Abstract
Background
Postmastectomy chest wall irradiation is recommended for high-risk breast cancer patients, such as those with ≥4 positive nodes. Irradiation is performed sequentially rather than concurrently with chemotherapy. However, the 5-year locoregional recurrence-free survival was statistically better in the concurrent method in node-positive patients in a prior study. The benefit of concurrent chemoradiotherapy for postmastectomy breast cancer patients is uncertain. Vinorelbine is often used as concurrent chemoradiotherapy for non-small cell lung cancer in Japan and has antitumor activity in breast cancer as well. Thus, we planned this dose-finding study of concurrent vinorelbine and radiation therapy in high-risk postmastectomy breast cancer patients.
Methods
High-risk postmastectomy breast cancer patients were recruited. Patients received weekly vinorelbine administered concurrently with radiation therapy. The radiation dose was 50 Gy in 25 fractions over 5 weeks. Vinorelbine was administered weekly without a break, so the maximum number of vinorelbine cycles was five. A 3 + 3 dose-escalation design was used for determining maximal tolerable dose, recommended dose and safety.
Results
A total of 10 patients were enrolled in cohorts of 10 and 15 mg/m2. Dose-limiting toxicity was observed in one case in 10 mg/m2 and two cases in 15 mg/m2. Therefore, the maximal tolerable dose was defined at 15 mg/m2 and the recommended dose was determined at 10 mg/m2. The main adverse events included radiation dermatitis and neutropenia. Recurrence was observed in one patient with a median follow-up of 40 months.
Conclusions
Concurrent vinorelbine and radiation therapy has a manageable safety profile at 10 mg/m2 in high-risk postmastectomy breast cancer patients.
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Acknowledgments
The authors would like to thank all the patients who participated in this study, their families, staff at the Nagoya 1st Red Cross Hospital for their help in conducting the study and Dr. Bishal Gyawali, Nagoya University Hospital, for his technical and linguistic assistance.
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Honda, K., Riku, M., Iwase, M. et al. Phase I study of concurrent vinorelbine and radiation therapy in high-risk postmastectomy breast cancer patients. Breast Cancer 23, 701–705 (2016). https://doi.org/10.1007/s12282-015-0627-6
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DOI: https://doi.org/10.1007/s12282-015-0627-6