International journal of clinical oncology · 2025
Efficacy and safety of FOLFOX for Japanese patients with advanced biliary tract cancer as second-line or later chemotherapy (JON2107-B study).
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Terashima Takeshi, Morizane Chigusa, Chida Akihiko, Todaka Akiko, Umemoto Kumiko, Kawakami Yujiro, Yamashita Tatsuya, Ueno Makoto, Furuse Junji, Nagano Hiroaki
Аннотация
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.
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.