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INTRODUCTION: Oncotype DX® (ODX) is a multigene assay estimating risk of distant recurrence and chemotherapy benefit in estrogen receptor (ER) positive breast cancer patients. Cost ($4,620.00) impedes its adoption in poorer countries, and the cost is unnecessary in certain patients. TAILORx results suggest that adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in women with hormone-positive, HER2-negative, node-negative invasive breast carcinomas with an ODX recurrence score < 26. Bhargava et al. and Turner et al. have suggested that a Magee scoreTM or a modified Magee score, respectively, of < 18 will identify patients who are highly likely to have an ODX recurrence score of < 26, and we previously presented data at SABCS 2019 (Abstract P3-07-06) that there is no significant difference in recurrence rate between patients with a modified Magee score of ≤ 18 and patients with an ODX recurrence score < 26 (in preparation for publication). We now present additional recurrence data on patients with a modified Magee score of > 18. METHODS: A total of 301 consecutive patients with ER+ invasive breast cancer from the University of Rochester and the University of Louisville were included in this study, with a mean of 6.6 years of follow-up. All patients had at least 5 years of follow-up (range 5-11 years) except for seven patients , who had a breast cancer recurrence prior to five years. Information on ER, PR, HER-2, Ki-67, Nottingham score , and tumor size were extracted from the pathology report in order to calculate the modified Magee score. Information, on hormone therapy, chemotherapy, radiation therapy, recurrence status, and mortality were extracted from the medical record. For all results, a p-value of < 0.05 was considered significant. RESULTS: 117/301 (39%) patients had a modified Magee score of > 18. The recuurence rate for patients with a modified Magee score > 18 was 11.1%. There was no significant difference in recurrence rate between patients with both a modified Magee score > 18 and ODX recurrence score < 26 compared to patients with both a modified Magee score >18 and ODX recurrence score ≥ 26 (p = 0.547, Table 1). CONCLUSIONS: Patients with a modified Magee score > 18 may be at increased risk for breast cancer recurrence, even if the ODX recurrence score is < 26. Additional studies are necessary to further evaluate these findings. Table 1: Modified Magee score > 18, Oncotype DX recurrence score (ODXRS), and outcomeRecurrenceNo recurrenceModified Magee score > 18 and ODXRS < 26870Modified Magee score > 18 and ODXRS ≥ 26633 Citation Format: Bradley M Turner, Mary Ann Gimenez-Sanders, Ioana Moisini, Huina Zhang, Xi Wang, Linda Schiffhauer, Hani Katerji, Kristin Skinner, Jessica Gooch, Michelle Shayne, Marilyn Ling, Carla Falkson, David Hicks. Are we missing something? Increased recurrence rates in patients with an oncotype DX score < 26 and a modified magee score > 18: A multi-institutional study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-24.

