In this issue of the FSP’s newsletter, I am thrilled to share exciting updates and successes from FSP’s recent events and continued efforts to strengthen our voice and presence in Florida.
This past summer, FSP was proud to participate in the Florida Medical Association (FMA) House of Delegates meeting in Orlando, Florida, where we represented our society’s interests alongside other medical specialties. The FSP had 4 seats to the delegation and delegates in attendance included me, Carmen Gomez-Fernandez, MD, Jesse Kresak, MD and Vatsal Patel, MD. In addition to our assigned delegates, we had other FSP leadership and members in attendance at the meeting including Rebecca Johnson, MD and Ronald Giffler, MD. Participating in this annual event provides FSP a platform to advocate for pathology-related issues and forge new partnerships. This year, the FSP was proud to support the FMA’s PAC with a donation personally delivered by our delegates in attendance. FSP is committed to collaborating with our physician colleagues across the state to ensure pathology remains at the forefront of advancing healthcare policies in Florida.
We recently concluded the 4th Annual Precision Medicine Symposium, a partnership with the Florida Society of Clinical Oncology (FLASCO) that brought together pathologists, oncologists, and advanced level health care providers. For the first time ever, the event was held at the state-of-the-art Moffitt Cancer Center in Tampa, FL. With over 100 attendees in attendance and 18 gracious supporters, the event was a tremendous success, demonstrating the growing relevance of precision medicine in improving patient outcomes.
Attendees engaged in interactive discussions and case reviews, exploring the evolving importance of communication and collaboration amongst pathologists and oncologists in molecular diagnostics and personalized treatments. Our collaboration with FLASCO marks a pivotal moment in shaping the future of precision medicine, and we are already looking forward to next year’s event.
I’m delighted to announce that the FSP membership is stronger than ever as shown through our recent dues outreach demonstrating that our membership numbers continue to grow. This growth reflects the value of our society to Florida pathologists and the incredible benefits we provide. Even more impressive is our member retention rate, which is now at an outstanding 96%! This speaks volumes about the sense of community, education, and professional development that FSP fosters for its members.
As we continue to advocate for pathologists and our members, we need your help to ensure our voice is heard in the legislative arena. The FSP Pathology PAC is essential for advancing policies that protect our profession and to promote high standards of patient care. Your donations are critical in supporting these efforts, allowing us to engage with key lawmakers and influence legislation that impacts our daily practice. Please consider donating to the FSP Pathology PAC and investing in the future of our specialty. You can donate online here.
Lastly, I am excited to announce that the FSP has been awarded an educational grant from AstraZeneca and Daiichi Sankyo to produce a groundbreaking Precision Medicine Academy for our members. The Precision Medicine Academy will provide a platform for continuous learning through lectures, workshops, and multidisciplinary tumor boards related to the integration of biomarker testing and molecular pathology. The FSP will launch a learning management center that will provide a repository of learning materials, research articles, case studies and more for our members. In addition to earn more CMES, in the future FSP will be offering visiting rotations that will provide hands-on training through in-person rotations at a local laboratory in Florida helping ensure that pathologists are proficient in utilizing the latest molecular tools for disease diagnosis, prognosis, and treatment selection. Travel scholarships will be awarded for these in-person rotations as well! Stay tuned for more information on this exciting initiative. If you are interested in being involved in the planning of this initiative, please reach out by emailing exec@flpath.org.
First Webinar: Cancer Diagnostics and Precision Medicine
The FSP hosted the first webinar of the Precision Medicine Academy on Cancer Diagnostics and Precision Medicine on Tuesday, November 26, 2024 at 12:00 pm ET. Led by Dr. Dahui Qin from Moffitt Cancer Center, the session explored cutting-edge advancements in molecular diagnostics and their impact on cancer care. We had over 100 people registered for the webinar and 60 people join us live! If you missed the live webinar, the on-demand recording will be available on the FSP website very soon. The second webinar of the series will take place in January and more information will be shared soon!
In closing, I would like to thank each one of you for your continued support and dedication to FSP and I would like to wish everyone a Happy Thanksgiving!
We have been fortunate to have enthusiastic pathologists in Florida meeting with their Legislators during this important cycle. Dr. Vatsel Pastel and Dr. Na’im Fanaian, for instance, had a very productive meeting with Senator Jason Brodeur in September to discuss issues of importance to pathologists. Senator Brodeur is currently the Vice-Chair of the Senate Health Care Committee and wields a great deal of influence when pathology issues come before his committee. They are out working, along with your FSP Board of Directors, all over the State to make certain your interests are protected.
