DELTA: A Randomized Trial of Decongestive Lymphatic Therapy for Women with Lymphedema following Treatment for Breast Cancer

Proceedings of the 51st Annual ASTRO Meeting Materials/Methods: We retrospectively identified 1,414 patients that underwent SLN biopsy at our institution between 1996 and 2007. Of these, 1,265 were either N0(i-) or had metastases greater than 2 mm and were excluded, leaving a cohort of 149 patients. For the analysis of subsequent ALN positivity, 20/149 were excluded as additional ALNs were not sampled, leaving 129 patients. For the analysis of recurrence, 39/149 were excluded due to: Tis (2), neoadjuvant chemotherapy (4), Stage III disease (2), subsequent positive ALNs on further dissection (5), or inadequate follow-up (26), leaving 110 patients; 60 N0(i+) and 50 N1mi. Our institution considered patients with N0(i+) disease node negative for adjuvant treatment decisions. Data was analyzed for baseline differences between the groups in terms of age, T-Stage, grade, ER/PR status, Her2 status, LVI, and type of adjuvant therapy. Results: In 129 patients with further ALN sampling, the rate of further ALN positivity was 5% (6/129); 4% and 5% for N0(i+), and N1mi, respectively. Patients in the N1mi group were more likely to receive chemotherapy (p = 0.002) including a taxane (p = 0.0012). With a median follow-up of 44 months, 8 (7.3%) patients recurred. Six patients (10%) in the N0(i+) group experienced a recurrence (3 local, 3 distant), whereas 2 (4%) in the N1mi group experienced a recurrence (both local). This difference approached statistical significance based on univariate (log–rank) analysis (p = 0.08). All recurrences in the N0(i+) group occurred within 36 months of completion of adjuvant therapy whereas recurrences in the N1mi group occurred after 60 months. Using a Wilcoxon test giving greater weight to early recurrences, there was an increased risk of recurrence in the N0(i+) group compared to the N1mi group (p = 0.0251). Age\56.5 and Grade 3 tumors were also associated with increased risk of recurrence (p = 0.049 and p = 0.044). Conclusions: Rates of subsequent +ALNs were low in N0(i+) and N1mi patients, comparing favorably to the known false neg rate of SLN biopsy. Additional axillary surgery or radiation, which increases lymphedema risk, is probably unnecessary. Patients with N0(i+) had higher rates of recurrence compared to patients with N1mi reflecting success of the more aggressive adjuvant therapy given to the N1mi group and should be considered for N0(i+) particularly in younger patients with Grade 3 tumors. Prospective randomized trials are needed to determine who may benefit from more aggressive adjuvant therapy. Author Disclosure: N. Galanopoulos, None; P. Silverman, None; A. Panneerselvam, None; R. Leeming, None; R. Shenk, None; M. Persons, None; E. Kim, None; B. Spencer, None; J. Lyons, None.

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DELTA: A Randomized Trial of Decongestive Lymphatic Therapy for Women with Lymphedema following Treatment for Breast Cancer

I. S. Dayes1, T. J. Whelan1, J. A. Julian1, S. Parpia1, L. Manchul2, K. I. Pritchard2, D. P. D’Souza3, L. Leblanc4, M. McNeely5, M. N. Levine1 1 McMaster University, Hamilton, ON, Canada, 2University of Toronto, Toronto, ON, Canada, 3University of Western Ontario, London, ON, Canada, 4Dr. Leon Richard Oncology Centre, Moncton, NB, Canada, 5University of Alberta, Edmonton, AB, Canada

Purpose/Objective(s): Arm lymphedema remains a concerning complication of breast cancer surgery and radiation treatment, due to its chronic nature and associated morbidity. While decongestive therapy is often recommended, no randomized trial has demonstrated clear benefit over more conservative measures. Materials/Methods: Women previously treated for breast cancer with arm lymphedema were enrolled from six institutions. Volumes were calculated from serial circumference measurements. Patients with a minimum 10% arm volume difference were randomized to immediate elastic compression sleeve or 4 weeks of 20 daily 1-hour sessions of manual decongestive therapy consisting of lymphedema-specific massage followed by arm bandaging until the next massage. All patients also received conservative care in accordance with published guidelines. Volume measurements were obtained at baseline, midtreatment and upon completion of treatment. Further follow-up visits were at 12, 24, and 52 weeks. Primary outcome was percentage reduction in excess arm volume at completion of decongestive therapy. Quality of life, arm function, infection rates, and toxicity were also collected. Analysis was on an intention-to-treat basis. Results: A total of 103 patients were randomized. A midstudy review identified no safety concerns. Mean excess volume of the affected arm, as compared to the unaffected arm, was 27% (684 mL) in all patients at baseline. Eight patients withdrew consent immediately following randomization, leaving a total of 95 evaluable patients. Preliminary, unadjusted analysis demonstrated a relative reduction of excess arm volume at the post-treatment visit of 29.8% in the decongestive therapy group and 22.6% in the group receiving elastic sleeve alone, for a difference of 7.13% (p = 0.28). This represented a mean volume loss of 256 mL and 143 mL, respectively, for an additional benefit of 113 mL (p = 0.019) in patients receiving decongestive therapy. The proportion of patients with less than 200 mL of excess fluid following treatment was not significant between treatment groups (17.9% for decongestive therapy vs. 10.2% for elastic sleeve alone; p = 0.38). Quality of life and arm function data will also be presented. Conclusions: The DELTA study is, to our knowledge, the largest and only multicenter randomized trial evaluating the role of decongestive therapy for lymphedema in breast cancer survivors. Treatment benefit appears modest at best and is in keeping with estimates from previous trials. Because volume loss and improvement in symptoms may not directly correlate, further exploration may reveal other benefits in patient-oriented outcomes such as arm function or pain. Author Disclosure: I.S. Dayes, None; T.J. Whelan, None; J.A. Julian, None; S. Parpia, None; L. Manchul, None; K.I. Pritchard, None; D.P. D’Souza, None; L. Leblanc, None; M. McNeely, None; M.N. Levine, None.

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Low-risk Ductal Carcinoma In Situ (DCIS) Treated with Breast Conserving Surgery and Radiotherapy: Comparison with Intergroup Study E5194

S. B. Motwani1, S. L. Galper2, S. Goyal1, M. S. Moran2, B. G. Haffty1 1

Department of Radiation Oncology, The Cancer Institute of New Jersey, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, NJ, 2Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT Purpose/Objective(s): Recent data from Intergroup Study E5194 prospectively defined a low-risk subset of ductal carcinoma in situ (DCIS) patients where radiation therapy was omitted after local excision alone. At 5 years, they found a 6.8% ipsilateral breast

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