INTRODUCTION: The literature suggests that there is no difference in the Oncotype DX® (ODX) recurrence score between African American (AA) women and Caucasian (CA) women; however, an analysis of clinical outcomes in participants enrolled in the TAILORx trial found that AA women had worse clinical outcomes than CA women, despite similar ODX recurrence scores. The TAILORx trial suggested that chemoendocrine therapy may not be necessary in women with hormone-positive, HER2-negative, node-negative invasive breast carcinomas with an ODX recurrence score < 26. We examine Ki-67 (a marker of tumor proliferation) in relation to an ODX recurrence score of 26 in AA and CA women from two seperate institutions. METHODS: A total of 851 consecutive cases of AA (n = 78) and CA women (n = 773) with ER+ invasive breast cancer and available ODX recurrence scores from the University of Rochester and the University of Louisville were included in this study. For all results, a p-value of < 0.05 was considered significant. RESULTS: Consistent with the previous literatuere, there was no significant difference between the average ODX recurrence score of AA and CA women (p = 0.44, Table 1), and we found no significant difference in average ER, PR, Nottingham score, or tumor size between AA and CA patients; however, the Ki-67 was significantly higher in AA patients with an ODX recurrence score < 26 compared to CA patients with and ODX recurrence score < 26 (p = 0.002, Table 2). This significant difference in Ki-67 was not evident with an ODX recurrence score ≥ 26 (p = 0.98, Table 2). CONCLUSIONS: Our preliminary results suggest that compared to CA women, AA patients are more likely to have a higher Ki-67 if the ODX recurrence score is < 26. AA breast cancer patients with an ODX < 26 are at increased risk for recurrence compared to CA women with an ODX < 26. Ki-67 evaluation is not routinely done as part of the breast cancer workup in many institutions. Ki-67 evaluation may be helpful to help guide treatments decisions in AA patients with and ODX < 26. Additional investigation is warranted. Table 1: Oncotype DX and histopathologic variables for African American and Caucasian womenODXRS* (mean)ER** (mean)PR** (mean)NS***(mean)Ki-67 (mean)****Tumor size (mean)ODXRS < 26 (n) ODXRS ≥ 26 (n)ALL17.6255.3168.96.016.42.2713138AA18.3250.7175.96.321.42.26315CA17.5255.8168.26.015.92.2650123*Oncotype DX recurrence score** modified H-score*** Nottingham score****n = KI-67 available for 777 total patients (650 with ODXRS < 26 and 127 with ODXRS ≥ 26); KI-67 available for 71 AA patients (51 with ODXRS < 26 and 14 with ODXRS ≥ 26); KI-67 available for 706 CA patients (593 with ODXRS < 26 and 113 with ODXRS ≥ 26) Table 2: Oncotype DX < 26 and ≥ 26 and associated histopathologic variables for African American and Caucasian womenODXRS* (mean)ER** (mean)PR** (mean)NS*** (mean)Ki-67 (mean)****Tumor size (mean)ODXRS < 2614.5260.5189.15.813.72.2AA15.4262.8200.76.019.22.3CA14.4260.3188.05.813.12.2ODX ≥ 2633.8228.464.47.330.52.1AA30.3199.871.97.730.41.6CA34.2231.963.57.330.52.2*Oncotype DX recurrence score** modified H-score*** Nottingham score****n = KI-67 available for 777 total patients (650 with ODXRS < 26 and 127 with ODXRS ≥ 26); KI-67 available for 71 AA patients (51 with ODXRS < 26 and 14 with ODXRS ≥ 26); KI-67 available for 706 CA patients (593 with ODXRS < 26 and 113 with ODXRS ≥ 26) Citation Format: Bradley M Turner, Mary Ann Gimenez-Sanders, Huina Zhang, Ioana Moisini, Xi Wang, Linda Schiffhauer, Hani Katerji, Kristin Skinner, Jessica Gooch, Michelle Shayne, Marilyn Ling, Carla Falkson, David Hicks. Are we missing something? Ki-67 evaluation is important in African American women with an oncotype DX score< 26: A multi-institutional study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS6-18.

PURPOSE: Despite advances in medical technology, radiation dermatitis occurs in 95% of patients receiving radiation therapy (RT) for cancer. Currently, there is no standard and effective treatment for the prevention or control of radiation dermatitis. The goal of the study was to determine the efficacy of oral curcumin, one of the biologically active components in turmeric, at reducing radiation dermatitis severity (RDS) at the end of RT, using the RDS scale, compared to placebo. METHODS: This was a multisite, randomized, double-blinded, placebo-controlled trial of 686 breast cancer patients. Patients took four 500 mg capsules of placebo or curcumin three times daily throughout their prescribed course of RT until one week post-RT. RESULTS: A total of 686 patients were included in the final analyses (87.5% white females, mean age = 58). Linear mixed model analyses demonstrated that curcumin did not reduce radiation dermatitis severity at the end of RT compared to placebo (B (95% CI) =0.044 (−0.101, 0.188), p=0.552). Fewer curcumin patients with RDS > 3.0 suggested a trend toward reduced severity (7.4% vs. 12.9%, p=0.082). Patient-reported changes in pain, symptoms, and quality of life were not statistically significant between arms. CONCLUSIONS: Oral curcumin did not significantly reduce radiation dermatitis severity compared to placebo. The skin rating variation and broad eligibility criteria could not account for the undetectable therapeutic effect. An objective measure for radiation dermatitis severity and further exploration for an effective treatment for radiation dermatitis is warranted.

