Partnering for Hope 2015 ANNUAL REPORT

Partnering for Hope 2015 ANNUAL REPORT

PATIENT CARE EVALUATION STUDY DISPARITIES IN THE MANAGEMENT OF ELDERLY BREAST CANCER PATIENTS Cynthia Osborne, MD, Mabel Mardones, MD, Janet Reynolds, CTR, Andrew Lupo, MS-IV Breast cancer is the most widespread cause of cancer among women in the United States. 1,2 In 2015, estimates of 231,840 new cases of invasive breast cancer will be diagnosed in women in the U.S., as well as an added 60,290 cases of in situ breast cancer. 1 Along with this high incidence of breast cancer, there is a high rate of death from breast cancer. In the U.S., estimates of 40,290 women will die from breast cancer in 2015, making it the second leading cause of death in women from cancer. 1 Worldwide, breast cancer was the leading cause of death in women in 2012. 2 Breast cancer is a disease of aging. In the U.S., the median age of diagnosis of breast cancer is 61 but peaks in the 70s and then declines. The U.S. population is aging; from 2003 to 2013, the population of people aged 60, and above increased from 48.1 million to 62.8 million people, a rise of over 30%. 3 These numbers are expected to more than double by 2060 to 98 million people aged 60 or older. Analysis of the current data shows that older women are more numerous, with 25.1 million women to 19.6 million men, with a sex ratio of 128.1 women for every 100 men. 3 By age 85 and over, this ratio increases to 195.9 women for every 100 men. 3 As a result, women age 80 years and older are one of the fastest-growing segments of the U.S. population. s of death from breast cancer continue to increase as women age, leading to the statistic that 57% of all breast cancer deaths occur in women in the 65 years of age and older group. 1 Even with this high rate of death from breast cancer in older women, little is known about the characteristics of their cancer, treatment choices, or survival among this cohort. Some of this lack of data is due to the fact that historically few randomized controlled trials evaluating breast cancer treatments included women age 70 years or older, and most observational studies are limited by small sample size. In addition, increasing age is often accompanied by increasing comorbidity with associated reduction in physical conditioning, organ reserve, and cognitive and social functioning. Therefore, this leads to an inherent uncertainty as to the optimal approach in treating elderly women with breast cancer. This may negatively impact treatment options. Both observational studies and a randomized clinical trial, the TEAM trial which did not exclude women from participation based on age, have demonstrated several trends in older women with breast cancer. At presentation the tumor stage is higher, lower rates of breast conserving surgery with radiation are performed, and lower rates of

surgery and chemotherapy are administered as compared to younger breast cancer patients. 4 Additionally, while older women have been observed to die more frequently from all other causes, the risk of dying from breast cancer increases significantly with age. In order to better address the conundrums in treating this rapidly growing population of older women with breast cancer, we are evaluating patterns of care of elderly breast cancer populations as compared to younger patients treated in the Baylor Health Care System facilities from 2009-2013. METHODS Using Baylor Health Care System Cancer Registry data, we identified all breast cancer cases seen throughout the system from 2009-2013. Accessing the Texas Oncology iknowmed EMR, we then determined the type of surgery used in the general population by age. Other treatment trends that were included were frequency of breast conserving surgery with adjuvant radiation (BCS with XRT), radiation for patients with four or more positive lymph nodes, receipt of chemotherapy for hormone negative breast cancers, and receipt of hormone therapy for hormone positive breast cancers. Additionally, we evaluated the type of surgery performed in the early stage (I-II) breast cancer patients by age. Briefly, we followed the 2013 NCCN guidelines. 5 They are as follows: women who underwent a total mastectomy or lumpectomy and surgical axillary staging with four or more positive nodes are to have radiation therapy. Women with hormone receptor positive disease should have adjuvant endocrine therapy, while those with HER2 positive disease should receive adjuvant therapy with trastuzumab. Lastly, women with hormone receptor negative and HER2 negative disease should be treated with chemotherapy. Finally, one important point is that these guidelines do not take age into account. Thus, there are no specific guidelines for older women with breast cancer. RESULTS Breast Cancer Surgery We encountered a total of 4,933 surgeries of which 2,943 (59.7%) were mastectomies and 1,990 (40.3%) were breast conserving surgeries. In those patients 80 years of age and above, patients were split almost evenly between mastectomies (49.6%) and breast conserving surgery (50.4%). These rates were similar to those for women from 65 to 79 years of age (49.9% mastectomy and 50.0% for BCS). However, a greater percentage of women under the age of 65 had mastectomies (64.2%) compared to breast conserving surgery (35.8%). When the patients with early stage disease (stage I-II) were grouped by type of surgery and age, it was noted that women under 60 had more mastectomies; however, after the age of 60, this trend was reversed. Radiation therapy post Breast Conserving Surgery (BCS) When looking at the trends in radiation post BCS, we noted a steady decrease in the percentages of radiation-treated patients, particularly in those over the age of 80. Only 66% of patients received XRT in the 80 and over group, in comparison to 81 to 91% in those women under 40 years of age to 69. About 79% of patients from age 70 to 79 received radiotherapy, still greater than women 80 years of age and above. In those patients over the age of 80, 11% were not offered XRT and about 10% of patients in this category refused the therapy. Radiation treatment in women with four or more positive lymph nodes The trends in radiotherapy given to patients with breast cancer with four or more positive lymph nodes were consistently above 50% across all groups. There was, however, quite a bit of variability in the numbers. Levels of radiotherapy for four or more positive lymph nodes declined from a high of 77% for women under 40 to a low of 58% for women 60 to 69 years of age, while for patients from 70 to 79 years of age, this number spiked to 81%. Levels then dropped to 65% and 50% for women in the 80 to 89 and 90 and over group, respectively. Interestingly, at the same time these changes were seen in women treated with radiotherapy, the number of cases where radiotherapy was not recommended increased from 17% for women under 40 years of age up to 31% for women 60 to 69 years of age. Then this percentage of women who were not recommended therapy dropped to 2% in women 70 to 79 years of age. Therefore, this spike of 81% of women treated in the 70- to 79-yearold group may represent the fact that more women were recommended to undergo radiation treatment compared to the younger age groups.

