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Yamada Y.,National Cancer Center Hospital | Boku N.,St. Marianna University School of Medicine | Nishina T.,Shikoku Cancer Center | Yamaguchi K.,Saitama Cancer Center | And 14 more authors.
Annals of Oncology | Year: 2013

Background: Since the best chemotherapy regimen for each patient with advanced gastric cancer is uncertain, we aimed to identify molecular prognostic or predictive biomarkers from biopsy specimens in JCOG9912, a randomized phase III trial for advanced gastric cancer. Patients and methods: Endoscopic biopsy specimens from primary lesions were collected in 445 of 704 randomized patients in JCOG9912. We measured the mRNA expression of excision repair cross-complementing group 1 (ERCC1), thymidylate synthase, dihydropyrimidine dehydrogenase, and five other genes, then, categorized them into low and high groups relative to the median, and examined whether gene expression was associated with efficacy end point. Results: Multivariate analyses showed that high ERCC1 expression [HR 1.37; 95% confidence interval (CI) 1.08-1.75; P = 0.010], performance status =1 (HR 1.45; 95% CI 1.13-1.86; P = 0.004), and number of metastatic sites =2 (HR 1.66; 95% CI 1.28-1.86; P < 0.001) were associated with a poor prognosis, and recurrent disease (versus unresectable; HR 0.75; 95% CI 0.56-1.00; P = 0.049) was associated with a favorable prognosis. None of these molecular factors were a predictive marker for choosing irinotecan plus cisplatin or 5-fluorouracil rather than S-1. Conclusion: These correlative analyses suggest that ERCC1 is an independent prognostic factor for overall survival in the first-line treatment of gastric cancer. © The Author 2013.


PubMed | Shizuoka Cancer Center, National Cancer Center Hospital East, Niigata University, Japan National Cardiovascular Center Research Institute and 2 more.
Type: Clinical Trial, Phase III | Journal: Japanese journal of clinical oncology | Year: 2015

A randomized Phase III trial commenced in Japan in September 2014. Endoscopic local steroid injection has been commonly used and considered acceptable as the current standard treatment for the prevention of esophageal stricture after endoscopic submucosal dissection for superficial esophageal cancer. The purpose of this study is to confirm the superiority of prophylactic oral steroid administration following endoscopic submucosal dissection in terms of stricture-free survival over endoscopic local steroid injection for patients with superficial esophageal cancer. A total of 360 patients will be accrued from 35 Japanese institutions within 2.5 years. The primary endpoint is stricture-free survival, and the secondary endpoints are the number of endoscopic balloon dilations for 12 weeks after endoscopic submucosal dissection, adverse events, serious adverse events and the proportion of patients with dysphagia score 1 at 12 weeks after endoscopic submucosal dissection. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015064 (http://www.umin.ac.jp/ctr/index.htm).


PubMed | Kochi Health science Center, Kanagawa Cancer Center, National Cancer Center Hospital East, National Cancer Center Hospital and 2 more.
Type: | Journal: Japanese journal of clinical oncology | Year: 2016

A randomized phase II/III trial was started in May 2015 comparing perioperative versus postoperative chemotherapy with modified infusional uorouracil and folinic acid with oxaliplatin for lower rectal cancer patients with suspected lateral pelvic node metastasis. The standard arm is total mesorectal excision or tumor-specific mesorectal excision with lateral pelvic node dissection (LND) followed by postoperative chemotherapy (modified infusional uorouracil and folinic acid with oxaliplatin; 12 cycles). The experimental (perioperative chemotherapy) arm is six courses of modified infusional uorouracil and folinic acid with oxaliplatin before and six courses after total mesorectal excision with lateral pelvic node dissection. The aim of this trial is to confirm the superiority of perioperative chemotherapy. A total of 330 patients will be enrolled over 7 years. The primary endpoint in Phase II part is proportion of R0 resection and that in Phase III part is overall survival. Secondary endpoints are progression-free survival, local progression-free survival, etc. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017603 [http://www.umin.ac.jp/ctr/index-j.htm].


PubMed | Shikoku Cancer Center Hospital, National Cancer Center Hospital East, National Cancer Center Hospital, Keio University and 3 more.
Type: Journal Article | Journal: Surgical endoscopy | Year: 2015

