A phase 2 study of capecitabine and concomitant radiation in women with advanced breast cancer.

PURPOSE: To examine the response rate of gross chemo-refractory breast cancer treated with concurrent capecitabine (CAP) and radiation therapy in a prospective Phase II study. METHODS AND MATERIALS: Breast cancer patients with inoperable disease after chemotherapy, residual nodal disease after definitive surgical resection, unresectable chest wall or nodal recurrence after a prior mastectomy, or oligometastatic disease were eligible. Response by RECIST criteria was assessed after 45 Gy. Conversion to operable, locoregional control, and grade ≥3 toxicities were assessed. The first 9 patients received CAP 825 mg/m2 twice daily continuously. Because of toxicity, subsequent patients received CAP only on radiation days. Kaplan-Meier analysis was used to estimate overall survival (OS) and locoregional recurrence-free survival. RESULTS: From 2009 to 2012, 32 patients were accrued; 26 received protocol-specified treatment. Median follow-up was 12.9 months (interquartile range, 7.10-42.9 months). Nineteen patients (73%) had partial or complete response. Fourteen patients (53.9%) experienced grade 3 non-dermatitis toxicity (7 of 9 continuous dosing). Three of four inoperable patients converted to operable. One-year actuarial OS in the treated cohort was 54%. The trial was stopped early after interim analysis suggested futility independent of response. Treatment was deemed futile (ie, conversion to operable but M1 disease immediately postoperatively) in 9 of 10 patients with triple-negative (TN) versus 6 of 16 with non-TN disease (P=.014). Median OS and 1-year locoregional recurrence-free survival among non-TN versus TN patients was 22.8 versus 5.1 months, and 63% versus 20% (P=.007). CONCLUSIONS: Capecitabine can be safely administered on radiation days with careful clinical monitoring and was associated with encouraging response in this chemo-refractory cohort. However, patients with TN breast cancer had poor outcomes even when response was achieved. Further study in non-TN patients may be warranted.

Topical hyaluronic acid vs. standard of care for the prevention of radiation dermatitis after adjuvant radiotherapy for breast cancer: single-blind randomized phase III clinical trial.

PURPOSE: To determine the efficacy of an emulsion containing hyaluronic acid to reduce the development of ≥ Grade 2 radiation dermatitis after adjuvant breast radiation compared with best supportive care. METHODS AND MATERIALS: Women with breast cancer who had undergone lumpectomy and were to receive whole-breast radiotherapy to 50 Gy with a 10- to 16-Gy surgical bed boost were enrolled in a prospective randomized trial to compare the effectiveness of a hyaluronic acid-based gel (RadiaPlex) and a petrolatum-based gel (Aquaphor) for preventing the development of dermatitis. Each patient was randomly assigned to use hyaluronic acid gel on the medial half or the lateral half of the irradiated breast and to use the control gel on the other half. Dermatitis was graded weekly according to the Common Terminology Criteria v3.0 by the treating physician, who was blinded as to which gel was used on which area of the breast. The primary endpoint was development of ≥ Grade 2 dermatitis. RESULTS: The study closed early on the basis of a recommendation from the Data and Safety Monitoring Board after 74 of the planned 92 patients were enrolled. Breast skin treated with the hyaluronic acid gel developed a significantly higher rate of ≥ Grade 2 dermatitis than did skin treated with petrolatum gel: 61.5% (40/65) vs. 47.7% (31/65) (p = 0.027). Only one patient developed Grade 3 dermatitis using either gel. A higher proportion of patients had worse dermatitis in the breast segment treated with hyaluronic acid gel than in that treated with petrolatum gel at the end of radiotherapy (42% vs. 14%, p = 0.003). CONCLUSION: We found no benefit from the use of a topical hyaluronic acid-based gel for reducing the development of ≥ Grade 2 dermatitis after adjuvant radiotherapy for breast cancer. Additional studies are needed to determine the efficacy of hyaluronic acid-based gel in controlling radiation dermatitis symptoms after they develop.

Prospective analysis of carotid artery flow in breast cancer patients treated with supraclavicular irradiation 8 or more years previously: no increase in ipsilateral carotid stenosis after radiation noted.

BACKGROUND: To the authors' knowledge, the effects of supraclavicular fossa radiation on the carotid artery are not well described. In the current study, the authors performed a prospective study to examine the long-term risk of carotid artery stenosis after supraclavicular irradiation for breast cancer. METHODS: A total of 46 breast cancer patients who were treated with adjuvant radiation to the supraclavicular fossa with >8 years of follow-up underwent bilateral Doppler imaging of the carotid artery. Two independent cardiologists interpreted each ultrasound study with no knowledge of which side was treated. RESULTS: The median follow-up from the date of diagnosis was 14.6 years and the mean patient age at the time of ultrasound was 55 years. The median prescribed dose to the supraclavicular fossa was 50 grays. Four patients were found to have clinically relevant, asymptomatic carotid stenosis, for which a cardiology referral was necessary. Only 1 of these 4 patients had stenosis involving the irradiated carotid artery only; 1 patient had bilateral stenosis and 2 patients had only contralateral stenosis. There was no difference noted with regard to isolated ipsilateral versus contralateral medial intimal thickening of the carotid artery (5 patients vs 6 patients, respectively). Furthermore, there were no differences noted with regard to ipsilateral versus contralateral peak systolic flow in the internal (83.5 vs 85.6 cm/seconds; P= .522 by the Student t test and P= .871 by the signed rank test) or common (74.4 vs 77.0 cm/seconds; P= .462 by the Student t test and P= .246 by the signed rank test) carotid artery. CONCLUSIONS: In this prospective study of breast cancer patients with long follow-up, there was no evidence of late, clinically relevant stenosis, increased intimal thickening, or increased peak systolic carotid artery flow secondary to supraclavicular irradiation.