Gefitinib in non small cell lung cancer

Journal of Biomedicine and Biotechnology

Volumn 2011, Issue , 2011, Pages

  Morabito, Alessandro ^a   Costanzo, Raffaele ^a   Piccirillo, Maria Carmela ^a   Sandomenico, Claudia ^a   Carillio, Guido ^b   Montanino, Agnese ^a   Daniele, Gennaro ^a   Giordano, Pasqualina ^a   Bryce, Jane ^a   De Feo, Gianfranco ^c   Di Maio, Massimo ^a   Rocco, Gaetano ^a   Normanno, Nicola ^d,e   Perrone, Francesco ^a  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b PUGLIESE CIACCIO HOSPITAL   (Italy)

^c Istituto Nazionale dei Tumori   (Italy)

^d NATIONAL CANCER INSTITUTE   (Italy)

^e Centro di Ricerche Oncologiche di Mercogliano CROM   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CISPLATIN; DOCETAXEL; ERLOTINIB; GEFITINIB; GEMCITABINE; NAVELBINE; PACLITAXEL; PLACEBO; ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR; PROTEIN KINASE INHIBITOR; QUINAZOLINE DERIVATIVE;

ADJUVANT THERAPY; ADULT RESPIRATORY DISTRESS SYNDROME; ADVANCED CANCER; ALOPECIA; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; ASTHENIA; BONE MARROW SUPPRESSION; CANCER ADJUVANT THERAPY; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; COLORECTAL CANCER; CONVULSION; DECREASED APPETITE; DIARRHEA; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFECT; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; EPISTAXIS; FATIGUE; GASTROINTESTINAL DISEASE; GENE MUTATION; HEAD AND NECK CANCER; HEMATOLOGIC DISEASE; HISTOPATHOLOGY; HUMAN; INTERSTITIAL LUNG DISEASE; LIVER DYSFUNCTION; LIVER TOXICITY; LUNG NON SMALL CELL CANCER; META ANALYSIS (TOPIC); METASTASIS; MONOTHERAPY; MUCOSAL BLEEDING; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; NAIL LESION; NAUSEA; NEUTROPENIA; OVARY CANCER; PATIENT SELECTION; PHARMACOKINETICS; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PNEUMONIA; PREMEDICATION; PROGRESSION FREE SURVIVAL; PROSTATE CANCER; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; REVIEW; SENSORY NEUROPATHY; SIDE EFFECT; SKIN TOXICITY; SOMNOLENCE; STOMATITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TREATMENT RESPONSE; TUMOR GROWTH; VOMITING; DRUG ANTAGONISM; GENETICS; LUNG TUMOR; MUTATION;

ANTINEOPLASTIC AGENTS; CARCINOMA, NON-SMALL-CELL LUNG; HUMANS; LUNG NEOPLASMS; MUTATION; PROTEIN KINASE INHIBITORS; QUINAZOLINES; RECEPTOR, EPIDERMAL GROWTH FACTOR;

EID: 80052674928     PISSN: 11107243     EISSN: 11107251     Source Type: Journal    
DOI: 10.1155/2011/815269     Document Type: Review

References (70)

1. Baselga J., Averbuch S. D., ZD1839 (Iressa) as an anticancer agent Drugs 2000 60 supplement 1 33 40
2. Normanno N., Bianco C., Strizzi L., Mancino M., Maiello M. R., De Luca A., Caponigro F., Salomon D. S., The ErbB receptors and their ligands in cancer: an overview Current Drug Targets 2005 6 3 243 257 (Pubitemid 40667793)
3. Olayioye M. A., Neve R. M., Lane H. A., Hynes N. E., The ErbB signaling network: receptor heterodimerization in development and cancer The EMBO Journal 2000 19 13 3159 3167 (Pubitemid 30428195)
4. Wells A., EGF receptor International Journal of Biochemistry and Cell Biology 1999 31 6 637 643 (Pubitemid 29248872)
5. De Luca A., Carotenuto A., Rachiglio A., Gallo M., Maiello M. R., Aldinucci D., Pinto A., Normanno N., The role of the EGFR signaling in tumor microenvironment Journal of Cellular Physiology 2008 214 3 559 567 (Pubitemid 351224199)
6. Wakeling A. E., Guy S. P., Woodburn J. R., Ashton S. E., Curry B. J., Barker A. J., Gibson K. H., ZD1839 (Iressa): an orally active inhibitor of epidermal growth factor signaling with potential for cancer therapy Cancer Research 2002 62 20 5749 5754 (Pubitemid 35204731)
