Targeted therapy for NSCLC - A double-edged sword?

Anticancer Research

Volumn 35, Issue 5, 2015, Pages 2503-2512

  Dempke, Wolfram C M ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

Author keywords

Clinical trials; Monoclonal antibodies; Novel therapies; NSCLC; Review; Tyrosine kinase inhibitors

Indexed keywords

AFATINIB; ANTINEOPLASTIC AGENT; BEVACIZUMAB; CERITINIB; CRIZOTINIB; ERLOTINIB; GEFITINIB; NECITUMUMAB; NINTEDANIB; RAMUCIRUMAB; SELUMETINIB; TIVANTINIB; ANAPLASTIC LYMPHOMA KINASE; EGFR PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; MITOGEN ACTIVATED PROTEIN KINASE; MONOCLONAL ANTIBODY; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRAZOLE DERIVATIVE; PYRIDINE DERIVATIVE;

ARTICLE; CANCER CHEMOTHERAPY; DRUG APPROVAL; HUMAN; MOLECULARLY TARGETED THERAPY; NON SMALL CELL LUNG CANCER; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); ANTAGONISTS AND INHIBITORS; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE FREE SURVIVAL; GENETICS; PATHOLOGY;

ANTIBODIES, MONOCLONAL, HUMANIZED; CARCINOMA, NON-SMALL-CELL LUNG; DISEASE-FREE SURVIVAL; EXTRACELLULAR SIGNAL-REGULATED MAP KINASES; HUMANS; PROTEIN KINASE INHIBITORS; PYRAZOLES; PYRIDINES; RECEPTOR PROTEIN-TYROSINE KINASES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 84929687699     PISSN: 02507005     EISSN: 17917530     Source Type: Journal    
DOI: None     Document Type: Article

References (48)

