Phase II study on pemetrexed in advanced and/or recurrent cervical cancer patients: a MITO study

Abstract

5515 Background: The objective of the study was to evaluate the activity of the new-generation multitarget antifolate drug, pemetrexed, in a population of advanced and/or recurrent cervical cancer patients. Methods: Patients with advanced and/or recurrent cervical cancer which failed a previous treatment with platinum-based chemotherapy and/or radiotherapy, not amenable for surgery and/or radiotherapy, with evidence of measurable disease in a not previously irradiated field, were treated with pemetrexed 500 mg/mq administered as a 10-min infusion on day 1 of a 21-day cycle. Patients received a supplementation with folic acid and vitamin B12. The evaluation of response rate was the primary endpoint of the study. This is a two stage phase II trial according to Simon design. Assuming that pemetrexed may obtain a 25% response rate, the study have enrolled initially 18 patients; in case of > 3 objective responses, the accrual will continue until the total number of 43 patients is reached (α=0.05; β=0.80). Results: 18 patients (median age: 62 yrs, range 30–77; ECOG performance status 0/1/2 of 3/10/5) were enrolled: 3 partial responses (16.7%) and 10 (55.6%) stabilization of disease were registered. The median response duration was 7 months (range 7–27) and the median stabilization of disease was 17.5 months (range 10–37). Overall, 72 cycles were administered with a median value of 3 (range 1–9) cycles/patient. Major toxicities were as follows: G4 thrombocytopenia occurred in 1(1.4%) cycles; G4 and G3 neutropenia in 4(5.5%) and 8 (11.1%) cycles, respectively; G3 anemia in 12 (16.7%) cycles; G4 and G3 fatigue in 1(1.4%) and 3(4.1%) cycles, respectively; G4 and G3 diarrhea in 1(1.4%) and 2(2.8%) cycles, respectively; G3 liver toxicity in 3(4.1%) cycles. Skin rash was observed in 4 patients (22.2%), all recovered with a short period of antihistaminic plus corticosteroid treatment. Two patients abandoned the study because of persistent G2 increase of creatinine serum levels. Conclusions: Pemetrexed treatment showed encouraging activity in the treatment of advanced or recurrent cervical cancer. The second step is warranted. No significant financial relationships to disclose.