Study on prediction of early adverse events by CapeOX therapy in patients with colorectal cancer.

CapeOX is a regimen used as postoperative adjuvant chemotherapy for the treatment of advanced recurrent colorectal cancer. If early adverse events occur, treatment may not progress as planned and further dose reduction may be necessary. In this study, we investigated whether pre-treatment medical records could be used to predict adverse events in order to prevent adverse events caused by CapeOX treatment. The 178 patients were classified into two groups (97 in the adverse event positive group and 81 in the adverse event-negative group) based on withdrawal or postponement of four or fewer courses. In univariate analysis, age, height, weight, body surface area (BSA), creatinine clearance, muscle mass, and lean body mass were associated with early adverse events (P<0.05). The area under the receiver operating characteristic curve obtained by Stepwise logistic regression analysis using the Akaike information criterion method was 0.832. For nested k-fold cross validation, the accuracy rates of the support vector machine, random forest, and logistic regression algorithms were 0.71, 0.70, and 0.75, respectively. The results of the present study suggest that a logistic regression prediction model may be useful in predicting early adverse events caused by CapeOX therapy in patients with colorectal cancer. J. Med. Invest. 71 : 141-147, February, 2024.

Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study.

INTRODUCTION: The use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs. METHODS AND ANALYSIS: This is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point. ETHICS AND DISSEMINATION: This research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021. REGISTRATION DETAILS: The study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023. TRIAL REGISTRATION NUMBER: UMIN000046418.

[Role of Cancer Chemotherapy Is Expected to Improve PS and QOL].

We report three cases of advanced lung cancer with poor PS treated with molecular-targeted drugs and consider the role of cancer chemotherapy to improve quality of life(QOL). Case 1: A 67-year-old woman(PS 3)with multiple liver, bone, and lymph node metastases from lung cancer received gefitinib and radiation therapy for bone metastasis. Abdominal CT then showed shrinkage of the liver metastasis, and daily life activities became possible after 2 months. Case 2: A 76-year-old woman with SVC syndrome from Stage ⅢA of lung cancer received gefitinib and radiation therapy. After that, edema and cough disappeared, and the PS improved from 3 to 0. Case 3: A 41-year-old woman with pleural dissemination from Stage Ⅳ lung cancer received ALK inhibitors and anticancer drug therapy for 5 years. Subsequently, a decrease in QOL was noted due to symptoms such as bloody sputum and persistence of cough. ALK inhibitors were administered as a re-challenge. A dramatic improvement in symptoms was observed in a few days. Even if the general condition is poor, PS can be improved by administering drugs such as molecular-targeted drugs.

[Clinical experience of the use of pemetrexed (PEM) combined with cisplatin (CDDP)/Carboplatin (CBDCA) followed by long-term maintenance PEM in patients with non-squamous non-small cell lung cancer].

This study evaluated the efficacy and safety of pemetrexed and carboplatin (CBDCA) or cisplatin (CDDP) followed by maintenance pemetrexed for cases of advanced non-squamous non-small cell lung cancer (NSCLC) that were treated in our hospital. Patients received pemetrexed (PEM 500mg/m²) and CBDCA(area under the curve, 5 mg/[mL/min]) or CDDP (75 mg/m²) every 21 days. For patients without disease progression after 4-6 courses, pemetrexed was continued until disease progression or unacceptable toxicity. Fourteen patients received maintenance pemetrexed(median, 11.5 courses; range, 4- 43 courses). Among the 14 patients, the median progression-free survival time from the beginning of the induction treatment was 13 months. Continuation maintenance with pemetrexed after cisplatin plus pemetrexed induction is recommended as a first-line treatment for patients who have advanced non-squamous NSCLC and as a maintenance strategy.