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Purpose: Achieving “good death” is one of the important goals of palliative care. Providing goal-concordant care and an environment tailored to the patient's preferences can contribute to “good death.” However, the concordance rate between the preferred and actual places of death among advanced cancer patients in Japan is less explored. This study aimed to identify the concordance between patients’ preferred and actual places of death, and the associated factors among patients with advanced cancer in Japan. Methods: Patients with advanced cancer who underwent chemotherapy between January 2015 and January 2016 were enrolled and followed up for 5 years. The enrolled patients were asked about their preference for their place of death. The response options were: “Own home,” “General ward” and “Palliative care unit (PCU).” We compared the actual place of death with the patient’s preference through a follow-up review of the medical records. Results: A total of 157 patients with advanced cancer were enrolled between January 2015 and January 2016. Of these patients, 22.9% (11/48) died at home according to their preference, 64.0% (16/25) in the general ward, and 37.9% (11/29) in the PCU. Only thirty-seven (37.3%) patients died where they wanted, based on the comparison between patients' preferences and actual places of death. Conclusion: The concordance rate between the preferred and actual places of death is not high in Japan. Improving concordance between patients' preferences and actual places of death has the potential to improve end-of-life care.

BACKGROUND For cancer patients nearing death, the prediction of their prognosis by physicians is crucial. This study examined the usefulness of the 1-Day Surprise Question (1DSQ). METHODS This study was conducted as part of a multicenter prospective observational study. The physicians answered the 1DSQ "Would I be surprised if this patient died in the next 1 day?" when patients have palliative performance scale (PPS) ≤20. We calculated the sensitivity and specificity of the 1DSQ. Moreover, using multivariate analysis, we evaluated the characteristics of patients who died among those whose physicians answered the 1DSQ as "not surprised". RESULTS Overall, 1,896 patients were enrolled, and 1411 (74.4%) were analyzed between January and December 2017. Among these, 847 (60.0%) patients were placed in the "not surprised" group. The sensitivity, specificity, and positive and negative predictive values of the 1DSQ were 82.0% [95% confidence interval (CI): 77.5-85.8%], 45.5% (95% CI: 44.4-46.4%), 27.4% (95% CI: 25.9-28.7%), and 91.0% (95% CI: 88.9-92.9%), respectively. Multivariate analysis revealed that urine output over last 12 hours

How clinicians treat patients with terminal dyspnea widely varies, which could hamper quality care. We visualized comprehensive pharmacological treatment delivered by palliative care physicians.To examine adherence to a comprehensive pharmacological treatment algorithm for patients with terminal dyspnea, and to explore its outcomes during 48 h.A multicenter cohort study at five sites (February 2020 to June 2021).We prospectively enrolled consecutive patients with advanced cancer, Eastern Cooperative Oncology Group performance status 3-4, and moderate/severe dyspnea. Participating palliative care physicians initiated algorithm-based treatment. The primary outcome was the proportion of adherence to the treatment algorithm over 24 h (predefined goal, 70%). We evaluated the adherence, goal achievement, and dyspnea level with a numerical rating scale (NRS), as well as adverse events over 48 h.All 108 patients received algorithm-based pharmacological treatment. Among 96 and 87 patients who were alive at 24 and 48 h, respectively, 96 (100%; 95% confidence interval [CI] = 96%-100%) and 82 (94%; 95%CI = 87%-98%) continued to receive the algorithm treatment, respectively, and 66 (69%; 95%CI = 59%-77%) and 64 (74%; 95%CI = 63%-82%) achieved the treatment goals, respectively. Using a complete case analysis with paired t-tests, mean dyspnea NRS scores significantly reduced from 7.3 (standard error, 0.2) at the baseline to 4.9 (0.3) at 24 h (n = 72; p 0.001), and 7.2 (0.3) at the baseline to 4.6 (0.4) at 48 h (n = 55; p 0.001). Most adverse events were mild to moderate.The comprehensive pharmacological treatment algorithm was feasible, and the study data supports its preliminary efficacy and safety. The use of this algorithm may help clinicians improve care for patients with terminal dyspnea.

