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Purpose: To assess if the time interval between concurrent chemo radiotherapy [conc ChemoRT] followed by brachytherapy [B] determines the clinical outcomes in cervical cancer patients (FIGO stage IB2 – IVA) among a predominantly African- American population in a state university medical center. Methods: A retrospective analysis of 147 cervical cancer patients diagnosed with stage IB2- IVA treated with conc ChemoRT followed by B at various time intervals between 2005 and 2018 was performed. Survival analysis with several treatment [TX] duration interval parameters (pre 2010 and post 2010 to evaluate the significant organizational advancements); conc ChemoRT and B completed ≤ 60 days and > 60 days per American College of Surgeons cervical cancer surveillance measure; and TX intervals 6 to 10 weeks were evaluated. The overall survival [OS], local control [LC] and distant control [DC] were estimated by using Kaplan- Meier method. Uni, bi and multi- variable Cox hazard regression analyses were used to compare the risk of death among cervical cancer patients with different TX intervals. The SPSS v.24.0 was used for statistical analyses. Results: The 147 cervical cancer patients (median age, 55 y; range 28-83 y) had a median follow-up of 32 months (range 0 to 164 months). Our patient cohort included 34% patients treated pre 2010 and 66% post 2010; 42.2% ≤60 days and 57.8% > 60 days; 53.1% ≤ 6 to 8 weeks, 12.2% ≤ 8 to 10 weeks and 34.7% d>10 weeks. The patients diagnosed and treated post 2010 had better 5-year OS rates (65% vs. 32%) compared to pre 2010; p=0.000; patients treated ≤ 60 days had better 5-year OS rates (59.3% vs. 40.3%) to > 60 days; p=0.094; patients treated ≤ 6 to 8 weeks had better 5-year OS rates (56.1% vs. 53.1% and 34.3%) compared to ≤ 8 to 10 weeks and > 10 weeks; p=0.188 respectively. The 5-y OS rates for FIGO stages were IB2 (65.8%); IIA (62.5%); IIB (40.4%); IIIA (50%); IIIB (42.4%); and IVA (25.2%); p=0.508. There was no trend for improved LC (p=0.331; p=0.962; p=0.616) and DC (p= 0.284; p=0.596; p=0.606) observed among patients with different TX intervals. In the bi-variate analysis for TX year group, after adjusting for age, race, insurance, income level, distance travelled, tobacco exposure, alcohol history, and tumor stage, BMI-lower had twice the risk of death (hazard ratio [HR], 2.74; 95% CI, 1.34-5.59; p= 0.005). For patients treated ≤ 60 days, their insurance-private had a 63% reduction (HR, 0.37; 95% CI, 0.15-0.90; p=0.029), and for the weekly TX group by the multivariate analysis, insurance-private showed a 76% reduction in the risk of death (HR, 0.35; 95% CI, 0.14-0.87; p=0.024). Conclusion: Our analysis suggests better OS among patients diagnosed and treated post 2010; ≤ 60 days duration; and ≤ 6 to 8 weeks with a shorter interval between conc ChemoRT and B to be superior to that of the patients undergoing longer TX’s. Citation Format: Mary R. Nittala, Satyaseelan Packianathan, Eswar K. Mundra, Maurice L. King, Shivanthidevi Gandhi, Robert M. Albright, Maria L. Smith, William C. Woods, Toms V. Thomas, Mildred Ridgway, Srinivasan Vijayakumar. Improved clinical outcomes with shorter intervals between concurrent chemoradiation and brachytherapy in FIGO IB2-IVA cervical cancer patients among a predominantly African-American population [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-230.

