A randomized trial to evaluate the preventive effect of lafutidine on chemotherapy-induced peripheral neuropathy in patients treated with carboplatin and paclitaxel for lung cancer.

BACKGROUND: Chemotherapy-induced peripheral neuropathy (CIPN) has a significant impact on the therapeutic efficacy of chemotherapy and patients' quality of life. The aim of this study was to assess the preventive effect of lafutidine on CIPN. METHODS: Patients were randomly assigned (1:1) to carboplatin and paclitaxel chemotherapy with lafutidine 10 mg twice daily (lafutidine group) or without lafutidine (control group). Peripheral neuropathy in both groups was assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and two patient-based questionnaires, the Patient Neurotoxicity Questionnaire (PNQ) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx). The primary outcome was the incidence of grade 2 or higher peripheral neuropathy in CTCAE version 5.0. The target number of cases was set at approximately 40. RESULTS: In total, 18 patients were screened, and 16 patients were assigned to the lafutidine group (n=9) or control group (n=7) between January 2021 and January 2023. Due to poor recruitment, the target number of cases was not reached. Grade 2 or higher neuralgia was 22.2% in the lafutidine group and 14.3% in the control group. Grade 2 or higher peripheral sensory neuropathy was 100% in the lafutidine group and 71.4% in the control group (P=0.175). Grade 3 or higher peripheral neuropathy was not detected in either group. There was no significant difference in PNQ scores between the two groups. Median FACT/GOG-Ntx scores after the fourth cycle tended to be lower in the lafutidine group than in the control group. There was no statistically significant difference in progression free survival (PFS) between the two groups. There were no adverse events due to lafutidine administration. CONCLUSIONS: Although the preventive effect of lafutidine on CIPN could not be demonstrated statistically, lafutidine FACT/GOG-Ntx scores showed a trend toward decreased neurotoxicity as chemotherapy proceeded. More reliable studies using lafutidine on the prevention of CIPN should be conducted. TRIAL REGISTRATION: Japan Registry of Clinical Trials, identifier: jRCTs021200031.

Relationship between Trace Element in Tumor and Prognosis in Lung Cancer Patients.

Background and Objectives: This study aimed to observe the relationship between trace element concentrations in lung tissue from lung non-small cell lung carcinoma (NSCLC) patients and prognosis. Materials and Methods: The concentrations of various trace elements in the lung tissues were measured by a particle-induced X-ray emission (PIXE) system, and the results were analyzed for statistical significance. Eight essential trace elements, Cr, Mn, Fe, Co, Cu, Zn, Se, and Mo, were analyzed. We investigated the relationship between trace element concentrations and disease-free survival (DFS) and overall survival (OS) in NSCLC patients. Results: A total of 129 NSCLC patients and 20 control patients were included in this study. As for DFS, Co was the only element that showed a significant difference, and the high Co group had better DFS (HR: 0.352, 95% CI = 0.128-0.97). No significant difference was observed for Cr, Mn, Fe, Se, or Mo, but DFS tended to be better in the high trace element group. No significant difference was observed for Cu and Zn, but DFS tended to be good in the low trace element group. As for OS, Cr was the only element that showed a significant difference, and the high Cr element group had better OS (HR: 0.477, 95% CI = 0.128-0.97). Conclusions: This study suggests that the prognosis is good in lung cancer cases with high intratumoral concentrations of Co and Cr. The dynamics of trace elements in body and in tumor tissue have not been well established, and we consider that more research is necessary in the future.