Long-Term Results of a Phase II Trial of Concomitant Cisplatin-Paclitaxel Chemoradiation in Locally Advanced Cervical Cancer.

OBJECTIVES: The aim of this study was to determine the long-term results of a 7-week schedule of external beam radiation therapy, high dose rate brachytherapy, and weekly cisplatin and paclitaxel in patients with locally advanced carcinoma of the cervix. METHODS: Thirty-seven patients with International Federation of Gynecology and Obstetrics stages IB2 to IVa cervical cancer were treated with 40 mg/m per week of intravenous cisplatin and 50 mg/m per week of intravenous paclitaxel combined with 45 Gy of pelvic external beam radiation therapy and 28 to 30 Gy of high dose rate brachytherapy. RESULTS: Sixteen patients (43.2%) were able to complete the 6 scheduled cycles of chemotherapy. The median number of weekly chemotherapy cycles administered was 5. Thirty-six (16.2%) of 222 cycles of chemotherapy were not given because of toxicity. The mean dose intensity of cisplatin was 29.6 mg/m per week (95% confidence interval, 27.0-32.1); that of paclitaxel was 40.0 mg/m per week (95% confidence interval, 36.9-43.1). Thirty-four patients (91.8%) completed the planned radiation course in less than 7 weeks. Median radiation treatment length was 43 days. After a median follow-up of 6 years, 7 patients (18.9%) experienced severe (RTOG grade 3 or higher) late toxicity. No fatal events were observed. Ten patients have failed, 1 locally and 9 at distant sites. The 14-year locoregional control rate was 96.7%, and the 14-year freedom from systemic failure rate was 64.6%. Fourteen-year actuarial disease-free survival and overall survival rates were 44.8% and 50%, respectively. CONCLUSIONS: This study demonstrates excellent very long-term results and tolerable toxicity although the target weekly dosage of cisplatin and paclitaxel needs to be adjusted in the majority of the patients.

Perioperative high dose rate brachytherapy (PHDRB) in previously irradiated head and neck cancer: Results of a phase I/II reirradiation study.

BACKGROUND AND PURPOSE: This study was undertaken to determine the feasibility of salvage surgery and PHDRB in patients with previously irradiated, recurrent head and neck cancer or second primary tumors arising in a previously irradiated field. METHODS AND MATERIALS: Sixty-three patients were treated with surgical resection and PHDRB. The PHDRB dose was 4Gy b.i.d.×8 (32Gy) for R0 resections and 4Gy b.i.d.×10 (40Gy) for R1 resections, respectively. Further external beam radiotherapy or chemotherapy was not given. RESULTS: Resections were categorized as R0 in 7 patients (11.1%) and R1 in 56 (88.9%). Thirty-four patients with R1 resections (54.0%) had microscopically positive margins, and 22 patients (34.9%) had close margins. Thirty-two patients (50.8%) developed RTOG grade 3 or greater adverse events including 3 fatal events. After a median follow-up of 6.8years, the 5-year locoregional control rate and 5-year overall survival rates were 55.0% and 35.6%, respectively. CONCLUSIONS: Surgical resection and PHDRB is a successful treatment strategy in selected patients with previously irradiated head and neck cancer. Long-term locoregional control can be achieved in a substantial number of cases despite a high rate of inadequate surgical resections although at the expense of substantial toxicity.