Experts Available and Research to Be Presented in Bladder Cancer, Disparities in Cancer and Other Areas at the 2021 ASCO Annual Meeting

NEW YORK, NY (May 19, 2021) The virtual Annual Meeting of the American Society of Clinical Oncology (ASCO), the largest medical meeting on the latest cancer research findings, will include several presentations by investigators from The Tisch Cancer Institute at Mount Sinai. Mount Sinai physician scientists will present leading research studies, including oral presentations on bladder cancer and disparities in cancer. 

  • Bladder Cancer: This is the first trial to explore the use of chemotherapy combined with immunotherapy, without surgical removal of the bladder, as a definitive approach to treat muscle-invasive bladder cancer. 
  • Cancer Disparities: This study shows that metastatic cancer patients of racial and ethnic minority groups and those with Medicare or Medicaid were more likely to receive low-value, aggressive interventions at the end of life.

Mount Sinai experts in the areas of breast, prostate, lung and colon cancer are also available for comment on top research coming out of the conference, being held online from June 4 through 8. To speak with a Mount Sinai expert and schedule an interview, contact [email protected].

Comprehensive List of Mount Sinai Research Presented at ASCO:

Please note embargoes are listed in red for oral presentations, and all posters are embargoed until 9 a.m. ET on June 4. 

Phase 2 trial of gemcitabine, cisplatin, plus nivolumab with selective bladder sparing in patients with muscle- invasive bladder cancer (MIBC): HCRN GU 16-257.

Oral Abstract Session (Abstract 4503) Session Date and Time: 6/7/2021, 8:00 AM-11:00 AM EDT

Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai

Conclusion: This is the first trial to explore the use of chemotherapy combined with immunotherapy, without surgical removal of the bladder, as a definitive approach to treat muscle-invasive bladder cancer. The standard diagnosis of bladder cancer involves removal of bladder cancer tissue through a scope placed through the urethra into the bladder. When that procedure reveals cancer invading the muscle layer of the bladder wall (ie, muscle-invasive bladder cancer), surgical removal of the bladder is a standard treatment. In this trial, we explored whether some patients could be treated definitively with a combination of chemotherapy and immunotherapy given intravenously rather than removing the bladder surgically. Results of the trial thus far demonstrate that bladder intact survival is possibly in a subset of patients with this approach, and ongoing work is seeking to identify features of tumors at baseline and after treatment that might allow better identification of such patients.

 

Disparities in end-of-life inpatient care received by patients with metastatic cancer, 2010 to 2017.

Oral Abstract Session (Abstract 12008) Session Date and Time: 6/4/2021, 9:00 AM EDT Stephanie Deeb, Icahn School of Medicine at Mount Sinai

Conclusion: Metastatic cancer patients of racial and ethnic minority groups and those with Medicare or Medicaid were more likely to receive low-value, aggressive interventions at the end of life. Further studies are needed to determine the underlying causes of these disparities in order to implement prospective interventions and advance appropriate end-of-life care.

 

Survival (OS) and progression-free survival (PFS) results after induction chemotherapy (IC) followed by de-escalated chemoradiotherapy (RDCRT) for locally advanced (LA) HPV positive oropharynx cancer (HPVOPC

Poster Session (Abstract 6058) 

Marshall R. Posner, MD, Director of Head and Neck Medical Oncology at The Tisch Cancer Institute at Mount Sinai

Conclusion: Induction with Taxotere, cisplatin and reduced 5-fluorouracil followed by de-escalated chemoradiotherapy resulted in excellent local regional control, progression-free survival and overall survival in patients with locally-advanced HPV-positive oropharynx cancer and significant risk factors. These results compare favorably to standard of care and other dose de-escalation trials in high and low risk categories. This treatment paradigm is highly effective in a locally advanced, high risk HPV-positive oropharynx cancer patients and is a reasonable treatment option to be compared to other de-escalation treatment plans in Phase 3 trials for this higher risk population.

 

Race, Subjective Social Status and Metabolic Syndrome in Women with Breast Cancer

Poster Session (Abstract 560)

Giampaolo Greco, PhD, Assistant Professor, Population Health Science and Policy at the Icahn School of Medicine at Mount Sinai

Conclusion: Race, age, diet, exercise and subjective social status all impact metabolic syndrome, a risk factor for breast cancer. Of concern, among breast cancer patients, black women are more likely to rate their subjective social status below white women, within each education or income level. Subjective social status among women with a new breast cancer diagnosis is associated with metabolic syndrome and may be important to address as a risk factor among breast cancer patients. 