Oncotype DX (Genomic Health, Redwood City, CA, USA, current list price $4,350.00) is a multigene quantitative reverse transcription-polymerase chain reaction-based assay that estimates the risk of distant recurrence and predicts chemotherapy benefit for patients with estrogen receptor (ER)-positive breast cancers. Studies have suggested that standard histologic variables can provide similar information. Klein and Dabbs et al have shown that Oncotype DX recurrence scores can be estimated by incorporating standard histologic variables into equations (Magee equations). Using a simple modification of the Magee equation, we predict the Oncotype DX recurrence score in an independent set of 283 cases. The Pearson correlation coefficient (r) for the Oncotype DX and average modified Magee recurrence scores was 0.6644 (n=283; P0.0001). 100% of cases with an average modified Magee recurrence score30 (n=8) or an average modified Magee recurrence score9 (with an available Ki-67, n=5) would have been correctly predicted to have a high or low Oncotype DX recurrence score, respectively. 86% (38/44) of cases with an average modified Magee recurrence score≤12, and 89% (34/38) of low grade tumors (NS6) with an ER and PR≥150, and a Ki-6710%, would have been correctly predicted to have a low Oncotype DX recurrence score. Using an algorithmic approach to eliminate high and low risk cases, between 5% and 23% of cases would potentially not have been sent by our institution for Oncotype DX testing, creating a potential cost savings between $56,550.00 and $282,750.00. The modified Magee recurrence score along with histologic criteria may be a cost-effective alternative to the Oncotype DX in risk stratifying certain breast cancer patients. The information needed is already generated by many pathology laboratories during the initial assessment of primary breast cancer, and the equations are free.

INTRODUCTION: Oncotype DX (ODX) (Genomic Health, Redwood City, CA, USA) is a multigene quantitative reverse transcription-polymerase chain reaction-based assay used to estimate the risk of distant recurrence for ER-positive, node negative-breast cancer patients. The quoted list price for ODX is $4.175.00. ODX reports a recurrence score (RS) that is divided into low (< 18), intermediate (18-30), and high risk (≥ 30). The ODX RS has been shown to be prognostic and predict chemotherapy benefit in receptor positive breast cancer patients. The RS most highly weights genes related to proliferation (including Ki-67), HER-2, ER and PR. Klein et al. have previously shown that standard histological variables, in combination with semiquantitative ER, PR, HER-2, and Ki-67 results, can provide information similar to that found in the ODX RS using equations derived by linear regression analysis (Magee equations). In the current study, we have used a modification of these equations to validate their use in a cohort of breast cancer cases that were sent for ODX from our institution. MATERIALS AND METHODS: 233 cases (2009-present) with available ODX RS's (208 of these with Ki-67 results) were obtained from the pathology files at the University of Rochester Medical Center (URMC), and the histopathologic variables were extracted from the reports. Estimated RS's (URMC RS) were calculated by averaging results from the three published Magee equations, with a modification of the H-score for ER and PR. We estimated the H-score by multiplying the average intensity of staining by the% positive tumor cells. URMC RS's were compared with their paired ODX RS’s. RESULTS: The table shows the correlation between the ODX RS and URMC RS. 100% of cases with a high URMC RS also had a high ODX RS. There were no two step discordant results between a URMC RS and an ODX RS. A URMC RS correlated with an ODX RS of high, intermediate, and low in 7/12 (58%), 48/79 (61%) and 97/117 (83%) cases, respectively. Most of the discordant cases involved the intermediate/low groups, and the higher RS's in the discordant pairs were consistently close to the lower end cutoff point.The URMC RS and ODX RS would have resulted in similar treatment in 100% of patients. Comparison of ODX RS and URMC RS; n = number of cases (URMC median, URMC range) ODX RS ⇒URMC RS ⇓HIGHINTERMEDIATELOWHIGH7 (35,32-40)00INTERMEDIATE5 (25,22-28)48 (22,18-30)20 (20,18-27)LOW031 (15,9-18)97 (14,7-18) CONCLUSION: The modified Magee equations provide similar information as the ODX RS using information already generated by many laboratories, and may be a more cost-effective alternative than ODX in identifying breast cancer patients who might benefit from chemotherapy, or be spared its potential toxicity. If the estimated RS is clearly high or low, it is predictive of the ODX RS with a high degree of certainty. In our population a potential cost of $556,875.00 might have been avoided using the estimated RS. The estimated RS should not be dramatically different from the ODX RS. If there is a significant difference, this should be thoroughly investigated before decisions on adjuvant therapy are made. Citation Information: Cancer Res 2013;73(24 Suppl): Abstract nr P2-11-12.

