A phase II trial of raltitrexed (Tomudex) in advanced pancreatic and biliary carcinoma.

Abstract

PURPOSE:

To evaluate the impact of raltitrexed (Tomudex) on the quality of life in a multicenter, phase II study in advanced pancreatic and biliary carcinomas.

PATIENTS AND METHODS:

Forty-six patients with advanced, histologically proven pancreatic (n = 37, 80.4%) or biliary (n = 9, 19.6%) carcinoma received 3 mg/m2 raltitrexed intravenously once every 3 weeks. For the quality of life assessments, EORTC QLQ-C30 was used, and the evaluation of the clinical benefit was performed according to the 4 criteria of the clinical benefit response. All patients were assessed for safety, and 41 patients were evaluable for objective response.

RESULTS:

Patients (63% male/37% female) had a mean age of 61.2 years, 71.7% had a PS of 0-1, 78.3% had metastatic disease, and 63% had at least 2 tumoral sites. A total of 176 cycles were administered with a mean of 4 cycles per patient (range 1-12). Three out of 43 patients evaluable for EORTC QLQ-C30 (7.0%; CI(95%) 1.4-19.0%) had a quality of life improvement. Thirty-two patients fulfilled the 4 criteria required to evaluate the clinical benefit response; 5 were responders (15.6%; CI(95%) 5.3-32.8%); 1 patient was a good responder based on both the EORTC questionnaire and the clinical benefit response. Forty-one patients were assessable for response, 3 responded to treatment (response rate: 6.5 %; CI(95%) 1.3-17.9%). Median survival was 4.6 months (CI(95%) 2.9-8.2 months), the 1-year survival rate was 21.8%. The most common grade 3-4 toxicities were neutropenia (8%), leukopenia (8%), thrombopenia (6%), anemia (6%), liver enzyme elevations (11%), asthenia (9%), vomiting (9%), abdominal pain (7%), and phlebitis (6%). One treatment-related death occurred (neutropenic sepsis).

CONCLUSION:

Raltitrexed appeared to be generally well tolerated and showed a clinical benefit response and/or quality of life improvement in a limited number of patients.

• Authors: Eric François, M Hebbar, J Bennouna, D Mayeur, H Perrier, E Dorval, C Martin, H Bourgeois, P Barthélemy, J Y Douillard
• Journal: Oncology (Oncology) Vol. 68 Issue 4-6 Pg. 299-305 ( 2005) ISSN: 0030-2414 [Print] Switzerland
• PMID: 16020956 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: (c) 2005 S. Karger AG, Basel

Chemical References

• Antimetabolites, Antineoplastic
• Quinazolines
• Thiophenes
• Thymidylate Synthase
• raltitrexed

Topics

• Antimetabolites, Antineoplastic (therapeutic use)
• Biliary Tract Neoplasms (drug therapy, pathology)
• Female
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasm Staging
• Pancreatic Neoplasms (drug therapy, pathology)
• Quality of Life
• Quinazolines (therapeutic use)
• Survival Rate
• Thiophenes (therapeutic use)
• Thymidylate Synthase (antagonists & inhibitors)
• Treatment Outcome