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

Branislav Jeremi, Biljana Milici, Ljubisa Acimovi, Slobodan Milisavljevi

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

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

PURPOSE: Feasibility and activity of concurrent hyperfractionated radiotherapy (Hfx RT) and low-dose, daily carboplatin and paclitaxel were investigated in patients with early-stage (I/II) non–small-cell lung cancer in a phase II study.

PATIENTS AND METHODS: Fifty-six patients started their treatment on day 1 with 30 mg/m² of paclitaxel. Hfx RT using 1.3 Gy bid to a total dose of 67.6 Gy and concurrent low-dose daily carboplatin 25 mg/m² and paclitaxel 10 mg/m², both given Mondays through Fridays during the RT course, started from the second day.

RESULTS: There were 29 complete responses (52%) and 15 partial responses (27%), and 12 patients (21%), experienced stable disease. The median survival time was 35 months, and 3- and 5-year survival rates were 50% and 36%, respectively. The median time to local progression has not been achieved, but 3- and 5-year local progression-free survival rates were 56% and 54%, respectively. The median time to distant metastasis has not been achieved, but 3- and 5- year distant metastasis-free survival rates were 61% and 61%, respectively. The median and 5-year cause-specific survivals were 39 months and 43%, respectively. Acute high-grade (> 3) toxicity was hematologic (22%), esophageal (7%), or bronchopulmonary (7%). No grade 5 toxicity was observed. Late high-grade toxicity was rarely observed (total, 10%).

CONCLUSION: Hfx RT and concurrent low-dose daily carboplatin/paclitaxel was feasible with low toxicity and effective in patients with stage I/II non–small-cell lung cancer. It should continue to be investigated for this disease.

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

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