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190 citation(s) found for "Otero, JR".

Abstract LB205: Feasibility and immunogenicity of adjuvant TG4050, a patient tailored cancer vaccine in head and neck and ovarian cancer
Jamet, Camille , Ottensmeier, Christian H. , Delord, Jean‐Pierre , Block, Matthew S. , Colón‐Otero, Gerardo , Knutson, Keith L. , Tavernaro, Annette, Lacoste, G, Grellier, Benoît, Noiriel, Xavier, Huss, Thierry, Burtin, Bernard, Yamashita, Yoshiko, Onoue, Kousuke, Onoguchi, Kazuhide, Malone, Brandon, Baker, Oliver, Quéméneur, Éric , Brandely, Maud , Lalanne, Ana Inés , Tourneau, Christophe Le , Knutson, Keith L. , Onoue, Kousuke, Lantz, Olivier J , Yamagata, Naoko, Tanaka, Yuki , Bendjama, Kaidre

Cancer Research | April 14, 2023 | Volume: 83 | Issue: 8_Supplement | Pages: LB205-LB205

10.1158/1538-7445.am2023-lb205 Get It

Abstract Background: Head and Neck (HNSCC) and Ovarian cancer (OC) are two indications for which immunotherapy had limited impact so far. Current treatments achieve high rates of initial success through surgery and adjuvant chemo/radiotherapy, but patients (pts) remain at high risk of relapse in both indications. Immune stimulation using a vaccine is a promising strategy to a clinically meaningful improvement. Herein we report phase I data of TG4050, a vaccine engineered to carry a pt tailored antigen payload, in pts with HNSCC (NCT04183166) or OC (NCT03839524). Methods: Tumor specific variants are identified using next generation sequencing of tumor and normal samples whereby immune relevant mutations are predicted using a machine learning algorithm factoring in parameters known to affect immunogenicity including MHC binding, level of expression, prevalence across clones, and antigen processing. DNA sequences of the mutations of interest, typically 30 per pt, are cloned in a viral vector (Modified Vaccinia Virus Ankara). Following curative intent treatment, HNSCC pts in complete remission were randomized to an immediate vaccination arm to receive weekly doses of TG4050 for 6 weeks followed by a maintenance period of one dose every 3 weeks for up to 20 doses or to a delayed vaccination arm where the same vaccination regimen is initiated at relapse. OC pts received the vaccine upon onset of signs of relapse. PBMC were collected at Baseline and after 6 doses of vaccine. Primary endpoint was vaccine safety and secondary endpoints included feasibility, immunogenicity. Results: 18 pts received TG4050 (5 OC and 13 HNSCC) treatment with no related grade ≥ 3 adverse events. Tumor mutational burden (TMB) was on average 3.00±0.98 and 2.43±0.69 mutations per megabase for HNSCC and OC respectively. Despite this low TMB, all pts had sufficient cancer specific neoantigens to design a vaccine. Ex-vivo ELISPOT was completed for 7 pts at the time of submission. A mean of 44% of selected mutations were associated with a reactive T cell responses either spontaneously or after TG4050 stimulation ranging from 6 to 22 mutations per pt. Vaccination induced a stimulation of T cell response in all tested pts on an average of 10 targeted mutations, induction of de novo responses was seen in all 7 tested pts and amplification of pre-existing response in 6/7 pts. None of the evaluable HNSCC pts receiving TG4050 immediately after first line treatment had relapse after a median follow-up of 7 months while 2 pts had relapse in the delayed vaccination arm. Furthermore, in OC pts treated at early relapse, TG4050 has normalized disease markers (ctDNA and/or CA-125) for 2/4 pts with stable disease for 9 and 11 months. Conclusion: TG4050 treatment is feasible and immunogenic in pts with low to moderate TMB. It is effective in inducing T cell responses and first signs of antitumor activity are encouraging for the continuation of development. Citation Format: Ana Lalanne, Camille Jamet, Christian H. Ottensmeier, Jean-Pierre Delord, Christophe Le Tourneau, Matthew S. Block, Gerardo Colon-Otero, Keith L. Knutson, Annette Tavernaro, Gisele Lacoste, Benoit Grellier, Xavier Noiriel, Thierry Huss, Bernard Burtin, Yoshiko Yamashita, Kousuke Onoue, Kazuhide Onoguchi, Brandon Malone, Olivier Lantz, Oliver Baker, Naoko Yamagata, Yuki Tanaka, Eric Quemeneur, Maud Brandely, Kaidre Bendjama. Feasibility and immunogenicity of adjuvant TG4050, a patient tailored cancer vaccine in head and neck and ovarian cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr LB205.
Abstract CT045: A randomized phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) human papilloma virus (HPV)-16 positive anogenital cancers
Daste, Amaury , Cassier, Philippe A. , Salas, Sébastien , Sánchez, Luis Manso, Colón‐Otero, Gerardo , Eberst, Lauriane , Tavernaro, Annette, Makhloufi, Hakim, Brandely, Maud , Delord, Jean‐Pierre , Tourneau, Christophe Le , Rolland, Frédéric , Sánchez, Luis Manso, Lantz, Olivier J , Lalanne, Ana Inés , Bendjama, Kaidre

