The impact of death rattle on bereaved families: not the sound itself, but the resonance with their feelings.

BACKGROUND: This study aimed to explore (i) the consistency between physician-rated and bereaved family-perceived intensity of death rattle, (ii) the relationship between intensity of death rattle and the bereaved family's distress and (iii) the bereaved family's experience and feelings related to suctioning for death rattle. METHODS: We used matched data for deceased patients from a prospective cohort study of cancer patients admitted to a palliative care unit, and their bereaved families from a nationwide questionnaire survey in Japan. The intensity of death rattle using Back's score was evaluated prospectively by physicians and retrospectively by bereaved families. RESULTS: In total, 1122 bereaved families answered (response rate: 66.7%). Of these, 297 reported the development of death rattle. The maximum intensity of death rattle evaluated by physicians and perceived by bereaved families was poorly correlated (Spearman correlation coefficient 0.188, P = 0.082). The optimal cut-off point of Back's score for detecting high-level distress was 1/2, with a low accuracy of prediction (area under the curve 0.62). More than 70% of bereaved families indicated suctioning reduced the intensity of death rattle, made patients comfortable and themselves relieved, whereas a similar proportion felt patients were in distress during suctioning. Families who felt suctioning was gently performed and discussed well whether to do suctioning with health care providers felt less needs for improvement. CONCLUSIONS: Bereaved family-perceived intensity of death rattle did not correlate to physician-evaluated intensity, and the intensity of death rattle itself seemed to poorly correlate to family distress. Gently performed suctioning based on sufficient discussion with families can help reduce family-perceived patient discomfort.

[Early Experience with MRI-Ultrasound Fusion-Guided Prostate Biopsy in Our Institution].

A total of 100 patients were retrospectively analyzed with magnetic resonance imaging-ultrasonography (MRI-US) fusion biopsy(KOELIS, TRINITY®) at our institution between October 2019 and May 2020. The median patient age was 71 years, median prostate specific antigen (PSA) level was 7.4 ng/ml, and median PSA-density was 0.183 mg/ml. Sixty-one of the patients were positive for cancer ; 14 of them were positive by targeted biopsy only, 9 were positive by systematic biopsy only, and 38 were positive by both. Clinically significant prostate cancer (CPSC ; Gleason Score ≥3＋4 and % core ≥50%) was detected by target biopsies in 46 patients and by systematic biopsies in 33 patients. The positive core detection rate for CSPC was 32.5% for targeted biopsies and 7.0% for systematic biopsies(P＜0.0001), with a significantly higher rate for targeted biopsies. These results indicate that in MRI-US fusion biopsy, targeted biopsy has a higher detection rate for cancer and a significantly higher detection rate for clinically significant prostate cancer compared with systematic biopsy.

Factors influencing spiritual well-being in terminally ill cancer inpatients in Japan.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSION: 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.

How successful are we in relieving terminal dyspnea in cancer patients? A real-world multicenter prospective observational study.

PURPOSE: Parenteral morphine is widely used for dyspnea of imminently dying cancer patients, but the outcomes to expect over time remain largely unknown. We examined outcomes after the administration of parenteral morphine infusion over 48 h in cancer patients with a poor performance status. METHODS: This was a multicenter prospective observational study. Inclusion criteria were metastatic/locally advanced cancer, ECOG performance status = 3-4, a dyspnea intensity ≥ 2 on a Support Team Assessment Schedule, Japanese version (STAS-J), and receiving specialized palliative care. After initiating parenteral morphine infusion, we measured dyspnea STAS-J as well as Memorial Delirium Assessment Scale (MDAS), item 9, and Communication Capacity Scale (CCS), item 4, every 6 h over 48 h. RESULTS: We enrolled 167 patients (median survival = 4 days). The mean age was 70 years, 80 patients (48%) had lung cancer, and 109 (65%) had lung metastases. The mean STAS-J scores decreased from 3.1 (95% confidence interval (CI) = 3.0-3.2) at the baseline to 2.1 (95%CI = 1.9-2.2) at 6 h, and remained 1.6-1.8 over 12-48 h. The proportion of patients with dyspnea relief (STAS-J ≤ 1) increased to 39% at 6 h, and ranged between 49 and 61% over 12-48 h. In contrast, up to 6.6 and 20% of patients showed hyperactive delirium (MDAS item 9 ≥ 2) and an inability to communicate (CCS item 4 = 3), respectively, over 48 h. CONCLUSIONS: Overall, terminal dyspnea was relatively well controlled with parenteral morphine, though a significant number of patients continued to suffer from dyspnea. Future efforts are needed to improve outcomes following standardized dyspnea treatment using patient-reported outcomes for imminently dying patients.

