Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study

André, Thierry; Tournigand, Christophe; Rosmorduc, Olivier; Provent, S.; Maindrault-Gœbel, F.; Avenin, D.; Selle, Frédèric; Paye, François; Hannoun, L.; Houry, S; Gayet, Brice; Lotz, Jean‐Pierre; Gramont, Armand de; Louvet, Christophe

doi:10.1093/annonc/mdh351

Cited by 341 publications

(225 citation statements)

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“…Fifty-two percent of patients had a 50% decrease in CA 19-9 concentration compared with baseline, 19% of patients had a PFS >12 months, and the median survival was 12.1 months. These results compare favorably with reported ORRs between 10% and 45% 22,27-33 and a median survival between 8 months and 11 months 22,[27][28][29][30][31][32][33] observed in the majority of reported clinical trials that included 2-drug combinations. The role of chemotherapy in advanced biliary tract cancer remains to be defined, and no standard regimen has been identified.…”

Section: Discussionsupporting

confidence: 81%

“…A wide range of response rates and OS data was reported in different clinical trials using a regimen of epirubicin, cisplatin, and FU (ORR 10%-40%; median OS, 5-11 months). 25,[35][36][37] Combinations of gemcitabine plus either oxaliplatin or capecitabine 22,32 yielded an ORRs from 31% to 33% and a median PFS of 5.7 to 7 months. The PEFG regimen produced better ORR and PFS with respect to all of those combinations, suggesting the contribution of each single agent in improving antitumor activity.…”

Section: Discussionmentioning

confidence: 99%

“…[17][18][19][20] Different combination chemotherapy regimens containing gemcitabine, anthracyclines, platinum analogs, S1, fluoropyrimidines, and mitomycin C reportedly produced ORRs between 15% and 45%, a median survival of 6 to 11 months, and a 1-year survival rate that ranged from 20% to 40%. [21][22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37] The combined regimen of cisplatin, epirubicin, FU, and gemcitabine (PEFG) is an effective, upfront treatment for advanced pancreatic cancer. 38,39 Because this combination regimen contains the most active drugs commonly administered in the therapeutic approach of biliary tract cancer, we decided to assess its activity against BTA.…”

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confidence: 99%

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The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

Cereda

Passoni

Reni

et al. 2010

Cancer

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BACKGROUND: Biliary tract adenocarcinoma (BTA) is an uncommon tumor with a poor prognosis and no standard, systemic chemotherapy. The combined cisplatin, epirubicin, 5-fluorouracil, and gemcitabine (PEFG) regimen is an effective, upfront treatment for advanced pancreatic cancer. In this study, the authors assessed the activity and safety of this combination regimen in patients with advanced BTA. METHODS: PEFG (cisplatin 40 mg/m 2 and epirubicin 40 mg/m 2 on Day 1; gemcitabine 600 mg/m 2 on Days 1 and 8; and 5-fluorouracil [FU] 200 mg/m 2 daily as a continuous infusion) was administered to chemotherapy-naive patients who had a cytologic or histologic diagnosis of locally advanced or metastatic BTA, aged 75 years, and a performance status (PS) >60 either until they had evidence progressive disease or for a maximum of 6 months. Tumor size was assessed every 2 months during treatment. RESULTS: Between May 1999 and December 2005, 37 patients (62% metastatic) who had a median age of 62 years and a median PS of 90 received the PEFG regimen at the authors' institution. Primary tumor sites were the intrahepatic bile duct in 10 patients (27%), the extrahepatic bile duct in 8 patients (22%), the gallbladder in 12 patients (32%), and the ampulla of Vater in 7 patients (19%). A partial response was observed in 16 patients (43%), and stable disease was observed in 12 patients (32%). The median overall survival (OS) was 12.1 months, and the 1-year OS rate was 52%. The median progression-free survival (PFS) was 7.9 months, and the 6-month PFS rate was 67%. The main grade 3/4 toxicity was neutropenia in 18% of cycles followed by thrombocytopenia in 9% of cycles, nausea/vomiting in 5% of cycles, and febrile neutropenia, fatigue, anemia, and stomatitis in 2% of cycles. CONCLUSIONS: The current results demonstrated that PEFG was an active regimen with a manageable toxicity profile for patients with advanced BTA.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 99%