Cancer Research | April 14, 2023 | Volume: 83 | Issue: 8_Supplement | Pages: CT045-CT045

10.1158/1538-7445.am2023-ct045 Get It

Abstract Background: Immune checkpoint inhibitors targeting the PD1/PD-L1 axis have made a breakthrough in advanced solid tumors, leading to improved overall survival (OS) in several cancer types. However, only a minority of patients experience durable responses, requiring further development of anti-tumoral immunotherapies to overcome tumor immune escape. We hypothesized that priming the immune system with TG4001, a vaccine using the highly attenuated Modified Vaccinia virus Ankara as vector expressing the HPV16 E6 and E7 proteins (rendered non-oncogenic) and interleukin-2, would increase the clinical benefit associated with PD-L1 blockade in HPV16+ cancer patients. In the single-arm part of the trial evaluating the combination of TG4001 and avelumab in terms of response rate, the overall response rate (ORR) was 22%. Presence of liver metastases had a profound impact on outcome in terms of ORR and Progression Free Survival (PFS). In patients (pts) without liver metastases an ORR of 32% was observed versus 0% in pts with liver metastases, warranting further development of this combination in this patient population (SITC 2020, Abstract ID 793). Methods: We have designed a randomized open-label two-arms trial evaluating the efficacy of the combination of TG4001 and avelumab versus avelumab alone (NCT03260023). Eligible pts have R/M HPV-16 positive anogenital cancer including cervical, vulvar, vaginal, penile, and anal cancers with no more than one prior line of chemotherapy for R/M disease and no previous exposure to cancer immunotherapy. HPV-16 positivity is determined in a central laboratory. Patients are randomly assigned 1:1 to receive either TG4001 plus avelumab or avelumab alone. Randomization is stratified by primary tumor type (cervical, anal, genital). TG4001 is administered subcutaneously (SC) at 5 × 107 plaque forming units (pfu) Q1w for 5 weeks, Q2w until month 6 and Q12w until progressive disease and avelumab intravenously (IV) at 800 mg Q2w until progressive disease. A total of up to 140 pts are currently being recruited into two cohorts (A and B) in France, Spain, and USA. For Cohort A, consisting of pts without liver metastases at Baseline (BL), a 2-stage sample size adjustment design is used with PFS by RECIST 1.1 as primary endpoint. Plans are to accrue 120 patients following Interim Analysis and Independent Data Monitoring Committee (IDMC) review. Cohort B recruits pts with liver metastases at BL. To be eligible, hepatic disease is restricted in terms of extent and number of lesions. A total of 20 pts will be recruited and analyzed for the percentage of early progressors. Secondary endpoints include overall survival, objective response rate according to RECIST1.1, duration of response, disease control rate. Exploratory endpoints comprise analyses of blood-based parameters and tumor-based proteins and RNA expression and their impact on clinical outcomes. Citation Format: Christophe Le Tourneau, Frédéric Rolland, Amaury Daste, Philippe Cassier, Sébastien Salas, Luis Manso Sánchez, Gerardo Colon-Otero, Lauriane Eberst, Olivier Lantz, Ana Lalanne, Annette Tavernaro, Hakim Makhloufi, Kaïdre Bendjama, Maud Brandely, Jean-Pierre Delord. A randomized phase II trial of TG4001 plus avelumab versus avelumab alone in recurrent/metastatic (R/M) human papilloma virus (HPV)-16 positive anogenital cancers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT045.
Abstract 5539: Assessing knowledge, vaccine hesitancy, and completion rates of free HPV vaccination in uninsured/underinsured low-income patients
Diaz, Hiram, Colón‐Otero, Gerardo , Casanova-Leyva, Sandra, Pacheco-Spann, Laura M. , DeStephano, Christopher C.

