Investigation of Prognostic Factors Affecting Efficacy in Carboplatin- and Paclitaxel-based First-line Chemotherapies for Advanced Non-small-cell Lung Cancer

Ferlay J. , Soerjomataram I. , Dikshit R. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015; 136(5): E359–E386.

Molina J.R. , Yang P. , Cassivi S.D. , Schild S.E. , Adjei A.A. Non-small cell lung cancer: epidemiology, risk factors, treatment, and survivorship. Mayo Clin Proc. 2008; 83(5): 584–594.

Goldstraw P. , Crowley J. , Chansky K. ; International Association for the Study of Lung Cancer International Staging Committee; Participating Institutions. The IASLC Lung Cancer Staging Project: proposals for the revision of the TNM stage groupings in the forthcoming (seventh) edition of the TNM Classification of malignant tumours [erratum 2007;2: 985]. J Thorac Oncol. 2007; 2(8): 706–714.

National Comprehensive Cancer Network. Clinical practice guidelines in oncology non-small cell lung cancer, version 2. Washington, DC: National Comprehensive Cancer Network; 2015.

Soo R.A. , Loh M. , Mok T.S. Ethnic differences in survival outcome in patients with advanced stage non-small cell lung cancer: results of a meta-analysis of randomized controlled trials. J Thorac Oncol. 2011; 6(6): 1030–1038.

Scagliotti G.V. , Vynnychenko I. , Park K. International, randomized, placebo-controlled, double-blind phase III study of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous non-small-cell lung cancer: MONET1. J Clin Oncol. 2012; 30(23): 2829–2836.

Lilenbaum R. , Axelrod R. , Thomas S. Randomized phase II trial of erlotinib or standard chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2. J Clin Oncol. 2008; 26(6): 863–869.

Lynch T.J. , Bondarenko I. , Luft A. Ipilimumab in combination with paclitaxel and carboplatin as first-line treatment in stage IIIB/IV non-small-cell lung cancer: results from a randomized, double-blind, multicenter phase II study [erratum 2012;30: 3654]. J Clin Oncol. 2012; 30(17): 2046–2054.

Niho S. , Kunitoh H. , Nokihara H. ; JO19907 Study Group. Randomized phase II study of first-line carboplatin-paclitaxel with or without bevacizumab in Japanese patients with advanced non-squamous non-small-cell lung cancer. Lung Cancer. 2012; 76(3): 362–367.

Soria J.C. , Márk Z. , Zatloukal P. Randomized phase II study of dulanermin in combination with paclitaxel, carboplatin, and bevacizumab in advanced non-small-cell lung cancer. J Clin Oncol. 2011; 29(33): 4442–4451.

Quoix E. , Zalcman G. , Oster J.P. ; Intergroupe Francophone de Cancérologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011; 378(9796): 1079–1088.

Lara P.N. Jr. , Douillard J.Y. , Nakagawa K. Randomized phase III placebo-controlled trial of carboplatin and paclitaxel with or without the vascular disrupting agent vadimezan (ASA404) in advanced non-small-cell lung cancer. J Clin Oncol. 2011; 29(22): 2965–2971.

Hirsh V. , Paz-Ares L. , Boyer M. Randomized phase III trial of paclitaxel/carboplatin with or without PF-3512676 (Toll-like receptor 9 agonist) as first-line treatment for advanced non-small-cell lung cancer. J Clin Oncol. 2011; 29(19): 2667–2674.

Digumarti R. , Wang Y. , Raman G. A randomized, double-blind, placebo-controlled, phase II study of oral talactoferrin in combination with carboplatin and paclitaxel in previously untreated locally advanced or metastatic non-small cell lung cancer. J Thorac Oncol. 2011; 6(6): 1098–1103.

Han B. , Xiu Q. , Wang H. A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of paclitaxel-carboplatin alone or with endostar for advanced non-small cell lung cancer. J Thorac Oncol. 2011; 6(6): 1104–1109.

