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1.
Asian J Endosc Surg ; 16(3): 608-612, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37161600

ABSTRACT

Surgery for rectal cancer patients with an ileal conduit after total cystectomy is difficult because adhesions in the pelvis and around the ileal conduit are expected. In the present case, we performed robot-assisted low anterior resection of the rectum in a 69-year-old male patient with rectal cancer who underwent ileal conduit diversion after total cystectomy. In this procedure, the port was inserted into the left upper abdomen as a first step, and two additional ports were added on the left side. Low anterior resection was performed using two left hands to create more space in the abdominal cavity for the ileal conduit. We present this minimally invasive robotic procedure that is extremely useful for dissection of adhesions in a narrow pelvic cavity.


Subject(s)
Rectal Neoplasms , Robotics , Urinary Bladder Neoplasms , Urinary Diversion , Male , Humans , Aged , Rectum , Urinary Diversion/methods , Cystectomy/methods , Urinary Bladder Neoplasms/surgery , Rectal Neoplasms/complications , Rectal Neoplasms/surgery
2.
Asian J Endosc Surg ; 16(3): 563-566, 2023 Jul.
Article in English | MEDLINE | ID: mdl-36958290

ABSTRACT

An 81-year-old man was referred to our hospital for anal bleeding. Colonoscopy revealed a type 3 tumor at the upper rectum and biopsy showed adenocarcinoma. An enhanced circumferential lesion at the upper rectum and a solitary soft-tissue shadow at the fifth sacral vertebra to the coccyx were detected on abdominal magnetic resonance imaging. Fluorodeoxyglucose uptake was observed at the same sites on positron emission tomography. The patient was diagnosed with rectal cancer with isolated sacrococcygeal metastasis and was treated with neoadjuvant chemoradiotherapy followed by robotic surgery. Hartmann's operation was performed in the lithotomy position. The left internal iliac artery and vein were then divided. The internal pudendal artery and vein, the piriformis muscle, and sacrospinous ligament were also divided while preserving the lumbosacral trunk. The scheduled transection line of the sacral surface was fully exposed to prevent massive bleeding during sacrectomy. The dorsal surface of the sacrum was then exposed in the prone position and communicated with the pelvic space. The sacrum was transected at the superior margin of S3 and a specimen was extracted. Pathological findings revealed the infiltration of cancer cells in the sacrococcygeal specimen. The postoperative course was uneventful and the patient was discharged on postoperative day 13.


Subject(s)
Rectal Neoplasms , Robotic Surgical Procedures , Male , Humans , Aged, 80 and over , Neoadjuvant Therapy , Rectal Neoplasms/surgery , Rectum/surgery , Pelvis , Chemoradiotherapy
3.
Asian J Endosc Surg ; 15(4): 832-835, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35765174

ABSTRACT

Double inferior vena cava (DIVC) is a rare but generally asymptomatic condition that is often detected incidentally by radiological examinations such as computed tomography (CT). Here, we describe the case of a 73-year-old woman with DIVC, who underwent robot-assisted surgery (RS) for rectal cancer. In this case, 3D CT angiography showed DIVC with an interiliac vein from the left common iliac vein and a tortuous aorta. Intraoperatively, we identified the presence of the left IVC in addition to the inferior mesenteric vein, gonadal vein, and ureter, which require meticulous attention during vascular processing. By optimizing the port placement, we were able to ensure mobility of the robotic arm and sufficient field of view to safely perform a robot-assisted anterior resection with lymph node dissection. Careful preoperative assessment and development of a strategy for port placement using CT imaging are essential in avoiding iatrogenic injury and performing safe RS.