Cancer Research | April 5, 2023 | Volume: 83 | Issue: 7_Supplement | Pages: 5539-5539

10.1158/1538-7445.am2023-5539 Get It

Abstract Background: Human Papillomavirus (HPV) vaccination rates remain low in the U.S., particularly among minorities and low-income patients. In 2014, a Mayo Clinic study of uninsured, low-income, working, Volunteer in Medicine (VIM) Clinic patients in Jacksonville, Florida found a statistically significant lower awareness of HPV (50.3% vs 63.6%) and the HPV vaccine (32.1% vs 62.7%) than the national population. As a result, our team collaborated with Merck to develop a free HPV vaccination program and video education campaign for VIM patients. Methods: We assessed VIM patients HPV vaccination knowledge, awareness, and prevalence of hesitancy towards receiving the vaccine. VIM patients (ages 18-45) with no previous history of HPV vaccination were invited to participate in this study. The Parents Attitudes about Childhood Vaccines (PACV) survey was used to evaluate vaccine hesitancy. Patients who declined the HPV vaccine were shown an educational video to assess effectiveness in persuading patients’ opinion. Each participant received a vaccine hesitancy PACV score, which was compared with their vaccine disposition. Mayo Clinic IRB approval of the study was obtained. Results: Our analysis included 43 patients (34 females, 9 males) with a median age of 40 (age range 27- 45). Patients had overall knowledge of HPV of 88.4%, with 69.8% having heard of the HPV vaccine. 85.7% PACV survey respondents were deemed non-hesitant (PACV scores 0-49), and 80.6% of the non-hesitant subset (29/36) agreed to undergo vaccination. The average PACV score of vaccine-interested participants was lower (25.2) than the average of participants not interested in the vaccine (36.7). Black participants had a statistically significant higher PACV score than White participants. The PACV scores of individuals who were already familiar with the HPV vaccine were significantly lower than those of participants who were unfamiliar with the HPV vaccine. Only 20% (2/10) of individuals, who had previously declined vaccination, agreed to receive the HPV vaccine after viewing the HPV educational video. Of the 33 participants who agreed to receive the free HPV vaccine, only 9 (27.3%) completed all three doses. Conclusions: HPV vaccine awareness and knowledge at VIM increased compared to the 2014 cohort. Vaccine hesitancy was not observed in most patients, yet video education was effective in only a small portion of patients with vaccine hesitancy. Additionally, a minority of patients who agreed to receive the free HPV vaccine series completed all three doses. Our results suggests that free HPV vaccination and video education is not sufficient to achieve adequate vaccination rates among low-income uninsured young adults, nor overcoming vaccine hesitancy. Innovative measures are warranted to improve vaccination rates in this population. Citation Format: Hiram Diaz, Gerardo Colon-Otero, Laura M. Pacheco-Spann, Christopher C. DeStephano, Sandra Casanova-Leyva. Assessing knowledge, vaccine hesitancy, and completion rates of free HPV vaccination in uninsured/underinsured low-income patients. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5539.
Abstract 1921: Universal genetic testing for hereditary cancer syndromes in an under-represented minority population
Khadarian, Kevork, Pisipati, Sailaja , Colón‐Otero, Gerardo , Northfelt, Donald W. , Gary, Lindsey, Ekpoh, Idara U., Moreno, Giovanna GG, Klint, Margaret A., Barrus, Kathleen , Sekulić, Aleksandar , Golafshar, Michael A. , Samadder, N. Jewel , Golafshar, Michael , Jones, Jeremy C , Esplin, Edward D. , Nussbaum, Robert L. , Leach, Brandie , Klint, Margaret, Bekaii‐Saab, Tanios , Kunze, Katie L. , Willman, Cheryl L. , Lazaridis, Konstantinos N.

