Trastuzumab deruxtecan versus trastuzumab emtansine in HER2-positive metastatic breast cancer patients with brain metastases from the randomized DESTINY-Breast03 trial.

BACKGROUND: DESTINY-Breast03 is a randomized, multicenter, open-label, phase III study of trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) previously treated with trastuzumab and a taxane. A statistically significant improvement in progression-free survival (PFS) versus T-DM1 was reported in the primary analysis. Here, we report exploratory efficacy data in patients with and without brain metastases (BMs) at baseline. PATIENTS AND METHODS: Patients were randomly assigned 1 : 1 to receive T-DXd 5.4 mg/kg or T-DM1 3.6 mg/kg. Patients with clinically inactive/asymptomatic BMs were eligible. Lesions were measured as per modified RECIST, version 1.1. Outcomes included PFS by blinded independent central review (BICR), objective response rate (ORR), and intracranial ORR as per BICR. RESULTS: As of 21 May 2021, 43/261 patients randomized to T-DXd and 39/263 patients randomized to T-DM1 had BMs at baseline, as per investigator assessment. Among patients with baseline BMs, 20/43 in the T-DXd arm and 19/39 in the T-DM1 arm had not received prior local BM treatment. For patients with BMs, median PFS was 15.0 months [95% confidence interval (CI) 12.5-22.2 months] for T-DXd versus 3.0 months (95% CI 2.8-5.8 months) for T-DM1; hazard ratio (HR) 0.25 (95% CI 0.13-0.45). For patients without BMs, median PFS was not reached (95% CI 22.4 months-not estimable) for T-DXd versus 7.1 months (95% CI 5.6-9.7 months) for T-DM1; HR 0.30 (95% CI 0.22-0.40). Confirmed systemic ORR was 67.4% for T-DXd versus 20.5% for T-DM1 and 82.1% for T-DXd versus 36.6% for T-DM1 for patients with and without BMs, respectively. Intracranial ORR was 65.7% with T-DXd versus 34.3% with T-DM1. CONCLUSIONS: Patients with HER2-positive mBC whose disease progressed after trastuzumab and a taxane achieved a substantial benefit from treatment with T-DXd compared with T-DM1, including those with baseline BMs.

The feasibility, usability, and clinical utility of traditional paper food and symptom journals for patients with irritable bowel syndrome.

BACKGROUND: Paper food and gastrointestinal (GI) symptom journals are used to help irritable bowel syndrome (IBS) patients determine potential trigger foods. The primary aim of this study was to evaluate the feasibility, usability, and clinical utility of such journals as a data collection tool. A secondary aim was to explore a method for analyzing journal data to describe patterns of diet and symptoms. METHODS: Participants (N=17) were asked to log three sets of 3-day food and symptom journals over a 15-day period. Feasibility was evaluated by journal completion rates, symptom logging compliance, and logging fatigability. The feasibility, usability, and clinical utility of journaling were also assessed by a customized evaluation and exit interview. For each journal, regression analyses were conducted to examine relationships between key meal nutrients and subsequent symptoms. KEY RESULTS: Most participants were young (mean age 35±12) Caucasian (N=13) women (N=14). Journal completion rates were 100% for all participants with no logging fatigability. Over half perceived paper journaling of food and symptoms as feasible, usable, and clinically useful. Thirteen participants demonstrated a strong association with at least one symptom and meal nutrient. Patterns of associations differed among participants. CONCLUSIONS AND INFERENCES: Paper journaling of food and GI symptoms for 9 days over a 15-day period appeared to be a feasible and usable data collection tool for IBS patients. Over half perceived journaling as at least somewhat clinically useful. Findings from this study support the anecdote that food trigger(s) and associated symptom(s) vary for each individual.

Orbital myiasis complicating squamous cell carcinoma of eyelid.

Myiasis is infestation of the body by fly maggots. Immobile patients with skin wounds in exposed areas are at high risk of developing myiasis. We report a case of orbital myiasis from the species Chrysomya bezziana complicating squamous cell carcinoma of the eyelid. Magnetic resonance imaging of the orbit is useful for delineating the extent of the infestation and identifying residual maggots. In extensive orbital myiasis, exenteration is needed to prevent intracranial extension of tissue destruction.

Enophthalmos caused by an orbital venous malformation.

Orbital vascular malformations usually present with proptosis. We report a case where a patient with an orbital venous malformation presented with enophthalmos. Since many underlying orbital pathologies, including orbital metastases, can cause enophthalmos, it is important to investigate patients properly. Computed tomographic imaging of the orbit remains the most useful tool in the management of patients with enophthalmos.

Subcutaneous extralesional triamcinolone acetonide injection versus conservative management in the treatment of chalazion.

OBJECTIVE: To compare the efficacy of subcutaneous extralesional triamcinolone acetonide injection versus conservative treatment for chalazion. DESIGN: Randomised controlled trial. SETTING: Eye clinics of two regional hospitals in Hong Kong. PATIENTS: Patients over 18 years old presenting with primary chalazion were randomised into two groups. In group 1, 12 patients were treated with lid hygiene, warm compresses, and chloramphenicol 1% ointment 4 times a day. In group 2, 16 patients were treated with 0.3 mL triamcinolone acetonide (10 mg/mL) injection to the subcutaneous tissue extralesionally via the percutaneous route. Exclusion criteria were: acutely infected chalazion with preseptal cellulitis, recurrent chalazion, small chalazion (< or =2 mm), and prior treatment to chalazion. MAIN OUTCOME MEASURES: Size of chalazion, recurrence of chalazion, intra-ocular pressure, and complications from treatment, including skin pigmentary change or atrophy and pyogenic granuloma. RESULTS: There was a clinically and statistically significant difference between the success rates in group 1 (58.3%) and group 2 (93.8%). In group 1, the mean prior duration of chalazion before treatment was significantly shorter in success cases than in failed cases. One patient with multiple chalazia in group 2 developed hypopigmentary skin changes at one treatment site. CONCLUSION: Subcutaneous extralesional triamcinolone acetonide injection was more effective than conservative treatment for chalazion.

Using gelatin scaffold with coated basic fibroblast growth factor as a transfer system for transplantation of human neural stem cells.

Gelatin scaffolds for ex vivo cell cultures are a promising development. These scaffolds can be used as three-dimensional skeletons for cell attachment and culture before transplantation. In this study, we isolated and cultivated neural stem cells from human brain tissues in serum-free medium (DMEM+F12 nutrient). Better neuron growth was observed using the tetrazolium assay (MTT) in the group when basic fibroblast growth factor (bFGF) was coated on the gelatin polymer scaffold. Further development of this nontoxic system may help the future development of transplantation of human neural stem cells.