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Purpose The adoption of hypofractionated whole-breast irradiation (HF-WBI) remains low, in part because of concerns regarding its safety when used with a tumor bed boost or in patients who have received chemotherapy or have large breast size. To address this, we conducted a randomized, multicenter trial to compare conventionally fractionated whole-breast irradiation (CF-WBI; 50 Gy/25 fx + 10 to 14 Gy/5 to 7 fx) with HF-WBI (42.56 Gy/16 fx + 10 to 12.5 Gy/4 to 5 fx). Patients and Methods From 2011 to 2014, 287 women with stage 0 to II breast cancer were randomly assigned to CF-WBI or HF-WBI, stratified by chemotherapy, margin status, cosmesis, and breast size. The trial was designed to test the hypothesis that HF-WBI is not inferior to CF-WBI with regard to the proportion of patients with adverse cosmetic outcome 3 years after radiation, assessed using the Breast Cancer Treatment Outcomes Scale. Secondary outcomes included photographically assessed cosmesis scored by a three-physician panel and local recurrence-free survival. Analyses were intention to treat. Results A total of 286 patients received the protocol-specified radiation dose, 30% received chemotherapy, and 36.9% had large breast size. Baseline characteristics were well balanced. Median follow-up was 4.1 years. Three-year adverse cosmetic outcome was 5.4% lower with HF-WBI ( Pnoninferiority = .002; absolute risks were 8.2% [n = 8] with HF-WBI v 13.6% [n = 15] with CF-WBI). For those treated with chemotherapy, adverse cosmetic outcome was higher by 4.1% (90% upper confidence limit, 15.0%) with HF-WBI than with CF-WBI; for large breast size, adverse cosmetic outcome was 18.6% lower (90% upper confidence limit, −8.0%) with HF-WBI. Poor or fair photographically assessed cosmesis was noted in 28.8% of CF-WBI patients and 35.4% of HF-WBI patients ( P = .31). Three-year local recurrence-free survival was 99% with both HF-WBI and CF-WBI ( P = .37). Conclusion Three years after WBI followed by a tumor bed boost, outcomes with hypofractionation and conventional fractionation are similar. Tumor bed boost, chemotherapy, and larger breast size do not seem to be strong contraindications to HF-WBI.

Purpose Previous research incorporating yoga (YG) into radiotherapy (XRT) for women with breast cancer finds improved quality of life (QOL). However, shortcomings in this research limit the findings. Patients and Methods Patients with stages 0 to III breast cancer were recruited before starting XRT and were randomly assigned to YG (n = 53) or stretching (ST; n = 56) three times a week for 6 weeks during XRT or waitlist (WL; n = 54) control. Self-report measures of QOL (Medical Outcomes Study 36-item short-form survey; primary outcomes), fatigue, depression, and sleep quality, and five saliva samples per day for 3 consecutive days were collected at baseline, end of treatment, and 1, 3, and 6 months later. Results The YG group had significantly greater increases in physical component scale scores compared with the WL group at 1 and 3 months after XRT (P = .01 and P = .01). At 1, 3, and 6 months, the YG group had greater increases in physical functioning compared with both ST and WL groups (P < .05), with ST and WL differences at only 3 months (P < .02). The group differences were similar for general health reports. By the end of XRT, the YG and ST groups also had a reduction in fatigue (P < .05). There were no group differences for mental health and sleep quality. Cortisol slope was steepest for the YG group compared with the ST and WL groups at the end (P = .023 and P = .008) and 1 month after XRT (P = .05 and P = .04). Conclusion YG improved QOL and physiological changes associated with XRT beyond the benefits of simple ST exercises, and these benefits appear to have long-term durability.