Subject(s)
Rectal Neoplasms , Robotics , Abdomen , Aged , Female , Humans , Lymph Node Excision/methods , Rectal Neoplasms/surgery , Vena Cava, Inferior/diagnostic imaging , Vena Cava, Inferior/surgery
4.
Asian J Endosc Surg ; 15(4): 812-815, 2022 Oct.
Article in English | MEDLINE | ID: mdl-35488505

ABSTRACT

A 69-year-old female underwent laparoscopic ileal partial resection for ileal adenocarcinoma. Pathological diagnosis was moderately differentiated tubular adenocarcinoma (UICC 8th; T4N0M0 StageIIB). The patient received adjuvant chemotherapy with modified 5-fluorouracil/leucovorin/oxaliplatin. Fourteen months after surgery, computed tomography revealed a mass in the upper rectum. Colonoscopy detected a submucosal protruding mass and a biopsy specimen showed moderately differentiated tubular adenocarcinoma. Robotic low anterior resection was performed. The tumor was located in the upper rectum and there was no macroscopic invasion or peritoneal dissemination. Pathologically, the tumor was moderately differentiated tubular adenocarcinoma located within the rectal wall with little evidence of a carcinoma component in the mucosal lining. Immunohistochemistry showed the same pattern as the previous ileal adenocarcinoma: negativity for cytokeratin 7 and positivity for cytokeratin 20 and caudal-type homeobox 2. In combination with the rectum showing no abnormalities in colonoscopy performed 15 mo previously, the mass was considered hematogenous metastasis from small bowel adenocarcinoma.


Subject(s)
Adenocarcinoma , Duodenal Neoplasms , Rectal Neoplasms , Robotic Surgical Procedures , Adenocarcinoma/pathology , Adenocarcinoma/surgery , Aged , Female , Fluorouracil/therapeutic use , Humans , Keratin-20/therapeutic use , Keratin-7 , Leucovorin/therapeutic use , Oxaliplatin/therapeutic use , Rectal Neoplasms/pathology
5.
Asian J Endosc Surg ; 15(2): 397-400, 2022 Apr.
Article in English | MEDLINE | ID: mdl-34874113

ABSTRACT

A 69-year-old woman underwent abdominoperineal resection for a gastrointestinal stromal tumor (GIST) of the rectum 15 years ago. She received adjuvant chemotherapy for 8 years. Seven years later, abdominal computed tomography revealed a soft-tissue shadow in the left lower abdomen, and fluorodeoxyglucose uptake was observed at the same site on positron emission tomography. The recurrence of GIST was suspected, and laparoscopic resection was performed. Laparoscopy showed that the tumor was located at the retroperitoneum near to the descending colon and invaded the left ovarian vessels. It also made contact with the left ureter; however, lighted ureteral catheters enabled us to identify and preserve the left ureter. An immunohistochemical examination revealed the recurrence of GIST. Recurrence may become apparent 15 years or more after GIST surgery, and, thus, a long-term follow-up is required. Lighted ureteral catheters were useful for identifying the ureter and preventing ureteral injury in a recurrent case suspected of invading the ureter.


Subject(s)
Gastrointestinal Stromal Tumors , Laparoscopy , Ureter , Aged , Female , Gastrointestinal Stromal Tumors/diagnostic imaging , Gastrointestinal Stromal Tumors/drug therapy , Gastrointestinal Stromal Tumors/surgery , Humans , Laparoscopy/methods , Retroperitoneal Space , Ureter/surgery , Urinary Catheters
6.
Surg Case Rep ; 7(1): 140, 2021 Jun 09.
Article in English | MEDLINE | ID: mdl-34106354

ABSTRACT

BACKGROUND: Median arcuate ligament syndrome (MALS), which results from compression of the median arcuate ligament (MAL), is a rare cause of abdominal pain and weight loss. Treatment is dissection of the MAL; however, the laparoscopic procedure is not yet established and it involves the risk of major vascular injury, especially in cases with an anomaly. CASE PRESENTATION: A 47-year-old man was evaluated at the hospital for epigastric pain. Contrast computed tomography scan revealed stenosis of the celiac artery origin due to the MAL. An Adachi V type vascular anomaly was also observed. Laparoscopic treatment was performed to release pressure on the celiac artery. Laparoscopic ultrasonography was used to less invasively confirm the release of the MAL. Despite a concomitant Adachi V type vascular anomaly, surgery was safely performed using the laparoscopic magnification view and intraoperative ultrasonography. Follow-up ultrasonography confirmed the celiac artery stenosis has not recurred. CONCLUSIONS: A rare case of MALS with an Adachi V type vascular anomaly is presented and the laparoscopic treatment is detailed.

