Naoko Sakata

Bio: Naoko Sakata is an academic researcher from University of Tokyo. The author has contributed to research in topics: Capecitabine & Palliative care. The author has an hindex of 5, co-authored 8 publications receiving 218 citations.

Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract: The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.

A randomized multicenter phase II trial of capecitabine versus S-1 as first-line treatment in unresectable or recurrent breast cancer patients.

Abstract: TPS136 Background: S-1 is a novel oral anticancer drug, composed of tegafur, gimestat, and otastat potassium in a molar ratio of 1:0.4:1, based on the biochemical modulation of 5-fluorouracil. Espe...

Effectiveness of using clinical guidelines for conducting palliative care family meetings in Japan

Abstract: The purpose of this study is to pilot test the effectiveness of using recently developed clinical guidelines from Australia for conducting palliative care family meetings in Japan. Palliative care family meetings were conducted using clinical guidelines with 15 primary family carers of cancer patients who were admitted to an acute care hospital in Japan. Using the pre-family meeting questionnaire, the primary carers were asked to write key concerns to discuss during the family meetings and rate their concerns via a numerical rating scale: how upset/worried they were about the problem, frequency in which problem occurs, life interference with the problem, and the confidence to deal with the problem. Within 3 days after the meeting, the primary carers were asked to complete the post-meeting questionnaire to evaluate the effectiveness of the family meeting. There was a significant improvement in family carers’ psychological well-being in the post-meeting questionnaires compared to the pre-meeting questionnaires as follows: how upset/worried they were about the problem, t(14) = 3.1071, p < 0.000011; frequency in which problem occurs, t(14) = 3.2857, p < 0.000013; life interference with the problem, t(14) = 2.7857, p < 0.000008; and the confidence to deal with the problem, t(13) = −2.3007, p < 0.005480. In accordance with the study aims, we were able to demonstrate the utility of a questionnaire as an essential tool to plan and conduct effective communication between health professionals and primary family carers in Japanese cancer patients. This pilot test should be followed up with a larger sample and a controlled trial.

A report that Fukushima residents are concerned about radiation from Land, Food and Radon.

Abstract: The Great East Japan Earthquake and subsequent TEPCO Fukushima Daiichi nuclear disaster occurred on 11 March 2011, which caused the leakage of radioactive materials into the environment. In this study, we report public concerns about radiation in Fukushima and Tokyo almost one year after the nuclear disaster. We examined the public concerns by analyzing the data from 1022 participants, 555 in Fukushima and 467 in Tokyo. They were asked whether they were concerned about radiation from some of six different types of sources, which could be answered in a binary way, 'yes' or 'no'. We found not only similarities, but also significant differences in the degrees of concerns between Fukushima residents and Tokyo ones. Fukushima residents more concerned about radiation from land, food and radon in larger rate than that of Tokyo ones, while Tokyo residents were concerned about radiation from medical care. Residents in neither location were concerned about radiation from space. Our results suggested that careful risk communication should be undertaken, adaptively organized depending on location and other factors, e.g. comprehension about radiation, presence of the experience of evacuation, and also age and gender of the people.

Chemotherapy with low-dose capecitabine as palliative treatment in a patient with metastatic breast cancer: a case report

Abstract: Chemotherapeutic agents are rarely used for symptom management in patients under palliative care setting. This is because chemotherapeutic agents not only have limited efficacy in palliative treatment but are also known to exert severe adverse effects. We describe our experience with a patient with metastatic breast cancer who was successfully treated with low-dose capecitabine, without the development of any severe toxicities and with significant improvement in activities of daily living (ADL) and quality of life (QOL). The patient, a 43-year-old female, had breast cancer with liver, bone, and cutaneous metastases. She visited our clinic after a year-long hiatus during which she underwent alternative therapy. She presented with ulcerated lesions on the anterior chest and dyspnea due to malignant pleural effusion. After treatment for the latter, we administered capecitabine (600 mg/day) in accordance with the wishes of the patient and her attendants. The ulcerated lesions on the anterior chest, dyspnea, ADL and QOL improved significantly, without the development of any serious adverse effects. The findings of this case indicate that chemotherapy in the form of low-dose capecitabine monotherapy may be considered in patients under palliative care setting.

First-in-human liver-tumour surgery guided by multispectral fluorescence imaging in the visible and near-infrared-I/II windows

Abstract: The second near-infrared wavelength window (NIR-II, 1,000–1,700 nm) enables fluorescence imaging of tissue with enhanced contrast at depths of millimetres and at micrometre-scale resolution. However, the lack of clinically viable NIR-II equipment has hindered the clinical translation of NIR-II imaging. Here, we describe an optical-imaging instrument that integrates a visible multispectral imaging system with the detection of NIR-II and NIR-I (700–900 nm in wavelength) fluorescence (by using the dye indocyanine green) for aiding the fluorescence-guided surgical resection of primary and metastatic liver tumours in 23 patients. We found that, compared with NIR-I imaging, intraoperative NIR-II imaging provided a higher tumour-detection sensitivity (100% versus 90.6%; with 95% confidence intervals of 89.1%–100% and 75.0%–98.0%, respectively), a higher tumour-to-normal-liver-tissue signal ratio (5.33 versus 1.45) and an enhanced tumour-detection rate (56.41% versus 46.15%). We infer that combining the NIR-I/II spectral windows and suitable fluorescence probes might improve image-guided surgery in the clinic. An optical-imaging instrument that integrates a visible multispectral imaging system with the detection of near-infrared fluorescence in the first and second windows aids the fluorescence-guided surgical resection of liver tumours in patients.

