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Volumn 11, Issue 5, 2010, Pages 352-357

Treatment rationale and study design for a randomized trial of pemetrexed/carboplatin followed by maintenance pemetrexed versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with advanced non-small-cell lung cancer of nonsquamous histology

Author keywords

Chemotherapy naive; G4PFS; Open label; Progression free survival

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; CIMETIDINE; CYANOCOBALAMIN; DEXAMETHASONE; DIPHENHYDRAMINE; FOLIC ACID; PACLITAXEL; PEMETREXED; RANITIDINE;

EID: 77957037908     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2010.n.045     Document Type: Article
Times cited : (13)

References (44)
  • 2
    • 36048959189 scopus 로고    scopus 로고
    • Optimal duration of chemotherapy in advanced non-small-cell lung cancer
    • Lustberg MB, Edelman MJ. Optimal duration of chemotherapy in advanced non-small-cell lung cancer. Curr Treat Options Oncol 2007; 8:38-46.
    • (2007) Curr Treat Options Oncol , vol.8 , pp. 38-46
    • Lustberg, M.B.1    Edelman, M.J.2
  • 3
    • 70350295050 scopus 로고    scopus 로고
    • Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small-cell lung cancer (NSCLC)
    • abstract 8037
    • Obasaju CK, Raju RN, Stinchcombe T, et al. Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small-cell lung cancer (NSCLC). J Clin Oncol 2009; 27(15 suppl):416s (abstract 8037).
    • (2009) J Clin Oncol , vol.27 , Issue.15 SUPPL.
    • Obasaju, C.K.1    Raju, R.N.2    Stinchcombe, T.3
  • 4
    • 0027367248 scopus 로고
    • Chemotherapy for advanced non-small-cell lung cancer: How much benefit is enough?
    • Grilli R, Oxman AD, Julian JA. Chemotherapy for advanced non-small-cell lung cancer: how much benefit is enough? J Clin Oncol 1993; 11:1866-1872
    • (1993) J Clin Oncol , vol.11 , pp. 1866-1872
    • Grilli, R.1    Oxman, A.D.2    Julian, J.A.3
  • 6
    • 0027210487 scopus 로고
    • Polychemotherapy in advanced non-small-cell lung cancer: A meta-analysis
    • Souquet PJ, Chauvin F, Boissel JP, et al. Polychemotherapy in advanced non-small-cell lung cancer: a meta-analysis. Lancet 1993; 342:19-21.
    • (1993) Lancet , vol.342 , pp. 19-21
    • Souquet, P.J.1    Chauvin, F.2    Boissel, J.P.3
  • 7
    • 0037377679 scopus 로고    scopus 로고
    • Gemcitabine and carboplatin in patients with locally advanced or metastatic non-small-cell lung cancer: A prospective phase II study
    • Kortsik C, Albrecht P, Elmer A. Gemcitabine and carboplatin in patients with locally advanced or metastatic non-small-cell lung cancer: a prospective phase II study. Lung Cancer 2003; 40:85-90.
    • (2003) Lung Cancer , vol.40 , pp. 85-90
    • Kortsik, C.1    Albrecht, P.2    Elmer, A.3
  • 8
    • 0036729263 scopus 로고    scopus 로고
    • Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: A phase III randomized trial
    • Kosmidis P, Mylonakis N, Nicolaides C, et al. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol 2002; 20:3578-3585
    • (2002) J Clin Oncol , vol.20 , pp. 3578-3585
    • Kosmidis, P.1    Mylonakis, N.2    Nicolaides, C.3
  • 9
    • 0036843105 scopus 로고    scopus 로고
    • Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer
    • Scagliotti GV, De Marinis F, Rinaldi M, et al. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol 2002; 20:4285-4291
    • (2002) J Clin Oncol , vol.20 , pp. 4285-4291
    • Scagliotti, G.V.1    De Marinis, F.2    Rinaldi, M.3
  • 10
    • 0037050352 scopus 로고    scopus 로고
    • Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer
    • Schiller JH, Harrington D, Belani CP, et al. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med 2002; 346:92-98
    • (2002) N Engl J Med , vol.346 , pp. 92-98
    • Schiller, J.H.1    Harrington, D.2    Belani, C.P.3
  • 11
    • 62349111622 scopus 로고    scopus 로고
    • Histology-based treatment: A new scenario in the management of advanced non-small-cell lung cancer
    • Gridelli C. Histology-based treatment: a new scenario in the management of advanced non-small-cell lung cancer. Curr Opin Oncol 2009; 21:97-98
    • (2009) Curr Opin Oncol , vol.21 , pp. 97-98
    • Gridelli, C.1
