Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer

Penz, Melitta; Kornek, Gabriela; Raderer, Markus; Ulrich‐Pur, Herbert; Fiebiger, Wolfgang; Lenauer, Alfred; Depisch, D.; Krauss, G.; Schneeweiß, Bruno; Scheithauer, Werner

doi:10.1023/a:1008352123009

Cited by 164 publications

(106 citation statements)

References 10 publications

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“…Traditionally, 5-fluorouracil-based chemotherapy regimen has been used as an adjuvant therapy for biliary tract malignancies including GB cancer [6,9,20,21]. Recently, gemcitabine-, capecitabine, or S-1-based regimens have been tried, and several studies have demonstrated somewhat promising results from GB cancer [22][23][24][25][26]. However, few comparative analyses of treatments between detailed TNM stages of GB cancer have been reported.…”

Section: Discussionmentioning

confidence: 99%

Adjuvant chemoradiation therapy in gallbladder cancer

Cho

Kim

Park

et al. 2010

Journal of Surgical Oncology

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Background and Objectives: Gallbladder cancer is a relatively uncommon gastrointestinal malgnancy. Indications for adjuvant chemoradiation therapy after surgical resection have not yet been determined. We aimed this study to elucidate the effectiveness of adjuvant chemoradiation therapy according to TNM stage for gallbladder cancer. Methods: Between March 2001 and March 2009, 100 patients with gallbladder cancer underwent surgical resection. We divided the patients according to TNM stage, and subdivided further according to whether adjuvant chemoradiation therapy was added or not. The clinicopathologic factors, recurrence and survival were retrospectively analyzed. Results: Patients with gallbladder cancer at T2N0M0, T2N1M0, T3N0M0, and T3N1M0 stages were enrolled in this study. Among the four stages, the two lymph node-negative stages (T2N0M0 and T3N0M0) did not show any gain in survival by adding adjuvant chemoradiation therapy. Conversely, the remaining lymph node-positive stages (T2N1M0 and T3N1M0) showed gain in disease-free survival, and the lymph node-positive T2 stage (T2N1M0) showed gain in disease-specific survival. In patients with lymph node-positive T2/T3 GB cancers, adjuvant chemoradiation therapy was an independent prognostic factor for survival. Conclusions: Adjuvant chemoradiation therapy is recommended for lymph node-positive T2/T3 gallbladder cancer following surgical resection.

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Section: Discussionmentioning

confidence: 99%

Adjuvant chemoradiation therapy in gallbladder cancer

Cho

Kim

Park

et al. 2010

Journal of Surgical Oncology

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“…In two phase II trials, both including only small numbers of patients, gemcitabine plus 5-FU/LV and 2 weekly high-dose gemcitabine (2.200 mg m 72 ) yielded disease control rates of 59 and 66%, respectively (Gebbia et al, 2001;Penz et al, 2001).…”

Section: Discussionmentioning

confidence: 99%

Oxaliplatin, fluorouracil and leucovorin for advanced biliary system adenocarcinomas: a prospective phase II trial

