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Published in: BMC Cancer 1/2010

Open Access 01-12-2010 | Research article

A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic Non-Small Cell Lung Cancer

Authors: Athanasios G Pallis, Sophia Agelaki, Athina Agelidou, Ioannis Varthalitis, Kostas Syrigos, Nikolaos Kentepozidis, Georgia Pavlakou, Athanasios Kotsakis, Emmanouel Kontopodis, Vassilis Georgoulias

Published in: BMC Cancer | Issue 1/2010

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Abstract

Background

To compare the activity and toxicity of docetaxel/carboplatin (DC) doublet vs single agent docetaxel (D) as second-line treatment in patients with advanced non-small cell lung cancer (NSCLC).

Methods

Patients pre-treated with front-line platinum-free regimens, were randomized to receive either docetaxel/carboplatin (DC), (docetaxel 50 mg/m2; carboplatin AUC4; both drugs administered on days 1 and 15) or docetaxel single-agent (D), (docetaxel 50 mg/m2 on days 1 and 15).

Results

Response rate was similar between the two arms (DC vs D: 10.4% vs 7.7%; p = 0.764). After a median follow-up time of 28.0 months for DC arm and 34.5 months for D arm, progression free survival (PFS) was significantly higher in the DC arm (DC vs D:3.33 months vs 2.60 months; p-value = 0.012), while no significant difference was observed in terms of overall survival (OS) (DC vs D: 10.3 months vs 7.70 months; p-value = 0.550). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed.

