Volume 87 � Number 2S � Supplement 2013 Poster Viewing Abstracts S493

observational cohort study since October 2010. Information on diagnosis,

stage, risk factors for cancer, and treatment plan are collected at the initial

visit. During subsequent phone calls and follow-up visits, treatment

response and survival are assessed. We report on patients enrolled through

February 2012.

Results: One hundred forty-four participants were enrolled; median age at

cancer diagnosis was 45.4 years and 64% were female. Of the 136 patients

with known HIV status, 85 (63%) were HIV-infected and 67 (49%) were

on antiretroviral therapy. For 90 (66%), the diagnosis of HIV preceded the

diagnosis of cancer, and median time from HIV diagnosis to cancer

diagnosis was 3.7 years. Forty patients (30%) had a smoking history but

only 14 (10%) were active smokers. The most common cancer types for

women were breast (24% of all women), cervix (20%), and Kaposi’s

sarcoma (KS, 14%), and for men were KS (33% of all men), head and neck

(19%), and non-Hodgkin lymphoma (15%). Nearly all patients (96%)

presented due to symptoms, the most common being palpable lump/mass,

pain, or bleeding. Of patients who had staging studies (n Z 124), 68% had

advanced stage cancers (III/IV). Pathologic confirmation of cancer diag-

nosis was obtained in 81% of patients. The treatment plan involved surgery

in 77 patients, chemotherapy in 81, and radiation therapy (RT) in 39. Of

the 38 patients who started RT (one died prior to starting), the most

common conditions were cervical cancer, breast cancer, and KS. Median

dose prescribed was 60 Gy (range, 8-78 Gy). Thirty-four patients

completed RT with the average course duration of 53.7 days (range, 1-113

days). RT was delivered at Gaborone Private Hospital on a linear accel-

erator with photon, electron, or combined modality therapy. With median

follow-up of 14.2 months, the median survival was 22.5 months for early

stage disease and 16.5 months for advanced disease.

Conclusions: In this limited sample of patients, the majority of cancers

were HIV-associated and diagnosed at advanced stage after presentation

with symptoms, even for preventable/detectable cancers such as cervix and

breast. A greater understanding of cancer in Botswana will inform deci-

sions of resource allocation and infrastructure development, including

cancer prevention/screening and RT availability.

Author Disclosure: G. Suneja: None. S. Dryden-Peterson: None. M. Boyer:

None. Z. Musimar: None. M. Nsingo-Bvochora: None. D. Ramogola-

Masire: None. H. Medhin: None. J. Bekelman: None. S. Lockman: None.

T. Rebbeck: None.

2760The National Radiation Oncology Registry: Approaches toRegulatory Compliance to Promote Wide ParticipationJ.E. Bekelman,1 T. Wall,2 D. Nassif,3 M. Mojarrad,4 B. Fraass,5

C. Lawton,6 C. Rose,7 A. Zietman,3 and J. Efstathiou3, On behalf of the

NROR4; 1University of Pennsylvania, Philadelphia, PA, 2St. Luke’s

Hospital of Kansas City, Kansas City, KS, 3Massachusetts General

Hospital, Boston, MA, 4Radiation Oncology Institute, Fairfax, VA,5Cedars-Sinai, Los Angeles, CA, 6Medical College of Wisconsin,

Milwaukee, WI, 7Vantage Oncology, Beverly Hills, CA

Purpose/Objective(s): The National Radiation Oncology Registry

(NROR), sponsored by the Radiation Oncology Institute (ROI) and

ASTRO, is a national electronic registry designed to collect information on

cancer care delivery among patients treated with radiation therapy. The

NROR mission is to improve cancer care by capturing reliable information

on treatment delivery, quality metrics and health outcomes. The NROR

pilot will focus on patients with prostate cancer. In this report, we describe

approaches to Health Insurance Portability and Accountability Act

(HIPAA) compliance and informed consent.

Materials/Methods: We exhaustively reviewed relevant security and

privacy standards for health information as outlined in HIPAA and Health

Information Technology for Economic and Clinical Health Act (HITECH).

