ASCO 2020 Press Releases
ASCO 2020 Press Releases
Phase III Trial Shows Avelumab an Immunotherapy Treatment for Advanced Urothelial Cancer Prolongs Overall Survival
Immunotherapy Following Chemotherapy Offers Extended Survival to Patients with Advanced Urothelial Cancer
ASCO Perspective: “In patients with advanced urothelial cancer, recurrence frequently happens following initial treatment with chemotherapy. This study shows the largest survival benefit seen to date in advanced urothelial cancer. When used as a maintenance therapy, avelumab significantly extended the period of time until recurrence,” said ASCO President Howard A. Burris III, MD, FACP, FASCO.
San Francisco, California (UroToday.com) — Treatment with avelumab combined with best supportive care following chemotherapy significantly extended overall survival compared with best supportive care alone in patients with advanced urothelial cancer in the JAVELIN Bladder 100 trial. The results of this study will be presented as part of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.
Study at a Glance
Focus: Avelumab as maintenance therapy in patients with unresectable locally advanced or metastatic urothelial cancer
Population: 700 patients with disease that had responded to chemotherapy
Findings: Avelumab improved overall survival by 7.1 months over best supportive care
Significance: Supports the use of avelumab as a maintenance treatment following initial chemotherapy
The study results represent the largest survival benefit seen to-date in advanced urothelial cancer in the maintenance setting. Bladder cancer is a top-10 cause of cancer deaths in the United States. While avelumab has already been shown to be effective in metastatic disease, this study reports the first data demonstrating efficacy of front-line treatment in the period following initial chemotherapy.
“The maintenance setting is an attractive time for using a checkpoint inhibitor. Patients have gone through chemotherapy and the disease is under control,” said lead author Thomas Powles, MD, a professor of genitourinary oncology and Director of Barts Cancer Centre in London. “But instead of waiting for disease to progress after chemotherapy — which it will quickly do in patients with advanced urothelial cancer — adding avelumab significantly improves survival.”
When combined with best supportive care, avelumab treatment resulted in a median overall survival of 21.4 months compared with 14.3 months for best supportive care alone.
The researchers also examined response in the group of patients with tumors that were positive for programmed death-ligand 1 (PD-L1). Avelumab plus best supportive care significantly prolonged overall survival in this group of patients, with median overall survival not yet established. Median overall survival was 17.1 months for patients who received best supportive care alone.
In addition, in all patients and in those with PD-L1+ tumors, progression-free survival was better with avelumab and best supportive care vs best supportive care alone.
Adverse events of grade 3 or higher occurred in 47.4% of patients who received avelumab plus best supportive care vs 25.2% in those who received best supportive care alone. The most common grade 3 or higher adverse events were urinary tract infection, anemia, hematuria, fatigue, and back pain.
About the Study
Patients included in this randomized, phase III trial had unresectable locally advanced or metastatic urothelial carcinoma, with no disease progression following chemotherapy (which was either gemcitabine with either cisplatin or carboplatin). The trial included 700 patients, 350 were randomized to receive maintenance avelumab along with best supportive care, and 350 to best supportive care alone. Patients were followed for a median of more than 19 months. Just over half (51%) had tumors that were positive for PD-L1.
Avelumab is a checkpoint inhibitor immunotherapy that works by blocking a protein on the surface of cancer cells, in this case PD-L1. This protein helps cancer cells evade the body’s immune system, and when avelumab blocks it, the immune system can better identify and target the cancer cells.
“In urothelial cancer, patients have high PD-L1 expression and high tumor mutational burden. Response rates associated with immune therapy are pretty high,” said Dr. Powles. “This means that checkpoint inhibitors can work quite well in urothelial cancer.”
Next Steps
Patients in the control group have been allowed to crossover to the avelumab group. The researchers plan to follow patients to see how long response is maintained.
Source: ASCO. “Immunotherapy Following Chemotherapy Offers Extended Survival to Patients with Advanced Urothelial Cancer,” May 28, 2020.
Related Content:
View all ASCO 2020 Virtual Scientific Program Coverage
Darolutamide Plus Androgen Deprivation Therapy Showed Significant Improvement in Overall Survival with Proven Efficacy and Tolerability in Men with Non-Metastatic Castration-Resistant Prostate Cancer
- NUBEQA reduced the risk of death by 31 percent (HR=0.69, 95% CI 0.53-0.88; p=0.003) compared to placebo in its secondary endpoint of overall survival in men with non-metastatic castration-resistant prostate cancer (nmCRPC)1
- Updated results on secondary endpoints also show that NUBEQA delayed the time to pain progression, time to first initiation of treatment with cytotoxic chemotherapy, and time to first symptomatic skeletal event (SSE)1
- Any grade treatment-emergent adverse events at final analysis were generally consistent with the primary analysis of the Phase III ARAMIS trial1,2
- These data will be presented at the American Society of Clinical Oncology (ASCO) 2020 Virtual Scientific Program on Friday, May 29, and will be available on the ASCO website
Early Data Show Cancer Progression Associated With Increased Risk of Death in Patients With COVID-19
ASCO Perspective:“The cancer care community urgently needs data on the effects of COVID-19, specifically in patients with cancer. How we improve the care we provide these patients and reduce the number of deaths and severe consequences associated with this disease are among the top questions. The COVID-19 and Cancer Consortium registry is a great example of the community quickly coming together to identify and collect the data we need on a large scale,” said ASCO President Howard A. Burris III, MD, FACP, FASCO.
