Phase II trial of a novel chemotherapy regimen CVEP (cyclophosphamide, vinblastine, etoposide and prednisolone) for acquired immunodeficiency syndrome (AIDS)-associated lymphomas.

Management of acquired immunodeficiency syndrome (AIDS)-related diffuse large B-cell (DLBCL) and plasmablastic lymphomas (PBL) poses significant challenges. The evidence supports use of dose-adjusted EPOCH (etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin) with or without rituximab as first-line therapy. The need for central venous access, growth factors and significant toxicities limits its use in resource-constrained settings. To address these challenges, we have developed a novel regimen, CVEP (cyclophosphamide, vinblastine, etoposide, and prednisolone) based on the pharmacodynamic principles of dose-adjusted EPOCH. This single-centre phase II study evaluated the efficacy and safety of CVEP regimen in patients with de novo systemic AIDS-related DLBCL and PBL. The primary objective was complete response (CR) rates as assessed by positron emission tomography-computed tomography. The secondary objectives were incidence of Grade 3/4 toxicities, toxicities requiring hospitalisation, and disease-free survival. From May 2011 to February 2017, 42 patients were enrolled. At the end of therapy the CR rates were 69% (29/42) in the intention-to-treat population and 80.5% (29/36) in evaluable patients. At a median follow-up of 69 months, the 5-year disease-free survival was 65.3%. Out of 217 cycles administered, febrile neutropenia occurred in 19.3% and hospitalisation was required in 18.3% of cycles. There were two treatment-related deaths. The CVEP regimen is an active and safe regimen for AIDS-related DLBCL and PBL.

Evaluation of an all-in-one hybrid model (EUS Magic Box) for stepwise teaching and training in multiple interventional EUS procedures.

Background and study aims While multiple interventional endoscopic ultrasound (EUS)-guided procedures have evolved over the past two decades, there is no model that allows for training in all of these procedures. We aimed to develop and validate an all-in-one hybrid model for stepwise learning in multiple EUS interventions. Methods A hybrid model was created utilizing a pig esophagus and stomach, a silicon-based duodenum and pancreato-biliary system, a pseudocyst, and biopsy targets. This model was designed to provide hands-on training in multiple interventional EUS procedures, such as EUS-guided fine-needle biopsy (EUS-FNB), biliary drainage (BD), pancreatic duct drainage (PD), pseudocyst drainage (PSD), and gastro-enterostomy (GE). Thirty-six trainees underwent training on this model over 6 days, in two batches. Lumen apposing metal stents were used for PSD and GE. Trainees were assessed for objective criteria of technical difficulties. Subjective assessment by trainees was done via a questionnaire. Results All the trainees were able to complete the requisite steps for all the procedures under supervision. On subjective assessment, 30 trainees (83 %) graded the model as good or excellent. A total of 107 technical difficulties were noted (scope position 55, duct puncture 27, guidewire-related problems 25). Time taken to complete the requisite steps of biopsy, PSD, and GE (10.5 minutes; range 3.5 to 22) was significantly less than that for BD and PD (28 minutes; range 17 to 40) ( P  < 0.001). Conclusions The hybrid model provided training for multiple EUS interventions with good acceptance by trainees. Stepwise mentoring with the possibility of performing multiple procedures in a single model with or without X-ray could prove useful in conference as well as institutional settings.

Feasibility of an EUS e-training course with live cases.

