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1.
Int J Clin Oncol ; 2024 Jun 04.
Article in English | MEDLINE | ID: mdl-38833114

ABSTRACT

BACKGROUND: The efficacy of adjuvant chemotherapy for high-risk stage II colon cancer (CC) has not been well established. Using propensity score matching, we previously reported that the 3-year disease-free survival (DFS) rate was significantly higher in patients treated with uracil and tegafur plus leucovorin (UFT/LV) against surgery alone. We report the final results, including updated 5-year overall survival (OS) rates and risk factor analysis outcomes. METHODS: In total, 1902 high-risk stage II CC patients with T4, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, and/or < 12 dissected lymph nodes were enrolled in this prospective, non-randomized controlled study based on their self-selected treatment. Oral UFT/LV therapy was administered for six months after surgery. RESULTS: Of the 1880 eligible patients, 402 in Group A (surgery alone) and 804 in Group B (UFT/LV) were propensity score-matched. The 5-year DFS rate was significantly higher in Group B than in Group A (P = 0.0008). The 5-year OS rates were not significantly different between groups. The inverse probability of treatment weighting revealed significantly higher 5-year DFS (P = 0.0006) and 5-year OS (P = 0.0122) rates in group B than in group A. Multivariate analyses revealed that male sex, age ≥ 70 years, T4, < 12 dissected lymph nodes, and no adjuvant chemotherapy were significant risk factors for DFS and/or OS. CONCLUSION: The follow-up data from our prospective non-randomized controlled study revealed a considerable survival advantage in DFS offered by adjuvant chemotherapy with UFT/LV administered for six months over surgery alone in individuals with high-risk stage II CC. TRIAL REGISTRATION: Japan Registry of Clinical Trials: jRCTs031180155 (date of registration: 25/02/2019), UMIN Clinical Trials Registry: UMIN000007783 (date of registration: 18/04/2012).

2.
Sensors (Basel) ; 23(23)2023 Dec 01.
Article in English | MEDLINE | ID: mdl-38067928

ABSTRACT

The aim of this study was to assess the characteristics of visual search behavior in elderly drivers in reverse parking. Fourteen healthy elderly and fourteen expert drivers performed a perpendicular parking task. The parking process was divided into three consecutive phases (Forward, Reverse, and Straighten the wheel) and the visual search behavior was monitored using an eye tracker (Tobii Pro Glasses 2). In addition, driving-related tests and quality of life were evaluated in elderly drivers. As a result, elderly drivers had a shorter time of gaze at the vertex of the parking space both in direct vision and reflected in the driver-side mirror during the Forward and the Reverse phases. In contrast, they had increased gaze time in the passenger-side mirror in the Straighten the wheel phase. Multiple regression analysis revealed that quality of life could be predicted by the total gaze time in the Straighten the wheel phase (ß = -0.45), driving attitude (ß = 0.62), and driving performance (ß = 0.58); the adjusted R2 value was 0.87. These observations could improve our understanding of the characteristics of visual search behavior in parking performance and how this behavior is related to quality of life in elderly drivers.


Subject(s)
Automobile Driving , Quality of Life , Humans , Aged , Vision, Ocular , Regression Analysis , Accidents, Traffic
3.
PLoS One ; 18(11): e0295156, 2023.
Article in English | MEDLINE | ID: mdl-38032987

