A po dose of 600,000 IU of D₂ or D₃ is initially more effective in increasing serum 25(OH)D than the equivalent im dose and is rapidly metabolized. Our RIA assay for 1,25(OH)₂D may not recognize 1,25(OH)₂D₂.
This study was performed to investigate the effect of monthly oral administration of 500 μg of calcidiol (25-hydroxyvitamin D(3)) for 4 months on both serum vitamin D levels and sequential changes of parameters of calcium metabolism; 18 normal women aged 24-72 years were investigated. There was a significant increase of serum 25(OH)D after the first administration; thereafter all values persisted significantly higher compared to the basal value (P < 0.001). Mean 1,25(OH)(2)D serum levels peaked at day 3 and then tended to stabilize following day 30. During the first month, all mean values observed following the initial administration were significantly higher than basal values. The first calcidiol dose produced a significant reduction of serum PTH levels (P < 0.001), which then remained constant over time. Concerning serum calcium and phosphorus, we were not able to demonstrate any significant change during the entire observation period. Considering the single values for both serum ionized and total calcium, the values of Ca(2+) exceeded upper limits of normal on only two occasions. Regarding biochemical markers of bone remodeling, mean changes of serum bone isoenzyme of alkaline phosphatase activity showed a significant trend to decrease, starting at day 30. No significant changes of serum CTX values were noted. Overall, 24-h urinary excretion of calcium did not change, seven values exceeding the threshold of 4 mg/kg body weight. Monthly administration of 500 μg of 25-hydroxyvitamin D(3) may be considered an alternative for vitamin D repletion, without any detrimental effect.
Aims and objectives
To assess the effectiveness of a specific home care nursing programme in addition to standard care in patients (pts) receiving oral anticancer treatments.
Background
Oral anticancer therapy present challenges for pts since treatment is a home‐based therapy. This study evaluates the potentiality of a home care nursing programme in decreasing hospital accesses for not severe toxicity.
Methods
This is an open‐label, multicentre, randomised trial including pts who were receiving an anticancer oral drug. The study complies with the CONSORT checklist published in 2010. Concomitant use of radiation therapy, intravenous or metronomic therapies, or the intake of previous oral drugs was not allowed. Pts were randomly assigned to home care nursing programme (A) or standard care (B). In arm A, dedicated nurses provided information to pts, a daily record on which pts would take note of drugs and dosages and a telephone monitoring during the first two cycles of therapy. The primary outcome was the reduction in improper hospital accesses for grade 1–2 toxicity according to CTCAE v4.0.
Results
Out of 432 randomised pts, 378 were analysed (184 pts in arm A and 194 in arm B). Hospital accesses were observed in 41 pts in arm A and in 42 pts in arm B (22.3% vs. 21.6%, respectively). No difference was detected in proportion of improper accesses between arm A and arm B (29.3% vs. 23.8%, respectively).
Conclusions
Our experience failed to support the role of a specific home care nursing programme for pts taking oral chemotherapy. An improved attention to specific educational practice and information offered to pts can explain these results.
Relevance to clinical practice
Our results underline the role of nurse educational practice and information offered to patients. A careful nurse information of patients about drugs is essential to reduce toxicities avoiding the opportunity of a specific home monitoring.
8513 Background: Systemic chemotherapy in MPM is inevitably followed by relapse, and response rates to second line treatment are limited. T is an antineoplastic agent targeting both the malignant cells and the tumor microenvironment with demonstrated activity against a range of tumors. We aimed to study the activity and safety of T in advanced MPM. Methods: ATREUS, an Italian multicenter single arm phase II trial, assessed the activity T in MPM evaluating the proportion of patients responding to treatment and achieving progression free survival for 12 weeks (PFS12w). Pre-treated epithelioid and naive or pre-treated biphasic/sarcomatoid pts were treated until progression or unacceptable toxicity. Initial dose was 1.3 mg/m2, over 3 hours every 21 days, later reduced to 1.1 mg/m2to improve tolerability. In the epithelioid cohort, sample size was based on a Simon's Optimal Two-Stage Design. The study was set to reject, at an alpha error of 10% the hypothesis that PFS12w was ≤25% and to demonstrate, with a power of 85% the hypothesis that PFS12w was ≥40%. At least 20 out of 62 pts with assessed disease, no major protocol violations, either receiving ≥12 weeks of treatment or interrupting before for progression or death (per protocol – PP analysis) were to reach PFS12w in order to consider T effective. Results: 71 pts were enrolled and evaluable. Average age was 65.8 ± 8.75 years. 71.8% were male and 82.5% presented stage III or IV disease. 42.4% (25/59) of pts included in the PP analysis obtained PFS12w (95% CI: 29.6% - 55.9%). In a second, more conservative analysis, including pts withdrawn prematurely for toxicity or intercurrent illness as failures, PFS12w rate reached 38.5% (25/65 pts). The most frequent grade ≥3 treatment-related toxicities werehepatic toxicity (60.5%), non-febrile neutropenia (21.1%), and fatigue (6.6%). Five pts (7%) interrupted treatment for toxicities (2 liver, 1 multi-organ failure, 1 thrombocytopenia, 1 T intolerance). Conclusions: In pts with advanced epithelioid MPM, second line treatment with T showed an elevated rate of disease stabilization. Safety data is promising but require further evaluation. Clinical trial information: NCT02194231.
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