et al. 2002

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We studied the activity of combined oxaliplatin and fluorouracil-leucovorin in 16 consecutive patients with advanced biliary tract adenocarcinomas. The disease control rate (responses and stable disease) was 56% (95% confidence interval, 29 -84%) and the median overall survival time was 9.5 months (range 0.9 -26.8+). Therefore, this regimen might be active in biliary adenocarcinomas with further evaluation necessary. While surgery currently provides the only curative treatment option in tumours of the biliary system, the majority of patients is diagnosed with advanced stages of disease. Patients with stage IV (UICC) gallbladder carcinoma with distant metastases or with unresectable biliary carcinomas only treated by best supportive care, have a poor prognosis with a median survival time of less than 3 months (Pitt et al, 1997;Hejna et al, 1998).However, in these tumour entities, palliative chemotherapy with single agents or combination therapies result in partial responses in about 10 to 20% of patients (Hejna et al, 1998). Moreover, innovative treatment modalities other than chemotherapy like photodynamic therapy have yielded preliminary beneficial results only in local tumour control but not for metastatic disease (Ortner et al, 1998). External beam radiation and brachytherapy have only demonstrated efficacy in individual patients (Hejna et al, 1998).Based on the preclinical evidence that oxaliplatin combined with 5-FU-LV possesses remarkable synergistic cytotoxicity in various human malignancies (Raymond et al, 1997), this prospective phase II trial was initiated to investigate for the first time, to the best of our knowledge, the activity and safety profile of this combination therapy for advanced biliary system adenocarcinomas. PATIENTS AND METHODSThis prospective multicentre study enrolled 16 consecutive patients with histologically or cytologically confirmed adenocarcinomas of the gallbladder or the intrahepatic or extrahepatic biliary tract between November 1997 and May 2001. All patients had locally advanced, unresectable or metastatic disease and fulfilled the standard eligibility criteria (Raderer et al, 1999). The trial protocol was approved by the ethics committee of the University of Tübingen, and written consent was obtained from all patients before study entry.The patients received the 2 weekly administered FOLFOX 3 regimen (André et al, 1998) including l-OHP 85 mg m 72 per 2 h on day 1 concurrent with LV 500 mg m 72 per 2 h, followed by continuous 5-FU infusion 1.5 to 2.0 g m 72 per 22 h on days 1 -2. Objective tumour evaluation for response was performed at 9 week intervals according to WHO standard criteria (World Health Organization, 1979). StatisticsOverall survival (OS) was calculated from the initiation of chemotherapy until death. Time to progression (TTP) was determined by the interval between the start of chemotherapy and the date of objectively measured disease progression, or the occurence of death by any cause. Statistical analysis was performed using SPSS for Windows 10.0 (SPSS, In...

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“…Several studies of single-agent gemcitabine have reported response rates of 8%-60%, and a median survival time ranging from 6.5 to 11.5 mo [20][21][22][23][24][25] . S-1 is an oral anticancer drug that contains two biochemical modulators, 5-chloro-2,4-dihydroxypridine and potassium oxonate, which improve the tumor-selective toxicity of 5-fluorouracil (5-FU) [26] .…”

Section: Introductionmentioning

confidence: 99%

Rational therapeutic strategy for T2 gallbladder carcinoma based on tumor spread

Kohya

Kono²,

Miyazaki

2010

WJG

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AIM:To evaluate the adequacy of surgical treatment of T2 gallbladder carcinoma (GBCa) according to tumor spread in the subserosal layer. METHODS:A series of 84 patients with GBCa were treated at Saga University Hospital, Japan between April 1989 and October 2008. The tumor stage was graded according to the TNM staging for GBCa from the American Joint Committee on Cancer Manual 6th edition. Tumor staging revealed 30 patients with T2 tumors. T2 GBCa was divided into three groups histologically by the extent of tumor spread in the subserosal layer, using a score of ss minimum (ss min), ss medium (ss med) or ss massive (ss mas). RESULTS:For ss min GBCa, there was no positive pathological factor and patient survival was satisfactory with simple cholecystectomy, with or without extra-hepatic bile duct resection. For ss med GBCa, some pathological factors, h-inf (hepatic infiltration), ly (lymphatic invasion) and n (lymph node metastasis), were positive. For ss mas GBCa, there was a high incidence of positive pathological factors. The patient group with extra-hepatic bile duct resection with D2 lymph node dissection (BDR with D2) and those with S4a5 hepatectomy had significantly better survival rates. CONCLUSION:We suggest that radical surgery is not necessary for ss min GBCa, and partial hepatectomy and BDR are necessary for both ss med and ss mas GBCa.

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Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer

Abstract: Two-weekly high-dose gemcitabine seems to represent a potentially effective, safe and well-tolerated regimen for the palliative treatment of patients with advanced biliary tract cancer.

Cited by 164 publications

References 10 publications

Adjuvant chemoradiation therapy in gallbladder cancer

Adjuvant chemoradiation therapy in gallbladder cancer

Oxaliplatin, fluorouracil and leucovorin for advanced biliary system adenocarcinomas: a prospective phase II trial

Rational therapeutic strategy for T2 gallbladder carcinoma based on tumor spread

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