Developments in pharmacotherapy for treating metastatic non-small cell lung cancer

References

• Ferlay J, Soerjomataram I, Dikshit R, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136:E358–86.
   Web of Science ®Google Scholar
• Gridelli C, Rossi A, Carbone DP, et al. Non-small-cell lung cancer. Nat Rev Dis Primers. 2015;21:15009
   Web of Science ®Google Scholar
• Newman DJ, Cragg GM. Natural products as sources of new drugs from 1981 to 2014. J Nat Prod. 2016;79:629–661.
   PubMed Web of Science ®Google Scholar
• Shih C, Chen VJ, Gossetti LS, et al. LY231514, a pirrolo[2, 3-d]pyrimidine-based antifolate that inhibits multiple folate requiring enzymes. Cancer Res. 1997;57:1116–1123.
   PubMed Web of Science ®Google Scholar
• Hazarika M, White RM, Johnson JR, et al. FDA drug approval summaries: pemetrexed (Alimta). Oncologist. 2004;9:482–488.
   PubMed Web of Science ®Google Scholar
• Niyikiza C, Baker SD, Seitz DE, et al. Homocysteine and methylmalonic acid: markers to predict and avoid toxicity from pemetrexed therapy. Mol Cancer Ther. 2002;1:545–552.
   PubMed Web of Science ®Google Scholar
• Ceppi P, Volante M, Saviozzi S, et al. Squamous cell carcinoma of the lung compared with other histotypes shows higher messenger RNA and protein levels for thymidylate synthase. Cancer. 2006;107:1589–1596.
   PubMed Web of Science ®Google Scholar
• Hanna N, Shepherd FA, Fossella FV, et al. Randomized phase III trial of pemetrexed versus docetaxel in patients with non-small cell lung cancer previously treated with chemotherapy. J Clin Oncol. 2004;22:1589–1597.
   PubMed Web of Science ®Google Scholar
• Scagliotti G, Hanna N, Fossella F, et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two phase III studies. Oncologist. 2009;14:253–263.
   PubMed Web of Science ®Google Scholar
• Scagliotti G, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage NSCLC. J Clin Oncol. 2008;26:3543–3551.
   PubMed Web of Science ®Google Scholar
• Gronberg BH, Bremnes RM, Flotten O, et al. Phase III study by the Norwegian lung cancer study group: pemetrexed plus carboplatin compared with gemcitabine plus carboplatin as first-line chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2009;27:3217–3224.
   PubMed Web of Science ®Google Scholar
• Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet. 2009;374:1432–1440.
   PubMed Web of Science ®Google Scholar
• Paz-Ares L, de Marinis F, Dediu M, et al. Maintenance therapy with pemetrexed plus best supportive care versus placebo plus best supportive care after induction therapy with pemetrexed plus cisplatin for advanced non-squamous non-small-cell lung cancer (PARAMOUNT): a double-blind, phase 3, randomised controlled trial. Lancet Oncol. 2012;13:347–355.
   Web of Science ®Google Scholar
• Paz-Ares LG, de Marinis F, Dediu M, et al. PARAMOUNT: final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer. J Clin Oncol. 2013;31:2895–2902.
   PubMed Web of Science ®Google Scholar
• Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA. 2014;311:1998–2006.
   PubMed Web of Science ®Google Scholar
• Shi Y, Au JS, Thongprasert S, et al. A prospective, molecular epidemiology study of EGFR mutations in Asian patients with advanced non-small-cell lung cancer of adenocarcinoma histology (PIONEER). J Thorac Oncol. 2014;9:154–162.
   PubMed Web of Science ®Google Scholar
• Swaisland HC, Smith RP, Laight A, et al. Single-dose clinical pharmacokinetic studies of gefitinib. Clin Pharmacokinet. 2005;44:1165–1177.
   PubMed Web of Science ®Google Scholar
• McKillop D, McCormick AD, Millar A, et al. Cytochrome P450-dependent metabolism of gefitinib. Xenobiotica. 2005;35:39–50.
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361:947–957.
   PubMed Web of Science ®Google Scholar
• Fukuoka M, Wu YL, Thongprasert S, et al. Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non-small-cell lung cancer in Asia (IPASS). J Clin Oncol. 2011;29:2866–2874.
   PubMed Web of Science ®Google Scholar
• 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;362:2380–2388.
   PubMed Web of Science ®Google Scholar
• Inoue A, Kobayashi K, Maemondo M, et al. Updated overall survival results from a randomized phase III trial comparing gefitinib with carboplatin–paclitaxel for chemo-naïve non-small cell lung cancer with sensitive EGFR gene mutations (NEJ002). Ann Oncol. 2013;24:54–59.
   PubMed Web of Science ®Google Scholar
• 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;11:121–128.
   PubMed Web of Science ®Google Scholar
• Yoshioka H, Mitsudomi T, Morita S, et al. Final overall survival results of WJTOG 3405, a randomized phase 3 trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer (NSCLC) harboring mutations of the epidermal growth factor receptor (EGFR). J Clin Oncol. 2014;32(5s):8117. (abstract).
