Vivek Subbiah: ASCO24 Highlights from the JAMA Network
The 2024 American Society of Clinical Oncology (ASCO) Annual Meeting was held from May 31st to June 4th 2024.
Vivek Subbiah, Chief of Early-Phase Drug Development at the Sarah Cannon Research Institute, shared the ASCO24 Highlights from the JAMA Network on X.
Read the article below:
“Nora Disis, MD, editor in chief of JAMA Oncology and a JAMA deputy editor, recently discussed important new studies from the JAMA Network that were presented at the American Society of Clinical Oncology’s annual meeting, ASCO 2024, which took place in Chicago this June.
Monica Morrow, MD, chief of breast surgery at Memorial Sloan Kettering in New York City and an associate editor at JAMA Oncology, and Vivek Subbiah, MD, chief of early-phase drug development at the Sarah Cannon Research Institute and web editor at JAMA, joined Disis to discuss new research on colorectal cancer screening, an antibody therapy for non–small cell lung cancer, access to oncology clinical trials, and a new model of palliative care for patients with cancer.
The following interview has been edited for clarity and length.
Dr Disis: The first paper that we’re going to be discussing is Lowering Fecal Immunochemical Test Positivity Threshold vs Multitarget Stool RNA Testing for Colorectal Cancer Screening, published in JAMA during the meeting. Vivek, could you tell us a little bit about the study?
Dr Subbiah: This study compared the sensitivity and specificity of a multitarget stool RNA, or mt-sRNA, test with a fecal immunohistochemical test for colorectal cancer screening. The multitarget sRNA test showed increased sensitivity for detecting colorectal cancer compared to the fecal immunohistochemical test alone but had a substantial loss of specificity.
The results here showed that lowering the fecal immunochemical test positivity threshold achieved similar sensitivities and specificities as a multitarget stool RNA test. So the findings suggest that comparable screening outcomes can be achieved without the need for additional stool RNA testing.
Dr Disis: What do you think the impact of these 2 tests on screening for colorectal cancer is compared to colonoscopy?
Dr Subbiah: Bottom line is we have to simplify screening protocols. If lowering the fecal immunochemical test positivity threshold can achieve similar levels of sensitivity and specificity as the multitarget stool RNA test, it could definitely simplify screening protocols by eliminating the need for additional stool testing. And if it is a really good test it can eliminate even colonoscopy screening. And this could streamline the screening process and make it even more cost-effective.
Dr Disis: So how far away is this from impacting clinical practice, Vivek?
Dr Subbiah: Lowering the fecal immunohistochemical tests positivity threshold may make colorectal cancer screening more accessible to a larger population. And the fecal immunohistochemical test is a widely available and relatively inexpensive test, making it more accessible in various clinical settings and regions.
And importantly, simplifying the screening process and reducing the number of invasive tests required may improve patient adherence to colorectal cancer screening. If patients perceive the screening process as less burdensome, less invasive, and less time-consuming, they may [be] more likely to participate in regular screening.
However, it’s important to note that further research and validation of such noninvasive screening studies are needed to confirm these findings to make sure that this is generalizable to different populations in different regions of the world. But if confirmed, these results could have significant implications for optimizing colorectal cancer screening programs.
Dr Disis: Great. Our next study is the randomized phase 3 study Ivonescimab Plus Chemotherapy in Non–Small Cell Lung Cancer With EGFR Variant, published in JAMA. Monica, can you tell us about this study?
Dr Morrow: As you said, this is a double-blind placebo-controlled trial, which included patients who had stage IIIB, IIIC, or IV non–small cell lung cancer with EGFR variants who had progressed on an EGFR tyrosine kinase inhibitor [TKI].
The randomization was to chemotherapy alone with pemetrexed and carboplatin or to the same chemotherapy plus ivonescimab, the study drug, which is an antibody targeting PD-L1 [programmed cell death ligand 1 protein] and VEGF [vascular endothelial growth factor].
At a median follow-up of 7.9 months, the median progression-free survival [PFS] was increased by the study drug from 4.8 months to 7.1 months—a net gain of 2.3 months. In terms of secondary end points, there was a 15.6% increase in overall response rate and the median duration of response was increased from 4.2 to 6.6 months.
Overall survival data at this point in time are immature and not reported. So overall, there was a modest but statistically significant increase in progression-free survival that was seen across patients in this study.
Dr Disis: Vivek, you do a lot of phase 1 studies. What do you think of these types of results in a TKI-treated patient population?
Dr Subbiah: This is a fascinating study. The standard of care right now for EGFR mutant non–small cell lung cancer is a third-generation TKI. But when patients still develop progression, they are left with few options, depending upon the mechanism of resistance. It’s a heterogeneous group and interestingly this antibody has shown signals of activity across all these groups.
Dr Disis: Monica, how do you think this study could impact clinical practice? This is a very active area, and we have so many drugs being tested in this patient population. How do we come to a consensus of what the next line of treatment would be after initial frontline therapy?
Dr Morrow: I think this addresses the specific subset of progression here, and it makes the point that with conventional chemotherapy, outcomes are not very good. The control group’s median PFS was only 4.8 months.
There are a number of other phase 3 trials going on looking at this drug both as monotherapy and combination therapy in non–small cell lung cancer, which may help refine the patient population likely to achieve the greatest benefit. But I think at this point, we can say it is a treatment at progression that can be applied fairly widely across this patient population with a modest but real benefit in PFS.