1. Ramalingam S and Belani C: Systemic chemotherapy for advanced non-small cell lung cancer: recent advances and future directions. Oncologist 13 (Suppl 1): 5-13, 2008.
2. Shepherd FA: Second-line chemotherapy for non-small cell lung cancer. Expert Rev Anticancer Ther 3: 435-442, 2003.
3. Scagliotti GV, Parikh P, von Pawel J, Biesma B, Vansteenkiste J, Manegold C, Serwatowski P, Gatzemeier U, Digumarti R, Zukin M, Lee JS, Mellemgaard A, Park K, Patil S, Rolski J, Goksel T, De Marinis F, Simms L, Sugarman KP and Gandara D: Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 26: 3543-3551, 2008.
4. Dempke WC, Suto T and Reck M: Targeted therapies for nonsmall cell lung cancer. Lung Cancer 67: 257-274, 2010.
5. Tartarone A, Lerose R, Lazzari G, Gregore V and Aieta M: Which tyrosine kinase inhibitor should be recommended as initial treatment for non-small-cell lung cancer patients with EGFR mutations? Med Oncol 31: 78-85, 2014.
6. Pilotto S, Di Maio M, Peretti U, Kinspergher S, Brunelli M, Massari F, Sperduti I, Giannarelli D, De Marinis F, Tortora G and Bria E: Predictors of outcome for patients with lung adenocarcinoma carrying the epidermal growth factor receptor mutation receiving first-line tyrosine kinase inhibitors: sensitivity and meta-regression analysis of randomized trials. Crit Rev Oncol Hematol 90: 135-145, 2014.
7. Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpawereyoung P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffiled EL, Watkins CL, Armour AA and Fukuoka M: Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361: 947-957, 2009.
8. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P and Seymour L: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 353: 123-132, 2005.
9. Zer A and Leighl NB. Second-line therapy in non-small-cell lung cancer: the DELTA between different genotypes widens. J Clin Oncol 32: 1874-81, 2014.
10. Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palermo R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre E, Bover I, Illiano A, Dansin E, De Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Munoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskvi A, Queralt C, De Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M and Paz-Ares L: Erlotinib versus standard chemotherapy for European patients with advanced EGFR mutation-positive nonsmall-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase III trial. Lancet Oncol 13: 239-246, 2012.
11. Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhnag Y, Xiu Q, Ma J, Zhang L and You C: 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 III study. Lancet Oncol 12: 735-742, 2011.
12. Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas A, Szczesna A, Juhasz E, Gonzalez EE, Molinier O, Klingelschmitt G and Giaccone G. SATURN: a double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC. J Clin Oncol 27(Suppl.): 8001, 2009.
13. Dempke WC: Gefitinib in non-small-cell lung cancer-an old lesson new re-visited. Transl Lung Cancer Res 6: 435-458, 2013.
14. Sequist LV, Yang JC, Yamamoto N, O'Byrne K, Hirsh V, Mok TS, Geater SL, Oriov S, Tsai CM, Boyer M, Su WC, Bennouna J, Kato T, Gorbunova V, Lee KH, Shah R, Massey D, Zazulina V, Shahidi M and Schuler M: Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol 31: 3327-3334, 2013.
15. Yang JC, Hirsh V, Schuler M, Yamamoto N, O'Byrne KJ, Mok TS, Zazulina V, Shahidi M, Lungerhausen J, Massey D, Palmer M and Sequist LV: Symptom control and quality of life in LUX-Lung 3: a phase III study of afatinib or cisplatin/pemetrexed in patients with advanced lung adenocarcinoma with EGFR mutations. J Clin Oncol 31: 3343-3350, 2013.
16. Yang JCH, Sequist LV, Schuler M, Mok T, Yamamoto N, O'Byrne KJ, Hirsh V, Geater SL, Zhou C, Massey D, Zazulina V and Wu YL: Overall survival (OS) in patients (pts) with advanced non-small-cell lung cancer (NSCLC) harbouring common (Del19/L858R) epidermal growth factor receptor mutations (EGFR mut): Pooled analysis of two large open-label phase III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6]) comparing afatinib with chemotherapy (CT). J Clin Oncol 32 (Suppl): abstract 8004, 2014.
17. Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Jänne PA, Costa DB, Varella-Garcia M, Kim WH, Lynch TJ, Fidias P, Stubbs H, Engelman JA, Sequist LV, Tan W, Gandhi L, Mino-Kenudson M, Wei GC, Shreeve SM, Ratain MJ, Settleman J, Christensen JG, Haber DA, Wilner K, Salgia R, Shapiro GI, Clark JW and Iafrate AJ: Anaplastic lymphoma kinase inhibition in non-small-cell lymphoma. N Engl J Med 363: 1693-1703, 2010.
