First-Line Treatment with Irinotecan and Raltitrexed in Metastatic Colorectal Cancer

Vol. 68, No. 1, 2005

Free Abstract Article (Fulltext) Article (PDF 124 KB)

Clinical Study

First-Line Treatment with Irinotecan and Raltitrexed in Metastatic Colorectal Cancer
Jorge Aparicio^a, José M. Vicent^b, Inmaculada Maestu^c, Carles Bosch^d, Antonio Galán^e, Isabel Busquier^f, Cristina Llorca^g, Salvador Garcerá^h, Juan M. Camposⁱ, Pedro López-Tendero^a, Miquel Balcells^j

Medical Oncology Departments of
^aHospital Universitario La Fe,
^bHospital General Universitario, Valencia,
^cHospital Virgen de los Lirios, Alcoy,
^dHospital Universitario Doctor Peset, Valencia,
^eHospital de Sagunto,
^fHospital Provincial, Castellón,
^gHospital General, Elda,
^hHospital de La Ribera, Alzira,
ⁱHospital Arnau de Vilanova, Valencia, and
^jMedical Department of Prasfarma, Barcelona, Spain

Address of Corresponding Author

Oncology 2005;68:58-63 (DOI: 10.1159/000084821)

Key Words

Irinotecan
Metastatic colorectal cancer
Phase II
Raltitrexed
First line

Abstract

Objectives: The combination of irinotecan and raltitrexed is safe and active in 5-fluorouracil-refractory, metastatic colorectal cancer (CRC), with the advantage of its convenient three-weekly schedule. The aim of this multicenter phase II study was to assess its efficacy and toxicity in first-line treatment. Methods: Between May 2000 and March 2001, 62 previously untreated patients received irinotecan (350 mg/m²) plus raltitrexed (3 mg/m²), with courses repeated every 21 days. Objective response was assessed every three courses, and treatment maintained until tumor progression or unacceptable toxicity. Results: A total of 331 cycles were administered, with a median of five cycles per patient (range, 1-16). Seventeen patients achieved a partial response and 2 a complete response, for an overall intention-to-treat response rate of 30% (95% confidence interval, 18-44%). The incidence of grade 3-4 toxicity per patient was diarrhea (27%), emesis (13%), anemia (12%), neutropenia (9%), and asthenia (7%). Three patients (5%) died from treatment-related adverse events (diarrhea plus neutropenia). The median potential follow-up is now 37 months. Median survival was 12.2 months, and median time to progression was 6.3 months. Conclusions: The combination of irinotecan plus raltitrexed is an easy comfortable schedule for patients with metastatic CRC, but both efficacy and toxicity results seem suboptimal for first-line treatment.

Author Contacts

Jorge Aparicio
Servicio de Oncología Médica, Hospital Universitario La Fe
Avda. Campanar 21
ES-46009 Valencia (Spain)
Tel./Fax +34 6 197 31 38, E-Mail japariciou@seom.org

Article Information

Preliminary results were presented at the 38th ASCO Meeting, Orlando, Fla., May 2002.

Received: April 1, 2004
Accepted after revision: August 8, 2004
Published online: March 31, 2005
Number of Print Pages : 6
Number of Figures : 2, Number of Tables : 2, Number of References : 24

Medline Abstract (ID 15809521)

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