메뉴 건너뛰기




Volumn 10, Issue , 2010, Pages

Treatment rationale and study design for a phase III, double-blind, placebo-controlled study of maintenance pemetrexed plus best supportive care versus best supportive care immediately following induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small cell lung cancer

Author keywords

[No Author keywords available]

Indexed keywords

CISPLATIN; PEMETREXED; PLACEBO; SODIUM CHLORIDE; THYMIDYLATE SYNTHASE; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; GLUTAMIC ACID DERIVATIVE; GUANINE;

EID: 77950357310     PISSN: None     EISSN: 14712407     Source Type: Journal    
DOI: 10.1186/1471-2407-10-85     Document Type: Article
Times cited : (27)

References (43)
  • 1
    • 79960106445 scopus 로고    scopus 로고
    • Surgical treatment of locally advanced non-small cell lung cancer
    • New York: Springer, Fossella FV, Komaki R, Putnam JB Jr, [Buzdar AU, Freedman RS (Series Editors): M. D. Anderson Cancer Care Series.]
    • Swisher SG. Surgical treatment of locally advanced non-small cell lung cancer. Lung Cancer 2002, 118-141. New York: Springer, Fossella FV, Komaki R, Putnam JB Jr, [Buzdar AU, Freedman RS (Series Editors): M. D. Anderson Cancer Care Series.].
    • (2002) Lung Cancer , pp. 118-141
    • Swisher, S.G.1
  • 2
    • 66549109768 scopus 로고    scopus 로고
    • Non-small-cell lung cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up
    • ESMO Guidelines Working Group
    • D'Addario G, Felip E, . ESMO Guidelines Working Group Non-small-cell lung cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009, 20(Suppl 4):iv68-iv70. ESMO Guidelines Working Group.
    • (2009) Ann Oncol , vol.20 , Issue.SUPPL. 4
    • D'Addario, G.1    Felip, E.2
  • 3
    • 1342268525 scopus 로고    scopus 로고
    • American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003
    • 10.1200/JCO.2004.09.053, 14691125, American Society of Clinical Oncology
    • Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker S, Olak J, Stover D, Strawn JR, Turrisi AT, Somerfield MR, . American Society of Clinical Oncology American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003. J Clin Oncol 2004, 22:330-353. 10.1200/JCO.2004.09.053, 14691125, American Society of Clinical Oncology.
    • (2004) J Clin Oncol , vol.22 , pp. 330-353
    • Pfister, D.G.1    Johnson, D.H.2    Azzoli, C.G.3    Sause, W.4    Smith, T.J.5    Baker, S.6    Olak, J.7    Stover, D.8    Strawn, J.R.9    Turrisi, A.T.10    Somerfield, M.R.11
  • 4
    • 31444448873 scopus 로고    scopus 로고
    • Optimizing first-line treatment options for patients with advanced NSCLC
    • 10.1634/theoncologist.10-90003-1, 16368866
    • Wakelee H, Belani CP. Optimizing first-line treatment options for patients with advanced NSCLC. Oncologist 2005, 10(Suppl 3):1-10. 10.1634/theoncologist.10-90003-1, 16368866.
    • (2005) Oncologist , vol.10 , Issue.SUPPL. 3 , pp. 1-10
    • Wakelee, H.1    Belani, C.P.2
  • 5
    • 0037050352 scopus 로고    scopus 로고
    • Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer
    • 10.1056/NEJMoa011954, 11784875, Eastern Cooperative Oncology Group
    • Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH, . Eastern Cooperative Oncology Group Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002, 346:92-98. 10.1056/NEJMoa011954, 11784875, Eastern Cooperative Oncology Group.
    • (2002) N Engl J Med , vol.346 , pp. 92-98
    • Schiller, J.H.1    Harrington, D.2    Belani, C.P.3    Langer, C.4    Sandler, A.5    Krook, J.6    Zhu, J.7    Johnson, D.H.8
  • 7
    • 36048959189 scopus 로고    scopus 로고
    • Optimal duration of chemotherapy in advanced non-small cell lung cancer
    • 10.1007/s11864-007-0020-6, 17634834
    • Lustberg MB, Edelman MJ. Optimal duration of chemotherapy in advanced non-small cell lung cancer. Curr Treat Options Oncol 2007, 8:38-46. 10.1007/s11864-007-0020-6, 17634834.