ABSTRACT

OBJECT: This study aimed to compare the reaching movement between two different spinal cord compression level groups in cervical myelopathy (CM) patients. METHODS: Nine CM patients with maximal cord compression at the C3-4 level (C3-4 group) and 15 CM patients with maximal cord compression at the C4-7 level (C4-7 group) participated in the study. We monitored three-dimensional (3D) reaching movement using an electronic-mechanical whack-a-mole-type task pre-and post-operatively. Movement time (MT) and 3D movement distance (MD) during the task were recorded. An analysis of variance for split-plot factorial design was performed to investigate the effects of compression level or surgery on MT and MD. Moreover, we investigated the relationship between these kinematic reaching parameters and conventional clinical tests. RESULTS: The 3D reaching trajectories of the C3-4 group was unstable with higher variability. The C3-4 group showed longer MT (p < 0.05) and MD (p < 0.01) compared with the C4-7 group both before and after surgery. Moreover, MT was negatively correlated with the Japanese Orthopedic Association score only in the C3-4 group (r = - 0.48). CONCLUSION: We found that spinal cord compression at the C3-4 level had a negative effect on 3D reaching movement and the kinematic alteration influenced the upper extremity performance. This new knowledge may increase our understanding of kinematic alteration in patients with CM.


Subject(s)
Spinal Cord Compression , Spinal Cord Diseases , Humans , Spinal Cord Compression/diagnostic imaging , Spinal Cord Compression/surgery , Biomechanical Phenomena , Spinal Cord Diseases/diagnostic imaging , Spinal Cord Diseases/surgery , Cervical Vertebrae/diagnostic imaging , Cervical Vertebrae/surgery , Magnetic Resonance Imaging/methods
4.
IEEE J Transl Eng Health Med ; 11: 460-468, 2023.
Article in English | MEDLINE | ID: mdl-37817824

ABSTRACT

OBJECTIVE: It is important to improve caregiving skills to help reduce the strain on inexperienced caregivers. Previous studies on quantifying caregiving skills have predominantly relied on expensive equipment, such as motion-capture systems with multiple infrared cameras or acceleration sensors. To overcome the cost and space limitations of existing systems, we developed a simple evaluation system for transfer care skills that uses capacitive sensors composed of conductive embroidery fibers. The proposed system can be developed with a few thousand US dollars. METHOD: The developed evaluation system was used to compare the seating position and velocity of a care recipient during transfers from a nursing-care bed to a wheelchair between groups of inexperienced and expert caregivers. To validate the proposed system, we compare the motion data measured by our system and the data obtained from a conventional three-dimensional motion-capture system and force plate. RESULTS: We analyze the relationship between changes in the center of pressure (CoP) recorded by the force plate and the center of gravity (CoG) obtained by the developed system. Evidently, the changes in CoP have a relation with the CoG. We show that the actual seating speed ([Formula: see text] measured by the motion-capture system is related to the speed coefficient calculated from our sensor output. A significant difference exists in [Formula: see text] between the inexperienced group and the physical therapists/occupational therapists' group. CONCLUSIONS: The proposed system can effectively estimate a caregiver's skill level in transferring patients from a bed to a wheelchair in terms of the seating position and velocity.


Subject(s)
Caregivers , Gravitation , Humans , Motion
5.
Cancer Immunol Immunother ; 71(11): 2743-2755, 2022 Nov.
Article in English | MEDLINE | ID: mdl-35429246

ABSTRACT

The aim of this study was to determine the efficacy and the biomarkers of the CHP-NY-ESO-1 vaccine complexed with full-length NY-ESO-1 protein and a cholesteryl pullulan (CHP) in patients with esophageal squamous cell carcinoma (ESCC) after surgery. We conducted a randomized phase II trial. Fifty-four patients with NY-ESO-1-expressing ESCC who underwent radical surgery following cisplatin/5-fluorouracil-based neoadjuvant chemotherapy were assigned to receive either CHP-NY-ESO-1 vaccination or observation as control. Six doses of CHP-NY-ESO-1 were administered subcutaneously once every two weeks, followed by nine more doses once every four weeks. The endpoints were disease-free survival (DFS) and safety. Exploratory analysis of tumor tissues using gene-expression profiles was also performed to seek the biomarker. As there were no serious adverse events in 27 vaccinated patients, we verified the safety of the vaccine. DFS in 2 years were 56.0% and 58.3% in the vaccine arm and in the control, respectively. Twenty-four of 25 patients showed NY-ESO-1-specific IgG responses after vaccination. Analysis of intra-cohort correlations among vaccinated patients revealed that 5% or greater expression of NY-ESO-1 was a favorable factor. Comprehensive analysis of gene expression profiles revealed that the expression of the gene encoding polymeric immunoglobulin receptor (PIGR) in tumors had a significantly favorable impact on outcomes in the vaccinated cohort. The high PIGR-expressing tumors that had higher NY-ESO-1-specific IgA response tended to have favorable prognosis. These results suggest that PIGR would play a major role in tumor immunity in an antigen-specific manner during NY-ESO-1 vaccinations. The IgA response may be relevant.


