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

André, T.
Tournigand, C.
Rosmorduc, O.
Provent, S.
Maindrault-Goebel, F.
Avenin, D.
Selle, F.
Paye, F.
Hannoun, L.
Houry, S.
Gayet, B.
Lotz, J. P.
de Gramont, A.
Louvet, C.

¹Oncology Department and Digestive Surgery Department, Tenon Hospital, Paris
²Internal Medicine and Oncology Department, Saint-Antoine Hospital, Paris
³Gastroenterology Department, Saint-Antoine Hospital, Paris
⁴Digestive Surgery Department, Saint-Antoine Hospital, Paris
⁵Digestive Surgery Department, Pitié-Salpétrière Hospital, Paris
⁶Digestive Surgery Department, Institut Mutualiste Montsouris, Paris, France

Received 31 March 2004; revised 2 May 2004; accepted 5 May 2004

^*Correspondence to: Dr T. André, Service d'Oncologie Médicale, Hôpital Tenon, 4 rue de la Chine, 75970 Paris cedex 20, France. Tel: +33-1-56-01-60-21; Fax: +33-1-56-01-73-04; E-mail: [email protected]

Annals of Oncology 15(9):p 1339-1343, September 2004.

Background

Since gemcitabine–oxaliplatin (GEMOX) has been used in pancreatic adenocarcinoma, we studied its activity and tolerability in advanced biliary tract adenocarcinoma (ABTA).

Patients and methods

Consecutive adult patients with confirmed ABTA were recruited from four centers. Those in group A had performance status (PS) 0–2, bilirubin <2.5× normal and received GEMOX as first-line chemotherapy. Those in group B had PS >2 and/or bilirubin >2.5× normal and/or prior chemotherapy. All received gemcitabine 1000 mg/m² as a 10 mg/m²/min infusion on day 1, followed by oxaliplatin 100 mg/m² as a 2-h infusion on day 2, every 2 weeks.

Results

Tumor sites were gallbladder (19), extrahepatic bile ducts (5), ampulla of vater (3) and intrahepatic bile ducts (29). Results for group A (n=33) were: objective response 36% [95% confidence interval (CI) 18.7% to 52.3%], stable disease 26%, progressive disease 39%, median progression-free survival (PFS) 5.7 months and overall survival (OS) 15.4 months. Results for group B (n=23) were: objective response 22% (95% CI 6.5% to 37.4%), stable disease 30%, progressive disease 48%, PFS 3.9 months and OS 7.6 months. National Cancer Institute Common Toxicity Criteria grade 3–4 toxicities were neutropenia 14% of patients, thrombocytopenia 9%, nausea/vomiting 5% and peripheral neuropathy 7%.

Conclusion

The GEMOX combination is active and well tolerated in ABTA.