Adding a Wider Range and "Hope for the Best, and Prepare for the Worst" Statement: Preferences of Patients with Cancer for Prognostic Communication.

INTRODUCTION: Although various phrases to communicate prognoses based on a certain concept have been proposed, no study has systematically investigated preferences of patients with cancer for actual phrases. We investigated whether phrases with a wider range and additional "hope for the best, and prepare for the worst" (hope/prepare) statement would be more preferable and explored variables associated with patients' preferences. MATERIALS AND METHODS: In a cross-sectional survey, 412 outpatients with cancer self-assessed their preferences for 13 phrases conveying prognostic information (e.g., phrases with or without median, typical range, and/or best/worst cases, and those with or without a hope/prepare statement) on a 6-point scale (1 = not at all preferable; 6 = very preferable). We evaluated demographic data and the Coping Inventory for Stressful Situations and conducted multivariate regression analysis. RESULTS: Regarding phrases with various ranges, the one including the median, typical range, and best/worst cases was more preferable (mean ± SD, 3.8 ± 1.3; 95% confidence interval [CI], 3.6-3.9) than the one with the median and typical range (3.4 ± 1.2; 3.3-3.6) or the one with only the median (3.2 ± 1.3; 3.1-3.3). Concerning the hope/prepare statement, the phrase including the median, typical range, uncertainty, and hope/prepare statement was more preferable (3.8 ± 1.4; 3.7-3.9) than the one without the statement (3.5 ± 1.2; 3.4-3.6). In multivariate analyses, task-oriented coping was significantly correlated with preferences for phrases with explicit information. CONCLUSION: Overall, phrases with a wider range and the hope/prepare statement were preferable to those without them. When patients with cancer ask about prognoses, especially those with task-oriented coping, clinicians may provide explicit information with a wider range and the hope/prepare statement. IMPLICATIONS FOR PRACTICE: Discussing prognoses with patients with advanced cancer is among the most important conversations for clinicians. In this cross-sectional survey to systematically investigate preferences of 412 patients with cancer for phrases conveying prognostic information, phrases with the median, typical range, and best/worst cases and those with the "hope for the best and prepare for the worst" (hope/prepare) statement were the most preferred. When patients with cancer ask about prognoses, clinicians may provide explicit information with a wider range and include the hope/prepare statement.

[Home Visit and Palliative Care from Hospital].

At Kawasaki Municipal Ida Hospital, medical oncology and palliative care have been integrated, and we have been building the "embedded palliative care model" which is responsible for anticancer drugs to home care. In the visit clinical practice in this model, it was possible to prepare the medicine immediately even in the emergency against the background that there are abundant medicines in the hospital pharmacies, so it is aggressive to prepare the home comfort set there was not. However, problems due to lack of comfort set at home came to be found, and I began to think that discussion should start on that creation. In this article, we outline how to think of comfort set in visit medical treatment from hospital, large scale clinic etc.

Predictors of response to corticosteroids for dyspnea in advanced cancer patients: a preliminary multicenter prospective observational study.