Subject(s)
Cancer Vaccines , Esophageal Neoplasms , Esophageal Squamous Cell Carcinoma , Receptors, Polymeric Immunoglobulin , Antibodies, Neoplasm , Antigens, Neoplasm , Cisplatin , Esophageal Squamous Cell Carcinoma/drug therapy , Fluorouracil , Glucans , Humans , Immunoglobulin A , Immunoglobulin G , Membrane Proteins , Prognosis
6.
BMC Cancer ; 22(1): 170, 2022 Feb 15.
Article in English | MEDLINE | ID: mdl-35168560

ABSTRACT

BACKGROUND: The efficacy of adjuvant chemotherapy for high-risk stage II colon cancer (CC) has not been well established. We compared the effects of surgery with and without oral uracil and tegafur plus leucovorin (UFT/LV) in patients with high-risk stage II CC, adjusting for potential risk factors. METHODS: We enrolled patients with histologically confirmed stage II colon adenocarcinoma with at least one of the following conditions: T4 disease, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, or < 12 dissected lymph nodes. Patients chose to be non-randomized or randomized to undergo surgery alone (NR-Group S or R-Group S) or surgery followed by 6 months of UFT/LV (NR-Group U or R-Group U). The primary endpoint was disease-free survival (DFS) after adjusting for previously reported risk factors using propensity score matching (1:2) and inverse probability of treatment weighting (IPTW) in the non-randomized arm. RESULTS: Overall, 1,902 (98%) and 36 (2%) patients were enrolled in the non-randomized and randomized arms, respectively. There were too few patients in the randomized arm and these were therefore excluded from the analysis. Of the 1,902 patients, 402 in NR-Group S and 804 in NR-Group U were propensity score-matched. The 3-year DFS rate (95% confidence interval) was significantly higher in NR-Group U (80.9% [77.9%-83.4%]) than in NR-Group S (74.0% [69.3%-78.0%]) (hazard ratio, 0.64 [0.50-0.83]; P = 0.0006). The 3-year overall survival rate was not significantly different between NR-Group S and NR-Group U. Significantly higher 3-year DFS (P = 0.0013) and overall survival (P = 0.0315) rates were observed in NR-Group U compared with NR-Group S using IPTW. CONCLUSIONS: Adjuvant chemotherapy with UFT/LV showed a significant survival benefit over surgery alone in patients with high-risk stage II CC characterized by at least one of the following conditions: T4 disease, perforation/penetration, poorly differentiated adenocarcinoma/mucinous carcinoma, or < 12 dissected lymph nodes. TRIAL REGISTRATION: Japan Registry of Clinical Trials: jRCTs031180155 (date of registration: 25/02/2019) (UMIN Clinical Trials Registry: UMIN000007783 , date of registration: 18/04/2012).


