So essentially, ASCO, as well as, the Friends of Cancer Research, were concerned that certain characteristics of trials would be underrepresented in studies because of overly restrictive eligibility criteria. So at City of Hope, what we did is we took a handful of phase 1 through 3 trials in patients with urothelial cancer. And we took trials that ranged from June, 2012 to June, 2022, so a 10 year time span. And what we did is we looked at the kinds of patients that were involved. So what we found is, patients with HIV, with hepatitis, with brain metastases or concurrent malignancies, they were oftentimes excluded from the study completely.
So for example, patients with HIV who were going to be undergoing immunotherapy or combination therapy we're entirely excluded from this study. And most people who were undergoing, I believe it's chemotherapy, they were, mostly excluded or they weren't even reported at all. So essentially what our conclusion is that eligibility criteria in studies like this should be expanded because in the real world, you're going to have patients who need a medication or who need a certain treatment, but they won't have been tested on. So you don't if the medication is gonna work on them. And in the real world, you're going to have patients with urothelial cancer who also have HIV or who also have brain metastases. And mainly the reason why they're excluded is because of safety and efficacy concerns like drug interactions, or because of a weakened immune system. But with modern technology, we can get past a lot of those barriers, and if we really don't think it's safe, then we can exclude them. But we wanna try to include as many people as we can.
I've gotten questions relating to if we're doing anything right now to overcome these barriers, and essentially what I tell them is I myself am not entirely sure, but I'd assume that because we were still looking at trials from 2022, which is relatively recent, and a lot of people were still being excluded. It's more of a goal that we're trying to work towards, not something that's, we snap our fingers and we're including everyone. But it's something that for the future we're trying to implement and we're trying to include more people as a whole. What exclusion criteria and conditional inclusion means. And so exclusion is kind of what it sounds like, you're completely not even taking into account these patients. You're excluding them completely from the trial. But conditional inclusion is you look at a patient, they have a brain metastas, to see they have brain metastases, but maybe it was treated 5 years ago or it was surgically removed so they can be included in the study. So conditional inclusion is essentially, they have certain characteristics that make them eligible for the study.
In my opinion, I think we should, take baby steps, it's obviously not going to be very easy to just start including people entirely, but I think in the next studies that we do, especially in or in the study that I'm doing urothelial cancer, we can maybe take a look at these patients and see if we can conditionally include more people, especially people with HIV, because they were entirely excluded for the most part. So maybe we can take a look at, their diagnosis and see, maybe they're on a drug that we're concerned about, but we can take a look at that and use modern technology and we get around that or we can just, figure out any other way to get around any problems that we're experiencing. I think it's just a matter of taking small steps to achieve a more balanced a more balanced sample, because that's what happens in the real world.
I just wanna say it was a pleasure working with City of Hope. I had a really wonderful time and I thank them for the opportunity.
The poster "Evaluation of eligibility criteria in contemporary renal cell carcinoma trials based on ASCO-FCR recommendations" examines the eligibility criteria used in research studies for renal cell carcinoma (RCC) and evaluates their alignment with the American Society of Clinical Oncology and Friends of Cancer Research (ASCO-FCR) recommendations.
The poster found that while the majority of the analyzed clinical trials adhered to the ASCO-FCR recommendations regarding inclusion criteria, there were still some areas where improvement could be made. Specifically, the authors found that some research studies had overly restrictive eligibility criteria that may limit patient enrollment and generalizability of the trial results.
The poster suggests that greater attention should be paid to aligning clinical trial eligibility criteria with ASCO-FCR recommendations, which could lead to improved patient enrollment, greater generalizability of clinical trial results, and ultimately, better treatment options for patients with RCC.
Renal cell carcinoma (RCC) is a type of kidney cancer that develops in the cells of the lining of small tubes in the kidney called tubules. It is the most common type of kidney cancer in adults, accounting for about 90% of all cases.
There are several different subtypes of RCC, including clear cell, papillary, chromophobe, and others. Clear cell RCC is the most common subtype, accounting for about 70% of all cases.
As for clinical trials in 2023, it is difficult to predict exactly where research will be focused and how to improve the standard of care, as clinical trials are constantly evolving and new studies are being initiated all the time. However, there are several areas of ongoing research and development for RCC treatments, including:
Immunotherapy: Immunotherapy drugs work by stimulating the immune system to attack cancer cells. Several immunotherapy drugs have been approved for the treatment of RCC, including checkpoint inhibitors such as nivolumab and ipilimumab.
Targeted therapy: Targeted therapy drugs work by targeting specific proteins or pathways that are involved in the growth and spread of cancer cells. Several targeted therapy drugs have been approved for the treatment of RCC, including tyrosine kinase inhibitors such as sunitinib and pazopanib.
Combination therapies: Researchers are studying combinations of different drugs to see if they can improve outcomes for patients with RCC. For example, some clinical trials are testing combinations of immunotherapy and targeted therapy drugs.
Biomarkers: Researchers are investigating biomarkers that can help identify patients who are most likely to benefit from certain treatments. For example, some trials are looking at biomarkers that may predict response to immunotherapy drugs.
Overall, the goal of clinical trials in RCC is to improve outcomes for patients by developing more effective and personalized treatments. It is important for patients with RCC to discuss their treatment options with their healthcare provider and to consider participating in clinical trials if they are eligible.
Anna Odell - About The Author, Credentials, and Affiliations
Anna Odell has greatly benefited from Dr. Pal's guidance and support in the City of Hope - Friends of Cancer Research program. Dr. Pal has helped Anna develop a strong foundation in medical oncology by providing her with opportunities to participate in cutting-edge research and clinical trials. Under Dr. Pal's mentorship, Anna has been able to develop her future skills as a physician or researcher, paving the way for a successful career in the field.
Dr. Monty Pal is a highly regarded physician and researcher who has made substantial contributions to the field of medical oncology. Dr. Pal has also distinguished himself as an exceptional mentor who has guided and inspired other young researchers and doctors, including Anna Odell.
Dr. Pal is renowned for his dedication to encouraging the professional growth and development of his mentees by providing them with the necessary tools and assistance. Dr. Pal has inspired many aspiring oncologists to make their own contributions to the field by assisting them in the development of their skills and expertise.
Overall, Dr. Pal's dedication to mentoring has helped mold the next generation of oncologists, and his influence on the field will be seen for decades to come.