18. Camidge DR, Bang YJ, Kwak EL, Iafrate AJ, Varella-Garcia M, Fox SB, Riely GJ, Solomon B, Ou SH, Kim DW, Salgia R, Fidias P, Engelman JA, Gandhi L, Jänne PA, Costa DB, Shapiro GI, Lorusso P, Ruffner, Stephenson P, Tang Y, Wilner K, Clark JW and Shaw AT: Activity and safety of crizotinib in patients with ALK-positive non-small-cell lung cancer: updated results from a phase I study. Lancet Oncol 13: 1011-1019, 2012.
19. Kim DW, Ahn MJ, Shi Y, De Pas TM, Yang PC, Riely GJ, Crino L, Evans TL, Liu XL, Han JY, Salgia R, Moro-Sibilot D, Ou SHI, Gettinger SN, Wu YL, Lanzalone S, Polli A, Iyer S and Shaw AT: Results of a global phase II study with crizotinib in advanced ALK-positive non-small-cell lung cancer (NSCLC). J Clin Oncol 30 (Suppl): abstract 7533, 2012.
20. Shaw AT, Kim DW, Nakagawa K, Seto T, Crino L, Ahn MJ, De Pas T, Besse B, Solomon BJ, Blackhall F, Wu YL, Thomas M, O'Byrne KJ, Moro-Sibilot D, Camidge DR, Mok T, Hirsh V, Riely GJ, Iyer S, Tassell V, Polli A, Wilner KD and Jänne PA: Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med 368: 2385-2394, 2013.
21. Solomon BJ, Mok T, Kim DW, Wu YL, Nakagawa K, Felip E, Cappuzzo F, Paolini J, Usari T, Iyer S, Reisman A, Wilner KD, Tursi J and Blackhall F: First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med 371: 2167-2177, 2014.
22. Aggarwal C, Somaiah N and Simon GR: Antiangiogenetic agents in the management of non-small cell lung cancer: Where do we stand now, where are we headed? Cancer Biol and Therapy 13: 247-263, 2012.
23. Wakelee HA, Dahlberg SE and Keller SM: Interim report of onstudy demographics and toxicity from Eastern Cooperative Oncology Group (ECOG) E1505, a phase III randomized trial of adjuvant chemotherapy with or without bevacizumab for completely resected early stage non-small cell lung cancer. J Thorac Oncol 6: abstract 042.03, 2011.
24. Scagliotti GV, Vynnychenko I, Park K, Ichinose Y, Kubota K, Blackhall F, Pirker R, Galiulin R, Ciluleanu TE, Sydorenko O, Dediu M, Papai-Szekely Z, Banaclocha NM, McCoy S, Yao B, Hei YJ, Galimi F and Spigel DR: International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol 30: 2829-2836, 2011.
25. Lara PN, Douillard JY, Nakagawa K, von Pawel J, McKeage MJ, Albert I, Losonczy G, Reck M, Heo DS, Fan X, Fandi A and Scagliotti G: Randomized phase III placebo-controlled trial of carboplatin and paclitaxel with or without the vascular disrupting agent vadimezan (ASA404) in advanced non-small-cell lung cancer. J Clin Oncol 29: 2965-2971, 2011.
26. Ramlau R, Gorbunova V, Ciuleanu TE, Novello S, Ozguroglu M, Goksel T, Baldotto C, Bennouna J, Shepherd FA, Le-Guennec S, Rey A, Miller V, Thatcher N and Scagliotti G: Aflibercept and docetaxel versus docetaxel alone after platinum failure in patients with advanced or metastatic non-small-cell lung cancer: a randomized, controlled phase III trial. J Clin Oncol 30: 3640-3647, 2012.
27. Herbst RS, Sun Y, Eberhardt WE, Geromonpre P, Saijo N, Wang J, Li L, Kabbinavar F, Ichinose Y, Qin S, Zhang L, Biesma B, Heymach JV, Langmuir P, Kennedy SJ, Tada H and Johnson BE: Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase III trial. Lancet Oncol 11: 619-626, 2010.
28. Scagliotto G, Novello S, von Pawel J, Reck M, Pereira JR, Thomas M, Abrao Miziara JE, Balint B, De Marinis D, Keller A, Aren O, Csollak M, Albert I, Barrios CH, Grossi F, Krzakowski M, Cupit L, Cihon F, Dimatteo S and Hanna N: Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol 28: 1835-1842, 2010.
29. Pirker R, Pereira JR, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Vynnychenko I, Park K, Yu CT, Ganul V, Roh JK, Bajeta E, O'Byrne K, De Marinis F, Eberhardt W, Goddemeier T, Emig M and Gatzemeier U: Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet 373: 1525-1531, 2009.
30. Sequist LV, von Pawel J, Garmey EG, Akerley WL, Brugger W, Ferrari D, Chen Y, Costa DB, Gerber DE, Orlov S, Ramlau R, Arthur S, Gorbachevsky I, Schwartz B and Schiller JH: Randomized phase II study of erlotinib plus tivantinib versus erlotinib plus placebo in previously treated non-small-cell lung cancer. J Clin Oncol 29: 3307-3315, 2011.
31. http://www.fiercebiotech.com/press-releases/arqule-and-daiichisankyo-announce-discontinuation-phase-3-marquee-clinical-0 (as on November 16, 2014)
32. http://www.onclive.com/web-exclusives/Onartuzumab-Becomes-Latest-Late-Stage-NSCLC-Agent-to-Falter (as on November 16, 2014)
33. Rolfo C, Raez LE, Bronte G, Santos ES, Papadimitriou K, Buffoni L, van Meerbeeck JP and Russo A: BIBF 1120/nintedanib: a new triple angiokinase inhibitor-directed therapy in patients with non-small cell lung cancer. Expert Opin Investig Drugs 22: 1081-1088, 2013.