Radiation dermatitis occurs in approximately 95% of patients receiving radiotherapy (RT) for breast cancer. We conducted a randomized, double-blind, placebo-controlled clinical trial to assess the ability of curcumin to reduce radiation dermatitis severity in 30 breast cancer patients. Eligible patients were adult females with noninflammatory breast cancer or carcinoma in situ prescribed RT without concurrent chemotherapy. Randomized patients took 2.0 grams of curcumin or placebo orally three times per day (i.e., 6.0 grams daily) throughout their course of RT. Weekly assessments included Radiation Dermatitis Severity (RDS) score, presence of moist desquamation, redness measurement, McGill Pain Questionnaire-Short Form and Symptom Inventory questionnaire. The 30 evaluable patients were primarily white (90%) and had a mean age of 58.1 years. Standard pooled variances t test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs. 3.4; P = 0.008). Fisher's exact test revealed that fewer curcumin-treated patients had moist desquamation (28.6% vs. 87.5%; P = 0.002). No significant differences were observed between arms for demographics, compliance, radiation skin dose, redness, pain or symptoms. In conclusion, oral curcumin, 6.0 g daily during radiotherapy, reduced the severity of radiation dermatitis in breast cancer patients.

Osteoporosis, a skeletal disorder characterized by a reduction in bone strength, increases fracture risk. Primary osteoporosis is usually a result of reduced bone mineral density as a consequence of natural aging. Secondary osteoporosis is usually a result of a disease, such as cystic fibrosis, or medical treatment, such as corticosteroids or cancer treatment.Currently, ten million Americans are osteoporotic and an additional 34 million have the precursor condition, osteopenia. Osteoporosis leads to 1.5 million fractures and 500,000 hospitalizations annually. Osteoporosis-related fractures increase mortality and reduce quality of life. Calcitriol, the active form of vitamin D, regulates intestinal calcium absorption, among other actions. During the past four decades, many clinical trials investigating the effect of calcitriol on bone loss have been performed.We conducted a systematic qualitative review of clinical trials that assessed calcitriol for the treatment of osteoporosis and bone loss. In these clinical trials, calcitriol was used as a monotherapy and in combination with other therapeutic bone agents.Studies using calcitriol monotherapy, although not conclusive, found that calcitriol slowed the rate of bone loss in a variety of populations. Calcitriol in combination with other therapeutic bone agents was shown to have additional bone-preserving effects when compared to the use of therapeutic bone agents alone. A common side-effect of calcitriol therapy was hypercalcemia and hypercalciuria, but the degree of hypercalcemia was mild. Recent research found that intermittent dosing can reduce hypercalcemia rates. Calcitriol, alone or in combination with other agents, should be considered for the therapy of osteoporosis.

Angiosarcoma is a rare subtype of sarcoma that usually arises after radiation therapy for primary breast cancer. Primary sarcomas of the breast are rare entities and account for less than 1% of all malignant breast neoplasms. We examine our institutional experience with angiosarcomas of the breast that were diagnosed and treated between 1996 and 2007.To conduct a retrospective review, all female patients with a diagnosis of angiosarcoma of the breast were identified from our pathology database. Their hospital records were retrieved to gather information on treatment, tumor response, failure, and survival.A total of 8 patients were identified who had a histologically confirmed diagnosis of angiosarcoma of the breast. Median age was 70.3 years at diagnosis (range, 35.6-85.7 years). Seven (87%) patients had a history of prior radiation to the breast, whereas 1 (13%) had primary angiosarcoma. The median overall survival was 37.4 months (8.7-92.8 months) and relapse-free survival was 17.9 months (2.5-69.4 months).Even though angiosarcomas are rare neoplasms, they are increasingly recognized as the result of more breast-conserving therapy. High clinical suspicion and MRI may contribute to early diagnosis but a biopsy is always necessary to confirm it. These tumors tend to behave aggressively and require a multidisciplinary approach to improve the outcome.

