Phase II study of bevacizumab plus irinotecan on the treatment of relapsed resistant small cell lung cancer

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• 作者：Dimitrios T. Trafalis ; Constantinos Alifieris…
• 关键词：Small cell lung cancer ; Resistant ; Irinotecan ; Bevacizumab ; VEGF ; Topoisomerase
• 刊名：Cancer Chemotherapy and Pharmacology
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：77
• 期：4
• 页码：713-722
• 全文大小：1,162 KB
• 参考文献：1.American Cancer Society (2015) Cancer facts & figures 2015. Retrieved from http://​www.​cancer.​org/​acs/​groups/​content/​@editorial/​documents/​document/​acspc-044552.​pdf
  2.Fischer B, Arcaro A (2008) Current status of clinical trials for small cell lung cancer. Rev Recent Clin Trials 3:40–61CrossRef PubMed
  3.Govindan R, Page N, Morgensztern D, Read W, Tierney R, Vlahiotis A, Spitznagel EL, Piccirilo J (2006) 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 24:4539–4544CrossRef PubMed
  4.Roth BJ, Johnson DH, Einhorn LH, Schacter LP, Cherng NC, Cohen HJ, Crawford J, Randolph JA, Goodlow JL, Broun GO (2010) Randomized study of cyclophosphamide, doxorubicin and vincristine versus etoposide and cisplatin versus alternation of these two regimens in extensive small-cell lung cancer: a phase III trial of the Southeastern Cancer Study Group. J Clin Oncol 21(5):v244–v247
  5.Niell HB, Herndon JE 2nd, Miller AA, Watson DM, Sandler AB, Kelly K, Marks RS, Perry MC, Ansari RH, Otterson G, Ellerton J, Vokes EE, Green MR, Cancer and Leukemia Group (2005) Randomized phase III intergroup trial of etoposide and cisplatin with or without paclitaxel and granulocyte colony-stimulating factor in patients with wxtensive-stage small-cell lung cancer: Cancer and Leukemia Group B Trial 9732. J Clin Oncol 23(16):3752–3759CrossRef PubMed
  6.Stathopoulos GP, Trafalis D, Dimitroulis J, Kosmas Ch, Stathopoulos J, Tsavdaridis D (2013) Combination of three cytotoxic agents in small-cell lung cancer. Cancer Chemother Pharmacol 71(2):413–418CrossRef PubMed PubMedCentral
  7.Ardizzoni A, Tiseo M, Boni L (2014) Validation of standard definition of sensitive versus refractory relapsed small cell lung cancer: a pooled analysis of topotecan second-line trials. Eur J Cancer 50(13):2211–2218CrossRef PubMed
  8.O’Brien ME, Ciuleanu TE, Tsekov H, Shparyk Y, Cuceviá B, Juhasz G, Thatcher N, Ross GA, Dane GC, Crofts T (2006) Phase III trial comparing supportive care alone with supportive care with oral topotecan in patients with relapsed small-cell lung cancer. J Clin Oncol 24:5441–5447CrossRef PubMed
  9.Stathopoulos GP, Ardavanis A, Papakotoulas P, Pectasides D, Papadopoulos G, Antoniou D, Athanasiadis A, Trafalis D, Anagnostopoulos A, Koutantos J, Vaslamatzis M (2010) Myelotoxicity of oral topotecan in relation to treatment duration and dosage: a phase I study. Anticancer Drugs 21:202–205CrossRef PubMed
  10.Eckardt JR, von Powel J, Pujol JL, Papai Z, Quiox E, Ardizzoni A, Poulin R, Preston AJ, Dane G, Ross G (2007) Phase III study of oral compared with intravenous topotecan as second-line therapy in small-cell lung cancer. J Clin Oncol 25:2086–2092CrossRef PubMed
  11.Noda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N, Japan Clinical Oncology Group (2002) Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med 346(2):85–91CrossRef PubMed
  12.Zatloukal P, Cardenal F, Szczesna A, Gorbunova V, Moiseyenko V, Zhang X, Cisar L, Soria JC, Domine M, Thomas M (2010) A multicenter international randomized phase III study comparing cisplatin in combination with irinotecan or etoposide in previously untreated small-cell lung cancer patients with extensive disease. Ann Oncol 21(9):1810–1816CrossRef PubMed
  13.Lara PN Jr, Natale R, Crowley J, Lenz HJ, Redman MW, Carleton JE, Jett J, Langer CJ, Kuebler JP, Dakhil SR, Chansky K, Gandara DR (2009) Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomics results from SWOG S0124. J Clin Oncol 27(15):2530–2535CrossRef PubMed PubMedCentral
