Lung Cancer
Volume 69, Issue 2 , Pages 218-224 , August 2010

First-line cisplatin with docetaxel or vinorelbine in patients with advanced non-small-cell lung cancer: A quality of life directed phase II randomized trial of Gruppo Oncologico Italia Meridionale

  • Vittorio Gebbia

      Affiliations

    • Medical Oncology Unit, University of Palermo, La Maddalena Clinic for Cancer, Palermo, Italy
    • Corresponding Author InformationCorresponding author at: University of Palermo c/o La Maddalena, Via San Lorenzo Colli n. 312d, 90100 Palermo, Italy. Tel.: +39 091 6806710; fax: +39 091 6806906.
    • ,
  • Vito Lorusso

      Affiliations

    • Medical Oncology Unit, Ospedale V. Fazzi, Lecce, Italy
    • ,
  • Domenico Galetta

      Affiliations

    • Experimental Oncology Unit, Istituto Oncologico, Bari, Italy
    • ,
  • Michele Caruso M

      Affiliations

    • Medical Oncology Unit, Centro Oncologico Catanese, Humanitas, Catania, Italy
    • ,
  • Giuseppe Palomba

      Affiliations

    • Medical Oncology Unit, Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy
    • ,
  • Fernando Riccardi

      Affiliations

    • Medical Oncology Unit, Ospedale Cardarelli, Napoli, Italy
    • ,
  • Nicolò Borsellino

      Affiliations

    • Medical Oncology Unit, Ospedale Buccheri-LaFerla, Palermo, Italy
    • ,
  • Francesco Carrozza

      Affiliations

    • Medical Oncology Unit, Ospedale Cardarelli, Campobasso, Italy
    • ,
  • Silvana Leo

      Affiliations

    • Medical Oncology Unit, Ospedale V. Fazzi, Lecce, Italy
    • ,
  • Francesco Ferraù

      Affiliations

    • Medical Oncology Unit, Ospedale S. Vincenzo, Taormina, Italy
    • ,
  • Saverio Cinieri

      Affiliations

    • Medical Oncology Unit, Ospedale Civile Perrino, Brindisi, Italy
    • ,
  • Gianfranco Mancuso

      Affiliations

    • Medical Oncology Unit, University of Palermo, La Maddalena Clinic for Cancer, Palermo, Italy
    • ,
  • Sergio Mancarella

      Affiliations

    • Medical Oncology Unit, Ospedale Civile, Galatina, Lecce, Italy
    • ,
  • Giuseppe Colucci

      Affiliations

    • Experimental Oncology Unit, Istituto Oncologico, Bari, Italy

Received 24 March 2009 ,Revised 6 October 2009 ,Accepted 9 October 2009.

