Journal of Clinical Oncology, Vol 11, 1852-1857, Copyright © 1993 by American Society of Clinical Oncology
A prospective phase II study on photodynamic therapy with photofrin II for centrally located early-stage lung cancer. The Japan Lung Cancer Photodynamic Therapy Study Group
K Furuse, M Fukuoka, H Kato, T Horai, K Kubota, N Kodama, Y Kusunoki, N Takifuji, T Okunaka and C Konaka
Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Osaka, Japan.
PURPOSE: A phase II study was conducted between June 1989 and February 1992
to evaluate the activity and toxicity of photodynamic therapy (PDT) with
photofrin II in centrally located early-stage lung cancer and to determine
the complete response (CR) rate as the primary end point. PATIENTS AND
METHODS: Patients had histologically proven lung cancer and endoscopically
superficial thickening or small protrusions. All lesions were located in
subsegmental or larger bronchi. All patients had a performance status (PS)
of 0 to 2 and arterial oxygen pressure tension (PaO2) > or = 60 mm Hg.
No lymph node or distant metastases were present. All patients received
photofrin II (2 mg/kg) intravenously 48 hours before PDT. Tumor lesions
were superficially photoradiated by an argon dye laser or an excimer dye
laser. RESULTS: Of 54 patients with 64 carcinomas, 51 with 61 carcinomas
were eligible for toxicity evaluation and 49 with 59 carcinomas were
assessable for response. Of the 59 assessable carcinomas, 50 (84.8%; 95%
confidence interval, 73.0% to 92.8%) showed a CR after initial PDT. The
median duration of CR was 14.0+ months (range, 2.0+ to 32.4+). The multiple
regression model indicates that estimated length of longitudinal tumor
extent was the only independent prognostic factor for CR (P = .002). Five
carcinomas that had a CR had a local recurrence at 6, 10, 12, 16, and 18
months after initial PDT, respectively. Toxicity assessment (World Health
Organization [WHO] grade 2) showed transient elevation of ALT (1.9%),
pulmonary toxicity (7.7%), and allergic reaction (7.7%), as well as sunburn
(1.9%). CONCLUSION: PDT with photofrin II has an excellent effect on
patients with centrally located early-stage lung cancer who have limited
tumor invasion extending over a small area (< or = 1 cm).
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