Combination of Oxaliplatin and 5-Fluorouracil/Leucovorin for Advanced Esophageal Squamous Cell Carcinoma Refractory or Intolerant to Standard Therapies

Here, we report the four cases with metastatic esophageal squamous cell carcinoma pretreated with standard chemotherapy who then received salvage-line chemotherapy with oxaliplatin and 5-fluorouracil plus l-leucovorin (FOLFOX) at our institution. We identified four men following the mentioned regimen; their median age was 68.5 years (range, 65–76 years). All patients developed disease progression on 5-fluorouracil, cisplatin, and taxanes. Two patients achieved partial response; the other two achieved stable disease on receiving cisplatin-containing regimens as first-line therapy. The Eastern Cooperative Oncology Group performance statuses were 1 in three patients and 2 in one patient. The best response was partial response in one patient, stable disease in one, and progressive disease in two. For the two patients who achieved partial response or stable disease, the times to progression were 5.7 and 5.2 months and the overall survival times were 8.1 and 9.5 months, respectively. A grade 3 encephalopathy in one patient improved soon after chemotherapy discontinuation and supportive therapies. There was no treatment-related death. This is the first report suggesting the potential effectiveness of FOLFOX as salvage chemotherapy for metastatic esophageal cancer

Efficacy and safety of teneligliptin add-on to insulin monotherapy in Japanese patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled trial with an open-label period

<p><b>Objective</b>: To assess the efficacy and safety of teneligliptin as add-on to insulin monotherapy in patients with type 2 diabetes mellitus (T2DM).</p> <p><b>Research design and methods</b>: In a 16-week, double-blind period, 148 Japanese T2DM patients with inadequate glycemic control with insulin and diet/exercise therapies were randomized to placebo or teneligliptin 20 mg. In a subsequent 36-week, open-label period, all patients received teneligliptin once daily. The primary outcome measure was change in HbA1c at the end of the double-blind period.</p> <p><b>Results</b>: The difference between placebo and teneligliptin in change in HbA1c in the double-blind period (least squares mean ± SE) was −0.80% ± 0.11%; teneligliptin was superior (ANCOVA, <i>P</i> < 0.001). The HbA1c-lowering effect of teneligliptin was maintained throughout the open-label period. The incidence of adverse events was 53.5% with placebo and 44.2% with teneligliptin in the double-blind period, 66.7% in the placebo/teneligliptin group in the open-label period, and 77.9% in the teneligliptin/teneligliptin group over both double-blind/open-label periods. The incidence of hypoglycemic symptoms was 11.1% in the placebo/teneligliptin group in the open-label period and 27.3% in the teneligliptin/teneligliptin group over both double-blind/open-label periods.</p> <p><b>Conclusion</b>: Teneligliptin was effective and well tolerated in Japanese T2DM patients with inadequate glycemic control.</p> <p><b>Clinical trial registration:</b> NCT02081599</p

Effectiveness of a facilitation programme using a mobile application for initiating advance care planning discussions between patients with advanced cancer and healthcare providers: protocol for a randomised controlled trial (J-SUPPORT 2104)

Introduction Timely implementation of the discussion process of advance care planning (ACP) is recommended. The communication attitude of healthcare providers is critical in ACP facilitation; thus, improving their communication attitudes may reduce patient distress and unnecessary aggressive treatment while enhancing care satisfaction. Digital mobile devices are being developed for behavioural interventions owing to their low space and time restrictions and ease of information sharing. This study aims to evaluate the effectiveness of an intervention programme using an application intended to facilitate patient questioning behaviour on improving communication related to ACP between patients with advanced cancer and healthcare providers.Methods and analysis This study uses a parallel-group, evaluator-blind, randomised controlled trial design. We plan to recruit 264 adult patients with incurable advanced cancer at the National Cancer Centre in Tokyo, Japan. Intervention group participants use a mobile application ACP programme and undergo a 30 min interview with a trained intervention provider for discussions with the oncologist at the next patient visit, while control group participants continue their usual treatment. The primary outcome is the oncologist’s communication behaviour score assessed using audiorecordings of the consultation. Secondary outcomes include communication between patients and oncologists and the patients’ distress, quality of life, care goals and preferences, and medical care utilisation. We will use a full analysis set including the registered participant population who receive at least a part of the intervention.Ethics and dissemination The study protocol was reviewed and approved by the Scientific Advisory Board of the Japan Supportive, Palliative and Psychosocial Oncology Group (Registration No. 2104) and the Institutional Review Board of the National Cancer Centre Hospital (registration No. 2020-500). Written informed consent is obtained from the patients. The results of the trial will be published in peer-reviewed scientific journals and presented at scientific meetings.Trial registration numbers UMIN000045305, NCT05045040

Identification of serum metabolome signatures associated with retinal and renal complications of type 2 diabetes

Tomofuji et al. perform non-targeted metabolomics on serum samples from people with type 2 diabetes with or without complications. The authors identify metabolites associated with retinal and renal complications