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Annals of Oncology 13:403-411, 2002
© 2002 European Society for Medical Oncology

Induction chemotherapy followed by concurrent chemotherapy and definitive high-dose radiotherapy for patients with locally advanced non-small-cell lung cancer (stages IIIa/IIIb): a pilot phase I/II trial

C. Pöttgen+,, W. Eberhardt1, S. Bildat1, G. Stüben, G. Stamatis2, L. Hillejan2, S. Sohrab3, H. Teschler3, S. Seeber1, H. Sack and M. Stuschke

Department of Radiotherapy and 1Department of Internal Medicine (Cancer Research), Medical School, University of Essen, Essen; 2Department of Thoracic Surgery and 3Department of Pulmonology, Ruhrlandklinik, Essen, Germany

Received 12 June 2001; revised 27 August 2001. accepted 17 September 2001.

Background

Overall prognosis of patients with locally advanced non-small-cell lung cancer (LAD-NSCLC) is still unfavourable. Different attempts to improve treatment results have been made using combinations of chemotherapy and radiotherapy. The aim of this pilot phase I/II investigation was to test the feasibility and toxicity of a definitive multimodality protocol in patients with irresectable NSCLC stages IIIA (N2) and IIIB.

Patients and methods

Thirty LAD-NSCLC patients (stages IIIA/IIIB: 3/27; median age: 54 years, range 34–70; male/female: 17/13) who were consecutively enrolled onto our ongoing neoadjuvant multimodality protocol from October 1996 to February 1999 remained inoperable after induction treatment. Three cycles of cisplatin/etoposide (PE) were followed by hyperfractionated accelerated radiotherapy (HF-RTx; 1.5 Gy bid up to a total dose of 45 Gy in 3 weeks) concurrent with one cycle of PE. Definitive local treatment was completed with a small volume boost of 20 Gy (qd), adding up to a total dose of 65 Gy to the primary. Patients were routinely offered prophylactic cranial irradiation (PCI; 30 Gy; 2 Gy qd).

Results

Overall toxicity of the definitive CTx/RTx protocol—the main endpoint of this investigation—turned out to be acceptable (oesophagitis grade 3/4: 6/4 patients; pneumonitis grade 3/4: 0/1 patients; no treatment-related deaths). Actuarial survival at 2 years was 31% with a loco-regional control rate of 21%.

Conclusions

This regimen turned out to be feasible with acceptable toxicity and will serve as a reference arm in a planned randomised trial in stage IIIB NSCLC, testing the value of surgery in this setting: preoperative induction CTx/RTx followed by surgery versus definitive CTx/RTx.

Key words: combined modality, neoadjuvant, non-small-cell lung cancer, stage III


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