Raltitrexed (tomudex) administration in patients failing multiple prior chemotherapy regimens in advanced colorectal cancer: a pilot study.

PURPOSE

To evaluate efficacy of Raltitrexed, a specific thymidilate synthase inhibitor, in patients with advanced colorectal cancer (ACC) failing multiple prior chemotherapy regimens (e.g. 5-FU+LV, CPT-11, etc).

METHODS

20 patients with ACC; 13 males/7 females, median age 64 (range: 53-69), median Karnovsky PS: 80 (70-90), and sites of metastases; liver: 16, lung: 6, lymph nodes: 9, peritoneal: 8 and a life expectancy of at least 3 months, were entered in the present pilot study of Raltitrexed administration. All patients had progressed after prior chemotherapy with 5-FU+LV and subsequently CPT-11, and some had received further infusional 5-FU, Raltitrexed was administered at a dose of 3 mg/m2 i.v. every 21 days.

RESULTS

3 patients obtained stable disease (SID), 15%, with tumor marker decline (CEA, CA-19.9). Time-to-progression was 4.8 months (2.2-7) and survival 7.4 months (6.0-7.8). Toxicity was in general not severe and consisted mainly of myelosuppression; neutropenia (WHO) grade 2: 45% and grade 3: 22%, and anemia grade 1-2: 40%.

CONCLUSION

Response to treatment with Raltitrexed is limited in patients with ACC failing multiple prior chemotherapy regimens, however, a limited percentage of patients with SD derived clinical benefit.