"We had a really meaningful conversation about Pathology, Pathologists, and the goals of FSP. Senator Brodeur was really open to hearing about issues that affect us and how he can help. I had never done anything like this before, but this experience has motivated me to get more involved with advocacy. If we can do this all across Florida, we can achieve big results on the state level." - Vatsal Patel
FSP PAC co-chair Dr. Khaled Algashaamy and his new bride, Briana Freeman, joined me in honoring Senator Gayle Harrell, Senate Health Care Appropriations Chair, at a fundraiser on October 15 in Jupiter, Florida. Dr. Algashaamy and I co-hosted the event!
Legislation will not be filed until after the November 5th elections, and we will update you on critical issues when the bills begin to surface. In the meantime, the crucial dates for the 2025 Legislative Session are below:
| Date | Event |
| Tuesday, November 19, 2024 | Organization Session |
| December 2-6, 2024 | Committee Week 1 (House Only) |
| December 9-13, 2024 | Committee Week 1 (Senate Only) |
| January-February, 2025 | Committee Weeks |
| January 13-17, 2025 | Committee Week 2 |
| January 21-24, 2025 | Committee Week 3 |
| by Sunday, February 2, 2025 | At least 30 days before the scheduled annual regular session, the Governor shall furnish each senator and representative with a copy of his recommended budget and revenues |
| February 3-7, 2025 | Committee Week 4 |
| February 10-14, 2025 | Committee Week 5 |
| February 17-21, 2025 | Committee Week 6 |
| Tuesday, March 4, 2025 | Regular Session Begins |
| Saturday, April 19, 2025 | All bills are immediately certified; Motion to reconsider made and considered the same day |
| Tuesday, April 22, 2025 | 50th Day rule (Senate) – last day for regularly scheduled committee meetings |
| Friday, May 2, 2025 | Regular Session Ends |
2024 Florida Election Summary
I am pleased to share a summary of 2024 Florida General Election results. The Florida 2024 Presidential Election was held Tuesday, November 5th. Florida officially eliminated its status as a swing state with Republican voter registration outpacing Democrats by over 1 million voters and Republicans winning down the ticket with double digit margins in most cases.
The Legislature will return to Tallahassee on November 19th for an Organizational Session to swear in all new members of the Legislative branch and to officially transition leadership of the chambers. Speaker- Designate Danny Perez (R-Miami) and President-Designate Ben Albritton (R-Bartow) will officially take the helm of their respective chambers and will officially name their leadership teams, committee chairs and committee assignments.
The Legislature will begin work right away with committee weeks scheduled in early December and throughout January and February of 2025. The regular legislative session is set to begin Tuesday, March 4th, 2025.
For further information or questions, please reach out to Amy at amylobby@ballardpartners.com.
The fight for proper reimbursement for hospital-based professional pathology services continues. Even with our victory and establishment of new law in the seminal case of Health Options, Inc. v. Palmetto Pathology Services, P.A. in 2008, insurance companies continue to try to get away with not paying for the professional component of pathology services. In recent years, we have seen commercial payors rely on a host of varying remark codes to deny and exclude claims for the professional component of clinical pathology. Notably, we have seen an uptick in remark codes/ denials such as: “The procedure code is inconsistent with the modifier used” and/or “The benefit for this service is included in the payment/allowance for another service/procedure that has already been adjudicated.” We are also seeing denials of professional anatomic services based on providers being out of network or other spurious reasons for nonpayment.
To ensure you and your group are being properly reimbursed for both CP and AP services, it is imperative that there be routine and careful monitoring of all claim adjudications and, specifically, claim denials and attendant remark codes. When faced with improper denials, appeals must be timely filed and documented. And, when appealing of claims itself is not being effective, consultation with counsel experienced in these matters is appropriate and likely the only way to recover.
If you have any questions, regarding the above, please feel free to contact Steven R. Weinstein (steven.weinstein@klgates.com), Patrick Montoya (psm@pathologylawyers.com), or Markus M. Kamberger (mmk@pathologylawyers.com).
The Florida Society of Pathologists’ number one priority is to protect our patients and our profession. We are committed to protecting to doing this through the efforts of the Pathology-PAC (FSP-PAC). The Pathology-PAC provides supportive candidates, political parties, and other political organizations with contributions to achieve our advocacy goals and ultimately protect our medical license. To be successful in legislative efforts, the FSP needs strong financial support from its members. Consider making a one-time donation or enrolling for an automatic monthly donation on the FSP website. Donate Online Now to the FSP-Pathology PAC!
