ShorTrip Trial: A Prospective, Multicentric Phase II Single-Arm Trial of Short-Course Radiotherapy Followed by Intensified Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer.

BACKGROUND: In patients with locally advanced rectal cancer (LARC) treated with preoperative (chemo) radiotherapy and surgery, adjuvant chemotherapy is poorly feasible and its benefit is questionable. In the last years, several total neoadjuvant treatment (TNT) strategies, moving the adjuvant chemotherapy to the neoadjuvant setting, have been investigated with the aim of improving compliance to systemic chemotherapy, treating micrometastases earlier and then reducing distant recurrence. PATIENTS AND METHODS: ShorTrip (NTC05253846) is a prospective, multicentre, single-arm phase II trial where 63 patients with LARC will be treated with short-course radiotherapy followed by intensified consolidation chemotherapy with FOLFOXIRI regimen and surgery. Primary endpoint is pCR. Among the first 11 patients who started consolidation chemotherapy, a preliminary safety analysis showed a high rate of grade 3 to 4 neutropenia (N = 7, 64%) during the first cycle of FOLFOXIRI. Therefore, the protocol has been emended with the recommendation to omit irinotecan during the first cycle of consolidation chemotherapy. After amendment, in a subsequent safety analysis focused on the first 9 patients treated with FOLFOX as first cycle and then with FOLFOXIRI, grade 3 to 4 neutropenia was reported in only one case during the second cycle. AIM OF THE STUDY: The aim of this study is to assess the safety and activity of a TNT strategy including SCRT, intensified consolidation treatment with FOLFOXIRI and delayed surgery. After protocol amendment, the treatment seems feasible without safety concern. Results are expected at the end of 2024.

Total neoadjuvant treatment and organ preservation strategies in the management of localized rectal cancer: A narrative review and evidence-based algorithm.

The multimodal approach with total mesorectal excision preceded by neoadjuvant (chemo)radiotherapy represented the mainstay treatment for locally advanced rectal cancer (LARC) for a long time. However, the benefit of adjuvant chemotherapy in terms of distant relapse reduction is limited. Recently, chemotherapy regimens administered before surgery and incorporated with (chemo)radiotherapy in total neoadjuvant treatment protocols have been established as new options in the management of LARC. Meanwhile, patients with clinical complete response to neoadjuvant treatment can benefit from organ preservation strategies, aimed at sparing surgery and long-term post-operative morbidities, while preserving an adequate disease control. However, the introduction of a non-operative management in clinical practice is a matter of debate with some concerns regarding the risk of local recurrence and long-term outcomes. In this review, we discuss how these recent advances are reshaping the multimodal management of localized rectal cancer and propose an algorithm to place them in the clinical practice.

Lenvatinib Administered via Nasogastric Tube in Poorly Differentiated Thyroid Cancer.

BACKGROUND: The tyrosine kinase inhibitors (TKIs) are indicated for the treatment of locally advanced or metastatic progressive thyroid carcinoma (CDT), refractory to radioactive iodine. The following report describes the efficacy of lenvatinib administered through a nose-gastric tube (SNG) in a patient affected with a poorly differentiated thyroid carcinoma (PDTC) which determined a stenosis of the esophagus. MATERIAL AND METHODS: A patient was followed up for papillary thyroid carcinoma follicular variant (T3NxMx), subjected to total thyroidectomy and treated with iodine-131 radio metabolic therapy. Two years after surgery, following the onset of dysphonia and dysphagia, patient was submitted to a computed tomography (CT) scan of the neck that showed the presence of a lesion of 6 × 2.5 × 3.5 cm, which determined trachea deviation and cervical esophagus compression. The biopsy indicated the presence of PDTC, triggering tracheal lumen reduction and sub-stenosis of the cervical esophagus for an ab-extrinsic compression. A nose-gastric tube (SNG) was placed and lenvatinib was started at a dose of 20 mg/day, administered via this probe after opening the capsules and diluting the drug in 10 ml of saline solution. RESULTS: One month later, CT showed a significant cervical lesion reduction. Bronchoscopy confirmed tracheal infiltration, but the residual caliber was improved from 50% to 75%. At the esophagogastroduodenoscopy (EGDS), the sub stenosis of the cervical esophagus was no longer appreciated; however, a double perforation of the esophagus was found, without fistula. CONCLUSION: Lenvatinib therapy is effective also when administered via SNG. Our result is of particular relevance in the management of thyroid cancer patients, especially in the presence of subjects unable to swallow. Further studies are needed to validate the administration of lenvatinib by SNG, in order to extend the indications to this alternative administration way, beside the oral one.