    • (2007) Curr Treat Options Oncol , vol.8 , pp. 38-46
    • Lustberg, M.B.1    Edelman, M.J.2
  • 9
    • 36849051803 scopus 로고    scopus 로고
    • Duration of first-line chemotherapy in advanced non small-cell lung cancer: less is more in the era of effective subsequent therapies
    • 10.1200/JCO.2007.13.4015, 18024862
    • Socinski MA, Stinchcombe TE. Duration of first-line chemotherapy in advanced non small-cell lung cancer: less is more in the era of effective subsequent therapies. J Clin Oncol 2007, 25:5155-5157. 10.1200/JCO.2007.13.4015, 18024862.
    • (2007) J Clin Oncol , vol.25 , pp. 5155-5157
    • Socinski, M.A.1    Stinchcombe, T.E.2
  • 10
    • 70349474052 scopus 로고    scopus 로고
    • Optimal duration of chemotherapy for advanced non-small cell lung cancer: a systematic review and meta-analysis [abstract]
    • PD4-2-1
    • Soon YY, Askie L, Stockler M, Boyer M. Optimal duration of chemotherapy for advanced non-small cell lung cancer: a systematic review and meta-analysis [abstract]. J Thorac Oncol 2007, 2(8 Suppl 4). PD4-2-1.
    • (2007) J Thorac Oncol , vol.2 , Issue.8 SUPPL. 4
    • Soon, Y.Y.1    Askie, L.2    Stockler, M.3    Boyer, M.4
  • 11
    • 19844362355 scopus 로고    scopus 로고
    • Epidermal growth factor receptor inhibitors in the treatment of non-small-cell lung cancer
    • 10.1200/JCO.2005.08.409, 15886311
    • Giaccone G. Epidermal growth factor receptor inhibitors in the treatment of non-small-cell lung cancer. J Clin Oncol 2005, 23:3235-3242. 10.1200/JCO.2005.08.409, 15886311.
    • (2005) J Clin Oncol , vol.23 , pp. 3235-3242
    • Giaccone, G.1
  • 12
    • 67649185593 scopus 로고    scopus 로고
    • Efficacy and safety of erlotinib in >1200 East/South-East (E/SE) Asian patients (pts) with advanced non-small-cell lung cancer (NSCLC) [abstract]
    • on behalf of the E/SE Asian TRUST investigators
    • Mok TS, Zhou C, Kim S, Wu Y, Perng R, . on behalf of the E/SE Asian TRUST investigators Efficacy and safety of erlotinib in >1200 East/South-East (E/SE) Asian patients (pts) with advanced non-small-cell lung cancer (NSCLC) [abstract]. J Clin Oncol 2008, 26(Suppl):19001. on behalf of the E/SE Asian TRUST investigators.
    • (2008) J Clin Oncol , vol.26 , Issue.SUPPL , pp. 19001
    • Mok, T.S.1    Zhou, C.2    Kim, S.3    Wu, Y.4    Perng, R.5
  • 14
    • 62449124416 scopus 로고    scopus 로고
    • Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil
    • 10.1200/JCO.2007.14.5466, 19188680
    • Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C. Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 2009, 27:1227-1234. 10.1200/JCO.2007.14.5466, 19188680.
    • (2009) J Clin Oncol , vol.27 , pp. 1227-1234
    • Reck, M.1    von Pawel, J.2    Zatloukal, P.3    Ramlau, R.4    Gorbounova, V.5    Hirsh, V.6    Leighl, N.7    Mezger, J.8    Archer, V.9    Moore, N.10    Manegold, C.11
  • 15
    • 65349154564 scopus 로고    scopus 로고
    • Preliminary treatment patterns and safety outcomes for non-small cell lung cancer (NSCLC) from ARIES, a bevacizumab treatment observational cohort study (OCS) [abstract]
    • for the ARIES Investigators
    • Lynch TJ, Brahmer J, Fischbach N, Garst J, Kumar P, Spigel DR, Teng S, Vidaver R, Wang L, Navarro W, . for the ARIES Investigators Preliminary treatment patterns and safety outcomes for non-small cell lung cancer (NSCLC) from ARIES, a bevacizumab treatment observational cohort study (OCS) [abstract]. J Clin Oncol 2008, 26(Suppl):8077. for the ARIES Investigators.