  • 12
    • 75749112866 scopus 로고    scopus 로고
    • Pattern of care for advanced non-small-cell lung cancer in the era of histology-based treatment: A survey of the Italian Association of Thoracic Oncology (AIOT)
    • Gridelli C, Rossi A, de Marinis F. Pattern of care for advanced non-small-cell lung cancer in the era of histology-based treatment: A survey of the Italian Association of Thoracic Oncology (AIOT). Lung Cancer 2010; 67:339-342
    • (2010) Lung Cancer , vol.67 , pp. 339-342
    • Gridelli, C.1    Rossi, A.2    De Marinis, F.3
  • 13
    • 61449455071 scopus 로고    scopus 로고
    • The prognostic and predictive role of histology in advanced non-small-cell lung cancer: A literature review
    • Hirsch F, Sperafico A, Novello S, et al. The prognostic and predictive role of histology in advanced non-small-cell lung cancer: a literature review. J Thorac Oncol 2008; 3:1468-1481
    • (2008) J Thorac Oncol , vol.3 , pp. 1468-1481
    • Hirsch, F.1    Sperafico, A.2    Novello, S.3
  • 14
    • 33845490014 scopus 로고    scopus 로고
    • Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer
    • Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 2006; 355:2542-2550
    • (2006) N Engl J Med , vol.355 , pp. 2542-2550
    • Sandler, A.1    Gray, R.2    Perry, M.C.3
  • 15
    • 2942657615 scopus 로고    scopus 로고
    • Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer
    • Johnson DH, Fehrenbacher L, Novotny WF, et al. Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer. J Clin Oncol 2004; 22:2184-2191
    • (2004) J Clin Oncol , vol.22 , pp. 2184-2191
    • Johnson, D.H.1    Fehrenbacher, L.2    Novotny, W.F.3
  • 16
    • 70350225538 scopus 로고    scopus 로고
    • Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: A randomised, double-blind, phase 3 study
    • Ciuleanu T, Brodowicz T, Zielinski C, et al. Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer: a randomised, double-blind, phase 3 study. Lancet 2009; 374:1432-1440
    • (2009) Lancet , vol.374 , pp. 1432-1440
    • Ciuleanu, T.1    Brodowicz, T.2    Zielinski, C.3
  • 17
    • 64049115311 scopus 로고    scopus 로고
    • The differential efficacy of pemetrexed according to NSCLC histology: A review of two phase III studies
    • Scagliotti G, Hanna N, Fossella F, et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two phase III studies. Oncologist 2009; 14:253-263
    • (2009) Oncologist , vol.14 , pp. 253-263
    • Scagliotti, G.1    Hanna, N.2    Fossella, F.3
  • 18
    • 49049089802 scopus 로고    scopus 로고
    • Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer
    • Scagliotti GV, Parikh P, von Pawel J, et al. 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 2008; 26:3543-3551
    • (2008) J Clin Oncol , vol.26 , pp. 3543-3551
    • Scagliotti, G.V.1    Parikh, P.2    Von Pawel, J.3
  • 19
    • 70349474052 scopus 로고    scopus 로고
    • Optimal duration of chemotherapy for advanced non-small-cell lung cancer: A systematic review and meta-analysis [abstract]
    • Sep 2-6; Seoul abstract PD4-2-1
    • Soon YY, Askie L, Stockler M, et al. Optimal duration of chemotherapy for advanced non-small-cell lung cancer: a systematic review and meta-analysis [abstract]. In: Proc World Conf Lung Cancer 12th annual meeting program; 2007 Sep 2-6; Seoul. J Thorac Oncol 2007; 2(8 suppl 4):S450-1 (abstract PD4-2-1).
    • (2007) J Thorac Oncol , Issue.8 SUPPL. 4
    • Soon, Y.Y.1    Askie, L.2    Stockler, M.3
  • 20
    • 0029608981 scopus 로고
    • Evaluation of the optimal duration of chemotherapy in phase II trials for inoperable non-small-cell lung cancer (NSCLC)
    • Larsen H, Sorensen JB, Nielsen AL, et al. Evaluation of the optimal duration of chemotherapy in phase II trials for inoperable non-small-cell lung cancer (NSCLC). Ann Oncol 1995; 6:993-997
    • (1995) Ann Oncol , vol.6 , pp. 993-997
    • Larsen, H.1    Sorensen, J.B.2    Nielsen, A.L.3
  • 21
    • 36849019938 scopus 로고    scopus 로고
    • Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non small-cell lung cancer
    • Park JO, Kim SW, Ahn JS, et al. Phase III trial of two versus four additional cycles in patients who are nonprogressive after two cycles of platinum-based chemotherapy in non small-cell lung cancer. J Clin Oncol 2007; 25:5233-5239
