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Background <p>Several gemcitabine-based regimens are effective as first-line treatments for advanced biliary tract carcinoma (BTC), while fluorouracil, folinic acid, and oxaliplatin (FOLFOX) is commonly used as second-line therapy in Western countries. This study aimed to investigate the efficacy and safety of FOLFOX in Japanese patients.</p> Methods <p>We retrospectively reviewed cases of BTC patients who were refractory to or intolerant of at least one gemcitabine-based regimen and subsequently received FOLFOX. Data on clinical characteristics, adverse events, treatment responses, and patient outcomes were collected. Because the FOLFOX regimen have not been approved in Japan, we have followed the appropriate procedures for the off-label use of FOLFOX in accordance with each institution's regulations and relevant laws and regulations.</p> Results <p>A total of 50 patients were included. Grade 3 or higher adverse events occurred in 30 patients (60%), 21 patients (42%) requiring dose reduction, and 24 patients (48%) requiring treatment delays. No treatment-related deaths occurred. The objective response rate (ORR) was 6%, with a disease control rate of 56%. The median progression-free survival (PFS) and overall survival (OS) were 3.4&#xa0;months and 6.8&#xa0;months, respectively. Among 14 patients who received FOLFOX as second-line treatment after gemcitabine and cisplatin, the ORR, median PFS, and median OS were 14%, 4.6&#xa0;months, and 7.5&#xa0;months, respectively.</p> Conclusion <p>This study suggested the efficacy and safety of FOLFOX as a second-line or later treatment option also for Japanese patients with advanced BTC.</p>

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Efficacy and safety of FOLFOX for Japanese patients with advanced biliary tract cancer as second-line or later chemotherapy (JON2107-B study)

  • 期刊论文

  • 发表日期：

    2025年10月19日

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  • Takeshi Terashima,
  • Chigusa Morizane,
  • Akihiko Chida,
  • Akiko Todaka,
  • Kumiko Umemoto,
  • Yujiro Kawakami,
  • Tatsuya Yamashita,
  • Makoto Ueno,
  • Junji Furuse,
  • Hiroaki Nagano

摘要

Background

Several gemcitabine-based regimens are effective as first-line treatments for advanced biliary tract carcinoma (BTC), while fluorouracil, folinic acid, and oxaliplatin (FOLFOX) is commonly used as second-line therapy in Western countries. This study aimed to investigate the efficacy and safety of FOLFOX in Japanese patients.

Methods

We retrospectively reviewed cases of BTC patients who were refractory to or intolerant of at least one gemcitabine-based regimen and subsequently received FOLFOX. Data on clinical characteristics, adverse events, treatment responses, and patient outcomes were collected. Because the FOLFOX regimen have not been approved in Japan, we have followed the appropriate procedures for the off-label use of FOLFOX in accordance with each institution's regulations and relevant laws and regulations.

Results

A total of 50 patients were included. Grade 3 or higher adverse events occurred in 30 patients (60%), 21 patients (42%) requiring dose reduction, and 24 patients (48%) requiring treatment delays. No treatment-related deaths occurred. The objective response rate (ORR) was 6%, with a disease control rate of 56%. The median progression-free survival (PFS) and overall survival (OS) were 3.4 months and 6.8 months, respectively. Among 14 patients who received FOLFOX as second-line treatment after gemcitabine and cisplatin, the ORR, median PFS, and median OS were 14%, 4.6 months, and 7.5 months, respectively.

Conclusion

This study suggested the efficacy and safety of FOLFOX as a second-line or later treatment option also for Japanese patients with advanced BTC.