7.
In Vivo ; 35(1): 475-482, 2021.
Article in English | MEDLINE | ID: mdl-33402499

ABSTRACT

BACKGROUND: Immune-checkpoint inhibitors (ICI), including nivolumab and pembrolizumab, are among the standard treatments for previously treated advanced gastric cancer (AGC). This study aimed to evaluate the frequency of immune-related adverse events (irAEs) and the correlation between irAEs and their efficacy in AGC cases. PATIENTS AND METHODS: Patients were divided into two groups according to irAE occurrence. The frequency of irAEs and the treatment outcome (response rate [RR], progression-free survival [PFS], and overall survival [OS]) were evaluated. The survival rates were evaluated by landmark analysis considering lead-time bias. RESULTS: Among 108 patients who received nivolumab or pembrolizumab, 17 (15.7%) had irAEs. In a 4-week landmark analysis, the RR, median PFS, and median OS were 28.5%, 3.9 months (95% CI=2.8-9.3), and 12.2 months (95% CI=3.8-NA) in patients with irAEs, while 3.0% (2/65), 1.8 months (95% CI=1.4-2.1), and 3.5 months (95% CI, 2.9-5.1) in patients without irAEs, respectively. In multivariate analysis, irAEs were associated with better PFS (HR=2.08, 95% CI=1.34-3.21). CONCLUSION: The occurrence of irAEs was associated with a better clinical outcome of ICIs in patients with AGC.


Subject(s)
Antineoplastic Agents, Immunological , Carcinoma, Non-Small-Cell Lung , Lung Neoplasms , Stomach Neoplasms , Antibodies, Monoclonal, Humanized , Antineoplastic Agents, Immunological/adverse effects , Carcinoma, Non-Small-Cell Lung/drug therapy , Humans , Immunotherapy , Lung Neoplasms/drug therapy , Nivolumab/adverse effects , Prognosis , Retrospective Studies , Stomach Neoplasms/drug therapy
8.
Gastric Cancer ; 22(1): 155-163, 2019 01.
Article in English | MEDLINE | ID: mdl-29855738

ABSTRACT

BACKGROUND: In the ABSOLUTE trial, weekly nanoparticle albumin-bound paclitaxel (w-nab-PTX) showed non-inferiority to weekly solvent-based paclitaxel (w-sb-PTX) for overall survival (OS). Thus, w-nab-PTX might be an option for second-line chemotherapy in advanced gastric cancer (AGC). However, predictive factors for efficacies of these agents have not been evaluated. METHODS: Patients previously enrolled in the ABSOLUTE trial were divided into apparent peritoneal metastasis group (PM group) and no apparent peritoneal metastasis group (no PM group) based on baseline imaging evaluated by RECIST ver. 1.1 criteria and amount of ascites. OS, progression-free survival, and overall response rate were compared between two arms in each group. RESULTS: This study included 240 and 243 patients in the w-nab-PTX and w-sb-PTX arms, respectively. In the PM group, the w-nab-PTX arm (n = 88) had longer OS than the w-sb-PTX arm (n = 103), and median survival time (MST) of 9.9 and 8.7 months [hazard ratio (HR) 0.63; 95% CI 0.45-0.88; P = 0.0060], respectively. In the no PM group, the w-nab-PTX arm (n = 140) had shorter OS than the w-sb-PTX arm (n = 152), and MST of 11.6 and 15.7 months (HR 1.40; 95% CI 1.06-1.86; P = 0.0180), respectively. After adjusting for prognostic factors, the HR for OS in the w-nab-PTX arm versus the w-sb-PTX arm was 0.59 (95% CI 0.42-0.83; P = 0.0023; PM group) and 1.34 (95% CI 1.01-1.78; P = 0.0414; no PM group), with significant interaction between treatment efficacy and presence of peritoneal metastasis (P = 0.0003). CONCLUSIONS: The presence of apparent peritoneal metastasis might be a predictive factor for selecting w-nab-PTX for pretreated AGC patients. TRIAL REGISTRATION NUMBER: JapicCTI-132059.