The FSP would like to thank the following individuals for their contributions to the FSP Pathology PAC in 2024:
As We Look Ahead to 2025
As we approach the end of the year, it's clear that our organization is not just thriving but surpassing expectations in both success and innovation. We’ve had a fantastic 2024, and 2025 is shaping up to be even more remarkable.
Member Benefit: CE Broker Professional Accounts
In case you missed it, back in May, we re-introduced a valuable benefit for members—A FREE CE Broker professional account. CE Broker provides powerful tools for tracking continuing education, making it easier than ever to stay compliant and manage your professional development. This is just one of the many ways we're working to enhance the value of your membership.
Save the Date for Upcoming Events
Don’t miss the FSP's 51st Annual Pathology Conference, Updates and Practical Approaches in Pathology, happening February 14-16, 2025, at Disney's Grand Floridian Resort in Orlando, FL. This premier event promises cutting-edge educational sessions, networking opportunities, and engaging discussions Also, mark your calendar for the Summer Pathology Conference on July 11-13, 2025, at the JW Marriott Turnberry Resort & Spa in Miami, FL. Both conferences are great opportunities to learn, connect, and grow.
Thank You for Your Support
I’d like to express my sincere gratitude to each and every member of the Florida Society of Pathologists for your dedication and contributions to our mission. Your commitment fuels our success, and I’m honored to serve as your Membership Chair.
FSP 2024 Summer Conference Recap
The FSP held the 2024 Summer Pathology Conference from July 12-14, 2024 at the Eau Palm Beach Resort & Spa. There were 130 attendees and 30 exhibitors at the meeting. The FSP 2024 Summer Pathology Conference provided education surrounding a wide range of topics. Topics included:
This two-and-a-half-day agenda was jam packed with recent scientific findings, opportunities to learn new strategies and tools to aid in the diagnosis and analysis of disease.
FSP + FLASCO Meeting Recap
The FSP, in collaboration with FLASCO, hosted the 4th annual Florida Society of Pathologists (FSP) + Florida Society of Clinical Oncology (FLASCO) collaborative meeting on September 13-14, 2024, in Tampa, Florida at the Moffitt Cancer Center. This innovative and interactive symposium brought together 115 pathologists and oncologists and 18 exhibitors to discuss the recent advancements in utilizing precision medicine for the diagnosis and treatment of cancer. Please scroll to the Resident & Fellows Update for an in-depth recap of this meeting from FSP's Residents and Fellows!
FSP 2025 Annual Meeting
Make plans to attend the FSP's 51st Annual Pathology Conference Updates and Practical Approaches in Pathology taking place February 14-16, 2025, at Disney's Grand Floridian Resort in Orlando, FL. Topics will include Soft Tissue Pathology, Cytopathology and GU Pathology. Mayo Clinic will be hosting the Educational Symposium this year. Keynote Faculty will include:
Jason L. Hornick, MD, PhD
Professor of Pathology, Harvard Medical School
Director of Surgical Pathology and Immunohistochemistry
Chief, Soft Tissue and Bone Pathology
Brigham & Women's Hospital
Boston, MA
Ritu Nayar, MD
Professor of Pathology and Medical Education
Executive Vice Chair, Department of Pathology.
Northwestern University, Feinberg School of Medicine.
Chicago, IL
Ming Zhou, MD, PhD
Professor/Vice Chair/Director, Urological Pathology and Fellowship
Icahn School of Medicine at Mount Sinai
New York, NY
We will be holding the 4th annual Rare & Interesting Case Conference at the annual meeting. Residents and fellows are all encouraged to submit their rare and interesting cases for a chance to present at the FSP 2025 Annual Meeting. Please submit your case here by November 24!
Poster Competition
The FSP will once again host the Poster Competition at the Annual Meeting. Posters can now be submitted online on the FSP website here. All pathologists are invited to submit case-based posters or research-based posters for inclusion in the Poster Hall. Residents and fellows in Florida are eligible to compete in the FSP Poster Competition for prizes. The top 48 eligible posters scored during prejudging will be accepted for the Poster Competition. Posters accepted during prescreening but not selected for the Poster Competition will still be displayed in the Poster Hall but are not eligible for oral presentation and prizes. The deadline to submit your poster is January 6, 2025.
Register Now to Receive Early Bird Rate Before December 15!
Register now for the FSP Annual Pathology Conference before the early bird deadline ends on December 15 and save $50! Register here
The residents and fellows who attended the FSP + FLASCO meeting wish to relay with you some key points from each session. The symposium began with a Lung Panel and a Breast Panel, followed by a welcome reception with exhibitors. The second day included the following panels: Melanoma Panel, Rare Disease Panel, GI Panel, and a Head and Neck Panel. There was also a Molecular Diagnostics Roundtable Discussion and a Process Improvement and Best Practices in Precision Medicine lecture. The meeting ended with Breakouts/Brainstorming Sessions and each breakout group reporting their findings back to the whole group.