Giant fibrovascular polyp of the esophagus-imaging techniques for proper treatment planning: report of two cases.

Giant fibrovascular polyps of the esophagus are rare, benign mesenchymal intraluminal lesions that arise from the cervical esophagus and can reach a very large size. Surgical excision is the treatment of choice, since endoscopic removal alone is not always feasible due to the presence of a very much vascularized stalk in most cases. We present two archetypal cases emphasizing the fact that these lesions can grow to huge masses with various and bizarre clinical presentation and they can arise (although rarely) at the level of the hypopharynx. We also aim to point out the role of imaging in defining the exact origin and characteristics of the stalk (width, vascularization) and the polyp structure (tissue components), thus providing useful information for planning the most appropriate surgical approach.

Patients' preferences about follow-up of medium size polyps detected at screening CT colonography.

PURPOSE: To evaluate patients' preferences regarding follow-up of medium size polyps detected at screening CT colonography (CTC). METHODS AND MATERIALS: 193 C-RADS2 asymptomatic patients were asked to fill in a form explaining the indications, technique and potential complications of CTC, and were invited to choose their preferred examination technique (CTC or optical colonoscopy: OC) and their follow-up interval by repeated consultations at 3-month intervals. The follow-up interval for CTC and OC was recorded. RESULTS: 87/193 C-RADS2 patients (45.1%) accepted follow-up. Average time interval for follow-up was comparable between CTC and OC (9.00 ± 4.24 vs. 9.00 ± 4.39 months, respectively; P = 0.7188). No patients chose to undergo a 3-year follow-up with either CTC or OC. Most patients elected to have follow-up with either CTC or OC before 18 months rather than later (P = 0.0004). CONCLUSIONS: A substantial fraction of C-RADS2 patients prefer to undergo immediate OC and polyp removal rather than follow-up, and the majority of those accepting follow-up are willing to wait for less than 18 months. Such findings may suggest a revision of the proposed C-RADS2 category.

CT colonography: role of a second reader CAD paradigm in the initial training of radiologists.

PURPOSE: To evaluate the influence of CAD for the evaluation of CT colonography (CTC) datasets by inexperienced readers during the attendance of a dedicated hands-on training course. METHOD AND MATERIALS: Twenty-seven radiologists inexperienced in CTC (11 with no CTC training at all, 16 having previously reviewed no more than 10 CTC cases overall) attended a hands-on training course based on direct teaching on fifteen workstations (four Advantage Windows 4.4 with Colon VCAR software, GE; six CADCOLON, Im3D; five ColonScreen (Toshiba/Voxar) with ColonCAD™ API, Medicsight). During the course, readers were instructed to analyze 26 CTC cases including 38 colonic lesions obtained through low-dose MDCT acquisitions, consisting of 12 polyps sized less than 6 mm, 9 polyps sized between 6 and 10 mm, 12 polyps sized between 11 mm and 30 mm, and 5 colonic masses sized>3 cm. CTC images were reviewed by each reader both in 2D and 3D mode, respectively by direct evaluation of native axial images and MPR reconstructions, and virtual endoscopy or dissected views. Each reader had 15 min time for assessing each dataset without CAD, after which results were compared with those provided by CAD software. Global rater sensitivity for each lesion size before and after CAD usage was compared by means of two-tailed Student's t test, while sensitivity of each single reader before and after CAD usage was assessed with the McNemar test. RESULTS: For lesions sized<6 mm, global rater sensitivity was 0.1852±0.1656 (mean±SD) before CAD-assisted reading and 0.2345±0.1761 after CAD (p=0.0018). For lesions sized 6-9 mm, sensitivity was 0.2870±0.1016 before CAD-assisted reading and 0.3117±0.1099 after CAD (p=0.0027). For lesions sized 10-30 mm, sensitivity was 0.5308±0.2120 before CAD-assisted reading and 0.5637±0.2133 after CAD (p=0.0086), while for lesions sized>30 mm, sensitivity before CAD-assisted reading was 0.3556±0.3105 and did not change after CAD usage (p=1). Sensitivity of each single rater did not significantly differ before and after CAD for any lesion size category (McNemar test, p>0.05). Specificity was not significantly different before and after CAD for any lesion size (>96% for all size categories). CONCLUSION: CAD usage led to increased overall sensitivity of inexperienced readers for all polyps sizes, except for lesions>30 mm, but sensitivity of individual raters was not significantly higher compared with CAD-unassisted reading.

