A Randomized Phase II Study of Pemetrexed in Combination With Cisplatin or Carboplatin as First-Line Therapy for Patients With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

作者：Schuette Wolfgang H W^*; Groeschel Andreas; Sebastian Martin; Andreas Stefan; Mueller Thomas; Schneller Folker; Guetz Sylvia; Eschbach Corinna; Bohnet Sabine; Leschinger Monika I; Reck Martin

来源：Clinical Lung Cancer, 2013, 14(3): 215-223.

DOI：10.1016/j.cllc.2012.10.001

• First-line treatment
• Nonsquamous histology
• Pemetrexed
• Platinum combinations
• Stage IIIB/IV non-small-cell lung cancer

A phase II randomized study of pemetrexed combined with cisplatin or carboplatin as first-line treatment for stage IIIB/IV non-small-cell lung cancer. Sixty-five patients were randomized to each arm. The results of the 6-month progression-free survival rate, median overall survival, and safety analyses demonstrated efficacy and tolerability of pemetrexed in combination with cisplatin or carboplatin as first-line therapy for patients with advanced non-small-cell lung cancer.
Background: Pemetrexed plus cisplatin was approved for first-line treatment of non-small-cell lung cancer (NSCLC) in patients with nonsquamous histology after initiation of this study. This phase II study evaluated pemetrexed plus cisplatin and pemetrexed plus carboplatin as first-line treatments for stage IIIB/IV NSCLC. Patients and Methods: The patients were randomized (1: 1) to 2 parallel arms: pemetrexed (500 mg/m(2)) plus cisplatin (75 mg/m(2)) or pemetrexed (500 mg/m(2)) plus carboplatin (area under the curve 6) day 1 every 3 weeks (maximum, 6 cycles). Progression-free survival (PFS) was the primary objective; secondary objectives included overall survival (OS), 1-year survival, and safety. Results: Sixty-five patients were randomized to each treatment arm. The patients treated with pemetrexed plus cisplatin had a median age of 64 years and were predominantly men (42 [64.6%]) with nonsquamous histology (53 [81.5%]), stage IV (61 [92.4%]) disease, and a performance status of 0 (40 [61.5%]). Median PFS was 6.0 months, 6-month PFS rate was 50.5%, median OS was 11.7 months, and 1-year survival rate was 47.5%. Drug-related grade 3/4 toxicities included neutropenia (11 [16.9%]), anemia (5 [7.7%]), thrombocytopenia (2 [3.1%]), and nausea (3 [4.6%]). Patients treated with pemetrexed plus carboplatin had a median age of 63 years, were predominantly men (46 [70.8%]) with nonsquamous histology (52 [80.0%]), stage IV (58 [86.6%]) disease, and a performance status of 0 (45 [69.2%]). The median PFS was 4.7 months, the 6-month PFS rate was 34.9%, median OS was 8.9 months, and 1-year survival rate was 39.2%. Drug-related grade 3/4 toxicities included neutropenia (17 [26.2%]), thrombocytopenia (11 [16.9%]), anemia (7 [10.8%]), and nausea (5 [7.7%]). Conclusions: Both the pemetrexed plus cisplatin and pemetrexed plus carboplatin arms met their primary endpoints and demonstrated efficacy and tolerability as first-line therapy in patients with advanced NSCLC. http://ClinicalTrials.gov: NCT00402051. Clinical Lung Cancer, Vol. 14, No.

• 出版日期2013-5