Preoperative chemoradiation with raltitrexed (tumodex) for T2/n+ T3/n+ rectal cancer:a phase I study
V. Valentini*, G.B Doglietto^, A.G. Morganti*, A. Turriziani*, D. Smaniotto*, M. De Santis*, C. Ratto^, L. Sofo^, N. Cellini*
*Radiation Therapy Department, Università Cattolica del Sacro Cuore, Rome, Italy
^Clinical Surgery Department, Università Cattolica del Sacro Cuore, Rome, Italy
Eur J Cancer 2001; 37:2050-5.
The use of raltitrexed (‘Tomudex’) as concomitant chemotherapy during preoperative radiotherapy in chemonaive patients with stage II/III rectal cancer has been examined in this study and its recommended dose in conjunction with radiotherapy investigated. Forty-five Gray (Gy) of radiotherapy (1.8 Gy daily, 5 days per week) was delivered to the posterior pelvis, followed by a 5.4 Gy boost. Single doses of raltitrexed (2.0, 2.5 and 3.0 mg/m(2)) were administered on days 1, 19 and 38. Only 1 of the 15 patients entered experienced a dose limiting toxicity (DLT) (grade 3 leucopenia) at the 3.0 mg/m(2) dose level. The overall response rate was 80% (five complete responses, seven partial responses). These preliminary data suggest that raltitrexed is a well tolerated and effective treatment when combined with preoperative radiotherapy in patients with stage II/III rectal cancer. The recommended dose of raltitrexed for future phase II studies will be 3.0 mg/m(2).