References 

  1. Jemal A, Sieger R, Ward E, et al. Cancer statistics, 2007. CA Cancer J Clin. 2007;57:43–66
  2. NSCLC Meta-Analyses Collaborative Group . Chemotherapy in addition to supportive care improves survival in advanced non-small-cell: a systematic review and meta-analysis of individual patient data from 16 randomized controlled trials. J Clin Oncol. 2006;26:4617–4625
  3. 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;14(355 (24)):2542–2550
  4. Pirker R, Szczesna A, von Pawel J, et al. A randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of patients with advanced non-small-cell lung cancer (NSCLC). Proc Am Soc Clin Oncol. 2008;26:[abstract 3]
  5. Scagliotti GV, Parikh P, von Pawel J, et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naïve patients with advanced-stage non-small-cell lung cancer. J Clin Oncol. 2008;26(July (21)):3543–3551
  6. Schiller J, Harrington D, Belani C, et al. A randomized phase III trial of four chemotherapy regimens in advanced non-small-cell lung cancer. N Engl J Med. 2002;346:92–98
  7. Ettinger DS, Akerley W, Bepler G, et al. Non-small-cell lung cancer. J Natl Compr Cancer Netw. 2008;6:228–269
  8. Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21:1404–1411
  9. Chassany O, Sagnier P, Marquis P, et al. Patient-reported outcomes: the example of health-related quality of life—a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inform J. 2002;36:209–238
  10. Hollen PJ, Gralla RJ, Kris MG, et al. Measurement of quality of life in patients with lung cancer in multicenter trials of new therapies. Psychometric assessment of the lung cancer symptom scale. Cancer. 1994;73:2087–2098
  11. Gotay CC, Kawamoto CT, Bottomley A, Efficace F. The prognostic significance of patient-reported outcomes in cancer clinical trials. J Clin Oncol. 2008;26:1355–1363
  12. 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
  13. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum versus vinorelbine plus platinum for advanced non-small-cell lung cancer: the TAX 326 Study Group. J Clin Oncol. 2003;21:3016–3024
  14. Martoni A, Marino A, Sperandi F, et al. Multicentre randomised phase III study comparing the same dose and schedule of cisplatin plus the same schedule of vinorelbine or gemcitabine in advanced non-small cell lung cancer. Eur J Cancer. 2005;41:81–92
  15. Gebbia V, Galetta D, Lorusso V, et al. Cisplatin plus weekly vinorelbine versus cisplatin plus vinorelbine day 1 and 8 in advanced non-small cell lung cancer: a prospective randomized phase III trial of the Gruppo Oncologico Italia Meridionale. Lung Cancer. 2008;61:369–377
  16. Gridelli C, Gallo C, Shepherd FA, et al. 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;21:1–11
  17. Winton T, Livingstone R, Johnson D, et al. Vinorelbine and cisplatin vs observation in resected non-small cell lung cancer. N Engl J Med. 2005;352:2589–2597
  18. Douillard JY, Rosell R, De Lena M, et al. Adjuvant vinorelbine plus cisplatin versus observation in completely resected stage IB–IIIA non-small-cell lung cancer (Adjuvant Navelbine International Trialist Association—ANITA): a randomized controlled trial. Lancet Oncol. 2006;7:719–727
  19. Therasse P, Arbuck SG, Eisenhauer EE, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205–216
  20. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143–151
  21. Cancer Therapy Evaluation Program Revised March 23, 1998. Common Toxicity Criteria, Version 2.0. DCTD, NCI, NIH, DHHS March 1998.
  22. Hryniuk WM, Goodyear M. The calculation of received dose intensity. J Clin Oncol. 1990;8:1935–1937
  23. Kaplan EL, Meier P. Nonparamentric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457–481
  24. Harper P, Plunkett T, Khayat D. Quality trials and quality of life in non-small-cell lung cancer. J Clin Oncol. 2003;21:3007–3008
  25. American Society of Clinical Oncology: outcomes of cancer treatment for technology assessment and cancer treatment guidelines. J Clin Oncol. 1996;14:671–679
  26. Gralla RJ, Thatcher N. Quality-of-life assessment in advanced lung cancer: consideration for evaluation in patients receiving chemotherapy. Lung Cancer. 2004;46(Suppl. 2):S41–47
  27. Stephens R. Quality of life issues in non-small cell lung cancer. Exp Rev Pharmacoeconom Outc Res. 2004;4:215–226
  28. Spiro SG, Rudd RM, Souhami RL, et al. Chemotherapy versus supportive care in advanced non-small cell lung cancer: improved survival without detriment to quality of life. Thorax. 2004;59:828–836
  29. NSCLC Meta-Analyses Collaborative Groups. Chemotherapy in addition to supportive care improves survival in advanced non-small-cell lung cancer: a systematic review and meta-analysis of individual patient data from 16 randomized controlled trials. J Clin Oncol. 2008;26:4617–4625
  30. Dediu M. Should we discard vinorelbine plus cisplatin from the first-line therapy of advanced non-small-cell lung cancer ?. J Clin Oncol. 2004;22:1345–1347
  31. Tan EH, Grodski T, Schneider CP, et al. Global lung oncology branch trial 3 (GLOB-3): final results of a randomised multinational phase III study of oral and iv vinorelbine (NVB) plus cisplatin (CDDP) versus docetaxel (DXT) plus CDDP as first line treatment for advanced non small cell lung cancer (NSCLC). J Thor Oncol. 2008;2(Suppl. 4):[abs s451]
  32. Douillard JY, Laporte S, Fossella F, et al. Comparison of docetaxel- and vinca alkaloid-based chemotherapy in the first-line treatment of advanced non-small cell lung cancer: a meta-analysis of seven randomized clinical trials. J Thor Oncol. 2007;2:939–946

PII: S0169-5002(09)00536-4

doi: 10.1016/j.lungcan.2009.10.008

Lung Cancer
Volume 69, Issue 2 , Pages 218-224 , August 2010

Article Tools

* Image Usage & Resolution