7. Ciardiello F., Caputo R., Bianco R., Damiano V., Pomatico G., De Placido S., Bianco A. R., Tortora G., Antitumor effect and potentiation of cytotoxic drugs activity in human cancer cells by ZD-1839 (Iressa), an epidermal growth factor receptor-selective tyrosine kinase inhibitor Clinical Cancer Research 2000 6 5 2053 2063 (Pubitemid 30305105)
8. Sirotnak F. M., Zakowski M. F., Miller V. A., Scher H. I., Kris M. G., Efficacy of cytotoxic agents against human tumor xenografts is markedly enhanced by coadministration of ZD1839 (Iressa), an inhibitor of EGFR tyrosine kinase Clinical Cancer Research 2000 6 12 4885 4892 (Pubitemid 32110433)
9. Swaisland H., Laight A., Stafford L., Jones H., Morris C., Dane A., Yates R., Pharmacokinetics and tolerability of the orally active selective epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in healthy volunteers Clinical Pharmacokinetics 2001 40 4 297 306 (Pubitemid 32458155)
10. Ranson M., Hammond L. A., Ferry D., Kris M., Tullo A., Murray P. I., Miller V., Averbuch S., Ochs J., Morris C., Feyereislova A., Swaisland H., Rowinsky E. K., ZD1839, a selective oral epidermal growth factor receptor-tyrosine kinase inhibitor, is well tolerated and active in patients with solid, malignant tumors: results of a phase I trial Journal of Clinical Oncology 2002 20 9 2240 2250 (Pubitemid 34441651)
11. Baselga J., Rischin D., Ranson M., Calvert H., Raymond E., Kieback D. G., Kaye S. B., Gianni L., Harris A., Bjork T., Averbuch S. D., Feyereislova A., Swaisland H., Rojo F., Albanell J., Phase I safety, pharmacokinetic, and pharmacodynamic trial of ZD1839, a selective oral epidermal growth factor receptor tyrosine kinase inhibitor, in patients with five selected solid tumor types Journal of Clinical Oncology 2002 20 21 4292 4302 (Pubitemid 35266289)
12. Herbst R. S., Maddox A. M., Rothenberg M. L., Small E. J., Rubin E. H., Baselga J., Rojo F., Hong W. K., Swaisland H., Averbuch S. D., Ochs J., LoRusso P. M., Selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 is generally well-tolerated and has activity in non-small-cell lung cancer and other solid tumors: results of a phase I trial Journal of Clinical Oncology 2002 20 18 3815 3825
13. Nakagawa K., Tamura T., Negoro S., Kudoh S., Yamamoto N., Takeda K., Swaisland H., Nakatani I., Hirose M., Dong R. P., Fukuoka M., Phase I pharmacokinetic trial of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor gefitinib (Iressa, ZD1839) in Japanese patients with solid malignant tumors Annals of Oncology 2003 14 6 922 930 (Pubitemid 36827209)
14. Giaccone G., Gonzlez-Larriba J. L., van Oosterom A. T., Alfonso R., Smit E. F., Martens M., Peters G. J., van der Vijgh W. J. F., Smith R., Averbuch S., Fandi A., Combination therapy with gefitinib, an epidermal growth factor receptor tyrosine kinase inhibitor, gemcitabine and cisplatin in patients with advanced solid tumors Annals of Oncology 2004 15 5 831 838 (Pubitemid 38714747)
15. Fukuoka M., Yano S., Giaccone G., Tamura T., Nakagawa K., Douillard J.-Y., Nishiwaki Y., Vansteenkiste J., Kudoh S., Rischin D., Eek R., Horai T., Noda K., Takata I., Smit E., Averbuch S., Macleod A., Feyereislova A., Dong R.-P., Baselga J., Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) Journal of Clinical Oncology 2003 21 12 2237 2246 (Pubitemid 46621858)
