Hirao M.,National Hospital Organization |
Takiguchi S.,Osaka University |
Imamura H.,Sakai Municipal Hospital |
Yamamoto K.,Osaka University |
And 6 more authors.
Annals of Surgical Oncology | Year: 2013
Purpose: This randomized, controlled trial evaluated the clinical efficacy of Billroth I (BI) and Roux-en-Y (RY) reconstruction at 1 year after distal gastrectomy for gastric cancer. Methods: The primary end point was the amount of body weight lost at 1 postoperative year, and secondary end points included other items related to nutritional status such as serum albumin and lymphocyte count, as well as endoscopic examination findings of the remnant stomach and esophagus. Of the 332 patients enrolled, 163 were assigned to the BI group and 169 were randomized to the RY group. Results: The loss in body weight 1 year after surgery did not differ significantly between the BI and RY groups (9.1 % and 9.7 %, respectively, p = 0.39). There were no significant differences in other aspects of nutritional status between the 2 groups. Endoscopic examination 1 year after gastrectomy showed reflux esophagitis in 26 patients (17 %) in the BI group versus 10 patients (6 %) in the RY group (p = 0.0037), while remnant gastritis was observed in 71 patients (46 %) in the BI group versus 44 patients (28 %) in the RY group (p = 0.0013); differences were significant for both conditions. Multivariable analysis showed that the only reconstruction was the independently associated factor with the incidence of reflux esophagitis. Conclusions: RY reconstruction was not superior to BI in terms of body weight change or other aspects of nutritional status at 1 year after surgery, although RY more effectively prevented reflux esophagitis and remnant gastritis after distal gastrectomy. © 2012 Society of Surgical Oncology.
Sequential paclitaxel followed by tegafur and uracil (UFT) or S-1 versus UFT or S-1 monotherapy as adjuvant chemotherapy for T4a/b gastric cancer (SAMIT): A phase 3 factorial randomised controlled trial
Tsuburaya A.,Yokohama City University |
Yoshida K.,Gifu University |
Kobayashi M.,Kochi Medical School |
Yoshino S.,Yamaguchi University |
And 16 more authors.
The Lancet Oncology | Year: 2014
Background: The prognosis for locally advanced gastric cancer is poor despite advances in adjuvant chemotherapy. We did the Stomach cancer Adjuvant Multi-Institutional group Trial (SAMIT) to assess the superiority of sequential treatment (paclitaxel then tegafur and uracil [UFT] or paclitaxel then S-1) compared with monotherapy (UFT or S-1) and also the non-inferiority of UFT compared with S-1. Methods: We did this randomised phase 3 trial with a two-by-two factorial design at 230 hospitals in Japan. We enrolled patients aged 20-80 years with T4a or T4b gastric cancer, who had had D2 dissection and a ECOG performance score of 0-1. Patients were randomly assigned to one of four treatment groups with minimisation for tumour size, lymph node metastasis, and study site. Patients received UFT only (267 mg/m2 per day), S-1 only (80 mg/m2 per day) for 14 days, with a 7-day rest period or three courses of intermittent weekly paclitaxel (80 mg/m2) followed by either UFT, or S-1. Treatment lasted 48 weeks in monotherapy groups and 49 weeks in the sequential treatment groups. The primary endpoint was disease-free survival assessed by intention to treat. We assessed whether UFT was non-inferior to S-1 with a non-inferiority margin of 1·33. This trial was registered at UMIN Clinical Trials Registry, number C000000082. Findings: We randomly assigned 1495 patients between Aug 3, 2004, and Sept 29, 2009. 374 patients were assigned to receive UFT alone, 374 to receive S-1 alone, 374 to received paclitaxel then UFT, and 373 to receive paclitaxel then S-1. We included 1433 patients in the primary analysis after at least 3 years of follow-up (359, 364, 355, and 355 in each group respectively). Protocol treatment was completed by 215 (60%) patients in the UFT group, 224 (62%) in the S-1 group, 242 (68%) in the paclitaxel then UFT group, and 250 (70%) in the paclitaxel then S-1 group. 3-year disease-free survival for monotherapy was 54·0% (95% CI 50·2-57·6) and that of sequential treatment was 57·2% (53·4-60·8; hazard ratio [HR] 0·92, 95% CI 0·80-1·07, p=0·273). 3-year disease-free survival for the UFT group was 53·0% (95% CI 49·2-56·6) and that of the S-1 group was 58·2% (54·4-61·8; HR 0·81, 95% CI 0·70-0·93, p=0·0048; pnon-inferiority=0·151). The most common grade 3-4 haematological adverse event was neutropenia (41 [11%] of 359 patients in the UFT group, 48 [13%] of 363 in the S-1 group, 46 [13%] of 355 in the paclitaxel then UFT group, and 83 [23%] of 356 in the paclitaxel then S-1 group). The most common grade 3-4 non-haematological adverse event was anorexia (21 [6%], 24 [7%], seven [2%], and 18 [5%], respectively). Interpretation: Sequential treatment did not improve disease-free survival, and UFT was not non-inferior to S-1 (and S-1 was superior to UFT), therefore S-1 monotherapy should remain the standard treatment for locally advanced gastric cancer in Japan. Funding: Epidemiological and Clinical Research Information Network. © 2014 Elsevier Ltd.