The drop in radiation treatment in women over 80 may be due to the fact that a greater percentage of these patients refused treatment compared to any other age group. Chemotherapy for women with hormone negative breast cancers We noted a high incidence of chemotherapy given to all patients with hormone negative breast cancer who were less than 70 years of age. Above this threshold, there was a steep decline in patients treated with chemotherapy, with only 32% of women above the age of 80 being treated. In this group of older patients, a greater number of patients were not recommended or were contraindicated for chemotherapy treatment. This contraindication may be a result of patient comorbidities, such that physicians may have been concerned about treatment side effects. Endocrine therapy for hormone positive breast cancers There were a consistently high percentage of patients being offered hormone therapy across all age groups for women with hormone positive breast cancers. However, compared to women under 70 years of age, there still was a slight decrease in those women above the age of 70 and 80 (73% vs 74%), respectively, compared to younger women (79% to 84%). When the combination of endocrine therapy and radiotherapy was investigated by age, the results were mixed. In patients under 40 to 49 years of age, the percentage of patients who received hormone therapy with radiotherapy versus without radiotherapy was about 50/50. Beginning at age 50 to 59 years of age, there was a divergence, with more patients on hormone therapy getting radiotherapy versus those who did not receive radiotherapy. This difference was greatest for patients from 80 to 89 years of age (65.4% versus 34.7%, respectively). DISCUSSION In 2006, there were several studies that used the Surveillance, Epidemiology and End Results (SEER)-Medicare data set and examined the effectiveness of radiotherapy and chemotherapy among older women with breast cancer. 6-10 Results from numerous studies support the notion that older women are not treated according to the NCCN guidelines for breast cancer; however, the impact this has on breast cancer specific survival is controversial. 11 One study demonstrated the efficacy of surgery on survival of a small number of older breast cancer patients. 12 In a follow-up study using 369 patients aged 80 years or more, standard mastectomy was associated with a better breast cancer specific survival. 13 The complications after surgery for older breast cancer patients primarily involve slower wound healing, wound infection, and seromas. 14 In a study of older women with hormone receptor positive breast cancer, they found that patients could be divided into one of three groups; either patient declined, where the patient ruled out surgery, patient considered where the patient considered surgery but decided to undergo endocrine therapy instead, or surgeon declined where the surgeon decided the patient comorbidities were incompatible with surgery. 15 Thus, this group of patients is extremely diverse and both patients and surgeons may be more hesitant to decide that surgery is a viable option. In looking at our patients, about the same number underwent BCS versus mastectomy from age 70 on. This may be a selected group, as we did not include patients who did not have surgery, but our numbers are still high. We had 254 patients from 80 to 89 years of age who either had BCS or mastectomy. In our analysis, we note that women over 80 with breast cancer received less XRT post BCS, and for known indications, lower rates of systemic chemotherapy were being offered compared to their younger counterparts. We should note that in the 80 and older group there were higher contraindications for chemotherapy than in the younger breast cancer patients, indicating there may be more comorbidities present in these patients. These findings seem

