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An 82-year-old woman presented to our hospital with chief complaints of lower abdominal pain and nausea. Contrast- enhanced CT showed ileus of sigmoid colon cancer and a solitary splenic tumor. A metallic stent was placed for the primary lesion. FDG-PET showed high FDG accumulation in the solitary splenic tumor, and synchronous solitary splenic metastasis was diagnosed. Laparoscopic sigmoid colectomy and laparoscopic splenectomy were performed without changing the intraoperative position or port arrangement. Postoperative progress was favorable. The patient was discharged 9 days after surgery, and no sign of recurrence has been observed to date, at 4 months after surgery. Solitary splenic metastasis of colorectal cancer is extremely rare. This is the first case report of synchronous solitary splenic metastasis of colorectal cancer treated with laparoscopic resection in Japan. This procedure is considered effective and minimally invasive. Cpd 20m concentration We review and discuss the Japanese literature on this rare disease.A 65-year-old woman was admitted to our institution with sonography results indicating a caudate lobe mass. CT showed a large low-density mass in the caudate lobe, extensively involving the inferior vena cava and main portal vein. Moderately differentiated adenocarcinoma was found on transcutaneous biopsy. We therefore regarded this tumor as a severe locally advanced hilar cholangiocarcinoma and initiated gemcitabine/cisplatin combined chemotherapy. The tumor gradually reduced in size. However, after 28 courses of treatment, CT showed persistent tumor invasion in the left trunk of the portal vein and inferior vena cava invasion in succession in the middle; the tumor had not yet invaded the left hepatic vein. Owing to myelosuppression and general malaise, it was difficult to continue chemotherapy. After 32 courses of treatment, the patient underwent a left trisegmentectomy with combined resection of the portal vein and inferior vena cava. Postoperative microscopic findings revealed no apparent invasion of the tumor in the inferior vena cava, thus suggesting successful R0 resection. The patient is alive without recurrence 18 months postoperatively.

A 37-year-old pregnant woman arrived at our hospital with an abnormal mammogram.

Mammography performed in June 2018 revealed an abnormal shadow on the left breast. Cytology from the 6-mm tumor in the left upper-outer quadrant revealed a malignancy. At the same time, a transvaginal echo revealed cysts, and the patient was diagnosed at 5 weeks gestation. Needle biopsy revealed a luminal A-like cStage Ⅰ, cT1bN0M0 invasive ductal carcinoma (IDC). Tumor resection and sentinel lymph node biopsy were performed under local anesthesia at 12 weeks gestation, and post-delivery adjuvant therapy was planned. Histologic examination of the resected tumor revealed that it was HER2-positive( immunohistochemistry score 3+); therefore, we had to reconsider the use of trastuzumab and decided to administer it to the patient after childbirth. The patient gave birth by cesarean section, and weekly paclitaxel plus trastuzumab was initiated 7 months after surgery. The patient is currently alive without recurrence.

