A prospective phase II study: High-dose pemetrexed as second-line chemotherapy in small-cell lung cancer

SummaryPurposeTo investigate the efficacy and tolerability of high-dose pemetrexed as second-line chemotherapy in small cell lung cancer (SCLC).Patients and methodsPatients with verified SCLC who had received one prior chemotherapy regimen, aged 18–75 years, WHO Performance Status 0–2, no clinical signs of brain metastases and measurable disease were eligible. Patients received pemetrexed 900 mg/m2 IV every 3 weeks. Four courses were planned for all patients. Patients 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.Results36 patients were accrued, 34 received study treatment. Median age was 61 (range 43–74), 18 (53%) males and 16 (47%) females. Mean number of courses administered was 2.5. One patient (3%) had partial response, three (9%) had stable disease and 29 (85%) progressed. One patient (3%) was not evaluable for response. Median TTP (n = 33) was 7.7 weeks (“sensitive”: 8.4 weeks, “refractory”: 5.1 weeks). Median OS (n = 34) was 17.6 weeks (“sensitive”: 22.6 weeks, “refractory”: 15.3 weeks). Of grade 3–4 haematological toxicity, anemia was observed in 2 (6%) patients, leukopenia in 6 (18%), granulocytopenia in 9 (27%) and thrombocytopenia in 3 (9%). Febrile neutropenia occurred in 6 (18%) patients. There were no treatment related deaths.ConclusionHigh-dose pemetrexed monotherapy to patients with recurrent SCLC yielded moderate toxicity, but limited treatment efficacy.