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.

Cardiac motion during deep-inspiration breath-hold: implications for breast cancer radiotherapy.

PURPOSE: Many patients with left-sided breast cancer receive adjuvant radiotherapy during deep-inspiration breath hold (DIBH) to minimize radiation exposure to the heart. We measured the displacement of the left anterior descending artery (LAD) and heart owing to cardiac motion during DIBH, relative to the standard tangential fields for left breast cancer radiotherapy. METHODS AND MATERIALS: A total of 20 patients who had undergone computed tomography-based coronary angiography with retrospective electrocardiographic gating were randomly selected for the present study. The patients underwent scanning during DIBH to control the influence of respiration on cardiac motion. Standard medial and lateral tangential fields were placed, and the LADs were contoured on the systolic- and diastolic-phase computed tomography data sets by the clinicians. Displacement of the LAD during cardiac contractions was calculated in three directions: toward the posterior edge of the treatment fields, left-right, and anteroposterior. Displacement of the entire heart was measured on the maximal and minimal intensity projection computed tomography images. RESULTS: The mean displacement of the LAD from cardiac contraction without the influence of respiration for 20 patients was 2.3 mm (range, 0.7-3.8) toward the posterior edge of the treatment fields, 2.6 mm (range, 1.0-6.8) in the left-right direction, and 2.3 mm (range, 0.6-6.5) in the anteroposterior direction. At least 30% of the LAD volume was displaced >5 mm in any direction in 2 patients (10%), and <10% of the LAD volume was displaced >5 mm in 10 patients (50%). The extent of displacement of the heart periphery during cardiac motion was negligible near the treatment fields. CONCLUSIONS: Displacement of the heart periphery near the treatment fields was negligible during DIBH; however, displacement of the LAD from cardiac contraction varied substantially between and within patients. We recommend maintaining ≥ 5 mm of distance between the LAD and the field edge for patients undergoing breast cancer radiotherapy during DIBH.

Automatic segmentation of whole breast using atlas approach and deformable image registration.

PURPOSE: To compare interobserver variations in delineating the whole breast for treatment planning using two contouring methods. METHODS AND MATERIALS: Autosegmented contours were generated by a deformable image registration-based breast segmentation method (DEF-SEG) by mapping the whole breast clinical target volume (CTVwb) from a template case to a new patient case. Eight breast radiation oncologists modified the autosegmented contours as necessary to achieve a clinically appropriate CTVwb and then recontoured the same case from scratch for comparison. The times to complete each approach, as well as the interobserver variations, were analyzed. The template case was also mapped to 10 breast cancer patients with a body mass index of 19.1-35.9 kg/m(2). The three-dimensional surface-to-surface distances and volume overlapping analyses were computed to quantify contour variations. RESULTS: The median time to edit the DEF-SEG-generated CTVwb was 12.9 min (range, 3.4-35.9) compared with 18.6 min (range, 8.9-45.2) to contour the CTVwb from scratch (30% faster, p = 0.028). The mean surface-to-surface distance was noticeably reduced from 1.6 mm among the contours generated from scratch to 1.0 mm using the DEF-SEG method (p = 0.047). The deformed contours in 10 patients achieved 94% volume overlap before correction and required editing of 5% (range, 1-10%) of the contoured volume. CONCLUSION: Significant interobserver variations suggested a lack of consensus regarding the CTVwb, even among breast cancer specialists. Using the DEF-SEG method produced more consistent results and required less time. The DEF-SEG method can be successfully applied to patients with different body mass indexes.

Effect of postmastectomy radiotherapy in patients <35 years old with stage II-III breast cancer treated with doxorubicin-based neoadjuvant chemotherapy and mastectomy.

PURPOSE: Postmastectomy radiotherapy (PMRT) improves locoregional control (LRC) in patients with high-risk features after mastectomy. Young age continues to evolve as a potentially important risk factor. The objective of this study was to assess the benefits of PMRT in patients <35 years old treated with doxorubicin-based neoadjuvant chemotherapy for Stage II-III breast cancer. PATIENTS AND METHODS: We retrospectively analyzed 107 consecutive breast cancer patients <35 years old with Stage IIA-IIIC disease treated at our institution with doxorubicin-based neoadjuvant chemotherapy and mastectomy, with or without PMRT. The treatment groups were compared in terms of LRC and overall survival. RESULTS: Despite more advanced disease stages, the patients who received PMRT (n = 80) had greater rates of LRC (5-year rate, 88% vs. 63%, p = 0.001) and better overall survival (5-year rate, 67% vs. 48%, p = 0.03) than patients who did not receive PMRT (n = 27). CONCLUSION: Among breast cancer patients <35 years old at diagnosis, the use of PMRT after doxorubicin-based neoadjuvant chemotherapy and mastectomy led to a statistically greater rate of LRC and overall survival compared with patients without PMRT. The benefit seen for PMRT in young patients provides valuable data to better tailor adjuvant, age-specific treatment decisions after mastectomy.

The safety of breast-conserving surgery in patients who achieve a complete pathologic response after neoadjuvant chemotherapy.

BACKGROUND: The objectives of this study were to determine the locoregional recurrence (LRR) rate and to evaluate the correlation between surgical resection volume (RV) and LRR in patients with breast cancer who underwent segmental mastectomy after achieving a pathologic complete response (pCR) on neoadjuvant chemotherapy. METHODS: The authors reviewed the outcomes of all 109 patients who underwent segmental mastectomy after the complete eradication of invasive disease by neoadjuvant chemotherapy at their institution between 1987 and 2002. LRRs were recorded, and RVs after segmental mastectomy were calculated and categorized as small, medium, or large. RESULTS: At a median follow-up of 6.6 years, 3 patients (2.7%) developed LRR. In 2 of those patients, the recurrence was located in the ipsilateral breast; in the other patient, the recurrence was located in the supraclavicular lymph nodes with synchronous distant metastases. The median RV was 73.12 cm3 (range, 2.82-451.51 cm3). Large RVs (>125 cm3) were less common than small RVs (up to 70 cm3) or medium RVs (between 70 cm3 and 125 cm3; P = .009 and P<.0001, respectively). One patient with a small RV had an LRR at 4 years, and 2 patients with medium RVs had LLRs at 2.3 years and 6 years, respectively. The 5-year and 10-year LRR-free survival rates were 98.1% and 96.5%, respectively, and the corresponding overall survival rates were 96% and 92%, respectively. CONCLUSIONS: Segmental mastectomy was associated with excellent locoregional control in patients who achieved a pCR after neoadjuvant chemotherapy. Prospective studies are needed to examine whether decreasing the RVs in this patient population leads to an increased LRR rate.