Search

This is a single arm phase 2 trial (Clinical trials.gov NCT05291780) to assess local control (LC) and safety of SAbR in patients with unresectable locally advanced non-small cell lung cancer (LA-NSCLC) unfit for concurrent chemo-radiation therapy (ChT-RT).Neoadjuvant ChT was prescribed in fit patients. The tumor volume included primary tumor and any regionally positive node/s. The coprimary study endpoints were LC and safety.Between December 31, 2015, and December 31, 2020, 50 patients with LA-NSCLC were enrolled. Histology was squamous cell carcinoma and adenocarcinoma (ADC) in 52% and 48%, respectively. Forty (80%) patients had ultracentral tumor. Twenty-seven (54%) received neoadjuvant ChT and 7 (14%) adjuvant durvalumab. Median prescribed dose was 45 Gy (range, 35-55) and 40 Gy (35-45) in 5 daily fractions to tumor and node/s, respectively. After a median follow-up of 38 months (range, 12-80), 19 (38%) patients had experienced local recurrence (LR) at a median time of 13 months (range, 7-34). The median LR-free survival (FS) was not reached (95% confidence interval [CI], 28 to not reached). The 1-, 2-, and 3-year LR-FS rates were 86% ± 5%, 66% ± 7%, and 56% ± 8%, respectively. At last follow-up, 33 (66%) patients were alive. Median overall survival (OS) was 55 months (95% CI, 43-55 months). The 1-, 2-, and 3-year OS rates were 94% ± 3%, 79% ± 6%, and 72% ± 7%, respectively. No patients developed ≥ grade (G) 3 toxicity. ADC (hazard ratio [HR], 3.61; 95% CI, 1.15-11.35) was a significant predictor of better LC, while OS was significantly conditioned by smaller planning target volumes (HR, 1.004; 95% CI, 1.001-1.010) and tumor, node, and metastasis stage (HR, 4.8; 95% CI, 1.34-17).Patients with LA-NSCLC treated with SABR had optimal LC and promising OS in absence of ≥G3 toxicity. Our early outcomes would suggest the feasibility of using this approach in patients with LA-NSCLC unfit for concurrent ChT-RT.

Even though systemic therapy is standard treatment for lymph node metastases, metastasis-directed stereotactic radiotherapy (SRT ) seems to be a valid option in oligometastatic patients with a low disease burden. Positron emission tomography-computed tomography (PET-CT ) is the gold standard for assessing metastases to the lymph nodes; co-registration of PET-CT images and planning CT images are the basis for gross tumor volume (GTV ) delineation. Appropriate techniques are needed to overcome target motion. SRT schedules depend on the irradiation site, target volume and dose constraints to the organs at risk (OARs) of toxicity. Although several fractionation schemes were reported, total doses of 48-60 Gy in 4-8 fractions were proposed for mediastinal lymph node SRT, with the spinal cord, esophagus, heart and proximal bronchial tree being the dose limiting OAR s. Total doses ranged from 30 to 45 Gy, with daily fractions of 7-12 Gy for abdominal lymph nodes, with dose limiting OARs being the liver, kidneys, bowel and bladder. SRT on lymph node metastases is safe; late side effects, particularly severe, are rare.

Purpose A prospective observational multicentre trial was carried out to assess the incidence, pattern, and prognostic factors of radiation-induced emesis (RIE), and to evaluate the use of antiemetic drugs in patients treated with radiotherapy or concomitant radio-chemotherapy. The application in clinical practice of the Multinational Association of Supportive Care in Cancer guidelines was also studied. Materials and methods Forty-five Italian radiation oncology centres took part in this trial. The accrual lasted for 3 consecutive weeks and only patients starting radiotherapy or concomitant radio-chemotherapy in this period were enrolled. Evaluation was based on diary card filled in daily by patients during treatment and one week after stopping it. Diary card recorded the intensity of nausea/vomiting and prophylactic/symptomatic antiemetic drug prescriptions. Results A total of 1020 patients entered into the trial, and 1004 were evaluable. Vomiting and nausea occurred in 11.0% and 27.1% of patients, respectively, and 27.9% patients had both vomiting and nausea. In multifactorial analysis, the only statistically significant patient-related risk factors were concomitant chemotherapy and previous experience of vomiting induced by chemotherapy. Moreover, two radiotherapy-related factors were significant risk factors for RIE, the irradiated site (upper abdomen) and field size (>400 cm2). An antiemetic drug was given only to a minority (17%) of patients receiving RT, and the prescriptions were prophylactic in 12.4% and symptomatic in 4.6%. Different compounds and a wide range of doses and schedules were used. Conclusions These data were similar to those registered in our previous observational trial, and the radiation oncologists’ attitude in underestimating RIE and under prescribing antiemetics was confirmed.