Dr Subbiah: I completely agree. Again, this analysis is very, very intriguing and hopefully this can be applied for a broad group of patients globally. However, the sample size is small, so we need to really interpret this with caution. We eagerly look forward to the overall survival analysis and all the subset analyses from future studies.
Dr Disis: It certainly could seem less toxic. Our next paper is Geographic Distribution of Clinical Trials for Advanced-Stage Cancer. This was published in JAMA Oncology at the time of the meeting. Vivek, can you tell us about it?
Dr Subbiah: As we know, clinical trials play a crucial role in advancing cancer research and treatment. The NCCN [National Comprehensive Cancer Network] guidelines state the best management of any patient with cancer is in a clinical trial.
So this study aimed to assess the geographical distribution of clinical trials for advanced-stage patients with cancer in the United States. The researchers analyzed data from the ClinicalTrials.gov database to identify interventional clinical trials that were actively recruiting patients with metastatic breast, colon, lung, pancreatic, and prostate cancers.
Then they used the [Maptitude] geographic information system software to calculate the population living within 30, 60, and 120 miles of a clinical trial site.
The results showed that the current clinical trial infrastructure provides access for most US residents diagnosed with common advanced-stage cancers. The majority of the US population lives within 30 miles of a clinical trial site, which is considered a reasonable distance for patients to travel for treatment and clinical trial participation.
The study also highlights uneven distribution of clinical trials across the country and potential barriers faced by certain racial and ethnic minority groups in accessing the clinical trials. So this raises important questions about equity, fairness in the distribution of health care resources, and opportunities for treatment.
Often it is cited that patients don’t have access to clinical trials, but it’s interesting and intriguing that this data analysis shows that the majority of the US population lives at least 30 miles within a clinical trial site
Dr Disis: Vivek, since this is what you do, how do we get these patients into clinical trials?
Dr Subbiah: We need to increase awareness and education about the availability of trials. Clinicians, especially community oncologists, can play a crucial role in informing their patients about ongoing trials and potential benefits of participation. Efforts should be made to ensure that patients, particularly those from racial and ethnic minority groups, are aware of the opportunities for treatment and research participation.
This study highlights disparities in access to clinical trials, particularly among American Indian and Alaska Native patients, and health care providers, especially oncologists and policymakers, should work toward addressing these disparities so that we can ensure equitable access to clinical trials for all patient populations regardless of their location or racial and ethnic background.
Efforts should be made to establish more trial sites in areas that are currently underserved, such as the rural regions that we call clinical trial deserts, especially those with a higher concentration of a minority population. This could help improve access to clinical trials for patients who face geographic barriers. Clinical trials should also aim for diversity in patient participation and patient recruitment to ensure that findings are applicable to a broader population.
And efforts should be also made to increase representation of diverse ethnic minority groups, which may require targeted outreach and culturally sensitive recruitment strategies addressing barriers specific to these populations. Many times something as simple as having an informed consent document also translated in Spanish makes a huge difference in areas such as Florida. Simple things can make a huge difference in terms of the type of patients enrolled in clinical trials in specific geographic regions.
Dr Disis: I’ll discuss the last paper for today, Stepped Palliative Care for Patients With Advanced Lung Cancer, a randomized clinical trial that was published in JAMA at the time of the meeting. We all know that palliative care is a really urgent unmet need in oncology. It’s recommended that we start patients earlier, that people should participate more frequently in palliative care, but we really have a lack of palliative care practitioners, so people aren’t participating in palliative care as much as they should.
This study attempts to address trying to provide palliative care in an era where we have fewer palliative care practitioners.
The study randomized 507 patients with advanced–stage lung cancer to either early palliative care, where the patients got palliative care visits every 4 weeks after enrollment, or stepped palliative care, where the patients got 1 palliative care visit within 4 weeks of enrollment, but then only got another palliative care visit when there was a change of treatment or a hospitalization.
But what they did get was a questionnaire about their quality of life every 6 weeks, and if there was a drop by 10 points or more in their quality of life, they flipped over to the regular palliative care visits every 4 weeks.
What was the result of this stepped palliative care? The stepped group of course had less palliative care visits, but they were noninferior to the regular palliative care in terms of quality of life and communication about palliative care, and they also spent less days in hospice.
So at the end of the day, the stepped palliative care turned out to be a rational approach in an era when we have less palliative care practitioners. It was very effective in delivering palliative care with less resources.
Dr Subbiah: I think it’s an interesting analysis. What do you think could potentially have an impact on patient-centered care with this stepped palliative care?
Dr Disis: I think that there definitely could be impact on clinical practice in terms of trying to provide better resource allocation, really as a model across all areas where we’re suffering from lack of providers. Clearly, this is a model that could be easily implemented.
The FACT-L [Functional Assessment of Cancer Therapy–Lung Quality of Life] tool that they use is a well-validated tool and easy to implement in the clinic. And this is something that could be done in any clinical practice that has palliative care providers.
So this is a modality that could be implemented today as a model for stepped palliative care in a place where there weren’t enough palliative care providers to go around. So this is something that could impact clinical practice today.
Dr Subbiah: Absolutely, and especially if they can incorporate some of these questionnaires, use technology directly where patients are so that they can sleep in their own bed, and provide telehealth and telepalliative care—I think that would add another layer of support for these patients.”
Read the article here.
For more information about ASCO24, visit oncodaily.com