Subject(s)
Albumins/therapeutic use , Antineoplastic Agents/therapeutic use , Paclitaxel/therapeutic use , Peritoneal Neoplasms/secondary , Stomach Neoplasms/drug therapy , Stomach Neoplasms/pathology , Adult , Aged , Drug Carriers , Drug Delivery Systems/methods , Female , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Nanoparticles , Paclitaxel/administration & dosage , Peritoneal Neoplasms/drug therapy , Peritoneal Neoplasms/mortality , Progression-Free Survival , Proportional Hazards Models , Salvage Therapy/methods , Salvage Therapy/mortality , Stomach Neoplasms/mortality , Treatment Outcome
10.
J Infect Chemother ; 24(5): 330-340, 2018 May.
Article in English | MEDLINE | ID: mdl-29555391

ABSTRACT

The principle of empirical therapy for patients with intra-abdominal infections (IAI) should include antibiotics with activity against Enterobacteriaceae and Bacteroides fragilis group species. Coverage of Pseudomonas aeruginosa, Enterobacter cloacae, and Enterococcus faecalis is also recommended for hospital-associated IAI. A nationwide survey was conducted to investigate the antimicrobial susceptibility of pathogens isolated from postoperative IAI. All 504 isolates were collected at 26 institutions and referred to a central laboratory for susceptibility testing. Lower susceptibility rates to ciprofloxacin and cefepime were demonstrated in Escherichia coli. Among E. coli, 24.1% of strains produced extended-spectrum ß-lactamase (ESBL). Carbapenems, piperacillin/tazobactam, cephamycins/oxacephem, aminoglycosides, and tigecycline had high activity against E. coli, including ESBL-producing isolates. Among E. cloacae, low susceptibility rates to ceftazidime were demonstrated, whereas cefepime retained its activity. P. aeruginosa revealed high susceptibility rates to all antimicrobials tested except for imipenem. Among B. fragilis group species, low levels of susceptibility were observed for cefoxitin, moxifloxacin, and clindamycin, and high susceptibility rates were observed for piperacillin/tazobactam, meropenem, and metronidazole. Ampicillin, piperacillin, and glycopeptides had good activity against E. faecalis. Imipenem had the highest activity against E. faecalis among carbapenems. In conclusion, we suggested the empirical use of antimicrobials with the specific intent of covering the main organisms isolated from postoperative IAI. Piperacillin/tazobactam, meropenem, or doripenem, are appropriate in critically ill patients. Combination therapy of cefepime (aztreonam in patients with ß-lactam allergy) plus metronidazole plus glycopeptides, imipenem/cilastatin or cephamycins/oxacephem plus ciprofloxacin plus metronidazole are potential therapeutic options.


Subject(s)
Anti-Bacterial Agents/pharmacology , Biliary Tract Diseases/microbiology , Enterobacteriaceae/drug effects , Enterococcus faecalis/drug effects , Peritonitis/microbiology , Postoperative Complications/microbiology , Pseudomonas aeruginosa/drug effects , Academic Medical Centers , Biliary Tract Diseases/drug therapy , Drug Resistance, Multiple, Bacterial , Drug Therapy, Combination , Enterobacteriaceae/enzymology , Enterobacteriaceae/isolation & purification , Enterococcus faecalis/enzymology , Enterococcus faecalis/isolation & purification , Humans , Japan , Microbial Sensitivity Tests , Peritonitis/drug therapy , Postoperative Complications/drug therapy , Pseudomonas aeruginosa/enzymology , Pseudomonas aeruginosa/isolation & purification , beta-Lactamases/metabolism
11.
J Anus Rectum Colon ; 2(3): 77-82, 2018.
Article in English | MEDLINE | ID: mdl-31559347