Background: Predictive factors for the development of dyspnea have not been reported among terminally ill cancer patients. Objective: This current study aimed to identify the predictive factors attributed to the development of dyspnea within 7 days after admission among patients with cancer. Methods: This was a secondary analysis of a multicenter prospective observational study on the dying process among patients admitted in inpatient hospices/palliative care units. Patients were divided into 2 groups: those who developed dyspnea (development group) and those who did not (non-development group). To determine independent predictive factors, univariate and multivariate analyses using the logistic regression model were performed. Results: From January 2017 to December 2017, 1159 patients were included in this analysis. Univariate analysis showed that male participants, those with primary lung cancer, ascites, and Karnofsky Performance Status score (KPS) of ≤40, smokers, and benzodiazepine users were significantly higher in the development group. Multivariate analysis revealed that primary lung cancer (odds ratio [OR]: 2.80, 95% confidence interval [95% CI]: 1.47-5.31; p = 0.002), KPS score (≤40) (OR: 1.84, 95% CI: 1.02-3.31; p = 0.044), and presence of ascites (OR: 2.34, 95% CI: 1.36-4.02; p = 0.002) were independent predictive factors for the development of dyspnea. Conclusions: Lung cancer, poor performance status, and ascites may be predictive factors for the development of dyspnea among terminally ill cancer patients. However, further studies should be performed to validate these findings.

Purpose: It is important for palliative care providers to identify what factors are associated with "good death" for patients with advanced cancer. We aimed to clarify factors associated with "good death" evaluated by the Good Death Scale (GDS) score among inpatients with advanced cancer in palliative care units (PCUs) in Japan. Methods: The study is a sub-analysis of a multicenter prospective cohort study conducted in Japan. All variables were recorded on a structured data collecting sheet designed for the study. We classified each patient into better GDS group or worse GDS group, and examined factors associated with better GDS using multivariate analysis. Results: Between January to December in 2017, 1896 patients were enrolled across 22 PCUs in Japan. Among them, a total of 1157 patients were evaluated. Five variables were significantly associated with a better GDS score in multivariate analysis: preferred place of death at PCU (odds ratio [OR] 2.85; 95% confidence interval [CI] 1.72–4.71; p p p p p = 0.03). Conclusions: We clarified factors associated with "good death" using GDS among advanced cancer patients in Japanese PCUs. Recognition of factors associated with GDS could improve the quality of end-of-life care.

Background The study aimed to clarify the efficacy of the “3‐Day Surprise Question (3DSQ)” in predicting the prognosis for advanced cancer patients with impending death. Patients and Methods This study was a part of multicenter prospective observational study which investigated the dying process in advanced cancer patients in Japan. For patients with a Palliative Performance Scale ≤20, the 3DSQ “Would I be surprised if this patient died in the next 3 days?” was answered by their physicians. In addition to the sensitivity and specificity of the 3DSQ, the characteristics of patients who survived longer than expected were examined via multivariate analysis. Results Among the 1896 patients enrolled, 1411 were evaluated. Among 1179 (83.6%) patients who were classified into the “Not surprised” group, 636 patients died within 3 days. Among 232 (16.4%) patients of “Yes surprised” group, 194 patients lived longer than 3 days. The sensitivity, specificity, positive predictive value, and negative predictive value of the 3DSQ were 94.3% (95% confidence interval [CI]: 92.7% to 95.8%), 26.3% (95% CI: 24.8% to 27.6%), 53.9% (95% CI: 53.0% to 54.7%), and 83.6% (95% CI: 78.7% to 87.7%), respectively. Multivariate analysis showed palpable radial artery, absent respiration with mandibular movement, SpO2 ≥ 90%, opioid administration, and no continuous deep sedation as characteristics of patients who lived longer than expected. Conclusions The 3‐Day Surprise Question can be a useful screening tool to identify advanced cancer patients with impending death., Survival prediction in cancer patients with impending death is important for patients, families, and physicians. The 3‐Day Surprise Question can be a useful screening tool to identify advanced cancer patients with impending death.

