Seton Medical Center Hepatocellular Carcinoma Patterns of Care Study Rate of Treatment with Chemoembolization N = 50

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1 General Data Seton Medical Center Hepatocellular Carcinoma Patterns of Care Study Rate of Treatment with Chemoembolization N = 50 The vast majority of the patients in this study were diagnosed at Seton, however, it is not known whether or not two- thirds received additional treatment elsewhere. The rate of diagnoses declined over the course of the study, with a surge in the last year of the study. Diagnosis by biopsy was highest among stage III patients and lowest in stage IV and stage II patients.

2 Demographics Two- thirds of the patients presenting with hepatocellular carcinoma were male, 6% lower than national rates of incidence[1]. Filipino and Chinese patients represented a vastly greater proportion of incidence than nationally, however, prevalence among those groups was proportionate when compared to the demographic makeup of the surrounding community[2]. Median age at diagnosis was 66, 3 years higher than national data shows, and patients over 60 represented nearly 75% of the patients in this study, in stark contrast to the 57% of total hepatocellular carcinoma diagnoses that this group represents in national data. This is despite the fact that the age distribution of the surrounding community is similar to national age distribution.

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4 Stage Overall Stage Incidence of stage!, II and IV disease were all lower when compared to national rates. Nearly half of all diagnoses at Seton were stage III, which is significantly higher than nationally[3] and accounts for the lower incidence of other states. Stage By Race There was a higher concentration of late stage diagnoses among Chinese, Filipino, South and Central Americans, Mexicans, and Asians NOS; accounting for nearly 90% of all late stage diagnoses.

5 Stage By Age Patients under the age of 60 had a 5:1 ratio of late to early stage diagnoses, in contrast to patients 60 and over, who exhibited a 2:1 ratio of early to late stage diagnosis. Patients between the ages of 50 and 59 represented nearly half of all stage III diagnoses. Treatment Overall Treatment The vast majority of the patients in this study were documented as receiving either chemotherapy or no treatment. Just 10% received other treatment modalities, including 6% that underwent surgery.

6 Treatment Given At Seton Alone When broken down by treatment given just at Seton, the data shows that stage I patients received chemotherapy at the same rate that they received no treatment. Stage III patients overwhelmingly received no treatment at Seton, with only 1 out of 11 patients undergoing treatment, while stage II patients were the only group that received treatment at Seton more frequently than not receiving treatment. Treatment By Stage Overall treatment data shows that in every stage except for stage IV, patients received treatment more often than not receiving treatment, with the primary modality being chemotherapy for all stages except for stage IV patients, none of which received chemotherapy as a treatment modality.

7 Treatment By Age Patients age 60 and over were given chemotherapy at a rate of 55%, while patients under 60 received a more diverse range of treatment modalities, with only 39% of those patients receiving chemotherapy. Treatment By Race Filipinos, who represented the largest portion of the study, received chemotherapy at the same rate that they received no treatment, as did Hispanic patients, Asians, and other Pacific Islanders. Non- Hispanic Whites were the only group to receive chemotherapy more than half the time, undergoing the treatment at a rate of 3:1.

8 Chemoembolization Review Rate Of Chemoembolization Of the 35 patients in this study that received chemotherapy, nearly three- quarters were documented as receiving it in the form of chemoembolization, with another 12% receiving chemotherapy in an unknown form. Only 16% were confirmed as not having received chemotherapy in the form of chemoembolization. Rate Of Chemoembolization By Stage Lower stages exhibited a higher rate of chemoembolization, with stage II patients receiving it at the highest rate. Despite the fact that stage III patients represented the largest portion of the study, they received chemoembolization only one- third of the time, the lowest rate among stage groups that received chemoembolization.

9 Recurrence And Survival Chemoembolization vs. Other Chemo Recurrence There did appear to be a slight advantage for patients that received chemoembolization, with 2 patients receiving the treatment achieving remission. None of the patients that did not receive chemoembolization achieved remission. Chemoembolization vs. Other Chemo Survival Survival rates showed mixed results for patients receiving chemoembolization versus patients that were administered chemotherapy through traditional means. 2 year and 4 year survival showed a slight increase, while 1 year and 5 year survival was lower.

10 Chemoembolization/Chemo vs. All Other Treatments Recurrence Again noted are 2 patients who received chemotherapy or chemoembolization that achieved remission. A patient that was not documented as receiving any treatment also went into remission. Chemoembolization/Chemo vs. All Other Treatments Survival Survival among patients that received chemotherapy through any means showed some advantage over patients that did not receive chemotherapy, although the results were again mixed.