We faced seveegnancy-associated breast cancer is predicted to increase as the number of elderly primigravida increases due to later marriage.To investigate the feasibility of utilizing electronically provided patient-reported outcomes(ePRO)to detect adverse events, we conducted a single-center prospective study targeting patients with advanced cancers who were receiving chemotherapy at our outpatient clinic. Participants were asked to respond to 71 relevant items from the PRO-CTCAE once a week for 8 consecutive weeks. An outpatient nurse evaluated the corresponding items on the CTCAE. Forty of 85 outpatients were enrolled. Thirty-four patients were excluded because of Bring Your Own Device(BYOD)restrictions and 11 were excluded for other reasons, including poor physical conditions. Those without BYOD were significantly older than the study participants(median age 72 and 66 years, respectively)and were more likely to be male(65% and 35%, respectively). The overall response rate was 77%. The median number of symptoms per participant rated as ≥Grade 1 was 26(range 0-48) by ePRO and 6(range 1-15)by the nurse(p less then 0.01). Among the total number of symptoms detected by ePRO, the percentage of symptoms detected by both the nurse and ePRO was low(median 4%, range 0-67%). Symptoms detected consistently by both the nurse and ePRO were alopecia(67%), anorexia(38%), paresthesia(36%), diarrhea(28%), malaise(27%), oral mucositis(25%), constipation(24%), limb edema(24%), pain(22%), and dysgeusia(21%), suggesting that healthcare professionals tend to pay more attention to the symptoms that they think lead to intervention. Our findings indicate that the implementation of the ePRO system in outpatient care may help clinicians accurately recognize adverse events at earlier stages.Preemptive skin treatment led by nurses and pharmacists was started for patients with metastatic colorectal cancer (mCRC)who received anti-EGFR antibody treatment. Incidence of skin-related toxicities, amount of topical moisturizers used, and administered cycles of anti-EGFR antibody were retrospectively compared between a preemptive skin treatment group and a control group. Thirty-four mCRC patients before the introduction of preemptive skin treatment led by nurses and 23 mCRC patients treated with preemptive skin treatment led by nurses were evaluated. The incidence of 6- and 12- week Grade 2 or higher skin-related toxicity was 23.5% in the control group and 8.7% in the preemptive group(p=0.18), and 67.7% in the control group and 30.4% in the preemptive group(p=0.0076), respectively. Mean amounts of moisturizer used were both lower in the control group than in the preemptive group at both 6 weeks and 7-12 weeks(6 weeks; 275 g vs 550 g, p=0.036, 7-12 weeks; 575 g vs 1,175 g, p=0.013). However, the amount of topical steroid used was similar in both groups. Preemptive moisturizer skin treatment led by nurses and pharmacists may decrease the incidence of skin- related toxicity.Randomization plays a key role to provide the fundamental validity to between-group comparison. However, randomization may not be the only tool to answer all clinical questions with respect to treatment selection for individual patients. This article first reviews statistical aspects of a randomized clinical trial, then discuss between-group comparison using real world data from real clinical settings, especially using statistical methods with propensity score.In recent years, there has been increasing interest in integrating evidence using network meta-analysis. Unlike conventional meta-analysis that integrates evidence from direct comparisons, network meta-analysis is a methodology that enables indirect comparison using a network of direct comparisons between treatment groups. In this paper, we discuss how the obtained results should be interpreted and the care required based on a network meta-analysis study comparing the onset of immune-related pneumonitis caused by immune checkpoint inhibitors in lung cancer. In particular, we introduce the significance of and evaluation methods for heterogeneity, similarity, consistency, and publication bias, and explain why paying attention to these aspects is critical. Software for application, textbooks for reference, and guidelines will also be introduced.Many clinical research and studies evaluate a time-to-event data, illustrate survival curves, and conventionally report an estimated hazard ratio to express the magnitude of the treatment effect when comparing between groups. However, it may not be straightforward to interpret the hazard ratio clinically and statistically when the proportional hazards assumption is invalid. In some recent papers published in clinical journals, the use of restricted mean survival time(RMST)or t-year mean survival time is discussed as one of the alternative summary measures for the time-to-event data. The RMST is defined as the expected value of time-to-event limited to a specific time point corresponding to the area under the survival curve up to the specific time point. This article summarizes the necessary information to conduct statistical analysis using the RMST, including the definition and statistical properties of the RMST, and clinical and statistical meaning and interpretation as compared with other summary measures of time-to-event data by application examples.Patients can experience different disease journeys and clinical trials that investigate the benefit of oncology treatments need to account for this diversity. When defining the treatment effect of interest in a trial, researchers thus have to account for events occurring after treatment initiation, such as the start of a new therapy, before observing the variable of interest. We review the estimand framework recently introduced by the International Council for Harmonisation(ICH, 2019)to structure discussions on the relationship between patient journeys and the treatment effect of interest in oncology trials. This framework is expected to improve coherence between trial objectives, design, analysis, reporting and interpretation, as illustrated in this article by examples in oncology disease settings.Like most complex(or multifactorial)diseases, cancer results not from a single factor, but rather from the interaction of multiple genes and environmental factors. Thus patients can experience different signs and symptoms that reflect more than one consequence of suffering the disease. When evaluating the effects of new treatments in cancer clinical trials, the multidimensional assessment using multiple outcomes to measure improvements in the patients' signs and symptoms associated with treatments would be preferred. Most cancer clinical trials use more than one clinical outcome as multiple primary, or primary and(key)secondary endpoints, such as overall survival, endpoints based on tumor assessments(e.g., disease-free survival, event-free survival, objective response rate, time to progression, progression-free survival), and endpoints involving symptom assessment. Utilizing multiple endpoints may provide the opportunity for characterizing the intervention's multidimensional effects, but also creates challenges, specifically controlling the Type Ⅰ and/or Type Ⅱ errors in hypotheses testing and trial designs associated with multiple endpoints. In this article, we review issues in design, monitoring, analysis and reporting of clinical trials with multiple endpoints, with illustrating examples in oncology disease settings. We outline several methods for controlling the Type Ⅰ error associated multiple tests, which have been commonly used in clinical trials. We also briefly discuss issues in interim analyses and group sequential designs for clinical trials with multiple endpoints.The primary objective of oncology dose-finding trials is to estimate the maximum tolerated dose(MTD)and determine the optimal dose(OD)for subsequent clinical trials by evaluating pharmacokinetics and pharmacodynamics of new drugs, treatment effects, and predictive markers. Oncology dose-finding trial designs can be categorized into 3 types based on their statistical bases and implementation approaches algorithm-based, model-based, and model-assisted designs. In this paper, we introduce the characteristics of various oncology dose-finding trial designs according to the categories. First, oncology dose-finding trial designs solely based on toxicity for MTD determination are discussed, followed by oncology dose-finding trial designs based on efficacy and toxicity for identifying OD. Sequential enrollment, combination therapy, toxicity grade, and historical data are also briefly introduced.