ABSTRACT

OBJECTIVE: The use of laparoscopic surgery for rectal disease is expected to provide good cosmetic benefits for patients postoperatively. However, this expectation is significantly reduced when a diverting ileostomy is created. We present a new technique that reduces the size of the skin wound by constructing a diverting ileostomy in the umbilicus. This procedure, diverting umbilical ileostomy (umbistoma) does not require special tools for its construction and closure. METHODS: Twenty-nine patients underwent treatment with umbilical diverting stoma, including five women and 24 men, with a mean age of 70 years (range: 40-88 years). At the time of ostomy closure, a new umbilicus was formed by subcutaneously suturing the wound to the fascia. In addition, we did not close the new umbilical upper and lower spaces, so as to allow open drainage of the healing wound. RESULTS: All procedures were completed successfully without any perioperative complications. CONCLUSIONS: Our findings suggest that the umbilical diverting stoma could provide improved safety and cosmetic advantages in laparoscopic rectal resection.

13.
Clin J Gastroenterol ; 10(6): 530-534, 2017 Dec.
Article in English | MEDLINE | ID: mdl-28913716

ABSTRACT

We report a case of a mucin-producing intraductal papillary neoplasm of the intrahepatic bile duct (M-IPNB) diagnosed over a period of 6 years. A 64-year-old man underwent follow-up evaluations for an abdominal aortic aneurysm at our hospital. In 2009, a computed tomography (CT) scan revealed a simple hepatic cyst in segment 3 of the liver. Annual CT scans initially showed almost no change in the size or shape of the cyst. The cystic lesion, which measured 5 cm in 2014, had increased to 11 cm by 2015, and a solid component was detected within the cyst. A biliary cystic tumor was suspected and we performed a left lateral hepatectomy. Pathological examination showed that the papillary lesion in the cyst included adenocarcinoma and adenoma components. We diagnosed M-IPNB in 2015. Identification of the solid component of the cyst, as well as an increase in cyst diameter in the image analyses, was critical for diagnosis of M-IPNB.


Subject(s)
Bile Duct Neoplasms/pathology , Bile Ducts, Intrahepatic/pathology , Cystadenocarcinoma, Mucinous/pathology , Cystadenocarcinoma, Papillary/pathology , Bile Duct Neoplasms/diagnostic imaging , Bile Duct Neoplasms/surgery , Bile Ducts, Intrahepatic/diagnostic imaging , Bile Ducts, Intrahepatic/surgery , Cystadenocarcinoma, Mucinous/diagnostic imaging , Cystadenocarcinoma, Mucinous/surgery , Cystadenocarcinoma, Papillary/diagnostic imaging , Cystadenocarcinoma, Papillary/surgery , Hepatectomy , Humans , Male , Middle Aged , Tomography, X-Ray Computed
14.
Asian J Endosc Surg ; 10(4): 430-433, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28612483

ABSTRACT

A 39 year-old woman with malignant foot melanoma underwent wide excision of the primary tumor with a safety margin and sentinel lymph node biopsy (SLNB) for the right inguinal lymph node. SLNB was positive and a computed tomography (CT) scan revealed right iliac lymph node swelling. Positron emission tomography computed tomography (PET-CT) scan of the lymph nodes revealed abnormal uptake of fluorodeoxyglucose (FDG). We performed a laparoscopic pelvic lymph node obturator, iliac lymph node) dissection. During the operation, several black lymph nodes were observed in the iliac lymph node. Pathologically, the iliac lymph node consisted of metastasized atypical melanocytes. This surgical method for pelvic lymph node dissection is not a standard procedure among institutions. There have been no reported cases of malignant melanoma with pelvic lymph node metastasis treated by laparoscopic surgery. However, due to the minimally invasive technique, this method is worth considering to be used for pelvic lymph node dissection in malignant melanoma as well as other cancers in the field of urology or gynecology.