Cancer Research | April 5, 2023 | Volume: 83 | Issue: 7_Supplement | Pages: 1921-1921

10.1158/1538-7445.am2023-1921 Get It

Abstract Hereditary factors play a role in the development of several cancers. Identification of germline predisposition can have implications for treatment and cancer prevention. While previous studies have found that universal multigene panel testing in patients with cancer yields increased detection of actionable heritable variants compared to targeted testing, patients belonging to racial and ethnic minority groups have been underrepresented in these studies. We undertook a prospective multi-site study of germline alternations among solid tumor cancer patients from under-represented minority (URM) populations receiving care at Mayo Clinic Comprehensive Cancer Centers between January 2020 and November 2022. Patients with a new or active cancer diagnosis (all stages) not selected for family history of cancer were tested with a >80-gene next generation sequencing panel. Of 532 patients (mean [SD] age, 57.2 [12.7] years; 320 (60.2%) female), 247 (46.4%) were Hispanic/Latino, 130 (24.4%) Black/African American, 80 (15.0%) Asian, 66 (12.4%) American Indian/Alaskan Native, 2 (0.4%) Native Hawaiian/Pacific Islander, and 7 (1.3%) other. PGV were found in 43 patients (8.1%), including 29 moderate- or high- penetrance cancer susceptibility genes. Variants of uncertain significance (VUS) were found in 272 patients (51.1%). Of those with a PGV, 29 (67.4%) had incremental clinically actionable findings that would not have been detected by established testing criteria, of which 16 were moderate- or high-penetrance variants. Younger age of diagnosis, gender, race, ethnicity, and stage of disease were not predictive of PGV. In this study of under-represented minority cancer patients, universal genetic testing found that 1 in 12 patients harbor a PGV, more than two-thirds of whom would remain undetected using current guidelines. The paucity of genomic data in URM populations also results in a large proportion of VUS which may lead to under-estimation of disease associated variants. Table 1. Clinical and Demographic Characteristics of Included Patients Positive Negative VUS Total N (%) 43 217 272 532 (8.1%) (40.8%) (51.1%) Age - mean (SD) 53.7 57.0 57.8 57.2 (12.7) (12.6) (12.8) (12.7) Gender - Female 26 132 162 320 (60.5%) (60.8%) (59.6%) (60.2%) Race/Ethnicity Hispanic/Latino 24 110 113 247 (55.8%) (50.7%) (41.5%) (46.4%) Black/African 5 56 69 130 American (11.6%) (25.8%) (25.4%) (24.4%) Asian 10 (23.3%) 23 (10.6%) 47 (17.3%) 80 (15.0%) American Indian/Alaskan Native 4 (9.3%) 26 (12.0%) 36 (13.2%) 66 (12.4%) Native Hawaiian/Pacific Islander 0 (0.0%) 0 (0.0%) 2 (0.7%) 2 (0.4%) Other 0 (0.0%) 2 (0.9%) 5 (1.8%) 7 (1.3%) Tumor Types Breast 19 (44.2%) 80 (36.9%) 110 (40.4%) 209 (39.3%) CNS 1 (2.3%) 2 (0.9%) 1 (0.4%) 4 (0.8%) GI 7 (16.3%) 46 (21.2%) 58 (21.3%) 111 (20.9%) GU 8 (18.6%) 57 (26.3%) 62 (22.8%) 127 (23.9%) GYN 0 (0.0%) 8 (3.7%) 10 (3.7%) 18 (3.4%) Head/Neck 5 (11.6%) 8 (3.7%) 6 (2.2%) 19 (3.6%) Lung 0 (0.0%) 6 (2.8%) 11 (4.0%) 17 (3.2%) Melanoma 0 (0.0%) 2 (0.9%) 1 (0.4%) 3 (0.6%) Sarcoma 2 (4.7%) 4 (1.8%) 4 (1.5%) 10 (1.9%) Other 1 (2.3%) 4 (1.8%) 9 (3.3%) 14 (2.6%) Citation Format: Kevork A. Khadarian, Sailaja Pisipati, Jeremy C. Jones, Gerardo Colon-Otero, Donald W. Northfelt, Lindsey Gary, Idara U. Ekpoh, Giovanna G. Moreno, Edward D. Esplin, Robert Nussbaum, Brandie Heald, Margaret A. Klint, Kathleen A. Barrus, Tanios S. Bekaii-Saab, Aleksandar Sekulic, Michael A. Golafshar, Katie L. Kunze, Cheryl L. Willman, Konstantinos N. Lazaridis, Niloy Jewel Samadder. Universal genetic testing for hereditary cancer syndromes in an under-represented minority population [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1921.
Abstract 1972: Potential predictors of prostate cancer screening: Findings from the MiCaP research digest study
Machuca, Jessica Otero , Fathi, Parisa , Walsh-Childers, Kim , Odedina, Folakemi T., Lee, Daniel