16. Kris M. G., Natale R. B., Herbst R. S., Lynch T. J., Prager D., Belani C. P., Schiller J. H., Kelly K., Spiridonidis H., Sandler A., Albain K. S., Cella D., Wolf M. K., Averbuch S. D., Ochs J. J., Kay A. C., Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial Journal of the American Medical Association 2003 290 16 2149 2158 (Pubitemid 37432975)
17. D'Addario G., Rauch D., Stupp R., Pless M., Stahel R., Mach N., Jost L., Widmer L., Tapia C., Bihl M., Mayer M., Ribi K., Lerch S., Bubendorf L., Betticher D. C., Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03 Annals of Oncology 2008 19 4 739 745 (Pubitemid 351461046)
18. Wang M. Z., Li L. Y., Wang S. L., Efficacy and safety of gefitinib as monotherapy for Chinese patients with advanced non-small cell lung cancer Chinese Medical Journal 2006 119 1 63 68
19. Lin W. C., Chiu C. H., Liou J. L., Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer Lung Cancer 2006 54 2 193 199
20. Niho S., Kubota K., Goto K., Yoh K., Ohmatsu H., Kakinuma R., Saijo N., Nishiwaki Y., First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study Journal of Clinical Oncology 2006 24 1 64 69 (Pubitemid 46630495)
21. Reck M., Buchholz E., Romer K. S., Gefitinib monotherapy in chemotherapy-naive patients with inoperable stage III/IV non-small-cell lung cancer Clinical Lung Cancer 2006 7 6 406 411 (Pubitemid 44043551)
22. Suzuki R., Hasegawa Y., Baba K., Saka H., Saito H., Taniguchi H., Yamamoto M., Matsumoto S., Kato K., Oishi T., Imaizumi K., Shimokata K., A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer British Journal of Cancer 2006 94 11 1599 1603 (Pubitemid 43924920)
23. Spigel D. R., Hainsworth J. D., Burkett E. R., Burris H. A., Yardley D. A., Thomas M., Jones S. F., Dickson N. R., Scullin D. C., Bradof J. E., Rubinsak J. R., Brierre J. E., Greco A. F., Single-agent gefitinib in patients with untreated advanced non-small-cell lung cancer and poor performance status: a minnie pearl cancer research network phase II trial Clinical Lung Cancer 2005 7 2 127 132 (Pubitemid 43192129)
24. Giaccone G., Herbst R. S., Manegold C., Scagliotti G., Rosell R., Miller V., Natale R. B., Schiller J. H., Von Pawel J., Pluzanska A., Gatzemeier U., Grous J., Ochs J. S., Averbuch S. D., Wolf M. K., Rennie P., Fandi A., Johnson D. H., Gefitinib in combination with gemcitabine and cisplatin in advanced non-small-cell lung cancer: a phase III trialINTACT 1 Journal of Clinical Oncology 2004 22 5 777 784 (Pubitemid 41103588)
25. Herbst R. S., Giaccone G., Schiller J. H., Natale R. B., Miller V., Manegold C., Scagliotti G., Rosell R., Oliff I., Reeves J. A., Wolf M. K., Krebs A. D., Averbuch S. D., Ochs J. S., Grous J., Fandi A., Johnson D. H., Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trialINTACT 2 Journal of Clinical Oncology 2004 22 5 785 794 (Pubitemid 41103589)
26. Gatzemeier U., Pluzanska A., Szczesna A., Kaukel E., Roubec J., De Rosa F., Milanowski J., Karnicka-Mlodkowski H., Pesek M., Serwatowski P., Ramlau R., Janaskova T., Vansteenkiste J., Strausz J., Manikhas G. M., Von Pawel J., Phase III study of erlotinib in combination with cisplatin and gemcitabine in advanced non-small-cell lung cancer: the Tarceva lung cancer investigation trial Journal of Clinical Oncology 2007 25 12 1545 1552 (Pubitemid 46733081)
27. Herbst R. S., Prager D., Hermann R., Fehrenbacher L., Johnson B. E., Sandler A., Kris M. G., Tran H. T., Klein P., Li X., Ramies D., Johnson D. H., Miller V. A., TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer Journal of Clinical Oncology 2005 23 25 5892 5899
