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

作者：Gronberg Bjorn H^*; Bremnes Roy M; Aasebo Ulf; Brunsvig Paal; Flotten Oystein; Amundsen Tore; von Plessen Christian; Wang Mari; Sundstrom Stein

来源：Lung Cancer, 2009, 63(1): 88-93.

DOI：10.1016/j.lungcan.2008.04.003

• Relapse
• Cytotoxic agents
• Antimetabolites
• Folic acid antagonists
• Medical oncology

Purpose: To investigate the efficacy and tolerability of high-dose pemetrexed as second-line chemotherapy in small cell lung cancer (SCLC).
Patients and methods: Patients 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/m(2) 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.
Results: 36 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.
Conclusion: High-dose pemetrexed monotherapy to patients with recurrent SCLC yielded moderate toxicity, but limited treatment efficacy.

• 出版日期2009-1
• 单位河北医科大学