To assess the role of Ultrasound (US), US Color Doppler (CD) and Power Doppler (PD) in the diagnosis and in the follow-up of renal graft pathology by evaluating morphological and functional features of the vasculature and comparing these to other clinical parameters.From January 1990 to June 2000, four hundred and thirty-six renal allograft recipients (mean age 45 years) underwent periodical US, CD and PD (mean follow-up 48 months) to evaluate morphology and perfusion of the graft. Resistive index (RI) and pulsatility index (PI) were measured in order to monitor flow variations from the renal to the arcuate arteries. PD was used mainly to study the morphology of the cortical vessels. The examinations were performed on an Esaote Biomedica AU-4/5 (Genoa, Italy) using a convex 3.5 MHz probe and a linear 7.5 MHz probe. On the basis of clinical data the patients were divided into 3 groups: A) Normal, B) Acute graft dysfunction, C) Chronic allograft nephropathy. In 87 patients (20%) percutaneous biopsy or FNAB was performed. RI and PI mean values +/-SD were calculated and compared to the other diagnostic parameters considered: serum creatinine level, US morphology, CD and PD vascularization. Finally RI and PI for each group were compared using the t -test in order to determine the statistical significance of the correlation between these indices and the patients clinical conditions.The 436 patients were divided as follows: Group A) 170 patients (39%); Group B) 105 patients (24%); Group C) 161 patients (37%). Urological and surgical complications were ruled out in all patients. RI and PI showed a similar trend exceeding cut-off values in Group B) and C) with highest peaks in Group B. Statistical analysis demonstrated the efficacy of this method in the differentiation between normal and pathological grafts, but there was a reduced statistical difference between the two pathological groups. Histological analysis performed on 87 patients (20%) showed good correlation with RI.CD is a non-invasive diagnostic method which provides flow-metric quantitative parameters for the hemodynamic assessment of the renal transplant. These values present a certain sensitivity but are not specific of renal graft dysfunction, as there is no reliable differentiation between acute rejection and other parenchymal pathologies. During the follow-up, RI and PI have no predictive value. RI variations from renal artery to cortical vessels (hylum-cortical ratio) show a good correlation with the clinical evolution of the transplant. The evaluation of RI and PI can generally be limited to renal and interlobar arteries as arcuate sampling is necessary only when the hylum-cortical ratio shows reduction or inversion. Integration of clinical and instrumental diagnoses can reduce the number of biopsies.

To prove the diagnostic value of color Doppler US in the evaluation of perianal external fistulae, using an endocavitary probe and a saline solution injection, in order to show the location of the fistulae, their extension, possible secondary tracts, residual abscesses and the relationship with adjacent tissues.From October 1999 to December 1999, thirty-five consecutive patients (21 males and 14 females, mean age 47.5) affected with Crohn's disease were examined prospectively. These patients presented postoperative recurring external perianal fistulae. From this first group, 10 patients (6 males and 4 females, mean age 45) were selected as the external fistula was open. A biplanar transrectal 7.5 MHz probe was used for the examination. First the external opening of the fistula was cannulated with a soft plastic catheter. Then the probe, covered with a lubricated condom filled with US gel, was introduced into the anal canal (males) or the vagina (females). An initial gray-scale US study was performed. Finally the color-box was positioned on the tract, the Pulse Repetition Frequency (PRF) adjusted and the saline solution introduced. The study was completed with axial and linear scans.The mean examination duration was 31 minutes. Only two patients found the examination annoying because of partial anorectal stricture. The wall layers and their thickness were clearly located and distinguished. Gray-scale US showed the local anatomy in all patients. In 4 patients it depicted the primary fistula as a thin hypoecoic line (40%, three intersphinteric and one transphinteric). Color Doppler US detected the fistula in all patients (100%, seven intersphinteric and three transphinteric). Moreover it showed 2 small secondary tracts in 2 patients. No abscesses were found at the time of the examination. In the patients who underwent a second operation, surgical findings showed a good correlation (90-100%) with color Doppler findings.This study demonstrated a greater diagnostic value of endosonography with color Doppler and saline solution injection as compared to conventional gray-scale endosonography in the evaluation of fistulae. Since this technique is also cost-effective and well tolerated by most patients we conclude that at present it makes an important diagnostic tool in the preoperative assessment of perianal fistulae.