PURPOSE: Although corticosteroids can relieve dyspnea in advanced cancer patients, factors predicting the response remain unknown. We aimed to explore potential factors predicting the response to corticosteroids for dyspnea in advanced cancer patients. METHODS: In this preliminary multicenter prospective observational study, we included patients who had metastatic or locally advanced cancer, were receiving specialized palliative care services, and had a dyspnea intensity of ≥3 on a 0-10 Numerical Rating Scale (NRS) (worst during the last 24 h). The primary endpoint was NRS of dyspnea on day 3 after the administration of corticosteroids. Univariate/multivariate analyses were conducted to identify factors predicting ≥1-point reduction in NRS. RESULTS: Of 74 patients who received corticosteroids, 50 (68%) showed ≥1-point reduction in dyspnea NRS. Factors that significantly predicted the response were an age of 70 years or older (82 vs. 53%, p = 0.008), absence of liver metastases (77 vs. 46%, p = 0.001), Palliative Prognostic Index (PPI) ≤ 6 (90 vs. 61%, p = 0.041), presence of pleuritis carcinomatosa with a small collection of pleural effusions (84 vs. 55%, p = 0.011), presence of audible wheezes (94 vs. 60%, p = 0.014), and baseline dyspnea NRS ≥7 (76% vs. 52%, p = 0.041). In a multivariate analysis, factors predicting response included PPI <6 (odds ratio (OR), 36.2; p = 0.021), baseline dyspnea NRS (worst) ≥7 (OR, 6.6; p = 0.036), and absence of liver metastases (OR, 0.19; p = 0.029) or ascites/liver enlargement (OR, 0.13; p = 0.050). CONCLUSIONS: The patient characteristics, etiologies of dyspnea, and clinical manifestations may predict responses to corticosteroids for dyspnea. Larger prospective studies are promising to confirm our findings.

Predictors of responses to corticosteroids for anorexia in advanced cancer patients: a multicenter prospective observational study.

PURPOSE: Although corticosteroids are widely used to relieve anorexia, information regarding the factors predicting responses to corticosteroids remains limited. The purpose of the study is to identify potential factors predicting responses to corticosteroids for anorexia in advanced cancer patients. METHODS: Inclusion criteria for this multicenter prospective observational study were patients who had metastatic or locally advanced cancer and had an anorexia intensity score of 4 or more on a 0-10 Numerical Rating Scale (NRS). Univariate and multivariate analyses were conducted to identify the factors predicting ≥2-point reduction in NRS on day 3. RESULTS: Among 180 patients who received corticosteroids, 99 (55 %; 95 % confidence interval [CI], 47-62 %) had a response with ≥2-point reduction. Factors that significantly predicted responses were Palliative Performance Scale (PPS) > 40 and absence of drowsiness. In addition, factors that tended to be associated with ≥2-point reduction in NRS included PS 0-3, absence of diabetes mellitus, absence of peripheral edema, presence of lung metastasis, absence of peritoneal metastasis, baseline anorexia NRS of >6, presence of pain, and presence of constipation. A multivariate analysis showed that the independent factors predicting responses were PPS of >40 (odds ratio = 2.7 [95 % CI = 1.4-5.2]), absence of drowsiness (2.6 [1.3-5.0]), and baseline NRS of >6 (2.4 [1.1-4.8]). CONCLUSIONS: Treatment responses to corticosteroids for anorexia may be predicted by PPS, drowsiness, and baseline symptom intensity. Larger prospective studies are needed to confirm these results.

Multicenter cohort study on the survival time of cancer patients dying at home or in a hospital: Does place matter?

BACKGROUND: Although the place of death has a great influence on the quality of death and dying for cancer patients, whether the survival time differs according to the place of death is unclear. The primary aim of this study was to explore potential differences in the survival time of cancer patients dying at home or in a hospital. METHODS: This multicenter, prospective cohort study was conducted in Japan from September 2012 through April 2014 and involved 58 specialist palliative care services. RESULTS: Among the 2426 patients recruited, 2069 patients were analyzed for this study: 1582 receiving hospital-based palliative care and 487 receiving home-based palliative care. A total of 1607 patients actually died in a hospital, and 462 patients died at home. The survival of patients who died at home was significantly longer than the survival of patients who died in a hospital in the days' prognosis group (estimated median survival time, 13 days [95% confidence interval (CI), 10.3-15.7 days] vs 9 days [95% CI, 8.0-10.0 days]; P = .006) and in the weeks' prognosis group (36 days [95% CI, 29.9-42.1 days] vs 29 days [95% CI, 26.5-31.5 days]; P = .007) as defined by Prognosis in Palliative Care Study predictor model A. No significant difference was identified in the months' prognosis group. Cox proportional hazards analysis revealed that the place of death had a significant influence on the survival time in both unadjusted (hazard ratio [HR], 0.86; 95% CI, 0.78-0.96; P < .01) and adjusted models (HR, 0.87; 95% CI, 0.77-0.97; P = .01). CONCLUSIONS: In comparison with cancer patients who died in a hospital, cancer patients who died at home had similar or longer survival. Cancer 2016;122:1453-1460. © 2016 American Cancer Society.

