TY - JOUR
T1 - Docetaxel- and 5-FU-concurrent radiotherapy in patients presenting unresectable locally advanced pancreatic cancer
T2 - A FNCLCC-ACCORD/0201 randomized phase II trial's pre-planned analysis and case report of a 5.5-year disease-free survival
AU - Oberic, Lucie
AU - Viret, Frédéric
AU - Baey, Charlotte
AU - Ychou, Marc
AU - Bennouna, Jaafar
AU - Adenis, Antoine
AU - Peiffert, Didier
AU - Mornex, Françoise
AU - Pignon, Jean Pierre
AU - Celier, Patrice
AU - Berille, Jocelyne
AU - Ducreux, Michel
N1 - Funding Information:
The authors would like to thank the long surviving patient who gave written consent for the description of his clinical case. They also thank Valère Lounnas who provided medical writing services on behalf of FNCLCC and Meredith Charpantier for editing grammar and syntax. We would like to thank the brave patients who participated in this study, and their families for their confidence. The trial was supported by Aventis and the French National League against Cancer It was organized and followed by the Bureau d’Etudes Cliniques of the French Federation of Anti Cancer Centres 1Institut Gustave Roussy, Villejuif, France. 2Institut Paoli Calmettes, Marseille, France. 3Centre Val d’Aurelle, Montpellier, France. 4Centre René Gauducheau, Nantes, France. 5Centre Oscar Lambret, Lille, France. 6Centre Alexis Vautrin, Nancy, France. 7Hôpital Lyon Sud, Lyon, France. 8Centre Paul Papin, Angers, France. 9FNCLCC, Paris, France. 10Université Paris Sud 11, Le Kremlin Bicetre, France.
PY - 2011/9/26
Y1 - 2011/9/26
N2 - Background: To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC) we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued.Methods: Forty (40) chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1) to either continuous fluorouracil (5-FU) 200 mg/m2/day (protracted IV) and docetaxel (DCT) 20 mg/m2/week or DCT 20 mg/m2 and cisplatin (CDDP) 20 mg/m2, plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR). Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients.Results: Eighteen (18) progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23). Six and 12-month survivals were 85% (95%CI: 64-95) and 40% (95%CI: 22-61); median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR) for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%), abdominal pain (10%) and fatigue (10%).Conclusions: Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen.Trial Registration: ClinicalTrials.gov: NCT00112697.
AB - Background: To explore possible improvement in the treatment of locally advanced pancreatic carcinoma (LAPC) we performed a randomized, non-comparative phase II study evaluating docetaxel - plus either daily continuous 5 FU or weekly cisplatin concurrent to radiotherapy. We report here the results of the docetaxel plus 5 FU regimen stopped according to the interim analysis. The docetaxel plus cisplatin arm was continued.Methods: Forty (40) chemotherapy-naive patients with unresectable LAPC were randomly assigned (1:1) to either continuous fluorouracil (5-FU) 200 mg/m2/day (protracted IV) and docetaxel (DCT) 20 mg/m2/week or DCT 20 mg/m2 and cisplatin (CDDP) 20 mg/m2, plus concurrent radiotherapy for a period of 6 weeks. The radiation dose to the primary tumor was 54 Gy in 30 fractions. The trial's primary endpoint was the 6-month crude non-progression rate (NPR). Secondary endpoints were tolerance, objective response rate, and overall survival. Accrual was to be stopped if at 6 months more than 13 disease progressions were observed in 20 patients.Results: Eighteen (18) progressions occurred at 6 months in the 5-FU-DCT arm. Six-month NPR was 10% (95%CI: 0-23). Six and 12-month survivals were 85% (95%CI: 64-95) and 40% (95%CI: 22-61); median overall survival was 10.1 months. Median progression-free survival was 4.3 months. We report the case of one patient who was amenable to surgery and has been in complete response (CR) for 5.5 years. Toxicities grade ≥ 3 were reported in 75% of patients; no treatment-related death occurred. Severe toxicities were mainly vomiting (35%), abdominal pain (10%) and fatigue (10%).Conclusions: Combination of 5-FU, docetaxel and radiotherapy has inadequate efficacy in the treatment of LAPC despite good tolerance for the 5-FU-DCT regimen.Trial Registration: ClinicalTrials.gov: NCT00112697.
UR - http://www.scopus.com/inward/record.url?scp=80053379301&partnerID=8YFLogxK
U2 - 10.1186/1748-717X-6-124
DO - 10.1186/1748-717X-6-124
M3 - Article
C2 - 21943032
AN - SCOPUS:80053379301
SN - 1748-717X
VL - 6
JO - Radiation Oncology
JF - Radiation Oncology
IS - 1
M1 - 124
ER -