COVID-19 and radiation oncology: the experience of a two-phase plan within a single institution in central Italy.

BACKGROUND: COVID-19 in Italy has led to the need to reorganize hospital protocols with a significant risk of interruption to cancer treatment programs. In this report, we will focus on a management model covering the two phases of the COVID-19 emergency, namely lockdown-phase I and post-lockdown-phase II. METHODS: The following steps were taken in the two phases: workload during visits and radiotherapy planning, use of dedicated routes, measures for triage areas, management of suspected and positive COVID-19 cases, personal protective equipment, hospital environments and intra-institutional meetings and tumor board management. Due to the guidelines set out by the Ministry of Health, oncological follow-up visits were interrupted during the lockdown-phase I; consequently, we set about contacting patients by telephone, with laboratory and instrumental exams being viewed via telematics. During the post-lockdown-phase II, the oncological follow-up clinic reopened, with two shifts operating daily. RESULTS: By comparing our radiotherapy activity from March 9 to May 4 2019 with the same period in 2020 during full phase I of the COVID-19 emergency, similar results were achieved. First radiotherapy visits, Simulation Computed Tomography and Linear Accelerator treatments amounted to 123, 137 and 151 in 2019 compared with 121, 135 and 170 in 2020 respectively. There were no cases of COVID-19 positivity recorded either in patients or in healthcare professionals, who were all negative to the swab tests performed. CONCLUSION: During both phases of the COVID-19 emergency, the planned model used in our own experience guaranteed both continuity in radiotherapy treatments whilst neither reducing workload nor interrupting treatment and, as such, it ensured the safety of cancer patients, hospital environments and staff.

Bioequivalence study of two tablet formulations of ramipril in healthy volunteers.

This study was conducted in order to assess the bioequivalence of a test and reference tablet formulation containing 10 mg of ramipril ((1S,5S,7S)-8-[(2S)-2-[[(1S)-1-ethoxycarbonyl-3-phenyl-propyl]amino]propanoyl]-8-azabicyclo[3.3.0] octane-7-carboxylic acid, CAS 87333-19-5). Forty healthy male and female volunteers were treated in a single-centre randomised, single-dose, open-label, 2-way crossover study, with a washout period of 35 days between treatments. Plasma samples were collected up to 168 h post-dosing for the determination of ramipril and its active metabolite, ramiprilat, by LC-MS/MS. The evaluation of bioequivalence was based on the following pharmacokinetic parameters that were calculated by standard non-compartmental methods: the area under the plasma concentration-time curve from zero to the time of the last quantifiable concentration (AUCt) and that extrapolated to infinity (AUC) and the maximum observed concentration (Cmax). The 90% confidence interval of the ratios (test/reference) (obtained by analysis of variance, ANOVA) were 0.83-1.20 for Cmax of ramipril, 0.90-1.10 for Cmax of ramiprilat, 0.95-1.23 for AUC(0-48) of ramipril, 0.97-1.11 for AUC(0-168) of ramiprilat, 0.96-1.23 for AUC of ramipril and 0.98-1.15 for AUC of ramiprilat, i.e. within the predefined acceptable range for the conclusion of bioequivalence. Tmax of the test formulation was 0.67 +/- 0.33 h for ramipril and 2.28 +/- 0.74 h for ramiprilat; Tmax of the reference formulation was 0.71 +/- 0.32 h for ramipril and 2.40 +/- 0.88 for ramiprilat. The ramipril and ramiprilat Tmax values estimated for the test and the reference formulations were not significantly different (p-value > 0.05). The study indicated that the test and reference formulations containing 10 mg of ramipril were equivalent in terms of both the rate and extent of bioavailability.

Efficacy and safety of piroxicam patch versus piroxicam cream in patients with lumbar osteoarthritis. A randomized, placebo-controlled study.

UNLABELLED: In order to assess the efficacy and safety of a new patch containing 14 mg of piroxicam (CAS 36322-90-4) 1%, applied once daily, in comparison with a reference marketed formulation, piroxicam 1% cream applied three times a day, placebo patch applied once daily, a randomized, placebo-controlled, parallel-group clinical trial was carried out by general practitioners in patients with lumbar osteoarthritis aged between 18 and 75 years. Pain during daily activities scored on a 100 mm visual analogue scale was the primary outcome measure. Other secondary outcome measures were pain on isometric contraction, on full passive motion, and on pressure, and functional disability. Statistical analysis was performed on the differences between the three groups in the intention-to-treat population (ITT). One hundred and eighty patients were enrolled. The available ITT population comprised 179 patients. The compliance was very good. Decrease in pain score during daily activities after the eight days of study treatment (at the final visit, Vf) was 42.2%, 41.7% and 25.8% in the piroxicam patch, piroxicam cream and placebo groups, respectively. The difference between the pain scores in two active treatments arms was not statistically significant at the Vf whereas the differences between the pain scores of two active treatment arms vs the placebo arm were statistically significant validating the study design. All efficacy measures improved during the study, for both the active treatment groups, and the results for the secondary efficacy variables were generally consistent with those concerning the main efficacy criterion. The difference between the two active treatments in pain during daily activities were statistically significant at the final visit; in fact the 95% CI of the difference between the mean of responder rate of the piroxicam patch and piroxicam cream was -18.3%, +24.4% indicating a trend of superiority of the piroxicam patch versus the cream (per-protocol analysis). The data obtained during the intermediate visit (V2, day 4) allow us to assess that the piroxicam patch was on average better than the piroxicam cream in terms of fast pain reduction (change from baseline: - 29.1% for piroxicam patch in comparison to -24.6% for piroxicam cream). Moreover the piroxicam patch proved to be on average more effective than the piroxicam cream in terms of secondary efficacy endpoints. Safety was considered satisfactory in all groups. CONCLUSIONS: The piroxicam patch is effective in the treatment of lumbar osteoarthritis and has demonstrated to be well tolerated and it improves patients compliance. The piroxicam patch offers a comparable alternative to the marketed piroxicam cream for the treatment of lumbar osteoarthritis with the advantage of a better compliance with the once a day application of the patch compared to three daily applications for the piroxicam cream.