Aim of our study was to assess the accuracy of diagnostic imaging in establishing site, morphology and size of the neoplasm comparing surgical specimens or endoscopic examination with esophagograms and CT in patients with esophageal cancer. CT accuracy in defining TNM staging was also evaluated.From 1993 to 2000 we examined 39 patients with esophageal cancer: 30 males (77%) and 9 females (23%), age range 41-85 years. All patients underwent esophagogram, digestive endoscopy, and chest and abdominal CT. In 22 patients who underwent surgery, we evaluated the correlation between diagnostic imaging and surgical specimens. Patients were divided into 3 groups on the basis of discrepancy between pathological and radiological measurements: =/1 cm (considered as no discrepancy); 1 to 3 cm;3 cm.Esophagogram identified neoplasm in 38 patients out of 39, while CT identified neoplasm in all patients. Location and morphology of the neoplasm established at endoscopy were confirmed in all patients. Lesion length measured at esophagogram corresponded to length of surgical specimens in 13 of the 22 surgically treated patients (59%). In this group there was a dominance of polypoid and stenotic tumor forms. In the remaining 9 cases there was a dominance of ulcerative tumor forms. CT measurement corresponded in 7 patients (32%) with a dominance of polypoid and stenotic tumor forms. T staging performed with CT corresponded to surgical specimens in 12 patients (54%, T3-T4). N staging correlated in 19 patients (86%). CT identified distant metastases in 6 patients (27%).Our study proves a high sensitivity of esophagogram and CT in the diagnosis of esophageal carcinoma. Esophagogram presented a higher accuracy in establishing tumor length (59% of cases, as compared to CT 32%). Tumor morphology influenced the accuracy of the esophagogram, and highest accuracy was obtained in polypoid and stenotic tumors. T staging performed with CT corresponded to surgical specimens in advanced stages (T3-T4), while accuracy was poorer in smaller superficial lesions (T1-T2) due to the inability of CT to differentiate the layers of the esophageal wall. N understaging in 14% of cases did not modify surgical management. CT presented a high sensitivity in the identification of loco-regional lymph nodes and identified distant metastases in 6 patients. In conclusion, these techniques are accurate and non-invasive and their role in establishing the correct management is therefore important.

Aim of this study is to describe the main characteristics of the European projects IAEVA II and HERMES whose principal objective is to render the already functioning computer systems more efficient. The medical environment is in continuous need of faster and better ways of communication, particularly in a radiological context, and this work therefore presents the above projects mainly from a radiological point of view.

To evaluate survival outcomes of patients in pStage II-III rectal cancer treated with adjuvant 5-fluorouracil-based radiochemotherapy and to retrospectively analyze the impact of prognostic variables on local control, metastasis-free survival and cause-specific survival.A total of 1,338 patients, treated between 1985-2005 for locally advanced rectal cancer, who underwent surgery and postoperative 5-fluorouracil-based chemoradiation, were selected.The actuarial 5- and 10-year outcomes were: local control 87.0%-84.1%, disease-free survival 61.6%-52.1%, metastasis-free survival 72.0%-67.2%, cause-specific survival 70.4%-57.5%, and overall survival 63.8%-53.4%. Better outcomes were observed in patients with IIA, IIIA stage. Multivariate analyses showed that variables significantly affecting metastasis-free survival were pT4 and pN2, while for cancer-specific survival those variables were age65 years, pT4, pN1, pN2, distal tumors and number of lymph nodes removed ≤ 12.This study confirmed that among stage II-III rectal cancer patients there are subgroups of patients with different clinical outcomes.