Late toxicities and clinical outcome at 5 years of the ACCORD 12/0405-PRODIGE 02 trial comparing two neoadjuvant chemoradiotherapy regimens for intermediate-risk rectal cancer

Autor: D. Azria, J. Doyen, M. Jarlier, I. Martel-Lafay, C. Hennequin, P. Etienne, V. Vendrely, E. François, G. de La Roche, O. Bouché, X. Mirabel, B. Denis, L. Mineur, J. Berdah, M. Mahé, Y. Bécouarn, O. Dupuis, G. Lledo, J. Seitz, L. Bedenne, S. Gourgou-Bourgade, B. Juzyna, T. Conroy, J. Gérard
Přispěvatelé: UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle (ICM), CRLCC Val d'Aurelle - Paul Lamarque, Centre de Lutte contre le Cancer Antoine Lacassagne [Nice] (UNICANCER/CAL), UNICANCER-Université Côte d'Azur (UCA), Centre Léon Bérard [Lyon], Service de cancérologie et radiothérapie [Saint-Louis], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7), CHU Bordeaux [Bordeaux], Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] (UNICANCER/Lille), Université Lille Nord de France (COMUE)-UNICANCER, Hôpital privé Jean Mermoz, Service d'hépato-gastroentérologie et cancérologie digestive (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), UNICANCER [Paris], Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Département d’Oncologie Médicale [Vandoeuvre Les Nancy], Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] (UNICANCER/ICL), UNICANCER-UNICANCER, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris Diderot - Paris 7 (UPD7)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Lille-UNICANCER
Rok vydání: 2017
Předmět:
0301 basic medicine
Oncology
Adult
Male
medicine.medical_specialty
Organoplatinum Compounds
Colorectal cancer
medicine.medical_treatment
Rectum
intermediate risk
[SDV.CAN]Life Sciences [q-bio]/Cancer
Adenocarcinoma
Gastroenterology
Disease-Free Survival
chemoradiotherapy
Capecitabine
03 medical and health sciences
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
rectal cancer
Neoadjuvant therapy
Aged
Aged
80 and over

business.industry
Rectal Neoplasms
neoadjuvant
Hazard ratio
Hematology
Chemoradiotherapy
Adjuvant

Middle Aged
medicine.disease
Neoadjuvant Therapy
3. Good health
Oxaliplatin
Survival Rate
Regimen
030104 developmental biology
medicine.anatomical_structure
030220 oncology & carcinogenesis
Female
business
Chemoradiotherapy
medicine.drug
Zdroj: Annals of Oncology
Annals of Oncology, Elsevier, 2017, 28 (10), pp.2436-2442. ⟨10.1093/annonc/mdx351⟩
Annals of Oncology, 2017, 28 (10), pp.2436-2442. ⟨10.1093/annonc/mdx351⟩
ISSN: 1569-8041
0923-7534
DOI: 10.1093/annonc/mdx351⟩
Popis: IF 11.855; International audience; BackgroundOutcome of intermediate risk rectal cancer may be improved by the addition of oxaliplatin during 5-fluoruracil concomitant neoadjuvant chemoradiotherapy. The purpose of this study is to analyze the main clinical results of the ACCORD12 trial (NCT00227747) in rectal cancer after 5 years of follow-up.Patients and methodsInclusion criteria were as follows: rectal adenocarcinoma accessible to digital examination staged T3-T4 Nx M0 (or T2 Nx distal anterior rectum). Two neoadjuvant chemoradiotherapy regimens were randomized: CAP45 (RT 45 Gy + capecitabine) and CAPOX50 (RT 50 Gy + capecitabine and oxaliplatin). Main end point was sterilization of the operative specimen. Acute and late toxicities were prospectively analyzed with dedicated questionnaires.ResultsBetween November 2005 and July 2008, 598 patients were included in the trial. After a median follow-up of 60.2 months, there was no difference between treatment arms in multivariate analysis either for disease-free survival or overall survival (OS) [P = 0.9, hazard ratio (HR)=1.02; 95% confidence interval (CI), 0.76–1.36 and P = 0.3, HR = 0.87; 95% CI, 0.66–1.15, respectively]. There was also no difference of local control in univariate analysis (P = 0.7, HR = 0.92; 95% CI, 0.51–1.66). Late toxicities were acceptable with 1.6% G3 anal incontinence, and
Databáze: OpenAIRE