A RANDOMIZED COMPARATIVE STUDY OF THE SAFETY and EFFICACY OF PHOTODYNAMIC THERAPY USING PHOTOFRIN II COMBINED WITH PALLIATIVE RADIOTHERAPY VERSUS PALLIATIVE RADIOTHERAPY ALONE IN PATIENTS WITH INOPERABLE OBSTRUCTIVE NON‐SMALL CELL BRONCHOGENIC CARCINOMA

Abstract To determine if photodynamic therapy (PDT) adds anything to conventional external beam radiotherapy (XRT) in patients with obstructive endobronchial tumors, 11 patients with inoperable non‐small cell bronchogenic carcinoma obstructing a central airway were randomized into either XRT alone or PDT followed by XRT. The most proximal site of obstruction was in the trachea (2), carina (3) or a main‐stem bronchus (6). The tumors involved more than one site in all patients. The histology was squamous cell in 9 and large cell carcinoma in 2. The age. location of tumor, degree of endobronchial obstruction and karnofsky rating were similar between the two groups. The radiation dose was 3000 cGy in 10 fractions over two weeks using a parallel pair technique. The patients were reassessed 4 and 12 weeks after completion of XRT and then quarterly thereafter. Response to treatment was assessed by changes in symptom scores, quality of life scores, bronchoscopy, quantitative ventilation perfusion lung scan, spirometric measurements and arterial blood gas sampling. All patients improved symptomatically with objective evidence of regression of their tumor at 4 weeks. Four out of five patients in the XRT group who had been followed for 12 weeks or more had progression of their tumor at 12 weeks. Three of them had died 155, 256 and 261 days respectively after treatment. Only i patients in the PDT + XRT group who had been followed for 12 weeks or more relapsed at 12 weeks and subsequently died 201 days after treatment. Two patients are still in complete remission 183 days and 310 days after treatment. Our preliminary results suggest that 3000 cGy radiation therapy alone offers only transient palliation for patients with obstructive endobronchial tumor. The addition of PDT prior to XRT provides significantly better and longer lasting local control. The combined treatment may also improve survival. It is possible that a therapeutic dose–6000 cGy radiation therapy may offer better local control than 3000 cGy.