Conclusions

This study has not achieved its primary objective of significant OS prolongation with docetaxel/carboplatin combination over single-agent docetaxel in patients who had not received front-line docetaxel; however, the docetaxel/carboplatin combination was associated with a significant clinical benefit in terms of PFS.
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Literature
1.
go back to reference Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P: Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol. 2007, 18: 581-592. 10.1093/annonc/mdl498.CrossRefPubMed Ferlay J, Autier P, Boniol M, Heanue M, Colombet M, Boyle P: Estimates of the cancer incidence and mortality in Europe in 2006. Ann Oncol. 2007, 18: 581-592. 10.1093/annonc/mdl498.CrossRefPubMed
2.
go back to reference Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ: Cancer statistics, 2006. CA Cancer J Clin. 2006, 56: 106-130. 10.3322/canjclin.56.2.106.CrossRefPubMed Jemal A, Siegel R, Ward E, Murray T, Xu J, Smigal C, Thun MJ: Cancer statistics, 2006. CA Cancer J Clin. 2006, 56: 106-130. 10.3322/canjclin.56.2.106.CrossRefPubMed
3.
go back to reference Yang P, Allen MS, Aubry MC, Wampfler JA, Marks RS, Edell ES, Thibodeau S, Adjei AA, Jett J, Deschamps C: Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005, 128: 452-462. 10.1378/chest.128.1.452.CrossRefPubMed Yang P, Allen MS, Aubry MC, Wampfler JA, Marks RS, Edell ES, Thibodeau S, Adjei AA, Jett J, Deschamps C: Clinical features of 5,628 primary lung cancer patients: experience at Mayo Clinic from 1997 to 2003. Chest. 2005, 128: 452-462. 10.1378/chest.128.1.452.CrossRefPubMed
4.
go back to reference Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002, 346: 92-98. 10.1056/NEJMoa011954.CrossRefPubMed Schiller JH, Harrington D, Belani CP, Langer C, Sandler A, Krook J, Zhu J, Johnson DH: Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002, 346: 92-98. 10.1056/NEJMoa011954.CrossRefPubMed
5.
go back to reference Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M, Palamidas P, Vlachonikolis I: Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial. Lancet. 2001, 357: 1478-1484. 10.1016/S0140-6736(00)04644-4.CrossRefPubMed Georgoulias V, Papadakis E, Alexopoulos A, Tsiafaki X, Rapti A, Veslemes M, Palamidas P, Vlachonikolis I: Platinum-based and non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a randomised multicentre trial. Lancet. 2001, 357: 1478-1484. 10.1016/S0140-6736(00)04644-4.CrossRefPubMed
6.
go back to reference Georgoulias V, Ardavanis A, Tsiafaki X, Agelidou A, Mixalopoulou P, Anagnostopoulou O, Ziotopoulos P, Toubis M, Syrigos K, Samaras N, Polyzos A, Christou A, Kakolyris S, Kouroussis C, Androulakis N, Samonis G, Chatzidaki D: Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol. 2005, 23: 2937-2945. 10.1200/JCO.2005.04.016.CrossRefPubMed Georgoulias V, Ardavanis A, Tsiafaki X, Agelidou A, Mixalopoulou P, Anagnostopoulou O, Ziotopoulos P, Toubis M, Syrigos K, Samaras N, Polyzos A, Christou A, Kakolyris S, Kouroussis C, Androulakis N, Samonis G, Chatzidaki D: Vinorelbine plus cisplatin versus docetaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol. 2005, 23: 2937-2945. 10.1200/JCO.2005.04.016.CrossRefPubMed
7.
go back to reference Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J, Fountzilas G, Skarlos D, Economopoulos T, Tsavdaridis D, Papakostas P, Bacoyiannis C, Dimopoulos M: 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. 10.1200/JCO.2002.12.112.CrossRefPubMed Kosmidis P, Mylonakis N, Nicolaides C, Kalophonos C, Samantas E, Boukovinas J, Fountzilas G, Skarlos D, Economopoulos T, Tsavdaridis D, Papakostas P, Bacoyiannis C, Dimopoulos M: 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. 10.1200/JCO.2002.12.112.CrossRefPubMed
8.
go back to reference Gridelli C, Gallo C, Shepherd FA, Illiano A, Piantedosi F, Robbiati SF, Manzione L, Barbera S, Frontini L, Veltri E, Findlay B, Cigolari S, Myers R, Ianniello GP, Gebbia V, Gasparini G, Fava S, Hirsh V, Bezjak A, Seymour L, Perrone F: Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003, 21: 3025-3034. 10.1200/JCO.2003.06.099.CrossRefPubMed Gridelli C, Gallo C, Shepherd FA, Illiano A, Piantedosi F, Robbiati SF, Manzione L, Barbera S, Frontini L, Veltri E, Findlay B, Cigolari S, Myers R, Ianniello GP, Gebbia V, Gasparini G, Fava S, Hirsh V, Bezjak A, Seymour L, Perrone F: Gemcitabine plus vinorelbine compared with cisplatin plus vinorelbine or cisplatin plus gemcitabine for advanced non-small-cell lung cancer: a phase III trial of the Italian GEMVIN Investigators and the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 2003, 21: 3025-3034. 10.1200/JCO.2003.06.099.CrossRefPubMed
9.
