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Articles by N. Boku
Total Records ( 3 ) for N. Boku
  K Nakamura , M Tahara , N Kiyota , R Hayashi , T Akimoto , H Fukuda , M Fujii and N. Boku
 

A Phase II study was started in Japan to evaluate the efficacy and safety of concurrent chemoradiotherapy with S-1 plus cisplatin in patients with unresectable locally advanced squamous cell carcinoma of the head and neck. This study began in July 2008, and a total of 45 patients will be accrued from 13 institutions within 2 years. The primary endpoint is the clinical complete remission rate. The secondary endpoints are local progression-free survival, overall survival, progression-free survival, time to treatment failure, proportion of patients who achieve nutritional support-free survival and adverse events.

  N. Boku
 

Since late 1990s, many molecular target agents have been introduced to clinical trials for various kinds of tumors, and some of them showing significant benefits have been approved. However, these global trials were mainly conducted outside Japan, and the ‘drag lag’ has been a serious problem in Japan recently. Nowadays, Japanese institutions have been participating in some global trials, and the drug lags are getting shorter. For colorectal cancer, molecular target agents such as bevacizumab and cetuximab have been approved in Japan, resulting in improved clinical outcomes. For gastric cancer, Japanese institutions not only contribute to the global Phase III trials of trastuzumab and bevacizumab but also show leadership in the early development of other new agents. For pancreatic cancer, only erlotinib has shown a survival benefit in these 10 years. Worldwide approach including Japan is warranted to achieve better clinical outcomes. For liver cancer, although Japanese institutions did not participate even in the Asian trial of sorafenib, it has been approved in Japan. For esophageal cancer, because there has been no new molecular target agents developed by pharmaceutical companies, investigator-initiated registration trial will play an important role. For all gastrointestinal malignancies, molecular target agents have made a progress in their treatments. In the near future, Japanese institutions will participate in more and more global trials and should play a specific role in worldwide drug development. Furthermore, the optimal use of these new drugs, molecular target agents, based on the daily practice should also be explored in Japan.

  S Hironaka , K Yamazaki , K Taku , T Yokota , K Shitara , T Kojima , S Ueda , N Machida , K Muro and N. Boku
  Objective

S-1 plus cisplatin is standard treatment for advanced gastric cancer in Japan. Triplet therapy with docetaxel, cisplatin and fluoropyrimidine showed a survival benefit over doublet therapy, but was associated with substantial toxicities. We investigated the maximum tolerated dose of combination chemotherapy with divided-dose docetaxel added to standard-dose S-1 plus cisplatin in advanced gastric cancer patients.

Methods

Patients with advanced gastric cancer, naive to chemotherapy or not refractory to fluoropyrimidine, were enrolled. Fixed doses of S-1 (40 mg/m2 twice daily for 3 weeks) and cisplatin (60 mg/m2 on day 1) were administered with increasing docetaxel dose levels of 20 mg/m2 (dose level 1), 25 mg/m2 (dose level 2) and 30 mg/m2 (dose level 3) on days 1, 8 and 15, or 40 mg/m2 (dose level 4) on days 1 and 15 of a 5-week cycle. Treatment cycles were repeated until disease progression, patient's refusal or unacceptable toxicity occurred.

Results

Fifteen patients were enrolled. During the first cycle, no dose-limiting toxicity was observed at dose levels 1 and 2. At dose level 3, grade 3 febrile neutropenia was seen in one patient. At dose level 4, grade 3 infection and grade 3 abdominal pain were observed. Thus, dose level 4 was determined to be the maximum tolerated dose. The response rate was 54% (7/13), and median progression-free survival and overall survival were 243 and 383 days, respectively.

Conclusions

The recommended dose of docetaxel added to standard-dose S-1 (80 mg/m2 days 1–21) plus cisplatin (60 mg/m2 day 1) was 40 mg/m2 on days 1 and 15 of a 5-week cycle.

 
 
 
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