Subject(s)
Laparoscopy , Lymph Node Excision , Melanoma/surgery , Pelvic Neoplasms/surgery , Skin Neoplasms/pathology , Adult , Female , Foot , Humans , Lymphatic Metastasis , Melanoma/secondary , Pelvic Neoplasms/secondary
15.
J Infect Chemother ; 23(6): 339-348, 2017 Jun.
Article in English | MEDLINE | ID: mdl-28391954

ABSTRACT

A nationwide survey was conducted in Japan from 2014 to 2015 to investigate the antimicrobial susceptibility of pathogens isolated from surgical site infections (SSI). The resulting data were compared with that obtained in an earlier survey, conducted in 2010. Seven main organisms were collected, and 883 isolates were studied. A significant reduction in methicillin resistance was observed among Staphylococcus aureus isolates, dropping from 72.5% in 2010 to 53.8% in 2014-2015 (p < 0.001). MRSA isolates with a vancomycin minimum inhibitory concentration (MIC) of 2 µg/mL accounted for 1.2% of all MRSA isolates, which was significantly lower than in 2010 (9.7%, p = 0.029). Of the Escherichia coli isolates, 23.0% produced an extended spectrum ß-lactamase (ESBL) in the 2014-2015 survey, which was a significant increase from 9.5% in 2010 (p = 0.011). The geometric mean MICs for ESBL-producing isolates were 0.07 µg/mL for meropenem, 9.51 µg/mL for tazobactam/piperacillin, 0.15 µg/mL for flomoxef, and 1.56 µg/mL for gentamycin. There was a significant increase in the isolation rate of non-fragilis Bacteroides among Bacteroides fragilis group species between the two study periods (35.2% vs. 53.1%, p = 0.007). More than 90% of isolates belonging to the B. fragilis group remained susceptible to tazobactam/piperacillin, meropenem, and metronidazole. In contrast, lower levels of susceptibility were observed for cefmetazole (49.6%), moxifloxacin (61.9%), and clindamycin (46.9%). Non-fragilis Bacteroides isolates had lower rates of antibiotic susceptibility compared with B. fragilis. Overall, the surveillance data clarified trends in antimicrobial susceptibility for organisms commonly associated with SSI.


Subject(s)
Anti-Bacterial Agents/pharmacology , Bacteria/drug effects , Surgical Wound Infection/epidemiology , Surgical Wound Infection/microbiology , Humans , Japan/epidemiology , Microbial Sensitivity Tests
16.
J Anus Rectum Colon ; 1(3): 84-88, 2017.
Article in English | MEDLINE | ID: mdl-31583306

ABSTRACT

OBJECTIVES: This study aimed to compare open stoma (OS) creation with laparoscopic stoma (LS) creation considering the operation time, blood loss, time of oral intake, and complications. We also compared multiport LS and single-incision laparoscopic stoma (SILS) creation. METHODS: We reviewed the demographic data, diagnosis, indications, operation time, blood loss, time of oral intake, operative procedure, and complications of 50 patients who underwent stoma creation between April 2014 and April 2016. RESULTS: The mean blood loss was significantly lower in the LS group (7.85±18.4 ml) than in the OS group (38.1±73.2 ml; P=0.02). There were no statistical differences between the groups in terms of the operation time (LS, 72.1±32.7 min; OS, 61.2±31.2 min; P=0.23) or time of oral intake (LS, 1.0±0 days; OS, 1.91±2.71 days; P=0.17). Peristomal skin problems occurred in 11 patients (47.8%) in the OS group and 5 patients (18.5%) in the LS group. There were no statistically significant differences between the SILS and multiport LS groups, considering the operation time, amount of bleeding, and time of oral intake. CONCLUSIONS: LS is comparable with OS in terms of operation time and time of oral intake and may cause lesser blood loss. Considering its advantages, LS is a useful approach for patients requiring biopsies or intra-abdominal inspection. SILS is a minimally invasive technique, suitable for patients in whom the stoma site is preoperatively decided.

