Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide.

PURPOSE: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. PATIENTS AND METHODS: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). RESULTS: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non-G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non-G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). CONCLUSION: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.     

Imaging of subcapsular hepatic and renal hematomas in pregnancy complicated by preeclampsia and the HELLP syndrome

The purpose of this report is to provide an illustrative case of spontaneous hepatic and renal hematomas that occurred during a pregnancy complicated by preeclampsia and the HELLP (hemolysis, elevated liver enzymes, and low platelet count) syndrome. The sonographic and computed tomographic findings included intrahepatic, subcapsular hepatic, and extracapsular perihepatic hematomas in addition to a large subcapsular renal hematoma. Since hepatic and renal hematomas that occur in association with preeclampsia and the HELLP syndrome are rare but potentially life‐threatening complications, prompt laboratory and radiologic evaluations are essential and may reduce the associated morbidity and mortality. © 1999 John Wiley & Sons, Inc. J Clin Ultrasound 27:35–40, 1999.     

Safety and clinical efficacy of the double switch from originator infliximab to biosimilars CT‐P13 and SB2 in patients with inflammatory bowel diseases (SCESICS): A multicenter cohort study

Data regarding double switching from originator infliximab (IFX) to IFX biosimilars in inflammatory bowel diseases (IBDs) are lacking. The purpose of this study was to evaluate the safety and efficacy of switching from originator IFX to CT‐P13 and subsequently to SB2 (double switch) in patients with IBD. Patients undergoing IFX‐double switch in eight Centers in Lombardy (Italy) from November 2018 to May 2019 were retrospectively analyzed. The IFX discontinuation rate, incidence and type of adverse events (AEs), and clinical remission rate were recorded. A comparison with a control group of patients with IBD single‐switched from originator IFX to CT‐P13 was performed, before and after an inverse probability of treatment weighting (IPTW)‐based propensity score analysis. Fifty‐two double‐switched patients with IBD were enrolled. The 24‐ and 52‐week proportions of patients continuing on IFX therapy following the second switch (CTP13 → SB2) were 98% (95% confidence interval [CI] 94%–100%) and 90% (95% CI 81%–99%), respectively. Four patients experienced a total of five AEs, all graded 1–3 according to Common Terminology Criteria for Adverse Events (CTCAE). No infusion reactions were observed. The 24‐week and follow‐up end clinical remission rates following the second switch were 94% and 88%, respectively. No differences were observed in the safety and efficacy outcomes by comparing the double‐switch group with a single‐switch group of 66 patients with IBD; all these results were confirmed by IPTW‐adjusted analysis. The study suggests both the safety and efficacy of the double switch from originator IFX to CT‐P13 and SB2 in patients with IBD is maintained. This strategy may be associated with potential cost implications.

Study Highlights

• WHAT IS THE CURRENT KNOWLEDGE ON THE TOPIC?

Biosimilars reduce the direct costs of therapy and facilitate access to high‐cost therapies to patients. Data show that switching from originator infliximab to infliximab biosimilars (CT‐P13 or SB2) is safe and effective. Few data are available on the outcomes of double switch (from biological originator to a first biosimilar and then to a second biosimilar), and caution has been expressed by the European Crohn’s and Colitis Organization (ECCO) and the Italian Group for the study of inflammatory bowel disease (IBD; IG‐IBD).

• WHAT QUESTION DID THIS STUDY ADDRESS?

The study was aimed to compare the effectiveness and safety of single and double switch of infliximab (IFX) in patients with IBDs.

• WHAT DOES THIS STUDY ADD TO OUR KNOWLEDGE?

No differences were found in clinical response and remission as well as adverse events between either single or double IFX switch. Data were consistent with the safety profile of IFX.

• HOW MIGHT THIS CHANGE CLINICAL PHARMACOLOGY OR TRANSLATIONAL SCIENCE?

Double switch strategy is safe and effective in IBD. These data assume high relevance in terms of cost‐savings strategies.     

Depression,the mood disease

(Revised Edition). Francis Mark Mondimore, M.D. Baltimore, Maryland: Johns Hopkins University Press, 1995, 237 p. $15.95 paperback.     

Is drug consumption correlated with benign paroxysmal positional vertigo (BPPV) recurrence?

European Archives of Oto-Rhino-Laryngology - Benign paroxysmal positional vertigo (BPPV) is the most common cause of peripheral vertigo and its recurrence is fairly common. Several studies...     

Thirty-eight kilograms ovary cystoadenoma. Case report and literature review

A clinical case of a patient with a giant tumoration of the ovary appears, that went to the external consultation declaring progressive picture of abdominal distension, postprandial fullness and general weakness. The diagnosis was elaborated as much by clinical and paraclinical methods (USG and RX) as well as by pathological anatomy; and the handling consisted firstly of puncture-drainage and later by laparotomy with the extraction of the same one. The gross weight of the tumoration was of 38 kg and the histopathologic study was of cystoadenoma serum giant of the left ovary. Evolution of the patient was satisfactory having a favorable prognosis, returning normally to her habitual activities.     