  14.Hanna N, Bunn PA Jr, Langer C, Einhorn L, Guthrie T Jr, Beck T, Ansari R, Ellis P, Byrne M, Morrison M, Hariharan S, Wang B, Sandler A (2006) Randomized phase III trial comparing irinotecan/cisplatin in patients with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 24:2038–2043CrossRef PubMed
  15.Masuda N, Fukuoka M, Kusunoki Y, Matsui K, Takifuji N, Kudoh S, Negoro S, Nishioka M, Nakagawa K, Takada M (1992) CPT-11: a new derivative of camptothecin for the treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 10(8):1225–1229PubMed
  16.Ready NE, Dudek AZ, Pang HH, Hodgson LD, Graziano SL, Green MR, Vokes EE (2011) Cisplatin, irinotecan, and bevacizumab for untreated extensive-stage small-cell lung cancer: CALGB 3306, a phase II study. J Clin Oncol 29:4436–4441CrossRef PubMed PubMedCentral
  17.Spigel DR, Greco FA, Zubkus JD, Murphy PB, Saez RA, Farley C, Yardley DA, Burris HA 3rd, Hainsworth JD (2009) Phase II trial of irinotecan, carboplatin, and bevacizumab in the treatment of patients with extensive-stage small-cell lung cancer. J Thorac Oncol 4(12):1555–1560CrossRef PubMed
  18.Jalal S, Bedano P, Einhorn L, Bhatia S, Ansari R, Bechar N, Koneru K, Govindan R, Wu J, Yu M, Schneider B, Hanna N (2010) Paclitaxel plus bevacizumab in patients with chemosensitive relapsed small cell lung cancer: a safety, feasibility, and efficacy study from the Hoosier Oncology Group. J Thorac Oncol 5(12):2008–2011CrossRef PubMed
  19.Mountzios G, Emmanouilidis C, Vardakis N, Kontopodis E, Hatzidaki D, Popis E, Karachaliou N, Kotsakis A, Agelidou M, Georgoulias V (2012) Paclitaxel plus bevacizumab in patients with chemoresistant relapsed small cell lung cancer as salvage treatment: a phase II multicenter study of the Hellenic Oncology research group. Lung Cancer 77:146–150CrossRef PubMed
  20.Wildiers H, Guetens G, De Boeck G, Verbeken E, Landuyt B, Landuyt W, de Brujin EA, van Oosterom AT (2003) Effect of antivascular endothelial growth factor treatment on the intratumoral uptake of CPT-11. Br J Cancer 88(12):1979–1986CrossRef PubMed PubMedCentral
  21.Spigel DR, Waterhouse DM, Lane S, Legenne P, Bhatt K (2013) Efficacy and safety of oral topotecan and bevacizumab combination as second-line treatment for relapsed small-cell lung cancer: an open-label multicenter single-arm phase II study. Clin Lung Cancer 14:356–363CrossRef PubMed
  22.Alifieris C, Trafalis DT (2015) Glioblastoma multiforme: pathogenesis and treatment. Pharmacol Ther 152:63–82CrossRef PubMed
  23.Basch E, Reeve B, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O’Mara AM, Chen A, Kelaghan J, Benett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D (2014) Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst 106(9):dju244. doi:10.​1093/​jnci/​dju244 CrossRef PubMed PubMedCentral
  24.Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar DoddL, Kaplan R, Lacombe D, Verweij J (2009) New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur J Cancer 45:228–247CrossRef PubMed
  25.Jung SH, Lee T, Kim K, George SL (2004) Admissible two-stage designs for phase II cancer clinical trials. Stat Med 23(4):561–569CrossRef PubMed
  26.Owonikoko TK, Behera M, Chen Z, Bhimani C, Curran WJ, Khuri FR, Ramalingam SS (2012) A systematic analysis of efficacy of second line chemotherapy in sensitive and refractory small cell lung cancer. J Thorac Oncol 7:866–872CrossRef PubMed PubMedCentral
  27.Jiang J, Liang X, Zhou X, Huang L, Huang R, Chu Z, Zhan Q (2012) A meta-analysis of randomized controlled trials comparing irinotecan/platinum with etoposide/platinum in patients with previously untreated extensive-stage small cell lung cancer. J Thorac Oncol 5(6):867–873CrossRef
  28.Pallis A, Agelidou A, Agelaki S, Varthalitis I, Pavlakou G, Gerogianni A, Papakotoulas P, Rapti A, Chandrinos V, Christophyllakis C, Georgoulias V (2009) A multicenter randomized phase II study of the irinotecan/gemcitabine doublet versus irinotecan monotherapy in previously treated patients with extensive stage small-cell lung cancer. Lung Cancer 65:187–191CrossRef PubMed