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Colonic Neoplasms/drug therapy , Leucovorin/administration & dosage , Tegafur/administration & dosage , Uracil/administration & dosage , Administration, Oral , Adult , Aged , Aged, 80 and over , Chemotherapy, Adjuvant , Colonic Neoplasms/mortality , Disease-Free Survival , Female , Humans , Japan , Lymph Node Excision , Male , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Neoplasm Staging , Propensity Score , Prospective Studies , Risk Factors , Survival Rate , Treatment Outcome
7.
Sensors (Basel) ; 21(24)2021 Dec 16.
Article in English | MEDLINE | ID: mdl-34960489

ABSTRACT

The purpose of this study was to examine aging and bimanual effects on finger spatial stability during precision grip. Twenty-one older and 21 younger adults performed precision grip tasks consisting of a single task (grip and lift an object with the thumb and index finger) and a dual task (the grip-lifting task with one hand and a peg board task with the other hand). The center of pressure (COP) trajectory and the grip force were evaluated using a pressure sensor with a high spatial resolution. In the COP trajectory, the main effects of age for the thumb (F1,140 = 46.17, p < 0.01) and index finger (F1,140 = 22.14, p < 0.01) and task difficulty for the thumb (F1,140 = 6.47, p = 0.01) were significant based on ANCOVA. The COP trajectory was statistically decreased in the older adults. The COP trajectory was also decreased in the dual task, regardless of age. The results suggest the existence of a safety strategy to prioritize the spatial stability in the elderly group and in the dual task. This study provides new insights into the interpretation of the COP trajectory.


Subject(s)
Fingers , Hand Strength , Aged , Aging , Hand , Humans , Thumb
8.
J Vis Exp ; (160)2020 06 04.
Article in English | MEDLINE | ID: mdl-32568217

ABSTRACT

The purpose of the protocol is to indirectly evaluate the direction of the finger force during manipulation of a handheld object based on the biomechanical relationships in which deviated force direction causes center of pressure (COP) replacement. To evaluate this, a thin, flexible, and high spatial resolution pressure sensor sheet is used. The system allows measurement of the COP trajectory in addition to the force amplitude and its temporal regulation. A series of experiments found that increased trajectory length reflected a sensorimotor deficit in stroke patients, and that decreased COP trajectory reflects a compensatory strategy to avoid an object slipping from the hand grip in the elderly. Moreover, the COP trajectory could also be decreased by dual task interference. This article describes the experimental procedure and discusses how finger COP contributes to an understanding of the physiology and pathophysiology of grasping.


Subject(s)
Hand Strength/physiology , Mechanical Phenomena , Adult , Aged , Biomechanical Phenomena , Female , Fingers/physiology , Fingers/physiopathology , Humans , Male , Stroke/physiopathology
9.
Spinal Cord ; 58(6): 689-694, 2020 Jun.
Article in English | MEDLINE | ID: mdl-31942043

ABSTRACT

STUDY DESIGN: Cross-sectional research. OBJECTIVES: To objectively evaluate grip force (GF) control while holding a freely movable object in individuals with cervical myelopathy (CM). SETTING: Harunaso Hospital, Takasaki, Japan. METHODS: We studied 52 hands from 26 individuals with CM. Participants performed a grip-and-lift task by pulp pinch using the thumb and index finger before surgery. We monitored individual finger GF (N) during the first 3 s while lifting and holding an object. Correlations between the GF and other clinical tests were evaluated. A multiple stepwise regression analysis was used to examine the contribution of the GF to the severity of clinical symptoms. RESULTS: Thumb GF was negatively correlated with the 10-s test (rs = -0.32), and index finger GF was positively correlated with its cutaneous pressure threshold (rs = 0.34). Multiple regression for the severity of upper extremity symptoms revealed that the model including the GF had a larger adjusted R2 and a lower AIC value than that of conventionally used clinical tests. CONCLUSIONS: These results suggested that the assessment of individual finger GF control could provide an indicator of the clinical severity of upper extremity in individuals with CM.


