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Concurrent Hyperfractionated Radiotherapy and Low-Dose Daily Carboplatin and Paclitaxel in Patients With Stage III Non–Small-Cell Lung Cancer: Long-Term Results of a Phase II Study

From the Departments of Oncology and Surgery, University Hospital, Kragujevac, Serbia

Address reprint requests to Branislav Jeremic, MD, PhD, Applied Radiation Biology and Radiotherapy section, Division of Human Health, International Atomic Energy Agency, Wagramer Strasse 5, A-1400 Vienna, Austria; e-mail: b.jeremic{at}iaea.org

PURPOSE: To investigate the feasibility and activity of hyperfractionated radiation therapy (Hfx RT) and concurrent chemotherapy (CT) consisting of low-dose, daily carboplatin and paclitaxel in patients with stage III non–small-cell lung cancer (NSCLC).

PATIENTS AND METHODS: Sixty-four patients started their treatment on day 1 with 30 mg/m² of paclitaxel administered by 1-hour infusion. Hfx RT began on day 2 using 1.3 Gy bid to a total dose of 67.6 Gy and concurrent low-dose daily CT consisting of 25 mg/m² of carboplatin and 10 mg/m² of paclitaxel, both given Mondays to Fridays during RT course.

RESULTS: Objective response rate was 83% and included complete response in 27 patients (42%) and partial response in 26 patients (41%). Ten patients (16%) had stable disease, whereas only one patient (2%) had progressive disease. The median survival time was 28 months, and 3- and 5-year survival rates were 37% and 26%, respectively. The median time to local progression was 26 months, and 3- and 5-year local progression-free survival rates were 37% and 33%, respectively. The median time to distant metastasis was 25 months, and 3- and 5- year distant metastasis-free survival rates were 37% and 31%, respectively. Acute high-grade ( grade 3) toxicity was hematologic (25%), esophageal (17%), bronchopulmonary (13%), and skin (9%). Late high-grade toxicity was infrequent.

CONCLUSION: This combined Hfx RT/TC regimen produced results that are among the best ever reported and warrants further study in a prospective randomized fashion.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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