AIM: The primary aims of this study were activity and toxicity evaluation of a new raltitrexed and oxaliplatin-based regimen, as a first-line chemotherapy, in patients with metastatic colorectal cancer (MCC). Survival evaluation was considered a secondary endpoint. PATIENTS AND METHODS: Forty-four patients were enrolled into this phase II trial. Treatment consisted of raltitrexed 3 mg/m2 iv on d 1 and oxaliplatin 70 mg/m2 iv on d 1 and d 8 every 3 wk. RESULTS: Twenty patients (45.5%) achieved a response [95% confidence interval (CI): 30.1% to 54.1%], 18 (40.9%) had stable disease, and only 6 (13.6%) developed progressive disease. After a median follow-up time of 14.7 mo (range 6.3-18.6 mo), the median time to disease progression was 6 mo (range 2.0-16.7) (95% CI: 4.4-7.6) and the overall survival was 14.8 mo (range 3-23) (95% CI: 11.2-18.4). Neutropenia was the most common hematological side effect, while transient AST/ALT increase, neurotoxicity, asthenia, and diarrhea were the most common nonhematological side effects. CONCLUSIONS: Our data confirmed that oxaliplatin administered weekly plus raltitrexed is an active combination in newly diagnosed patients with advanced colorectal carcinoma that merits further investigation versus the classic schedule in a randomized, phase III trial.
RCT Entities:
AIM: The primary aims of this study were activity and toxicity evaluation of a new raltitrexed and oxaliplatin-based regimen, as a first-line chemotherapy, in patients with metastatic colorectal cancer (MCC). Survival evaluation was considered a secondary endpoint. PATIENTS AND METHODS: Forty-four patients were enrolled into this phase II trial. Treatment consisted of raltitrexed 3 mg/m2 iv on d 1 and oxaliplatin 70 mg/m2 iv on d 1 and d 8 every 3 wk. RESULTS: Twenty patients (45.5%) achieved a response [95% confidence interval (CI): 30.1% to 54.1%], 18 (40.9%) had stable disease, and only 6 (13.6%) developed progressive disease. After a median follow-up time of 14.7 mo (range 6.3-18.6 mo), the median time to disease progression was 6 mo (range 2.0-16.7) (95% CI: 4.4-7.6) and the overall survival was 14.8 mo (range 3-23) (95% CI: 11.2-18.4). Neutropenia was the most common hematological side effect, while transient AST/ALT increase, neurotoxicity, asthenia, and diarrhea were the most common nonhematological side effects. CONCLUSIONS: Our data confirmed that oxaliplatin administered weekly plus raltitrexed is an active combination in newly diagnosed patients with advanced colorectal carcinoma that merits further investigation versus the classic schedule in a randomized, phase III trial.
Authors: W Scheithauer; G V Kornek; B Schuell; H Ulrich-Pur; M Penz; M Raderer; F Lang; B Schneeweiss; A Lenauer; D Depisch Journal: Ann Oncol Date: 2001-05 Impact factor: 32.976
Authors: K Fizazi; M Ducreux; P Ruffié; M Bonnay; C Daniel; J C Soria; C Hill; A Fandi; M Poterre; M Smith; J P Armand Journal: J Clin Oncol Date: 2000-06 Impact factor: 44.544
Authors: N Petrelli; L Herrera; Y Rustum; P Burke; P Creaven; J Stulc; L J Emrich; A Mittelman Journal: J Clin Oncol Date: 1987-10 Impact factor: 44.544
Authors: S Giacchetti; B Perpoint; R Zidani; N Le Bail; R Faggiuolo; C Focan; P Chollet; J F Llory; Y Letourneau; B Coudert; F Bertheaut-Cvitkovic; D Larregain-Fournier; A Le Rol; S Walter; R Adam; J L Misset; F Lévi Journal: J Clin Oncol Date: 2000-01 Impact factor: 44.544
Authors: W Scheithauer; G V Kornek; H Ulrich-Pur; M Penz; M Raderer; T Salek; K Haider; W Kwasny; D Depisch Journal: Cancer Date: 2001-04-01 Impact factor: 6.860
Authors: J-F Seitz; J Bennouna; B Paillot; E Gamelin; E François; T Conroy; J-L Raoul; Y Becouarn; F Bertheault-Cvitkovic; M Ychou; S Nasca; A Fandi; P Barthelemy; J-Y Douillard Journal: Ann Oncol Date: 2002-07 Impact factor: 32.976
Authors: S Cascinu; F Graziano; F Ferraù; V Catalano; C Massacesi; D Santini; R R Silva; S Barni; A Zaniboni; N Battelli; S Siena; P Giordani; D Mari; A M Baldelli; S Antognoli; R Maisano; D Priolo; M A Pessi; G Tonini; S Rota; R Labianca Journal: Ann Oncol Date: 2002-05 Impact factor: 32.976
Authors: B Neri; L Doni; C Fulignati; F Perfetto; M Turrini; F Andreoli; D Pantalone; L M Pernice; F Taruffi; V Martini; A Poma; A Valeri; G Bacci; L Sancez; R Moretti Journal: Anticancer Drugs Date: 2002-08 Impact factor: 2.248
Authors: K Fizazi; H Doubre; T Le Chevalier; A Riviere; J Viala; C Daniel; L Robert; P Barthélemy; A Fandi; P Ruffié Journal: J Clin Oncol Date: 2003-01-15 Impact factor: 44.544
Authors: J Feliu; C Castañón; A Salud; J R Mel; P Escudero; A Pelegrín; L López-Gómez; M Ruiz; E González; F Juárez; J Lizón; J Castro; M González-Barón Journal: Br J Cancer Date: 2005-11-28 Impact factor: 7.640