Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973)

Belderbos, José;Uitterhoeve, Lon;van Zandwijk, Nico;Belderbos, Huub;Koning, Caro;et.al.
(2007) European Journal of Cancer — Vol. 43, n° 1, p. 114-121 (2007)

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Authors
  • Belderbos, JoséThe Netherlands Cancer Institute
    Author
  • Uitterhoeve, LonAcademic medical Center Amsterdam
    Author
  • van Zandwijk, NicoThe Netherlands Cancer Institute - Antoni Van Leeuwenhoek Hospital Amsterdam
    Author
  • Belderbos, HuubAmphia Hospital
    Author
  • Legrand, CatherineUCLouvain
    Author
  • Koning, CaroAcademic Mecical Center Amsterdam
    Author
  • et. al.
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Abstract
A randomised phase III study was performed comparing sequential (S) and concurrent (C) chemo-radiotherapy (CRT) in non-small cell lung cancer (NSCLC) patients. Methods : One hundred and fifty-eight patients were randomised to receive two courses of Gemcitabine (1250 mg/m2 days 1, 8) and Cisplatin (75 mg/m2 day 2) prior to, or daily low-dose Cisplatin (6 mg/m2) concurrent with radiotherapy, consisting of 24 fractions of 2.75 Gy in 32 days, with a total dose of 66 Gy. Results : Acute haematological toxicity grade 3/4 was more pronounced in the sequential (S) (30% versus 6%), oesophagitis grade 3/4 more frequent in the concurrent (C) arm (5% versus 14%). Late oesophagitis grade 3 was 4% (S and C), pneumonitis grade 3/4 14% (S) and 18% (C). Because of the poor power of the study no significant differences in median survival (MS), overall survival (OS) and progression-free survival (PFS) could be detected. MS was 16.2 (S) and 16.5 (C) months, 2-year OS was 34% (S) and 39% (C), 3-year OS was 22% (S) and 34% (C). Conclusion : Radiotherapy 66 Gy given concurrently with daily low-dose Cisplatin or after two courses of Gemcitabine/Cisplatin was well tolerated. Due to early closure no conclusions can be reached on the relative merits; both arms showed good OS.
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Belderbos, J., Uitterhoeve, L., van Zandwijk, N., Belderbos, H., Rodrigus, P., van de Vaart, P., Price, A., van Walree, N., Legrand, C., Dussenne, S., Bartelink, H., Giaccone, G., Koning, C., & et al. (2007). Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). European Journal of Cancer, 43(1), 114-121. https://doi.org/10.1016/j.ejca.2006.09.005 (Original work published 2007)