11 Overall Recurrence Recurrence for all patients in this study was fairly uniform, with very few patients ever becoming disease free. Those patients that went into remission were stage I or the stage was unknown, and one of those patients ultimately had recurrence of disease. Overall Survival Survival data reveals that no stage of disease had a survival advantage over another, with the majority of patients in the study expiring in the first 3 years after diagnosis.

12 Abstract This study looked at patterns of care for hepatocellular carcinoma diagnosed and treated at Seton between 2007 and 2012, with a special focus on the rate of chemoembolization administration. National Comprehensive Cancer Network (NCCN) Cancer Treatment Guidelines were consulted to compare Seton s patterns of care to established national standards of care. The study also looked at survival and recurrence, comparing differences in outcomes for patients who received chemoembolization to those of patients that did not receive the treatment, as well as evaluating differences in outcome by treatment and stage. The number of patients diagnosed with hepatocellular carcinoma declined each year of the study, except for the last year of the study when the number jumped to its highest point. Less than half of the diagnoses were made pathologically, although stage III patients were diagnosed by pathology nearly two- thirds of the time. Of note, only one- third of the patients in this study were confirmed to have received all of their treatment either at Seton, or a combination of Seton and another facility. Therefore, it is possible that some of the two- thirds of the remaining patients in the study received additional treatment elsewhere. Demographic breakdown of these patients reveals a somewhat mixed picture when compared to national data. Race and ethnicity did not match up with national data, however, it was closely reflective of the makeup of the surrounding community. National incidence shows a much higher rate of incidence in males than females, but this was less apparent for Seton patients in this study, despite the fact that the proportion of males to females in the surrounding community is similar to national proportions. In addition, the stratification of age at diagnosis reveals that patients diagnosed with HCC at Seton present at a much older age. The median age was 3 years older than nationally, however, the incidence rate for patients over 60 was 18% higher than national incidence rates. Stage III disease represented nearly half of all diagnosis, which was almost double the national rate. As a result, the remaining stages fell short of national rates. In addition, late stage diagnoses were dominated by Chinese, Filipino, South and Central Americans, Mexicans, and Asians NOS patients, who accounted for 90% of all late stage diagnoses. There was also a stark difference in the rate of late stage diagnoses among different age groups, with patients under the age of 60 showing a 5:1 ratio of late to early stage diagnoses, in contrast to patients 60 and over, who exhibited a 2:1 ratio of early to late stage diagnosis. Of note, patients between the ages of 50 and 59 represented nearly half of all stage III diagnoses. NCCN Hepatocellular Treatment Guidelines depend on several factors that were not evaluated in this study, such as the resectability of the tumor and comorbidities. Although they only represented 22% of the cases in this study, 60% of stage I and II patients received chemotherapy and none underwent surgery or transplant, which would not appear to match up with NCCN recommendations that these treatments be considered for resectable tumors that are 5 cm or less, or when there are multiple tumors that are 3 cm or less each and there would be adequate liver reserve left after resection[4]. However, the bulk of the patients in this study were stage III and IV and NCCN guidelines recommend locoregional therapy (including chemoembolization), clinical trials, radiation therapy, or supportive care;

13 and the care that is documented for these patients appears to match up with those guidelines. In addition, 72% of the patients that were given chemotherapy received it in the form of chemoembolization, with an additional 12% that were given chemotherapy by an undocumented method. The use of chemoembolization was highest in the lower stages, although patients without a documented stage also underwent chemoembolization 43% of the time. There were no stage IV patients that were documented as receiving chemotherapy as a treatment modality. Recurrence and survival did not appear to benefit significantly from any form of treatment, including chemoembolization, with only 3 patients achieving remission and 1 of those patients developing recurrent disease. The vast majority did not live more than 3 years from the date of diagnosis, with stage I and II patients showing the greatest survival rates during those 3 years. When compared to NCCN treatment guidelines, the data in this study does appear to suggest that there is room to increase the use of certain treatment modalities for lower stage patients, although there are many complex factors that were not evaluated in this study that make that difficult to completely evaluate. However, it appears that treatment for late stage patients, who made up the majority of the patients in this study, was in line with NCCN treatment recommendations. The racial and ethnic makeup of the the late stage population of this study also suggests that the overall stage at diagnosis for many of these patients could be improved through education and outreach to some of the communities frequently presenting with late stage disease about the risk factors, symptoms and screening for hepatocellular carcinoma.

14 References [1] American Cancer Society. Cancer Facts & Figures Atlanta: American Cancer Society; 2013 [2] 2010 United States Census [3] NCI SEER Stat Fact Sheet, Liver Cancer [4] National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Liver, Hepatocellular Carcinoma, Version /25/12 National Comprehensive Cancer Network, Inc. 2012

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