    • (2008) J Clin Oncol , vol.26 , Issue.SUPPL , pp. 8077
    • Lynch, T.J.1    Brahmer, J.2    Fischbach, N.3    Garst, J.4    Kumar, P.5    Spigel, D.R.6    Teng, S.7    Vidaver, R.8    Wang, L.9    Navarro, W.10
  • 16
    • 51349109631 scopus 로고    scopus 로고
    • FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) [abstract]
    • Pirker R, Szczesna A, von Pawel J, Krzakowski M, Ramlau R, Park K, Gatzemeier U, Bajeta E, Emig M, Pereira JR. FLEX: A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) [abstract]. J Clin Oncol 2008, 26(Suppl):3.
    • (2008) J Clin Oncol , vol.26 , Issue.SUPPL , pp. 3
    • Pirker, R.1    Szczesna, A.2    von Pawel, J.3    Krzakowski, M.4    Ramlau, R.5    Park, K.6    Gatzemeier, U.7    Bajeta, E.8    Emig, M.9    Pereira, J.R.10
  • 17
    • 36148992949 scopus 로고    scopus 로고
    • The role of bevacizumab in the treatment of non-small cell lung cancer: Current indications and future developments
    • 10.1634/theoncologist.12-10-1183, 17962612
    • Gridelli C, Maione P, Rossi A, De Marinis F. The role of bevacizumab in the treatment of non-small cell lung cancer: Current indications and future developments. Oncologist 2007, 12:1183-1193. 10.1634/theoncologist.12-10-1183, 17962612.
    • (2007) Oncologist , vol.12 , pp. 1183-1193
    • Gridelli, C.1    Maione, P.2    Rossi, A.3    De Marinis, F.4
  • 19
    • 64049115311 scopus 로고    scopus 로고
    • The differential efficacy of pemetrexed according to NSCLC histology: A review of two phase III studies
    • 10.1634/theoncologist.2008-0232, 19221167
    • Scagliotti G, Hanna N, Fossella F, Sugarman K, Blatter J, Peterson P, Simms L, Shepherd FA. The differential efficacy of pemetrexed according to NSCLC histology: A review of two phase III studies. Oncologist 2009, 14:253-263. 10.1634/theoncologist.2008-0232, 19221167.
    • (2009) Oncologist , vol.14 , pp. 253-263
    • Scagliotti, G.1    Hanna, N.2    Fossella, F.3    Sugarman, K.4    Blatter, J.5    Peterson, P.6    Simms, L.7    Shepherd, F.A.8
  • 21
    • 0032950347 scopus 로고    scopus 로고
    • Enzyme inhibition, polyglutamation, and the effect of LY231514 (MTA) on purine biosynthesis
    • Mendelsohn LG, Shih C, Chen VJ, Habeck LL, Gates SB, Shackelford KA. Enzyme inhibition, polyglutamation, and the effect of LY231514 (MTA) on purine biosynthesis. Semin Oncol 1999, 26(2 Suppl 6):42-47.
    • (1999) Semin Oncol , vol.26 , Issue.2 SUPPL. 6 , pp. 42-47
    • Mendelsohn, L.G.1    Shih, C.2    Chen, V.J.3    Habeck, L.L.4    Gates, S.B.5    Shackelford, K.A.6
  • 22
    • 33749587054 scopus 로고    scopus 로고
    • Squamous cell carcinoma of the lung compared with other histotypes shows higher messenger RNA and protein levels for thymidylate synthase
    • 10.1002/cncr.22208, 16955506
    • Ceppi P, Volante M, Saviozzi S, Rapa I, Novello S, Cambieri A, Lo Iacono M, Cappia S, Papotti M, Scagliotti GV. 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. 10.1002/cncr.22208, 16955506.