Purpose: To develop and implement a non-invasive immobilization system guided by a dedicated quality assurance (QA) program for dynamic intensity-modulated radiotherapy (IMRT) of intracranial and head and neck disease, with IMRT delivered using the NOMOS Corporation’s Peacock System and MIMiC collimator. Methods and Materials: Thermoplastic face masks are combined with cradle-shaped polyurethane foaming agents and a dedicated quality assurance program to create a customized headholder system (CHS). Plastic shrinkage was studied to understand its effect on immobilization. Fiducial points for computerized tomography (CT) are obtained by placing multiple dabs of barium paste on mask surfaces at intersections of laser projections used for patient positioning. Fiducial lines are drawn on the cradle along laser projections aligned with nasal surfaces. Lateral CT topograms are annotated with a crosshair indicating the origin of the treatment planning and delivery coordinate system, and with lines delineating the projections of superior-inferior field borders of the linear accelerator’s secondary collimators, or with those of the fully open MIMiC. Port films exposed with and without the MIMiC are compared to annotated topograms to measure positional variance (PV) in superior-inferior (SI), right-left (RL), and anterior posterior (AP) directions. MIMiC vane patterns superposed on port films are applied to verify planned patterns. A 12-patient study of PV was performed by analyzing positions of 10 anatomic points on repeat CT topograms, plotting histograms of PV, and determining average PV. Results and Discussion: A 1.5 ± 0.3 mm SD shrinkage per 70 cm of thermoplastic was observed over 24 h. Average PV of 1.0 ± 0.8, 1.2 ± 1.1, and 1.3 ± 0.8 mm were measured in SI, AP, and RL directions, respectively. Lateral port films exposed with and without the MIMiC showed PV of 0.2 ± 1.3 and 0.8 ± 2.2 mm in AP and SI directions. Vane patterns superimposed on port films consistently verified the planned patterns. Conclusion: The CHS provided adequately reproducible immobilization for dynamic IMRT, and may be applicable to decrease PV for other cranial and head and neck external beam radiation therapy.

To verify that optimized dose distributions provided by an intensity-modulated radiation therapy (IMRT) system are delivered accurately to human patients.Anthropomorphic phantoms are used to measure IMRT doses. Four types of verification are developed for: I) system commissioning with beams optimized to irradiate simulated targets in phantoms, II) plans with patient-optimized beams directed to phantoms simulating the patient, III) patient-phantom hybrid plans with patient-optimized beams calculated in phantom without further optimization, and IV) in vivo measurements. Phantoms containing dosimeters are irradiated with patient-optimized beams. Films are scanned and data were analyzed with software. Percent difference between verified and planned maximum target doses is defined as "dose discrepancy" (deltavp). The frequency distribution of type II deltavp from 204 verification films of 92 IMRT patients is fit to a Gaussian. Measurements made in vivo yield discrepancies specified as deltaivp, also fit to a Gaussian.Verification methods revealed three systematic errors in plans that were corrected prior to treatment. Values of [deltavp] for verification type I are2%. Type II verification discrepancies are characterized by a Gaussian fit with a peak 0.2% from the centroid, and 158 [deltavp]5%. The 46 values of [deltavp]5% arise from differences between phantom and patient geometry, and from simulation, calculation, and other errors. Values of [deltavp] for verification III are less than half of the values of [deltavp] for verification II. A Gaussian fit of deltaivp from verification IV shows more discrepancy than the fit of deltavp, attributed to dose gradients in detectors, and exacerbated by immobilization uncertainty.Dosimetric verification is a critical step in the quality assurance (QA) of IMRT. Hybrid Verification III is suggested as a preliminary quality standard for IMRT.