to be in agreement with previously published trials. 7,11,16,17 Based on the results of our initial survey of patients treated at BHCS, we intend to compare women with early stage breast cancer outcomes into two groups; older and younger (>80 years of age and 65-79 years of age). We will examine the impact of age on breast-related and other causes of death. Analysis will be performed within stage, adjusted for tumor characteristics, treatments received, and comorbidities. REFERENCES 1. Breast Cancer Facts & Figures 2015-2016. Atlanta, American Cancer Society, Inc., 2015 2. Torre LA, Bray F, Siegel RL, et al.: Global cancer statistics, 2012. CA Cancer J Clin 65:87-108, 2015 3. A Profile of Older Americans: 2014. Washington, DC, Administration on Aging, Administration for Community Living, the US Department of Health and Human Services, 2014 4. Schonberg MA, Marcantonio ER, Li D, et al.: Breast cancer among the oldest old: tumor characteristics, treatment choices, and survival. J Clin Oncol 28:2038-45, 2010 5. Theriault RL, Carlson RW, Allred C, et al.: Breast cancer, version 3.2013: featured updates to the NCCN guidelines. J Natl Compr Canc Netw 11:753-60; quiz 761, 2013 6. Elkin EB, Hurria A, Mitra N, et al.: Adjuvant chemotherapy and survival in older women with hormone receptornegative breast cancer: assessing outcome in a population-based, observational cohort. J Clin Oncol 24:2757-64, 2006 7. Giordano SH, Duan Z, Kuo YF, et al.: Use and outcomes of adjuvant chemotherapy in older women with breast cancer. J Clin Oncol 24:2750-6, 2006 8. Smith BD, Gross CP, Smith GL, et al.: Effectiveness of radiation therapy for older women with early breast cancer. J Natl Cancer Inst 98:681-90, 2006 9. Smith BD, Haffty BG, Buchholz TA, et al.: Effectiveness of radiation therapy in older women with ductal carcinoma in situ. J Natl Cancer Inst 98:1302-10, 2006 10. Smith BD, Haffty BG, Hurria A, et al.: Postmastectomy radiation and survival in older women with breast cancer. J Clin Oncol 24:4901-7, 2006 11. Owusu C, Lash TL, Silliman RA: Effect of undertreatment on the disparity in age-related breast cancer-specific survival among older women. Breast Cancer Res Treat 102:227-36, 2007 12. Cortadellas T, Gascon A, Cordoba O, et al.: Surgery improves breast cancer-specific survival in octogenarians with early-stage breast cancer. Int J Surg 11:554-7, 2013 13. Cortadellas T, Cordoba O, Gascon A, et al.: Surgery improves survival in elderly with breast cancer. A study of 465 patients in a single institution. Eur J Surg Oncol 41:635-40, 2015 14. Lavelle K, Sowerbutts AM, Bundred N, et al.: Pretreatment health measures and complications after surgical management of elderly women with breast cancer. Br J Surg 102:653-67, 2015 15. Sowerbutts AM, Griffiths J, Todd C, et al.: Why are older women not having surgery for breast cancer? A qualitative study. Psychooncology 24:1036-42, 2015 16. Gajdos C, Tartter PI, Bleiweiss IJ, et al.: The consequence of undertreating breast cancer in the elderly. J Am Coll Surg 192:698-707, 2001 17. Yood MU, Owusu C, Buist DS, et al.: Mortality impact of less-than-standard therapy in older breast cancer patients. J Am Coll Surg 206:66-75, 2008 CANCER SCREENINGS BAYLOR SCOTT & WHITE MEDICAL CENTER FORT WORTH 2015 Screening Normal ABNORMAL Oral 92 4 Skin Cancer 169 16 Low Dose CT Lung 126 Colonoscopies 1,868