28. Morabito A., Piccirillo M. C., Monaco K., Methodological issues of clinical research with EGFR inhibitors Current Cancer Therapy Reviews 2007 3 4 292 302 (Pubitemid 350237832)
29. Takeda K., Hida T., Sato T., Ando M., Seto T., Satouchi M., Ichinose Y., Katakami N., Yamamoto N., Kudoh S., Sasaki J., Matsui K., Takayama K., Kash T. II, Iwamoto Y., Sawa T., Okamoto I., Kurata T., Nakagawa K., Fukuoka M., Randomized phase III trial of platinum-doublet chemotherapy followed by gefitinib compared with continued platinum-doublet chemotherapy in Japanese patients with advanced non-small-cell lung cancer: results of a west Japan thoracic oncology group trial (WJTOG0203) Journal of Clinical Oncology 2010 28 5 753 760
30. Thatcher N., Chang A., Parikh P., Pereira J. R., Ciuleanu T., Von Pawel J., Thongprasert S., Tan E. H., Pemberton K., Archer V., Carroll K., Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer) The Lancet 2005 366 9496 1527 1537 (Pubitemid 41540110)
31. Hirsch F. R., Varella-Garcia M., Bunn P. A. Jr., Franklin W. A., Dziadziuszko R., Thatcher N., Chang A., Parikh P., Pereira J. R., Ciuleanu T., Von Pawel J., Watkins C., Flannery A., Ellison G., Donald E., Knight L., Parums D., Botwood N., Holloway B., Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer Journal of Clinical Oncology 2006 24 31 5034 5042 (Pubitemid 46631407)
32. Cufer T., Vrdoljak E., Gaafar R., 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 Anti-Cancer Drugs 2006 17 4 401 409 (Pubitemid 44309982)
33. Kim E. S., Hirsh V., Mok T., Socinski M. A., Gervais R., Wu YI. L., Li L. Y., Watkins C. L., Sellers M. V., Lowe E. S., Sun Y., Liao M. L., sterlind K., Reck M., Armour A. A., Shepherd F. A., Lippman S. M., Douillard J. Y., Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial The Lancet 2008 372 9652 1809 1818
34. Douillard J. Y., Shepherd F. A., Hirsh V., Mok T., Socinski M. A., Gervais R., Liao M. L., Bischoff H., Reck M., Sellers M. V., Watkins C. L., Speake G., Armour A. A., Kim E. S., Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial Journal of Clinical Oncology 2010 28 5 744 752
35. Maruyama R., Nishiwaki Y., Tamura T., Yamamoto N., Tsuboi M., Nakagawa K., Shinkai T., Negoro S., Imamura F., Eguchi K., Takeda K., Inoue A., Tom K. II, Harada M., Masuda N., Jiang H., Itoh Y., Ichinose Y., Saijo N., Fukuoka M., Phase III study, V-15-32, of gefitinib versus docetaxel in previously treated Japanese patients with non-small-cell lung cancer Journal of Clinical Oncology 2008 26 26 4244 4252
36. Lee D. H., Park K., Kim J. H., Lee J. S., Shin S. W., Kang J. H., Ahn M. J., Ahn J. S., Suh C., Kim S. W., Randomized phase III trial of gefitinib versus docetaxel in non-small cell lung cancer patients who have previously received platinum-based chemotherapy Clinical Cancer Research 2010 16 4 1307 1314
37. Shepherd F. A., Douillard J., Fukuoka M., Comparison of gefitinib and docetaxel in patients with pretreated advanced non-small cell lung cancer (NSCLC): meta-analysis from four clinical trials Journal of Clinical Oncology 2009 27 15, supplement. (abstract no. 8011)
38. Goss G. D., Lorimer I., Tsao M. S., A phase III randomized, double-blind, placebo-controlled trial of the epidermal growth factor receptor inhibitor gefitinb in completely resected stage IB-IIIA non-small cell lung cancer (NSCLC): NCIC CTG BR.19 Journal of Clinical Oncology 2010 28 18, supplement. (abstract no. LBA7005)
39. Kelly K., Chansky K., Gaspar L. E., Albain K. S., Jett J., Ung Y. C., Lau D. H. M., Crowley J. J., Gandara D. R., Phase III trial of maintenance gefitinib or placebo after concurrent chemoradiotherapy and docetaxel consolidation in inoperable stage III non-small-cell lung cancer: SWOG S0023 Journal of Clinical Oncology 2008 26 15 2450 2456