Background and study aims One-on-one endoscopic ultrasound (EUS) mentorship was not possible at most institutions during the COVID-19 pandemic. We decided to test the feasibility of structured training in EUS with virtual e-classes with live cases. The aim of this study was to assess the feasibility of a virtual EUS training course with objective end points. Patients and methods Twenty-one trainees were trained on a virtual platform over 16 classes of 90 minutes each, over 3 months. The virtual training screen had two equal parts, one showing the endoscopist's hand movements, and another the resultant EUS display. The course curriculum included EUS anatomy of the mediastinum, pancreatico-biliary region and rectum. The assessment was done on videos of procedures performed by trainees. Results Twenty trainees performed 251 EUS procedures (range 8-25, mean 12.5 ±â€Š4.9) at their institutions. At the end of the course, all students (100 %) could maneuver the echo-endoscope through to the duodenum. Fifteen trainees sent a video for final assessment. The successful specified area identification rates were 12 of 15 (80 %) for the subcarinal space, 10 of15 (66.6 %) for the head of the pancreas, 10 of 15 (66.6 %) for the common bile duct, and nine of 15 (60 %) for the tail of pancreas. The success rate of ability to get appropriate windows was 10 of 15 (67 %) for the subcarinal space, eight of 15 (53.3 %) for the head of the pancreas, seven of 15 (46.6 %) for the common bile duct and six of 15 (40 %) for the tail of pancreas. No adverse events were reported. Conclusions A virtual EUS training course with live cases appears feasible. It allows the possibility of training a large number of students. Further evaluation is needed, especially of virtual assessment methods and training benchmarks.

Head and neck squamous cell carcinoma in HIV, HBV and HCV seropositive patients - Prognosis and its predictors.

INTRODUCTION: Patients receiving treatment for head-and-neck squamous cell carcinoma (HNSCC) also may have coexisting viral infections caused by HIV, HBV, and HCV (seropositive). There is scarce literature regarding the clinical presentation and treatment outcomes for these patients with coexisting viral infections (seropositive HNSCC). We conducted this study to assess the clinical presentation and treatment outcomes (overall survival [OS] and disease-specific survival [DSS]) of seropositive HNSCC patients. METHODOLOGY: This was a retrospective cohort study on seropositive HNSCC patients registered at our center from 2012 to 2014. The viral infections were identified by the presence of the antibodies to these viruses in the patient's blood samples. RESULTS: Out of the 19,137 HNSCC patients registered, 156 patients had HBV, HCV, and/or HIV infection. Among these, HBV infection was the most common (n = 86/156, 55.1%) followed by HIV infection (n = 36/156, 23.1%) and HCV infection (n = 29/156, 18.6%). The oral cavity was the most common subsite involved. Majority of these patients presented at an advanced stage (advanced T stage - 71.8% and node positive - 62.2%). The majority of the patients received curative-intent treatment (65.4%). The OS at 3 years for these HNSCC patients with coexisting HIV, HBV, and HCV infection was 60%, 62.6%, and 57.5%, respectively, and their DSS at 3 years was 58.8%, 78.6%, and 53.8%, respectively. CONCLUSIONS: Seropositive patients with HNSCC often present in the advanced stage but have a good survival if treated appropriately.

First clinical report of helical tomotherapy with simultaneous integrated boost for synchronous bilateral breast cancer.

OBJECTIVE: Radiotherapy (RT) for synchronous bilateral breast cancer (SBBC) is technically very challenging. This study reports the clinical feasibility, dosimetry and safety of helical tomotherapy (HT) with simultaneous integrated boost (SIB) in patients treated with adjuvant radiotherapy for SBBC. METHODS: 21 women with SBBC treated with HT from January 2013 to June 2016 were retrospectively evaluated. Radiation lung toxicity was assessed using pulmonary function test (PFT) and high-resolution computerized tomography scan (HRCT) scan at baseline and 1 yearpost-RT in 18 patients. Survival was calculated using Kaplan-Meier curves. Significance of the difference between pre- and post-RT PFT values was assessed using paired t-test. RESULTS: The dose prescription was 50Gy to the breast, chest wall or regional nodes and 61Gy to the tumour bed as SIB, delivered in 25 fractions. Dosimetric outcome was excellent both for target volumes and normal tissues. Acute skin and oesophageal toxicities were minimal. Symptomatic radiation-induced pnuemonitis was not observed. Subclinical radiological Grade I-II changes were apparent in 14 patients. Only one patient developed Grade III radiological change whereas no change was documented for three patients. PFTs did not show any significant change in any of the measured parameters. At a median follow-up of 25 months, 3-year disease-free survival, overall survival and loco-regional control were 65.6%, 83.3% and 85.7% respectively. CONCLUSION: Women with SBBC can be safely treated with HT and this is not associated with adverse short- to intermediate term radiation toxicity. Advances in knowledge: This is the first report that establishes the safety of HT for adjuvant RT using SIB technique in SBBC.