A novel endoscopic technique using fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy: the saddle-cross technique (with video).

BACKGROUND: In recent years, the number of patients with hepaticojejunostomy anastomotic strictures has increased. Balloon dilation and placement of multiple plastic stents have proven effective for hepaticojejunostomy anastomotic strictures. However, for refractory strictures, there is often a need for repeated endoscopic procedures within a short period. This study aimed to assess the efficacy and safety of the new saddle-cross technique, which uses two fully covered self-expandable metallic stents. METHODS: This was a retrospective analysis of 20 patients with benign hepaticojejunostomy anastomotic strictures who underwent placement of two fully covered self-expandable metallic stents at the National Cancer Center, Japan, from November 2017 to June 2021. RESULTS: The technical and clinical success rates were 100% (20/20). The median time of the procedure was 61 (range 25-122) min. The scheduled stent removal rate was 70% (14/20). Spontaneous dislodgement of the stent was observed on computed tomography in five patients (25.0%). The non-restenosis rate 12 months after the saddle-cross technique was 88.2% (15/17). Procedure-related early adverse events included mild ascending cholangitis in three patients (15.0%) and sepsis in one patient (5.0%). Procedure-related late adverse events included mild ascending cholangitis in three patients (15.0%) and bile duct hyperplasia in one patient (5.0%). CONCLUSIONS: The saddle-cross technique performed using two fully covered self-expandable metallic stents resulted in promising long-term stricture resolution with a high technical success rate. Based on these findings, the saddle-cross method can be considered an option for the standard procedure for benign hepaticojejunostomy anastomotic strictures.

Image-guided core needle biopsy for musculoskeletal lesions.

BACKGROUND: Image-guided percutaneous core needle biopsy (CNB) has been an important diagnostic procedure for musculoskeletal lesions. Here we surveyed the variety of diagnostic strategies available and assessed the clinical usefulness and limitations of image-guided CNB carried out by a multidisciplinary team comprising specialists in various fields. METHODS: We conducted a retrospective study of 284 image-guided CNBs among 1899 consecutive biopsy procedures carried out at our institution for musculoskeletal tumorous conditions, focusing on their effectiveness including diagnostic accuracy and utility for classification of specimens according to malignant potential and histological subtype as well as their correlation with biopsy routes. RESULTS: Among the 284 studied biopsies, 252 (88.7%) were considered clinically "effective". The sensitivity for detection of malignancy was 94.0% (110/117) and the specificity was 95.3% (41/43). The diagnostic accuracy for detection of malignancy was 94.4% (151/160) and that for histological subtype was 92.3% (48/52). The clinical effectiveness of the procedure was correlated with the complexity of the biopsy route (P = 0.015); the trans-pedicular, trans-retroperitoneal and trans-sciatic foramen approaches tended to yield ineffective results. Repeat biopsy did not have a significant impact on the effectiveness of image-guided CNB (P = 0.536). CONCLUSIONS: The diagnostic accuracy rates of image-guided CNB performed at multidisciplinary sarcoma units were usable even for patients who have variety of diagnostic biopsy procedures. It is important to establish and implement diagnostic strategies based on an understanding that complicated routes, especially for spine and pelvic lesions, may be associated with ineffectiveness and/or complications.

Consensus Guidelines for the Definition of Time-to-Event End Points in Image-guided Tumor Ablation: Results of the SIO and DATECAN Initiative.

There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes standardized definitions for a broad range of oncologic outcome measures with recommendations on how to uniformly document, analyze, and report outcomes. The initiative was coordinated by the Society of Interventional Oncology in collaboration with the Definition for the Assessment of Time-to-Event End Points in Cancer Trials, or DATECAN, group. According to predefined criteria, based on experience with clinical trials, an international panel of 62 experts convened. Recommendations were developed using the validated three-step modified Delphi consensus method. Consensus was reached on when to assess outcomes per patient, per session, or per tumor; on starting and ending time and survival time definitions; and on time-to-event end points. Although no consensus was reached on the preferred classification system to report complications, quality of life, and health economics issues, the panel did agree on using the most recent version of a validated patient-reported outcome questionnaire. This article provides a framework of key opinion leader recommendations with the intent to facilitate a clear interpretation of results and standardize worldwide communication. Widespread adoption will improve reproducibility, allow for accurate comparisons, and avoid misinterpretations in the field of interventional oncology research. Published under a CC BY 4.0 license. Online supplemental material is available for this article. See also the editorial by Liddell in this issue.

