Seminars in radiation oncology
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Clinical Trial
Preoperative paclitaxel, carboplatin, and radiation therapy in advanced head and neck cancer (stage III and IV).
Preoperative chemotherapy and chemoradiation protocols are generally associated with high clinical response rates but limited pathologic responses for large primary tumors. We have initiated a prospective phase II study of weekly paclitaxel and carboplatin plus concurrent, fractionated external-beam radiation, followed by organ-preserving or function-restorative surgery (when applicable to maximize locoregional tumor control). Operable patients staged by triple endoscopy received a percutaneous gastrostomy and vigorous dental and nutritional support during therapy. ⋯ All were resected with function-preserving reconstruction (two patients required total laryngectomy and one patient refused surgery). At a median follow-up of more than 16 months, progression-free and overall survival rates were 64% and 68%, respectively. Preoperative paclitaxel, carboplatin, and radiation was associated with a high clinical response rate at the primary site and a high level of organ preservation or functional restoration, if ablation was performed.
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Randomized Controlled Trial Clinical Trial
Concurrent chemoradiation using paclitaxel and carboplatin in locally advanced non-small cell lung cancer.
Evidence suggests that locally advanced non-small cell lung cancer may be more effectively treated with induction chemotherapy followed by radiation or concurrent chemoradiation compared with radiation alone. The majority of combined modality regimens evaluated in mature clinical trials incorporated cisplatin-based combinations, but none has incorporated newer active systemic agents or fully examined the potential role of induction chemotherapy followed by concurrent chemoradiation. The Fox Chase Cancer Center and its affiliate network have evaluated induction chemotherapy with paclitaxel plus carboplatin with or without granulocyte colony-stimulating factor priming followed by concurrent systemic chemotherapy and radiation therapy in patients with locally advanced non-small cell lung cancer. ⋯ Other studies evaluating different chemoradiation regimens have reported varying results. Paclitaxel/carboplatin-based combinations, administered cyclically at or near full systemic dose in combination with radiation, are feasible. Randomized studies are needed to determine the proper sequencing, potential survival benefits, and relative safety profiles of these combined modality regimens.
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Clinical Trial
Concurrent twice-weekly paclitaxel and thoracic irradiation for stage III non-small cell lung cancer.
Concurrent twice-weekly paclitaxel and thoracic radiation (XRT) for stage III non-small cell lung cancer were studied in a phase I trial. Radiation was delivered in fractions of 1.8 to 2.0 Gy/d to a total dose of 61 Gy. Paclitaxel, at a starting dose of 25 mg/m2/d, was administered intravenously over 1 hour before daily XRT on Mondays and Thursdays for 6 weeks for a total of 12 doses. ⋯ The overall median survival was 20 months and the 3-year survival rate was 20%. We conclude that the maximum tolerated dose of paclitaxel is 35 mg/m2 given twice weekly for 6 weeks concurrently with XRT. This study provides the basis for using paclitaxel, given twice weekly at 30 mg/m2, with weekly carboplatin and concurrent XRT for stage III non-small cell lung cancer in an ongoing phase II trial.
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Review
Protection of normal tissues from the cytotoxic effects of radiation therapy: focus on amifostine.
Evidence for the use of amifostine (Ethyol, ALZA Pharmaceuticals, Palo Alto, CA/US Bioscience, West Conshohocken, PA) as a radioprotectant has been gathered in a number of clinical trials conducted over the past decade. This report briefly reviews those trials, as well as highlights results of a recent phase II trial conducted to evaluate the efficacy of daily amifostine administration in reducing the incidence of radiation-induced esophagitis in patients with stage III non-small cell lung cancer. ⋯ There was a 60% objective response rate and 1-, 2-, and 3-year survival rates were 55%, 23%, and 23%, respectively. Thus, amifostine administration reduced radiation-induced toxicities without reducing antitumor efficacy.
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We have assessed radiation therapy physics quality assurance (QA) elements in the United States and compared the results with the Patterns of Care Study (PCS) Consensus Guidelines for Treatment Planning and the American College of Radiology (ACR) Standard for Radiation Oncology Physics for External Beam Therapy. Data were obtained during PCS site visits to 73 facilities randomly selected from the 1,321 radiation therapy facilities in the United States: 21 academic, 26 hospital, and 26 freestanding. The following is a representative sample of results. ⋯ Twenty-six percent of facilities surveyed did not have in vivo dosimetry capability. These results and others in the study were compared with PCS consensus guidelines and ACR standards, This is the first such study performed in the United States, and the results establish a baseline for future studies. A recommendation for a comprehensive national physics QA study is based on deficiencies found in this study and the implementation of new technologies in radiation therapy.