go back to reference Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G: Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003, 21: 3909-3917. 10.1200/JCO.2003.03.195.CrossRefPubMed Smit EF, van Meerbeeck JP, Lianes P, Debruyne C, Legrand C, Schramel F, Smit H, Gaafar R, Biesma B, Manegold C, Neymark N, Giaccone G: Three-arm randomized study of two cisplatin-based regimens and paclitaxel plus gemcitabine in advanced non-small-cell lung cancer: a phase III trial of the European Organization for Research and Treatment of Cancer Lung Cancer Group--EORTC 08975. J Clin Oncol. 2003, 21: 3909-3917. 10.1200/JCO.2003.03.195.CrossRefPubMed
10.
go back to reference Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J: 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.PubMed Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O'Rourke M, Levitan N, Gressot L, Vincent M, Burkes R, Coughlin S, Kim Y, Berille J: 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.PubMed
11.
go back to reference Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L: 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. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol. 2000, 18: 2354-2362.PubMed Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, Kalman L, Miller V, Lee JS, Moore M, Gandara D, Karp D, Vokes E, Kris M, Kim Y, Gamza F, Hammershaimb L: 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. The TAX 320 Non-Small Cell Lung Cancer Study Group. J Clin Oncol. 2000, 18: 2354-2362.PubMed
12.
go back to reference Hanna N, Shepherd FA, Fossella FV, Pereira JR, De MF, von PJ, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar , Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA: 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. 10.1200/JCO.2004.08.163.CrossRefPubMed Hanna N, Shepherd FA, Fossella FV, Pereira JR, De MF, von PJ, Gatzemeier U, Tsao TC, Pless M, Muller T, Lim HL, Desch C, Szondy K, Gervais R, Shaharyar , Manegold C, Paul S, Paoletti P, Einhorn L, Bunn PA: 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. 10.1200/JCO.2004.08.163.CrossRefPubMed
13.
go back to reference Shepherd FA, Rodrigues PJ, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van KM, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005, 353: 123-132. 10.1056/NEJMoa050753.CrossRefPubMed Shepherd FA, Rodrigues PJ, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van KM, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L: Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005, 353: 123-132. 10.1056/NEJMoa050753.CrossRefPubMed
14.
go back to reference Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY: Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008, 372: 1809-1818. 10.1016/S0140-6736(08)61758-4.CrossRefPubMed Kim ES, Hirsh V, Mok T, Socinski MA, Gervais R, Wu YL, Li LY, Watkins CL, Sellers MV, Lowe ES, Sun Y, Liao ML, Osterlind K, Reck M, Armour AA, Shepherd FA, Lippman SM, Douillard JY: Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008, 372: 1809-1818. 10.1016/S0140-6736(08)61758-4.CrossRefPubMed
15.
go back to reference Laack E, Dierlamm T, Knuffmann C, Popp J, Schmied B, Durk H, Wacker-Backerhaus G, Zeller W, Verpoort K, Fiedler W, Kurt HD: Docetaxel and carboplatin as second-line chemotherapy for metastatic non-small cell lung cancer. Lung Cancer. 2002, 36: 303-307. 10.1016/S0169-5002(01)00477-9.CrossRefPubMed Laack E, Dierlamm T, Knuffmann C, Popp J, Schmied B, Durk H, Wacker-Backerhaus G, Zeller W, Verpoort K, Fiedler W, Kurt HD: Docetaxel and carboplatin as second-line chemotherapy for metastatic non-small cell lung cancer. Lung Cancer. 2002, 36: 303-307. 10.1016/S0169-5002(01)00477-9.CrossRefPubMed
16.
go back to reference Wachters FM, van Putten JW, Boezen HM, Groen HJ: Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC. Lung Cancer. 2004, 45: 255-262. 10.1016/j.lungcan.2004.02.006.CrossRefPubMed Wachters FM, van Putten JW, Boezen HM, Groen HJ: Phase II study of docetaxel and carboplatin as second-line treatment in NSCLC. Lung Cancer. 2004, 45: 255-262. 10.1016/j.lungcan.2004.02.006.CrossRefPubMed
17.
go back to reference D'Addario G, Pintilie M, Leighl NB, Feld R, Cerny T, Shepherd FA: Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005, 23: 2926-2936. 10.1200/JCO.2005.03.045.CrossRefPubMed D'Addario G, Pintilie M, Leighl NB, Feld R, Cerny T, Shepherd FA: Platinum-based versus non-platinum-based chemotherapy in advanced non-small-cell lung cancer: a meta-analysis of the published literature. J Clin Oncol. 2005, 23: 2926-2936. 10.1200/JCO.2005.03.045.CrossRefPubMed
18.