40. Crin L., Cappuzzo F., Zatloukal P., Reck M., Pesek M., Thompson J. C., Ford H. E. R., Hirsch F. R., Varella-Garcia M., Ghiorghiu S., Duffield E. L., Armour A. A., Speake G., Cullen M., Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study Journal of Clinical Oncology 2008 26 26 4253 4260
41. Goss G., Ferry D., Wierzbicki R., Laurie S. A., Thompson J., Biesma B., Hirsch F. R., Varella-Garcia M., Duffield E., Ataman O. U., Zarenda M., Armour A. A., Randomized phase II study of gefitinib compared with placebo in chemotherapy-naive patients with advanced non-small-cell lung cancer and poor performance status Journal of Clinical Oncology 2009 27 13 2253 2260
42. Lynch T. J., Bell D. W., Sordella R., Gurubhagavatula S., Okimoto R. A., Brannigan B. W., Harris P. L., Haserlat S. M., Supko J. G., Haluska F. G., Louis D. N., Christiani D. C., Settleman J., Haber D. A., Activating mutations in the epidermal growth factor receptor underlying responsiveness of nonsmall-cell lung cancer to gefitinib The New England Journal of Medicine 2004 350 21 2129 2139 (Pubitemid 38637993)
43. Paez J. G., Jnne P. A., Lee J. C., Tracy S., Greulich H., Gabriel S., Herman P., Kaye F. J., Lindeman N., Boggon T. J., Naoki K., Sasaki H., Fuj Y. II, Eck M. J., Sellers W. R., Johnson B. E., Meyerson M., EGFR mutations in lung, cancer: correlation with clinical response to gefitinib therapy Science 2004 304 5676 1497 1500 (Pubitemid 38720929)
44. Asahina H., Yamazaki K., Kinoshita I., Sukoh N., Harada M., Yokouchi H., Ishida T., Ogura S., Kojima T., Okamoto Y., Fujita Y., Dosaka-Akita H., Isobe H., Nishimura M., A phase II trial of gefitinib as first-line therapy for advanced non-small cell lung cancer with epidermal growth factor receptor mutations British Journal of Cancer 2006 95 8 998 1004 (Pubitemid 44606825)
45. Inoue A., Suzuki T., Fukuhara T., Maemondo M., Kimura Y., Morikawa N., Watanabe H., Saijo Y., Nukiwa T., Prospective phase II study of gefitinib for chemotherapy-naive patients with advanced non-small-cell lung cancer with epidermal growth factor receptor gene mutations Journal of Clinical Oncology 2006 24 21 3340 3346 (Pubitemid 46638887)
46. Yang C. H., Yu C. J., Shih J. Y., Chang Y. C., Hu FU. C., Tsai M. C., Chen K. Y., Lin Z. Z., Huang C. J., Shun C. T., Huang C. L., Bean J., Cheng A. L., Pao W., Yang P. C., Specific EGFR mutations predict treatment outcome of stage IIIB/IV patients with chemotherapy-naive non-small-cell lung cancer receiving first-line gefitinib monotherapy Journal of Clinical Oncology 2008 26 16 2745 2753
47. Sequist L. V., Martins R. G., Spigel D., Grunberg S. M., Spira A., Jnne P. A., Joshi V. A., McCollum D., Evans T. L., Muzikansky A., Kuhlmann G. L., Han M., Goldberg J. S., Settleman J., Iafrate A. J., Engelman J. A., Haber D. A., Johnson B. E., Lynch T. J., First-line gefitinib in patients with advanced non-small-cell lung cancer harboring somatic EGFR mutations Journal of Clinical Oncology 2008 26 15 2442 2449
48. Sutani A., Nagai Y., Udagawa K., Uchida Y., Koyama N., Murayama Y., Tanaka T., Miyazawa H., Nagata M., Kanazawa M., Hagiwara K., Kobayashi K., Gefitinib for non-small-cell lung cancer patients with epidermal growth factor receptor gene mutations screened by peptide nucleic acid-locked nucleic acid PCR clamp British Journal of Cancer 2006 95 11 1483 1489 (Pubitemid 44863350)
