In the September 2017 on-line issue of La Radiologia Medica, Splendiani et al. published a clinical study on the effects of multiple injections of the macrocyclic GBCAs gadoterate meglumine and gadobutrol on dentate nuclei T1-weighted signal intensities (SI) in patients with multiple sclerosis [1]. In the abstract, the authors concluded: "SI increases on unenhanced T1-weighted images possibly indicative of gadolinium retention occur after serial administrations of the macrocyclic GBCAs, gadoterate meglumine and gadobutrol". This conclusion is, however, not supported by the results presented in the core of the article and the abstract.The authors showed an increase in dentate nucleusto-pons (DNP) SI ratio of extremely limited amplitude: 0.0032 ± 0.0216 for gadoterate meglumine and 0.0019 ± 0.0346 for gadobutrol. This increase was shown to be non-significant, as stated in the results section and in Fig. 3: "in neither case (gadoterate meglumine and gadobutrol) was the difference significantly different from 0 (P > 0.01)".The means of the DNP SI ratios were extremely close to the minimum and far from the maximum of the 95% confidence intervals: mean [min; max] were 0.0032 [0.0025; 0.0495] for gadoterate meglumine and 0.0019 [0.0017; 0.0235] for gadobutrol. Therefore, it is likely that the values within these intervals did not follow a normal Gaussian distribution and that the statistical tests used for comparisons were not appropriate.Furthermore, the authors compared their results with those of Radbruch et al. [2] and Weberling et al. [3]. They concluded that "linear regression revealed overall similarity between our findings and those of other authors regarding macrocyclic GBCAs". The publications referenced for comparison found no significant effect on the DNP SI ratio with macrocyclic GBCAs, even following multiple injections.Contrary to these previous publications, the authors mentioned a visible T1-weighted hyperintensity in approximately one third of the patients. No specific analyses were performed to correlate hyperintensities and numbers of injections. Interestingly, the example shown in Fig. 4a, b is from a patient who received the highest level of injections, and the signal was already visible in the DN prior to injection of gadoterate meglumine.We would also like to highlight several inaccuracies or mistakes along the publication such as the use of gadoteridol name instead of gadoterate meglumine in the results section, the nonscientific representation of the Fig. 3 which shows the means of SI ratios without error bars and whose scale should be extended by a factor 10 to include such error bars, and finally the inconsistency regarding the maximum number of gadobutrol injections in Table 1 compared to the results Sections (14 vs. 15).To conclude, we consider that Splendiani et al. should have been cautious and consistent in their conclusions, as they were not fully supported by their results. The data reported in this article confirm the previous studies, showing no evidence of gadolinium retention in b...
Background: Coronavirus Disease 2019 (COVID-19) pandemic had an overwhelming impact on healthcare worldwide. Outstandingly, the aftermath on neoplastic patients is still largely unknown, and only isolated cases of COVID-19 during radiotherapy have been published. We will report the two-months experience of our Department, set in Lombardy "red-zone". Methods: Data of 402 cancer patients undergoing active treatment from February 24 to April 24, 2020 were retrospectively reviewed; several indicators of the Department functioning were also analyzed. Results: Dedicated measures allowed an overall limited reduction of the workload. Decrease of radiotherapy treatment number reached 17%, while the number of administration of systemic treatment and follow up evaluations kept constant. Conversely, new treatment planning faced substantial decline. Considering the patients, infection rate was 3.23% (13/402) and mortality 1.24% (5/402). Median age of COVID-19 patients was 69.7 years, the large majority were male and smokers (84.6%); lung cancer was the most common tumor type (61.5%), 84.6% of subjects were stage III-IV and 92.3% had comorbidities. Remarkably, 92.3% of the cases were detected before March 24. Globally, only 2.5% of ongoing treatments were suspended due to suspect or confirmed COVID-19 and 46.2% of positive patients carried on radiotherapy without interruption. Considering only the last month, infection rate among patients undergoing treatment precipitated to 0.43% (1/232) and no new contagions were reported within our staff. Conclusions: Although mortality rate in COVID-19 cancer patients is elevated, our results support the feasibility and safety of continuing anticancer treatment during SARS-Cov-2 pandemic by endorsing consistent preventive measures.
