A Phase II Trial of Gemcitabine in the Treatment of Advanced Bile Duct and Periampullary Carcinomas

Abstract

Background: Gemcitabine is a novel nucleoside analogue with clinical anticancer activity in several malignancies. From September 1998 to April 2000, we treated patients with advanced bile duct and periampullary carcinomas with gemcitabine alone. Methods: Gemcitabine 1,000 mg/m²/day was administered in 200 ml of normal saline as a 30-min intravenous infusion on day 1 weekly for 3 weeks, followed by a 1-week rest. Results: A total of 24 consecutive patients (15 men, 9 women), with a median age of 59.5 years (range 40–72 years), were enrolled. All patients were evaluable for response: 1 patient achieved complete remission (CR); 2 patients had partial remission (PR); 8 patients remained stable (SD), and 13 patients had progressive disease (PD). The overall response rate (CR + PR) was 12.5% with a 95% confidence interval (CI) of 2.7–32.4%. The median progression-free survival (PFS) was 2.5 months (95% CI 1.6–5.5 months), and the median overall survival (OS) was 7.2 months (95% CI 3.8–8.9 months). Patients with disease control (CR + PR + SD) had better PFS and OS than those with PD. There were no treatment-related deaths. Few patients encountered grade 3/4 toxicity. Conclusion: Chemotherapy with gemcitabine demonstrated notable activity and was associated with a well-tolerable toxicity profile in patients with advanced biliary tract malignancies.

Gemcitabine Alone or in Combination with Cisplatin for Advanced Biliary Tract Carcinomas: an Overview of Clinical Evidence

“…As for the different articles published on the results of the same trial, we only included the recently published one (excluding 1). Finally, 23 trials (Metzger et al, 1998;Valencak et al, 2000;Gallardo et al, 2001;Penz et al, 2001;Lin et al, 2003;Eng et al, 2004;Doval et al, 2004; DOI:http://dx.doi.org/10.7314/APJCP.2013.14.2.877 Gemcitabine-cisplatin vs G, gemcitabine; C, cisplatin; GC, gemcitabine + cisplatin; (1) G, i.v., on d1, 8; C, i.v., on d1; every 3 Wks; (2) G, i.v. on d1, 8, 15; C, i.v.…”

“…There were 10 phase II studies (Metzger et al, 1998;Valencak et al, 2000;Gallardo et al, 2001;Penz et al, 2001;Lin et al, 2003;Eng et al, 2004;Tsavaris et al, 2004;Park et al, 2005;Okusaka et al, 2006) of gemcitabine for advanced BTC and the number of patients ranged from 14 to 40. Study characteristics are presented in Table 1.…”

“…Study characteristics are presented in Table 1. Unlike that most of the uncontrolled trials of gemcitabine-cisplatin combination were conducted in Asia, only three uncontrolled trials (Lin et al, 2003;Park et al, 2005;Okusaka et al, 2006) of gemcitabine were performed in Asia. The other trials were conducted in either Europe or Americas.…”

Hepatic metastasis from bile duct cancer of the ampulla is effectively controlled by multidisciplinary treatment including S-1, gemcitabine and bevacizumab: A case report

“…other promising agents include gemcitabine (9,10) and bevacizumab (11). to date, however, few reports are available regarding the effects of a combination of these agents on metastatic BDc.…”

Single-Agent Gemcitabine for Biliary Tract Cancers

“…In most studies, a large number of agents, including 5-fluorouracil (5-FU), mitomycin C, cisplatin, methotrexate, etoposide, doxorubicin, nitrosoureas, paclitaxel and irinotecan, have been tested as a single-agent or combination therapy, and have been reported to have response rates varying from 20 to 30% [5]. Among several different new anticancer drugs currently being investigated in the treatment of inoperable biliary tract cancer, gemcitabine has generated particular interest [1, 5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24]. Apart from its favorable toxicity profile, this novel nucleoside analog has shown activity in many solid tumors, including pancreatic adenocarcinoma [6, 25, 26].…”