 

Prognostic and predictive factors in patients treated with ramucirumab (RAM) with advanced hepatocellular carcinoma (aHCC) and elevated alpha-fetoprotein (AFP): Results from two phase III trial 

Poster Session (Abstract 4146)

Josep Llovet, MD, PhD, Founder and Director of the Liver Cancer Program at The Tisch Cancer Institute

Conclusion: Several poor prognostic factors for overall survival were identified in patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein. Ramucirumab provided an overall survival benefit irrespective of baseline prognostic covariates, with greater benefit observed in patients with aggressive hepatocellular carcinoma and those who experienced treatment emergent-hypertension or treatment emergent-ascites. 

 

Impact of recurrence on health-related quality of life in patients at high risk of recurrence after radical surgery for muscle-invasive urothelial carcinoma: results from the phase 3 CheckMate 274 trial

Poster Session (Abstract 4540)

Matthew Galsky, MD, Co-Director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai

Conclusion: Recurrence had a significant, negative impact on health-related quality of life.

Treatment delaying recurrence after radical surgery for high-risk muscle-invasive urothelial carcinoma may prevent or delay health-related quality of life deterioration.

 

Phase 1b dose escalation study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of GS-3583, a FLT3 agonist Fc fusion protein, in patients with advanced solid tumors 

Poster Session (Abstract TPS3147)

Joshua Brody, MD, Director of the Lymphoma Immunotherapy Program at The Tisch Cancer Institute at Mount Sinai

Background: This phase 1b, open-label, multicenter, dose-finding study will evaluate safety, tolerability, PK, and preliminary efficacy of GS-3583 monotherapy in patients with advanced solid tumors (NCT04747470).  

 

Molecular markers of response to anti-PD1 therapy in advanced hepatocellular carcinoma.

Poster Presentation (Abstract 4100)

Philipp K. Haber, MD, Icahn School of Medicine

Conclusion: Here we define an 11-gene signature of response to anti-PD1 in first line advanced hepatocellular carcinoma. The signature was validated in patients with other solid cancer types, where it retained its predictive ability. Of note, the signature was not able to identify responders among hepatocellular carcinoma patients that were treated with tyrosine kinase inhibitors prior to anti-PD1 therapy. The molecular changes induced by different treatment lines would, thus require fresh biopsies prior to anti-PD1 to enable biomarker-driven treatment.

 

Quality of life analysis of HPV-positive oropharyngeal cancer patients in a randomized trial of reduced-dose (rdCRT) versus standard (sdCRT) chemoradiotherapy: 5-year follow-up 

Poster Session (Abstract 6062)

Mai Takahashi, MD, Mount Sinai Beth Israel

Conclusion: In HPV-positive oropharyngeal cancer patients, randomized trial of reduced-dose chemoradiotherapy resulted in comparable long-term survival and greater improvement in specific domains of quality of life when compared to patients who received the standard dose. Our results support the need for a larger, long-term Phase 3 study in locally-advanced HPV-positive oropharyngeal cancer patients to assess these two treatments with respect to survival, quality of life, and safety.

 

Distant metastases after diagnosis: racial disparities in breast cancer outcomes.

Poster Session (Abstract 1084)

Julia Blanter, MD, Mount Sinai Hospital

Conclusions: Black women demonstrated a far higher percentage of distant metastases after diagnosis even when accounting for age and stage. These findings suggest that racial disparities still exist in the development of distant metastases, independent from a late-stage diagnosis. The source of existing disparities needs to be further understood and may be found in surveillance, treatment differences, or follow up.

 

Radical surgery in malignant pleural mesothelioma (MPM): An analysis of SEER database. 

Poster Session (Abstract 8554)

Qian Wang, MD, Mount Sinai West and Mount Sinai Morningside

Our findings demonstrate that the presence of high-risk clinical and pathologic features do not impact overall survival benefit of radical surgery in epithelioid malignant pleural mesothelioma, however, they should be considered when deciding on radical surgery in sarcomatoid and biphasic histologies. Poor prognostic histology especially sarcomatoid subtype may experience improved survival with radical surgery if in conjunction with other treatment modalities.

 

Forecasting Asparaginase Quantity Required to Treat Pediatric ALL in LMICs Using ACCESS FORxECAST

Poster Session (Abstract 10031)

Terence M Hughes, BA, Icahn School of Medicine at Mount Sinai

We adapted FORxECAST, a publicly available tool that forecasts pediatric cancer drug quantity and cost, to be asparaginase -specific and estimated demand in low and middle income countries for a range of scenarios, including for second line Erwinase; accounting for hypersensitivity is particularly important because discontinuation typically results in lower cure rates. We also estimated how quantity of asparaginase required would increase with treatment intensity. These results provide the first quantification of asparaginase need for pediatric acute lymphoblastic leukemia in low and middle income countries, creating a demand estimate that can inform private and public efforts to produce a reliable supply of high quality asparaginase for all children with acute lymphoblastic leukemia.

