European Journal of Cancer
Volume 39, Issue 9 , Pages 1271-1276 , June 2003

Temozolomide in patients with advanced non-small cell lung cancer with and without brain metastases: a phase II study of the EORTC Lung Cancer Group (08965)

  • R Dziadziuszko

      Affiliations

    • Department of Oncology and Radiotherapy, Medical University of Gdansk, 7 Debinki St., 80-211 Gdansk, Poland
    • Corresponding Author InformationCorresponding author. Tel./Fax: +48-58-349-2270
    • ,
  • A Ardizzoni

      Affiliations

    • Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
    • ,
  • P.E Postmus

      Affiliations

    • Vrije Universiteit Medical Center, Amsterdam, The Netherlands
    • ,
  • E.F Smit

      Affiliations

    • Vrije Universiteit Medical Center, Amsterdam, The Netherlands
    • ,
  • A Price

      Affiliations

    • University of Edinburgh, Edinburgh, UK
    • ,
  • C Debruyne

      Affiliations

    • European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium
    • ,
  • C Legrand

      Affiliations

    • European Organisation for Research and Treatment of Cancer Data Center, Brussels, Belgium
    • ,
  • G Giaccone

      Affiliations

    • Vrije Universiteit Medical Center, Amsterdam, The Netherlands
    • ,
  • on behalf of the EORTC Lung Cancer Group

Received 31 January 2003 ,Accepted 14 February 2003.

References 

  1. Levi F, Lucchini F, Negri E, La Vecchia C. Cancer mortality in the European Union, 1988–1997 (the fall may approach 80,000 deaths a year). Int. J. Cancer. 2002;98:636–637
  2. Kelly K, Bunn PA. Is it time to reevaluate our approach to the treatment of brain metastases in patients with non-small cell lung cancer?. Lung Cancer. 1998;20:85–91
  3. Sundstrom JT, Minn H, Lertola KK, Nordman E. Prognosis of patients treated for intracranial metastases with whole-brain irradiation. Ann. Med. 1998;30:296–299
  4. Nieder C, Nestle U, Motaref B, et al.  Prognostic factors in brain metastases (should patients be selected for aggressive treatment according to recursive partitioning analysis (RPA) classes?). Int. J. Radiat. Oncol. Biol. Phys. 2000;46:297–302
  5. Postmus PE, Smit EF. Chemotherapy for brain metastases of lung cancer (a review). Ann. Oncol. 1999;10:753–759
  6. Van Vulpen M, Kal HB, Taphoorn MJ, El Sharouni SY. Changes in blood-brain barrier permeability induced by radiotherapy (implications for timing of chemotherapy?). Oncol. Rep. 2002;9:683–688
  7. Stupp R, Gander M, Leyvraz S, Newlands E. Current and future developments in the use of temozolomide for the treatment of brain tumours. Lancet Oncol. 2001;2:552–560
  8. Prados M. Temozolomide in combination with other cytotoxic agents. Semin. Oncol. 2001;4(Suppl. 13):24–33
  9. Friedman HS, Dolan ME, Pegg AE, et al.  Activity of temozolomide in the treatment of central nervous system tumor xenografts. Cancer Res. 1995;55:2853–2857
  10. Stupp R, Ostermann S, Leyvraz S, et al. Cerebrospinal fluid levels of temozolomide as a surrogate marker for brain penetration. PASCO 2001 (abstr. 232).
  11. Newlands ES, Blackledge GRP, Slack JA, et al.  Phase I trial of temozolomide (CCRG 81045: M and B 39831: NSC 362856). Br. J. Cancer. 1992;65:287–291
  12. Bower M, Newlands ES, Bleehen NM, et al.  Multicentre CRC phase II trial of temozolomide in recurrent or progressive high-grade glioma. Cancer Chemother. Pharmacol. 1997;40:484–488
  13. Bleehen NM, Newlands ES, Lee SM, et al.  Cancer Research Campaign phase II trial of temozolomide in metastatic melanoma. J. Clin. Oncol. 1995;13:910–913
  14. Woll PJ, Crowther D, Johnson PW, et al.  Phase II trial of temozolomide in low-grade non-Hodgkin's lymphoma. Br. J. Cancer. 1995;72:183–184
  15. Britten CD, Rowinsky EK, Baker SD, et al.  A phase I and pharmacokinetic study of temozolomide and cisplatin in patients with advanced solid malignancies. Clin. Cancer Res. 1999;5:1629–1637
  16. Dhodapkar M, Rubin J, Reid JM, et al.  Phase I trial of temozolomide (NSC 362856) in patients with advanced cancer. Clin. Cancer Res. 1997;3:1093–1100
  17. Brada M, Judson I, Beale P, et al.  Phase I dose-escalation and pharmacokinetic study of temozolomide (SCH 52365) for refractory or relapsing malignancies. Br. J. Cancer. 1999;81:1022–1030
  18. Brock CS, Newlands ES, Wedge SR, et al.  Phase I trial of temozolomide using an extended continuous oral schedule. Cancer Res. 1998;58:4363–4367
  19. Vantongelen K. A Practical Guide to EORTC Studies: Evaluation, Criteria, Scoring Scales and Instruments. 1st edn.. Brussels: EORTC; 1994; pp. 119–131
  20. National Cancer Institute of Canada (NCIC). CTC Expanded Common Toxicity Criteria (http://ctep.info.nih.gov/c3/ctc/htm).
  21. Simon R. Optimal two-stage design for phase II clinical trials. Controlled Clin. Trials. 1989;10:1–10
  22. 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
  23. Abrey LE, Olson JD, Raizer JJ, et al.  A phase II trial of temozolomide for patients with recurrent or progressive brain metastases. J. Neurooncol. 2001;53:259–265
  24. Christodoulou C, Bafaloukos D, Kosmidis P, et al.  Phase II study of temozolomide in heavily pretreated cancer patients with brain metastases. Ann. Oncol. 2001;12:249–254
  25. Antonadou D, Paraskevaidis M, Sarris G, et al.  Phase II randomized trial of temozolomide and concurrent radiotherapy in patients with brain metastases. J. Clin. Oncol. 2002;20:3644–3650
  26. van Meerbeeck JP, Baas P, Debruyne C, et al.  A phase II EORTC study of temozolomide in patients with malignant pleural mesothelioma. Eur. J. Cancer. 2002;38:779–783

PII: S0959-8049(03)00234-X

doi: 10.1016/S0959-8049(03)00234-X

European Journal of Cancer
Volume 39, Issue 9 , Pages 1271-1276 , June 2003

Article Tools