    • (2007) J Clin Oncol , vol.25 , pp. 5233-5239
    • Park, J.O.1    Kim, S.W.2    Ahn, J.S.3
  • 22
    • 0035281498 scopus 로고    scopus 로고
    • Duration of chemotherapy in advanced non-small-cell lung cancer: A randomized trial of three versus six courses of mitomycin, vinblastine, and cisplatin
    • Smith IE, O'Brien ME, Talbot DC, et al. Duration of chemotherapy in advanced non-small-cell lung cancer: a randomized trial of three versus six courses of mitomycin, vinblastine, and cisplatin. J Clin Oncol 2001; 19:1336-1343
    • (2001) J Clin Oncol , vol.19 , pp. 1336-1343
    • Smith, I.E.1    O'Brien, M.E.2    Talbot, D.C.3
  • 23
    • 0036499649 scopus 로고    scopus 로고
    • Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer
    • Socinski MA, Schell MJ, Peterman A, et al. Phase III trial comparing a defined duration of therapy versus continuous therapy followed by second-line therapy in advanced-stage IIIB/IV non-small-cell lung cancer. J Clin Oncol 2002; 20:1335-1343
    • (2002) J Clin Oncol , vol.20 , pp. 1335-1343
    • Socinski, M.A.1    Schell, M.J.2    Peterman, A.3
  • 24
    • 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
    • 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
    • (2007) J Clin Oncol , vol.25 , pp. 5155-5157
    • Socinski, M.A.1    Stinchcombe, T.E.2
  • 25
    • 33645799784 scopus 로고    scopus 로고
    • Maintenance therapy (MT) with weekly paclitaxel improves outcome for advanced non-small-cell lung cancer (NSCLC) patients
    • abstract 7143
    • Belani CP, Perry MC, La Rocca RV, et al. Maintenance therapy (MT) with weekly paclitaxel improves outcome for advanced non-small-cell lung cancer (NSCLC) patients. J Clin Oncol 2005; 23 (16 suppl):656s (abstract 7143).
    • (2005) J Clin Oncol , vol.23 , Issue.16 SUPPL.
    • Belani, C.P.1    Perry, M.C.2    La Rocca, R.V.3
  • 26
    • 33646485007 scopus 로고    scopus 로고
    • Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small-cell lung cancer: A phase III trial
    • Brodowicz T, Krzakowski M, Zwitter M, et al. Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small-cell lung cancer: a phase III trial. Lung Cancer 2006; 52:155-163
    • (2006) Lung Cancer , vol.52 , pp. 155-163
    • Brodowicz, T.1    Krzakowski, M.2    Zwitter, M.3
  • 27
    • 59149092945 scopus 로고    scopus 로고
    • Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non-small-cell lung cancer
    • Fidias PM, Dakhil SR, Lyss AP, et al. Phase III study of immediate compared with delayed docetaxel after front-line therapy with gemcitabine plus carboplatin in advanced non-small-cell lung cancer. J Clin Oncol 2009; 27:591-598
    • (2009) J Clin Oncol , vol.27 , pp. 591-598
    • Fidias, P.M.1    Dakhil, S.R.2    Lyss, A.P.3
  • 28
    • 34248364457 scopus 로고    scopus 로고
    • Docetaxel consolidation therapy following cisplatin, vinorelbine, and concurrent thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer
    • Sekine I, Nokihara H, Sumi M, et al. Docetaxel consolidation therapy following cisplatin, vinorelbine, and concurrent thoracic radiotherapy in patients with unresectable stage III non-small-cell lung cancer. J Thorac Oncol 2006; 1:810-815
    • (2006) J Thorac Oncol , vol.1 , pp. 810-815
    • Sekine, I.1    Nokihara, H.2    Sumi, M.3
  • 29
    • 19944426696 scopus 로고    scopus 로고
    • Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small-cell lung cancer: A multicenter, randomized, phase II trial
    • Scagliotti GV, Kortsik C, Dark GG, et al. Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small-cell lung cancer: a multicenter, randomized, phase II trial. Clin Cancer Res 2005; 11:690-696
    • (2005) Clin Cancer Res , vol.11 , pp. 690-696
    • Scagliotti, G.V.1    Kortsik, C.2    Dark, G.G.3
  • 30
    • 28044463139 scopus 로고    scopus 로고
    • Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced non-small-cell lung cancer
    • Zinner RG, Fossella FV, Gladish GW, et al. Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced non-small-cell lung cancer. Cancer 2005; 104:2449-2456
