A phase II study of gemcitabine and oxaliplatin (gemox) in advanced biliary adenocarcinoma (ABA). Preliminary results

Thewis, André; Louvet, Christophe; Artru, Pascal; Selle, F.; Tournigand, Christophe; Garcia, M.L.; Avenin, D.; Maindrault, F.; Provent, S.; Gramont, Armand de

doi:10.1016/s0959-8049(01)80552-9

Cited by 7 publications

(5 citation statements)

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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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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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“… 13 , 14 , 19 In addition, the feasibility and safety of gemcitabine combined with platinum adjuvant chemotherapy in the treatment of BTCs have been confirmed by a number of studies. 24–28 These studies suggest that gemcitabine-based adjuvant chemotherapy can benefit patients. Based on experience at first-line treatment, previous retrospective study data and small sample clinical trials, European Society for Medical Oncology (ESMO) clinical practice guidelines suggest that gemcitabine-based adjuvant chemotherapy regimen were optional.…”

Section: Discussionmentioning

confidence: 99%

Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study

Gao¹,

Tian²,

Li³

et al. 2021

CMAR

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Purpose Biliary tract cancers (BTCs) have a poor overall prognosis, as patients who underwent curative surgery frequently experience disease recurrence. At present, there is a paucity of well-documented adjuvant chemotherapy regimen. This study aimed to assess whether gemcitabine plus platinum or S-1 adjuvant chemotherapy have different impact on relapse-free survival (RFS). Patients and Methods We selected patients undergoing radical biliary tract cancer surgery, pathologically confirmed adenocarcinoma and received gemcitabine plus platinum (cisplatin or oxaliplatin) or S-1 adjuvant chemotherapy from September 2013 to May 2020. The primary study endpoint was RFS. The secondary endpoint was safety. Results Overall 136 patients were enrolled. The median follow-up was 32.3 months and the median RFS was 17.0 months (95% CI 8.9–25.1). The median RFS was 14.1 months (95% CI 6.7–21.5) in gemcitabine plus platinum group and 33.0 months (95% CI 9.3–56.7) in gemcitabine plus S-1 (GS) group, a non-significant difference both in univariate (P=0.092) and in multivariate analysis (P=0.058). Lymph node status (N- vs N+: HR=0.477, 95% CI 0.285–0.799; P=0.005) and chemotherapy cycles (<6 vs 6–8: HR=1.828, 95% CI 1.117–2.993; P=0.016) were independent impact factors for RFS. GS group had lower incidence of adverse reactions. Conclusion Compared with gemcitabine plus platinum, GS regimen has a tendency to obtain longer RFS (although there is no statistically significant difference) and less toxic. GS regimen has the potential to be investigated as a standard regimen for adjuvant chemotherapy.

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“…Objective response rate of more than 30% for patients with advanced CBT was reported by using the combinations of gemcitabine with cisplatin or oxaliplatin (Andre et al, 2001;Carraro et al, 2001;Doval et al, 2001). It is difficult, however, to compare directly the response rate in different trials because of the relatively small sample size and the heterogeneous patient populations of their series.…”

Section: Discussionmentioning

confidence: 99%

Weekly gemcitabine plus 24-h infusion of high-dose 5-fluorouracil/leucovorin for locally advanced or metastatic carcinoma of the biliary tract

et al. 2004

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Both gemcitabine and weekly 24-h infusion of high-dose 5-fluorouracil/leucovorin (HDFL) have shown promising antitumour activity for patients with locally advanced or metastatic carcinoma of the biliary tract (CBT). From April 1999 through December 2002, 30 patients with inoperable CBT were treated with gemcitabine 800 mg m À2 , intravenous infusion for 30 min, followed by 5-FU, 2000 mg m À2 and leucovorin, 300 mg m À2 , intravenous infusion for 24 h, on day 1, 8 and 15, every 4 weeks. A total of 166 cycles were given (median of four cycles per patient, range 1 -24 cycles). Response was evaluable in 28 patients and toxicity in 29 patients. Partial response was obtained in six patients, stable disease in 13, while progressive disease occurred in nine. The objective response rate was 21.4% (95% CI: 5.2 -37.6%). The most common grade 3 or 4 toxicity was infection (nine patients). Other types of grade 3 or 4 toxicity included leucopenia (four patients), thrombocytopenia (three patients), anaemia (three patients), nausea/vomiting (two patients) and elevation of liver transaminases (three patients). As of 30 September 2003, the median progression-free survival was 3.7 months (95% CI: 2.8 -4.6 months) and the median overall survival was 4.7 months (95% CI: 0.8 -8.6 months). Our data suggest that weekly gemcitabine plus HDFL is modestly active with acceptable treatment-related toxicity for patients with advanced CBT.

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A phase II study of gemcitabine and oxaliplatin (gemox) in advanced biliary adenocarcinoma (ABA). Preliminary results

Cited by 7 publications

References 0 publications

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

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

Efficacy Analysis of Adjuvant Chemotherapy with Gemcitabine Plus Platinum or S-1 in Biliary Tract Carcinoma: A Multi-Center Retrospective Study

Weekly gemcitabine plus 24-h infusion of high-dose 5-fluorouracil/leucovorin for locally advanced or metastatic carcinoma of the biliary tract

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