The effect of pulmonary function testing on bleomycin dosing in germ cell tumors.

Abstract

227 Background: Lung function testing (LFT) during chemotherapy with bleomycin is controversial. We describe the impact of LFT on bleomycin dosing in a phase II trial of accelerated BEP for advanced germ cell tumors. Methods: Patients had measurable disease and were stratified with the International Germ Cell Cancer Consensus Classification (IGCCC). The planned number of weekly bleomycin doses was 12 for intermediate risk (IR) and poor risk (PR) disease, and 9 for good risk (GR) disease. Clinical assessments, CXR, DLCO corrected for haemoglobin, and FVC were done 2-weekly. Bleomycin was to be stopped for: predefined clinical or CXR evidence of pulmonary toxicity; or a >25% reduction in DLCO or FVC; or GFR <35mL/min. We determined bleomycin doses planned, received, and omitted; and, patients receiving all, ≥2/3, or <2/3 of their planned bleomycin doses. Results: The first 30 patients had a median age of 28 (range 19-39) and 10 with lung metastases. 80% (259/324) of planned bleomycin doses were received; 75 doses (20%) were omitted in 15 pts, all for >25% reduction in DLCO. 16 patients had a 10 to 24% reduction in DLCO but none had >35%. In all patients the decline in FVC was < 10%. No patient developed other evidence of pulmonary toxicity. Patients with lung metastases were 2.5 times as likely to have a >25% reduction in DLCO (50% vs 20%, p=0.15), and 4 times as likely to receive <2/3 of their planned doses (40% v 10%, p=0.14). Conclusions: Asymptomatic reductions in DLCO caused 20% of bleomycin doses to be omitted and 20% of patients to receive < 2/3 of their planned doses. A 25% reduction in DLCO may be too cautious a threshold, particularly in those with lung metastases. [Table: see text] No significant financial relationships to disclose.