Thoracoscopic esophagectomy is rapidly and increasingly being used worldwide because it is a less invasive alternative to open esophagectomy. However, few prospective multicenter studies have evaluated its safety profile. This study aimed to evaluate the safety profile of thoracoscopic esophagectomy using perioperative data from the Japan Clinical Oncology Group Study (JCOG0502).JCOG0502 is a four-arm prospective study comparing esophagectomy with chemoradiotherapy for esophageal cancer, with randomized and patient preference arms. Patients with clinical stage T1bN0M0 esophageal cancer were enrolled until patient accrual was completed. Open or thoracoscopic esophagectomy was selected at the surgeons discretion. Perioperative complications were defined as adverse events of grade 2 as per Common Terminology Criteria for Adverse Events ver. 3.0.A total of 379 patients were enrolled between December 2006 and February 2013. Of the 210 patients who underwent surgery, 109 patients underwent open esophagectomy, and 101 patients underwent thoracoscopic esophagectomy. Although thoracoscopic esophagectomy decreased the incidence of postoperative atelectasis (open: 22.0%, thoracoscopy: 10.9%; P = 0.041), reoperation was more frequent in the thoracoscopy group (open: 1.8%, thoracoscopy: 9.9%; P = 0.016). The incidence of overall complications did not differ between the two groups (open: 44.0%, thoracoscopy: 44.6%; P = 1.00). There was one in-hospital death in each group (open: 0.9%, thoracoscopy: 1.0 %; P = 1.00).Thoracoscopic esophagectomy is a safe procedure with morbidity and mortality comparable with those of open esophagectomy. However, it is associated with a higher frequency of reoperation.


PubMed | Cancer Institute Hospital of Japanese Foundation for Cancer Research, Aichi Cancer Center Hospital, Saitama Cancer Center, National Hospital Organization Shikoku Cancer Center and 13 more.
Type: | Journal: European journal of cancer (Oxford, England : 1990) | Year: 2016

We conducted a phase III, non-inferiority trial comparing upfront primary debulking surgery (PDS) and interval debulking surgery (IDS) following neoadjuvant chemotherapy (NAC) for stage III/IV ovarian, tubal, and peritoneal cancers (JCOG0602). Two earlier studies, EORTC55971 and CHORUS, demonstrated non-inferior survival of patients treated with NAC. However, they could not evaluate true treatment invasiveness because of adding diagnostic laparotomy or laparoscopy before treatment in over 30% of both arms of EORTC55971 and in 16% of NAC arm of CHORUS.Patients were randomised into the standard arm (PDS followed by eight cycles of paclitaxel and carboplatin [TC]) and NAC arm (four cycles of TC, IDS, and four cycles of TC). In the standard arm, IDS was optional for patients who had undergone suboptimal or incomplete PDS. Treatment invasiveness was compared between arms(UMIN000000523).Between November 2006 and October 2011, 301 patients were randomised. In the standard arm, 147/149 underwent PDS and 49 underwent IDS. In the NAC arm, 130/152 underwent IDS. The NAC arm required fewer surgeries (mean 0.86 versus 1.32, p<0.001) and shorter total operation time (median 273minversus 341min, p<0.001) than the standard arm and required a lower frequency of abdominal organ resection (23.7% versus 37.6%, p=0.012) or distant metastases resection (3.9% versus 10.7%, p=0.027). In the NAC arm IDS, blood/ascites loss was smaller (median 787ml versus 3235ml, p<0.001) and albumin transfusion and G3/4 adverse events after surgery in total were less frequent (26.2% versus 58.5%, p<0.001; 4.6% versus 15.0%, p=0.005, respectively).Our findings demonstrated that NAC treatment is less invasive than standard treatment. NAC treatment may become the new standard treatment for advanced ovarian cancer when non-inferior survival is confirmed in the planned primary analysis in 2017.


PubMed | Oita University, Shizuoka Cancer Center, Aichi Cancer Center Hospital, Saitama Cancer Center and 8 more.
Type: Journal Article | Journal: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association | Year: 2016

This randomized phase II study compared weekly administration of paclitaxel (wPTX) with the best available 5-fluorouracil (5-FU) regimen as second-line treatment for advanced gastric cancer patients with severe peritoneal metastasis refractory to fluoropyrimidine.In the best available 5-FU arm, continuous infusion of 5-FU (800mg/m(2)/day, days1-5, every 4weeks) was given to patients with prior chemotherapy including bolus 5-FU, and methotrexate and 5-FU sequential bolus injection (methotrexate at 100mg/m(2) followed by bolus 5-FU at 600mg/m(2) with leucovorin, weekly) was given to those who had previously received continuous infusion of 5-FU or oral administration of fluoropyrimidine. In the wPTX arm, paclitaxel (80mg/m(2)) was administered on days 1, 8, and 15, every 4weeks. This study adopted a screening design (one-sided =30%) with the primary end point of overall survival.One hundred patients were randomized to the 5-FU arm (n=49) or the wPTX arm (n=51). Although the median survival time was 7.7months in both arms, the 2-year survival rates were 2.9% in the 5-FU arm and 9.1% in the wPTX arm [hazard ratio0.89 (95% confidence interval 0.57-1.38), one-sided p=0.298}. The median progression-free survival was longer with wPTX than with 5-FU [3.7months vs 2.4months; hazard ratio 0.58 (95% confidence interval 0.38-0.88), one-sided p=0.005]. The incidences of grade 4 neutropenia, grade 3/4 febrile neutropenia, diarrhea, and treatment-related death were 6%, 4%, 10%, and 2%, respectively, in the 5-FU arm and 2%, 0%, 0%, and 0%, respectively, in the wPTX arm.As second-line chemotherapy, wPTX appears feasible and promising. This regimen can be included in a test arm in future phase III trials for treatment of advanced gastric cancer with severe peritoneal metastasis.