Transgastric Feeding Tube Insertion into the Jejunum after Esophagectomy: Direct Puncture of the Gastric Conduit.

PURPOSE: To evaluate the safety and efficacy of percutaneous ultrasound (US)-guided direct puncture of a reconstructed gastric conduit after esophagectomy for performing a percutaneous radiologic gastrojejunostomy. MATERIALS AND METHODS: Between 2014 and 2020, 26 consecutive patients with esophageal cancer (mean age, 70 years ± 8.3) with a total of 27 attempts of percutaneous radiologic gastrojejunostomy for postsurgical enteral feeding at the National Cancer Center Hospital were included in this study. One patient required a repeat procedure because of persistent anorexia after the removal of the first tube. All patients except 1 had a gastric conduit reconstructed via a retrosternal route. All procedures were performed under local anesthesia with moderate sedation and analgesia. A gastric conduit was directly punctured with an 18-gauge needle under ultrasonographic guidance, followed by feeding tube insertion into the proximal jejunum. Technical details of the procedures, technical success (defined as adequate tube placement), procedure-related complications, and clinical outcomes were reviewed. RESULTS: The mean procedure time was 25 minutes ± 15, and technical success was obtained in every attempt. Minor complications included mild local pain (n = 7), unintentional tube removal (n = 2), local abdominal wall hematoma (n = 1), and superficial cellulitis (n = 1); no major complications were observed. During a mean follow-up period of 118.3 days ± 85.8, 13 patients resumed oral intake, and the feeding tube could be removed in 4 patients. No procedure-related deaths occurred. CONCLUSIONS: The US-guided direct puncture technique is feasible for percutaneous gastrojejunal tube insertion in postsurgical patients with esophageal cancer with gastric conduit reconstruction.

Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.

OBJECTIVE: This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE. DESIGN: Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing. RESULTS: Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities. CONCLUSION: TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials. TRIAL REGISTRATION NUMBER: NCT01217034.

Hepatic Arterial Infusion Chemotherapy of 5-Fluorouracil for Patients with Unresectable Liver Metastases from Colorectal Cancer Refractory to Standard Systemic Chemotherapy: A Multicenter Retrospective Study.

INTRODUCTION: Hepatic arterial infusion chemotherapy (HAIC) is a feasible treatment for patients with colorectal cancer (CRC) with unresectable liver metastases. OBJECTIVE: The aim of this retrospective study was to assess HAIC of 5-fluorouracil (5FU) in patients with unresectable liver metastases from CRC refractory to standard systemic chemotherapy. METHODS: A total of 137 patients (85 men, 52 women; median age, 62 years; with KRAS mutation, n = 57) were recruited from seven institutions from September 2008 to December 2015. These patients were refractory to systemic chemotherapy including three cytotoxic agents (fluoropyrimidine, oxaliplatin, and irinotecan) with two molecular-targeted agents (bevacizumab and epidermal growth factor receptor antibody [cetuximab or panitumumab]). All patients underwent HAIC of continuous 5FU for unresectable liver metastases. Overall survival time, time to treatment failure, objective response rate, disease control rate, and incidence of adverse events to HAIC were assessed retrospectively. RESULTS: The median overall survival time was 4.8 months (95% confidence interval [CI], 4.0-5.7 months), whereas time to treatment failure was 2.4 months (95% CI, 2.0-2.8 months). The objective overall response rate and disease control rate were 12.4 and 64%, respectively. Grade 3 or 4 adverse events were observed in 2.9% of the patients (hyperbilirubinemia in 2, liver abscess in 1, and myelosuppression in 1). CONCLUSIONS: There were few incidences of severe adverse events to HAIC of 5FU for liver metastases from CRC refractory to standard systemic chemotherapy. Therefore, it might present as a treatment option as last-line chemotherapy.

