Erlotinib versus docetaxel as second-line treatment of patients with advanced non-small-cell lung cancer and wild-type EGFR tumours (TAILOR): A randomised controlled trial

The Lancet Oncology

Volumn 14, Issue 10, 2013, Pages 981-988

  Garassino, Marina Chiara ^a,k   Martelli, Olga ^b   Broggini, Massimo ^c   Farina, Gabriella ^a   Veronese, Silvio ^d   Rulli, Eliana ^c   Bianchi, Filippo ^a   Bettini, Anna ^e   Longo, Flavia ^f   Moscetti, Luca ^g   Tomirotti, Maurizio ^h   Marabese, Mirko ^c   Ganzinelli, Monica ^a   Lauricella, Calogero ^d   Labianca, Roberto ^e   Floriani, Irene ^c   Giaccone, Giuseppe ⁱ   Torri, Valter ^c   Scanni, Alberto ^a   Marsoni, Silvia ^j  

^a FATEBENEFRATELLI HOSPITAL   (Italy)

^b SAN GIOVANNI ADDOLORATA HOSPITAL   (Italy)

^c MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH   (Italy)

^d OSPEDALE NIGUARDA CA GRANDA   (Italy)

^e Hospital Papa Giovanni XXIII   (Italy)

^f SAPIENZA UNIVERSITY OF ROME   (Italy)

^g BELCOLLE HOSPITAL   (Italy)

^h FONDAZIONE IRCCS CA GRANDA OSPEDALE MAGGIORE POLICLINICO   (Italy)

ⁱ GEORGETOWN UNIVERSITY   (United States)

^j CANDIOLO CANCER INSTITUTE   (Italy)

^k NATIONAL CANCER INSTITUTE   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

DOCETAXEL; EPIDERMAL GROWTH FACTOR RECEPTOR; ERLOTINIB;

ADULT; ADVANCED CANCER; AGED; ALOPECIA; ARTICLE; ASTHENIA; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; FEBRILE NEUTROPENIA; FEMALE; GENE MUTATION; HUMAN; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; METASTASIS POTENTIAL; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUROLOGIC DISEASE; NEUTROPHIL COUNT; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SKIN DISEASE; SKIN TOXICITY; SURVIVAL RATE; SURVIVAL TIME; WILD TYPE;

EID: 84883055532     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(13)70310-3     Document Type: Article

References (40)