go back to reference Vazquez S, Grande C, Amenedo M, Firvida JL, Lazaro M, Alonso G, Curiel T, Huidobro G, Mel JR, Ramos M: Biweekly docetaxel as second-line chemotherapy of patients with advanced non-small cell lung cancer: a phase II study of the Galician Lung Cancer Group (GGCP 006-00). Anticancer Drugs. 2004, 15: 489-494. 10.1097/01.cad.0000127333.06439.0e.CrossRefPubMed Vazquez S, Grande C, Amenedo M, Firvida JL, Lazaro M, Alonso G, Curiel T, Huidobro G, Mel JR, Ramos M: Biweekly docetaxel as second-line chemotherapy of patients with advanced non-small cell lung cancer: a phase II study of the Galician Lung Cancer Group (GGCP 006-00). Anticancer Drugs. 2004, 15: 489-494. 10.1097/01.cad.0000127333.06439.0e.CrossRefPubMed
19.
go back to reference Firvida JL, Esquerdo G, Amenedo M, Salgado M, Lorca C, Perez E, Cervera-Grau J, Ramos M: Biweekly docetaxel and carboplatin as first-line therapy in patients with advanced non-small cell lung cancer. Final results of a phase II study. J Clin Oncol. 2008, 26: abstr 19097 Firvida JL, Esquerdo G, Amenedo M, Salgado M, Lorca C, Perez E, Cervera-Grau J, Ramos M: Biweekly docetaxel and carboplatin as first-line therapy in patients with advanced non-small cell lung cancer. Final results of a phase II study. J Clin Oncol. 2008, 26: abstr 19097
20.
go back to reference Cho SH, Go SI, Lee GW, Kang JH, Kim HJ, Kim SH, Cho YJ, Jeong YY, Kim HC, Lee JD, Hwang Y: Phase II study of a biweekly schedule of docetaxel and cisplatin in patients with metastatic non-small cell lung cancer. Lung Cancer. 2010, 69: 94-98. 10.1016/j.lungcan.2009.09.005.CrossRefPubMed Cho SH, Go SI, Lee GW, Kang JH, Kim HJ, Kim SH, Cho YJ, Jeong YY, Kim HC, Lee JD, Hwang Y: Phase II study of a biweekly schedule of docetaxel and cisplatin in patients with metastatic non-small cell lung cancer. Lung Cancer. 2010, 69: 94-98. 10.1016/j.lungcan.2009.09.005.CrossRefPubMed
21.
go back to reference Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van GM, 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.CrossRefPubMed Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van GM, 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.CrossRefPubMed
22.
go back to reference Cancer Therapy Evaluation Program: Common toxicity criteria. Version 2.0. DCTD, NCI, NIH, DHHS. 1998 Cancer Therapy Evaluation Program: Common toxicity criteria. Version 2.0. DCTD, NCI, NIH, DHHS. 1998
23.
go back to reference Collet D: Modelling survival data in medical research. 1994, Oxford:Blackwell Scientific, 3CrossRef Collet D: Modelling survival data in medical research. 1994, Oxford:Blackwell Scientific, 3CrossRef
24.
go back to reference Takeda K, Negoro S, Tamura T, Nishiwaki Y, Kudoh S, Yokota S, Matsui K, Semba H, Nakagawa K, Takada Y, Ando M, Shibata T, Saijo N: Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol. 2009 Takeda K, Negoro S, Tamura T, Nishiwaki Y, Kudoh S, Yokota S, Matsui K, Semba H, Nakagawa K, Takada Y, Ando M, Shibata T, Saijo N: Phase III trial of docetaxel plus gemcitabine versus docetaxel in second-line treatment for non-small-cell lung cancer: results of a Japan Clinical Oncology Group trial (JCOG0104). Ann Oncol. 2009
25.
go back to reference Smit EF, Burgers SA, Biesma B, Smit HJ, Eppinga P, Dingemans AM, Joerger M, Schellens JH, Vincent A, van ZN, Groen HJ: Randomized Phase II and Pharmacogenetic Study of Pemetrexed Compared With Pemetrexed Plus Carboplatin in Pretreated Patients With Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2009, 27: 2038-2045. 10.1200/JCO.2008.19.1650.CrossRefPubMed Smit EF, Burgers SA, Biesma B, Smit HJ, Eppinga P, Dingemans AM, Joerger M, Schellens JH, Vincent A, van ZN, Groen HJ: Randomized Phase II and Pharmacogenetic Study of Pemetrexed Compared With Pemetrexed Plus Carboplatin in Pretreated Patients With Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2009, 27: 2038-2045. 10.1200/JCO.2008.19.1650.CrossRefPubMed
26.
go back to reference Georgoulias V, Agelidou A, Syrigos K, Rapti A, Agelidou M, Nikolakopoulos J, Polyzos A, Athanasiadis A, Tselepatiotis E, Androulakis N, Kalbakis K, Samonis G, Mavroudis D: Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study. Br J Cancer. 2005, 93: 763-769. 10.1038/sj.bjc.6602748.CrossRefPubMedPubMedCentral Georgoulias V, Agelidou A, Syrigos K, Rapti A, Agelidou M, Nikolakopoulos J, Polyzos A, Athanasiadis A, Tselepatiotis E, Androulakis N, Kalbakis K, Samonis G, Mavroudis D: Second-line treatment with irinotecan plus cisplatin vs cisplatin of patients with advanced non-small-cell lung cancer pretreated with taxanes and gemcitabine: a multicenter randomised phase II study. Br J Cancer. 2005, 93: 763-769. 10.1038/sj.bjc.6602748.CrossRefPubMedPubMedCentral
27.
