Phase II Trial of the Use of Gemcitabine and 5-Fluorouracil in the Treatment of Advanced Pancreatic and Biliary Tract Cancer

Murad, André M.; Guimarães, Ricardo Queiroz; Aragão, B.; Rodrigues, Victor Hugo Vieira; Scalabrini-Neto, Antonio O.; Padua, Charles; Moore, Flavio C.

doi:10.1097/00000421-200304000-00010

Cited by 28 publications

(19 citation statements)

References 8 publications

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“…The median survival time of advanced GBC patients who receive best supportive care is approximately 6 mo [14] . Some new chemotherapeutic agents have been used in treatment of patients with advanced biliary tract cancer recently, such as gemcitabine, 5-fluorouracil [15][16][17] , capecitabine [18] , cisplatin [19,20] , oxaliplatin or carboplatin. It was reported that gemcitabine is active against pancreatic and advanced biliary tract adenocarcinoma, and able to induce a response rate of 8.0%-60.0% [21,22] .…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

Qin¹,

Zhao²,

Yun³

et al. 2008

WJG

110

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A I M :To e v a l u a t e t h e e f f i c a c y a n d s a f e t y o f gemcitabine-oxaliplatin (GEMOX) combined with huachansu (cinobufagin) injection treatment in patients with locally advanced or metastatic gallbladder carcinoma (GBC), and to assess the quality of life (QOL) of such patients. METHODS: Twenty-five patients with locally advanced or metastatic GBC were treated with intravenous gemcitabine (1000 mg/m 2 ) over 30 min on days 1 and 8, 2 h infusion of oxaliplatin (120 mg/m 2 ) on day 1, and 2-3 h infusion of huachansu (20 mL/m 2 ) on days -3-11, every 3-4 wk. Treatment was continued until occurrence of unacceptable toxicity or disease progression. QOL of patients was assessed by the EORTC QLQ-C30 at baseline, at the end of the first, third and sixth chemotherapy cycles, and 1 mo after the treatment. RESULTS: Among the 25 patients with a median age of 64 years (range 42-78 years), 23 were evaluable in the study. A total of 137 cycles of therapy were performed and the median cycle was 5 (range 1-8) per patient. Out of the 23 patients whose response could be evaluated, 8 partial responses (PR) were observed (34.8%), while 7 patients (30.4%) demonstrated a stable disease (SD). The disease control rate was 65.2%. Progression of cancer was observed in 8 (34.8%) patients. The median progression-free and overall survival time was 5.8 mo (95% CI: 4.5-7.1 mo) and 10.5 mo, respectively. The therapy was well tolerated, with moderate myelosuppression as the main toxicity. Anemia grade 2 was seen in 16.0%, neutropenia grade 3 in 8.0% and thrombocytopenia grade 3 in 24.0% of patients, respectively. Nonhematologic toxicity ranged from mild to moderate. No death occurred due to toxicity. The QOL of patients was improved after chemotherapy, and the scores of QOL were increased by 10 to 20 points. CONCLUSION: GEMOX combined with huachansu (cinobufagin) injection is well tolerated, effective, thus improving the QOL of patients with advanced GBC.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

Qin¹,

Zhao²,

Yun³

et al. 2008

WJG

110

View full text Add to dashboard Cite

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“…Combination chemotherapy of gemcitabine with other agents in phase II trials involving approximately 130 patients has shown responses ranging from 9 to 53%, with a tolerable toxicity profile (Andre et al, 2001;Carraro et al, 2001;Gebbia et al, 2001;Kuhn et al, 2001;Kornek et al, 2002;Scheithauer, 2002;Murad et al, 2003). Overall survival in these studies ranged from 6.3 to 16 months.…”