Cancer Research | April 4, 2023 | Volume: 83 | Issue: 7_Supplement | Pages: 1972-1972

10.1158/1538-7445.am2023-1972 Get It

Abstract Introduction: Black men are disproportionately affected by prostate cancer (CaP) and havebeen found to experience more aggressive forms of cancer. The Minority Prostate Cancer(MiCaP) Research Digest is a dissemination platform with the goal of spreading community-based and culturally relevant ways to provide prostate cancer discoveries, interventions, andclinical trials among Black men. In collecting pretest data, the MiCaP team was also able tocollect data on whether participants had been tested for CaP in the last year. We were also ableto collect data on various social determinant variables to test for association. Methods: Black men living in the United States ages 35 to 70 were recruited for this studythrough community-based methods. Participants were randomly assigned to an interventiongroup that received the MiCaP information material and a control group that watched a generalvideo. Both groups received baseline and follow-up surveys to assess their knowledge relatedto CaP clinical trials, testing, and treatment. Associations of characteristics from the baselinesurvey were evaluated using logistic regression models. Results: A total of 220 responses are included in this dataset. The majority of participants wereborn in the United States (93.06%), single (49.52%), attended/graduated college (35.65%),between 60 and 69 years (25.58%), had full-time employment (52.07%), and had a householdincome between 20,000 and 39,999 (21.66%). Only about 35% had read or heard about clinicaltrials within the last year. Logistic regression found a positive association between the followingvariables and getting tested for prostate cancer in the past year: if participants had heard ofcurrent prostate cancer research or discoveries, if an immediate family member had beendiagnosed with prostate cancer, age, and level of education. No association was found betweeninsurance status, utilization of healthcare, clinical trial participation, or clinical trial knowledge. Conclusion: There is an association between being aware of CaP discoveries, diagnosis of familymembers, education, and age with prostate cancer screening. Future work should be done tofurther explore this association and how to overcome the barriers those determinants mightprovide in screening. These data and future data on this can be used to further community-based interventions delivered in culturally relevant ways with the goal of encouraging positivehealth behaviors to reduce CaP in Black men. Citation Format: Jessica Otero Machuca, Parisa Fathi, Daniel Lee, Kim Walsh-Childers, Folakemi Odedina. Potential predictors of prostate cancer screening: Findings from the MiCaP research digest study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1972.
Abstract 4371: iCCaRe: Social determinants of health navigation, psycho-oncology, and emotional support for Black prostate cancer survivors: Review of current practices
Fullwood, Dottington , Merriweather, AJ, Balaji, KC, Dronca, Roxana , Colón‐Otero, Gerardo , Crook, Jennifer , Fathi, Parisa , Asto-Flores, Emelina , Pressey, Shannon, Ngufor, Che , Pereira, Deidre Byrnes

Cancer Research | April 4, 2023 | Volume: 83 | Issue: 7_Supplement | Pages: 4371-4371