Glasgow prognostic score predicts prognosis for cancer patients in palliative settings: a subanalysis of the Japan-prognostic assessment tools validation (J-ProVal) study.

PURPOSE: The Glasgow prognostic score (GPS), which uses C-reactive protein and albumin levels, is a good predictor of prognosis in cancer patients undergoing anti-tumor therapy. The objective of this study was to investigate the correlation between GPS and survival among cancer patients in palliative settings, as findings in such populations have not been well described. METHODS: This was a subanalysis of a multicenter, prospective, cohort study in patients who were adults, diagnosed with advanced cancer, and first referred to palliative care service in Japan. Patients who were not receiving anti-tumor therapy and who had undergone laboratory examinations were eligible. Clinical features were analyzed to investigate prognostic factors. RESULTS: A total of 1160 patients were enrolled (41.6 % female; median age, 72 years). The independent predictors were Eastern Cooperative Oncology Group performance status (ECOG PS) score of 4 (hazard ratio (HR), 1.54), liver metastasis (HR, 1.21), dyspnea (HR, 1.35), edema (HR, 1.25), prognostic performance index (HR, 1.56), neutrophil-lymphocyte ratio (HR, 1.43), and GPS of 2 (HR, 1.36). The sensitivity and specificity for 3-week prognosis of a GPS of 2 were 0.879 and 0.410. Median survival time with GPS of 0, 1, and 2 was 58 days (95 % confidence interval, 48-81), 43 days (37-50), and 21 days (19-24), respectively (log-rank test, p < 0.001). CONCLUSION: The GPS was a good prognostic indicator for cancer patients in palliative settings.

Collision tumors of hepatocellular carcinoma and malignant peritoneal mesothelioma.

We report a case of synchronous hepatocellular carcinoma (HCC) and malignant peritoneal mesothelioma (MM-per). A 56-year-old man with no past history of asbestos exposure, chronic viral hepatitis, or alcoholic liver injury was admitted to our hospital with left flank pain and abdominal tumor. Partial hepatectomy, splenectomy, partial diaphragm resection, and partial gastrectomy were performed. The tumor in the lateral segment of the liver was gray to white, massive in appearance, and contained focal bile-producing nodules and extensive fibrous firm lesion. It had directly invaded the spleen and diaphragm. Liver cirrhosis was not found. The peritoneum contained multiple small nodules especially around the diaphragm, which mimicked carcinoma dissemination. After histological examination, the liver tumor was diagnosed as HCC. It had trabecular and scirrhous patterns and positive immunoreactivities for Hep-Par-1 and α-fetoprotein. The peritoneal nodules were diagnosed as MM-per, epithelioid type, with positive immunoreactivities for calretinin and cytokeratin 5/6. The two tumors collided around the diaphragm. Cases of MM synchronous with other primary malignant tumors have been reported, but most had a history of asbestos exposure unlike the present case. The carcinogenic background was unclear for two tumors in this case. This is an extremely rare and valuable case.

[An autopsy case of unresectable colon cancer who developed lung injury by cetuximab].

We report the case of a woman in her 60s with unresectable advanced colon cancer. After the first course of cetuximab as second-line therapy, she had developed drug-induced lung injury. Steroid pulse therapy had been ineffective, and she died of respiratory failure on day 9. The pathological examination of autopsy lung specimens revealed diffuse alveolar damage(DAD). Details of the cetuximab-induced lung injury are unclear. However, in 3 previous reports of lung injury by cetuximab, the postmortem findings were similar to this case. We concluded that DAD seems to be one of the pathological features of lung injury caused by cetuximab.

Comparison of survival times of advanced cancer patients with palliative care at home and in hospital.

