Raltitrexed plus weekly oxaliplatin as first-line chemotherapy in metastatic colorectal cancer: a multicenter non-randomized phase ii study

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. Forty-four patients were enrolled into...

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Published in:Medical oncology (Northwood, London, England) London, England), 2004-01, Vol.21 (1), p.59-66
Main Authors: Santini, Daniele, Massacesi, Cristian, D'Angelillo, Rolando Maria, Marcucci, Fabiana, Campisi, Costantino, Vincenzi, Bruno, Pilone, Alberta, Bianco, Vincenzo, Bonsignori, Maurizio, Tonini, Giuseppe
Format: Article
Language:English
Subjects:
Adult
Aged
Antimetabolites, Antineoplastic - adverse effects
Antimetabolites, Antineoplastic - therapeutic use
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Colorectal cancer
Colorectal Neoplasms - drug therapy
Colorectal Neoplasms - mortality
Colorectal Neoplasms - pathology
Female
Follow-Up Studies
Humans
Male
Middle Aged
Neoplasm Metastasis
Oncology
Organoplatinum Compounds - administration & dosage
Organoplatinum Compounds - adverse effects
Quinazolines - administration & dosage
Quinazolines - adverse effects
Survival Rate
Thiophenes - administration & dosage
Thiophenes - adverse effects
Treatment Outcome
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Summary: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. 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. 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. 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.
ISSN:1357-0560
1559-131X
1357-0560
DOI:10.1385/MO:21:1:59