17.
Surg Case Rep ; 2(1): 74, 2016 Dec.
Article in English | MEDLINE | ID: mdl-27460130

ABSTRACT

A 59-year-old man presenting with fecal occult blood visited our hospital. He was diagnosed with advanced lower rectal cancer, which was contiguous with the prostate and the left seminal vesicle. There were no metastatic lesions with lymph nodes or other organs. We performed laparoscopic total pelvic exenteration (LTPE) using transanal minimal invasive surgery technique with bilateral en bloc lateral lymph node dissection for advanced primary rectal cancer after neoadjuvant chemoradiotherapy. The total operative time was 760 min, and the estimated blood loss was 200 ml. LTPE is not well established technically, but it has many advantages including good visibility of the surgical field, less blood loss, and smaller wounds. A laparoscopic approach may be an appropriate choice for treating locally advanced lower rectal cancer, which requires TPE.

18.
Cancer Sci ; 105(7): 812-7, 2014 Jul.
Article in English | MEDLINE | ID: mdl-24716542

ABSTRACT

This multicenter phase II study first investigated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) when given every 3 weeks to patients with unresectable or recurrent gastric cancer who had received a prior round of fluoropyrimidine-containing chemotherapy. Patients with unresectable or recurrent gastric cancer who experienced progression despite fluoropyrimidine-containing treatment were studied. Nab-paclitaxel was given i.v. at 260 mg/m(2) on day 1 of each 21-day cycle without anti-allergic premedication until disease progression or study discontinuation. The primary endpoint was the overall response rate. The secondary endpoints were the disease control rate, progression-free survival, overall survival, and safety. From April 2008 to July 2010, 56 patients were enrolled, 55 patients received the study treatment, and 54 patients were evaluable for responses. According to an independent review committee, the overall response rate was 27.8% (15/54; 95% confidence interval [CI], 16.5-41.6) and the disease control rate was 59.3% (32/54; 95% CI, 45.0-72.4). One patient had a complete response. The median progression-free survival and overall survival were 2.9 months (95% CI, 2.4-3.6) and 9.2 months (95% CI, 6.9-11.4), respectively. The most common grade 3/4 toxicities were neutropenia (49.1%), leucopenia (20.0%), lymphopenia (10.9%), and peripheral sensory neuropathy (23.6%). There were no treatment-related deaths. Nab-paclitaxel, given every 3 weeks, showed promising activity against previously treated unresectable or recurrent gastric cancers, with well-tolerated toxicities. (Trial registration, ClinicalTrials.gov: NCT00661167).


Subject(s)
Albumins/adverse effects , Albumins/therapeutic use , Paclitaxel/adverse effects , Paclitaxel/therapeutic use , Stomach Neoplasms/drug therapy , Stomach Neoplasms/mortality , Adult , Aged , Antineoplastic Agents, Phytogenic/administration & dosage , Antineoplastic Agents, Phytogenic/adverse effects , Antineoplastic Agents, Phytogenic/therapeutic use , Disease-Free Survival , Female , Humans , Kaplan-Meier Estimate , Leukopenia/chemically induced , Male , Middle Aged , Neoplasm Recurrence, Local/drug therapy , Neutropenia/chemically induced , Stomach Neoplasms/pathology , Treatment Outcome
19.
J Cancer Res Clin Oncol ; 140(2): 319-28, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24366758

