Response rate is associated with prolonged survival in patients with advanced non-small cell lung cancer treated with gefitinib or erlotinib

Journal of Thoracic Oncology

Volumn 4, Issue 8, 2009, Pages 994-1001

  Tsujino, Kazuyuki ^a   Kawaguchi, Tomoya ^b   Kubo, Akihito ^b   Aono, Nana ^b   Nakao, Keiko ^b   Koh, Yasuhiro ^c   Tachibana, Kazunobu ^b   Isa, Shun Ichi ^b   Takada, Minoru ^b,d   Kurata, Takayasu ^e  

^a OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^b NATIONAL HOSPITAL ORGANIZATION   (Japan)

^c SHIZUOKA CANCER CENTER   (Japan)

^d KINKI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^e OSAKA MEDICAL COLLEGE HOSPITAL   (Japan)

Author keywords

EGFR; Erlotinib; Gefitinib; Non small cell lung cancer; Response rate

Indexed keywords

ERLOTINIB; GEFITINIB;

ADVANCED CANCER; ARTICLE; CANCER SURVIVAL; CLINICAL TRIAL; CORRELATION ANALYSIS; HUMAN; LUNG NON SMALL CELL CANCER; MONOTHERAPY; PRIORITY JOURNAL; TREATMENT RESPONSE;

EID: 68349097213     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3181a94a2f     Document Type: Article

References (42)