Efficacy of ascitic fluid cell block for diagnosing primary ovarian, peritoneal, and tubal cancer in patients with peritoneal carcinomatosis with ascites.

OBJECTIVE: To compare the efficacy of ascitic fluid cell block (ACB) with that of core needle biopsy (CNB) or the CA125/CEA ratio in diagnosing primary tubo-ovarian cancer in female patients with peritoneal carcinomatosis (PC) with ascites. METHODS: This retrospective study examined female patients with PC with ascites who had available results for ACB, peritoneal tumor CNB, and the CA125/CEA ratio. Several measures of the accuracy of ACB and the CA125/CEA ratio were calculated and compared, with CNB as the reference standard. RESULTS: Of 81 patients with available results, 57 were clinically diagnosed with primary tubo-ovarian cancer. Overall, 52, 47, and 64 patients were diagnosed via CNB, ACB, and CA125/CEA ratio > 25, respectively. CNB and ACB identified the cancer origin in 91.4% and 82.7% cases, respectively. The concordance ratio of the immunohistochemical findings between ACB and CNB was 93.6%. Two patients with inconclusive CNB results were diagnosed with primary tubo-ovarian cancer via ACB. The sensitivity, specificity, positive predictive value, negative predictive value, and positive likelihood ratio were 86.5%, 93.1%, 95.7%, 79.4%, and 12.5, respectively, for ACB and 94.2%, 48.3%, 76.6%, 82.4%, and 1.82, respectively, for CA125/CEA ratio > 25. CONCLUSIONS: ACB is not inferior to CNB in diagnosing primary tubo-ovarian cancer; the two methods complement each other. ACB can substitute CNB in diagnosing primary tubo-ovarian cancer in selected PC patients. ACB is superior to a CA125/CEA ratio of >25 in diagnosing primary tubo-ovarian cancer. ACB is effective, reliable, and convenient for diagnosing primary tubo-ovarian cancer in PC patients with ascites.

Transhepatic Placement of Metallic Biliary Stent for Internal Drainage of Persistent Liver Abscesses.

Transhepatic placement of a metallic biliary stent for internal drainage of persistent liver abscesses was performed in 9 patients (males; median age, 65 years; range, 57-82 years) with refractory liver abscess. The median follow-up period was 2.8 months (range, 0.4-50.3 months). Technical success was achieved in all cases without any major complications. Clinical success, defined as the removal of the drainage tube without recurrent symptoms of infection, was achieved in 8 cases. Median duration until removal of the drainage tube from stent placement was 7 days (range, 0-36).

Percutaneous Gastrojejunostomy Catheter Placement Using a Slow-Leak Balloon through the Reconstructed Gastric Tube after Esophagectomy.

Twelve patients who had undergone esophageal reconstruction because of cancer and in whom conventional percutaneous radiologic or endoscopic gastrostomy was considered difficult are reported. These patients underwent placement of a percutaneous gastrojejunostomy catheter through the reconstructed gastric tube using a slow-leak balloon that had been developed for percutaneous transesophageal gastrotubing. Retrospective evaluation showed successful outcomes without severe complications in all patients. Eight (66.6%) were able to resume oral intake, which allowed gastrojejunostomy catheter withdrawal in 3 (25%). This technique is feasible with acceptable clinical outcomes for patients who have undergone gastric tube reconstruction after esophagectomy.

Radiologic Assessment for Endoscopic US-guided Biliary Drainage.

