Michel Ducreux1, Marc Giovannini2, Charlotte Baey3, Carmen Llacer4, Jaafar Bennouna5, Antoine Adenis6, Didier Peiffert7, Françoise Mornex8, Moncef Abbas3, Valèrie Boige3, Jean-Pierre Pignon3, Thierry Conroy7, Patrice Cellier9, Beata Juzyna10, Frédéric Viret2. 1. Gustave Roussy, Villejuif, France; Université Paris Sud, Le Kremlin Bicetre, France. Electronic address: michel.ducreux@gustaveroussy.fr. 2. Institut Paoli Calmettes, Marseille, France. 3. Gustave Roussy, Villejuif, France. 4. Institut du Cancer Montpellier - Val d'Aurelle, Montpellier, France. 5. Institut de Cancérologie de l'Ouest - René Gauducheau, Nantes, France. 6. Centre Oscar Lambret, Lille, France. 7. Institut de Cancérologie de Lorraine - Alexis Vautrin, Nancy, France. 8. Hôpital Lyon Sud, Lyon, France. 9. Institut de Cancérologie de l'Ouest - Paul Papin, Angers, France. 10. Unicancer, Paris, France.
Abstract
BACKGROUND: We performed a randomized, non-comparative phase II study evaluating docetaxel in combination with either daily continuous (protracted IV) 5-fluorouracil or cisplatin administered weekly, concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma. Results of the docetaxel plus cisplatin regimen are reported. METHODS:Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20mg/m(2) and cisplatin 20mg/m(2)/week, plus concurrent radiotherapy for 6 weeks. The radiation dose to the primary tumour was 54Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate. RESULTS:51 patients from 7 centres were included in thedocetaxel-cisplatin treatment group. Six-month non-progression rate was 39% (95% confidence interval: 26-53). Median overall survival was 9.6 months (95% confidence interval: 2.4-60.7); 6 complete and 8 partial responses were obtained. Six patients survived more than 2 years after their inclusion in the trial. Grade ≥3 toxicity was reported in 63% of patients; no treatment-related death occurred. Severe toxicities were mainly anorexia (22%), vomiting (20%) and fatigue (24%). CONCLUSIONS: Despite inadequate efficacy according to the main end point, this regimen gave a satisfactory rate of objective response (27%) with tolerable toxicity.
RCT Entities:
BACKGROUND: We performed a randomized, non-comparative phase II study evaluating docetaxel in combination with either daily continuous (protracted IV) 5-fluorouracil or cisplatin administered weekly, concurrent to radiotherapy in the treatment of locally advanced pancreatic carcinoma. Results of the docetaxel plus cisplatin regimen are reported. METHODS: Forty chemotherapy-naive patients with locally advanced pancreatic carcinoma were randomly assigned to receive 5-fluorouracil and docetaxel or docetaxel 20mg/m(2) and cisplatin 20mg/m(2)/week, plus concurrent radiotherapy for 6 weeks. The radiation dose to the primary tumour was 54Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate. RESULTS: 51 patients from 7 centres were included in the docetaxel-cisplatin treatment group. Six-month non-progression rate was 39% (95% confidence interval: 26-53). Median overall survival was 9.6 months (95% confidence interval: 2.4-60.7); 6 complete and 8 partial responses were obtained. Six patients survived more than 2 years after their inclusion in the trial. Grade ≥3 toxicity was reported in 63% of patients; no treatment-related death occurred. Severe toxicities were mainly anorexia (22%), vomiting (20%) and fatigue (24%). CONCLUSIONS: Despite inadequate efficacy according to the main end point, this regimen gave a satisfactory rate of objective response (27%) with tolerable toxicity.