Subject(s)
Cervical Cord/physiopathology , Fingers/physiopathology , Hand Strength/physiology , Motor Activity/physiology , Psychomotor Performance/physiology , Spinal Cord Diseases/physiopathology , Upper Extremity/physiopathology , Adult , Cervical Cord/surgery , Cross-Sectional Studies , Female , Humans , Male , Neurosurgical Procedures , Pinch Strength/physiology , Preoperative Care , Severity of Illness Index , Spinal Cord Diseases/surgery , Thumb/physiopathology
10.
J Phys Ther Sci ; 31(10): 760-764, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31645802

ABSTRACT

[Purpose] The aim of this study was to evaluate the changes in reaching function during a reaching task in cervical spondylosis (CS) patients before and after surgery. [Participants and Methods] Nine patients participated in the study. Wrist acceleration peaks were monitored pre- and postoperatively using a tri-axial accelerometer, and the Japanese Orthopedic Association (JOA) score was recorded preoperatively. Additional upper extremity function tests were performed pre- and postoperatively. Multiple stepwise regression analysis was used to investigate the contribution of wrist acceleration peak to the severity of clinical symptoms. Moreover, we compared the acceleration peaks produced during the reaching task before and after surgery. [Results] Multiple regression analysis showed that wrist acceleration peak, grip strength and pinch strength were associated with the upper extremity function of the JOA score, explaining 61.0% of the variance. There was a significant improvement in x-axis acceleration peak after surgery. [Conclusion] Our results suggested that quantitative assessments of reaching function are useful to objectively evaluate the changes in reaching function in patients undergoing cervical decompression surgery.

11.
Diabetes Res Clin Pract ; 149: 1-8, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30711436

ABSTRACT

AIMS: It was recently reported that lactate acts as a metabolic mediator and rises in the diabetic state, but the physiological effects are as yet poorly understood. The objective of the current study was to evaluate the significance of serum lactate elevation in type 2 diabetes mellitus (T2DM) patients. METHODS: Fasting serum lactate levels, hematological and inflammatory serum markers and anthropometric parameters, obtained employing bioelectric impedance analysis, were measured in 103 patients with T2DM. RESULTS: Statistically significant correlations of serum lactate levels with C-reactive peptide, insulin, aspartate aminotransferase, alanine aminotransferase (ALT), serum lipids, total bilirubin, adiponectin, homeostasis model assessment-insulin resistance, body weight, body mass index and body fat (weight or percentage of subcutaneous fat, visceral fat or total body fat), but neither fasting plasma glucose nor HbA1c, were detected. Stepwise regression analysis showed ALT to be independently positively associated with total bilirubin, while being negatively associated with serum lactate levels. Furthermore, serum lactate levels were significantly higher in patients with ALT-predominant liver dysfunction. CONCLUSION: We found fasting serum lactate elevation in T2DM patients to be associated with the serum levels of ALT and total bilirubin independently of blood glucose control. TRIAL REGISTRATION: UMIN clinical trials registry (UMIN000029178).


Subject(s)
Alanine Transaminase/metabolism , Bilirubin/metabolism , Diabetes Mellitus, Type 2/blood , Lactates/metabolism , Cross-Sectional Studies , Female , Humans , Male , Middle Aged
12.
Zhongguo Zhong Yao Za Zhi ; 44(23): 5124-5128, 2019 Dec.
Article in Chinese | MEDLINE | ID: mdl-32237348

ABSTRACT

Cultivated ginseng in the farmland would become the mainly planting mode of Panax ginseng. However,there are relatively few cultivation ginseng varieties for farmland in China. Correlative analysis of qualitity and agronomic traits of P. ginseng cultivation in the farmland could provide a reference for the selection of excellent germplasm and new variety breeding of P. ginseng. In this study,the main index of saponin and agronomic traits of 4-6 years' samples were analyzed by UPLC and measured. The results show that there was significant difference in agronomic indexes of Damaya. The coefficient of variation of the root length( CV = 41. 97%) and fresh weight( CV = 31. 81%) were maximum,and the coefficient of variation of the stems thickness( 16. 72%) and root thickness were minimum. There was a significant correlation between yield and root thickness( P<0. 05). There was significant difference in drug yield of different harvest years( P<0. 05),and the yield of 6-years was 31. 52%-39. 69% higher than 4-years. However,there wasn't significant difference in total ginsenosides between 4 and 6 years old P. ginseng,but there was significant difference in ginseng Rg2,Rc and Rb2( P<0. 05),and the ginsenoside contents of different harvesting years were accorded with the criterion standards of 2015 Chinese Pharmacopoeia. There was no significant correlation between the saponin and the agronomic trait,while there was positive correlation with root thickness( P < 0. 05). Therefore,the stem diameter was positive correlation with yield of P. ginseng. Selection of the stem thickness of seedlings is beneficial to the increase of the yield and breeding of P. ginseng.


