-free survival (PFS) and overall survival (OS); safety was
evaluated using the CTCAE (Common Terminology Criteria for Adverse
Events) classification version 5.0 of the National Cancer Institute
(NCI). Results Median overall survival (OS) was 9.1 months with
nivolumab (n=34) vs. 6.3 months with cetuximab (n=12)(HR=0.5; 95%CI:
0.24-1.03; p=0.058). Progression free survival (PFS) were 4.3 for
nivolumab and 4.65 months for cetuximab (HR=0.59; 95%CI: 0.29-1.19;
p=0.14). Any grade adverse events (AEs) were reported in 97% and 100%
of the patients treated with nivolumab and cetuximab. Serious AEs were
observed in 26% and 58% of the patients respectively. Elevated albumin
values, lymphocytosis, neutropenia and elevated neutrophil/lymphocyte
ratio values have positive prognostic value on the response to nivolumab
in R/M CCECC. Conclusion Effectiveness of nivolumab in terms of OS
remains superior to cetuximab. OS, PFS and severe or any grade AEs were
superior in both arms of our study than in the clinical trials. The AEs
profile of nivolumab differs in our study from the clinical trials’
observations. We have identified four positive statistically significant
prognostic variables on the response to nivolumab in R/M HNSCC.
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