Background/aim:Low dose rate brachytherapy has been used as salvage therapy for locally recurrent prostate cancer (PC) after primary external beam radiation therapy (EBRT), along with surgery and cryotherapy. All these techniques, in particular, when applied to the whole gland, involve a relatively high risk of toxicity and may worsen the patient’s quality of life. Our aim is to evaluate the results of whole-gland salvage brachytherapy (SBT) after primary EBRT in terms of toxicity, functional outcomes, and efficacy.Materials and methods:We retrospectively reviewed clinical data on 19 patients consecutively treated with SBT at our institution between June 2012 and November 2015. Local recurrences were identified with 11C-choline positron emission tomography/computed tomography and pelvic magnetic resonance imaging after biochemical recurrence according to Phoenix criteria (prostate-specific antigen nadir + 2). Low dose rate brachytherapy was performed by 125I permanent seeds implantation to the whole prostate gland, with a prescription dose of 130 Gy. At the time of SBT, only 2 patients were receiving androgen deprivation therapy. Acute and late toxicities were recorded using the CTCAE 4.0 scoring system. Quality of life was assessed using IPSS (International Prostate Symptoms Score) and IIEF (International Index of Erectile Function) questionnaires at baseline and 6, 12, and 24 months after SBT, and the respective mean values were compared using Student t test. Biochemical relapse-free survival (BRFS) was also calculated.Results:Median follow-up after SBT was 24 months. Of 19 patients, 2 patients experienced a G3 cystitis (10.2%) and 1 patient experienced a G4 proctitis (5.3%), respectively. Mean pre-SBT IPSS scores and 6, 12, and 24 months after SBT were 5.84, 10.22, 15.72, and 8.10, respectively. Mean pre-SBT IIEF scores and 6, 12, and 24 months after SBT were 8.42, 3.55, 7.89, and 6.40, respectively. At the time of analysis, only 2 patients showed a biochemical relapse (3-year BRFS 85.2%). The Student t test demonstrated a worsening of functional outcome 6 months and 1 year after treatment but a subsequent improvement 2 years after SBT.Conclusions:Salvage brachytherapy for recurrent PC after primary EBRT seems to be a feasible treatment for selected patients. Our series revealed a severe toxicity peak 6 months and 1 year after local re-treatment and then they decrease. Early BRFS rates are good. However, these are very preliminary results so further patient accrual, long-term follow-up, and prospective trials are needed in the future.
TPS400 Background: Oligometastatic prostate cancer (OPC) may represent the initial step of an unavoidable, rapid progression to a polymetastatic state, or the expression of a real oligometastatic phenotype related to a condition of stable disease for a long time. In the last scenario, stereotactic body radiation therapy (SBRT) can be considered as a potentially curative treatment option for hormone-naïve OPC. We propose a prospective, explorative trail with the aim of identifying by liquid biopsy a molecular signature (genes or differential expression of miRNA), and related clonal evolution, underlying metastatic prostate cancer progression after a course of SBRT. Methods: Study population will be 30 adult, hormone-naïve OPC undergoing SBRT. Table 1 summarizes gene and miRNA panel for molecular analysis. For each patient, 15 ml of peripheral blood will be collected before and at the end of SBRT, every 3 months for the first year, then every 6 months until disease progression, when another blood sample will be collected in case of instrumental evidence of failure (using PET-Choline or CT-scan plus bone scintigraphy). 7.5 ml of peripheral blood will be centrifuged to separate sera and 7.5 ml of peripheral blood will be centrifuged to separate plasma from the other blood components, respectively. Sera and plasma will be stored at -20°C and centralized to CREA Laboratory at our Institution, then immediately processed for cell free DNA (cfDNA) and miRNA extraction for NGS of target genes (by Illumina platforms MiSeq and MiniSeq) and dPCR analysis. Study duration will be 36 months. This protocol has been written and will be conducted in agreement with either the Declaration of Helsinki and subsequent amendments and ICH Harmonized Tripartite Guideline for Good Clinical Practice, and has received approval of local Ethics Committee. Panel for analysis. [Table: see text]
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