49. Yoshida K., Yatabe Y., Park J. Y., Shimizu J., Horio Y., Matsuo K., Kosaka T., Mitsudomi T., Hida T., Prospective validation for prediction of gefitinib sensitivity by epidermal growth factor receptor gene mutation in patients with non-small cell lung cancer Journal of Thoracic Oncology 2007 2 1 22 28 (Pubitemid 47163924)
50. Sunaga N., Tomizawa Y., Yanagitani N., Iijima H., Kaira K., Shimizu K., Tanaka S., Suga T., Hisada T., Ishizuka T., Saito R., Dobashi K., Mori M., Phase II prospective study of the efficacy of gefitinib for the treatment of stage III/IV non-small cell lung cancer with EGFR mutations, irrespective of previous chemotherapy Lung Cancer 2007 56 3 383 389 (Pubitemid 46679091)
51. Tamura K., Okamoto I., Kash T. II, Negoro S., Hirashima T., Kudoh S., Ichinose Y., Ebi N., Shibata K., Nishimura T., Katakami N., Sawa T., Shimizu E., Fukuoka J., Satoh T., Fukuoka M., Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403) British Journal of Cancer 2008 98 5 907 914 (Pubitemid 351341609)
52. Sugio K., Uramoto H., Onitsuka T., Mizukami M., Ichiki Y., Sugaya M., Yasuda M., Takenoyama M., Oyama T., Hanagiri T., Yasumoto K., Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene mutations Lung Cancer 2009 64 3 314 318
53. Inoue A., Kobayashi K., Usui K., Maemondo M., Okinaga S., Mikami I., Ando M., Yamazaki K., Saijo Y., Gemma A., Miyazawa H., Tanaka T., Ikebuchi K., Nukiwa T., Morita S., Hagiwara K., First-line gefitinib for patients with advanced non-small-cell lung cancer harboring epidermal growth factor receptor mutations without indication for chemotherapy Journal of Clinical Oncology 2009 27 9 1394 1400
54. Cappuzzo F., Ligorio C., Jnne P. A., Toschi L., Rossi E., Trisolini R., Paioli D., Holmes A. J., Magrini E., Finocchiaro G., Bartolini S., Cancellieri A., Ciardiello F., Patelli M., Crino L., Varella-Garcia M., Prospective study of gefitinib in epidermal growth factor receptor fluorescence in situ hybridization-positive/phospho-akt-positive or never smoker patients with advanced non-small-cell lung cancer: the ONCOBELL trial Journal of Clinical Oncology 2007 25 16 2248 2255 (Pubitemid 46954651)
55. West H. L., Franklin W. A., McCoy J., Gumerlock P. H., Vance R., Lau D. H. M., Chansky K., Crowley J. J., Gandara D. R., Granados B., Gefitinib therapy in advanced bronchioloalveolar carcinoma: Southwest Oncology Group study S0126 Journal of Clinical Oncology 2006 24 12 1807 1813 (Pubitemid 46638977)
56. Lee D. H., Han J. Y., Lee H. G., Jae J. L., Eun K. L., Hyae Y. K., Hark K. K., Eun K. H., Jin S. L., Gefitinib as a first-line therapy of advanced or metastatic adenocarcinoma of the lung in never-smokers Clinical Cancer Research 2005 11 8 3032 3037 (Pubitemid 40525209)
57. Mok T. S., Wu Y. L., Thongprasert S., Yang C. H., Chu DA. T., Saijo N., Sunpaweravong P., Han B., Margono B., Ichinose Y., Nishiwaki Y., Ohe Y., Yang J. J., Chewaskulyong B., Jiang H., Duffield E. L., Watkins C. L., Armour A. A., Fukuoka M., Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma The New England Journal of Medicine 2009 361 10 947 957
58. Lee J. S., Park K., Kim S. W., A randomized phase III study of gefitinib (IRESSA) versus standard chemotherapy (gemcitabine plus cisplatin) as a first-line treatment for never-smokers with advanced or metastatic adenocarcinoma of the lung Proceedings of the World Conference on Lung Cancer 2009. (abstract no. PRS.4)