OBJECTIVES: One primary concern about receiving care at home is that survival might be shortened because the quality and quantity of treatment provided at home will be inferior to that given in the hospital. Although our previous study demonstrated a longer survival of those with home-based palliative care (PC), it lacked adjustment for some potential confounders including symptoms and treatments during the stay. We aimed to compare the survival times among advanced cancer patients receiving home-based and hospital-based PC with adjusting for symptoms and treatments. METHOD: We compared survival time of participants who enrolled two multicenter, prospective cohort studies of advanced cancer patients at 45-home-based PC services between July 2017 and December 2017, and at 23-hospital-based PC services between January 2017 and December 2017. We analyzed with stratification by the estimated survival of Days, Weeks, and Months, which were defined by modified Prognosis in Palliative care Study predictor models-A. We conducted a Cox regression analysis with adjusting for potential confounders including symptoms and treatments during the stay. RESULTS: A total of 2,998 patients were enrolled in both studies and 2,878 patients were analyzed; 988 patients receiving home-based PC and 1,890 receiving hospital-based PC. The survival time of patients receiving home-based PC was significantly longer than that of patients receiving hospital-based PC for the Days Prognosis (estimated median survival time: 10 days [95% CI 8.1-11.8] vs. 9 days [95% CI 8.3-10.4], p = 0.157), the Weeks prognosis (32 days [95% CI 28.9-35.4] vs. 22 days [95% CI 20.3-22.9], p < 0.001), and the Months Prognosis, (65 days [95% CI 58.2-73.2] vs. 32 days [95% CI 28.9-35.4], p < 0.001). CONCLUSION: In this cohort of advanced cancer patients with a Weeks or Months prognosis, those receiving home-based PC survived longer than those receiving hospital-based PC after adjusting for symptoms and treatments.

[2 cases of successful symptom management at home by using opioid rotation from a fentanyl preparation to a continuous subcutaneous injection of morphine hydrochloride, at a dose less than the equivalent dose based on the conversion table].

We report our experiences of 2 cases of successful pain management at home by using opioid rotation from a fentanyl preparation to a continuous subcutaneous injection of morphine hydrochloride, at a dose less than the equivalent dose based on the conversion table. Our experiences also suggested that opioid rotation according to the conversion ratios might be associated with the risk of delay in the detection of adverse reactions to opioid overdose in patients under home care, whose conditions cannot be checked frequently by health care providers.

[A complete response of scirrhous gastric carcinoma treated with trastuzumab combination therapy].

Trastuzumab is the first molecular-target medicine for gastric cancer in acknowledgment of the effectiveness and safety in a randomized controlled trial for the HER2-positive gastric cancer. The HER2-positive rate of gastric cancer tends to be high for a well-differentiated adenocarcinoma. We report a case of HER2-positive scirrhous gastric carcinoma we treated, for whom a complete response was obtained by trastuzumab combination therapy. He was a 62-year-old man. In April, 2006, he was diagnosed with metastatic scirrhous gastric carcinoma(mainly poorly-differentiated adenocarcinoma). We become clear with HER2 strong positive in a pathology tissue and started capecitabine+cisplatin+trastuzumab therapy. We confirmed the disappearance of the lesion at the 10th cycle and judged it to be a complete response. The HER2 of advanced gastric cancer must be screened immediately without asking patients for their background or their clinical and pathologic features.

[Modified FOLFOX6(mFOLFOX6)in metastatic colorectal carcinoma patients with poor performance status].

Because mFOLFOX6 has few contraindications, it is useful for poor performance status(PS)cases. However, in Japan, there are some reports that the dose is reduced easily. We retrospectively examined the safety/usefulness of the full dose mFOLFOX6(first-line)for advanced colon cancer patients with poor PS. Four of five cases had improved PS. The response rate was 60%. Grade 3/4 adverse events were infection, leukopenia, and neutropenia. Treatment-related deaths within 60 days of starting treatment were absent. Full-dose mFOLFOX6 for poor PS may be beneficial. However, we must consider the increased risk of adverse events.

[Evaluation of family function in home care].

Quantitative and qualitative analyses of a caring family are needed to improve home care. We propose a three-dimensional quantitative evaluation of family functioning. The first dimension is food, clothing, and shelter; the second dimension is patient, medical, and caring conditions; and the third dimension is the caring family condition. We used the home care score and Family Adaptability and Cohesion Evaluation Scale at Kwansei Gakuin(FACESKG)IV for the quantitative evaluation of family functioning. Narrative medicine and ethnography are valuable for the qualitative evaluation of a caring family.

Epidemiology of Respiration with Mandibular Movement in Advanced Cancer Patients: A Multicenter Prospective Cohort Study.

