References
- Papers of special note have been highlighted as:
- • of interest
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- Lee DH, Lee JS, Kim S-W, et al. Three-arm randomised controlled phase 2 study comparing pemetrexed and erlotinib to either pemetrexed or erlotinib alone as second-line treatment for never-smokers with non-squamous non-small cell lung cancer. Eur J Cancer. 2013;49(15):3111–3121.
- Michael M, Pavlakis N, Clingan P, et al. A multi-centre randomized, open-label phase II trial of continuous erlotinib plus gemcitabine or gemcitabine as first-line therapy in ECOG PS2 patients with advanced non-small cell lung cancer. Oncol Rep. 2012;28(3):763–767.
- Wu Y-L, Kim J-H, Park K, et al. Efficacy and safety of maintenance erlotinib in Asian patients with advanced non-small-cell lung cancer: a subanalysis of the phase III, randomized SATURN study. Lung Cancer. 2012;77(2):339–345.
- Zhou C, Wu Y-L, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011;12(8):735–742.
- Randomized phase II trial of sorafenib and erlotinib or sorafenib alone in patients with advanced non-small cell lung cancer progressing on erlotinib [ cited 2015 Jul 1]. ClinicalTrials.gov Identifier: NCT00609804.
- A phase 2 study of pemetrexed versus pemetrexed plus erlotinib in second-line treatment in patients with nonsquamous NSCLC [ cited 2015 Jul 1]. ClinicalTrials.gov Identifier: NCT00447057.
- Cappuzzo F, Ciuleanu T, Stelmakh L, et al. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010;11(6):521–529.
- Mok TS, Wu Y-L, Yu C-J, et al. Randomized, placebo-controlled, phase II study of sequential erlotinib and chemotherapy as first-line treatment for advanced non–small-cell lung cancer. J Clin Oncol. 2009;27(30):5080–5087.
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- Ahn M-J, Yang JC-H, Liang J, et al. Randomized phase II trial of first-line treatment with pemetrexed-cisplatin, followed sequentially by gefitinib or pemetrexed, in East Asian, never-smoker patients with advanced non-small cell lung cancer. Lung Cancer. 2012;77(2):346–352.
• In this study, elevated ALT was reported in 5 (12.8%) in gefitinib arm vs. 6 (19.3%) in chemotherapy arm.
- Zhang L, Ma S, Song X, et al. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2012;13(5):466–475.
• In this study, elevated ALT was reported in 31 (21%) in gefitinib arm vs. 12 (8%) in placebo arm.
- Han J-Y, Park K, Kim S-W, et al. First-SIGNAL: first-line single-agent Iressa versus gemcitabine and cisplatin trial in never-smokers with adenocarcinoma of the lung. J Clin Oncol. 2012;30(10):1122–1128.
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- Maemondo M, Inoue A, Kobayashi K, et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med. 2010;362(25):2380–2388.
- Lee DH, Park K, Kim JH, et al. Randomized phase III trial of gefitinib versus docetaxel in non–small cell lung cancer patients who have previously received platinum-based chemotherapy. Clin Cancer Res. 2010;16(4):1307–1314.
- Mitsudomi T, Morita S, Yatabe Y, et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol. 2010;11(2):121–128.
- Mok TS, Wu Y-L, Thongprasert S, et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947–957.
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- Maruyama R, Nishiwaki Y, Tamura T, et al. Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer. J Clin Oncol. 2008;26(26):4244–4252.
- Cufer T, Vrdoljak E, Gaafar R, et al. Phase II, open-label, randomized study (SIGN) of single-agent gefitinib (IRESSA) or docetaxel as second-line therapy in patients with advanced (stage IIIb or IV) non-small-cell lung cancer. Anticancer Drugs. 2006;17(4):401–409.
- Sequist LV, Yang JC-H, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013;31(27):3327–3334.
- Wu Y-L, Zhou C, Hu C-P, et al. Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial. Lancet Oncol. 2014;15(2):213–222.
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- Abdel-Rahman O, Fouad M. Does the use of lapatinib increase the risk of fatigue and hepatic toxicities in patients with solid tumors? A critical literature review and meta-analysis. Expert Opin Drug Saf. 2014;13(8):999–1008.
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- Abdel-Rahman O, ElHalawani H, Fouad M. Risk of elevated transaminases in cancer patients treated with immune checkpoint inhibitors: a meta-analysis. Expert Opin Drug Saf. 2015;14(10):1507–1518.
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- Sim SH, Keam B, Kim D-W, et al. The gefitinib dose reduction on survival outcomes in epidermal growth factor receptor mutant non-small cell lung cancer. J Cancer Res Clin Oncol. 2014;140(12):2135–2142.
- Lai Y, Lin P, Lai J, et al. Successful treatment of erlotinib-induced acute hepatitis and acute interstitial pneumonitis with high-dose corticosteroid: a case report and literature review. Int J Clin Pharmacol Ther. 2011;49(7):461–466.
- Kijima T, Shimizu T, Nonen S, et al. Safe and successful treatment with erlotinib after gefitinib-induced hepatotoxicity: difference in metabolism as a possible mechanism. J Clin Oncol. 2011;29(19):e588–e590.
- Takeda M, Okamoto I, Nakagawa K. Pooled safety analysis of EGFR-TKI treatment for EGFR mutation-positive non-small cell lung cancer. Lung Cancer. 2015;88(1):74–79.
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- Yonesaka K, Suzumura T, Tsukuda H, et al. Erlotinib is a well-tolerated alternate treatment for non-small cell lung cancer in cases of gefitinib-induced hepatotoxicity. Anticancer Res. 2014;34(9):5211–5215.
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- Kobayashi H, Sato K, Niioka T, et al. Relationship among gefitinib exposure, polymorphisms of its metabolizing enzymes and transporters, and side effects in Japanese patients with non–small-cell lung cancer. Clin Lung Cancer. 2015;152:125–134.
- Takimoto T, Kijima T, Otani Y, et al. Polymorphisms of CYP2D6 gene and gefitinib-induced hepatotoxicity. Clin Lung Cancer. 2013;14(5):502–507.