Targeted α-Therapy of Metastatic Castration-Resistant Prostate Cancer with 225Ac-PSMA-617: Dosimetry Estimate and Empiric Dose Finding.

Abstract: The aim of this study was to develop a treatment protocol for 225Ac-PSMA-617 α-radiation therapy in advanced-stage, metastatic castration-resistant prostate cancer patients with prostate-specific membrane antigen (PSMA)-positive tumor phenotype. Methods: A dosimetry estimate was calculated on the basis of time-activity curves derived from serially obtained 177Lu-PSMA-617 scans extrapolated to the physical half-life of 225Ac, assuming instant decay of unstable daughter nuclides. Salvage therapies empirically conducted with 50 (n = 4), 100 (n = 4), 150 (n = 2), and 200 kBq/kg (n = 4) of 225Ac-PSMA-617 were evaluated retrospectively regarding toxicity and treatment response. Eight of 14 patients received further cycles in either 2- or 4-mo intervals with identical or deescalated activities. Results: Dosimetry estimates for 1 MBq of 225Ac-PSMA-617 assuming a relative biologic effectiveness of 5 revealed mean doses of 2.3 Sv for salivary glands, 0.7 Sv for kidneys, and 0.05 Sv for red marrow that are composed of 99.4% α, 0.5% β, and 0.1% photon radiation, respectively. In clinical application, severe xerostomia became the dose-limiting toxicity if treatment activity exceeded 100 kBq/kg per cycle. At 100 kBq/kg, the duration of prostate-specific antigen decline was less than 4 mo, but if therapy was repeated every 2 mo patients experienced additive antitumor effects. Treatment activities of 50 kBq/kg were without toxicity but induced insufficient antitumor response in these high-tumor-burden patients. Remarkable antitumor activity by means of objective radiologic response or tumor marker decline was observed in 9 of 11 evaluable patients. Conclusion: For advanced-stage patients, a treatment activity of 100 kBq/kg of 225Ac-PSMA-617 per cycle repeated every 8 wk presents a reasonable trade-off between toxicity and biochemical response.

The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events

Abstract: The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed by the National Cancer Institute as an adverse event assessment system to evaluate patients’ symptoms, which tend to be underestimated in cancer clinical trials. The aim of this study was to assess the psychometric properties of the Japanese version of the PRO-CTCAE and the degree of adverse event assessment discordance between clinicians and patients. A total of 187 cancer patients receiving systemic therapy were enrolled. Reproducibility, criterion validity, and responsiveness of the Japanese version of PROCTCAE were assessed. The EORTC QLQ-C30 was used as an external anchor. Discordance of assessment of adverse events between clinician and patients were also assessed using the CTCAE and PRO-CTCAE. A total of 187 participants (187 for criterion validity, 80 for reproducibility, and 100 for responsiveness), were analyzed (Mage = 62.4 years). All patients responded to at least one symptom item (M = 16). The mean (SD) intra-class correlation coefficients of overall reproducibility for the Japanese PRO-CTCAE was 0.63 (0.02). The correlation coefficient for the corresponding items in the EORTC QLQ-C30 and the Japanese PRO-CTCAE was high (Pearson r = 0.56–0.76). The analysis of responsiveness revealed significant dose-response trends (Jonckheere-Terpstra test, ps < 0.001). Depending on the adverse events, a discrepancy was observed in evaluation between the clinician and patient. These results revealed that there is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms.

Japanese translation and linguistic validation of the US National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Abstract: The US National Cancer Institute (NCI) has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to capture patients’ self-reported symptomatic adverse events in cancer clinical trials. The aim of this study was to develop and linguistically validate a Japanese translation of PRO-CTCAE. Forward- and back-translations were produced, and an independent review was performed by the Japan Clinical Oncology Group (JCOG) Executive Committee and the US NCI. We then conducted cognitive interviews with 21 patients undergoing cancer treatment. Participants were asked to complete the PRO-CTCAE and were interviewed using semi-structured scripts and predetermined probes to investigate whether any items were difficult to understand or answer. The interviews were recorded and transcribed, and a thematic analysis was performed. The data were split into two categories: 1) remarks on the items and 2) remarks on the questionnaire in general. Twenty-one cancer patients undergoing chemotherapy or hormone therapy were interviewed at the University of Tokyo Hospital and the Kansai Medical University Hirakata Hospital during 2011 and 2012. Thirty-three PRO-CTCAE items were evaluated as “difficult to understand,” and 65 items were evaluated as “difficult to answer” by at least one respondent. However, on further investigation, only 24 remarks were categorized as “comprehension difficulties” or “clarity” issues. Most of these remarks concerned patients’ difficulties with rating their experience of individual symptomatic events. The study provides preliminary evidence supporting the linguistic validity of the Japanese version of PRO-CTCAE. Further cognitive interviewing is warranted for PRO-CTCAE items relating to sexuality and anxiety and for response options on severity attribute items.