Endoscopic US-guided biliary drainage (BD) is performed for various types of biliary obstruction and is mainly indicated for unsuccessful conventional transpapillary endoscopic retrograde cholangiodrainage. In endoscopic US BD, an extra-anatomic drainage route between the gastrointestinal (GI) tract and the biliary system is created with a covered metallic stent or plastic stent. Procedural types of endoscopic US BD include hepaticogastrostomy, hepaticojejunostomy (after gastrectomy), choledochoduodenostomy, hepaticoduodenostomy, and endoscopic US-guided gallbladder drainage. The technical and clinical success rates of endoscopic US BD are reported to be 94%-97% and 88%-100%, respectively. CT is crucial both in preprocedural assessment and postprocedural monitoring. CT is used to determine the indications for endoscopic US BD, which include the type of biliary obstruction, collateral vessels in the puncture route, ascites, the volume of the liver segment, the distribution of an intrahepatic tumor, and GI tract patency. After endoscopic US BD, common subclinical findings are a small amount of intraperitoneal gas, localized edematous change in the GI tract, a notch in the placed stent, and localized biliary dilatation caused by stent placement. Stent malfunction after endoscopic US BD is caused by impaction of debris and/or food, stent migration into the GI tract, or tumor overgrowth and/or hyperplasia. Complications that can occur include internal stent migration, intraperitoneal biloma, arterial bleeding or pseudoaneurysm, perforation of the GI tract, and portobiliary fistula. The incidence of clinical endoscopic US BD-related complications is 11%-23%. ©RSNA, 2020.

Impact of gender and employment type on job loss among cancer survivors.

OBJECTIVE: To identify factors associated with cancer-related job loss following cancer diagnosis. METHODS: A multicentre cross-sectional survey was conducted among adult cancer survivors employed at the time of cancer diagnosis. Hierarchical multivariate logistic regression was used to examine the association of gender and employment type with job loss after cancer diagnosis and if the interaction between gender and employment type predicted job loss. RESULTS: Of 1618 patients recruited, 1483 returned questionnaires (91.7% response rate). Data from 708 patients were eligible for analyses. Approximately 21% of patients had lost their job within 10 years of diagnosis. Patients who had undergone chemotherapy were more likely to lose their jobs than those who had not (OR = 3.24, 95% CI 2.13-4.91). Women were more likely to lose their jobs than men (OR = 2.58, 95% CI 1.48-4.50). Temporary employees were more likely to lose their jobs than regular employees (OR = 2.62, 95% CI 1.72-3.99). After controlling for demographic and clinical characteristics, no interaction effects between gender and employment type were observed (P = 0.44). CONCLUSIONS: Women and temporary employees are more vulnerable to cancer-related job loss. Clinicians need greater awareness of the risk of patient job loss, and they need to assess patients' employment types and provide appropriate support to balance treatment schedules and work.

A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial.

BACKGROUND: A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted. SUBJECTS AND METHODS: The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life. RESULTS: Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3-178.8) and 44.9 (16.4-73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed. CONCLUSIONS: In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.

Retrospective Comparative Study of Absolute Ethanol with N-Butyl-2-Cyanoacrylate in Percutaneous Portal Vein Embolization.

PURPOSE: This study compared the efficacy of absolute ethanol with that of N-butyl-2-cyanoacrylate (NBCA) in portal vein embolization (PVE) before partial hepatectomy. MATERIALS AND METHODS: Between January 2012 and February 2016, 61 patients (43 men, 18 women; median; 69 years of age) underwent PVE using absolute ethanol (January 2012 to January 2014; n = 27) or NBCA (February 2014 to February 2016; n = 34). The primary endpoint was increase in the nonembolized liver volume (NELV)-to-total functional liver volume (TFLV) ratio, and the secondary endpoints were changes in embolized liver volume (ELV) and NELV, changes in laboratory data, and adverse events. RESULTS: The increase in the NELV/TFLV ratio was significantly higher in the ethanol group than in the NBCA group (13.0% vs. 9.5%, respectively; P = 0.003). The decrease in ELV was significantly greater in the ethanol group (-191.9 vs. -99.2 mL, respectively; P = 0.001). The increase in NELV did not differ significantly (129.4 vs. 116.0 mL, respectively; P = 0.316). In the ethanol group, grade 3-4 transient elevation of aspartate aminotransferase and alanine aminotransferase occurred in 22 patients (81.5%) and 22 patients (81.5%) patients, respectively, whereas it occurred in 1 patient (3.0%) and 1 patient (3.0%), respectively, in the NBCA group. One patient in the ethanol group (3.7%) showed grade 2 hepatic necrosis, and 2 patients with grade 3 subcapsular biloma (5.9%) and 1 with grade 3 liver abscess (2.9%) occurred in the NBCA group (P = 0.696). CONCLUSIONS: PVE with ethanol conferred greater increase in the NELV/TFLV ratio than NBCA due to its severe atrophic effect in ELV, but no significant differences in NELV increase were found.