Integrating Geriatric Assessment and Management Into Cancer Care Improves Quality of Life, Reduces Hospital Admissions for Older Patients
San Francisco, California (UroToday.com) — Older people with cancer set to receive anti-cancer therapy had significant improvements in quality of life when comprehensive geriatric assessment and geriatrician-led management was integrated into their care plan. The prospective, randomized, open-label INTEGERATE trial, according to the study authors, is the first randomized clinical trial in geriatric oncology to show that an integrated approach involving geriatricians and oncologists working in partnership helped improve quality of life, and reduced hospital admissions and early discontinuation of treatment due to adverse events.
Foundation Medicine and Collaborators to Share New Data During the ASCO20 Virtual Scientific Program Showcasing the Importance of Comprehensive Genomic Profiling (CGP) in Informing Advanced Cancer Clinical Decision-Making
Videoconference Intervention Significantly Reduces Anxiety and Distress Among Remote Caregivers of People With Cancer
San Francisco, California (UroToday.com) — A videoconferencing intervention significantly reduced levels of anxiety and distress among “distance caregivers" who live more than an hour away from the patients with cancer they support, according to the results of a federally funded study.
Study at a Glance:
These findings have particular relevance during the COVID-19 pandemic as social distancing practices have increased the number of caregivers providing remote support for their loved ones with cancer. The study will be featured in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting.
Key Findings: Distance caregivers report higher levels of distress and anxiety than caregivers who live nearby, which can negatively affect their employment, quality of life, and overall physical health. This distress and anxiety are often caused by uncertainty regarding the patient’s condition or a lack of first-hand information from clinical visits.
Approximately 20% of caregivers live more than 1 hour away from patients with cancer,i,ii and nearly a third of distance caregivers are the sole caregiver for their loved ones.iii,iv
Despite the unique challenges facing distance caregivers, no interventions have been developed specifically for this group until now.
To address these challenges, researchers developed a three-part intervention to support distance caregivers, comprised of monthly videoconference coaching sessions with a nurse practitioner or social worker, focused on providing information and support; videoconference participation in patient-oncologist visits; and access to a website with resources designed specifically for distance caregivers. Of the distance caregivers who received the full intervention (those in arm 1), 19.2% experienced significantly reduced anxiety and 24.8% reported reduced distress. In Arm 2, 17.3% had improvements in anxiety scores and 19.8% had improvements in distress scores.
“Distance caregivers experience a tremendous amount of anxiety and distress – often greater than people with cancer themselves,” said Sara L. Douglas, Ph.D., RN, lead author of the study, the Gertrude Perkins Oliva Professor in Oncology Nursing and Assistant Dean for Research at the Case Western Reserve University School of Nursing. “With COVID-19, the challenges that distance caregivers face are now the same challenges facing many local caregivers who can’t attend their loved ones’ appointments. Our video conferencing intervention shows that it’s possible to meaningfully reduce anxiety and distress for distance caregivers through fairly simple technology.”About the Study: The randomized controlled trial was conducted at a large urban comprehensive cancer center, though distance caregivers in the study lived in a variety of settings. Participants were randomized to receive one of three interventions. Participants in arm 1 received 4 monthly videoconference coaching sessions with a nurse practitioner or social worker, focused on providing information and support; were able to participate in patient-oncologist visits via videoconference; and had access to a website with information specifically designed for distance caregivers. Arm 2 participated in virtual patient-oncologist visits and had access to the same website. Arm 3 had access to the website only.
A total of 441 patient-caregiver groups were enrolled. The average age of distance caregivers was 47 years; 71% were female, and 63% of caregivers were children of the patient. The average age of patients was 65 years; 60% were female, and 30% and 18% had gastrointestinal and hematologic cancers respectively. Of patients with solid tumors, 59% had stage-IV disease.
The researchers assessed changes in levels of distress and anxiety before and after the interventions using a questionnaire completed before randomization and at the end of the 4-month intervention.
Though providing online coaching sessions with advanced practice nurses or social workers may not be feasible for all cancer centers due to cost and resource limitations, the authors note that videoconferencing distance caregivers into patient appointments and providing web resources designed specifically for distance caregivers will still yield some improvement in distress and anxiety levels.
Next Steps: The researchers plan to test this intervention in other caregiver populations (e.g. patients with Alzheimer's disease). They also plan to work with healthcare providers to offer video conference technology to cancer patients with a distance caregiver.
Source: ASCO. “Videoconference Intervention Significantly Reduces Anxiety and Distress Among Remote Caregivers of People With Cancer,” May 8, 2020.
Related Content:
View all ASCO 2020 Virtual Scientific Program Coverage
Results from COSMIC-021 Trial Announced: Cabozanitinib in Combination with Atezolizumab with Multiple Advanced Solid Tumor Types
Greater Decline in Cancer-Related Deaths Seen in Medicaid Expansion States in First Nationwide Study
“This study provides needed data to understand the effects of Medicaid expansion on cancer care. Better access to quality cancer care, in this case through state expansion of Medicaid, leads to fewer cancer deaths,” said ASCO Chief Medical Officer and Executive Vice President Richard L. Schilsky, MD, FACP, FSCT, FASCO.