A Technique to Reconstruct a Nerve Injured at Its Bifurcation Site Using Autograft and End-to-Side Neurorrhaphy

Peripheral nerves injuries are relatively frequent after high-energy trauma in both upper and lower limb. This case report describes the reconstruction of a 5-cm nerve defect involving the superficial peroneal nerve (SPN) where it divides into its two terminal branches. A 5-cm nerve graft was harvested from the proximal part of the medial dorsal cutaneous nerve (MDN) and interposed to fill the gap between the distal stump of the SPN and the intermediate dorsal cutaneous nerve (IDN). The stump of the MDN was then sutured with an end-to-side (ETS) technique to the IDN, distally to the nerve graft, by opening a window in the epineurium of IDN. The sensory restoration of the dorsal area of the foot after 8 months was evaluated satisfactory from the authors. Tenderness and Tinel’s sign at the lesion site were not present. The patient’s satisfaction was excellent. The results of this case may suggest that a nerve defect involving a bifurcation point can be treated with satisfactory results using one distal stump as donor nerve for a nerve autograft to bridge the nerve gap followed by an ETS neurorrhaphy of donor one on the other stump. In this way, it is possible to reconstruct a bifurcation point by creating a new division point with the same Y-shape in a more distal position, without adding morbidity due to the harvesting of a nerve graft from another area of the body.     

Efficacy and tolerability of high and low-volume bowel preparation compared: A real-life single-blinded large-population study

BACKGROUNDLow-volume preparations for colonoscopy have shown similar efficacy compared to high-volume ones in randomized controlled trials (RCT). However, most RCTs do not provide data about clinical outcomes including lesions detection rate. Moreover, real-life comparisons are lacking. AIMTo compare efficacy (both in terms of adequate bowel preparation and detection of colorectal lesions) and tolerability of a high-volume (HV: 4 L polyethylene glycol, PEG) and a low-volume (LV: 2 L PEG plus bisacodyl) bowel preparation in a real-life setting.METHODSConsecutive outpatients referred for colonoscopy were prospectively enrolled between 1 December 2014 and 31 December 2016. Patients could choose either LV or HV preparation, with a day-before schedule for morning colonoscopies and a split-dose for afternoon procedures. Adequate bowel preparation according to Boston Bowel Preparation Scale (BBPS), clinical outcomes including polyp detection rate (PDR), adenoma detection rate (ADR), advanced adenoma detection rate (AADR), sessile/serrated lesion detection rate (SDR) and cancer detection rate and self-reported tolerability of HV and LV were blindly assessed.RESULTSTotal 2040 patients were enrolled and 1815 (mean age 60.6 years, 50.2% men) finally included. LV was chosen by 52% of patients (50.8% of men, 54.9% of women). Split-dose schedule was more common with HV (44.7% vs 38.2%, P = 0.005). High-definition scopes were used in 33.4% of patients, without difference in the two groups (P = 0.605). HV and LV preparations showed similar adequate bowel preparation rates (89.2% vs 86.6%, P = 0.098), also considering the two different schedules (HV split-dose 93.8% vs LV split-dose 93.6%, P = 1; HV day-before 85.5% vs LV day-before 82.3%, P = 0.182). Mean global BBPS score was higher for HV preparations (7.1 ± 1.7 vs 6.8 ± 1.6, P < 0.001). After adjustment for sex, age and indications for colonoscopy, HV preparation resulted higher in PDR [Odds ratio (OR) 1.32, 95%CI: 1.07-1.63, P = 0.011] and ADR (OR 1.29, 95%CI 1.02–1.63, P = 0.038) and comparable to LV in AADR (OR 1.51, 95%CI 0.97-2.35, P = 0.069), SDR and cancer detection rate. The use of standard-definition colonoscopes was associated to lower PDR (adjusted OR 1.59, 95%CI: 1.22-2.08, P < 0.001), ADR (adjusted OR 1.71, 95%CI: 1.26–2.30, P < 0.001) and AADR (adjusted OR 1.97, 95%CI: 1.09-3.56, P = 0.025) in patients receiving LV preparation. Mean Visual Analogue Scale tolerability scored equally (7, P = 0.627) but a ≥ 75% dose intake was more frequent with LV (94.6% vs 92.1%, P = 0.003). CONCLUSIONIn a real-life setting, PEG-based low-volume preparation with bisacodyl showed similar efficacy and tolerability compared to standard HV preparation. However, with higher PDR and ADR, HV should still be considered as the reference standard for clinical trials and the preferred option in screening colonoscopy, especially when colonoscopy is performed with standard resolution imaging.     

Sonographic findings in methamphetamine-induced ischemic colitis

Ischemic colitis is a clinicopathologic condition that commonly occurs in elderly patients with atherosclerotic disease or diabetes mellitus. Uncommon etiologies include vasculitis and use of drugs such as oral contraceptives, phenobarbital, nasal decongestants, dextroamphetamine, and cocaine. Recent studies have shown sonography and CT to be helpful in the evaluation of the colitides. We report the sonographic and CT findings in an unusual case of methamphetamine-induced ischemic colitis. Sonography and CT revealed diffuse thickening of the large bowel wall. Methamphetamine abuse should be considered in the differential diagnosis of the colitides, particularly in the setting of a young patient with a history of drug use and no other predisposing conditions. © 1998 John Wiley & Sons, Inc. J Clin Ultrasound 26:479–482, 1998.