Evaluation of stent placement for vena cava syndrome: phase II trial and phase III randomized controlled trial.

PURPOSE: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS. METHODS: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment. RESULTS: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups. CONCLUSIONS: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS. TRIAL REGISTRATION: JIVROSG-0402, JIVROSG-0807.

Clinical trial for development of a steerable microcatheter.

PURPOSE: A steerable microcatheter provided with a mechanism on the handle for changing the direction of the catheter tip was developed by Sumitomo Bakelite and evaluated in a clinical trial before introduction into clinical use. MATERIAL AND METHODS: The steerable microcatheter has a 2.4F/2.9-F external diameter (distal/proximal portion) and a 0.021-inch internal diameter with a dial on the proximal portion for moving the tip. In patients scheduled to undergo selective transarterial procedures, selective arteriography of target arterial branches chosen by the evaluator was performed using the steerable microcatheter during the procedure. Efficacy was evaluated based on operability (technical success, procedure time, use of guidewire, usefulness of tip mobility), and safety was evaluated based on defects and adverse events. RESULTS: Between September 2013 and October 2013, 20 patients were enrolled at four institutions. The success rate for guidewireless insertion of the steerable microcatheter into the target vessels was 96.7%, and operability was judged as good in all 20 patients. Poor tip movement was identified as a defect of the steerable microcatheter in one patient. There were no adverse events associated with the use of the steerable microcatheter. CONCLUSION: This trial confirmed that the steerable microcatheter had the utility required for medical device approval. Thereafter, it obtained marketing approval.

Job resignation after cancer diagnosis among working survivors in Japan: timing, reasons and change of information needs over time.

OBJECTIVE: Despite advances in work-related policies for cancer survivors, support systems for working survivors in healthcare settings in Japan remain underdeveloped. We aimed to reveal (i) the present situation of cancer survivors' job resignation, the timing of resignation, and reasons for resignation; (ii) healthcare providers' screening behaviors of cancer survivors' work-related difficulties and (iii) changes to cancer survivors' information/support needs over time since diagnosis. METHODS: We conducted an anonymous, cross-sectional survey using a convenience sample of re-visiting outpatients at three cancer centers in Japan in 2015. The questionnaire covered participants' demographic and clinical characteristics, change to job status, timing of and reasons for job resignation, screening experience regarding work-related difficulties by healthcare providers, and information/support needs at four distinct timings (at diagnosis, between diagnosis and initial treatment, between initial treatment and return-to-work, and after return-to-work). The results of 950 participants were eligible for statistical analysis. RESULTS: Only 23.5% of participants were screened about work-related issues by healthcare providers despite 21.3% participants reporting resigning at least once. Among participants who resigned, 40.2% decided to do so before initial treatment began. Regarding reasons for resignation, self-regulating and pessimistic reasons were ranked highly. Respondents' work-related information and support needs were observed to change over time. While treatment-related information (schedule and cost) was ranked highly at diagnosis, the need for more individually tailored information and support on work increased after treatment began. CONCLUSIONS: This study provides important basic data for developing effective support systems for working survivors of cancer in hospital settings.

Transarterial (Chemo)Embolization for Liver Metastases in Patients with Neuroendocrine Tumors.