10.1158/1538-7445.am2023-4371 Get It

Abstract Background: Black men continue to be disproportionately affected by prostate cancer incidence and mortality as compared to their White counterparts, despite worldwide declining prostate cancer diagnosis rates. This complex phenomenon remains poorly understood, especially at the point of a prostate cancer diagnosis. Newly diagnosed Black men report initial feelings ranging from being “shocked,” to “receiving a death sentence,” and both an ineptness of asking questions and a reliance on physicians for treatment options due to lack of knowledge. The psychological distress from prostate cancer uncertainties affects health management and treatment decisions, though it is unclear to what extent the role of social determinants of health factor in making informed healthcare decisions. Aim: In this scoping review, we examined the influence of the social determinants of health at point of prostate cancer diagnosis among Black men seeking to make an informed decision about their treatment plans. Methods: We followed the methodological framework: the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Five electronic databases, Emabase, Pubmed, PsycInfo, Scopus, and Web of Science were searched for quantitative and qualitative primary studies from the period 2005 until March 2022. Two authors independently screened titles and abstracts, and full texts, against predefined criteria: empirical research, post 2000, in English-language peer-reviewed journals; participants included Black prostate cancer survivors and research explored social determinants of health at point of prostate cancer diagnosis. Studies were quality assessed for data charting. Results: The search yielded 283 studies, with 45 included studies for synthesis. Traditional social determinants of health were frequent. However, identification of themes such as social support, masculinity and stigma, fear of abandonment by medical staff, and cost of diagnostic procedures were prominent determinants. Notably, sub-themes emerged that included coping factors such as emotional distress, perceptions of normalcy, and poor prostate cancer knowledge. Conclusion: Understanding the social determinants of health impact on Black men, especially at point of prostate cancer diagnosis will allow survivors, physicians, and researchers to work at solving these health disparities. Citation Format: Dottington Fullwood, AJ Merriweather, Che Ngufor, Deidre Pereira, KC Balaji, Roxana Dronca, Gerardo Colon-Otero, Jennifer Crook, Parisa Fathi, Emelina Asto-Flores, Shannon Pressey, Folakemi Odedina. iCCaRe: Social determinants of health navigation, psycho-oncology, and emotional support for Black prostate cancer survivors: Review of current practices. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4371.
Abstract P2-11-05: Effects of Intrinsic Subtypes and 21-gene Assay on the Early and Late Recurrence Risks in Patients with Early Stage HER2+ Breast Cancer: An Analysis of the North Central Cancer Treatment Group (NCCTG) N9831 (Alliance) Trial
Chumsri, Saranya , Li, Zhuo , Norton, Nadine , Moreno‐Aspitia, Alvaro , Colón‐Otero, Gerardo , Knutson, Keith L. , Perez, Edith A. , Thompson, E. A., Norton, Nadine , Knutson, Keith L. , Wolff, Antonio C. , Thompson, E. Aubrey

Cancer Research | March 2, 2023 | Volume: 83 | Issue: 5_Supplement | Pages: P2-11-05-P2-11-05

