Concurrent paclitaxel, capecitabine, mitomycin C and pelvic radiation therapy for patients with squamous cell anal carcinoma.

PURPOSE: The goals of this study were to assess safety and efficacy of triplet chemoradiotherapy (CRT) with paclitaxel for squamous cell anal carcinoma (SCAC). METHODS: Patients with stage I-IIIB SCAC were enrolled and received 52-58 Gy intensity-modulated radiotherapy (IMRT) (with dose based on the T stage) in consecutive daily 1.8-2.2 Gy fractions. The concurrent chemotherapy consisted of paclitaxel 45 mg/m2 days 3, 10, 17, 24, 31, capecitabine 625 mg/m2 bid on treatment days and mitomycin C 10 g/m2 on day 1. Primary endpoints were complete clinical response at 26 weeks and protocol compliance; secondary endpoints included toxicity, overall survival (OS) and progression-free survival (PFS). RESULTS: Thirty-eight patients were enrolled. The percentage of patients with stage I, II, IIIA, and IIIB disease were 1 (2.6%), 5 (13.2%), 15 (39.5%), and 17 (44.7%), respectively. 32 patients (84.2%) completed CRT without significant alterations. Grade 3-4 toxicity occurred in 23 (60.5%) patients. 33 (86.8%) patients had complete clinical response at 26 weeks. Median follow-up was 25.6 months. Seven (18.4%) patients experienced disease progression: four patients had residual tumor after CRT, 2 patients developed distant metastases and 1 patient developed a local recurrence 12 months after CRT. Two-year OS was 93.6%, 2-year PFS was 83.9%. CONCLUSIONS: Investigated treatment scheme is feasible despite high toxicity profile, and may be beneficial for patients with advanced SCAC. Further research is warranted.

Neoadjuvant chemotherapy and local radiotherapy for high-grade osteosarcoma of the extremities.

OBJECTIVE: To determine the effectiveness of radiation therapy for local control of nonmetastatic osteosarcoma of the extremities after induction chemotherapy. PATIENTS AND METHODS: Of 187 patients with nonmetastatic osteosarcoma of the extremities treated with induction chemotherapy since 1986, 31 refused surgery and underwent standard, fractionated external beam radiotherapy for local control. The median radiation dose to the limb was 60 Gy (range 40-68 Gy). Records were reviewed through April 2002, and outcomes including radiologic and biochemical response, local control, limb function, and survival were analyzed. The end points were local progression-free survival, metastases-free survival, and overall survival. RESULTS: Overall survival, local progression-free survival, and metastases-free survival at 5 years were a mean +/- SD of 61%+/-11%, 56%+/-12%, and 62%+/-10%, respectively. The outcome correlated significantly with patients' imaging and biochemical response. In patients who had a pronounced response, overall survival and metastases-free survival at 5 years were 90%+/-9% and 91%+/-9%, respectively, but it was only 35%+/-15% and 42%+/-13% in the nonresponders (P=.005 and P=.005, respectively). Local control was also related to response after induction chemotherapy. None of the 11 patients with both a good imaging and a good biochemical response had local relapse; median follow-up was 67 months. The estimated local progression-free survival among nonresponders was 31%+/-16% at 3 years and 0% at 5 years. Of 22 patients surviving without local disease progression, 19 (86%) had excellent limb function (Enneking score between 90% and 100%) at the time of most recent evaluation. CONCLUSION: When used after effective induction chemotherapy for osteosarcoma of the extremities, radiation therapy can be a reliable modality to control local disease and preserve limb function.