OBJECTIVE: The aim of this study was to evaluate the safety and efficacy of transarterial (chemo)embolization [TA(C)E] for the control of liver metastasis in patients with neuroendocrine tumors (NETs). METHODS: In this retrospective study, we enrolled 43 patients with metastatic NETs who had been treated with TA(C)E between December 1999 and June 2013 at the National Cancer Center Hospital, Tokyo or the National Cancer Center Hospital East, Kashiwa. We assessed tumor response, time to treatment failure (TTF), overall survival (OS), and frequency of adverse events in these patients, and attempted to identify predictors of TTF. RESULTS: The site of the primary tumor was the pancreas in 29 patients (67%), the gastrointestinal tract in 11 patients (26%), and unknown in 3 patients (7%). Response rate, disease control rate, median TTF, and median OS were 56%, 96%, 24.7 months, and 86.1 months, respectively. No significant predictors of TTF could be identified. While 3 patients developed serious adverse events (including liver abscess in 2 patients and acute renal failure in 1 patient), the adverse events were well tolerated in all other patients. CONCLUSION: TA(C)E appears to be effective and feasible for controlling the liver metastases in patients with NETs.

Distress from changes in physical appearance and support through information provision in male cancer patients.

OBJECTIVE: This study aims to reveal the present situation of changes in physical appearance induced by treatment, the effects of these changes on social activities, and support from medical staff in male cancer patients. METHODS: A questionnaire survey was administered to 949 male patients (response rate: 90.1%) visiting the National Cancer Center Hospital in Tokyo over 3 days in January 2015. RESULTS: The final respondents were 823 patients (mean age: 65.3, standard deviation (SD) = 12.32). Fifty-two percent of the sample, and 79.4% of patients aged under 65 were employed. A total of 84.9% experienced changes in physical appearance, and the highest mean scores of psychological were observed for stoma (3.1) and skin eczema (2.9). A total of 66.4% reported no difference in daily life even after their physical appearance changed. However, patients younger than 65 years old who were employed experienced high social difficulties (12.5%). Many wanted to stop going to work and experienced severe distress in their social lives; 74.1% reported it is important to have the same physical appearance at work as before treatment. The majority of patients obtained information from doctors (35.2%) and consulted with their wife or partner (66.2%) regarding their appearance changes, and 5.7% did not have anyone to consult with. CONCLUSION: This study clarified important aspects for supporting male cancer patients: timing, content, target audience and steps of information provision. Appropriate information provision from medical staff prior to treatment can be useful in preparing patients for physical appearance changes and decreasing the severity of symptoms.

A Phase I/II trial of continuous hepatic intra-arterial infusion of 5-fluorouracil, mitoxantrone and cisplatin for advanced hepatocellular carcinoma.

BACKGROUND: The aim of this study was to investigate the dose-limiting toxicities (DLTs) and determine the recommended doses in the Phase I part of the study, and to evaluate the efficacy and toxicity in the Phase II part, of continuous hepatic intra-arterial infusion therapy with 5-fluorouracil, mitoxantrone and cisplatin (FMP therapy) in patients with advanced hepatocellular carcinoma (HCC). METHODS: Forty-five patients with advanced HCC were enrolled. The therapy consisted of continuous intra-arterial infusion of 5-fluorouracil from Day 1 through Day 5, and intra-arterial administration of mitoxantrone and cisplatin on Day 1 [5-fluorouracil/mitoxantrone/cisplatin (mg/m2): Level 1; 400/4/60, Level 2; 400/6/60, Level 3; 500/6/60]. RESULTS: In the Phase I part of the study, one of the six patients at Level 1 developed DLTs, including Grade 3 pulmonary embolism, while none of the patients at either Level 2 or Level 3 exhibited any DLTs. In the Phase II part, at Level 3, 36 patients were enrolled. Nine patients (25%) showed partial response, representing a response rate of 25% (95% confidence interval: 12-42%). The overall median survival time, 1-year survival rate and median progression-free survival time were 11.3 months, 46.9% and 7.0 months, respectively. The main Grade 3 or 4 hematological and non-hematological toxicities were leukopenia (36%), neutropenia (39%), thrombocytopenia (19%), and elevated serum aspartate aminotransferase (22%), elevated serum alanine aminotransferase (14%) and occlusion of hepatic artery (22%), respectively. CONCLUSION: Hepatic intra-arterial infusion therapy of FMP could not demonstrate a favorable tumor response and overall survival in patients with advanced HCC.