Spiritual well-being is very important in patients undergoing palliative care. Although psychosocial factors have been suggested to be associated with spiritual well-being, the relationship between physical signs and spiritual well-being has not been fully elucidated. The aim of this study was to explore diverse factors associated with spiritual well-being among palliative care patients in Japan. This study is a secondary analysis of a multicenter prospective cohort study involving patients admitted to palliative care units in Japan. Physicians recorded all data prospectively on a structured sheet designed for the study. The spiritual well-being score was measured using the Integrated Palliative Outcome Scale after patients’ death in regard to symptoms over the previous 3 days. We classified each patient into “better” score (0–1) and “worse” score (2–4) groups and examined diverse factors associated with spiritual well-being. Among the 1896 patients enrolled, 1313 were evaluated. In the multivariate analysis, seven variables were significantly associated with “worse” score: worse spiritual well-being on admission (2–4) (p < 0.0001), younger age (< 80) (p = 0.0001), hyperactive delirium over 3 days before death (mild/moderate/severe) (p = 0.0001), expressed wish for hastened death (yes) (p = 0.0006), worse communication among patients and families (Support Team Assessment Schedule score 2–4) (p = 0.0008), pleural effusion (present) (p = 0.037), and marital status (unmarried) (p = 0.0408). Recognizing factors associated with spiritual well-being is potentially useful for identifying high-risk groups with lower spiritual well-being at the end of life. Further study is required to investigate factors associated with patient-reported spiritual well-being.

Objectives Patients with concomitant advanced non-small cell lung cancer (NSCLC) and interstitial lung disease (ILD) are excluded from most clinical chemotherapy trials because of the high risk of exacerbating the latter condition. This study prospectively investigated the efficacy and safety of albumin-bound paclitaxel (nab-paclitaxel) in combination with carboplatin in patients with both advanced NSCLC and ILD. Patients and methods The enrolled patients had treatment-naive, advanced NSCLC with ILD. Patients received 100 mg/m2 nab-paclitaxel weekly and carboplatin at an area under the concentration-time curve of 6 once every 3 weeks for 4–6 cycles. The primary endpoint was the overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS), and overall survival (OS). Results Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had adenocarcinoma, 15 (41.7%) had squamous cell carcinoma (Sq), and 5 (13.9%) had non-small cell carcinoma. The median number of cycles administered were 4 (range: 1–6). The ORR was 55.6% (95% confidence interval [CI]: 39.6–70.5). The median PFS and OS were 5.3 months (95% CI: 3.9–8.2) and 15.4 months (95% CI: 9.4–18.7), respectively. A greater proportion of patients with Sq experienced improvements than did those with non-Sq: ORRs, 66.7% (95% CI: 41.7–84.8) vs. 47.6% (95% CI: 28.3–67.6) (P = 0.254); median PFS, 8.2 months (95% CI: 4.0–10.2) vs. 4.1 months (95% CI: 3.3–5.4) (HR, 0.60 [95% CI, 0.30–1.20]; P = 0.15); and median OS, 16.8 months (95% CI: 9.8–not reached) vs. 11.9 months (95% CI: 7.3–17.4) (HR, 0.56 [95% CI, 0.24–1.28]; P = 0.17). Two patients (5.6%) experienced grade ≥2 pneumonitis and 1 patient (2.8%) died. Conclusion Weekly nab-paclitaxel combined with carboplatin showed favorable efficacy with acceptable toxicity in patients with both advanced NSCLC and ILD.

ObjectivesDyspnoea is a common and distressing symptom in patients with cancer. We aimed to analyse the association between dyspnoea and related factors and to estimate their causal relationship.MethodsA cross-sectional study was conducted. Patients with cancer with dyspnoea and a mean Numerical Rating Scale (NRS) of ≥3 over 24 hours were enrolled at 10 institutions in Japan from December 2019 to February 2021. The outcomes included dyspnoea, cough and pain NRS over 24 hours, Eastern Cooperative Oncology Group Performance Status, Hospital Anxiety and Depression Scale, Somatosensory Amplification Scale, opioids for dyspnoea and respiratory failure. Path analyses were conducted to estimate the direct and indirect paths with reference to dyspnoea and related factors.ResultsA total of 209 patients were enrolled and 208 patients were included in the analysis. Cough worsened dyspnoea (β=0.136), dyspnoea increased emotional distress (β=1.104), emotional distress increased somatosensory amplification (β=0.249) and somatosensory amplification worsened cough (β=0.053) according to path analysis.ConclusionThere may be a vicious circle among dyspnoea and related factors: cough worsened dyspnoea, dyspnoea increased emotional distress, emotional distress increased somatosensory amplification and somatosensory amplification worsened cough. When treating dyspnoea in patients with cancer, managing these factors aimed at interrupting this vicious circle may be useful.Trial registration numberUMIN Clinical Trials Registry (UMIN000038820).