Below you will find summaries and highlights of each session, contributed by our members:
Lung Cancer Statistics
Lung cancer is a major global health concern, leading to 1.4 million deaths yearly. In the U.S., lung cancer claims 125,070 lives annually, surpassing the combined mortality rates of breast, prostate, and colorectal cancers. The overall 5-year survival rate remains low at 25%, and for metastatic cases, it drops to just 8%. Most patients (55%) are diagnosed at advanced stages (IIIB or IV).
Molecular Profiling and Targeted Therapies
Enhanced molecular profiling has revealed actionable genetic mutations in NSCLC, leading to the development of targeted therapies that significantly impact treatment strategies. Key gene mutations include EGFR, ALK, ROS1, BRAF, KRAS, RET, NTRK, MET, and HER2.
Key Updates on Targeted Therapies
Emerging Treatments
Adjuvant/Consolidation Targeted therapy in NSCLC
Challenges in Small Biopsies and Lung Biopsy Protocols
Small biopsies often limit tissue availability, necessitating accurate handling protocols. Recommendations include collecting ample tissue, embedding samples separately for molecular testing, and maintaining specimen sterility.
Updated on PD-L1 Testing of Lung Carcinomas
Use validated PD-L1 IHC assays with genomic biomarkers for advanced NSCLC, ensuring specimen validation and reporting results as percentage scores. Avoid using tumor mutation burden alone for treatment decisions.
This two-part panel on breast cancer was presented by Dr. Han and Dr. Jaffer, focusing on the evolution of biomarker-guided therapies, highlighting both traditional and recent advancements. Biomarkers such as ER, PR, and HER2 remain foundational in breast cancer diagnosis and treatment planning, and the use of next-generation sequencing (NGS) has expanded the potential for personalized therapies. NGS allows for the identification of genetic mutations, including PIK3CA and BRCA1/2, which guide targeted therapy choices like PARP inhibitors (e.g., olaparib) and PI3K inhibitors (e.g., alpelisib). These therapies have proven effective in improving progression-free survival (PFS), particularly for hormone receptor-positive (HR-positive) breast cancers.
The panel emphasized the ongoing relevance of endocrine therapies, from tamoxifen to modern CDK4/6 inhibitors like palbociclib and ribociclib. CDK4/6 inhibitors have revolutionized HR-positive metastatic breast cancer treatment since their approval in 2015. Additionally, Dr. Han highlighted the utility of circulating tumor DNA (ctDNA) as a non-invasive method for tracking disease progression and identifying resistance mechanisms, suggesting its potential for real-time treatment adjustments.
A key area of Dr. Han’s focus was the management of mutations such as ESR1, which drive resistance to endocrine therapies. New treatments like elacestrant, a selective estrogen receptor degrader, have shown improved PFS in ESR1-mutant patients. Other targeted therapies include PARP inhibitors for BRCA mutations and HER2-targeted therapies, particularly for HER2-low breast cancers. Recent clinical trials, such as Destiny-Breast04, demonstrated the benefits of trastuzumab deruxtecan (T-DXd) in HER2-low breast cancer, prompting FDA approval for this subset.
Additionally, Dr. Jaffer reviewed the pre-analytic factors such as specimen processing which are crucial for optimal biomarker evaluation. The challenges of interpreting HER2 status, particularly in cases of HER2-low/ultra-low expression were summarized. HER2 testing techniques, including IHC and FISH, remain crucial for accurate treatment decisions. Additional biomarkers, such as Ki67, PD-L1, might also be useful for risk stratification. Emerging technologies such as AI-based digital analysis may further enhance the detection of low HER2 levels and improve patient outcomes.
This three-part panel highlighted advances in precision medicine for melanoma, the relevance of genomic testing for diagnosis and therapy, and recent advances in the surgical management of melanoma.
Dr. Eroglu covered the current treatment options for melanoma, particularly focusing on the challenges in tailoring therapies to individual patients with metastatic and early-stage melanoma. Immunotherapy combinations, such as nivolumab with ipilimumab or relatlimab, are primary first-line treatments, with targeted therapies as second-line options, particularly for mutations like BRAF V600E. However, there remains a significant need for more personalized treatment selection as some mutations, like NRAS, show low response rates to targeted therapies. A limitation in melanoma treatment is the lack of validated biomarkers that predict how a patient might respond to various therapies, as common markers in other cancers, such as PD-L1 or tumor mutation burden, have not been predictive for melanoma. Consequently, patient monitoring relies heavily on imaging and physical exams, as there is no specific blood-based biomarker.