Terashima M.,Shizuoka Cancer Center |
Kitada K.,Research Center for Innovative Oncology |
Ochiai A.,Research Center for Innovative Oncology |
Ichikawa W.,National Defense Medical College |
And 6 more authors.
Clinical Cancer Research | Year: 2012
Purpose: EGF receptor (EGFR) and HER2 positivity are considered to be negative prognostic factors in gastric cancer. Biomarker analysis was conducted to evaluate the impact of EGFR and HER2 expression on the outcome of patients enrolled in the Adjuvant Chemotherapy Trial of TS-1 for Gastric Cancer (ACTS-GC), a randomized controlled trial comparing postoperative adjuvant S-1 therapy with surgery alone in 1,059 patients with stage II/III gastric cancer. Experimental Design: Formalin-fixed, paraffin-embedded surgical specimens were retrospectively examined in 829 patients (78.3%). The effects of EGFR and HER2 positivity on survival were analyzed on the basis of the 5-year survival data from the study. EGFR positivity was defined as an immunohistochemistry (IHC) score of 3+, and HER2 positivity as an IHC score of 3+ or an IHC score of 2+ with a positive dual-color in situ hybridization status. Results: EGFR and HER2 were positive in 75 (9.0%) and 113 (13.6%) patients, respectively. The overall and relapse-free survival rates were significantly lower in EGFR-positive patients than in EGFR-negative patients, whereas they were similar in HER2-positive and HER2-negative patients. Multivariate analysis showed that EGFR positivity correlated with poor outcomes [HR = 1.504; 95% confidence interval (CI) = 1.020-2.149; P = 0.040]. Treatment with S-1 improved survival compared with surgery alone, irrespective of EGFR and HER2 status. Conclusions: EGFR positivity, but not HER2 positivity, was associated with poor patient outcomes after curative resection of stage II/III gastric cancer. There was no interaction between S-1 and EGFR or HER2 status with respect to survival outcome. ©2012 AACR.
Ikeda H.,Sakai Municipal Hospital
Japanese Journal of Clinical Radiology | Year: 2012
This issue describes current status and prospects of physics/technology aspects of quality assurance in radiotherapy in Japan. With the advent of several radiotherapy accidents in Japan around 2001-04, radiotherapy QA/QC system was totally reviewed. After all, in 2004 a Working Group composed of executives from 5 societies related to radiological practices (later named as Japanese Organization for Radiotherapy Quality Management) issued a proposal for radiotherapy institutions (1) to settle radiotherapy quality assurance committee in each institution, (2) to nurture certified radiotherapy quality manager, and (3) to conduct third-party auditing. The Japanese Government approved designated hospitals for cancer control since 2000, and number of designated hospitals increased from 266 in 2005 to 372 in 2009. However the structure of radiotherapy institutions has not substantially been improved in terms of installations and staffs, which has not kept up with the natural increase of number of patients, even in designated hospitals. Under these circumstances QA activities has to be conducted. Now, with respect to third-party QA activities, Association of Nuclear Technology in Medicine conducts several activities, namely, standardized calibration of dosimeter and postal dosimetry system using glass-rod dosimeter.
Matsushita A.,Sakai Municipal Hospital
Gan to kagaku ryoho. Cancer & chemotherapy | Year: 2013
Bisphosphonates have been used clinically as highly effective drugs in the treatment of hypercalcemia of malignancy, and bone metastasis of solid cancers. Despite these benefits, however, the emergence of bisphosphonate-related osteonecrosis of the jaws has become a growing and significant problem in a subset of patients receiving these drugs. We report a rare case of brain abscess secondary to BRONJ in metastatic bone lesions from breast carcinoma.