CANCER REGISTRY NCDB Target CoC State of Texas CoC Census Region (West) All CoC Programs Baylor Scott & White Fort Worth Breast Cancer 2015 Forward Diagnosis Year 2011 (CoC) 2012* 2013* 2014* BCS: Breast Conservation surgery rate for women with AJCC clinical stage 0, I, or II breast cancer (Surveillance Measure) NbX: Image or palpation-guided needle biopsy (core or FNA) is performed for the treatment of breast cancer (Quality Improvement Measure) HT: Adjuvant Hormonal Therapy: Tamoxifen or third generation aromatase inhibitor is considered or administered within 1 year (365 days) of diagnosis for women with AJCC T1cNoMo, or Stage II or III hormone receptor positive breast cancer (Accountability Measure) MASTRT: Radiation therapy is considered or administered following any mastectomy within 1 year (365 days) of diagnosis for women with >= 4 positive lymph nodes (Accountability Measure) BCRST: Post Breast Conserving Surgery Irradiation: Radiation therapy is administered within 1 year (365 days) of diagnosis for women under age 70 and receiving breast conserving surgery for breast cancer (Accountability Measure) MACl: Adjuvant Chemotherapy: Combination chemotherapy is considered or administered within 4 months (120 days) of diagnosis for women under 70 with AJCC T1cNoMo, or Stage II or III hormone receptor negative breast cancer (Accountability Measure) NA 54.3% 57.0% 63.9% 37.7% 34.1% 36.5% 80.0% 73.2% 74.0% 76.4% 89.9% 94.6% 95.4% 90% 86.1% 87.1% 90.3% 95.2% 91.5% 93.1% 90.0% 56.6% 61.4% 71.7% 96.3% 93.8% 93.3% 90% 86.8% 88.6% 91.8% 93.9% 93.8% 98.2% 90% 90.0% 90.5% 92.5% 100.0% 89.3% 97.4% Colorectal Cancer ACT: Adjuvant Chemotherapy: Adjuvant chemotherapy is considered or administered within 4 months (120 days) of diagnosis to patients under age 80 with AJCC III (lymph node positive) colon cancer (Accountability Measure) 12 RLN: Surgical Resection Includes at Least 12 Lymph Nodes: At least 12 regional lymph nodes are removed and pathologically examined for resected colon cancer (Surveillance Measure) NA 88.5% 89.4% 90.6% 100.0% 100.0% 100.0% 85% 90.5% 89.0% 87.8% 92.3% 96.7% 82.7% Rectal Cancer RECRCT: Pre-operative chemo and radiation are administered for clinical AJCC T3N0, T4N0, or Stage III; or Postoperative chemo and radiation are administered within 180 days of diagnosis for clinical AJCC T1-2N0 with pathologic AJCC T3N0, T4N0, or Stage III; or treatment is considered, for patients under the age of 80 receiving resection for rectal cancer (Quality Improvement) 85% 66.7% 100.0% 100.0%

NCDB Target CoC State of Texas CoC Census Region (West) All CoC Programs Baylor Scott & White Fort Worth Gastric 2015 Forward Diagnosis Year 2011 (CoC) 2012* 2013* 2014* G15RLN: At least 15 regional lymph nodes are removed and pathologically examined for resected gastric cancer (Quality Improvement) 80% NA 33.3% NA Non Small Cell Lung 10RLN: At least 10 regional lymph nodes are removed and pathologically examined for AJCC Stage 1A, 1B, IIA, and IIB resected NSCLC (Surveillance Measure) NA 33.3% NA 0.0% LNoSurg: Surgery is not first course of treatment for cn2, M0 cases (Quality Improvement) 85% 100.0% 100.0% NA LCT: Systemic chemotherapy is considered or administered within 4 months to the day pre-operatively or day of surgery to 6 months postoperatively or surgically resected cases with pathologic lymph node positive (pn1) and (pn2) NSCLC (Quality Improvement) 85% NA NA NA Cervix CBRRT: Use of brachytherapy in patients treated with primary radiation with curative intent in any stage of cervical cancer (Surveillance Measure) CERRT: Radiation therapy completed within 60 days of initiation of radiation among women diagnosed with any stage of cervical cancer (Surveillance Measure) CERCT: Chemotherapy administered to cervical cancer patients who received radiation for Stages IB2-IV cancer (Group 1) or with positive pelvic nodes, positive surgical margin, and/or positive parametrium (Group 2) (Surveillance Measure) NA NA NA NA NA NA NA NA NA 100.0% 100.0% 100.0% Endometrium ENDLRC: Endoscopic, laparoscopic, or robotic performed for all endometrial cancer (excluding sarcoma and lymphoma), for all stages except Stage IV (Surveillance Measure) ENDCTRT: Chemotherapy and/or radiation administered to patients with Stage IIIC or IV Endometrial cancer (Surveillance Measure) NA 69.1% 80.6% 48.9% NA 60.0% 50.0% NA Ovary OVSAL: Salpingo-oophorectomy with omentectomy, debulking/cytoreductive surgery, or pelvic exteneration in Stages I-IIIC Ovarian Cancer (Surveillance Measure) NA 60.0% 63.6% 66.6% *Source: Data is pending results by the Rapid Quality Reporting Process via the National Cancer Data Base.

Photography may include models or actors and may not represent actual patients. Physicians provide clinical services as members of the medical staff at one of Baylor Scott & White Health s subsidiary, community or affiliated medical centers and do not provide clinical services as employees or agents of those medical centers, Baylor Health Care System, Scott & White Healthcare or Baylor Scott & White Health. 2016 Baylor Scott & White Health. BID BHCSONC_89 5.16