Preliminary report. Concomitant irradiation and paclitaxel as radiosensitizer to increase the operability of unresectable locally advanced breast cancer

The objective of this non-randomized, single-arm pilot study was to investigate whether paclitaxel (50 mg/m2 body surface area) concomitantly administered with radiation (2 Gy/fr, total 50 Gy) could increase the operability of unresectable locally advanced breast cancer (LABC). Operability was assessed based on the Haagensen criteria, toxicity based on EORTC criteria, and response to therapy based on WHO criteria. Thus far 13 inoperable LABC patients have participated in the study as subjects in the treatment group, and 12 of the cases have been analyzable. As a result of radiopaclitaxel therapy, 10 of the 12 tumors became operable (>83%), and in 3 of the 10 patients there was no evidence of residual tumor. To date there have been no cases of local relapse in the treatment group. Given these results, the preliminary conclusions of the study are as follows: The results of radiochemotherapy, specifically with radiopaclitaxel, are quite promising as a method of treating inoperable LABC by reducing tumor size until it becomes operable. The efficacy and safety of the 50 mg/m2 body surface area dose of paclitaxel were adequate, allowing use of higher doses with the expectation of better results. The schedule of administration in this study yielded effective results. (K.H.)