Purpose: To assess the prognostic significance of tumor HPV/p16 status among oropharyngeal squamous-cell carcinoma (SCC) patients. Methods: A retrospective analysis of 80 patients diagnosed with oropharyngeal SCC between 2008 and 2018 at an academic medical center with known HPV/p16 status was performed. Pearson’s Chi-squared test was used to compare the proportional differences between the known tumor HPV status among positive and negative p16 staining groups. Kaplan- Meier analysis was used to estimate overall survival [OS] and local control [LC] between the HPV groups stratified by risk and compared using the log-rank test. Uni and multi-variable Cox hazard regression analyses were used to compare the risk of death among patients with HPV- positive and HPV- negative cancer. The SPSS v.24.0 was used for all statistical analyses. Results: Our patient cohort included 37.5% HPV- positive and 62.5% HPV-negative (median age, 61 y; range 45-86 y) patients. Patient groups were classified on the basis of risk factors: HPV/p16 status, pack-years [py] of tobacco smoking, and tumor stage into low (p16+, ≤ 10 py), intermediate (p16+, > 10 py/p16-, < 10 py), and high risk (p16-, > 10 py/ any T4), accounting for 36.7%, 36.7% and 26.7% of HPV-positive and 0%, 20% and 40% of HPV-negative patients, respectively (p=0.000). The median follow-up duration for this cohort was 34 months (range 0 to 154 months). The low risk HPV-positive group had better 5-year OS rates (87.5%, vs. 59.5% and 27.2%) compared to intermediate and high risk groups (p=0.003 by the log-rank test). After adjustment for gender, age, race, income level, distance travelled, tobacco exposure, alcohol history, tumor stage, and treatment modality, this group had a 63% reduction in the risk of death (hazard ratio, 0.37; 95% CI, 0.18-0.77; p= 0.008). Insurance and BMI was associated with a 71% reduction (hazard ratio, 0.29; 95% CI, 0.97-0.89; p=0.032), and a 49% reduction in the risk of death (hazard ratio, 0.51; 95% CI, 0.37-0.71; p=0.000), respectively. In terms of LC, the low risk HPV-positive patients had better 3-year rates 70.1%, vs. 55.7% and 39.9% compared to the intermediate and, high risk groups (p=0.379). Conclusion: Tumor HPV/p16 status may be an independent prognostic factor along with insurance status and BMI for overall survival among oropharyngeal SCC patients. Citation Format: Mary R. Nittala, Eswar K. Mundra, Ashley Albert, William C. Woods, Maria L. Smith, Robert D. Hamilton, Lana Jackson, Gina Jefferson, Satyaseelan Packianathan, Eldrin Bhanat, Varsha Manucha, Srinivasan Vijayakumar. Univariate and multivariate prognostic factors for overall survival among oropharyngeal cancer patients with known HPV/p16 status [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-232.

Purpose: To evaluate the impact of race (African-American [AA] vs. Caucasians [C]) on the survival outcome in patients with oropharyngeal squamous-cell carcinoma (SCC) known HPV/p16 status. Methods: Between 2008 and 2018, eighty patients with known HPV/p16 status were diagnosed with oropharyngeal SCC in our academic state institution. Chi-square test, Kaplan-Meier method, and Cox regression models were used to assess for racial influence; p-values less than 0.05 were considered statistically significant. The SPSS v.24.0 was used for all statistical analyses. Results: The median follow-up duration was 34 months (range 0 to 154 months). Our patient cohort included 48.8% AA and 51.2% C (median age, 61 y; range 45-86 y) patients. Patient risk groups were stratified based on HPV/p16 status, pack-years [py] of tobacco smoking, and tumor stage into low (p16+, ≤10 py), intermediate (p16+, >10 py/p16-, 10 py/ any T4), accounting for 2.6%, 25.6% and 71.8% of AA vs. 24.4%, 26.8% and 48.8% of C patients, respectively (p=0.013). The C patients had better 5-year overall survival [OS] rates (88.9%, 62.2% and 37.5% vs. na, 48.0% and 25.6% compared to AA patients stratified by risk (p=0.009). The OS of low risk AA patients was not assessable because of a low number (1) of patients in that group. In the bivariate Cox regression analysis, the covariates stratified by race, type of insurance, BMI level, HPV/p16 status, risk groups, and 8th AJCC staging were statistically significant with p-value less than 0.05. In the multivariate analysis, the covariates of insurance-private was associated with 87% reduction (hazard ratio, 0.13; 95% CI, 0.03-0.61; p=0.010), insurance-Medicare was associated with 71% reduction (hazard ratio, 0.29; 95% CI, 0.11-0.74; p=0.010), and AJCC TNM stages III, IV and IVB (98%, 97% and 93%) with reduction in the risk of death (hazard ratio, 0.02; 95% CI, 0.00-0.38; p=0.009), (hazard ratio, 0.03; 95 CI, 0.00-0.55; p=0.017), (hazard ratio, 0.07; 95% CI, 0.00-0.92), respectively. In terms of local control [LC], the C patients also had better 3-year rates 66.4%, vs. 32.8% compared to AA patients (p=0.049). Conclusion: In our patient population, race appears to be an independent prognostic factor for OS and LC in oropharyngeal SCC patients with known HPV/p16 status. Citation Format: Mary R. Nittala, Eswar K. Mundra, Maurice L. King, Ashley Albert, Williams C. Woods, Maria L. Smith, Robert D. Hamilton, Lana Jackson, Gina Jefferson, Satyaseelan Packianathan, Varsha Manucha, Srinivasan Vijayakumar. Impact of race on outcomes in oropharyngeal squamous-cell carcinoma patients with known HPV/p16 status [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-104.