Context Conducting randomized controlled trials on palliative care is difficult owing to barriers like fragility of the patients’ health status and health care providers’ concerns for patients. However, quality randomized controlled trials are required for care improvement. Objectives To investigate the willingness of cancer patients and their relatives to participate in a clinical study on cancer dyspnea and identify feasible clinical study designs for this condition. Methods A nationwide, cross-sectional, web-based survey was conducted with 206 cancer patients and 206 relatives of cancer patients. Their willingness to participate in clinical studies on cancer dyspnea and factors influencing this willingness were assessed in two scenarios: outpatients receiving anticancer treatment and terminally ill inpatients. Results About 23% patients and 23% relatives were willing to participate in clinical trials while 40% and 32%, respectively, were unwilling. Factors related to patient participation were quick and easy trials (outpatient 57%, terminally ill 53%) and oral medication with minimal potential side effects (outpatient 48%). Factors related to unwillingness to participate were placebo-controlled trials (outpatient 51%, terminally ill 50%), disagreements about participation between patients and families (outpatient 49%, terminally ill 49%), and continuous injections (outpatient 61%, terminally ill 47%). Compared to patients, relatives responded more reluctantly, especially for patients in terminal care. Conversely, patients were less reluctant in the terminal setting than the outpatient setting. Conclusion Some patients and relatives were reluctant to participate in clinical trials on cancer dyspnea. Thus, trials need to be minimally invasive, quick, and fully explained to and understood by patients and families.

Background and Objective: Recently, AmoyDx™RT-PCR Kit has been approved for ROS1 fusion gene (ROS1) test. Formalin-Fixed Paraffin-Embedded tissue (FFPE-t) materials are recommended to test. However, the quality of RNA in FFPE-t is often inadequate. Therefore, we retrospectively analyzed success rate of ROS1 test of non-small cell lung cancer (NSCLC) in clinical practice cases. Patients and Methods: From April 2017 to December 2018, 156 cases of NSCLC were subjected to ROS1 test using FFPE-t (surgical and/or biopsy) or bronchoscopic cytologic specimens. Success rates of each specimen were analyzed. Results: Among 156 cases, one case was positive, 132 cases were negative, and 23 cases were not evaluable. Examination success rate was 133/156(85%). Success rate of surgery specimen was 45/45(100%), and that of bronchoscopic biopsy specimen was 63/83(76%). There ware 25 cases in which ROS1 test were examined using both FFPE-t and cytologic specimens via bronchoscopy. The success rate was 18/25(72%) in FFPE-t and 18/25(72%) in cytologic specimens. The average turn-around-time was significantly shorter in cytologic specimen than that of FFPE-t (8.0 vs. 10.8 days; p Conclusion: ROS1 test using FFPE-t specimen from surgery or bronchoscopy was a high success rate. ROS1 test using cytologic specimen via bronchoscopy was equivalent to that using FFPE.