To compare the dosimetry achievable with an intensity modulated radiotherapy (IMR) system to that of stereotactic radiosurgery (SRS) for an irregularly shaped moderate size target. A treatment plan was selected from 109 single fraction SRS cases having had multiple non-coplanar arc therapy using a 6 MV linear accelerator fitted with circular tertiary collimators 1.00 to 4.00 cm in diameter at isocenter. The CT scan with delineated regions of interest was then entered into an IMR treatment planning system and optimized dose distributions, using a back projection technique for dynamic multileaf collimator delivery, were generated with a simulated annealing algorithm. Dose volume histograms (DVH), homogeneity indices (HI), conformity indices (CI), minimum and maximum doses to surrounding highly sensitive intracranial structures, as well as the volume of tissue treated to >80, 50, and 20% of the prescription dose from the IMR plan were then compared to those from the single isocenter SRS plan used and a hypothetical three isocenter SRS plan. For an irregularly shaped target, the IMR plan produced a HI of 1.08 and CI of 1.50 compared to 1.75 and 4.41, respectively, for the single isocenter SRS plan (SRS1) and 3.33 and 3.43 for the triple isocenter SRS plan (SRS3). The maximum and minimum doses to surrounding critical structures were less with the IMR plan in comparison to both SRS plans. However, the volume of non-target tissue treated to >80, 50, and 20% of the prescription dose with the IMR plan was 137, 170, and 163%, respectively, of that treated with the SRS1 plan and 85, 100, and 123% of the volume when compared to SRS3 plan. The IMR system provided more conformal target doses than were provided by the single isocenter or three isocenter SRS plans. IMR delivered less dose to critical normal tissues and provided increased homogeneity within the target volume for a moderate size irregularly shaped target, at the cost of a larger penumbra. Radiat. Oncol. Invest. 6:18–25, 1998. © 1998 Wiley-Liss, Inc.

Purpose: A two-step procedure is described for accurate planning of stereotactic brain implants prior to headringtion. Methods and Materials: Approximately 2 weeks prior to implant a CT scan without the head ring is performed for treatment-planning purposes. An entry point and a reference point, both marked with barium and later tattooed, facilitate planning and permit correlation of the images with a later CT scan. A plan is generated using a conventional treatment-planning system to determine the number and activity of I-125 seeds required and the position of each catheter. I-125 seed anisotropy is taken into account by means of a modification to the treatment planning program. On the day of the implant a second CT scan is performed with the head ring affixed to the skull and with the same points marked as in the previous scan. The planned catheter coordinates are then mapped into the coordinate system of the second CT scan by means of a manual translational correction and a computercalculated rotational correction derived from the reference point coordinates in the two scans. Results: The rotational correction algorithm was verified experimentally in a Rando phantom before it was used clinically. For analysis of the results with individual patients a third CT scan is performed 1 day following the implant and is used for calculating the final dosimetry. Conclusion: The technique that is described has two important advantages: 1) the number and activity of seeds required can be accurately determined in advance; and 2) sufficient time is allowed to derive the best possible plan. 0 1997 Elsevier Science Inc.

We analyzed our recent stereotactic radiosurgery (SRS) experience to determine the radiographic response of intracranial metastatic melanomas to SRS. Twelve patients with 21 intracranial melanoma metastases treated with SRS were evaluated. Fifteen (72%) metastases were hemispheric, 3 (14%) were cerebellar, and 3 (14%) were in the basal ganglion or thalamus. All lesions were 2.5 cm or less in maximum diameter. Eleven patients also had whole brain external beam radiotherapy. Mean SRS dosage was 1,800 cGy to the 85% isodose surface and median dose was 1,800 cGy to the 80% isodose surface (range 1,100–3,100 cGy at the 80–95% isodose surface). Overall, 12 (57%) lesions showed decrease or stabilization of tumor volume (i.e., local control), while 9 (43%) showed enlargement. Division of metastases into small (≤1.0 cm diameter) and large (>1.0 cm diameter) tumors showed that the small tumors were more likely to regress than the large tumors (chi-square test; P < 0.03). Only 1 of 9 (11%) large lesions regressed as opposed to 7 of 12 (58%) small lesions regressed with SRS. We conclude that SRS is suited for small melanoma brain metastases, but lesions between 1.0 and 2.5 cm in diameter, while still generally considered appropriate for SRS, may not be as responsive to SRS at currently employed dosages. Radiat. Oncol. Invest. 5:72–80, 1997. © 1997 Wiley-Liss, Inc.