Saito H. , Nakagawa K. , Takeda K. Randomized phase II study of carboplatin-paclitaxel or gemcitabine-vinorelbine in patients with advanced nonsmall cell lung cancer and a performance status of 2: West Japan Thoracic Oncology Group 0004. Am J Clin Oncol. 2012; 35(1): 58–63.

Biesma B. , Wymenga A.N. , Vincent A. ; Dutch Chest Physician Study Group. Quality of life, geriatric assessment and survival in elderly patients with non-small-cell lung cancer treated with carboplatin-gemcitabine or carboplatin-paclitaxel: NVALT-3 a phase III study. Ann Oncol. 2011; 22(7): 1520–1527.

Weissman C.H. , Reynolds C.H. , Neubauer M.A. , Pritchard S. , Kobina S. , Asmar L. A phase III randomized trial of gemcitabineoxaliplatin versus carboplatin-paclitaxel as first-line therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2011; 6(2): 358–364.

Okamoto I. , Yoshioka H. , Morita S. Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naïve patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study. J Clin Oncol. 2010; 28(36): 5240–5246.

Belani C.P. , Ramalingam S. , Perry M.C. Randomized, phase III study of weekly paclitaxel in combination with carboplatin versus standard every-3-weeks administration of carboplatin and paclitaxel for patients with previously untreated advanced non-small-cell lung cancer. J Clin Oncol. 2008; 26(3): 468–473.

Goss G.D. , Arnold A. , Shepherd F.A. Randomized, double-blind trial of carboplatin and paclitaxel with either daily oral cediranib or placebo in advanced non-small-cell lung cancer: NCIC clinical trials group BR24 study. J Clin Oncol. 2010; 28(1): 49–55.

Blumenschein G.R. Jr. , Khuri F.R. , von Pawel J. Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. J Clin Oncol. 2008; 26(11): 1879–1885.

Scagliotti G. , Novello S. , von Pawel J. Phase III study of carboplatin and paclitaxel alone or with sorafenib in advanced non-small-cell lung cancer. J Clin Oncol. 2010; 28(11): 1835–1842.

Herbst R.S. , Prager D. , Hermann R. ; TRIBUTE Investigator Group. TRIBUTE: a phase III trial of erlotinib hydrochloride (OSI-774) combined with carboplatin and paclitaxel chemotherapy in advanced non-small-cell lung cancer. J Clin Oncol. 2005; 23(25): 5892–5899.

Herbst R.S. , Giaccone G. , Schiller J.H. Gefitinib in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: a phase III trial: INTACT 2. J Clin Oncol. 2004; 22(5): 785–794.

Leighl N.B. , Paz-Ares L. , Douillard J.Y. Randomized phase III study of matrix metalloproteinase inhibitor BMS-275291 in combination with paclitaxel and carboplatin in advanced non-small-cell lung cancer: National Cancer Institute of Canada-Clinical Trials Group Study BR.18. J Clin Oncol. 2005; 23(12): 2831–2839.

Lilenbaum R.C. , Herndon J.E. II , List M.A. Single-agent versus combination chemotherapy in advanced non-small-cell lung cancer: the cancer and leukemia group B (study 9730). J Clin Oncol. 2005; 23(1): 190–196.

Heymach J.V. , Paz-Ares L. , De Braud F. Randomized phase II study of vandetanib alone or with paclitaxel and carboplatin as first-line treatment for advanced non-small-cell lung cancer. J Clin Oncol. 2008; 26(33): 5407–5415.

Langer C. , Li S. , Schiller J. , Tester W. , Rapoport B.L. , Johnson D.H. ; Eastern Cooperative Oncology Group. Randomized phase II trial of paclitaxel plus carboplatin or gemcitabine plus cisplatin in Eastern Cooperative Oncology Group performance status 2 non-small-cell lung cancer patients: ECOG 1599. J Clin Oncol. 2007; 25(4): 418–423.

