Phase II trial of oxaliplatin and tegafur/uracil and oral folinic acid for advanced or metastatic colorectal cancer in elderly patients.

Abstract

OBJECTIVES:

Colorectal cancer is usually diagnosed in elderly patients. Since there is clear evidence that such patients are under-treated and under-represented or even excluded from clinical studies and there are no reliable and prospective data on the feasibility and efficacy of an oxaliplatin (L-OHP)-based chemotherapy in this setting, we have tested the L-OHP plus oral uracil/tegafur (UFT) and oral folinic acid (FA) combination as first-line therapy in patients with advanced or metastatic colorectal cancer (MCRC) aged 70 or older.

PATIENTS AND METHODS:

Forty-seven patients with advanced or MCRC, aged over 70, were treated with L-OHP 65 mg/m(2) as an intravenous 3-hour infusion on day 1 and 8 plus UFT 300 mg/m(2) and FA 90 mg in 3 divided doses given orally on days 1-14 for each 3-week cycle. Patients were followed by a geriatric and a quality of life (QoL) assessment with specific scales and EORTC-QLQ-C30 questionnaire.

RESULTS:

All patients were assessable for toxicity and 45 for response to treatment. Complete response was achieved in 2 patients (4%) and partial response in 22 (47%) [overall response rate, 51%; 95% confidence interval (CI): 40.7-61.2%]; 18 patients (38%) had stable disease, and 5 (11%) had disease progression. The median duration of response was 8 months (range, 3-19+ months). After a minimum follow-up of 17 months, the median time to disease progression and the median overall survival were 8.0 (95% CI: 6.7-9.3%) and 14.1 (95% CI: 11.0-17.1%) months, respectively. Regimen safety was manageable. Most adverse events were mild to moderate, and this did not result in QoL impairment. The most common grade 3-4 treatment-related adverse events were diarrhea (17%), neutro- and thrombocytopenia (2%), laryngeal spasm (2%), and peripheral neuropathy (12.7%). No treatment-related deaths occurred.

CONCLUSIONS:

These results confirmed that this tested chemotherapy combination is active with acceptable tolerability and QoL maintenance in elderly patients with advanced or MCRC.

• Authors: Gerardo Rosati, Stefano Cordio, Aniello Tucci, Giuseppina Blanco, Roberto Bordonaro, Giorgio Reggiardo, Luigi Manzione
• Journal: Oncology (Oncology) Vol. 69 Issue 2 Pg. 122-9 ( 2005) ISSN: 0030-2414 [Print] Switzerland
• PMID: 16118508 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Organoplatinum Compounds
• Oxaliplatin
• Tegafur
• Uracil
• Leucovorin

Topics

• Administration, Oral
• Age Factors
• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Colorectal Neoplasms (drug therapy, pathology)
• Female
• Humans
• Infusions, Intravenous
• Leucovorin (administration & dosage)
• Male
• Neoplasm Metastasis
• Organoplatinum Compounds (administration & dosage)
• Oxaliplatin
• Tegafur (administration & dosage)
• Treatment Outcome
• Uracil (administration & dosage)