1. Govindan R, Page N, Morgensztern D, et al. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 2006, 24:4539-4544.
2. Fossella FV, DeVore R, Kerr RN, et al. Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. J Clin Oncol 2000, 18:2354-2362.
3. Shepherd FA, Dancey J, Ramlau R, et al. Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy. J Clin Oncol 2000, 18:2095-2103.
4. 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.
5. 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.
6. Nabhan C, Bitran JD Erlotinib in lung cancer. N Engl J Med 2005, 353:1739-1741.
7. Lynch TJ, Bell DW, Sordella R, et al. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med 2004, 350:2129-2139.
8. 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.
9. Paez JG, Janne PA, Lee JC, et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 2004, 304:1497-1500.
10. Lee CK, Brown C, Gralla RJ, et al. Impact of EGFR inhibitor in non-small cell lung cancer on progression-free and overall survival: a meta-analysis. J Natl Cancer Inst 2013, 105:595-605.
11. Garassino MC, Marsoni S, Floriani I Testing epidermal growth factor receptor mutations in patients with non-small-cell lung cancer to choose chemotherapy: the other side of the coin. J Clin Oncol 2011, 29:3835-3837.
12. Laurie SA, Goss GD Role of epidermal growth factor receptor inhibitors in epidermal growth factor receptor wild-type non-small-cell lung cancer. J Clin Oncol 2013, 31:1061-1069.
13. Ciuleanu T, Stelmakh L, Cicenas S, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. Lancet Oncol 2012, 13:300-308.
14. Karampeazis A, Voutsina A, Souglakos J, et al. Pemetrexed versus erlotinib in pretreated patients with advanced non-small cell lung cancer: a Hellenic Oncology Research Group (HORG) randomized phase 3 study. Cancer 2013, published online May 9. 10.1002/cncr.28132.
15. 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.
16. 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, 16:1307-1314.
17. 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.
18. Sun JM, Lee KH, Kim SW, et al. Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01): an open-label, phase 3 trial. Cancer 2012, 118:6234-6242.
19. 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.
20. Farina G, Longo F, Martelli O, et al. Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor receptor mutations. Clin Lung Cancer 2011, 12:138-141.
21. Freidlin B, McShane LM, Korn EL Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst 2010, 102:152-160.
22. Travis WD, Brambilla E, Müller-Hermelink HK, Harris CC Pathology and genetics of tumours of the lung, pleura, thymus and heart 2004, IARC Press, Lyon.
23. Thelwell N, Millington S, Solinas A, Booth J, Brown T Mode of action and application of Scorpion primers to mutation detection. Nucleic Acids Res 2000, 28:3752-3761.
24. Newton CR, Graham A, Heptinstall LE, et al. Analysis of any point mutation in DNA. The amplification refractory mutation system (ARMS). Nucleic Acids Res 1989, 17:2503-2516.
25. Keedy VL, Temin S, Somerfield MR, et al. American Society of Clinical Oncology provisional clinical opinion: epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small-cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol 2011, 29:2121-2127.
26. Lachin JM, Foulkes MA Evaluation of sample size and power for analyses of survival with allowance for nonuniform patient entry, losses to follow-up, noncompliance, and stratification. Biometrics 1986, 42:507-519.
27. Di Maio M, Perrone F, Chiodini P, et al. Individual patient data meta-analysis of docetaxel administered once every 3 weeks compared with once every week second-line treatment of advanced non-small-cell lung cancer. J Clin Oncol 2007, 25:1377-1382.
28. Common terminology criteria for adverse events National Cancer Institute, (accessed July 10, 2013). http://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/ctcaev3.pdf.
29. Bergman B, Aaronson NK, Ahmedzai S, et al. The EORTC QLQ-C13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. Eur J Cancer 1994, 30A:635-642.
30. Broglio KR, Berry DA Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009, 101:1642-1649.
31. Roberts PJ, Stinchcombe TE KRAS mutation: should we test for it, and does it matter?. J Clin Oncol 2013, 31:1112-1121.
32. 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, 11:521-529.
33. 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, 13:466-475.
34. Janne PA, Wang X, Socinski MA, et al. Randomized phase II trial of erlotinib alone or with carboplatin and paclitaxel in patients who were never or light former smokers with advanced lung adenocarcinoma: CALGB 30406 trial. J Clin Oncol 2012, 30:2063-2069.
35. Mok TS, Wu YL, Thongprasert S, et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009, 361:947-957.
36. Garraway LA, Janne PA Circumventing cancer drug resistance in the era of personalized medicine. Cancer Discov 2012, 2:214-226.
37. Weinstein IB Cancer. Addiction to oncogenes-the Achilles heel of cancer. Science 2002, 297:63-64.
38. Oxnard GR, Binder A, Janne PA New targetable oncogenes in non-small-cell lung cancer. J Clin Oncol 2013, 31:1097-1104.
39. Lee SM, Khan I, Upadhyay S, et al. First-line erlotinib in patients with advanced non-small-cell lung cancer unsuitable for chemotherapy (TOPICAL): a double-blind, placebo-controlled, phase 3 trial. Lancet Oncol 2012, 13:1161-1170.
40. Garassino MC, Borgonovo K, Rossi A, et al. Biological and clinical features in predicting efficacy of epidermal growth factor receptor tyrosine kinase inhibitors: a systematic review and meta-analysis. Anticancer Res 2009, 29:2691-2701.