Scientists with the National Health Research Institutes’ Taiwan Cooperative Oncology Group have developed a new immune chemotherapy combination against biliary tract cancers. The results of a study of 48 patients in Taiwan showed a tumor response rate of 45% and a median overall survival of 19 months, compared with Taiwan’s current averages of a 25% tumor response rate and median overall survival of 11.4 months for such patients. Furthermore, only 6% of patients experienced grade 3-4 neutropenia during this new treatment, compared with the 60% of such patients with standard treatment in a study in Japan. Thus, this NHRI study could lead to a new standard of care for patients with biliary tract cancer in Taiwan.
Biliary tract cancers include intra-hepatic cholangiocarcinoma, extra-hepatic cholangiocarcinoma, and gallbladder cancer. Because those individual cancers are counted separately in statistics, there is little public awareness of this disease. Yet on average more than 2300 patients are diagnosed with biliary tract cancers yearly in Taiwan, nearly the same number of people diagnosed with pancreatic cancer.
Diagnosis of biliary cancer often comes too late for surgical treatment. The standard of care in unresectable disease is a combination chemotherapy of gemcitabine plus cisplatin (GC). However, the tumor response rate of GC was only 25%, with a median overall survival of 11.4 months; and grade 3-4 neutropenia was observed in about 25% of patients. Furthermore, the toxicities of GC were even higher in an Asian population, as demonstrated by the Japanese study. Therefore, a new regimen fit for Taiwanese patients was called for.
On the behalf of the National Health Research Institutes’ Taiwan Cooperative Oncology Group, Dr. Li-Tzong Chen, Dr. Nai-Jung Chiang and Dr. Ming-Huang Chen initiated a phase II clinical trial (TG1308) to use a novel chemotherapy regimen of biweekly gemcitabine plus oral S-1. This modified regimen had lower toxicity than standard treatment but similar efficacy. The tumor response rate was 22%, with a median overall survival of 12.7 months. Only 4% of patients experienced grade 3-4 neutropenia during this modified treatment.
The investigators then initiated a study to evaluate an immune chemotherapy combination that built on the previous study but added biweekly nivolumab. A total of 48 patients were enrolled. In preliminary analysis, the tumor response rate was 45%, with a median overall survival of 19 months. Three patients underwent conversion surgery. Only 6% of patients experienced grade 3-4 neutropenia during this treatment.