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Fludarabine combined with radiotherapy in patients with locally advanced NSCLC lung carcinoma: a phase I study
Mirko Nitsche1, Hans Christiansen, Katinka Lederer
1Center of Radiation-Oncology, Gröpelinger Heerstr. 406-408, 28239 Bremen, Germany. nitsche@strahlentherapie-bremen.com
Background And Purpose:
Fludarabine is an adenine nucleoside analogue that has significant activity in hematological malignancies and has shown promising activity in combination with radiation in preclinical solid tumor models. We designed a phase I trial exploring concurrent fludarabine and radiotherapy in patients with advanced non-small cell lung cancer (NSCLC) to determine the maximum tolerated dose (MTD) of fludarabine given with concurrent irradiation.
Materials And Methods:
Thirteen patients with stage IIIB NSCLC received thoracic irradiation of 60 Gy. Fludarabine was administered during the 5th and 6th week of radiotherapy. Doses started at 10 mg/m(2) per day and increased by steps of 3 mg/m(2) per day.
Results:
At a daily dose of 16 mg/m(2), one out of six patients developed a grade 4 leukopenia, and one a grad 3 pneumonitis. Further grade III toxicity was not observed. The dose of 13 mg/m(2) was identified as the MTD. All patients developed a fludarabine dose-dependent lymphocytopenia.
Conclusion:
Fludarabine can be safely administered concurrently with radiation at a daily dose of 13 mg/m(2) during the final 2 weeks of radiotherapy. Further prospective clinical studies are required to establish the potential role of concurrent fludarabine and radiotherapy in the treatment of locally advanced inoperable NSCLC.
