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Articles by N Boku
Total Records ( 5 ) for N Boku
  Y Kurokawa , N Hasuike , H Ono , N Boku , H Fukuda and for the Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)
 

A Phase II trial was started in Japan to evaluate the efficacy and safety of endoscopic submucosal dissection for macroscopic mucosal (cT1a) gastric cancer beyond the present indication described in the Gastric Cancer Treatment Guidelines by the Japan Gastric Cancer Association. Patients with cT1a gastric cancer, which is histologically proven differentiated (intestinal) type adenocarcinoma, are eligible. In this study, the tumor is >2 cm for ulceration (UL)-negative cases or ≤3 cm for UL-positive cases. A total of 330 patients are enrolled from 26 institutions over 2 years. The primary endpoint is the 5-year overall survival (OS). The secondary endpoints are OS in the UL-negative subset and the UL-positive subset, recurrence-free survival (RFS), 5-year RFS with preserved stomach, proportion of en bloc resection, proportion of pathological curative resection and adverse events.

  Y Kurokawa , M Muto , K Minashi , N Boku , H Fukuda and for the Gastrointestinal Oncology Study Group of Japan Clinical Oncology Group (JCOG)
 

Standard treatment for clinical stage I esophageal cancer with submucosal invasion (T1b) has been surgical resection. We conducted a Phase II trial to evaluate the efficacy and the safety of combined treatment of endoscopic mucosal resection (EMR) and chemoradiotherapy for clinical stage I (T1b) esophageal cancer. Patients diagnosed as having clinical stage I (T1b) esophageal cancer which is considered to be resectable by EMR are eligible. When pathological examination of the EMR specimen confirms T1b tumor with negative or positive resection margin, the patient undergoes chemoradiotherapy. The study continues until 82 patients with T1b tumor with negative resection margin are enrolled from 20 institutions. The primary endpoint is 3-year overall survival (OS) in pT1b cases with negative resection margin. The secondary endpoints are 3-year OS and progression-free survival in all eligible cases, OS in pT1a-MM cases with margin-negative, complications of EMR and adverse events of chemoradiotherapy. The data from this trial will be expected to provide a non-surgical treatment option to the patients with clinical stage I (T1b) esophageal cancer.

  T Doi , N Boku , K Kato , Y Komatsu , K Yamaguchi , K Muro , Y Hamamoto , A Sato , W Koizumi , N Mizunuma and H. Takiuchi
  Objective

The addition of bevacizumab to fluoropyrimidine-based combination chemotherapy as first-line therapy for metastatic colorectal cancer results in clinically significant improvements in patient outcome. However, clinical trials have been conducted primarily in Caucasian patients with only a small proportion of Asian patients. This Phase I/II study was designed to evaluate the efficacy and safety of XELOX (capecitabine plus oxaliplatin) plus bevacizumab in Japanese patients with metastatic colorectal cancer.

Methods

Patients with previously untreated, measurable metastatic colorectal cancer received bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m2 on day 1, plus capecitabine 1000 mg/m2 twice daily on days 1–14, every 3 weeks. A three-step design evaluated in: step 1, initial safety of XELOX in six patients; step 2, initial safety of XELOX plus bevacizumab in six patients; and step 3, efficacy and safety in a further 48 patients. The primary study endpoints were safety and response rate.

Results

No dose-limiting toxicity occurred during Steps 1 and 2. Fifty-eight patients were enrolled in Steps 2 and 3 and received XELOX plus bevacizumab. In the 57 patients assessed for response, the overall response rate was 72% (95% confidence interval, 58.5–83.0). Median progression-free survival was 11.0 months (95% confidence interval, 9.6–12.5) and median overall survival was 27.4 months (95% confidence interval, 22.0–not calculated). Eight patients (14%) underwent surgery with curative intent. The most common grade 3/4 adverse events were neurosensory toxicity (17%) and neutropenia (16%).

Conclusions

XELOX plus bevacizumab is effective and has a manageable tolerability profile when given to Japanese patients with metastatic colorectal cancer.

  T Shukuya , H Yasui , N Boku , Y Onozawa , A Fukutomi , K Yamazaki , K Taku , T Kojima and N. Machida
  Objectives

Peritoneal metastasis is one of the major sites of disease progression of pancreatic cancer. There have been few trials in the second-line setting after gemcitabine failure because patients can hardly be candidates for chemotherapy after failure in the first-line chemotherapy, especially those with malignant ascites. The safety and efficacy of weekly paclitaxel therapy was evaluated for pancreatic cancer patients with malignant ascites in this retrospective study.

Methods

The subjects of this retrospective study were 23 advanced pancreatic cancer patients with malignant ascites who received weekly paclitaxel therapy after gemcitabine failure. Paclitaxel (80 mg/m2, div. for 1 h) was administered on Days 1, 8 and 15, every 4 weeks.

Results

While the disease control rate was 35%, decrease of ascites was obtained in 30% of the patients and ascites control rate was 61%. The median survival time was 101 days. Toxicities were mild, although one treatment-related death occurred.

Conclusions

Weekly paclitaxel therapy may be useful treatment option for pancreatic cancer patients with malignant ascites after gemcitabine failure.

 
 
 
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