PubMed | Hiroshima Precise Radiotherapy Center, Koshigaya Municipal Hospital, National Cancer Center Hospital, Hiroshima University and 3 more.
Type: | Journal: Japanese journal of clinical oncology | Year: 2017

A randomized Phase III trial commenced in Japan in February 2016. Currently, 42 Gy in four fractions of stereotactic body radiotherapy prescribed at the D


PubMed | Juntendo University, Niigata Cancer Center Hospital, Koshigaya Municipal Hospital, National Cancer Center Hospital and 4 more.
Type: Journal Article | Journal: Japanese journal of clinical oncology | Year: 2016

No randomized controlled trials comparing stereotactic body radiotherapyand lobectomy for operable early-stage non-small-cell lung cancer have been successfully conducted. This study compared survival outcomes in two multi-institutional clinical trials for stereotactic body radiotherapy (Japan Clinical Oncology Group JCOG0403) and lobectomy (Japan Clinical Oncology Group JCOG0201) with propensity score analysis.Inclusion criteria were operable, cT1N0M0 and adenocarcinoma diagnosed prior to registration of each trial. Forty of 169 patients from JCOG0403 and 219 of 811 patients fromJCOG0201 were included. The primary endpoint was overall survival adjusted with propensity score analysis. The patient selection factors included in the logistic model to estimate the propensity score were age, sex, tumor diameter and consolidation/tumor ratio.Among patient selection factors, age distribution was quite different with little overlap: the median was 79 (interquartile range: 74.5-83.5) instereotactic body radiotherapy and 62 (interquartile range: 55-68) in lobectomy. In propensity score analysis, 21 patients from each group were matched and the hazard ratioforstereotactic body radiotherapy over lobectomy was 9.00 (95% confidence interval: 1.14-71.04). In the post hoc subgroup analysis with propensity score analysis of inverse probability of treatment weighting, patients were limited to be aged 75 or younger because JCOG0201 only included them when aged 75 or younger. Thirteen patients forstereotactic body radiotherapy and 219 for lobectomy were compared, and thehazard ratio for stereotactic body radiotherapy over lobectomy was 1.19 (95%confidence interval: 0.38-3.73).The point estimates ofhazard ratio favored lobectomy overstereotactic body radiotherapy in the limited number of patients. A randomized controlled study is needed for valid comparison.


PubMed | Kochi Health science Center, Shizuoka Cancer Center, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Chiba Cancer Center and 4 more.
Type: Clinical Trial, Phase III | Journal: Japanese journal of clinical oncology | Year: 2015

Chemotherapy with cisplatin plus fluorouracil is the current standard treatment for metastatic or recurrent esophageal cancer. We have developed a 2-weekly docetaxel combined with CF regimen and conducted a Phase I/II trial for metastatic or recurrent esophageal cancer (JCOG0807). Promising efficacy and safety were shown in JCOG0807, and we have commenced a Phase III trial in September 2014 to confirm the superiority of 2-weekly DCF to CF for patients with metastatic or recurrent esophageal cancer. A total of 240 patients will be accrued from 41 Japanese institutions over a period of 4 years. The primary end point is overall survival. The secondary end points are progression-free survival, response rate and proportion of adverse events. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000015107 (http://www.umin.ac.jp/ctr/index.htm).


PubMed | Shizuoka Cancer Center, National Cancer Center Hospital East, National Cancer Center Hospital, Keio University and 2 more.
Type: Clinical Trial, Phase III | Journal: Japanese journal of clinical oncology | Year: 2016

A randomized Phase III study was commenced in May 2015 to confirm the non-inferiority of thoracoscopic esophagectomy to open esophagectomy in terms of overall survival for clinical Stage I-III esophageal cancer. A total of 300 patients will be accrued from Japanese institutions over 6 years. The primary endpoint is overall survival. The secondary endpoints are relapse-free survival, proportion of patients with R0 resection, proportion of patients who underwent re-operation, adverse events, postoperative respiratory function change, postoperative quality-of-life score (EORTC QLQ-C30), and proportion of patients who need conversion from thoracoscopic surgery to open surgery. This trial has been registered in the UMIN Clinical Trials Registry as UMIN000017628.

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