Comparison of CT colonography vs. conventional colonoscopy in mapping the segmental location of colon cancer before surgery.

Once presence of a colorectal cancer has been diagnosed, a key factor for patient's prognosis in view of surgical intervention is the correct segmental localization and resection of the tumor. The aim of this work was to compare the accuracy of the current gold standard technique, conventional colonoscopy (CC), to computed tomography colonography (CTC) in the segmental localization of tumor. Sixty-five patients (mean age 64; 45 female and 19 male) with colorectal cancer diagnosed at colonoscopy underwent CTC before surgery. In 45 out of 65 cases (69%), patients were referred to CTC after incomplete CC. Reasons were patient intolerance to CC or presence of stenosing cancer, with consistent difficulties in crossing the tract of the colon involved by the lesion. CTC allowed the complete colonic examination in 63/65 cases, since in 2 patients with an obstructing lesion of the sigmoid colon, pneumocolon could not be obtained. However, per patient and per lesion sensitivity of CTC was 100%. Difference from colonoscopy was statistically significant (P < 0.05). In terms of segmental localization of masses, CTC located precisely all lesions, while colonoscopy failed in 16/67 (24%) lesions, though six were missed for incomplete colonoscopy (9%). In the remaining 10/67 (15%) lesions, detected by colonoscopy but incorrectly located, the mismatch occurred in the rectum (n = 3), sigmoid (n = 2), descending (n = 1), transverse (n = 2), ascending colon, and cecum. Agreement between CTC and CC was fair (k value 0.62). Sensitivity, specificity, positive predictive value and negative predictive value of CTC in determining the precise location of colonic masses were respectively 100%, 96%, 85%, and 100%. CT detected hepatic (6/65 patients) and lung metastases (3/65 patients). CT colonography has better performance in the identification of colonic masses (diameter > 3 cm), in the completion of colonic evaluation and in the segmental localization of tumor. CTC should replace colonoscopy for preoperative staging of colorectal cancer.

Post-surgical follow-up of colorectal cancer: role of contrast-enhanced CT colonography.

AIM: To evaluate the role of CT colonography (CTC) in the follow-up of patients having received partial colectomy for colorectal cancer. METHODS AND MATERIALS: CTC was performed in 72 subjects with history of partial colectomy for colorectal cancer. Colectomy had been performed in the right colon (n = 18), descending colon (n = 15), sigmoid colon (n = 21), and rectum (n = 18). Patients underwent CTC following incomplete conventional colonoscopy due to intolerance to endoscope insertion or luminal stenosis. In 70 cases pneumocolon was obtained through a rectal tube, and in 2 cases through a cutaneous anastomosis. CTC datasets were analyzed in combined 2D and 3D mode. All patients in whom CTC was suggestive for or raised the suspicion of disease recurrence underwent colonoscopy in sedation for confirmation of CTC findings. RESULTS: CTC detected 7 cases of anastomotic stenosis. In 6/7 patients the stenosis was located in the sigmoid colon and in 1/7 patients at the level of the ileo-colic junction in the transverse colon. Out of these cases, four were fibrotic and three were neoplastic stenoses. In none of these cases was the CT appearance of the stenoses specific for disease recurrence, and conventional colonoscopy together with biopsy was necessary in order to characterize such findings. However, sensitivity of CTC in detecting anastomotic stenosis was 100% (7/7). One colonic mass (5 cm largest diameter) was detected in one case at the level of the proximal transverse colon in a patient with left colectomy performed 2 years before. The study of the residual colon showed 3 polyps in three patients (8, 6, and 5 mm, respectively). All CT findings were confirmed and characterized by conventional colonoscopy. In all cases the residual colon was entirely visualized by CTC with a completion rate of 100%. CONCLUSIONS: CTC is a feasible and minimally invasive method for full exploration of the colon after surgical resection allowing detection of cancer recurrence, metachronous disease, and distant metastases in one single study, and represents a valid alternative to conventional colonoscopy in this patient population.

CT colonography: same-day tagging regimen with iodixanol and reduced cathartic preparation.