    • (2005) Cancer , vol.104 , pp. 2449-2456
    • Zinner, R.G.1    Fossella, F.V.2    Gladish, G.W.3
  • 31
    • 70249116447 scopus 로고    scopus 로고
    • Phase II study of pemetrexed and carboplatin plus bevacizumab with maintenance pemetrexed and bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer
    • Patel JD, Hensing TA, Rademaker A, et al. Phase II study of pemetrexed and carboplatin plus bevacizumab with maintenance pemetrexed and bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer. J Clin Oncol 2009; 27:3284-3289
    • (2009) J Clin Oncol , vol.27 , pp. 3284-3289
    • Patel, J.D.1    Hensing, T.A.2    Rademaker, A.3
  • 32
    • 70349452141 scopus 로고    scopus 로고
    • Treatment rationale and study design for the pointbreak study: A randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/bevacizumab versus paclitaxel/carboplatin/ bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer
    • Patel JD, Bonomi P, Socinski MA, et al. Treatment rationale and study design for the pointbreak study: a randomized, open-label phase III study of pemetrexed/carboplatin/bevacizumab followed by maintenance pemetrexed/ bevacizumab versus paclitaxel/carboplatin/bevacizumab followed by maintenance bevacizumab in patients with stage IIIB or IV nonsquamous non-small-cell lung cancer. Clin Lung Cancer 2009; 10:252-256
    • (2009) Clin Lung Cancer , vol.10 , pp. 252-256
    • Patel, J.D.1    Bonomi, P.2    Socinski, M.A.3
  • 33
    • 33845382806 scopus 로고
    • Nonparametric estimation of incomplete observations
    • Kaplan E, Meier P. Nonparametric estimation of incomplete observations. J Am Stat Assoc 1958; 53:457-481
    • (1958) J Am Stat Assoc , vol.53 , pp. 457-481
    • Kaplan, E.1    Meier, P.2
  • 34
    • 34249843852 scopus 로고    scopus 로고
    • Survival without common toxicity criteria grade 3/4 toxicity for pemetrexed compared with docetaxel in previously treated patients with advanced non-small-cell lung cancer (NSCLC): A risk-benefit analysis
    • Pujol JL, Paul S, Chouaki N, et al. Survival without common toxicity criteria grade 3/4 toxicity for pemetrexed compared with docetaxel in previously treated patients with advanced non-small-cell lung cancer (NSCLC): a risk-benefit analysis. J Thorac Oncol 2007; 2:397-401.
    • (2007) J Thorac Oncol , vol.2 , pp. 397-401
    • Pujol, J.L.1    Paul, S.2    Chouaki, N.3
  • 35
    • 68749101759 scopus 로고    scopus 로고
    • Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaive patients with advanced non-small-cell lung cancer: A risk-benefit analysis of a large phase III study
    • Scagliotti GV, Park K, Patil S, et al. Survival without toxicity for cisplatin plus pemetrexed versus cisplatin plus gemcitabine in chemonaive patients with advanced non-small-cell lung cancer: a risk-benefit analysis of a large phase III study. Eur J Cancer 2009; 45:2298-2303
    • (2009) Eur J Cancer , vol.45 , pp. 2298-2303
    • Scagliotti, G.V.1    Park, K.2    Patil, S.3
  • 36
    • 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
    • Therasse P, Arbuck S, Eisenhauer EA. 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
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.2    Eisenhauer, E.A.3
  • 37
    • 3242881591 scopus 로고    scopus 로고
    • National Cancer Institute Accessed: January 18, 2010
    • National Cancer Institute. Common Terminology Criteria for Adverse Events v3.0 (CTCAE). http://ctep.cancer.gov/protocolDevelopment/electronic- applications/docs/ctcaev3.pdf. Accessed: January 18, 2010.
    • Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
  • 42
    • 0000336139 scopus 로고
    • Regression models and life-tables
    • Cox DR. Regression models and life-tables. J R Stat Soc 1972; 74:187-220.
    • (1972) J R Stat Soc , vol.74 , pp. 187-220
    • Cox, D.R.1
  • 43
    • 0020399170 scopus 로고
    • Tables of the number of patients required in clinical trials using the logrank test
    • Freedman LS. Tables of the number of patients required in clinical trials using the logrank test. Stat Med 1982; 1:121-129
    • (1982) Stat Med , vol.1 , pp. 121-129
    • Freedman, L.S.1


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