Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas

Lee, Jeeyun; Kim, Tae-You; Lee, Myung Ah; Ahn, Myung Ju; Kim, Hoon-Kyo; Lim, Ho Yeong; Lee, Nam Su; Park, Byung Joo; Kim, Jun Suk

doi:10.1007/s00280-007-0444-5

Cited by 35 publications

(31 citation statements)

References 16 publications

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“…The GEMOX administered every 2 weeks was well tolerated and conferred an ORR of 14.9%, with 50.7 % of patients achieving a PR or SD. The ORR is somewhat lower than previously reported for GEMOX (André et al, 2004) or for gemcitabine in combination with other chemotherapy agents Eckel and Schmid, 2007;Riechelmann et al, 2007;Lee et al, 2008). Our goal of achieving a 20% RR in this phase II study was not reached, when responses were assessed using RECIST.…”

Section: Discussioncontrasting

confidence: 42%

“…As previously observed with the GEMOX combination (André et al, 2004), the most frequent grade 3/4 AEs were neutropenia, thrombocytopenia, pain and vomiting, all of which occurred in o15% of patients. Neutropenia and thrombocytopenia appear to occur less frequently with the GEMOX regimen than with the combination of gemcitabine and cisplatin Lee et al, 2008;Meyerhardt et al, 2008). Patients with advanced BTCs are very susceptible to infection and disease progression.…”

Section: Discussionmentioning

confidence: 99%

“…Gemcitabine has shown promising activity against advanced BTCs, with response rates (RRs) in the range of 12 -35% when used in combination with agents such as 5-fluorouracil, cisplatin, mitomycin C, or capecitabine (Kornek et al, 2004;Alberts et al, 2005;Kim et al, 2006;Riechelmann et al, 2007;Lee et al, 2008). A recent randomised phase II study suggested that combination chemotherapy with gemcitabine and cisplatin may be more effective than gemcitabine alone (Valle et al, 2006).…”

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confidence: 99%

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Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study

et al. 2008

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Advanced biliary tract carcinomas (BTCs) are often diagnosed at an advanced/metastatic stage and have a poor prognosis. The combination of gemcitabine and oxaliplatin (GEMOX) has shown promising activity in this setting. This international phase II study evaluated the efficacy and safety of GEMOX as first-line therapy in patients with advanced BTCs. Eligible patients with previously untreated locally advanced or metastatic BTC received gemcitabine 1000 mg m À2 (day 1) and oxaliplatin 100 mg m À2 (day 2), every 2 weeks. Seventy patients were enroled; 72.9% had metastatic disease. Sixty-seven patients were treated. There were 10 confirmed partial responses (14.9%; 95% confidence interval (CI), 7.4 -25.7%) in the treated population (RECIST). Twenty-four patients (35.8 %) had stable disease. The objective response rate was 20.5% in patients with non-gallbladder cancers (9/44 patients) and 4.3% in patients with gallbladder cancers (1/23). Median overall survival for the intent-to-treat population was 8.8 months (95% CI, 6.9 -11.1%) and progression-free survival was 3.4 months (95% CI, 2.5 -4.6%). Grade 3/4 toxicities included thrombocytopenia (14.9% of patients), alanine aminotransferase elevation (13.4%), anaemia (10.4%), neutropenia (11.9%) and pain (11.9%). In this study, GEMOX demonstrated activity in non-gallbladder carcinoma, but poor activity in gallbladder carcinoma. GEMOX is well tolerated in advanced BTCs.

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Section: Discussioncontrasting

confidence: 42%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study

et al. 2008

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“…weekly, every 3 Wks; (8) G, i.v. weekly; every 2 Wks, 1 Wks rest; (9) G, days 1, 8, and 15 for every 28 days; BTC, biliary tract carcinomas; GBC, gallbladder carcinoma; CC, cholangiocarcinoma; ORR, overall response rate; TCR, tumour control rate; OS, overall survival; PFS: progression-free survival Tsavaris et al, 2004;Park et al, 2005;Thongprasert et al, 2005;Giuliani et al, 2006;Lee et al, 2006;Okusaka et al, 2006;Park et al, 2006;Charoentum et al, 2007;Lee et al, 2008;Meyerhardt et al, 2008;Okusaka et al, 2010;Sasaki et al, 2010;Valle et al, 2010;Goldstein et al, 2011) were selected for the purposes of this study (Figure 1).…”

Section: Search Resultsmentioning

confidence: 99%

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

Sun

Wang²,

Fang³

2013

Asian Pacific Journal of Cancer Prevention

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Background and Objective: There has been no universally agreed standard chemotherapy regimen for patients with advanced biliary tract carcinomas (BTC). We aimed to fully display and evaluate the clinical evidence for gemcitabine or gemcitabine-cisplatin combination for advanced BTC. Methods: Systematic searches were performed to identify relevant randomized controlled trials (RCTs) and uncontrolled trials. Available evidence was limited with low quality, which showed that both gemcitabine-cisplatin and gemcitabine alone had clinical activity with acceptable safety profiles, and gemcitabine-cisplatin appeared to be more useful for advanced BTC patients than gemcitabine alone.

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“…Based on the data of studies from advanced and metastatic pancreatic cancer, gemcitabine has also been evaluated biliary cancers at the similar setting (7,12,15,16,(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41) (Table 1). As a single agent, gemcitabine showed only moderate efficacy with RRs ranging from 0% to 30% at varied dosing schemes demonstrated.…”

Section: Cytotoxic Chemotherapymentioning

confidence: 99%

Targeted therapy in biliary tract cancers—current limitations and potentials in the future

Sahu¹,

Sun²

2017

J. Gastrointest. Oncol.

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Biliary tract cancers (BTC)/Cholangiocarcinoma (CCA) is an aggressive biliary tract epithelial malignancy from varying locations within the biliary tree with cholangiocyte depreciation., including intrahepatic cholangiocarcinoma (iCCA) (iCCA), extrahepatic cholangiocarcinoma (eCCA) and gallbladder carcinoma (GBC). The disease is largely heterogeneous in etiology, epidemiology, and molecular profile.There are limited treatment options and low survival rates for those patients with advanced or metastatic disease. Systemic treatment is confined to cytotoxic chemotherapy with the combination of gemcitabine and cisplatin. Lack of a stereotype genetic signature makes difficult in identification of potential actionable target directly, which may also explain lack of obvious clinic benefit with target oriented agents from current studies. It is crucial to understand of BTC carcinogenesis, tumor-stroma interactions, and key molecular pathways, and herald to establish targeted, individualized therapies for the heterogeneous disease, and eventually to improve the survival and overall outcome of patients.

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Phase II trial of gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas

Abstract: The combination chemotherapy with gemcitabine and cisplatin in this trial demonstrated moderate antitumor activity with favorable toxicity profile.

Cited by 35 publications

References 16 publications

Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study

Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study

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

Targeted therapy in biliary tract cancers—current limitations and potentials in the future

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