10.1158/1538-7445.sabcs22-p2-11-05 Get It

Abstract Background: We previously demonstrated that intrinsic subtypes were associated with prognosis for early recurrence risk in patients (pts) with early-stage HER2-positive (HER2+) BC treated with trastuzumab (H) in the N9831 trial. Here, we evaluated the prognostic value of Intrinsic subtypes and 21-gene assay and the risk of early and late recurrence in the N9831 trial. Methods: NanoString custom code set, which included PAM50 and housekeeping genes, was used to quantify mRNA and generated intrinsic subtypes and risk of recurrence (ROR) score from the N9831 trial in Arms A and C: Arm A chemotherapy alone and arm C concurrent H. Quantitative RT-PCR of 21 genes, calculation of the axis, including estrogen axis (ER, PGR, BCL2, SCUBE2), HER2 axis (GRB7, HER2), proliferation axis (Ki67, STK15, Survivin, CCNB1, MYBL2), invasion axis (MMP11, CTSL2), and recurrence score (RS) risk group assignment (RS group 1 and 2: RS < 31 and RS group 3: RS ≥ 31) were performed using Oncotype DX assay. Cox regression models for RFS were used for analysis. Early recurrence was defined as a recurrence that occurred at ≤ 5 years, and late recurrence was defined as recurrence at > 5 years. Results: A total of 783 patients (Arm A 409 and Arm C 374) were included in this analysis. Using multivariate Cox regression analysis to evaluate the risk of early recurrence in patients who received chemotherapy alone in arm A, both invasion genes (MMP11 HR 1.23, 95%CI 1.05-1.44, p 0.01 and CTSL2 HR 1.36, 95%CI 1.1-1.69, p 0.005) and invasion axis (HR 1.64, 95%CI 1.26-2.13, p < 0.001) were associated with a higher rate of early recurrence. CD68 was associated with improved outcomes (HR 0.56, 95%CI 0.38-0.83, p 0.004). For the risk of early recurrence in patients treated with trastuzumab in arm C, ER (HR 0.85, 95%CI 0.74-0.97, p 0.02), PR (HR 0.78, 95%CI 0.64-0.94, p 0.008), and estrogen axis (HR 0.7, 95%CI 0.57-0.87, p 0.001) were associated with improved outcomes. Invasion axis (HR 1.61, 95%CI 1.08-2.41, p 0.02), Oncotype Dx risk group (3 vs. 1 and 2, HR 8.89, 95%CI 1.27-1124, p 0.02), and basal subtype (HR 2.77, 95%CI 1.1-5.95, p 0.03) were also significantly associated with worse outcomes. For risk of late recurrence, in arm A, ER (HR 1.22, 95%CI 1.04-1.44, p 0.02), PR (1.26, 95%CI 1.05-1.5, p 0.01), and estrogen axis (1.39, 95%CI 1.09-1.77, p 0.008) were associated with worse outcomes. Oncotype Dx risk group (3 vs. 1 and 2, HR 0.4, 95%CI 0.16-0.98, p 0.05) was associated with improved outcomes. However, neither individual gene, axis, nor intrinsic subtypes were associated with the risk of late recurrence in patients treated with trastuzumab. Conclusions: For risks of early recurrence, the invasion genes/axis were associated with increased risks of recurrence in patients with early-stage HER2+ BC regardless of trastuzumab treatment. Among patients treated with trastuzumab, ER genes/axis, Oncotype Dx risk group, and intrinsic subtype were prognostic for risks of recurrence in the first five years. For risks of late recurrence, ER genes/axis and Oncotype Dx risk group were prognostic but only in patients treated with chemotherapy alone. The ER genes/axis were associated with less recurrence in the first five years but worse after five years, reflecting a higher risk of late recurrence in ER/PR+ HER2+ BC patients treated with chemotherapy alone. However, none of the individual gene, axis, or intrinsic subtypes were associated with the risk of late recurrence in patients treated with trastuzumab. Therefore, future studies are needed to identify biomarkers for the risk of late recurrence in HER2+ BC patients treated with adjuvant trastuzumab. Support: BCRF-19-161; U10CA180821, U10CA180882, Genentech. https://acknowledgments.alliancefound.org; Clinicaltrials.gov Identifier: NCT00005970 Citation Format: Saranya Chumsri, Zhuo Li, Nadine Norton, Alvaro Moreno-Aspitia, Gerardo Colon-Otero, Keith L. Knutson, Antonio C. Wolff, Edith A. Perez, E. A. Thompson. Effects of Intrinsic Subtypes and 21-gene Assay on the Early and Late Recurrence Risks in Patients with Early Stage HER2+ Breast Cancer: An Analysis of the North Central Cancer Treatment Group (NCCTG) N9831 (Alliance) Trial [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-11-05.
Efficacy of gemcitabine in combination with nanoparticle albumin‐bound paclitaxel in the treatment of recurrent ovarian cancer: A retrospective single institution review
Kase, Adam M. , Azzouqa, Abdel‐Ghani, Kochuveettil, Swapna, Colón‐Otero, Gerardo