Purpose: The objective of this study is to evaluate local control and survival rates of node negative triple negative breast cancer patients (TNBCs) treated with radiotherapy (RT) in our institution. Methods: This is a retrospective analysis of 67 TNBCs (2007 - 2017) at an academic state institution who underwent lumpectomy and /or mastectomy (surgery) followed by adjuvant irradiation to median total dose of 50 Gy (range 40.5-50.40 Gy). Chemotherapy was administered in a neoadjuvant (31) or adjuvant setting (36). For all 67 TNBCs, local control (LC), overall survival (OS) and disease free survival (DFS) were estimated using the Kaplan-Meier method. The significance of survival variables were analyzed using the Cox univariate and multivariate proportional hazards model. A p-value of less than 0.05 was considered statistically significant. The SPSS 24.0 software was used for data analysis. Results: The baseline characteristics of all 67 TNBCs were measured with median follow up of 58 months (range 10-142 months). Patients were stratified into two groups (neoadjuvant chemotherapy-RT (31) vs. adjuvant chemotherapy-RT (36)). The median rates for LC, DFS and OS were 27 % vs. 68 % (p= 0.001), 27.2% vs. 63.2 % (p= 0.034), and 63.4% vs. 92.5% (0.001) respectively. On Cox multivariate analysis, patients who received adjuvant chemotherapy were associated with statistically improved significant LC (p= 0.002) and OS (p=0.005). The variables included were: ethnicity (p=0.251), age (p=0.984), BMI (p=0.032), lump boost (p=0.300), TNM (p=0.162) and tumor grade (p=0.336). Conclusion: Among TNBC patients undergoing RT, adjuvant chemotherapy appears to be better than neoadjuvant chemotherapy in determining the clinical outcomes. Citation Format: Mary R. Nittala, Eswar K. Mundra, Satya Packianathan, Divyang Mehta, Maria L. Smith, William C. Woods, Shawn McKinney, Barbara S. Craft, Srinivasan Vijayakumar. Triple negative breast cancer patients treated with radiation therapy: Improvement in survival and local control with adjuvant chemotherapy compared to neoadjuvant chemotherapy [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr 6177.

Purpose: As survival alone does not give a holistic view on the complete picture associated with outcomes of a treatment, the main purpose of this study is to interpret the evidence of quality adjusted life year (QALY) and disability adjusted life year (DALY) on the outcomes of the nasopharyngeal carcinoma patients (NCP) treated with definitive chemo radiation therapy (chemoRT) with or without neoadjuvant induction chemotherapy. Methods: Retrospective analysis of 85 NCPs treated by concurrent chemoRT (60 %), induction chemo followed by concurrent chemoRT (23.5 %) and hospice (16.5 %) at an academic state institution. Overall survival (OS) was estimated by using Kaplan–Meier method and the differences between survival curves were calculated by log-rank test. The SPSS 24.0 software was used for data analysis. QALYs are calculated by multiplying the utility value associated with a given nasopharyngeal carcinoma phase by the years lived in that state. DALYs are calculated by combining measures of life expectancy (LE) and the adjusted quality of life during the disease phase. The relationship between QALYs gained and DALYs saved were calculated from age of the disease onset, duration of the disease, quality of life and disability weights. Results: Of the total 85 eligible NCPs of this cohort, the frequency distribution as per WHO classification was for keratinizing SCCa (Type I) 41.2 %, non-keratinizing SCCa (Type II) 42.4 % and undifferentiated carcinoma (Type III) 16.5 %. The OS median follow up for this cohort was 24 months. WHO Type I had OS of 48.6 %, Type II 29 % and Type III 39.7 % (P = 0.042). The OS of concurrent chemoRT was 32.8 % and induction chemo followed by concurrent chemoRT 14.8 % (P = 0.029) Average LE for 85 NCP cohort is 34.56 years, average DALYs saved with treatment is 20.06 years and average QALYs gained with treatment is 11.72 years. The average DALYs saved with concurrent chemoRT is 12.2 years vs 5 years with induction chemo followed by concurrent chemoRT. The average QALYs gained with concurrent chemoRT is 6.9 years vs 3.1 years with induction chemo followed by concurrent chemoRT. Summary and Conclusion: This study is significant for the following: 1. This study uses QALYs and DALYs calculated not by using survey forms but alternative methods. 2. It shows that concurrent chemoRT is superior to induction chemotherapy followed by concurrent chemoRT using outcomes based on QALYs and DALYs. Our retrospective cohort OS reports similar findings to previous studies by Liang et.al and Tan et.al, that induction chemo has not shown to improve OS compared to definitive chemoRT. In addition, our data show that patients treated with concurrent chemoRT had an increased quality of life when compared to the patients treated with induction chemo followed by concurrent chemoRT. The average DALYs saved are higher in the patients treated with concurrent chemoRT over patients treated with induction chemo followed by concurrent chemoRT. Citation Format: Mary R Nittala, Madhava R Kanakamedala, Eswar K Mundra, Srinivasan Vijayakumar. Qalys and dalys are better with concurrent chemoRT than induction chemo followed by chemoRT in nasopharyngeal carcinoma [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C016.

