Induction gemcitabine in standard dose or prolonged low-dose with cisplatin followed by concurrent radiochemotherapy in locally advanced non-small cell lung cancer: a randomized phase II clinical trial

1. Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JWW, Comber H, et al. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer 2013; 49: 1374-403.10.1016/j.ejca.2012.12.02723485231Search in Google Scholar

2. Siegel R, Naishadham D, Jemal A. Cancer statistics. CA Cancer J Clin 2012; 62: 10-29.10.3322/caac.2013822237781Search in Google Scholar

3. Pfister DG, Johnson DH, Azzoli CG, Sause W, Smith TJ, Baker Jr S, et al. American Society of Clinical Oncology treatment of unresectable non-small cell lung cancer guideline: update 2003. J Clin Oncol 2004; 22: 330-53.10.1200/JCO.2004.09.05314691125Search in Google Scholar

4. O´Rourke N, Roque i Figuls M, Farre Bernardo N, Macbeth F. Concurrent chemoradiotherapy in non-small cell lung cancer. Cohrane Database Systematic Reviews 2010; CD002140.10.1002/14651858.CD002140.pub320556756Search in Google Scholar

5. Curran WJ Jr, Paulus R, Langer CJ, Komaki R, Lee JS, Hauser S, et al. Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst 2012; 104: 79.Search in Google Scholar

6. Aupérin A, Le Péchoux C, Rolland E, Curran WJ, Furuse K, Fournel P, et al. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol 2010; 28: 2181-90.10.1200/JCO.2009.26.254320351327Search in Google Scholar

7. Kovac V, Smrdel U. Meta-analyses of clinical trials in patients with non-small cell lung cancer. Minireview. Neoplasma 2004; 51: 334-40.Search in Google Scholar

8. Rezonja R, Knez L, Cufer T, Mrhar A. Oral treatment with etoposide in small cell lung cancer - dilemmas and solutions. Radiol Oncol 2013; 47: 1-13.10.2478/raon-2013-0008357382823450046Search in Google Scholar

9. Zwitter M, Kovac V, Smrdel U, Vrankar M, Zadnik V. Gemcitabine in brief versus prolonged low-dose infusion, both combined with cisplatin, for advanced non-small cell lung cancer: a randomized phase II clinical trial. J Thorac Oncol 2009; 4: 1148-55.10.1097/JTO.0b013e3181ae280f19546818Search in Google Scholar

10. Zwitter M, Kovac V, Rajer M, Vrankar M, Smrdel U. Two schedules of chemotherapy for patients with non-small cell lung cancer in poor performance status: a phase II randomized trial. Anticancer Drugs 2010; 21: 662-8.10.1097/CAD.0b013e32833ab7a020453635Search in Google Scholar

11. Fossela FV, Lipman SM, Shin DM, Tarassoff P, Calayag-Jung M, Perez-Soler R, et al. Maximum-tolerated dose defined for single-agent gemcitabine: a phase I dose-escalation study in chemotherapy-naive patients with advanced non-small-cell lung cancer. J Clin Oncol 1997; 15: 310-6.10.1200/JCO.1997.15.1.3108996158Search in Google Scholar

12. Touroutoglou N, Gravel D, Raber MN, Plunkett W, Abbruzzese JL. Clinical results of a pharmacodynamically-based strategy for higher dosing of gemcitabine in patients with solid tumors. Ann Oncol 1998; 9: 1003-8.10.1023/A:1008487932384Search in Google Scholar

13. Anderson H, Thacher N, Walling J, Hansen H. A phase I study of a 24 hour infusion of gemcitabine in previously untreated patients with inoperable non-small-cell lung cancer. Br J Cancer 1996; 74: 460-2.10.1038/bjc.1996.38220746288695365Search in Google Scholar

14. Maurel J, Zorrila M, Puertolas T, Antón A, Herrero A, Artal A, et al. Phase I trial of weekly gemcitabine at 3-h infusion in refractory, heavily pretreated advanced solid tumors. Anticancer Drugs 2001; 12: 713-7.10.1097/00001813-200110000-0000111593051Search in Google Scholar

15. Pollera CF, Ceribelli A, Crecco M, Oliva C, Calabresi F. Prolonged infusion gemcitabine: a clinical phase I study at low- (300mg/m2) and high-dose (875mg/m) levels. Invest New Drugs 1997; 15: 115-21.10.1023/A:1005817024382Search in Google Scholar