Cancer Medicine | February 21, 2023 | Volume: 12 | Issue: 8 | Pages: 9434-9438

10.1002/cam4.5705 | PMID 36806695 Get It

AbstractBackgroundThe objective of this study was to evaluate the efficacy of gemcitabine plus nab‐paclitaxel in patients with recurrent ovarian cancer.MethodsWe performed a single institution retrospective review of patients with recurrent ovarian cancer who were treated with gemcitabine plus nab‐paclitaxel from 2012 to 2018 at the Mayo Clinic in Florida.ResultsTwenty patients were identified and the median PFS for patients treated with gemcitabine plus nab‐paclitaxel was 9 months (95% CI, 5.7–20.7). Overall, 17 of the 20 patients (85%) achieved a clinical benefit (complete response 5%, partial response 55%, or stable disease at 3 months 25%). For platinum‐sensitive disease and platinum‐resistant disease, the median OS were 38.7 months (95% CI, 5.8–63.1) and 31.2 months (95% CI, 12.8–51.8), respectively (p = 0.4306).ConclusionThis well‐tolerated regimen shows promising activity in recurrent ovarian cancer and is a viable option for patients who are intolerant to paclitaxel or carboplatin because of allergic reactions.
Abstract B072: Influence of access to care on cancer diagnoses in the CaPTC Prostate Cancer Familial Cohort Study of African Ancestry in Nigeria, Cameroon, and the United States
Otero, Jessica, Jibrin, Paul, Sowumi, Anthonia, Nkegoum, Blaise , Oladoyinbo, Catherine, Salako, Abdulkadir Ayo, Omonisi, Abidemi , Bassey, Iya Eze , Adenji, Kayode, Asura, Nggada Haruna, Kukoyi, Oluwole, Fathi, Parisa , Enuka, Ruth, Toye, Oluwaseyi, Crook, Jennifer , Odedina, Folakemi T., Iweala, Emeka Eze Joshua , Popoola, Ademola , Faruk, Mohammed , Fatiregun, Omolara , Okoye, Ifeoma Joy , Kaninjing, Ernest , Enuka, Ruth, Toye, Oluwaseyi

Cancer Epidemiology, Biomarkers & Prevention | January 9, 2023 | Volume: 32 | Issue: 1_Supplement | Pages: B072-B072

10.1158/1538-7755.disp22-b072 Get It

Abstract BACKGROUND Black populations are disproportionately affected by prostate cancer globally. The leading countries in prostate cancer mortality are found in Africa and the Caribbean. This data is being presented as part of the Prostate Cancer Transatlantic Consortium (CaPTC) Prostate Cancer Familial Cohort Study of African Ancestry study with the purpose of identifying the various factors that influence prostate cancer risk factors. Access to care, a known cancer risk factor, not only affects a person’s ability to receive treatment but to receive accurate health information, preventative care, diagnoses, and more. Researching exactly how different social determinants, such as this one, affect cancer risk factors for specific populations is imperative to reducing their cancer burden. METHODS: This ten-year prospective study started in 2017 and has been conducted in Nigeria, Cameroon, and the United States. Participants have been recruited in clinics and different community settings. Upon consent, participants were asked to complete a validated survey with a unique identifier on epidemiological, behavioral, clinical, and anthropometric variables. They were then asked to provide a saliva sample that was also given a unique identifier. Associations of characteristics from the survey were evaluated using logistic regression models. Others were tested for statistical significance using a Chi-Squared test. RESULTS: A total of 803 responses are included in this dataset. Of these participants, 9.6% were from Cameroon, 82.6% from Nigeria, and 7.3% from the United States. More than half of the participants (54.9%) shared they did not have healthcare coverage. In addition, a chi-squared test showed 10.2% in the United States, 13.9% in Nigeria and 35.1% in Cameroon were unable to see a physician due to cost with a p-value of less than .001 indicating statistical significance. While participants in the United States did not report any cancer diagnoses, logistical regression found a significant inverse relationship between health literacy and increased risk of a cancer diagnosis. CONCLUSION Research shows a relationship between health access factors and cancer risk factors, but little research is done for specific populations. Further research should be done to measure the exact impact access to care has on cancer diagnoses for specific communities. It is very important that health equity researchers assess exactly how these factors affect the specific populations they work with to tailor evidence-based interventions to their needs. Citation Format: Jessica Otero, Emeka Iweala, Ademola Popoola, Paul Jibrin, Mohammed Faruk, Anthonia Sowumi, Omolara Fatiregun, Nkegoum Blaise, Catherine Oladoyinbo, Ifeoma Okoye, Abdulkadir Ayo Salako, Abidemi Omonisi, Iya Eze Bassey, Kayode Adenji, Nggada Haruna Asura, Ernest Kaninjing, Oluwole Kukoyi, Parisa Fathi, Ruth Enuka, Oluwaseyi Toye, Jennifer Crook, Folakemi Odedina. Influence of access to care on cancer diagnoses in the CaPTC Prostate Cancer Familial Cohort Study of African Ancestry in Nigeria, Cameroon, and the United States [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr B072.