To determine whether "standard" lateral pelvic radiation therapy portals provide adequate margins for treating the external iliac lymph nodes (EILNs).With computed tomographic (CT) data and a computerized algorithm, the course of the EILN chain was reconstructed in 48 patients. The marginal distance between a consistently localized portion of the EILNs and the anterior field border that was placed at the front of the pubic symphysis was recorded for each patient.The EILNs were covered adequately in only 50% of both men and women. More adequate EILN margins were observed in (a) women older than 68 years, (b) women with small anteroposterior separations, (c) men older than 70 years, and (d) men and women with a low central obesity index. Less adequate margins were observed in men who were obese or men with large anteroposterior separations. In the study population, no correlation was observed for sex, race, or tumor site.The authors recommend portals that are designed specifically for patients rather than standard portals that may inadequately cover the intended targets.

Background. Cancer-related fatigue (CRF) is the most frequently reported side effect of cancer and its treatment. In previous research, Polarity Therapy (PT), an energy therapy, was shown to reduce CRF in patients receiving radiation. This study reports on a small randomized clinical trial designed to collect preliminary data on the efficacy of PT compared with an active control (massage) and passive control (standard care) for CRF among cancer patients receiving radiation therapy. Methods. Forty-five women undergoing radiation therapy for breast cancer were randomized to 1 of 3 weekly treatment conditions. Patients received standard clinical care, 3 modified massages, or 3 PT treatments. CRF and health-related quality of life (HRQL) were assessed during baseline and the 3 intervention weeks. Results. TResults show CRF ratings were reduced after PT. The effect sizes for PT versus modified massage and versus standard care were small when using the primary measure of CRF (Brief Fatigue Inventory) and large when using the secondary measure of CRF (Daily CRF Diaries).The effect size was medium when assessing the benefit of PT on maintaining HRQL compared with standard care with very little difference between the PT and modified massage conditions. Patients’ feedback showed that both the modified massage and PT treatments were deemed useful by radiation patients. Conclusion. The present pilot randomized clinical trial supports previous experimental research showing that PT, a noninvasive and gentle energy therapy, may be effective in controlling CRF. Further confirmatory studies as well as investigations of the possible mechanisms of PT are warranted.

Background: Postmastectomy irradiation often negatively impacts breast reconstruction outcomes. Further investigation is necessary to recognize factors contributing to adverse results. The purpose of this study was to (1) accurately assess the impact of radiation on autologous breast reconstruction and (2) identify patient and treatment factors affecting reconstructive outcomes. Methods: One hundred twenty-six patients were considered after postmastectomy breast reconstruction and irradiation. The records of 76 patients were studied after excluding for radiation therapy before reconstruction, complications before irradiation, implant reconstruction, mastectomy for recurrent disease, and history of cancer. Patient demographics and comorbidities, operative details, adjuvant therapy, and treatment outcomes were assessed. Results: Seventy-six patients underwent autologous microsurgical breast reconstruction. Complications occurred in 53 patients (70 percent) 7.2 ± 6 months after irradiation; 36 cases (47 percent) required reoperation for postirradiation effects. Parenchymal complications (fat necrosis or parenchymal fibrosis) were noted in 19.7 percent, skin complications (tissue envelope retraction or hypertrophic scarring) were recorded in 30.3 percent, and general dissatisfaction (physician or patient dissatisfaction) arose in 27.6 percent of patients. Parenchymal complications were associated with smoking (odds ratio, 9.3; p = 0.03), type II diabetes mellitus (odds ratio, 8.5; p = 0.02), and age (odds ratio, 1.1; p = 0.02). Neoadjuvant chemotherapy increased the development of complications (odds ratio, 4.4; p = 0.04), particularly skin changes (odds ratio, 2.4; p = 0.01). Conclusions: Patient-specific factors, including diabetes mellitus and smoking, increase the risk of postirradiation parenchymal changes, and neoadjuvant chemotherapy is associated with a greater than twofold increase in skin complications. Breast reconstruction followed by irradiation can be successful, but patients with specific risks should be aware of increased complication rates.