Subject(s)
Crop Production , Ginsenosides/analysis , Panax/chemistry , China , Plant Breeding , Plant Roots/growth & development , Plant Stems/growth & development
13.
Cancer Chemother Pharmacol ; 81(6): 1035-1041, 2018 06.
Article in English | MEDLINE | ID: mdl-29644459

ABSTRACT

BACKGROUND: The aim of this single-arm phase II clinical trial was to evaluate whether the alternate-day administration of S-1 plus irinotecan would reduce the incidence of severe diarrhea in comparison to consecutive-day S-1 administration (standard IRIS regimen) in second-line treatment for patients with metastatic colorectal cancer. METHODS: Patients with metastatic colorectal cancer after failure with first-line treatment of oxaliplatin and fluoropyrimidine were enrolled. Irinotecan (150 mg/m2) and bevacizumab (5 mg/kg) were given intravenously on day 1. Oral S-1 was administered on alternate days at a dose of 40-60 mg twice a day. Cycles were repeated every 2 weeks. The primary endpoint was the incidence of grade ≥ 3 diarrhea. Our hypothesis set 21% as a threshold incidence and 10% as an expected incidence from previous studies with one-sided alpha 0.05. The secondary endpoints included the relative dose intensity, progression-free survival, overall survival and other adverse events. RESULTS: A total of 51 patients were enrolled. The incidence of grade ≥ 3 diarrhea was 15.7% (8/51). Other common grade ≥ 3 adverse events were neutropenia, anemia, thrombocytopenia and fatigue were 13.7% (7/51), 5.9% (3/51), 2.0% (1/51) and 5.9% (3/51), respectively. The relative dose intensities of irinotecan, bevacizumab, and S-1 were 80.0, 86.8, and 77.7%, respectively. The median progression-free survival and overall survival were 8.4 months (5.8-9.8) and 17.1 months (11.8-22.3). CONCLUSIONS: The alternate-day S-1 administration does not have significant effectiveness to reduce diarrhea in patients who received second-line treatment for metastatic colorectal cancer.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Colorectal Neoplasms/drug therapy , Diarrhea/chemically induced , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bevacizumab/administration & dosage , Colorectal Neoplasms/pathology , Diarrhea/epidemiology , Disease-Free Survival , Drug Administration Schedule , Drug Combinations , Female , Follow-Up Studies , Humans , Incidence , Irinotecan/administration & dosage , Male , Neoplasm Metastasis , Oxonic Acid/administration & dosage , Survival Rate , Tegafur/administration & dosage
15.
Oncol Lett ; 13(2): 747-753, 2017 Feb.
Article in English | MEDLINE | ID: mdl-28356954