 

Evaluating the role of aromatase inhibitors (AIs) in the treatment of endometrial stromal sarcomas (ESS).

Poster Session (Abstract 5575)

Fionnuala Crowley, MD, Mount Sinai Morningside and Mount Sinai West

Conclusions: This study represents the largest study of aromatase inhibitors use in endometrial stromal sarcomas to date. We found the overall response rate to be more modest than previously reported. The majority of pts had prolonged stable disease with a disease control rate of 58% even in stage 4 disease. Pts who progress on one aromatase inhibitors may benefit from trial of a 2nd aromatase inhibitors. A phase 2 study of interruption versus maintenance aromatase inhibitors in locally advanced/metastatic endometrial stromal sarcomas is currently underway (NCT03624244).

 

Incidence of hepatitis associated with addition of immune checkpoint blockade to conventional solid tumor therapy: A meta-analysis of phase 3 randomized clinical trials

Poster Session (Abstract 2645)

Yu Fujiwara, MD, Mount Sinai Beth Israel

Addition of immune checkpoint blockade to conventional solid tumor therapy was associated with increased incidence of any-grade and severe hepatitis, and elevations of aspartate aminotransferase and alanine aminotransferase, regardless of the mechanism of immune checkpoint blockade. Clinicians should weigh the risk of liver toxicity when considering addition of immune checkpoint blockade therapy in patients with solid tumors.

 

Nivolumab/Ipilimumab Primed Immunotransplant in post-CAR-T and post-ASCT DLBCL

Poster Session (Abstract 2593)

Bailey Gleason Fitzgerald, MD, Department of Hematology and Medical Oncology

Conclusion: Nivolumab/Ipilimumab primed immunotransplant is well tolerated in patients with refractory diffuse large b cell lymphoma (DLBCL) for which there are few treatment options. Preliminary results demonstrate remissions in heavily pre-treated patients, including prior after chimeric antigen receptor T cell therapy (CAR-T) or autologous stem cell transplant. Pre-clinical models in melanoma, non-small cell lung cancer, and T cell lymphoma all demonstrate synergy when dual checkpoint blockade is administered with lymphodepletion and autologous T cell transfer. These data support further investigation of dual checkpoint blockade -primed immunotransplant.

 

Prognostic Disclosure: A Scoping Review on Communication Guidelines and their Application in Oncology

(Abstract e24107)

Julie R Bloom

Conclusions: Communicating prognosis is a core competency skill in cancer care, yet remains underprioritized in training and practice. This review highlights available models and acknowledges areas in need of assessment including how to maintain learned communication skills for lifelong practice. 

 

Tolerance of Aromatase Inhibitors in Post-Menopausal Patients with Early-Stage Hormone Receptor Positive (HR+) Breast Cancer: A Real-World Retrospective Analysis in a Large Oncotype Database.

(Abstract e12532)

Shana Berwick, MD

Conclusions: This study enforces previous findings that a significant proportion of women require a change in their adjuvant ET, most commonly due to adverse medication effects such as joint pain. The majority of the women in this database were initiated on anastrozole as initial adjuvant ET of whom 24% required a drug switch. 

 

Trends in use of ovarian suppression (OS) for premenopausal patients with early-stage hormone positive breast cancer and Intermediate Risk (IR) Oncotype Recurrence Scores (RS) from 2006-2020: A retrospective database analysis. 

(Abstract e12522)

Sara Malin Hovstadius, BS

Conclusions: There has been a significant increase in the use of OS with ET in premenopausal women with IR RS in our study population. This study shows how the results of the SOFT-TEXT trial have been adapted into current practice. Future studies are needed to evaluate real-world recurrence rates with the use of increased OS and whether chemotherapy rates have decreased over time.

 

Application of RSClin to guide treatment recommendations for premenopausal patients with early-stage hormone-positive breast cancer and intermediate risk oncotype recurrence scores. 

(Abstract e12511)

Brittney Shulman Zimmerman, MD

Conclusions: The RSClin model would have changed management of premenopausal patients with IR RS in 23% of patients. This model, although not yet prospectively validated, may help individualize therapy for patients with less definitive treatment plans. Using RSClin, we can aim to minimize recurrence rates and avoid unnecessary chemotherapy in selected patients. This model is easy to apply and will have important clinical utility moving forward.

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