Purpose: In patients with advanced malignancies, local palliation is undertaken if the patient is not a candidate for aggressive intervention. We developed a prospective study using the same radiotherapy schedule as the Radiation Therapy Oncology Group (RTOG) 85-02 with the addition of the radiosensitizer paclitaxel to evaluate its effect on the tumor response rate, palliation of symptoms, and toxicity.
Methods: Twenty subjects with advanced pelvic or head and neck cancer were enrolled after signing an informed consent. Paclitaxel 60 mg/m(2) was administered 1 hour prior to the first day of each radiation cycle. Radiation therapy was delivered in 2 daily fractions of 3.7 Gy for 2 days every 3 weeks for three cycles (total dose 44.4 Gy). This radiotherapy schedule is referred to as "Quad Shot'' at our institution.
Results: Nineteen patients had adequate follow-up data and were considered evaluable. Five patients had a complete response (CR) and 13 patients had a partial response (PR) with symptomatic improvement for a response rate of 94.7%. One patient only had a minimal response. Seventeen patients (89.5%) had palliation of their presenting symptom(s). Eight patients had effective palliative benefit lasting more than 6 months. Two patients experienced a grade 2 allergic reaction to paclitaxel, one of them received the last cycle of treatment with cisplatin obtaining a CR. No late toxicities have been observed.
Conclusions: This palliative schedule has been shown to provide good tumor response and palliation of symptoms. The toxicity profile remains low with the addition of paclitaxel. Further investigation is warranted in a larger trial. Palliation of symptoms resulted in improved quality of life for this group of patients.