ABSTRACT

The current phase II study investigated the efficacy and safety of biweekly cetuximab combined with standard oxaliplatin-based chemotherapy [infusional 5-fluorouracil (5-FU), leucovorin, and oxaliplatin (FOLFOX-6)] in the first-line treatment of KRAS wild-type metastatic colorectal cancer (mCRC). Sixty patients with a median age of 64 years (range, 38-82 syears) received a biweekly intravenous infusion of cetuximab (500 mg/m2 on day 1) followed by FOLFOX-6 (2-hour oxaliplatin 85 mg/m2 infusion on day 1 in tandem with a 2-h leucovorin 200 mg/m2 infusion on days 1 and 2, and 5-FU as a 400 mg/m2 bolus followed by a 46-hour 2,400 mg/m2 infusion on days 1-3). Patient response rate was 70%, with 95% disease control rates. The median progression-free survival was 13.8 months. Thirteen patients (21.7%) were able to undergo resection of previously unresectable metastases, with the aim of curing them. The median follow-up was 22.7 months, and median overall survival was 31.0 months. Cetuximab did not increase FOLFOX-6 toxicity and was generally well tolerated. The results of the current study demonstrate that the combination of biweekly cetuximab with FOLFOX-6 was well tolerated and had a manageable safety profile for the first-line treatment of KRAS wild-type metastatic colorectal cancer. Efficacy was comparable to other treatment regimens. The results support the administration of biweekly cetuximab in combination with FOLFOX-6, which may be more convenient and provide treatment flexibility in this setting for patients with metastatic colorectal cancers.

16.
Int J Clin Oncol ; 22(3): 494-504, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28078540

ABSTRACT

BACKGROUND: Six months of adjuvant chemotherapy is regarded as the standard of care for patients with stage III colon cancer. However, whether longer treatment can improve prognosis has not been fully investigated. We conducted a phase III study comparing 6 and 12 months of adjuvant capecitabine chemotherapy for stage III colon cancer, and report here the results of our preplanned safety analysis. METHODS: Patients aged 20-79 years with curatively resected stage III colon cancer were randomly assigned to receive 8 cycles (6 months) or 16 cycles (12 months) of capecitabine (2500 mg/m2/day on days 1-14 of each 21-day cycle). Treatment exposure and adverse events (AEs) were evaluated. RESULTS: A total of 1304 patients (642 and 636 in the 6-month and 12-month groups, respectively) were analyzed. The most common AE was hand-foot syndrome (HFS). HFS, leukocytopenia, neutropenia, and hyperbilirubinemia (any grade) occurred more frequently in the 12-month group than in the 6-month group. HFS was the only grade ≥3 AE to have a significantly higher incidence in the 12-month group (23 vs 17%, p = 0.011). The completion rate for 8 cycles was 72% in both groups, while that for 16 cycles was 46% in the 12-month group. HFS was the most common AE requiring dose reduction and treatment discontinuation. CONCLUSIONS: Twelve months of adjuvant capecitabine demonstrated a higher cumulative incidence of HFS compared to the standard 6-month treatment period, while toxicities after 12 months of capecitabine were clinically acceptable. TRIAL REGISTRATION: UMIN-CTR, UMIN000001367.


Subject(s)
Antimetabolites, Antineoplastic/therapeutic use , Capecitabine/adverse effects , Capecitabine/therapeutic use , Colonic Neoplasms/drug therapy , Adult , Aged , Antimetabolites, Antineoplastic/administration & dosage , Antimetabolites, Antineoplastic/adverse effects , Capecitabine/administration & dosage , Chemotherapy, Adjuvant/adverse effects , Chemotherapy, Adjuvant/methods , Dose-Response Relationship, Drug , Female , Hand-Foot Syndrome/etiology , Humans , Male , Middle Aged , Treatment Outcome
17.
Ann Surg Oncol ; 24(2): 546-553, 2017 02.
Article in English | MEDLINE | ID: mdl-27638675

