Since salvage surgery after failure of cheomradiotherapy (CRT) for esophageal cancer (EC) is associated with high morbidity and mortality, the development of curative and safety salvage treatment options has been needed to improve the patients' survival.Aim
We conducted a phase I/II study to establish the recommended dose (RD) of laser irradiation and to evaluate safety and efficacy of Taraporfin sodium-based photodynamic therapy (PDT) as a salvage treatment after CRT (UMIN000003970).Patients and methods
We recruited patients with residual or recurrent EC at primary site and who were treated with more than 50 Gy of (chemo)radiotherapy. To determine the dose-limiting toxicity (DLT) according to the energy of the diode laser, dose escalation was set at three energy levels (50, 75 and 100 J/cm2). The primary end point of phase I and II study were RD of laser irradiation and the complete response (CR) rate, respectively.Results
In the phase I study, 9 patients were recruited and were treated using up to the third energy level in groups of three individuals. Since none of the patients experienced DLT at all energy levels, the recommended laser dose was 100 J/m2. In the phase II study, 10 patients were recruited and a complete response of the patients treated by RD was achieved in 6 of 13 patients (46%), which included the patients in level 3 of phase I. There was no patient with PDT-related adverse events.Conclusion
Taraporfin sodium-based PDT could be a safe and effective treatment option for the local failure after CRT for EC.