Section: Discussionmentioning

confidence: 99%

A Phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer

et al. 2004

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The primary objective of this study was to determine the response rates of the gemcitabine and cisplatin combination in unresectable gall bladder cancer patients. The secondary objectives were to evaluate the toxicity, time to progressive disease, and overall survival. Chemonaïve patients with histologically proven, unresectable bidimensionally measurable gall bladder cancer were enrolled into this study. All patients were required to have a Zubrod's performance status p2, no prior radiotherapy, and adequate major organ function. Patients received gemcitabine (1000 mg m À2 intravenously over 30 -60 min) on days 1 and 8, and cisplatin (70 mg m À2intravenously over 2 h) on day 1, every 21 days. Response assessment was done by a CT scan after every other cycle of chemotherapy. In all, 30 patients were eligible for efficacy and toxicity analysis. There were four (13.3%) complete responders, seven (23.3%) partial responders, and seven (23.3%) with stable disease, with four (13.2%) patients showing disease progression. The median time to progression was 18 weeks (95% confidence interval (CI) 14 -24 weeks), and the median duration of response was 13.5 weeks (range 5.5 -104 weeks). The median overall survival was 20 weeks (95% CI 14 -31 weeks), with 1-year survival rate of 18.6%. WHO grade 3 or 4 anaemia was seen in seven (23.3%) and four (13.3%) patients, respectively. Five (16.6%) patients each experienced grade 3 or 4 neutropenia, and grade 3 or 4 thrombocytopenia was seen in three (10%) and two (6.6%) patients, respectively. The present study shows that gemcitabine/cisplatin combination is well tolerated and active in advanced unresectable gall bladder cancer.

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“…7 However, in a trial of gemcitabine combined with a 3-hour infusion of 5-FU for biliary tract and pancreatic carcinoma, a higher response rate was observed. 28 In that trial, 9 patients with biliary tract carcinoma received the combination of gemcitabine and prolonged infusion of 5-FU weekly for 3 weeks. Three of the nine patients had a PR.…”

Section: Discussionmentioning

confidence: 99%

Gemcitabine, 5‐fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma

Alberts

Alkhatib

Mahoney

et al. 2004

Cancer

114

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BACKGROUNDGemcitabine has broad activity in a variety of solid tumors including biliary tract carcinomas. The authors evaluated 6‐month survival, response, and toxicity associated with a combination of gemcitabine, 5‐fluorouracil (5‐FU), and leucovorin (LV) in patients with unresectable or metastatic biliary tract or gallbladder adenocarcinoma (ACA).METHODSA 4‐week course included 1000 mg/m2 gemcitabine by intravenous infusion over 30 minutes on Days 1, 8, and 15, 25 mg/m2 LV by intravenous push, and 600 mg/m2 5‐FU by intravenous push after LV.RESULTSForty‐two patients were enrolled in 6 months, 35 of whom had metastatic disease. Patients with biliary tract ACA included 24 with hepatic disease (19 patients had intrahepatic disease and 5 patients had extrahepatic disease) and 4 with disease in the ampulla of Vater. All patients were evaluable and received a median of 4 courses of treatment (range, 1–21 courses). Commonly occurring severe toxicity (NCI CTC Grade 3 or worse) included: dyspnea (four patients), nausea (four patients), fatigue (seven patients), thrombocytopenia (six patients), emesis (four patients), and diarrhea (four patients). Five partial responses (9.5%) occurred, 3 of which were sustained for ≥ 8 weeks. No treatment‐related deaths occurred. Thirty‐two patients had disease progression and 38 died after a median follow‐up of 20 months (range, 1.4–24 months). The median time to disease progression was 4.6 months (95% confidence interval [95% CI], 2.4–6.6%). The median survival period was 9.7 months (95% CI, 7–12%).CONCLUSIONSThis combination regimen was manageable in patients with advanced biliary tract and gallbladder ACA. Of 42 patients, 24 (57%) survived ≥ 6 months, satisfying the primary end point of the trial. The length of survival suggested that gemcitabine, 5‐FU, and LV had benefit equivalent to gemcitabine alone. Cancer 2005. © 2004 American Cancer Society.

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Phase II Trial of the Use of Gemcitabine and 5-Fluorouracil in the Treatment of Advanced Pancreatic and Biliary Tract Cancer

Cited by 28 publications

References 8 publications

Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

Efficacy and safety of gemcitabine-oxaliplatin combined with huachansu in patients with advanced gallbladder carcinoma

A Phase II study of gemcitabine and cisplatin in chemotherapy-naive, unresectable gall bladder cancer

Gemcitabine, 5‐fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma

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