Purpose: To assess whether the Will Roger’s phenomenon [WRP] exists with the move from the AJCC 7th to AJCC 8th edition in Breast Cancer staging and if racial differences are manifested in the expression of the WRP. Methods: A retrospective analysis of 300 women diagnosed with breast cancer between 2007 and 2017 at an academic medical center was performed. Pearson’s square test was used to compare the proportional differences between the anatomic staging system represented by the 7th edition and the prognostic staging of the 8th edition among Caucasian [C] and African-American [AA] women. Kaplan- Meier analysis was used to estimate overall survival [OS] and disease-free survival [DFS] between the races and compared using the log-rank test. Bi and multi-variate Cox hazard regression analyses were used to identify any racial factors associated with outcomes. The SPSS v.24.0 was used for all statistical analyses. Results: Our patient cohort included 30.3% C and 69.7% AA (median age, 62 y; range 34- 92 y). Stages I, II, III, and IV accounted for 46.2%, 26.3%, 23.1%, and 4.4% of C and 28.7%, 43.1%, 24.4%, and 3.8% of AA respectively, in anatomic staging (p= 0.043). In prognostic staging, 52.8%, 18.7%, 23%, and 5.5% were C while 35%, 17.2%, 43.5%, and 4.3 % were AA, respectively (p=0.011). A total number of 41 C (45.05 %) were upstaged compared to 100 AA (47.85 %) patients. Fifteen C patients (16.49 %) and 30 AA patients (14.35 %) were down-staged. Of the remainder, 35 C (38.46 %) and 79 AA (37.79 %) patients had their stages unchanged (P=0.859). The median follow-up duration for this cohort was 58 months (range 4- 235 months). The AA patients showed better stage -by- stage 5- year OS rates using 8th edition compared to the 7th edition, suggesting a manifestation of the WRP. Among the C patients, those who were stage IIIA in the 7th edition but became stage IB in the 8th had a better prognosis than stages IIA and IIB in the 8th edition (p=0.000). For AA patients, stage IIIA, IIIB, IIIC, and IV all demonstrated better prognoses in the 8th edition when compared to the 7th edition (p=0.000). In terms of DFS, the 8th edition’s clinical staging showed complex results (p=0.176) compared to DFS estimated using the 7th’s anatomic staging system (p=0.004). For C patients, stages IA, IB, IIB, and IIIC all recorded better DFS when using the 8th edition while for AA patients, only those with stages IB and IIIC showed better DFS in the 8th edition compared to the 7th. Conclusion: Our analyses suggest that the WRP exists in the move from the AJCC 7thto the 8th edition in breast cancer staging in both C and AA patients. However, there was significant variability between the races in the extent of its manifestation. We suggest that caution needs to be exercised when results are compared across staging systems to account for the WRP in the interpretation of the data. Citation Format: Mary R Nittala, Eswar K Mundra, SatyaSeelan Packianathan, Divyang Mehta, William C Woods, Shawn Mckinney, Barbara S Craft, Srinivasan Vijayakumar. The Will Rogers phenomenon in breast cancer: The AJCC 8th Ed. and the importance of caution in the interpretation of outcomes differences for overall population and race-specific cohorts [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr B126.