Phase II trial of fortnightly irinotecan (CPT-11) in the treatment of colorectal cancer patients resistant to previous fluoropyrimidine-based chemotherapy
Clin. transl. oncol. (Print)
; 7(6): 244-249, jul. 2005. tab, graf
Article
in En
| IBECS
| ID: ibc-040765
Responsible library:
ES1.1
Localization: ES1.1 - BNCS
RESUMEN
Introduction. This phase II study investigated the anti-tumour activity and toxicity of CPT-11 (250 mg/m² i.v. infusion over 60 minutes) administered every 2 weeks as second-line chemotherapy in patients with advanced colorectal cancer (CRC). Material and methods. Patients (n=63) with histology diagnosis of advanced CRC and proven resistance to previous fluoropyrimidine therapy were enrolled. Results. A total of 510 CPT-11 cycles were administered, with a mean of 8 cycles per patient (range 1-32). The median relative dose intensity was 93%. Partial response (PR) was obtained in 11 patients (17.5%; 95%CI 8.1%-26.7%) and 29 patients (46.0%) showed stable disease (clinical benefit of 63.5%). The median duration of response was 6.8 months (95%CI 6.1-7.5 months), median survival was 8.8 months (95%CI 6.3-11.5 months) and median time to disease progression was 4.5 months (95%CI 3.9-5.0 months). Overall, this schedule of CPT-11 chemotherapy was well tolerated by the patient. Neutropenia was the most frequent grade 3/4 haematological toxicity (20.6% of patients and 4.1% of cycles). Neutropenia with concurrent fever or infection occurred in 7 patients (11.1%). Late onset diarrhoea was the most frequent grade 3/4 non-haematological toxicity (19.0% of patients and 2.3% of cycles). Other, lower-incidence, toxicities were anaemia, fever, infection, mucositis, nausea and vomiting. There were no toxic deaths. Conclusions. We found that CPT-11, administered as 250 mg/m² i.v. infusion over 60 minutes every 2 weeks, was active and well tolerated schedule in the second-line chemotherapy of advanced CRC patients. This bi-weekly scheme could be used as an alternative to the weekly or the every-three-week schedule as well as in combined therapies with other chemotherapeutic agents for the treatment of advanced, metastatic, CRC
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Collection:
National databases
/
Spain
Health context:
Neglected Diseases
Health problem:
Diarrhea
/
Neglected Diseases
Database:
IBECS
Main subject:
Colorectal Neoplasms
/
Antineoplastic Agents
Limits:
Humans
Language:
English
Journal:
Clin. transl. oncol. (Print)
Year:
2005
Document type:
Article
Institution/Affiliation country:
Fundación Jiménez Díaz/España
/
Hospital General Yagüe/España
/
Hospital General de Albacete/España
/
Hospital Provincial de Zamora/España
/
Hospital Príncipe de Asturias/España
/
Hospital Virgen Blanca/España
/
Hospital Virgen de la Luz/España
/
Hospital de Cruces/España
/
Hospital de Móstoles/España