The purpose of the study was to test the tagging performance and patient's acceptance of a reduced cathartic preparation, based on iodixanol and PEG, administered to patients 3 h before the exam. One hundred and thirty-two asymptomatic patients were enrolled. As colonic cleansing we used PEG macrogol 3350. For fluid tagging iodixanol was orally administered 3 h before the exam, in a total dose of 50 mL mixed with 34.8 g of PEG in 750 mL of water. Image's review showed 446 segments (56.4%) clean of feces and 346 segments (43.6%) with feces. Untagged fluid was observed in 74/706 (10.5%) segments; inhomogeneous tagging in 129/706 (16%); the average density of fluid was 1054.74 UH in the cecum-ascending colon and 905.14 UH in the descending-sigmoid colon; the average difference of density between right and left colonic segments was 149 UH, and it was statistically significant (P = 0.016). No side effects related to the consumption of Movicol were reported. Very few side effects related to the tagging solution were reported: mild nausea in 7 (0.05%) patients, mild diarrhea in 10 (0.07%). An average rank of 9 points (SD +/- 1) on a 10-point scale (10 = no discomfort, 0 = severe discomfort) resulted from the self-administered questionnaire, showing an excellent acceptance of the preparation. Same day fluid tagging with iodixanol provides an optimal fluid tagging, it is completely tolerated by the patient, and it can be performed under medical control.

Time efficiency of CT colonography: 2D vs 3D visualization.

We aimed to compare the time efficiency of three visualization methods in CT colonography and to identify the colonic factors influencing the time for interpretation. Twenty CT colonographic examinations were prospectively analysed. Three reading methods were adopted: method 1, primary 2D analysis with the use of virtual endoscopy as problem solver, method 2, primary standard virtual endoscopy with semiautomatic navigation through the colon and use of 2D images as problem solver; method 3, primary virtual endoscopy with automatic navigation and the use of 2D images as problem solver. In method 1, time for 2D analysis ranged between 6 and 18min (mean 12) for evaluation of both supine and prone decubitus with a synchronization method. In method 2, time for 3D manual navigation in supine plus prone ranged between 9 and 24min (mean 17). In method 3, time for automated navigation ranged between 6 and 20min (mean 12) for evaluation of both supine and prone decubitus. A statistically significant difference was found between time efficiency of methods 1 and 2 (p=0.009, t-test, unequal variances). Methods 2 and 3 showed a tendency to significant differences (p=0.054, t-test, unequal variances). Faecal or fluid residuals were reported as major drawbacks in 3D navigations, requiring constant correlation with 2D images; tortuous folds influenced mostly the 2D analysis; diverticula were reported as influencing factor in all three methods. No differences in sensitivity and specificity were observed between the three viewing methods. The 3D semiautomatic navigation method* tended to increase the time for interpretation in almost all cases. There is, in particular, greatest time efficiency for 2D analysis as compared with 3D manual analysis. Two-dimensional and automated 3D navigation reading have comparable time efficiencies in a routine clinical setting.

CT colonography interpretation times: effect of reader experience, fatigue, and scan findings in a multi-centre setting.

Our purpose was to assess the effect of reader experience, fatigue, and scan findings on interpretation time for CT colonography. Nine radiologists (experienced in CT colonography); nine radiologists and ten technicians (both groups trained using 50 validated examinations) read 40 cases (50% abnormal) under controlled conditions. Individual interpretation times for each case were recorded, and differences between groups determined. Multi-level linear regression was used to investigate effect of scan category (normal or abnormal) and observer fatigue on interpretation times. Experienced radiologists (mean time 10.9 min, SD 5.2) reported significantly faster than less experienced radiologists and technicians; odds ratios of reporting times 1.4 (CI 1.1, 1.8) and 1.6 (1.3, 2.0), respectively (P

Polyp measurement and size categorisation by CT colonography: effect of observer experience in a multi-centre setting.

The extent measurement error on CT colonography influences polyp categorisation according to established management guidelines is studied using twenty-eight observers of varying experience to classify polyps seen at CT colonography as either 'medium' (maximal diameter 6-9 mm) or 'large' (maximal diameter 10 mm or larger). Comparison was then made with the reference diameter obtained in each patient via colonoscopy. The Bland-Altman method was used to assess agreement between observer measurements and colonoscopy, and differences in measurement and categorisation was assessed using Kruskal-Wallis and Chi-squared test statistics respectively. Observer measurements on average underestimated the diameter of polyps when compared to the reference value, by approximately 2-3 mm, irrespective of observer experience. Ninety-five percent limits of agreement were relatively wide for all observer groups, and had sufficient span to encompass different size categories for polyps. There were 167 polyp observations and 135 (81%) were correctly categorised. Of the 32 observations that were miscategorised, 5 (16%) were overestimations and 27 (84%) were underestimations (i.e. large polyps misclassified as medium). Caution should be exercised for polyps whose colonographic diameter is below but close to the 1-cm boundary threshold in order to avoid potential miscategorisation of advanced adenomas.