16. Cattel L, Airoldi M, Delprino L, Passera R, Milla P, Pedani F. Pharmacokinetic evaluation of gemcitabine and 2´,2´-difluorodeoxycytidine-5´-triphosphate after prolonged infusion in patients affected by different solid tumors. Ann Oncol 2006; 17(Suppl 5): v142-7.10.1093/annonc/mdj97016807444Search in Google Scholar

17. Kovac V, Zwitter M, Rajer M, Marin A, Debeljak A, Smrdel U, et al. A phase II trial of low-dose gemcitabine in a prolonged infusion and cisplatin for malignant pleural mesothelioma. Anticancer Drugs 2012; 23: 230-8.10.1097/CAD.0b013e32834d7a1c22027538Search in Google Scholar

18. Zwitter M, Kovac V, Smrdel U, Kocijancic I, Segedin B, Vrankar M. Phase I-II trial of low-dose gemcitabine in prolonged infusion and cisplatin for advanced non-small cell lung cancer. Anticancer Drugs 2005; 16: 1129-34.10.1097/00001813-200511000-0001316222156Search in Google Scholar

19. Schallier D, Bral S, Ilsen B, Neyns B, Fontaine C, Decoster L, et al. Final overall results of a study with a novel triplet induction chemotherapy regimen (PACCAGE) followed by consolidation radiotherapy in locally advanced inoperable non-small cell lung cancer (NSCLC). J Thorac Oncol 2009; 4: 728-35.10.1097/JTO.0b013e3181a4ec1419404217Search in Google Scholar

20. Hirsh V, Soulieres D, Duclos M, Faria S, Dell Vecchio P, Ofiara L, et al. Phase II multicenter trial with carboplatin and gemcitabine induction chemotherapy followed by radiotherapy concomitantly with low-dose paclitaxel and gemcitabine for Stage IIIA and IIIB non-small cell lung cancer. J Thorac Oncol 2007; 2: 927-32.10.1097/JTO.0b013e3181560b9217909355Search in Google Scholar

21. Krzakowski M, Provencio M, Utracka-Hutka B, Villa E, Codes M, Kuten A, et al. Oral vinorelbine and cisplatin as induction chemotherapy and concomitant chemo-radiotherapy in stage III non-small cell lung cancer: final results of an international phase II trial. J Thorac Oncol 2008; 3: 994-1002.10.1097/JTO.0b013e31818396cb18758302Search in Google Scholar

22. Leong SS, Fong KW, Lim WT, Toh CK, Yap SP, Hee SW, et al. A phase II trial of induction gemcitabine and vinorelbine followed by concurrent vinorelbine and radiotherapy in locally advanced non-small cell lung cancer. Lung Cancer 2010; 67: 325-9.10.1016/j.lungcan.2009.04.02219481290Search in Google Scholar

23. Descourt R, Vergnenegre A, Barlesi F, Lena H, Fournel P, Falchero L, et al Oral vinorelbine and cisplatin with concurrent radiotherapy after induction chemotherapy with cisplatin and docetaxel for patients with locally advanced non-small cell lung cancer: the GFPC 05-03 study. J Thorac Oncol 2011; 6: 351-7.10.1097/JTO.0b013e318200f47e21164367Search in Google Scholar

24. Grasic Kuhar C, Mesti T, Zakotnik B. Digital ischemic events related to gemcitabine: report of two cases and a systematic review. Radiol Oncol 2010; 44: 257-61.Search in Google Scholar

25. Holstein A, Batge R, Egberts EH. Gemcitabine induced digital ischemia and necrosis. Eur J Cancer Care (Engl) 2010; 19: 408-9.10.1111/j.1365-2354.2008.01057.x19490003Search in Google Scholar

26. Curran WJ, Paulus R, Langer CR, Komaki R, Lee JS, Hauser S, et al. Sequential vs concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410. J Natl Cancer Inst 2011; 103: 1452-60.10.1093/jnci/djr325318678221903745Search in Google Scholar