We evaluated best practices for registries with the American College of

Cardiology, American College of Radiology, and ROI’s legal counsel. We

specifically addressed the regulatory challenges of establishing a multi-

center study with minimal burden to patients and providers while

maintaining health information security and privacy. Because our goal is to

register all patients with intact prostate cancer at NROR facilities, we also

examined methods of informed consent to promote participation and

collection of an unbiased study population.

Results: In compliance with HIPAA and HITECH, we developed stan-

dardized participation agreements that include both a business associate

agreement and a data use agreement. These agreements govern data

sharing and outline the legal and business obligations of the covered

entities (participating sites) and the business associate (ROI). This

approach ensures HIPAA compliance, maximizes the use of collected data

for quality improvement efforts, and simplifies administrative and risk

management through the use of standardized agreements. To address the

informed consent process, we developed an “opt-out” consent, which

meets institutional review board (IRB) requirements and allows for

maximum patient participation. The opt-out consent will be implemented

with an informational handout that describes the pilot and provides the

option to refuse participation. Privacy protection is further assured by the

separation of data collection from analysis: aggregate data for the purposes

of quality improvement and benchmarking will be stripped of direct

identifiers. To minimize the site regulatory burden, we selected a central

IRB after performing due diligence on four candidates.

Conclusions: The National Radiation Oncology Registry has utilized

innovative approaches to HIPAA compliance and informed consent that

will maximize health information security and privacy while easing the

regulatory burden on NROR sites and promoting patient participation.

Author Disclosure: J.E. Bekelman: None. T. Wall: None. D. Nassif: None.

M. Mojarrad: None. B. Fraass: None. C. Lawton: None. C. Rose: None. A.

Zietman: None. J. Efstathiou: None. -. On behalf of the NROR: None.

2761Breast Cancer Mortality Reduction in the United States Between1969-2009 Was Independent of Screening Mammography in the 9Geographically Disperse SEER Regions: More Evidence for LessBenefit of Screening MammographyC.R. Thomas1 and A. Bleyer2; 1Oregon Health and Science University

Portland, OR, 2St. Charles Health System, Bend, OR

Purpose/Objective(s): From the abrupt increase in incidence of early-

stage breast cancer, all nine geographical areas represented by the original

SEER registries initiated screening mammography between 1982 and 1986

and by 1990 each had a doubling in the rate of early-stage diagnosis. The

subsequent steady-stage proportion of the population screened varied by

40%, however. If screening mammography were effective in reducing

breast cancer mortality, a null hypothesis generated from this trend of low-,

mid- and high-screening penetrance is that the reduction in mortality rate

was proportional to penetrance.

Materials/Methods: Annual early-stage (DCIS and localized) breast

cancer incidence and overall breast cancer mortality rates from 1976 to

2009 in each the SEER9 regions (Atlanta, Connecticut, Detroit, Hawaii,

Iowa, New Mexico, San Francisco/Oakland, Seattle/Puget Sound, Utah)

were obtained via SEERStat (www.seer.cancer.gov) on December 8, 2012.

Results: From the patterns of early-stage incidence acceleration, the reg-

istry’s region implemented widespread screening mammography in 1982,

1983, 1984, or more gradually during 1981-1985. Two SEER regions (New

Mexico, Utah) did not achieve as widespread screening as did the other 7

registries. Four registries (Connecticut, Hawaii, San Francisco/Oakland,

Western Washington) had the highest implementation rate. The remaining

three regions (Atlanta, Detroit, Iowa) had intermediate penetrance. Despite

differences from region to region, the breast cancer mortality rate trends

since 1980 are essentially identical in all nine regions until 2000, with

simultaneous onset of mortality reduction in 1990 and the same 22%

reduction in low-, mid-, and high-screening-penetrance regions by 2000.

After 2000, the high- and mid-penetrance regions continued similarly

whereas low-penetrance regions had a slower reduction. There was also no

correlation from region-to region between the onset of early-stage breast