    • (2006) Cancer , vol.107 , pp. 1589-1596
    • Ceppi, P.1    Volante, M.2    Saviozzi, S.3    Rapa, I.4    Novello, S.5    Cambieri, A.6    Lo Iacono, M.7    Cappia, S.8    Papotti, M.9    Scagliotti, G.V.10
  • 24
    • 0032914341 scopus 로고    scopus 로고
    • Biological activity of the multitargeted antifolate, MTA (LY231514), in human cell lines with different resistance mechanisms to antifolate drugs
    • Schultz RM, Chen VJ, Bewley JR, Roberts EF, Shih C, Dempsey JA. Biological activity of the multitargeted antifolate, MTA (LY231514), in human cell lines with different resistance mechanisms to antifolate drugs. Semin Oncol 1999, 26(2 Suppl 6):68-73.
    • (1999) Semin Oncol , vol.26 , Issue.2 SUPPL. 6 , pp. 68-73
    • Schultz, R.M.1    Chen, V.J.2    Bewley, J.R.3    Roberts, E.F.4    Shih, C.5    Dempsey, J.A.6
  • 25
    • 0344393780 scopus 로고    scopus 로고
    • Resistance to antifolates
    • 10.1038/sj.onc.1206946, 14576850
    • Zhao R, Goldman ID. Resistance to antifolates. Oncogene 2003, 22:7431-7457. 10.1038/sj.onc.1206946, 14576850.
    • (2003) Oncogene , vol.22 , pp. 7431-7457
    • Zhao, R.1    Goldman, I.D.2
  • 26
    • 33645803198 scopus 로고    scopus 로고
    • Maintenance chemotherapy in non-small cell lung cancer
    • 10.1093/annonc/mdj928, 16608989
    • Rinaldi M, Belvedere O, Cauchi C, Defferrari C, Viola G, Grossi F. Maintenance chemotherapy in non-small cell lung cancer. Ann Oncol 2006, 17(Suppl 2):ii67-ii70. 10.1093/annonc/mdj928, 16608989.
    • (2006) Ann Oncol , vol.17 , Issue.SUPPL. 2
    • Rinaldi, M.1    Belvedere, O.2    Cauchi, C.3    Defferrari, C.4    Viola, G.5    Grossi, F.6
  • 27
    • 34247882769 scopus 로고    scopus 로고
    • Sequential, alternating, and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer: a review of the literature
    • 10.1634/theoncologist.12-4-451, 17470688
    • Grossi F, Aita M, Follador A, Defferrari C, Brianti A, Sinaccio G, Belvedere O. Sequential, alternating, and maintenance/consolidation chemotherapy in advanced non-small cell lung cancer: a review of the literature. Oncologist 2007, 12:451-464. 10.1634/theoncologist.12-4-451, 17470688.
    • (2007) Oncologist , vol.12 , pp. 451-464
    • Grossi, F.1    Aita, M.2    Follador, A.3    Defferrari, C.4    Brianti, A.5    Sinaccio, G.6    Belvedere, O.7
  • 28
    • 63849290363 scopus 로고    scopus 로고
    • Potential treatment options after first-line chemotherapy for advanced NSCLC: maintenance treatment or early second-line?
    • 10.1634/theoncologist.2008-0152, 19190239
    • Gridelli C, Maione P, Rossi A, Ferrara ML, Bareschino MA, Schettino C, Sacco PC, Ciardiello F. Potential treatment options after first-line chemotherapy for advanced NSCLC: maintenance treatment or early second-line?. Oncologist 2009, 14:137-147. 10.1634/theoncologist.2008-0152, 19190239.
    • (2009) Oncologist , vol.14 , pp. 137-147
    • Gridelli, C.1    Maione, P.2    Rossi, A.3    Ferrara, M.L.4    Bareschino, M.A.5    Schettino, C.6    Sacco, P.C.7    Ciardiello, F.8
  • 33
    • 70349092474 scopus 로고    scopus 로고
    • Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC) [abstract]
    • Belani CP, Brodowicz T, Ciuleanu T, Kim JH, Krzakowski M, Laack E, Wu YL, Peterson P, Krejcy K, Zielinski C. Maintenance pemetrexed (Pem) plus best supportive care (BSC) versus placebo (Plac) plus BSC: A randomized phase III study in advanced non-small cell lung cancer (NSCLC) [abstract]. J Clin Oncol 2009, 27(Suppl):CRA8000.