CT-guided radiofrequency ablation of osteoid osteoma: long-term results.

The aim of the study was to assess the safety and efficacy of CT-guided percutaneous radiofrequency (RF) ablation of osteoid osteoma (OO). From 1997 to 2001, RF ablation was performed on 38 patients with OO, diagnosed clinically and by radiography, scintigraphy, contrast-enhanced MRI, and CT. Treatment was performed via percutaneous (n=29) or surgical (n=9) access, under CT guidance in all cases, with an 18-gauge straight electrode. Patients were discharged within 24 h and followed up clinically (at 1 week and every 6-12 months) and with MRI (at 6 months) and scintigraphy (after 1 year). The technical success rate was 100%. Complications occurred in two patients, consisting in local skin burns. The follow-up range was 12-66 months (mean +/- SD, 35.5+/-7.5 months). Prompt pain relief and return to normal activities were observed in 30 of 38 patients. Persistent pain occurred in eight patients; two patients refused further RF ablation and were treated surgically; RF ablation was repeated in six cases achieving successful results in five. One patient reported residual pain and is being evaluated for surgical excision. Primary and secondary clinical success rates were 78.9 (30/38 patients) and 97% (35/36 patients), respectively. CT-guided RF ablation of OO is safe and effective. Persistent lesions can be effectively re-treated. Several imaging modalities are needed for the diagnosis of OO and for the follow-up after treatment, particularly in patients with persistent symptoms.

Double-contrast MR colonography: in vivo experimental study in an animal model.

BACKGROUND: We evaluated the performance of double-contrast MR colonography in detecting colorectal tumors experimentally induced by chemical substances in the large bowel of the rat. MATERIAL/METHODS: Eight Sprague-Dawley rats developed 67 chemically induced tumors of the large bowel. The animals were imaged with a double-contrast MR technique at 0.5T, using a head coil for both signal transmission and reception. Prior to MR acquisition, room air was insufflated into the rats' large bowel. Unenhanced and contrast-enhanced T1, proton-density and T2 sequences were obtained in the axial and coronal planes. Autopsy was performed immediately after MR examination. MR images were interpreted by consensus of two observers, and the results were compared with post-mortem data. RESULTS: Sensitivity (60% vs. 93%), specificity (63% vs. 81%), positive (85% vs. 93%) and negative (30% vs. 81%) predictability, and global diagnostic accuracy (60% vs. 89%) were obtained for all tumors (n=67) and for the group of tumors larger than 1.5 cm (n=43), respectively. No tumors less than 1.5 cm were detected. CONCLUSIONS: Double-contrast MR colonography is a promising modality in detecting colorectal neoplasms larger than 1.5 cm in an animal tumor model.

Colorectal cancer: role of CT colonography in preoperative evaluation after incomplete colonoscopy.

PURPOSE: To evaluate computed tomographic (CT) colonography in patients with clinical suspicion of colorectal cancer and in whom colonoscopy was incomplete. MATERIALS AND METHODS: After incomplete colonoscopy, 34 patients underwent CT colonography before and after intravenous injection of iodinated contrast agent, in supine and prone positions. Twenty patients with no evidence of colon cancer after complete colonoscopy were included as a control group. Sensitivity and specificity of CT colonography were determined for detection of cancers, polyps, and metastases to liver. RESULTS: In 29 patients, surgery revealed 30 colorectal cancers (three synchronous cancers) and two ischemic lesions of the descending colon. Colonoscopy missed 10 colorectal cancers and three synchronous cancers; all were detected with CT colonography. Sensitivity and specificity for detection of colorectal cancer were 56% and 92%, respectively, for incomplete colonoscopy and 100% and 96%, respectively, for CT colonography (P <.01). Sensitivity and specificity of CT colonography in detection of polyps were 86% and 70%, respectively, for diameters of 5 mm or less; 100% and 80%, respectively, for 5-10-mm diameters; and 100% for diameters greater than 10 mm. Spiral CT of the liver revealed four metastases (2-5 cm); sensitivity and specificity were 100% and 43% for nonenhanced scans and 100% for contrast-enhanced scans (P <.01). CONCLUSION: In this selected group of patients, CT colonography provided complete information to properly address surgery of colorectal cancer and treatment of liver metastases.