34. Reck M, Kaiser R, Mellemgaard A, Douillard JY, Orlov S, Krzakowski MJ, von Pawel J, Gottfried M, Bondarenko I, Liao M, Barrueco J, Gaschler-Markefski B and Novello S: Nintedanib (BIBF 1120) plus docetaxel in NSCLC patients progressing after first-line chemotherapy: LUME Lung 1, a randomized, double-blind phase III trial. J Clin Oncol 31 (Suppl): abstract LBA8011, 2013.
35. Jänne PA, Shaw AT, Pereira JR, Jeannin G, Vansteenkiste J, Barrios C, Franke FA, Grinsted L, Zuzulina V, Smith I and Grino L: Selumetinib plus docetaxel for KRAS-mutant advanced nonsmall-cell lung cancer: a randomised, multicentre, placebocontrolled, phase II study. Lancet Oncol 14: 38-47, 2013.
36. Camidge DR, Berge EM, Doebele RC, Ballas MS, Jahan T, Haigentz M, Hoffman D, Spicer J, West H, Lee P, Yang L, Joshi A, Gao L, Yurasov S and Mita A: A phase II, open-label study of ramucirumab in combination with paclitaxel and carboplatin as first-line therapy in patinets with stage IIIB/IV non-small-cell lung cancer. J Thorac Oncol 9:1532-1539, 2014.
37. Perol M, Cinleanu TE, Arrieta O, Prabhash K, Syrigos KN, Göksel T, Park K, Kowalyszyn RD, Pikiel J, Czyzewicz G, Orlov S, Lewanski CR, Alexabdris E, Zimmerman A, Chouaki N, John WJ, Yurasov S and Garon EB: REVEL: A randomized, double-blind, phase III study of docetaxel (DOC) and ramucirumab (RAM; IMC-1121B) versus DOC and placebo (PL) in the second-line treatment of stage IV non-small cell lung cancer (NSCLC) following disease progression after one prior platinumbased therapy. J Clin Oncol 32 (Suppl): abstract LBA8006, 2014.
38. Dienstmann R and Felip E: Necitumumab, a fully human IgG1 mAb directed against the EGFR for the potential treatment of cancer. Expert Opin Biol Ther 11: 1223-1231, 2011.
39. Yee D. Receptor kinase inhibitors target NSCLC: two antibodies and a small-molecule MET inhibitor. BioDrugs 25: 271-273, 2011.
40. Thatcher N, Hirsch FR, Szczesna A, Ciuleanu TE, Szafanski W, Dediu M, Ramlau R, Galiulin R, Balint B, Losonczy G, Kazarnowsicz A, Park K, Schumann C, Reck M, Paz-Ares L, Depenbrock H, Nanda S, Kruljac-Letunic A and Socinski MA: A randomized, multicenter, open-label, phase III study of gemcitabine-cisplatin (GC) chemotherapy plus necitumumab (IMC-11F8/LY3012211) versus GC alone in the first-line treatment of patients (pts) with stage IV squamous non-small cell lung cancer (sq-NSCLC). J Clin Oncol 32 (Suppl): abstract 8008, 2014.
41. Marsilje TH, Pei W, Chen B, Lu W, Uno T, Jin Y, Jiang T, Kim S, Li N, Warmuth M, Sarkisova Y, Sun F, Steffy A, Pferdekamper AC, Li AG, Joseph SB, Kim Y, Liu B, Tuntland T, Cui X, Gray NS, Steensma R, Wan Y, Jiang J, Chopiuk G, Gordon WP, Richmond W, Johnson K, Chang J, Groessl T, He YQ, Phimister A, Aycinena A, Lee CC, Bursulaya B, Karanewskv DS, Seidel HM, Harris JL and Michellys PY: Synthesis, structure-activity relationships, and in vivo efficacy of the novel potent and selective anaplastic lymphoma kinase (ALK) inhibitor 5-chloro-N2-(2-isopropoxy-5-methyl-4-(piperidin-4-yl)phenyl)-N4-(2-(isopropylsulfonyl)-phenyl)pyrimidine-2,4-diamine (LDK378) currently in phase I and phase II clinical trials. J Med Chem 56: 5675-5690, 2013.
42. Shaw AT, Kim DM, Mehra R, Tan DS, Felip E, Chow LQ, Camidge DR, Vansteenkiste J, Sharma S, De Pas T, Riely GJ, Solomon BJ, Wolf J, Thomas M, Schuler M, Liu G, Santoro A, Lau YY, Goldwasser M, Boral AL and Engelman JA: Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 370: 1189-1197, 2014.
43. Perez CA, Velez M, Raez LE and Santos ES: Overcoming the resistance to crizotinib in patients with non-small cell lung cancer harbouring EML/ALK translocation. Lung Cancer 84: 110-115, 2014.
44. Sharma SV, Fischbach MA, Haber DA and Settleman J: 'Oncogenic shock': explaining oncogene addiction through differential signal attenuation. Clin Cancer Res 15: 4392s-4395s, 2006.
45. Dempke W and Heinemann V: Resistance to EGFR (ERBB-1) and VEGFR modulating agents. Eur J Cancer 45: 1117-1128, 2009.
46. Yoshida T, Yamada K, Azuma K, Kawahara A, Abe H, Hattori S, Yamashita F, Zaizen Y, Kage M and Hoshino T: Comparison of adverse events and efficacy between gefitinib and erlotinib in patients with non-small-cell lung cancer: a retrospective analysis. Med Oncol 30: 349-356, 2013.
47. Haspinger ER, Agustoni F, Celsomino F, Garassino MC, Torri V and Cinquini M: Indirect comparisons of harm/benefit profile of EGFR tyrosine kinase inhibitors as first line treatment in EGFR0-mutated NSCLC patients: a systematic review and meta-analysis. WCLC Congress, abstract P2.11-034, 2013.
48. Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, Garrett-Mayer E, Herbst RS, Lilenbaum RC, Sima C, Venook AP, Gonen M, Schilsky RL, Meropol NJ and Schnipper LE: American Society of Clinical Oncology Perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol 32: 1277-1280, 2014.