Hypofractionated radiotherapy in ten fractions for postmastectomy patients: a phase II study compared with another hypofractionation schedule with sixteen fractions

Background The purpose of this phase II study was to evaluate the feasibility of hypofractionated radiotherapy (HFRT) with a dose of 36.5 Gy in 10 fractions in postmastectomy patients. Methods From March 2014 to December 2015, 85 patients with locally advanced breast cancer were eligible to participate in this study with a schedule of 36.5 Gy in 10 fractions. Intensity-modulated radiation therapy (IMRT) was delivered to the chest wall with or without the supraclavicular region. The primary endpoint was radiation-related toxicities. The secondary endpoints were locoregional failure-free survival (LRFFS), disease-free survival (DFS) and overall survival (OS). And the outcomes were compared with our retrospective study of 72 patients with 42.5 Gy in 16 fractions. Results The median follow-up was 69.0 (range 66.5-71.5) months in the 36.5 Gy group and 93.0 (range 91.9-94.1) months in the 42.5 Gy group, respectively. Radiation-related toxicities were mainly grade 1, although a few patients had grade 2 plexopathy (1.2%) and acute skin toxicity (1.2%) in the 36.5 Gy group, and grade 2 acute skin toxicity (5.6%) and lymphedema (4.2%) in the 42.5 Gy group. There were no significant differences between the groups in acute and late toxicities. For all the patients, the 5-year LRFFS, DFS and OS were 97.7 and 100.0%, 93.1 and 90.3%, 98.8 and 97.2%, respectively, without significant differences between the groups. Conclusion Postmastectomy HFRT with a schedule of 36.5 Gy in 10 fractions was feasible, with mild toxicities and excellent 5-year clinical outcome. Trial registration Trial registration number: ChiCTR-ONRC-14004391. Date of registration: 9/3/2014.

Accelerated Hypofractionated Radiotherapy With Simultaneous Integrated Boost With Volumetric Modulated Arc Technique in Patients With Breast Cancer: a Phase 2 Study.

PurposeTo assess feasibility of accelerated hypofractionated radiotherapy with simultaneous integrated boost (SIB) with volumetric modulated arc technique (VMAT) in patients with breast cancer.Methods Total 27 patients after breast conserving surgery (BCS) were included in this study. Patients were planned on 4-dimensional computerized tomogram (4D-CT) and contouring was done using RTOG guidelines. Dose delivered was 34 Gy/10#/2wk to the breast and 40 Gy/10#/2wk to the tumor bed as SIB with VMAT technique. The primary endpoint was grade 2 acute skin toxicity. Doses to the organs at risk were calculated. Toxicities and cosmesis were assessed using RTOG LENT-SOMA and HARVARD/NSABP/RTOG grading scales, respectively. Disease-free survival (DFS) and overall survival (OS) was calculated with Kaplan Meier curves.ResultsMean age of the patients was 42 years. Left and right breast cancer was seen in 17 (63%) and 10 (37%) patients, respectively. Ipsilateral lung mean V16 and contralateral lung V5 was 16.01% and 3.73%, respectively. Mean heart dose from the left and right breast was 7.25Gy and 4.37Gy, respectively. Mean dose to the contralateral breast, oesophagus and spinal cord was 2.64Gy, 3.69Gy and 3.15Gy, respectively. Thyroid V25 mean was 19.69%.Grade 1 and 2 acute skin toxicity was observed in 9 (33%) and 5 (18.5%) patients, respectively. Grade 2 hyperpigmentation, edema and induration were observed in 1 (3.7%), 2 (7.4%) and 4(14.8%) patients, respectively. Mild breast pain and arm/shoulder discomfort were reported by 1 (3.4%) patient each. Median follow-up was 48 months (range 12-58 months). At 4 years breast induration, edema and fibrosis each were observed in 1(3.7%) patient. Cosmesis was excellent and good in 21 (78%) and 6 (22%) patients, respectively. Local recurrence and distant metastases occurred 1(3.7%) and 2(7.4%) patients, respectively. DFS and OS at 3-years was 88% and 92%, respectively.ConclusionWith this RT schedule acute and late toxicity rates were acceptable with no adverse cosmesis. Local control, DFS and OS were good.

External Beam Partial Breast Irradiation Versus Whole Breast Irradiation for in Early Breast Cancer：A Systematic Review and Meta-Analysis