27. Berghmans T, Van Houtte P, Paesmans M, Giner V, Lecomte J, Koumakis G, et al. A phase III randomized sstudy comparing concomitant radiochemotherapy as induction versus consolidation treatment in patients with locallyy advanced unresectable non-small cell lung cancer. Lung Cancer 2009; 64: 187-93.10.1016/j.lungcan.2008.08.00418804894Search in Google Scholar

28. Senan S, Cardenal F, Vansteenkiste J, Stigt J, Akyol F, De Neve W, et al. A randomized phase II study comparing induction or consolidation chemotherapy with cisplatin-docetaxel, plus radical concurrent chemoradiotherapy with cisplatin-docetaxel, in patients with unresectable locally advanced nonsmall- cell lung cancer. Ann Oncol 2011; 22: 553-8. 10.1093/annonc/mdq38820696676Search in Google Scholar

29. Garrido P, Rosell R, Arellano A, Andreu F, Domine M, Perez-Casas A, et al. Randomized phase II trial of non-platinum iduction or consolidation chemotherapy plus concomitant chemoradiation in stage III NSCLC patients: mature results of the Spanish Lung Cancer Group 0008 study. Lung Cancer 2013; 81: 84-90.10.1016/j.lungcan.2013.03.00923611405Search in Google Scholar

30. Tsujino K, Kurata T, Yamamoto S, Kawaguchi T, Kubo A, Isa S, et al. Is consolidation chemotherapy after concurrent chemo-radiotherapy beneficial for patients with locally advanced non-small-cell lung cancer? A pooled analysis of the literture. J Thorac Oncol 2013; 8: 1181-9.10.1097/JTO.0b013e318298834823883782Search in Google Scholar

31. Ramalingam SS, Kotsakis A, Tarhini AA, Heron DE, Smith R, Friedland D, et al. A multicenter phase II study of cetuximab in combinaton with chest radiotherapy and consolidation chemotherapy in patients with stage III non-small cell lung cancer. Lung Cancer 2013; 81: 416-21.10.1016/j.lungcan.2013.06.00223849982Search in Google Scholar

32. Hallquist A, Wagenius G, Rylander H, Brodin O, Holmberg E, Loden B, et al. Concurrent cetuximab and radiotherapy after docetaxel-cisplatin induction chemotherapy in stage III NSCLC: satellite-a phase II study from the Swedish Lung Cancer Study Group. Lung Cancer 2011; 71: 166-72.10.1016/j.lungcan.2010.05.01120541833Search in Google Scholar

33. Gadgeel SM, Ruckdeschel JC, Patel BB, Wozniak A, Konski A, Valdivieso M, et al. Phase II study of pemetrexed and cispaltin, with chest radiotherapy followed by docetaxel in patients with stage III non-small cell lung cancer. J Thorac Oncol 2011; 6: 927-33.10.1097/JTO.0b013e318215610921415776Search in Google Scholar

34. Govindan R, Bogart J, Stinchcombe T, Wang X, Hodgson L, Kratzke R, et al. Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B Trial 30407. J Clin Oncol 2011; 29: 3120-5.10.1200/JCO.2010.33.4979Search in Google Scholar

35. Kelly K, Chansky K, Gaspar LE, Albain KS, Jett J, Ung YC, et al. Phase-III trial of maitanance gefitinib or placebo after concurrent chemoradiation and docetaxel consolidation in inoperable stage III non-small cell lung cancer. SWOG S0023. J Clin Oncol 2008; 26: 2450-6.10.1200/JCO.2007.14.4824Search in Google Scholar

36. Eberhardt WEE, Gauler TC, LePechoux, Stamatis G, Bildat S, Krbek T, et al. 10-year long-term survival (LTS) of induction chemotherapy with three cycles cisplatin/paclitaxel followed by concurrent chemoradiation cisplatin/ etoposide/45Gy (1.5Gy bid) plus surgery in locally advanced non-small-cell lung cancer (NSCLC) - a multicenter phase-II trial (CISTAXOL). Lung Cancer 2013; 82: 83-9.10.1016/j.lungcan.2013.06.007Search in Google Scholar

37. Albain KS, Swann RS, Rusch VA, Turrisi AT 3rd, Shepherd FA, Smith C, et al. Radiotherapy plus chemotherapy with or without surgical resection for stage III non-small-cell lung cancer. Lancet 2009; 374: 379-86. 10.1016/S0140-6736(09)60737-6Search in Google Scholar