   Google Scholar
• Moyer JD, Barbacci EG, Iwata KK, et al. Induction of apoptosis and cell cycle arrest by CP-358,774, an inhibitor of epidermal growth factor receptor tyrosine kinase. Cancer Res. 1997;57:4838–4848.
   PubMed Web of Science ®Google Scholar
• Hidalgo M, Bloedow D. Pharmacokinetics and pharmacodynamics: maximizing the clinical potential of erlotinib (Tarceva). Semin Oncol. 2003;30(Suppl. 7):25–33.
   PubMed Web of Science ®Google Scholar
• Shepherd FA, Pereira JR, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005;353:123–132.
   PubMed Web of Science ®Google Scholar
• Zhou C, Wu YL, 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;12:735–742.
   PubMed Web of Science ®Google Scholar
• Zhou C, Wu YL, Chen G, et al. Final overall survival results from a randomised, phase III study of erlotinib versus chemotherapy as first-line treatment of EGFR mutation-positive advanced nonsmall-cell lung cancer (OPTIMAL, CTONG-0802). Ann Oncol. 2015;26:1877–1883.
   PubMed Web of Science ®Google Scholar
• Rosell R, Carcereny E, Gervais R, et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012;13:239–246.
   PubMed Web of Science ®Google Scholar
• Benlloch S, Botero ML, Beltran-Alamillo J, et al. Clinical validation of a PCR assay for the detection of EGFR mutations in non-small-cell lung cancer: retrospective testing of specimens from the EURTAC trial. Plos ONE. 2014;9:e89518.
   PubMed Web of Science ®Google Scholar
• Wu YL, Zhou C, Liam CK, et al. First-line erlotinib versus gemcitabine/cisplatin in patients with advanced EGFR mutation-positive non-small-cell lung cancer: analyses from the phase III, randomized, open-label, ENSURE study. Ann Oncol. 2015;26:1883–1889.
   PubMed Web of Science ®Google Scholar
• Eskens FA, Mom CH, Planting AS, et al. A phase I dose escalation study of BIBW 2992, an irreversible dual inhibitor of epidermal growth factor receptor 1 (EGFR) and 2 (HER2) tyrosine kinase in a 2-week on, 2-week off schedule in patients with advanced solid tumours. Br J Cancer. 2008;98:80–85.
   PubMed Web of Science ®Google Scholar
• Sequist LV, Yang JC, 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;31:3327–3334.
   PubMed Web of Science ®Google Scholar
• Yang JC-H, Wu YL, Schuler M, et al. Afatinib versus cisplatin-based chemotherapy for EGFR mutation-positive lung adenocarcinoma (LUX-Lung 3 and LUX-Lung 6): analysis of overall survival data from two randomised, phase 3 trials. Lancet Oncol. 2015;16:141–151.
   PubMed Web of Science ®Google Scholar
• Wu YL, Zhou C, Hu CP, 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;15:213–222.
   PubMed Web of Science ®Google Scholar
• Park K, Tan EH, O’Byrne K, et al. Afatinib versus gefitinib as first-line treatment of patients with EGFR mutation-positive non-small-cell lung cancer (LUX-Lung 7): a phase 2B, open-label, randomized controlled trial. Lancet Oncol. 2016;17:577–589.
   PubMed Web of Science ®Google Scholar
• Paz-Ares L, Tan EH, Zhang L, et al. Afatinib versus gefitinib in patients with EGFR mutation-positive NSCLC: overall survival data from the phase IIB trial LUX-Lung 7. European Society for Medical Oncology (ESMO) 2016 Congress; 2016 Oct 7–11; Copenhagen, Denmark. (abstract #LBA43).
   Google Scholar
• Soria JC, Felip E, Cobo M, et al. Afatinib versus erlotinib as second-line treatment of patients with advanced squamous cell carcinoma of the lung (LUX-Lung 8): an open-label randomised controlled phase 3 trial. Lancet Oncol. 2015;16:897–907.
   PubMed Web of Science ®Google Scholar
• Rossi A, Di Maio M. LUX-Lung: determining the best EGFR inhibitor in NSCLC?”. Lancet Oncol. 2015;16:118–119.
   PubMed Web of Science ®Google Scholar
• Lee CK, Davies L, Wu YL, et al. The impact on overall survival of first-line gefitinib and erlotinib and of clinical factors in advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor mutations based on meta-analysis of 1231 patients enrolled in 6 major randomized trials. J Clin Oncol. 2015;33(5S):8072. (abstract).
   Google Scholar
• Yang JC-H, Sequist LV, Geater SL, et al. Clinical activity of afatinib in patients with advanced non-small-cell lung cancer harbouring uncommon EGFR mutations: a combined post-hoc analysis of LUX-Lung 2, LUX-Lung 3, and LUX-Lung 6. Lancet Oncol. 2015;16:830–838.
   PubMed Web of Science ®Google Scholar
• Cross DA, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4:1046–1061.
   PubMed Web of Science ®Google Scholar
• Jänne PA, Yang JC, Kim DW, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015;372:1689–1699.