PurposePostoperative radiotherapy can reduce the recurrence of breast cancer. Postoperative radiotherapy is divided into whole breast irradiation (WBI) and partial breast irradiation (PBI) for early breast cancers. Due to the characters of saving time, money, and easy to deliver, external beams PBI (EB PBI) is brought into focus. However, the researches on outcomes, safety, and efficacy between EB PBI and WBI are still insufficient. We concluded a meta-analysis for LRR, regional node recurrence, contralateral breast cancer, distant recurrence, mortality, less acute skin toxicity (˃ 1 grade), late skin toxicity and the cosmetic score of external beam partial breast irradiation (EB PBI) and whole breast irradiation(WBI) to develop a radiotherapy plan for early low recurrence risk breast cancer patients. MethodWe searched Pubmed、Embase、Cochrane Library、Clinicaltrals. Study eligibility criteria are as below: (1) RCTs for EB PBI vs WBI; (2) Histologically confirmed breast cancer; (3) AJCC staged Tis-2N0-1M0; (4) ≥ 40 years old; (5) Tumor size ≤ 3 cm;(6) microscopically clear margins ≤ 5 cm; (7) Mean follow-up time༞5 years. All data is used by Cochrane’s Review Manager 5.3 (RevMan) to process.ResultsThere were 4 RCT studies included in our study with 1999 patients in EB PBI group and 1999 patients in EB PBI. There was no statistic difference between PBI and WBI groups in local recurrence rates (RR = 1.15; 95% CI, 0.76 to 1.74; p = 0.52; I2 = 0%), regional node recurrence(RR = 1.00; 95% CI, 0.49 to 2.04, p = 0.99, I2 = 0%), contralateral breast cancer (RR = 0.79; 95% CI, 0.54 to 1.16; p = 0.23; I2 = 0%), distant recurrence(RR = 1.00; 95% CI, 0.63 to 1.59; p = 1.00; I2 = 0%), non-breast second cancer (RR = 1.03; 95% CI, 0.50 to 2.16; p = 0.93; I2 = 83%), mortality(RR = 0.96; 95% CI, 0.60 to 1.55; p = 0.88, I2 = 54%). EB PBI had worse cosmetic score (RR = 1.56; 95% CI, 1.04 to 2.34; p = 0.003, I2 = 84%), less acute skin toxicity (˃ 1 grade) (RR = 0.17; 95% CI, 0.07 to 0.42; p༜ 0.0001, I2 = 87%) and late skin toxicity(RR = 0.65; 95% CI, 0.48 to 0.88; p = 0.005; I2 = 27%) than WBI.ConclusionEB PBI has similar LRR, regional node recurrence, contralateral breast cancer, distant recurrence, non-breast second cancer and mortality with WBI. But EB PBI has worse cosmetic score, less acute skin toxicity (˃ 1 grade) and late skin toxicity than WBI.

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China

PURPOSE No randomized trials have compared hypofractionated radiotherapy (HFRT) with conventional fractionated radiotherapy (CFRT) after breast-conserving surgery in the Asian population. This study aimed to determine whether a 3.5-week schedule of HFRT is noninferior to a standard 6-week schedule of CFRT in China. PATIENTS AND METHODS Patients from 4 Chinese institutions who had undergone breast-conserving surgery and had T1-2N0-3 invasive breast cancers participated this study. Patients were randomly assigned (1:1) using a computer-generated central randomization schedule, without stratification, to receive whole-breast irradiation with or without nodal irradiation, followed by tumor-bed boost, either at a dose of 50 Gy in 25 fractions over 5 weeks with a boost of 10 Gy in five fractions over 1 week (CFRT) or 43.5 Gy in 15 fractions over 3 weeks with a boost of 8.7 Gy in three daily fractions (HFRT). The primary endpoint was 5-year local recurrence (LR), and a 5% margin of 5-year LR was used to establish noninferiority. RESULTS Between August 2010 and November 2015, 734 patients were assigned to the HFRT (n = 368) or CFRT (n = 366) group. At a median follow-up of 73.5 months (interquartile range, 60.5-91.4 months), the 5-year cumulative incidence of LR was 1.2% in the HFRT group and 2.0% in the CFRT group (hazard ratio, 0.62; 95% CI, 0.20 to 1.88; P = .017 for noninferiority). There were no significant differences in acute and late toxicities, except that the HFRT group had less grade 2-3 acute skin toxicity than the CFRT group ( P = .019). CONCLUSION CFRT and HFRT with a tumor-bed boost may have similar low LR and toxicity.

Effectiveness and Tolerability of Natural Herbal Formulations in the Prevention of Radiation-Induced Skin Toxicity in Patients Undergoing Radiotherapy

The aim of this study is to investigate the preventive role of 3 herbal formulation products on reducing the incidence of radiation-induced dermatitis in patients undergoing radiotherapy for either breast or head and neck cancer. A total of 59 patients participated in the study. The novel herbal products, a combination of beeswax, olive oil, Calendula and Hypericum oils and Aloe gel, were daily and regularly being used by the patients during radiotherapy and 2 weeks after treatment end. Acute skin toxicity was scored weekly during radiotherapy and after treatment for a further 4-week follow-up period. Demographic data were analyzed by descriptive statistics. Statistical analyses of the study objectives were based on an intent-to-treat principle. Most of the patients presented with grade I (RTOG/EORTC) toxicity in the first weeks of radiotherapy, progressed to grade II but reverted to grade I toxicity up until the study end. A total of 94.9% of the patients had Dermatology Life Quality Index up to 1, and 66.1% remained in this scale. The application of the novel natural product combinations proved to be statistically significantly effective in reducing the intensity of radiation dermatitis, positively affecting the quality of life of the patients.