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Randomized Phase II Study of Afatinib Plus Simvastatin Versus Afatinib Alone in Previously Treated Patients with Advanced Nonadenocarcinomatous Non-small Cell Lung Cancer

Cancer Research and Treatment
2017년 49권 4호 p.1001 ~ p.1011
이영주 ( Lee Young-Joo ) - National Cancer Center Center for Lung Cancer

이기형 ( Lee Ki-Hyeong ) - Chungbuk National University Hospital Department of Internal Medicine
이건국 ( Lee Geon-Kook ) - National Cancer Center Center for Lung Cancer
이수현 ( Lee Soo-Hyun ) - National Cancer Center Center for Lung Cancer
임건영 ( Lim Kun-Young ) - National Cancer Center Center for Lung Cancer
주정남 ( Joo Jung-Nam ) - National Cancer Center Biometric Research Branch
고윤정 ( Go Yun-Jung ) - National Cancer Center Center for Lung Cancer
이진수 ( Lee Jin-Soo ) - National Cancer Center Center for Lung Cancer
한지연 ( Han Ji-Youn ) - National Cancer Center Center for Lung Cancer

Abstract

Purpose: This phase II study examined whether the addition of simvastatin to afatinib provides a clinical benefit compared with afatinib monotherapy in previously treated patients with nonadenocarcinomatous non-small cell lung cancer (NA-NSCLC).

Materials and Methods: Patientswith advancedNA-NSCLCwho progressed after one ortwo chemotherapy regimens were randomly assigned to a simvastatin (40 mg/day) plus afatinib (40 mg/day) (AS) arm or to an afatinib (A) arm. The primary endpoint was response rate (RR).

Results: Sixty-eight patients were enrolled (36 in the AS arm and 32 in the A arm). The RR was 5.7% (95% confidence interval [CI], 0.7 to 19.2) for AS and 9.4% (95% CI, 2.0 to 25.0) for A (p=0.440). In arms AS and A, the median progression-free survival (PFS) was 1.0 versus 3.6 months (p=0.240) and the overall survival was 10.0 months versus 7.0 months (p=0.930), respectively. Skin rash, stomatitis, and diarrhea were the most common adverse events in both arms. More grade 3 or 4 diarrhea was observed in arm A (18.8% vs. 5.6% in arm AS). In all patients, the median PFS for treatment including afatinib was not correlated with the status of epidermal growth factor receptor (EGFR) mutation (p=0.122), EGFR fluorescence in situ hybridization (p=0.944), or EGFR immunohistochemistry (p=0.976). However, skin rash severity was significantly related to the risk of progression for afatinib (hazard ratio for skin rash grade ≥ 2 vs. grade < 2, 0.44; 95% CI, 0.25 to 0.78; p=0.005).

Conclusion: There were no significant differences in the efficacy between AS and A arms in patients with NA-NSCLC.

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