Paccagnella A. , Oniga F. , Bearz A. Adding gemcitabine to paclitaxel/carboplatin combination increases survival in advanced non-small-cell lung cancer: results of a phase II-III study [erratum 2006;24: 2220]. J Clin Oncol. 2006; 24(4): 681–687.

Williamson S.K. , Crowley J.J. , Lara P.N. Jr. ; Southwest Oncology Group Trial S0003. Phase III trial of paclitaxel plus carboplatin with or without tirapazamine in advanced non-small-cell lung cancer: Southwest Oncology Group Trial S0003. J Clin Oncol. 2005; 23(36): 9097–9104.

Ohe Y. , Ohashi Y. , Kubota K. Randomized phase III study of cisplatin plus irinotecan versus carboplatin plus paclitaxel, cisplatin plus gemcitabine, and cisplatin plus vinorelbine for advanced non-small-cell lung cancer: Four-Arm Cooperative Study in Japan. Ann Oncol. 2007; 18(2): 317–323.

Kubota K. , Kawahara M. , Ogawara M. ; Japan Multi-National Trial Organisation. Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study. Lancet Oncol. 2008; 9(12): 1135–1142.

Sakakibara T. , Inoue A. , Sugawara S. Randomized phase II trial of weekly paclitaxel combined with carboplatin versus standard paclitaxel combined with carboplatin for elderly patients with advanced non-small-cell lung cancer. Ann Oncol. 2010; 21(4): 795–799.

Stathopoulos G.P. , Veslemes M. , Georgatou N. Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial. Ann Oncol. 2004; 15(7): 1048–1055.

Scagliotti G.V. , De Marinis F. , Rinaldi M. ; Italian Lung Cancer Project. Phase III randomized trial comparing three platinum-based doublets in advanced non-small-cell lung cancer. J Clin Oncol. 2002; 20(21): 4285–4291.

Schiller J.H. , Harrington D. , Belani C.P. ; Eastern Cooperative Oncology Group. Comparison of four chemotherapy regimens for advanced non-small-cell lung cancer. N Engl J Med. 2002; 346(2): 92–98.

Rosell R. , Gatzemeier U. , Betticher D.C. Phase III randomised trial comparing paclitaxel/carboplatin with paclitaxel/cisplatin in patients with advanced non-small-cell lung cancer: a cooperative multinational trial. Ann Oncol. 2002; 13(10): 1539–1549.

Sandler A. , Gray R. , Perry M.C. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer [erratum 2007;356: 318]. N Engl J Med. 2006; 355(24): 2542–2550.

Belani C.P. , Lee J.S. , Socinski M.A. Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer. Ann Oncol. 2005; 16(7): 1069–1075.

Kosmidis P. , Mylonakis N. , Nicolaides C. Paclitaxel plus carboplatin versus gemcitabine plus paclitaxel in advanced non-small-cell lung cancer: a phase III randomized trial. J Clin Oncol. 2002; 20(17): 3578–3585.

Kelly K. , Crowley J. , Bunn P.A. Jr. Randomized phase III trial of paclitaxel plus carboplatin versus vinorelbine plus cisplatin in the treatment of patients with advanced non-small-cell lung cancer: a Southwest Oncology Group trial. J Clin Oncol. 2001; 19(13): 3210–3218.

Treat J.A. , Gonin R. , Socinski M.A. ; Alpha Oncology Research Network. A randomized, phase III multicenter trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin in patients with advanced or metastatic non-small-cell lung cancer. Ann Oncol. 2010; 21(3): 540–547.

Mok T.S. , Wu Y.L. , Thongprasert S. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009; 361(10): 947–957.

Langer C.J. , O'Byrne K.J. , Socinski M.A. Phase III trial comparing paclitaxel poliglumex (CT-2103, PPX) in combination with carboplatin versus standard paclitaxel and carboplatin in the treatment of PS 2 patients with chemotherapy-naïve advanced non-small cell lung cancer. J Thorac Oncol. 2008; 3(6): 623–630.