ABSTRACT

BACKGROUND: Advantages of neoadjuvant chemotherapy combined with monoclonal antibodies for treating patients with resectable colorectal cancer liver metastasis (CLM) have not been established. The purpose of this study was to evaluate the efficacy and safety of oxaliplatin-based regimen (FOLFOX or XELOX) plus monoclonal antibodies (cetuximab or bevacizumab) treatment in patients with resectable CLM. METHODS: A single-arm, open-label, multicenter, phase II trial was conducted for patients aged ≥ 20 years with resectable and untreated CLM. Patients received preoperative FOLFOX (6 cycles) or XELOX (4 cycles). Cetuximab or bevacizumab was administered to patients with wild-type or mutated KRAS codons 12 and 13, respectively. The primary endpoint was progression-free survival (PFS). RESULTS: Between January 2010 and June 2012, 47 patients were enrolled from 12 institutions. Wild-type or mutant KRAS sequences were examined in 32 and 15 patients, respectively. Twenty-one (45 %) patients experienced Grades 3/4 adverse events, and 55 % of all patients responded to therapy. The sizes of tumors of patients in the wild-type KRAS group were significantly reduced compared with those of the mutant KRAS group. The overall rates of liver resection and postoperative morbidity were 83 and 14 %, respectively, and the median PFS was 15.6 months. The median PFS times of the KRAS wild-type and mutant groups were 22.5 months and 10.5 months, respectively. CONCLUSIONS: Neoadjuvant therapy using FOLFOX/XELOX combined with monoclonal antibodies did not improve PFS, although it was administered safely and had less adverse effects after liver resection.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Colorectal Neoplasms/drug therapy , Liver Neoplasms/drug therapy , Molecular Targeted Therapy , Neoadjuvant Therapy , Aged , Aged, 80 and over , Antibodies, Monoclonal/administration & dosage , Bevacizumab/administration & dosage , Capecitabine/administration & dosage , Cetuximab/administration & dosage , Colorectal Neoplasms/pathology , Female , Follow-Up Studies , Humans , Leucovorin/administration & dosage , Liver Neoplasms/secondary , Male , Middle Aged , Organoplatinum Compounds/administration & dosage , Oxaliplatin , Prognosis , Prospective Studies , Survival Rate
18.
Opt Lett ; 41(21): 4971-4974, 2016 Nov 01.
Article in English | MEDLINE | ID: mdl-27805662

ABSTRACT

We demonstrate rapid characterization of complex optical properties of solids via dual-comb spectroscopy (DCS) in the near-infrared region. The fine spectral structures in the complex refractive index of an Er:YAG are successfully deduced using the developed system and Fourier analysis. Moreover, simultaneous determination of the refractive index and the thickness is demonstrated for a silicon semiconductor wafer through the use of multireflected echo signals. The results indicate the potential of DCS as a powerful measurement tool for the rapid and full characterization of solid materials.

20.
Surg Case Rep ; 2(1): 39, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27108123

ABSTRACT

Acinar cell cystadenoma (ACA) of the pancreas has been newly recognized as an entity by the World Health Organization (WHO) definition (2010), and its pathogenesis has not been known adequately because of the rarity. Here, we report a case of a 22-year-old female who had been followed up for a cystic lesion at the tail of the pancreas pointed out by a screening computed tomography (CT) scan 7 years ago. The tumor grew in size from 3.3 to 5.1 cm in diameter for 6 years (0.3 cm per year). Particularly, it rapidly grew up to 6.3 cm in the latest 3 months in concurrence with the emergence of epigastralgia. A contrasted CT scan revealed the irregularly formed, multilocular cystic tumor having thin septum and calcification. The intratumoral magnetic resonance imaging intensity in the T1 and T2 weighted images were low and high, respectively. No communications between the tumor and the main pancreatic duct (MPD) were found, but the tumor displaced the MPD. She underwent surgical resection because the tumor was growing, turned symptomatic, and it seemed difficult to be diagnosed correctly until totally biopsied. Spleen-preserved distal pancreatectomy was performed. It was pathologically diagnosed as ACA; the cyst was lined by cells with normal acinar differentiation; cuboidal cells with round, basally oriented nuclei and eosinophilic granules in its apical cytoplasm. The abdominal pain has disappeared, and no recurrences have been found during a 5-year follow-up. Clinicians are recommended to consider an ACA as one of differential diagnoses of cystic tumors of the pancreas to provide appropriate diagnostics and therapeutics.

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