go back to reference Georgoulias V, Kouroussis C, Agelidou A, Boukovinas I, Palamidas P, Stavrinidis E, Polyzos A, Syrigos K, Veslemes M, Toubis M, Ardavanis A, Tselepatiotis E, Vlachonikolis I: Irinotecan plus gemcitabine vs irinotecan for the second-line treatment of patients with advanced non-small-cell lung cancer pretreated with docetaxel and cisplatin: a multicentre, randomised, phase II study. Br J Cancer. 2004, 91: 482-488. 10.1038/sj.bjc.6602010.CrossRefPubMedPubMedCentral Georgoulias V, Kouroussis C, Agelidou A, Boukovinas I, Palamidas P, Stavrinidis E, Polyzos A, Syrigos K, Veslemes M, Toubis M, Ardavanis A, Tselepatiotis E, Vlachonikolis I: Irinotecan plus gemcitabine vs irinotecan for the second-line treatment of patients with advanced non-small-cell lung cancer pretreated with docetaxel and cisplatin: a multicentre, randomised, phase II study. Br J Cancer. 2004, 91: 482-488. 10.1038/sj.bjc.6602010.CrossRefPubMedPubMedCentral
28.
go back to reference Pectasides D, Pectasides M, Farmakis D, Kostopoulou V, Nikolaou M, Gaglia A, Koumpou M, Mylonakis N, Xiros N, Economopoulos T, Raptis SA: Comparison of docetaxel and docetaxel-irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial. Ann Oncol. 2005, 16: 294-299. 10.1093/annonc/mdi053.CrossRefPubMed Pectasides D, Pectasides M, Farmakis D, Kostopoulou V, Nikolaou M, Gaglia A, Koumpou M, Mylonakis N, Xiros N, Economopoulos T, Raptis SA: Comparison of docetaxel and docetaxel-irinotecan combination as second-line chemotherapy in advanced non-small-cell lung cancer: a randomized phase II trial. Ann Oncol. 2005, 16: 294-299. 10.1093/annonc/mdi053.CrossRefPubMed
29.
go back to reference Di MM, Chiodini P, Georgoulias V, Hatzidaki D, Takeda K, Wachters FM, Gebbia V, Smit EF, Morabito A, Gallo C, Perrone F, Gridelli C: Meta-Analysis of Single Agent Chemotherapy Compared With Combination Chemotherapy as Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2009 Di MM, Chiodini P, Georgoulias V, Hatzidaki D, Takeda K, Wachters FM, Gebbia V, Smit EF, Morabito A, Gallo C, Perrone F, Gridelli C: Meta-Analysis of Single Agent Chemotherapy Compared With Combination Chemotherapy as Second-Line Treatment of Advanced Non-Small-Cell Lung Cancer. J Clin Oncol. 2009
30.
go back to reference Fidias PM, Dakhil SR, Lyss AP, Loesch DM, Waterhouse DM, Bromund JL, Chen R, Hristova-Kazmierski M, Treat J, Obasaju CK, Marciniak M, Gill J, Schiller JH: 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. 10.1200/JCO.2008.17.1405.CrossRefPubMed Fidias PM, Dakhil SR, Lyss AP, Loesch DM, Waterhouse DM, Bromund JL, Chen R, Hristova-Kazmierski M, Treat J, Obasaju CK, Marciniak M, Gill J, Schiller JH: 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. 10.1200/JCO.2008.17.1405.CrossRefPubMed
31.
go back to reference Ciuleanu TE, Brodowicz T, Belani CP, Kim J, Krzakowski M, Laack E, Wu Y, Peterson P, Adachi S, Zielinski CC: Maintenance pemetrexed plus best supportive care (BSC) versus placebo plus BSC: A phase III study. J Clin Oncol. 2008, 26: abstr 8011 Ciuleanu TE, Brodowicz T, Belani CP, Kim J, Krzakowski M, Laack E, Wu Y, Peterson P, Adachi S, Zielinski CC: Maintenance pemetrexed plus best supportive care (BSC) versus placebo plus BSC: A phase III study. J Clin Oncol. 2008, 26: abstr 8011
32.
go back to reference Cappuzzo F, Ciuleanu TE, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban-Gonzalez E, Molinier O, Klingelschmitt G, Giaccone G: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC. J Clin Oncol. 2009, 27: 10.1200/JCO.2008.19.1635. abstr 8001 Cappuzzo F, Ciuleanu TE, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban-Gonzalez E, Molinier O, Klingelschmitt G, Giaccone G: SATURN: A double-blind, randomized, phase III study of maintenance erlotinib versus placebo following nonprogression with first-line platinum-based chemotherapy in patients with advanced NSCLC. J Clin Oncol. 2009, 27: 10.1200/JCO.2008.19.1635. abstr 8001
33.
go back to reference Ardizzoni A, Boni L, Tiseo M, Fossella FV, Schiller JH, Paesmans M, Radosavljevic D, Paccagnella A, Zatloukal P, Mazzanti P, Bisset D, Rosell R: Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst. 2009, 99: 847-857.CrossRef Ardizzoni A, Boni L, Tiseo M, Fossella FV, Schiller JH, Paesmans M, Radosavljevic D, Paccagnella A, Zatloukal P, Mazzanti P, Bisset D, Rosell R: Cisplatin- versus carboplatin-based chemotherapy in first-line treatment of advanced non-small-cell lung cancer: an individual patient data meta-analysis. J Natl Cancer Inst. 2009, 99: 847-857.CrossRef
Metadata
Title
A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic Non-Small Cell Lung Cancer
Authors
Athanasios G Pallis
Sophia Agelaki
Athina Agelidou
Ioannis Varthalitis
Kostas Syrigos
Nikolaos Kentepozidis
Georgia Pavlakou
Athanasios Kotsakis
Emmanouel Kontopodis
Vassilis Georgoulias
Publication date
01-12-2010
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2010
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-10-633

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