The herbal medicine rikkunshito has the potential to improve chemotherapy-induced nausea and vomiting (CINV) by stimulating ghrelin secretion. We aimed to evaluate the efficacy and safety of rikkunshito in preventing CINV for patients with lung cancer. Two separate prospective, randomized, phase II parallel design studies were conducted in patients with lung cancer. Fifty-eight and sixty-two patients scheduled to receive highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC), respectively, were randomized 1:1 to receive either standard antiemetic therapy in accordance with international guidelines (S group) or standard antiemetic therapy plus oral rikkunshito (R group). The primary endpoint was overall complete response (CR)—that is, no emesis and rescue medication in the first 120 h post-chemotherapy. Secondary endpoints included CR in the acute (0–24 h) and delayed (>24–120 h) phases and safety. Fifty-seven patients (S group, 28; R group, 29) receiving HEC and sixty-two patients (S group, 30; R group, 32) receiving MEC with comparable characteristics were evaluated. The CR rates were similar across the S and R groups for the HEC study in the overall (67.9% vs. 62.1%), acute (96.4% vs. 89.6%), and delayed (67.9% vs. 62.1%) phases, respectively, and for the MEC study in the overall (83.3% vs. 84.4%), acute (100% vs. 100%), and delayed (83.3% vs. 84.4%) phases, respectively. No severe adverse events were observed. Although rikkunshito was well tolerated, it did not demonstrate an additional preventative effect against CINV in lung cancer patients receiving HEC or MEC.Clinical Trial Registry Information: This study is registered with the University Hospital Medical Information Network (UMIN) Clinical Trial Registry1, identification numbers UMIN 000014239 and UMIN 000014240.

Background Because of the high risk of exacerbation of ILD, patients with concomitant advanced NSCLC and ILD have been excluded from most clinical trials of chemotherapy, despite around 10% of all NSCLC cases. This study prospectively evaluated the efficacy and safety of nab-paclitaxel in combination with CBDCA in advanced NSCLC patients with ILD. Methods Enrolled patients had treatment-naive, advanced NSCLC with ILD. Patients received 100 mg/m2nabPTX weekly and CBDCA at area under the concentration-time curve (AUC) 6 once every 3 weeks for 4-6 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints included toxicity, progression-free survival (PFS) and overall survival (OS). Results Thirty-six patients were enrolled between April 2014 and September 2017. Sixteen patients (44.4%) had an adenocarcinoma, followed by 15 (41.7%) squamous cell carcinoma, and 5 (13.9%) non-small cell carcinoma. The median number of cycles administered were 4 (range: 1-6). The ORR was 55.6% (95% confidence interval [CI]: 39.6-70.5). The median PFS and OS were 5.3 months (95% CI: 3.9-8.2) and 15.4 months (95% CI: 9.4-18.7). There was no significant difference between two groups, however, numerically better treatment outcomes were observed in the Sq group: the ORR was 66.7% (95% CI: 41.7–84.8) in the Sq group compared with 47.6% (95% CI: 28.3–67.6) in the Non-Sq group (P = 0.254); median PFS was 8.2 months (95% CI: 4.0–10.2) in the Sq group vs. 4.1 months (95% CI: 3.3-5.4) in the Non-Sq group (HR, 0.60 [95% CI, 0.30–1.20]; p = 0.15); median OS was 16.8 months (95% CI: 9.8–not reached) in the Sq group vs. 11.9 months (95% CI: 7.3-17.4) in the Non-Sq group (HR, 0.56 [95% CI, 0.24–1.28]; p = 0.17). Two patients (5.6%) experienced grade ≥2 pneumonitis and one patient (2.8%) died. After the protocol treatment, 24 patients (66.7%) underwent second-line therapy. Most preferred regimen were S-1 (n = 12, 50%), followed by vinorelbine (n = 4, 16.7%) and docetaxel (n = 3, 12.5%). Conclusions This is the first prospective phase II trial of weekly nabPTX in combination with CBDCA in advanced NSCLC patients with ILD. This treatment showed favorable efficacy and was well tolerated. Clinical trial identification UMIN000012901. Legal entity responsible for the study The authors. Funding Has not received any funding. Disclosure T. Harada: Honoraria (institution): GlaxoSmithKline K.K.; Honoraria (institution): Hisamitsu Pharmaceutical Co.,Inc; Honoraria (institution): Boehrnger INgelheim. S. Oizumi: Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Chugai Pharmaceutical Co.; Research grant / Funding (institution): Pfizer; Speaker Bureau / Expert testimony: AstraZeneca; Speaker Bureau / Expert testimony: Eli Lilly. Y. Fujita: Honoraria (institution): Eli Lilly; Honoraria (institution): Chugai Pharma; Honoraria (institution): Taiho Pharmaceutical; Honoraria (institution): Pfizer; Honoraria (institution): Hisamitsu Pharmaceutical; Honoraria (institution): Novartis; Honoraria (institution): Ono Pharmaceutical. All other authors have declared no conflicts of interest.