Pathak A.K. , Bhutani M. , Guleria R. Chemotherapy alone vs. chemotherapy plus high dose multiple antioxidants in patients with advanced non small cell lung cancer. J Am Coll Nutr. 2005; 24(1): 16–21.

Lilenbaum R.C. , Chen C.S. , Chidiac T. Phase II randomized trial of vinorelbine and gemcitabine versus carboplatin and paclitaxel in advanced non-small-cell lung cancer. Ann Oncol. 2005; 16(1): 97–101.

Chen Y.M. , Perng R.P. , Tsai C.M. , Whang-Peng J. A Phase II randomized study of paclitaxel plus carboplatin or cisplatin against chemo-naive inoperable non-small cell lung cancer in the elderly. J Thorac Oncol. 2006; 1(2): 141–145.

Chen Y.M. , Perng R.P. , Lee Y.C. Paclitaxel plus carboplatin, compared with paclitaxel plus gemcitabine, shows similar efficacy while more cost-effective: a randomized phase II study of combination chemotherapy against inoperable non-small-cell lung cancer previously untreated. Ann Oncol. 2002; 13(1): 108–115.

Marsland T.A. , Garfield D.H. , Khan M.M. , Look R.M. , Boehm K.A. , Asmar L. Sequential versus concurrent paclitaxel and carboplatin for the treatment of advanced non-small cell lung cancer in elderly patients and patients with poor performance status: results of two Phase, II, multicenter trials. Lung Cancer. 2005; 47(1): 111–120.

Belani C.P. , Barstis J. , Perry M.C. 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(15): 2933–2939.

Socinski M.A. , Ivanova A. , Bakri K. A randomized phase II trial comparing every 3-weeks carboplatin/paclitaxel with every 3-weeks carboplatin and weekly paclitaxel in advanced non-small cell lung cancer. Ann Oncol. 2006; 17(1): 104–109.

Kosmidis P. , Mylonakis N. , Skarlos D. Paclitaxel (175 mg/m²) plus carboplatin (6 AUC) versus paclitaxel (225 mg/m²) plus carboplatin (6 AUC) in advanced non-small-cell lung cancer (NSCLC): a multicenter randomized trial. Hellenic Cooperative Oncology Group (HeCOG). Ann Oncol. 2000; 11(7): 799–805.

Socinski M.A. , Schell M.J. , Peterman A. 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(5): 1335–1343.

Schuette W. , Blankenburg T. , Guschall W. Multicenter randomized trial for stage IIIB/IV non-small-cell lung cancer using every-3-week versus weekly paclitaxel/carboplatin. Clin Lung Cancer. 2006; 7(5): 338–343.

Laurie S.A. , Solomon B.J. , Seymour L. Randomised, double-blind trial of carboplatin and paclitaxel with daily oral cediranib or placebo in patients with advanced non-small cell lung cancer: NCIC Clinical Trials Group study BR29. Eur J Cancer. 2014; 50(4): 706–712.

Paz-Ares L. , Bálint B. , de Boer R.H. A randomized phase 2 study of paclitaxel and carboplatin with or without conatumumab for first-line treatment of advanced non-small-cell lung cancer. J Thorac Oncol. 2013; 8(3): 329–337.

Socinski M.A. , Bondarenko I. , Karaseva N.A. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012; 30(17): 2055–2062.

Ou S.H. , Ziogas A. , Zell J.A. Asian ethnicity is a favorable prognostic factor for overall survival in non-small cell lung cancer (NSCLC) and is independent of smoking status. J Thorac Oncol. 2009; 4(9): 1083–1093.

Ahn M.J. , Lee J. , Park Y.H. Korean ethnicity as compared with white ethnicity is an independent favorable prognostic factor for overall survival in non-small cell lung cancer before and after the oral epidermal growth factor receptor tyrosine kinase inhibitor era. J Thorac Oncol. 2010; 5(8): 1185–1196.