1. El-Maraghi RH, Eisenhauer EA. Review of phase II trial designs used in studies of molecular targeted agents: outcomes and predictors of success in phase III. J Clin Oncol 2008;26:1346-1354.
2. Chan JK, Ueda SM, Sugiyama VE, et al. Analysis of phase II studies on targeted agents and subsequent phase III trials: what are the predictors for success? J Clin Oncol 2008;26:1511-1518.
3. Shepherd FA, Rodrigues Pereira J, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med 2005;353: 123-132. (Pubitemid 41058344)
4. Allegra C, Blanke C, Buyse M, et al. End points in advanced colon cancer clinical trials: a review and proposal. J Clin Oncol 2007;25:3572-3575. (Pubitemid 47372593)
5. Saad ED, Katz A. Progression-free survival and time to progression as primary end points in advanced breast cancer: often used, sometimes loosely defined. Ann Oncol 2009;20:460-464.
6. Cappuzzo F, Gregorc V, Rossi E, et al. Gefitinib in pretreated non-smallcell lung cancer (NSCLC): analysis of efficacy and correlation with HER2 and epidermal growth factor receptor expression in locally advanced or metastatic NSCLC. J Clin Oncol 2003;21:2658-2663. (Pubitemid 46606308)
7. Fukuoka M, Yano S, Giaccone G, et al. Multi-institutional randomized phase II trial of gefitinib for previously treated patients with advanced non-small-cell lung cancer (The IDEAL 1 Trial) [corrected]. J Clin Oncol 2003;21:2237-2246. (Pubitemid 46621858)
8. Kris MG, Natale RB, Herbst RS, et al. 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. JAMA 2003;290:2149-2158. (Pubitemid 37432975)
9. Cappuzzo F, Bartolini S, Ceresoli GL, et al. Efficacy and tolerability of gefitinib in pretreated elderly patients with advanced non-small-cell lung cancer (NSCLC). Br J Cancer 2004;90:82-86. (Pubitemid 38174943)
10. Cappuzzo F, Magrini E, Ceresoli GL, et al. Akt phosphorylation and gefitinib efficacy in patients with advanced non-small-cell lung cancer. J Natl Cancer Inst 2004;96:1133-1141. (Pubitemid 39207049)
11. Ceresoli GL, Cappuzzo F, Gregorc V, Bartolini S, Crinò L, Villa E. Gefitinib in patients with brain metastases from non-small-cell lung cancer: a prospective trial. Ann Oncol 2004;15:1042-1047. (Pubitemid 39089780)
12. Perez-Soler R, Chachoua A, Hammond LA, et al. Determinants of tumor response and survival with erlotinib in patients with non-small-cell lung cancer. J Clin Oncol 2004;22:3238-3247. (Pubitemid 41103678)
13. Chen YM, Perng RP, Tsai CM. Gefitinib treatment is highly effective in non-small-cell lung cancer patients failing previous chemotherapy in Taiwan: a prospective phase II study. J Chemother 2005;17:679-684.
14. Chiu CH, Tsai CM, Chen YM, Chiang SC, Liou JL, Perng RP. Gefitinib is active in patients with brain metastases from non-small cell lung cancer and response is related to skin toxicity. Lung Cancer 2005;47: 129-138. (Pubitemid 39643250)
15. Han SW, Kim TY, Hwang PG, et al. Predictive and prognostic impact of epidermal growth factor receptor mutation in non-small-cell lung cancer patients treated with gefitinib. J Clin Oncol 2005;23:2493-2501. (Pubitemid 47050839)
16. Spigel DR, Hainsworth JD, Burkett ER, et al. 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. Clin Lung Cancer 2005;7:127-132.
17. Thatcher N, Chang A, Parikh P, et al. 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). Lancet 2005;366: 1527-1537. (Pubitemid 41540110)
18. Giaccone G, Gallegos Ruiz M, Le Chevalier T, et al. Erlotinib for frontline treatment of advanced non-small cell lung cancer: a phase II study. Clin Cancer Res 2006;12:6049-6055. (Pubitemid 44703768)
19. Lee DH, Han JY, Yu SY, et al. The role of gefitinib treatment for Korean never-smokers with advanced or metastatic adenocarcinoma of the lung: a prospective study. J Thorac Oncol 2006;1:965-971.
20. Lin WC, Chiu CH, Liou JL, Chen YM, Perng RP, Tsai CM. Gefitinib as front-line treatment in Chinese patients with advanced non-small-cell lung cancer. Lung Cancer 2006;54:193-199. (Pubitemid 44764919)
21. Niho S, Kubota K, Goto K, et al. First-line single agent treatment with gefitinib in patients with advanced non-small-cell lung cancer: a phase II study. J Clin Oncol 2006;24:64-69. (Pubitemid 46630495)
22. Jackman DM, Yeap BY, Lindeman NI, et al. Phase II clinical trial of chemotherapy-naive patients > or = 70 years of age treated with erlotinib for advanced non-small-cell lung cancer. J Clin Oncol 2007; 25:760-766. (Pubitemid 350002874)
23. Wu C, Li YL, Wang ZM, Li Z, Zhang TX, Wei Z. Gefitinib as palliative therapy for lung adenocarcinoma metastatic to the brain. Lung Cancer 2007;57:359-364. (Pubitemid 47285416)
24. Goss G, Ferry D, Laurie S, et al. Randomized, double-blind, multicenter, parallel-group, Phase II study of gefitinib (IRESSA) plus best supportive care (BSC) versus placebo plus BSC in chemotherapy-naïve patients with advanced non-small-cell lung cancer and poor performance status (INSTEP). J Thorac Oncol 2007;2:s340; Abstract B343-302.
25. Nishimura T, Katakami N, Kobayashi M, et al. Phase II study of gefitinib as a first-line therapy in elderly patients with lung adenocarcinoma (WJTOG 0402-DI). J Thorac Oncol 2007;2:s730 -s731; Abstract P733-121.
26. Paz-Ares L, González-Larriba J-L, Viñolas N, et al. A large Spanish experience with erlotinib in advanced non-small cell lung cancer. J Thorac Oncol 2007;2:s734 -s735; Abstract P733-130.
27. Tamura T, Nishiwaki Y, Watanabe K, et al. Evaluation of efficacy and safety of erlotinib as monotherapy for Japanese patients with advanced non-small cell lung cancer (NSCLC); integrated analysis of two Japanese phase II studies. J Thorac Oncol 2007;2:s742-s743; Abstract P743-148.
28. Tan E-H, Ramlau R, Pluzanska A, et al. MERIT: a prospective study of putative relationships between tumour biomarkers and clinical benefit from erlotinib in advanced non-small cell lung cancer (NSCLC). J Thorac Oncol 2007;2:s394; Abstract D392-304.
29. Crino L, Cappuzzo F, Zatloukal P, et al. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol 2008;26: 4253-4260.
30. Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008;372:1809-1818.
31. 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;26:4244-4252.
32. Hesketh PJ, Chansky K, Wozniak AJ, et al. Southwest oncology group phase II trial (S0341) of erlotinib (OSI-774) in patients with advanced non-small cell lung cancer and a performance status of 2. J Thorac Oncol 2008;3:1026-1031.
33. Nottage M, Siu LL. Principles of clinical trial design. J Clin Oncol 2002;20:42S- 46S.
34. Shanafelt TD, Loprinzi C, Marks R, Novotny P, Sloan J. Are chemotherapy response rates related to treatment-induced survival prolongations in patients with advanced cancer? J Clin Oncol 2004;22:1966-1974. (Pubitemid 41095190)
35. Tang PA, Bentzen SM, Chen EX, Siu LL. Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 2007;25:4562-4568.
36. Kurata T, Matsuo K, Takada M, et al. Is the importance of achieving stable disease different between epidermal growth factor receptor tyrosine kinase inhibitors and cytotoxic agents in the second-line setting for advanced non-small cell lung cancer? J Thorac Oncol 2006;1:684-691. (Pubitemid 47163957)
37. Johnson KR, Ringland C, Stokes BJ, et al. Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis. Lancet Oncol 2006;7:741-746. (Pubitemid 44283658)
38. Berlin JA, Santanna J, Schmid CH, Szczech LA, Feldman HI; Anti- Lymphocyte Antibody Induction Therapy Study Group. Individual patient- versus group-level data meta-regressions for the investigation of treatment effect modifiers: ecological bias rears its ugly head. Stat Med 2002;21:371-387. (Pubitemid 34144648)
39. Riely GJ, Kris MG, Zhao B, et al. Prospective assessment of discontinuation and reinitiation of erlotinib or gefitinib in patients with acquired resistance to erlotinib or gefitinib followed by the addition of everolimus. Clin Cancer Res 2007;13:5150-5155. (Pubitemid 47502083)
40. Takano T, Ohe Y, Sakamoto H, et al. Epidermal growth factor receptor gene mutations and increased copy numbers predict gefitinib sensitivity in patients with recurrent non-small-cell lung cancer. J Clin Oncol 2005;23:6829-6837. (Pubitemid 46260269)
41. Bell DW, Lynch TJ, Haserlat SM, et al. Epidermal growth factor receptor mutations and gene amplification in non-small-cell lung cancer: molecular analysis of the IDEAL/INTACT gefitinib trials. J Clin Oncol 2005;23:8081-8092. (Pubitemid 46657411)
42. Eberhard DA, Johnson BE, Amler LC, et al. Mutations in the epidermal growth factor receptor and in KRAS are predictive and prognostic indicators in patients with non-small-cell lung cancer treated with chemotherapy alone and in combination with erlotinib. J Clin Oncol 2005;23:5900-5909.