Background: Respiration with mandibular movement (RMM) is one of the important clinical signs of impending death. However, there is very limited data on its natural course. Objective and Methods: This study was conducted in 23 inpatient palliative care units in Japan. It aimed to explore the natural course of RMM. Results: Among a total of 1526 cancer patients included, 1065 patients (69.8%) had RMM. A total of 14.8% patients experienced respiratory arrest within 30 minutes from RMM onset, 14.3% within 30-60 minutes, 34.4% within 1-4 hours, 17.5% within 4-12 hours, 8.9% within 12-24 hours, and 10.4%> 24 hours. Mean oxygen saturation and percentage of patients with SpO2 ≥90% at RMM onset were found to be significantly higher in patients with longer durations from RMM onset to death (p < 0.001). Conclusion: RMM occurred in a majority (80%) of dying patients within 12 hours. A minority of the patients survived >24 hours.

Effects of Antibiotics on Respiratory Symptoms in Terminally Ill Cancer Patients With Pneumonia: A Multicenter Cohort Study.

CONTEXT: Patients in the terminal stages of cancer are frequently affected by infection, especially pneumonia; but the effects of antibiotics on respiratory symptoms and factors associated with improvement are still unclear. OBJECTIVES: This study aimed to clarify the effects of antibiotics on respiratory symptoms of terminally ill cancer patients with pneumonia, and to explore factors associated with the improvement. METHODS: This was a prospective cohort study in which we consecutively recruited terminally ill cancer patients diagnosed with pneumonia and treated with antibiotics at one of 23 palliative care units across Japan. At the baseline and Day 3, primarily responsible palliative care specialists recorded patient backgrounds, the results of physical and laboratory examination, and patient symptoms using the Support Team Assessment Schedule. Improvement was defined as improvement of dyspnea, cough, and sputum production on Day 3. RESULTS: Among all 1896 patients admitted during the study periods, 137 patients (7.2%) were enrolled into this study. Improvement was achieved in 65 patients (47.4%; 95% confidence intervals, 39-56). Univariate analyses revealed that the Palliative Prognostic Index (PPI), respiratory rate (RR), and oxygen requirement were significantly associated with the improvement. A multiple logistic regression analysis identified that PPI score of ≤ 6 and RR of <20 were independently associated with the improvement (odds ratios, 4.4 [1.6-12] and 2.5 [1.1-5.5], respectively). CONCLUSION: Antibiotics may relieve respiratory symptoms from pneumonia in approximately half of the terminally ill cancer patients. PPI and respiratory rate are useful to identify the patients who received benefits of antibiotics.

Retrospective analysis of the international standard-dose FOLFIRI (plus bevacizumab) regimen in Japanese patients with unresectable advanced or recurrent colorectal carcinoma.

BACKGROUND: When applying the topoisomerase inhibitor irinotecan (CPT) with the infusional fluorouracil/levofolinate (FOLFIRI) ± bevacizumab chemotherapy regimen in cases of advanced colorectal carcinoma, the international standard dose for CPT is 180 mg/m(2). Despite this, 150 mg/m(2) CPT is widely prescribed and is the maximum dosage covered by Japanese health insurance. Consequently, the safety of dosing at the international standard has not been tested comprehensively and the efficacy of FOLFIRI in Japan may be underestimated. METHODS: To evaluate the safety of FOLFIRI (+bevacizumab) in clinical practice using international standards, we reviewed medical records of 53 patients who received FOLFIRI (+bevacizumab) with CPT 180 mg/m(2) as first-line treatment between September 2004 and August 2009. The primary endpoint of the study was to measure the relative dose intensity (RDI) of CPT after four courses. The secondary endpoint was to assess treatment completion rate, adverse events, response rate, progression-free survival (PFS) and overall survival (OS) among all patients. RESULTS: The RDI and the treatment completion rate were 88.9% and 69.8%, respectively, in the 53 patients. Accompanying grade 3 or 4 adverse events included neutropenia (35.8%), febrile neutropenia (7.5%), and diarrhea (3.8%). Supportive care managed all toxicity symptoms. Median durations for PFS and OS were 10.3 and 26.5 months, respectively. CONCLUSION: FOLFIRI (+bevacizumab) with the international standard dose of CPT is feasible in clinical practice. In order to minimize deviation of the Japanese regimen from global best practice, international dose standards should be followed.