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confidence: 99%

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The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

Cereda

Passoni

Reni

et al. 2010

Cancer

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“…We explored any potential explanation for this survival advantage in IHC patients despite similar PFS. In this subgroup, the median number of cycles was 6 (range, [3][4][5][6][7][8][9][10][11][12] in the P-GEMOX group and 11 (range, 2-12) in the GEMOX group, with more patients in the standard arm completing the preplanned 12-cycle treatment (10 patients in the GEMOX group vs 6 patients in the P-GEMOX group). Moreover, we could not demonstrate any significant difference in the causes of the end of treatment, occurrence of adverse events, second-line treatments, or surgery between the arms (data not shown).…”

Section: Resultsmentioning

confidence: 95%

Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild‐type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti‐BIL study)

Leone

Marino

Cereda

et al. 2015

Cancer

121

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BACKGROUND: Biliary tract cancer (BTC) is a rare and lethal disease with few therapeutic options. Preclinical data suggest that the epidermal growth factor receptor (EGFR) pathway could be involved in its progression. METHODS: This open-label, randomized phase 2 trial recruited chemotherapy-naive patients with advanced BTC displaying a wild-type (WT) KRAS status. Patients were randomized to gemcitabine (1000 mg/m 2 ) and oxaliplatin (100 mg/m 2 ) with (arm A) or without (arm B) panitumumab (6 mg/kg) for up to 12 cycles. The primary endpoint was progression-free survival (PFS) analyzed in an intention-to-treat fashion. RESULTS: Eighty-nine patients (45 in arm A and 44 in arm B) were enrolled between June 2010 and September 2013. After a median follow-up of 10.1 months, the median PFS was 5.3 months (95% confidence interval, 3.3-7.2 months) in arm A and 4.4 months (95% confidence interval, 2.6-6.2 months) in arm B (P 5.27). No survival differences were observed: the median overall survival was 9.9 months in arm A and 10.2 months in arm B (P 5.42). In a subgroup analysis, no differences in PFS according to the site of the primary tumor were observed; patients with intrahepatic cholangiocarcinoma treated with panitumumab may have had a survival benefit in comparison with the control group (15.1 vs 11.8 months, P 5.13). As for safety, skin toxicity was the main adverse event in arm A (80% of the patients). A higher incidence of diarrhea (55.5% vs 31.8%), mucositis (22.2% vs 13.6%), and constipation (24.4% vs 15.9%) was seen in arm A. CONCLUSIONS: These results confirm the marginal role of anti-EGFR therapy even for WT KRAS-selected BTC. Cancer 2016;122:574-81.

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“…The anticancer effects of these drugs, used as a single treatment or in multiple treatments, in BDC patients were previously reported. [21][22][23][24] The adequate concentration of each of the anticancer drugs was determined using the MTT assay.…”

Section: Photodynamic Therapymentioning

confidence: 99%

Synergic effect of photodynamic therapy using talaporfin sodium with conventional anticancer chemotherapy for the treatment of bile duct carcinoma

Nonaka¹,

Nanashima²,

Nonaka³

et al. 2013

Journal of Surgical Research

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Gemcitabine combined with oxaliplatin (GEMOX) in advanced biliary tract adenocarcinoma: a GERCOR study

Abstract: The GEMOX combination is active and well tolerated in ABTA.

Cited by 341 publications

References 19 publications

The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

The cisplatin, epirubicin, 5‐fluorouracil, gemcitabine (PEFG) regimen in advanced biliary tract adenocarcinoma

Panitumumab in combination with gemcitabine and oxaliplatin does not prolong survival in wild‐type KRAS advanced biliary tract cancer: A randomized phase 2 trial (Vecti‐BIL study)

Synergic effect of photodynamic therapy using talaporfin sodium with conventional anticancer chemotherapy for the treatment of bile duct carcinoma

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