Grønberg BH et al. - In a study to investigate the efficacy and tolerability of high-dose pemetrexed as second-line chemotherapy in small cell lung cancer (SCLC), it was shown that use of high-dose pemetrexed monotherapy in pts with recurrent SCLC yielded moderate toxicity, but limited treatment efficacy Methods
Pts with verified SCLC who had received 1 prior chemotherapy regimen, aged 18–75 years, WHO Performance Status 0–2, no clinical signs of brain metastases and measurable disease were eligible
Pts received pemetrexed 900 mg/m2 IV every 3 weeks
4 courses were planned for all pts
Pts with relapse later than 3 months since last course of first-line chemotherapy were defined as “sensitive”, those with relapse within 3 months as “refractory”
Toxicity was graded using the CTCAE v3.0
Results
36 pts were accrued, 34 received study treatment
Median age was 61, 18 males and 16 females
Mean number of courses administered was 2.5
1 pt had partial response, 3 had stable disease and 29 progressed; 1 pt was not evaluable for response
Median TTP was 7.7 weeks (“sensitive”: 8.4 weeks, “refractory”: 5.1 weeks)
Median OS was 17.6 weeks (“sensitive”: 22.6 weeks, “refractory”: 15.3 weeks)
Of grade 3–4 haematological toxicity, anemia was observed in 2 pts, leukopenia in 6, granulocytopenia in 9, and thrombocytopenia in 3
Febrile neutropenia occurred in 6 pts; there were no treatment-related deaths