180 Background: AR after negative SNB is a rare event. The purpose of this study was to identify factors associated with AR. Methods: A breast cancer (BC) database was reviewed identifying 4 cases of AR among 424 (0.9%) patients with a negative SNB over a 5 year period. Demographic, pathologic and treatment data were collected. Patients with AR were compared those without using standard methods for contingency tables to identify factors associated with AR. Results: Tumor and treatment factors are shown in the table. There was no difference in age, race, menopausal status, tumor size or palpability, or the average number of SLNs harvested between the groups. Recurrences were only seen in patients with triple negative (TN), high grade tumors. AR occurred in 12.5% of pN0(i+) BCs compared to 6% of pN0 BCs (p

9027 Background: Radiation dermatitis occurs in approximately 95% of patients receiving radiation therapy for cancer and often leads to pain and treatment delays. There is no standard treatment with demonstrated effectiveness for the prevention of radiation dermatitis. We conducted a randomized, double-blind, placebo-control clinical trial to assess the efficacy of curcumin, a potent antioxidant and anti-inflammatory component of turmeric, to reduce radiation dermatitis in 30 breast cancer patients. Methods: Eligible patients included adult females with non-inflammatory breast cancer or carcinoma in situ prescribed radiation therapy without concurrent chemotherapy. After randomization, patients took four 500 mg capsules of curcumin or placebo three times daily throughout their course of radiation therapy (total daily dose = 6.0 g). Weekly assessments included Radiation Dermatitis Severity (RDS) Score, presence/absence of moist desquamation, erythema measure, and McGill Pain and Symptom Inventory (SI) questionnaires. Results: The 30 evaluable patients were white (90%; mean age = 58.1 years) with ER+PR+ breast cancer (76.7%) who did not have total mastectomy (90%) or chemotherapy prior to start of radiation therapy (56.7%). No significant differences were observed between arms for demographics, compliance, erythema, pain, symptoms, or radiation skin dose. Standard pooled variances t-test showed that curcumin reduced RDS at end of treatment compared to placebo (mean RDS = 2.6 vs 3.4; p=0.008). Fisher’s exact test showed that curcumin significantly reduced the presence of moist desquamation at the end of radiation therapy (28.6% vs. 87.5 %; p=0.002). Repeated measures analysis confirmed divergence of RDS between curcumin and placebo arms at Week 5. Conclusions: Oral curcumin, 6.0 g daily during radiation therapy, reduced radiation dermatitis severity and moist desquamation in breast cancer patients. A multisite CCOP trial (N=700) is underway to confirm the effectiveness of curcumin to reduce radiation dermatitis severity during various radiation therapy regimens for breast cancer. Support: IND 75,444, Dermatology Foundation, KL2 RR024136, NCI PHS 1R25CA10618.

9100 Background: CTIBL is a long-term side effect of hormone therapy (HT) and occurs in up to 80% of women being treated for BC. Daily calcitriol (active vitamin D) therapy improves bone metabolism...

8158 Background: Mounting evidence suggests that patients’ expectancies relating to nausea development are significant predictors of, and likely, contributing factors to treatment-related nausea. E...

Radiolabeled antibodies to tumor associated proteins localize in both experimental and clinical cancers. In the therapeutic applications of radiolabeled antibody, tumor effective half-life (composite of biological and physical half-lives), along with the concentration of isotope deposited and energies of the isotope used, determine the tumor dose. Antibodies directed against the same antigenic specificity but derived from different species have varied tumor and whole body effective half-lives and as a result, achieve different tumor doses. In vitro testing does not evaluate the in vivo differences in effective half-life that affect tumor dose. We have developed an animal model to evaluate the effective half-life and biodistribution of radiolabeled immunoglobulin (IgG) from diverse species. To determine the relevance of such a model, the effective half-lives and tissue distributions of the different immunoglobulins in the model were compared to those obtained from the clinical program using the same radiolabeled antibody preparations. In both the experimental model and in the clinical trials, radiolabeled immunospecific and normal IgG derived from monkey, rabbit, and porcine sources had the longest effective half-lives, goat and sheep had intermediate effective half-lives, and chicken and turkey had the shortest effective half-lives. Prescreening of bovine and baboon normal IgG predict long half-lives and similar organ distributions. These species have been immunized for clinical use. Bovine IgG has a long clinical half-life and has been added to our other successful antibodies. Baboon IgG is now ready for clinical testing. The value of this model system is that it appears to be an effective in vivo preclinical screen for tumor effective half-life of antibodies and IgG from diverse species, thus guiding potential clinical use.