  29.Masuda N, Matsui K, Negoro S, Takifuji N, Takeda K, Yana T, Kobayashi M, Hirashima T, Kusunoki Y, Ushjima S, Kawase I, Tada T, Sawaguchi H, Fukuoka M (1998) Combination of irinotecan and etoposide for treatment of refractory or relapsed small-cell lung cancer. J Clin Oncol 16:3329–3334PubMed
  30.Ramalingam SS, Foster J, Gooding W, Evans T, Sulecki M, Belani CP (2010) Phase 2 study of irinotecan and paclitaxel in patients with recurrent or refractory small cell lung cancer. Cancer 116:1344–1349CrossRef PubMed
  31.Lucchi M, Mussi A, Fontanini G, Faviana P, Ribechini A, Angeletti C (2002) Small cell lung carcinoma (SCLC): the angiogenic phenomenon. Eur J Cardiothorac Surg 21:1105–1110CrossRef PubMed
  32.Ustuner Z, Saip P, Yasasever V, Vural B, Yazar A, Bal C, Ozturk B, Ozbek U, Topuz E (2008) Prognostic and predictive value of vascular endothelial growth factor and its soluble receptors, VEGFR-1 and VEGFR-2 levels in the sera of small cell lung cancer patients. Med Oncol 25:394–399CrossRef PubMed
  33.Zhan P, Wang J, Lv XJ, Wang Q, Qiu LX, Lin XQ, Yu LK, Song Y (2009) Prognostic value of vascular endothelial growth factor expression in patients with lung cancer: a systematic review with meta-analysis. J Thorac Oncol 4:1094–1103CrossRef PubMed
  34.Spigel DR, Hainsworth JD, Yardley DA, Raefsky E, Patton J, Peacock N, Farley C, Burris HA 3rd, Greco FA (2010) Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab. J Clin Oncol 28:43–48CrossRef PubMed
  35.Harmsma M, Schutte B, Ramaekers FC (2013) Serum markers in small cell lung cancer: opportunities for improvement. Biochim Biophys Acta 1836(2):255–272PubMed
  36.Naka N, Kawahara M, Okishio K, Hosoe S, Ogawara M, Atagi S, Takemoto Y, Ueno K, Kawaguchi T, Tsuchiyama T, Furuse K (2002) Phase II study of weekly irinotecan and carboplatin for refractory or relapsed small-cell lung cancer. Lung Cancer 37:319–323CrossRef PubMed
  37.Ichiki M, Gohara R, Rikimaru T, Kitajima T, Fujiki R, Shimada A, Aizawa H (2003) Combination chemotherapy with irinotecan and ifosfamide as second-line treatment of refractory or sensitive relapsed small cell lung cancer: a phase II study. Chemotherapy 49:200–205CrossRef PubMed
  38.Schuette W, Nagel S, Juergens S, Bork I, Wollschlaeger B, Schaedlich S, Blankenburg T (2005) Phase II trial of gemcitabine/irinotecan in refractory or relapsed small-cell lung cancer. Clin Lung Cancer 7:133–137CrossRef PubMed
  39.Rocha-Lima CM, Herndon JE 2nd, Lee ME, Atkins JN, Mauer A, Vokes E, Green MR, Cancer and Leukemia Group B (2007) Phase II trial of irinotecan/gemcitabine as second-line therapy for relapsed and refractory small-cell lung cancer: Cancer and Leukemia Group B Study 39902. Ann Oncol 18(2):331–337CrossRef PubMed
  40.Xenidis N, Vardakis N, Varthalitis I, Giassas S, Kontopodis E, Ziras N, Gioulbasanis I, Samonis G, Kalbakis K, Georgoulias V (2011) A multicenter phase II study of pegylated liposomal doxorubicin in combination with irinotecan as second-line treatment of patients with refractory small-cell lung cancer. Cancer Chemother Pharmacol 68:63–68CrossRef PubMed
  
• 作者单位：Dimitrios T. Trafalis (1) (2)
  Constantinos Alifieris (1) (2)
  George P. Stathopoulos (2)
  Nikolaos Sitaras (1)
  
  1. Laboratory of Pharmacology, Medical School, University of Athens, 75 Mikras Asias, Goudi, 115-27, Athens, Greece
  2. Department of Medical Oncology-A, “Henry Dunant” Hospital Center, Athens, Greece
  
• 刊物类别：Biomedical and Life Sciences
• 刊物主题：Biomedicine
  Cancer Research
  Pharmacology and Toxicology
  Oncology
  
• 出版者：Springer Berlin / Heidelberg
• ISSN：1432-0843

文摘

Purpose This phase II study investigates the efficacy and safety of DNA topoisomerase I inhibitor irinotecan plus bevacizumab a monoclonal antibody against VEGF (BEVIRI) in patients with relapsed chemo-resistant SCLC.