Radiotherapy & Oncology
Volume 89, Issue 1 , Pages 44-50 , October 2008

A phase II trial of low-dose gemcitabine and radiation alternated to cisplatin and 5-fluorouracil: An active and manageable regimen for stage IV squamous cell carcinoma of the head and neck

  • Marco Benasso

      Affiliations

    • Department of Medical Oncology A, National Institute for Cancer Research, Genoa, Italy
    • Corresponding Author InformationCorresponding author. Marco Benasso, S.C. Oncologia Medica A, National Institute for Cancer Research, Largo Rosanna Benzi, 10, 16132 Genova, Italy.
    • ,
  • Viviana Vigo

      Affiliations

    • Department of Medical Oncology A, National Institute for Cancer Research, Genoa, Italy
    • ,
  • Almalina Bacigalupo

      Affiliations

    • Department of Radiation Oncology, National Institute for Cancer Research, Genoa, Italy
    • ,
  • Anna Ponzanelli

      Affiliations

    • Department of Medical Oncology A, National Institute for Cancer Research, Genoa, Italy
    • ,
  • Michela Marcenaro

      Affiliations

    • Department of Radiation Oncology, National Institute for Cancer Research, Genoa, Italy
    • ,
  • Renzo Corvò

      Affiliations

    • Department of Otholaryngology, National Institute for Cancer Research, Genoa, Italy
    • ,
  • Giovanni Margarino

      Affiliations

    • Department of Otholaryngology, National Institute for Cancer Research, Genoa, Italy

Received 14 December 2007 ,Revised 13 March 2008 ,Accepted 1 April 2008.

References 

  1. Forastiere A, Koch W, Trotti A, et al. Head and neck cancer. N Engl J Med. 2001;26:1890–1900
  2. Forastiere A, Goepfert H, Maor M, et al. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003;349:2091–2098
  3. Forastiere A, Maor M, Weber RS et al. Long-term results of Intergroup RTOG 91-11: a phase III trial to preserve the larynx. Induction cisplatin/5-FU and radiation therapy versus concurrent cisplatin and radiation therapy versus radiation therapy. In: Proc. ASCO 2006, abs no 5517.
  4. Pignon JP, Bourhis J, Domenge C, et al. Chemotherapy added to loco-regional treatment for head and neck squamous cell carcinoma: three meta-analyses of updated individual data. Lancet. 2000;355:949–955
  5. Pignon JP, le Maıˆtre A, Bourhis J, et al. Meta-analyses of chemotherapy in head and neck cancer (MACH-NC): an update. Int J Radiat Oncol Biol Phys. 2007;69:112–114
  6. Merlano M, Vitale V, Rosso R, et al. Treatment of advanced squamous-cell carcinoma of the head and neck with alternating chemotherapy and radiotherapy. N Engl J Med. 1992;327:1115–1121
  7. Merlano M, Benasso M, Corvò R, et al. Five-year update of a randomized trial of alternating radiotherapy and chemotherapy compared with radiotherapy alone in treatment of unresectable squamous cell carcinoma of the head and neck. J Natl Cancer Inst. 1996;88:583–589
  8. Corvò R, Benasso M, Sanguineti G, et al. Alternating chemoradiotherapy versus partly accelerated radiotherapy in locally advanced squamous cell carcinoma of the head and neck. Cancer. 2001;92:2856–2867
  9. Lefebvre J, Horiot J, Rolland F et al. Phase III study on larynx preservation comparing induction chemotherapy and radiotherapy versus alternating chemoradiotherapy in resectable hypopharynx and larynx cancers: EORTC protocol 24954-22950. In: Proceed. ASCO 2007, abs no LBA6016.
  10. Peters GJ, Bergman AM, Ruiz van Haperen VWT, et al. Interaction between cisplatin and gemcitabine in vitro and in vivo. Semin Oncol. 1995;22:72–79
  11. Hitt R, Castellano D, Hidalgo M, et al. Phase II trial of cisplatin and gemcitabine in advanced squamous-cell carcinoma of the head and neck. Ann Oncol. 1998;9:1347–1349
  12. Shewach DS, Lawrence TS. Gemcitabine and radiosensitization in human tumor cells. Invest New Drugs. 1996;14:257–263
  13. Eisbruch A, Shewach DS, Bradford CR, et al. Radiation concurrent with gemcitabine for locally advanced head and neck cancer: a phase I trial and intracellular drug incorporation study. J Clin Oncol. 2001;19:792–799
  14. Benasso M, Merlano M, Sanguineti G, et al. Gemcitabine, cisplatin, and radiation for advanced, unresectable squamous cell carcinoma of the head and neck. A feasibility study. Am J Clin Oncol. 2001;24:618–622
  15. Benasso M, Corvò R, Ponzanelli A, et al. Alternating gemcitabine and cisplatin with gemcitabine and radiation in stage IV squamous cell carcinoma of the head and neck. Ann Oncol. 2004;15:646–652
  16. Samlowski WE, Gundacker H, Kuebler JP, et al. Evaluation of gemcitabine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Invest New Drugs. 2001;19:311–315
  17. Miller AB, Hoogstraten B, Staquet M, et al. Reporting results of cancer treatment. Cancer. 1981;47:207–214
  18. Ang KK, Kaander JHAM, Peters LJ. Radiotherapy for head and neck cancers. Philadelphia: Lea & Febiger; 1994;
  19. Fleming TR. One-sample multiple testing procedure for phase II clinical trial. Biometrics. 1982;38:143–151
  20. Kaplan EL, Meyer P. Non-parametric estimation for incomplete observation. J Am Stat Assoc. 1958;53:457–474
  21. Rubin P, Constine LS, Fajardo LF, et al. Overview of late effects normal tissues (LENT) scoring system. Radiotherapy & Oncology. 1995;35:9–10
  22. Ang KK, Harris J, Garden AS, et al. concomitant boost radiation plus concurrent cisplatin for advanced head and neck carcinomas: Radiation Therapy Oncology Group phase II trial 99-14. J Clin Oncol. 2005;23:3008–3015
  23. Tsao AS, Garden AS, Kies MS, et al. Phase I/II study of docetaxel, cisplatin, and concomitant boost radiation for locally advanced squamous cell carcinoma of the head and neck. J Clin Oncol. 2006;24:4163–4169
  24. Numico G, Russi EG, Vitiello R, et al. Gemcitabine and cisplatin in a concomitant alternating chemoradiotherapy program for locally advanced head-and-neck cancer: a pharmacology-guided schedule. Int J Radiat Oncol Biol Phys. 2006;66:731–737
  25. Aguilar-Ponce J, Granados-Garcia M, Villavicencio V, et al. Phase II trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck. Ann Oncol. 2004;15:301–306
  26. Argiris A, Brockstein BE, Haraf DJ, et al. Competing causes of death and second primary tumor in patients with locoregionally advanced head and neck cancer treated with chemoradiotherapy. Clin Cancer Res. 2004;10:1956–1962

PII: S0167-8140(08)00196-5

doi: 10.1016/j.radonc.2008.04.002

Radiotherapy & Oncology
Volume 89, Issue 1 , Pages 44-50 , October 2008

Article Tools

* Image Usage & Resolution