PurposeThis study estimated the economic burden of breast cancer–related lymphedema (BCRL) among working-age women, the incidence of lymphedema, and associated risk factors.MethodsWe used claims data to study an incident cohort of breast cancer patients for the 2 years after the initiation of cancer treatment. A logistic regression model was used to ascertain factors associated with lymphedema. We compared the medical costs and rate of infections likely associated with lymphedema between a woman with BCRL and a matched control. We performed nonparametric bootstrapping to compare the unadjusted cost differences and estimated the adjusted cost differences in regression analysis.ResultsApproximately 10% of the 1,877 patients had claims indicating treatment of lymphedema. Predictors included treatment with full axillary node dissection (odds ratio [OR] = 6.3, P < .001) and chemotherapy (OR = 1.6, P = .01). A geographic variation was observed; women who resided in the West were more likely to have lymphedema claims than those in the Northeast (OR = 2.05, P = .01). The matched cohort analysis demonstrated that the BCRL group had significantly higher medical costs ($14,877 to $23,167) and was twice as likely to have lymphangitis or cellulitis (OR = 2.02, P = .009). Outpatient care, especially mental health services, diagnostic imaging, and visits with moderate or high complexity, accounted for the majority of the difference.ConclusionAlthough the use of claims data may underestimate the true incidence of lymphedema, women with BCRL had a greater risk of infections and incurred higher medical costs. The substantial costs documented here suggest that further efforts should be made to elucidate reduction and prevention strategies for BCRL.

Purpose To evaluate the efficacy of radiation in patients treated with neoadjuvant chemotherapy and mastectomy. Patients and Methods We retrospectively analyzed the outcomes of 542 patients treated on six consecutive institutional prospective trials with neoadjuvant chemotherapy, mastectomy, and radiation. These data were compared to those of 134 patients who received similar treatment in these same trials but without radiation. Results Irradiated patients had a lower rate of local-regional recurrence (LRR) (10-year rates: 11% v 22%, P = .0001). Radiation reduced LRR for patients with clinical T3 or T4 tumors, stage ≥ IIB disease (AJCC 1988), pathological tumor size >2 cm, or four or more positive nodes (P ≤ .002 for all comparisons). Patients who presented with clinically advanced stage III or IV disease but subsequently achieved a pathological complete response to neoadjuvant chemotherapy still had a high rate of LRR, which was significantly reduced with radiation (10-year rates: 33% v 3%, P = .006). Radiation improved cause-specific survival (CSS) in the following subsets: stage ≥ IIIB disease, clinical T4 tumors, and four or more positive nodes (P ≤ .007 for all comparisons). On multivariate analyses of LRR and CSS, the hazard ratios for lack of radiation were 4.7 (95% CI, 2.7 to 8.1; P < .0001) and 2.0 (95% CI, 1.4 to 2.9; P < .0001), respectively. Conclusion After neoadjuvant chemotherapy and mastectomy, comprehensive radiation was found to benefit both local control and survival for patients presenting with clinical T3 tumors or stage III-IV (ipsilateral supraclavicular nodal) disease and for patients with four or more positive nodes. Radiation should be considered for these patients regardless of their response to initial chemotherapy.

Purpose: To evaluate how implementation of the 2003 American Joint Committee on Cancer (AJCC) staging system will affect stage-specific survival of breast cancer patients. Patients and Methods: Records of 1,350 patients treated on sequential institutional protocols with mastectomy and adjuvant doxorubicin-based chemotherapy were reviewed. Pathologic stage was assigned retrospectively according to the 1988 and the 2003 AJCC staging criteria. Overall stage-specific survival (OS) was calculated using the Kaplan-Meier method, and hypothetical differences were compared by the log-rank test. Results: Six hundred five of 1,087 patients with stage II disease according to the 1988 classification system had stage II disease according to the 2003 system. The 10-year OS for patients with stage II disease was significantly improved using the 2003 system (76% [2003] v 65% [1988]; P < .0001). Two hundred eighty-nine of 633 patients with stage IIb disease using the 1988 system were stage IIb with the 2003 system, and 10-year OS was 58% (1988) versus 70% (2003; P = .003). The number of patients with stage III disease increased from 207 (1988) to 443 (2003), and the 10-year OS changed from 45% (1988) to 50% (2003; P = .077). Most of this difference resulted from changes within stage IIIa: OS, 45% (1988) versus 59% (2003; P < .0001). Conclusion: Stage reclassification using the new AJCC staging system for breast cancer will result in significant changes in reported outcome by stage. It is imperative that careful attention is devoted to this effect so that accurate conclusions regarding the efficacy of new treatment strategies can be drawn.