Kawaguchi T. , Matsumura A. , Fukai S. Japanese ethnicity compared with Caucasian ethnicity and never-smoking status are independent favorable prognostic factors for overall survival in non-small cell lung cancer: a collaborative epidemiologic study of the National Hospital Organization Study Group for Lung Cancer (NHSGLC) in Japan and a Southern California Regional Cancer Registry databases. J Thorac Oncol. 2010; 5(7): 1001–1010.

Gandara D.R. , Kawaguchi T. , Crowley J. Japanese-US commonarm analysis of paclitaxel plus carboplatin in advanced non-small-cell lung cancer: a model for assessing population-related pharmacogenomics. J Clin Oncol. 2009; 27(21): 3540–3546.

Mitsudomi T. , Kosaka T. , Endoh H. Mutations of the epidermal growth factor receptor gene predict prolonged survival after gefitinib treatment in patients with non-small-cell lung cancer with postoperative recurrence. J Clin Oncol. 2005; 23(11): 2513–2520.

Han S.W. , Kim T.Y. , Hwang P.G. 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(11): 2493–2501.

Takano T. , Ohe Y. , Sakamoto H. 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(28): 6829–6837.

Cortes-Funes H. , Gomez C. , Rosell R. Epidermal growth factor receptor activating mutations in Spanish gefitinib-treated non-small-cell lung cancer patients. Ann Oncol. 2005; 16(7): 1081–1086.

Taron M. , Ichinose Y. , Rosell R. Activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor are associated with improved survival in gefitinib-treated chemorefractory lung adenocarcinomas. Clin Cancer Res. 2005; 11(16): 5878–5885.

Miller V.A. , Riely G.J. , Zakowski M.F. Molecular characteristics of bronchioloalveolar carcinoma and adenocarcinoma, bronchioloalveolar carcinoma subtype, predict response to erlotinib. J Clin Oncol. 2008; 26(9): 1472–1478.

Lynch T.J. , Bell D.W. , Sordella R. Activating mutations in the epidermal growth factor receptor underlying responsiveness of non-small-cell lung cancer to gefitinib. N Engl J Med. 2004; 350(21): 2129–2139.

Paez J.G. , Jänne P.A. , Lee J.C. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004; 304(5676): 1497–1500.

Pao W. , Miller V. , Zakowski M. EGF receptor gene mutations are common in lung cancers from “never smokers” and are associated with sensitivity of tumors to gefitinib and erlotinib. Proc Natl Acad Sci USA. 2004; 101(36): 13306–13311.

Shigematsu H. , Lin L. , Takahashi T. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst. 2005; 97(5): 339–346.

Huang T.C. , Campbell T.C. Comparison of weekly versus every 3 weeks paclitaxel in the treatment of advanced solid tumors: a meta-analysis. Cancer Treat Rev. 2012; 38(6): 613–617.

Gao G. , Chu H. , Zhao L. , Gui T. , Xu Q. , Shi J. A meta-analysis of paclitaxel-based chemotherapies administered once every week compared with once every 3 weeks first-line treatment of advanced non-small-cell lung cancer. Lung Cancer. 2012; 76(3): 380–386.

Treat J. , Edelman M.J. , Belani C.P. ; Alpha Oncology Research Network. A retrospective analysis of outcomes across histological subgroups in a three-arm phase III trial of gemcitabine in combination with carboplatin or paclitaxel versus paclitaxel plus carboplatin for advanced non-small cell lung cancer. Lung Cancer. 2010; 70(3): 340–346.

Simmonds M.C. , Higgins J.P. , Stewart L.A. , Tierney J.F. , Clarke M.J. , Thompson S.G. Meta-analysis of individual patient data from randomized trials: a review of methods used in practice. Clin Trials. 2005; 2(3): 209–217.