   PubMed Web of Science ®Google Scholar
• Goss G, Tsai CM, Shepherd FA, et al. Osimertinib for pretreated EGFR Thr790Met-positive advanced non-small-cell lung cancer (AURA2): a multicentre, open-label, single-arm, phase 2 study. Lancet Oncol. 2016;17:1643–1652.
   PubMed Web of Science ®Google Scholar
• Mok TS, Wu YL, Ahn MJ, et al. Osimertinib or platinum-pemetrexed in EGFR T790M-positive lung cancer. N Engl J Med. 2016. [Epub ahead of print].
   PubMedGoogle Scholar
• Soda M, Choi YL, Enomoto M, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature. 2007;448:561–566.
   PubMed Web of Science ®Google Scholar
• Barlesi F, Mazieres J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet. 2016;387:1415–1426.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368:2385–2394.
   PubMed Web of Science ®Google Scholar
• Solomon BJ, Mok T, Kim D-W, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. New Engl J Med. 2014;371:2167–2177.
   PubMed Web of Science ®Google Scholar
• De Castro G Jr, Tan DSW, Crinò L, et al. First-line ceritinib versus chemotherapy in patients with ALK-rearranged (ALK+) NSCLC: randomized, phase 3 study (ASCEND-4). J Thorac Oncol. 2017;12(S1):S4 abstractPL03.07.
   PubMedGoogle Scholar
• Nokihara H, Hida T, Kondo M, et al. Alectinib (ALC) versus crizotinib (CRZ) in ALK-inhibitor naive ALK-positive non-small cell lung cancer (ALK+ NSCLC): primary results from the J-ALEX study. J Clin Oncol. 2016;34(S5):9008. (abstract).
   Google Scholar
• Christensen JG, Zou HY, Arango ME, et al. Cytoreductive antitumor activity of PF-2341066, a novel inhibitor of anaplastic lymphoma kinase and c-Met, in experimental models of anaplastic large-cell lymphoma. Mol Cancer Ther. 2007;6:3314–3322.
   PubMed Web of Science ®Google Scholar
• Cui JJ, Tran-Dubé M, Shen H, et al. Structure based drug design of crizotinib (PF-02341066), a potent and selective dual inhibitor of mesenchymal-epithelial transition factor (c-MET) kinase and anaplastic lymphoma kinase (ALK). J Med Chem. 2011;54:6342–6363.
   PubMed Web of Science ®Google Scholar
• Yamazaki S, Vicini P, Shen Z, et al. Pharmacokinetic/pharmacodynamic modeling of crizotinib for anaplastic lymphoma kinase inhibition and antitumor efficacy in human tumor xenograft mouse models. J Pharmacol Exp Ther. 2012;340:549–557.
   PubMed Web of Science ®Google Scholar
• Doebele RC, Pilling AB, Aisner DL, et al. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res. 2012;18:1472–1482.
   PubMed Web of Science ®Google Scholar
• Cooper MR, Chim H, Chan H, et al. Ceritinib: a new tyrosine kinase inhibitor for non-small-cell lung cancer. Ann Pharmacother. 2015;49:107–112.
   PubMed Web of Science ®Google Scholar
• Friboulet L, Li N, Katayama R. The ALK inhibitor ceritinib overcomes crizotinib resistance in non-small cell lung cancer. Cancer Discov. 2014;4:662–673.
   PubMed Web of Science ®Google Scholar
• Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med. 2014;370:1189–1197.
   PubMed Web of Science ®Google Scholar
• Scagliotti G, Kim TM, Crinò L, et al. Ceritinib vs chemotherapy (CT) in patients (pts) with advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC) previously treated with CT and crizotinib (CRZ): results from the confirmatory phase 3 ASCEND-5 study. Ann Oncol. 2016;27(Suppl. 6):LBA42. (abstract).
   Google Scholar
• Choi YL, Soda M, Yamashita Y, et al. EML4-ALK mutations in lung cancer that confer resistance to ALK inhibitors. N Engl J Med. 2010;363:1734–1739.
   PubMed Web of Science ®Google Scholar
• Katayama R, Sakashita T, Yanagitani N, et al. P-glycoprotein mediates ceritinib resistance in anaplastic lymphoma kinase-rearranged non-small cell lung cancer. EBioMedicine. 2016;3:54–66.
   PubMed Web of Science ®Google Scholar
• Seto T, Kiura K, Nishio M, et al. CH5424802 (RO5424802) for patients with ALK-rearranged advanced non-small-cell lung cancer (AF-001JP study): a single-arm, open-label, phase 1-2 study. Lancet Oncol. 2013;14:590–598.
   PubMed Web of Science ®Google Scholar
• Rosell R, Moran T, Queralt C, et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med. 2009;361:958–967.
   PubMed Web of Science ®Google Scholar
• Wanesson L, Viteri S, Costa C, et al. Signaling pathways modulating dependence of lung cancer on mutant epidermal growth factor receptor and mechanisms of intrinsic and acquired resistance to tyrosine kinase inhibitors. Curr Pharm Des. 2014;20:3883–3893.
   PubMed Web of Science ®Google Scholar