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A randomized phase II study of gefitinib plus simvastatin versus gefitinib alone in previously treated patients with advanced non-small cell lung cancer.
| Content Provider | Semantic Scholar |
|---|---|
| Author | Han, Ji-Youn Lee, Soo-Hyun Hyung, Lee Suk Moon, Yoon Joo Kim, Heung Tae |
| Copyright Year | 2011 |
| Abstract | PURPOSE To evaluate the efficacy and safety of gefitinib plus simvastatin (GS) versus gefitinib alone (G) in previously treated patients with advanced non-small cell lung cancer (NSCLC). EXPERIMENTAL DESIGN Between May 2006 and September 2008, 106 patients (51% men, 75% adenocarcinoma, 50% never smoker) were randomly assigned to G alone (250 mg/d, n = 54) or GS (250 and 40 mg/d, respectively, n = 52). One cycle was 4 weeks of treatment. Therapy was continued until disease progression or intolerable toxicity was observed. The primary endpoint was response rate (RR). Secondary endpoints included toxicity, progression-free survival (PFS), and overall survival (OS). RESULTS The RR was 38.5% (95% CI, 25.3-51.7) for GS and 31.5% (95% CI, 19.1-43.9) for G. The median PFS was 3.3 months [M] (95% CI, 1.4-5.2M) for GS and 1.9M (95% CI, 1.0-2.8M) for G. The median OS was 13.6M (95% CI, 7.1-20.1M) for GS and 12.0M (95% CI, 7.8-16.2M) for G. In exploratory subgroup analysis, GS showed higher RR (40% vs. 0%, P = 0.043) and longer PFS (3.6M vs. 1.7M, P = 0.027) compared with G alone in patients with wild-type epidermal growth factor receptor (EGFR) nonadenocarcinomas. Adverse events in both arms were generally mild and mainly consisted of skin rashes. CONCLUSIONS Although no superiority of GS to G was demonstrated in this unselected NSCLC population, GS showed higher RR and longer PFS compared with G alone in patients with wild-type EGFR nonadenocarcinomas. Simvastatin may improve the efficacy of gefitinib in that subgroup of gefitinib-resistant NSCLC patients. |
| File Format | PDF HTM / HTML |
| DOI | 10.1158/1078-0432.CCR-10-2525 |
| PubMed reference number | 21411446 |
| Journal | Medline |
| Volume Number | 17 |
| Issue Number | 6 |
| Alternate Webpage(s) | http://clincancerres.aacrjournals.org/content/clincanres/17/6/1553.full.pdf |
| Alternate Webpage(s) | https://doi.org/10.1158/1078-0432.CCR-10-2525 |
| Journal | Clinical cancer research : an official journal of the American Association for Cancer Research |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