9539 Background: Mind-body practices improve quality of life (QOL), yet prior trials have not included active control groups. Our prior work found a Tibetan Yoga Program (TYP) resulted in fewer sle...

9009 Background: Radiotherapy (XRT) can decrease quality of life (QOL), disrupt cortisol rhythm and contribute to cardiovascular disease. We examined the effects of yoga on buffering changes in QOL...

9639 Background: A yoga program was developed that included postures, a breathing exercise, a relaxation technique, and meditation for patients with breast cancer who were undergoing radiotherapy. ...

8505 Background: Yoga, an ancient Indian science, incorporates stress-reduction techniques that include regulated breathing, visual imagery, and meditation, as well as various postures that may be useful for cancer patients. Methods: A yoga program was developed that including loosening and breathing exercises, postures, alternate nostril breathing, a deep relaxation technique, and meditation for patients with breast cancer who were undergoing radiotherapy. Women participated in bi-weekly classes during their 6 weeks of radiation treatment. Sixty-one women with breast cancer were randomly assigned to either the yoga program or to a waitlist control group. Patients completed measures of intrusive thoughts and avoidance behaviors (Impact of Events Scale: IES), depressive symptoms (CES-D), sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (BFI), and quality of life (SF-36) at baseline, 1 week, and 1 and 3 months after the last radiation therapy. We report on the outcomes 1 week after the end of radiotherapy. Results: The average age of the women was 52, 3% stage 0, 28% stage I, 43% stage II, and 26% stage III, 48% had undergone breast-conserving surgery, and 75% had received chemotherapy prior to starting radiotherapy. Analysis of covariance, controlling for baseline, revealed that the yoga group had significantly better SF-36 physical function scores (adjusted means: yoga 81.8 vs. control 68.6, P < 0.01), significantly higher SF-36 general health scores (adjusted means: yoga 78.3 vs. control 67.9, P < 0.03), marginally better SF-36 social functioning scores (adjusted means: yoga 85.3 vs. control 76.0, P > 0.1), significantly lower levels of sleep-related daytime dysfunction (adjusted means: yoga 0.5 vs. control 1.2, P < 0.04), and marginally lower levels of fatigue (adjusted means: yoga 1.9 vs. control 3.1, P < 0.06) than the control group. There were no other group differences on the SF-36 subscales or for the CES-D or IES scores. Conclusions: The results indicated that the yoga program was associated with statistically and clinical significant improvements in aspects of quality of life. No significant financial relationships to disclose.

1012 Body: Purpose: Tamoxifen is a proven chemopreventive modality that reduces the risk of invasive breast cancer by over 50% in high risk women. LCIS is a known risk factor for the development of...

671 Background: Medullary carcinoma of the breast is an uncommon histological type consisting of poorly differentiated cells surrounded by a prominent lymphoid stroma. It is also suggested that the...

777 Background: In contrast with female breast cancer, there is limited data on the expression of biologic markers and significance of clinicopathologic features in male breast cancer. Methods: We reviewed pathology and clinical data for 33 evaluable patients with MBC from 1981–1999. Immunohistochemical staining for ER, PR, AR, and cyclin D1 was performed. Results: Mean patient age was 61 years (range 35–80). 70% were Caucasian, 18% Hispanic, 12% African-American. 27% had a family history of breast/ovarian cancer in first-degree relatives. Patients presented as follows: with gynecomastia (33%), with a painless mass (33%), with nipple inversion/discharge (27%). Mean tumor size was 1.7 cm (range 0.1– 5.0 cm). The tumor was retroareolar/central in 67% patients. 88% had invasive ductal carcinoma while 12% had intracystic papillary DCIS. Tumor grade was as follows: high-grade (15), intermediate-grade (17), and low-grade (1). 40% had lymphovascular invasion, 15% presented with dermal involvement, and 12% had ni...