59. Mitsudomi T., Morita S., Yatabe Y., Negoro S., Okamoto I., Tsurutani J., Seto T., Satouchi M., Tada H., Hirashima T., Asami K., Katakami N., Takada M., Yoshioka H., Shibata K., Kudoh S., Shimizu E., Saito H., Toyooka S., Nakagawa K., Fukuoka M., 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 The Lancet Oncology 2010 11 2 121 128
60. Maemondo M., Inoue A., Kobayashi K., Sugawara S., Oizumi S., Isobe H., Gemma A., Harada M., Yoshizawa H., Kinoshita I., Fujita Y., Okinaga S., Hirano H., Yoshimori K., Harada T., Ogura T., Ando M., Miyazawa H., Tanaka T., Saijo Y., Hagiwara K., Morita S., Nukiwa T., Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR The New England Journal of Medicine 2010 362 25 2380 2388
61. Yang C. H., Fukuoka M., Mok T. S., Final overall survival results from a phase III, randomised, open-label, first-line study of gefitinib vs. carboplatin/paclitaxel in clinically selected patients with advanced non-small cell lung cancer in Asia (IPASS) Proceedings of the European Society of Medical Oncology Meeting 2010. (abstract no. LBA2)
62. Di Maio M., Gallo C., De Maio E., Morabito A., Piccirillo M. C., Gridelli C., Perrone F., Methodological aspects of lung cancer clinical trials in the era of targeted agents Lung Cancer 2010 67 2 127 135
63. Morabito A., Di Maio M., De Maio E., Normanno N., Perrone F., Methodology of clinical trials with new molecular-targeted agents: where do we stand? Annals of Oncology 2006 17 supplement 7 vii128 vii131
64. Betensky R. A., Louis D. N., Cairncross J. G., Influence of unrecognized molecular heterogeneity on randomized clinical trials Journal of Clinical Oncology 2002 20 10 2495 2499 (Pubitemid 34525735)
65. Mitsudomi T., Kosaka T., Endoh H., Horio Y., Hida T., Mori S., Hatooka S., Shinoda M., Takahashi T., Yatabe Y., Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence Journal of Clinical Oncology 2005 23 11 2513 2520 (Pubitemid 47050841)
66. Zhou C., Wung Y. I., Chen G., Efficacy results from the randomised phase III OPTIMAL (CTONG 0802) study comparing first-line erlotinib versus carboplatin plus gemcitabine, in chinese advanced non-small-cell lung cancer patients with EGFR activating mutations Proceedings of the European Society of Medical Oncology Meeting 2010. (abstract no. LBA13)
67. Gridelli C., Ciardiello F., Feld R., International multicenter randomized phase III study of first-line erlotinib (E) followed by second-line cisplatin plus gemcitabine (CG) versus first-line CG followed by second-line E in advanced non-small cell lung cancer (aNSCLC): the TORCH trial Journal of Clinical Oncology 2010 28 15, supplement. (abstract no. 7508)
68. Rosell R., Moran T., Queralt C., Porta R., Cardenal F., Camps C., Majem M., Lopez-Vivanco G., Isla D., Provencio M., Insa A., Massuti B., Gonzalez-Larriba J. L., Paz-Ares L., Bover I., Garcia-Campelo R., Moreno M. A., Catot S., Rolfo C., Reguart N., Palmero R., Snchez J. M., Bastus R., Mayo C., Bertran-Alamillo J., Molina M. A., Sanchez J. J., Taron M., Screening for epidermal growth factor receptor mutations in lung cancer The New England Journal of Medicine 2009 361 10 958 967
69. Morita S., Okamoto I., Kobayashi K., Yamazaki K., Asahina H., Inoue A., Hagiwara K., Sunaga N., Yanagitani N., Hida T., Yoshida K., Hirashima T., Yasumoto K., Sugio K., Mitsudomi T., Fukuoka M., Nukiwa T., Combined survival analysis of prospective clinical trials of gefitinib for non-small cell lung cancer with EGFR mutations Clinical Cancer Research 2009 15 13 4493 4498
70. Belani C. P., The role of irreversible EGFR inhibitors in the treatment of non-small cell lung cancer: overcoming resistance to reversible EGFR inhibitors Cancer Investigation 2010 28 4 413 423