Safety and Effectiveness of Gemcitabine in 260 Patients with Biliary Tract Cancer in a Japanese Clinical Practice Based on Post-marketing Surveillance in Japan

Abstract

Objective: Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Methods: Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Results: Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9 -58.7%). Conclusions: In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

Safety and Effectiveness of Chemotherapy in Elderly Biliary Tract Cancer Patients

“…Gemcitabine monotherapy has been reported to be similarly safe and effective in elderly BTC patients, with cutoffs set at 70 [ 26 ] and 75 [ 20 ] years of age. With respect to combination therapy, patients aged 70 years or older predicted poor prognoses in a study on BTC patients receiving gemcitabine and S-1 (GS) [ 27 ].…”

“…Another alternative to be considered is whether or not gemcitabine monotherapy can be combined with ICIs in elderly patients. As most prospective studies have neglected to perform subgroup analyses based on age [ 26 ], more research is needed to serve unmet needs for safe and effective treatment in elderly BTC patients.…”

Alvopem ® (pemetrexed) safety assessment in patients with non-small cell lung cancer or malignant pleural mesothelioma: a post-marketing surveillance

“…The surveillance results showed no apparent difference in total adverse drug reactions (ADRs) compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrated the safety and effectiveness of pemetrexed treatment for NSCLC patients in daily clinical settings [ 19 ]. According to results of a phase 3 study that added pemetrexed to bevacizumab for maintenance therapy, in the combination arm, the OS was improved but not statistically significant (23.3 vs. 19.6 months, P = 0.069), although the PFS improved significantly (5.7 vs. 4.0 months, P < 0.001).…”

Advances in systemic therapy for advanced pancreatobiliary malignancies

“…Gemcitabine, either alone or in combination with other chemotherapeutic agents, is commonly used for patients who wish to receive chemotherapy, but multiple other regimens not containing gemcitabine do exist 63– 70 . Gemcitabine has been shown to be both safe and effective, even in elderly patients 65 . Gemcitabine has been used in combination with platinum agents and fluoropyrimidines in multiple small phase II trials, but it was not until 2009 that a regimen that can be considered a standard emerged.…”