    • (2009) J Clin Oncol , vol.27 , Issue.SUPPL
    • Belani, C.P.1    Brodowicz, T.2    Ciuleanu, T.3    Kim, J.H.4    Krzakowski, M.5    Laack, E.6    Wu, Y.L.7    Peterson, P.8    Krejcy, K.9    Zielinski, C.10
  • 34
    • 66749132459 scopus 로고    scopus 로고
    • Tolerability of pemetrexed versus placebo as a maintenance therapy in advanced non-small cell lung cancer: evidence from a large randomized study [abstract]
    • Zielinski CC, Yang S, Santoro A, Ramlau R, Liepa AM, Peterson P, Brodowicz T, Madhavan J, Franke FA, Cucevic B. Tolerability of pemetrexed versus placebo as a maintenance therapy in advanced non-small cell lung cancer: evidence from a large randomized study [abstract]. J Clin Oncol 2008, 26(Suppl):8060.
    • (2008) J Clin Oncol , vol.26 , Issue.SUPPL , pp. 8060
    • Zielinski, C.C.1    Yang, S.2    Santoro, A.3    Ramlau, R.4    Liepa, A.M.5    Peterson, P.6    Brodowicz, T.7    Madhavan, J.8    Franke, F.A.9    Cucevic, B.10
  • 35
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada
    • 10.1093/jnci/92.3.205, 10655437
    • Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216. 10.1093/jnci/92.3.205, 10655437.
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3    Wanders, J.4    Kaplan, R.S.5    Rubinstein, L.6    Verweij, J.7    Van Glabbeke, M.8    van Oosterom, A.T.9    Christian, M.C.10    Gwyther, S.G.11
  • 36
    • 0025688231 scopus 로고
    • EuroQol-a new facility for the measurement of health-related quality of life. The EuroQol Group
    • 10.1016/0168-8510(90)90421-9, 10109801
    • EuroQol-a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy 1990, 16:199-208. 10.1016/0168-8510(90)90421-9, 10109801.
    • (1990) Health Policy , vol.16 , pp. 199-208
  • 37
    • 3242881591 scopus 로고    scopus 로고
    • Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
    • Common Terminology Criteria for Adverse Events v3.0 (CTCAE). , http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_v30
  • 38
    • 33845382806 scopus 로고
    • Nonparametric estimation from incomplete observations
    • Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958, 53:457-481.
    • (1958) J Am Stat Assoc , vol.53 , pp. 457-481
    • Kaplan, E.L.1    Meier, P.2
  • 40
    • 0041885404 scopus 로고    scopus 로고
    • Multicenter, randomized trial for stage IIIB or IV non-small-cell lung cancer using weekly paclitaxel and carboplatin followed by maintenance weekly paclitaxel or observation
    • 10.1200/JCO.2003.02.563, 12885812
    • Belani CP, Barstis J, Perry MC, La Rocca RV, Nattam SR, Rinaldi D, Clark R, Mills GM. Multicenter, randomized trial for stage IIIB or IV non-small-cell lung cancer using weekly paclitaxel and carboplatin followed by maintenance weekly paclitaxel or observation. J Clin Oncol 2003, 21:2933-2939. 10.1200/JCO.2003.02.563, 12885812.
    • (2003) J Clin Oncol , vol.21 , pp. 2933-2939
    • Belani, C.P.1    Barstis, J.2    Perry, M.C.3    La Rocca, R.V.4    Nattam, S.R.5    Rinaldi, D.6    Clark, R.7    Mills, G.M.8
  • 41
    • 33645799784 scopus 로고    scopus 로고
    • Maintenance therapy (MT) with weekly paclitaxel improves outcome for advanced non-small cell lung cancer (NSCLC) patients [abstract]
    • Belani CP, Perry MC, La Rocca RV, Rinaldi D, Gable PS, Tester WJ. Maintenance therapy (MT) with weekly paclitaxel improves outcome for advanced non-small cell lung cancer (NSCLC) patients [abstract]. J Clin Oncol 2005, 23(16 Suppl):7143.
    • (2005) J Clin Oncol , vol.23 , Issue.16 SUPPL , pp. 7143
    • Belani, C.P.1    Perry, M.C.2    La Rocca, R.V.3    Rinaldi, D.4    Gable, P.S.5    Tester, W.J.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.