ABSTRACT

PURPOSE: Cisplatin plus 5-fluorouracil has been globally accepted as a standard regimen for the treatment for advanced gastric cancer. However, cisplatin has several disadvantages, including renal toxicity and the need for admission. S-1 plus cisplatin has become a standard treatment for advanced gastric cancer in East Asia. This phase III study was designed to evaluate the potential benefits of adding docetaxel to S-1 without a platinum compound in patients with advanced gastric cancer. METHODS: Patients were randomly assigned to receive docetaxel plus S-1 or S-1 alone. The docetaxel plus S-1 group received docetaxel on day 1 and oral S-1 on days 1-14 of a 21-day cycle. The S-1 alone group received oral S-1 on days 1-28 of a 42-day cycle. The primary end point was overall survival. RESULTS: Of the 639 patients enrolled, 635 were eligible for analysis. The median overall survival was 12.5 months in the docetaxel plus S-1 group and 10.8 months in the S-1 alone group (p = 0.032). The median progression-free survival was 5.3 months in the docetaxel plus S-1 group and 4.2 months in the S-1 alone group (p = 0.001). As for adverse events, neutropenia was more frequent in the docetaxel plus S-1 group, but remained manageable. CONCLUSION: As first-line treatment for advanced gastric cancer, docetaxel plus S-1 significantly improves median overall and progression-free survival as compared with S-1 alone. (ClinicalTrials.gov number: NCT00287768).


Subject(s)
Adenocarcinoma/mortality , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Stomach Neoplasms/mortality , Adenocarcinoma/drug therapy , Adenocarcinoma/pathology , Adult , Aged , Cisplatin/administration & dosage , Docetaxel , Drug Combinations , Female , Follow-Up Studies , Humans , Male , Middle Aged , Neoplasm Metastasis , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/pathology , Neoplasm Staging , Oxonic Acid/administration & dosage , Prognosis , Prospective Studies , Stomach Neoplasms/drug therapy , Stomach Neoplasms/pathology , Survival Rate , Taxoids/administration & dosage , Tegafur/administration & dosage , Young Adult
20.
Gastric Cancer ; 14(4): 332-8, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21465339

ABSTRACT

BACKGROUND: Our previous phase I study provided evidence that weekly paclitaxel, cisplatin, and bolus 5-fluorouracil (weekly PCF) was effective and well tolerated in patients with advanced gastric cancer. This study was conducted to confirm the efficacy and toxicity of weekly PCF. METHODS: Eligibility criteria were as follows: pathological confirmation; measurable lesion(s); and no history of treatment with taxanes, platinum-based compounds, or intravenous 5-fluorouracil (1 regimen of pre-treatment with oral 5-fluorouracil agents was allowed). Paclitaxel (80 mg/m(2), 1 h), cisplatin (25 mg/m(2), 2 h), and 5-fluorouracil (600 mg/m(2), bolus) were administered on days 1, 8, and 15, every 4 weeks. RESULTS: Between March 2006 and May 2009, 46 patients were enrolled and 45 were assessed. Eighteen had a history of pre-treatment with oral 5-fluorouracil agents. The response rate was 56% [95% confidence interval (CI) 41-70%]. Median progression-free survival was 160 days (95% CI 145-214 days). Median overall survival was 552 days (95% CI 350-843 days). Grade 3-4 major adverse reactions observed were neutropenia (76%), leucopenia (38%), anaemia (27%), febrile neutropenia (22%), exacerbation of performance status (16%), and anorexia (13%). CONCLUSION: A weekly PCF regimen is promising for advanced gastric cancer, although it is associated with moderate hematological and minimal non-hematological toxicities.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Cisplatin/adverse effects , Fluorouracil/adverse effects , Paclitaxel/adverse effects , Stomach Neoplasms/drug therapy , Aged , Aged, 80 and over , Anemia/chemically induced , Anorexia/chemically induced , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cisplatin/administration & dosage , Cisplatin/therapeutic use , Disease-Free Survival , Drug Administration Schedule , Female , Fluorouracil/administration & dosage , Fluorouracil/therapeutic use , Humans , Male , Middle Aged , Neutropenia/chemically induced , Paclitaxel/administration & dosage , Paclitaxel/therapeutic use , Stomach Neoplasms/mortality , Stomach Neoplasms/pathology
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