The lecture also discusses the potential role of blood-based biomarkers, like circulating tumor DNA (ctDNA), in monitoring melanoma. In several studies, ctDNA has shown potential to indicate prognosis, such as in patients with undetectable ctDNA post-surgery, who generally have better recurrence-free survival. Longitudinal monitoring of ctDNA levels could provide earlier detection of relapse compared to imaging, potentially allowing for treatment adjustments. However, current ctDNA assays have limitations in sensitivity, prompting ongoing research into more sensitive next-generation assays. Incorporating ctDNA into clinical decision-making could personalize treatment approaches, but further validation in melanoma-specific trials is necessary. As the field progresses, future trials aim to explore ctDNA's role in real-time treatment decisions, balancing clinical efficacy and cost-effectiveness.
Dr. Tsai's talk focused on the genetics of skin cancers, including basal cell carcinoma, squamous cell carcinoma, melanoma, and Merkel cell carcinoma. He explained that most skin cancers have a common cause in UVB-induced mutagenesis, leading to specific DNA damage patterns. Skin cancers exhibit high tumor mutation burdens (except virus-positive Merkel cell carcinoma) and often have identifiable mutational profiles. Dr. Tsai highlighted how these genetic insights aid both diagnosis and treatment, mentioning therapies targeting specific mutations, such as Pembrolizumab for high mutation burdens, and BRAF and hedgehog pathway inhibitors for certain skin cancer types.
Through case studies, Dr. Tsai illustrated how molecular profiling can resolve diagnostic challenges, such as differentiating melanoma from other cancers. For example, in one case, mutational profiling led to a revised diagnosis of dedifferentiated melanoma, guiding appropriate treatment. Another case showed how a UV mutation signature supported diagnosing desmoplastic melanoma. Dr. Tsai concluded by underscoring the value of molecular testing for distinguishing skin-origin cancers and noted the potential of expanding routine profiling for viral oncogenes in cancer diagnosis and treatment.
Ashley concluded the panel presentation by discussing the staging and surgical treatment advances for melanoma. Surgical management of melanoma has evolved from non-histologic excisions to precise surgeries influenced by tumor thickness (Breslow's depth) and lymph node involvement. Clinical trials like the MelMarT and MERLIN are examining optimal surgical margins and the necessity of sentinel lymph node biopsies. MelMarT compares 1 cm versus 2 cm margins to assess recurrence and healing, while MERLIN uses gene expression profiling to identify patients who may avoid sentinel node biopsies. The PRADO trial was also discussed, which focused on nodal basin recurrences. This study examined whether patients responding well to neoadjuvant therapy could forgo full lymph node dissection, relying instead on targeted (index) node excision. Early findings suggest that complete lymph node dissection may be unnecessary for patients with a strong pathologic response, potentially reducing surgical burden without compromising outcomes. The importance of biopsy precision was highlighted, and Ashley advocated for minimal intervention where appropriate to optimize patient quality of life and reduce surgical impact.
Understanding Castleman Disease: Unraveling a Rare Lymphoproliferative Disorder
Castleman Disease (CD) is a rare lymphoproliferative disorder with two main forms: unicentric Castleman disease (UCD) and multicentric Castleman disease (MCD). UCD involves a single lymph node or region, often linked to the hyaline-vascular variant (HV-CD). This variant presents with distinctive “lollipop” blood vessels, concentric lymphocyte layers around follicles ("onion skin" appearance), and prominent follicular dendritic cells (FDCs). UCD generally has a favorable outcome when treated with surgical resection.
MCD, in contrast, affects multiple lymph nodes and is frequently associated with the plasma cell variant (PC-CD), showing increased plasma cells and interfollicular plasma cell proliferation. MCD can be related to conditions such as human herpesvirus-8 (HHV-8) infection or HIV, especially in HIV-positive individuals. Additionally, MCD may coincide with complex syndromes like TAFRO (thrombocytopenia, anasarca, fever, reticulin fibrosis, organomegaly) and POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma cell disorder, skin changes), each requiring tailored management.
Differential diagnoses include autoimmune lymphadenopathy, immunoglobulin G4-related disease, and Hodgkin lymphoma. Accurate diagnosis of CD necessitates a comprehensive clinical, histologic, and molecular evaluation. The World Health Organization (WHO) 5th edition diagnostic criteria emphasize the importance of an integrated approach, incorporating these diagnostic insights for effective classification and management of Castleman Disease.
Systemic Mastocytosis: A Clonal Mast Cell Disorder
Systemic Mastocytosis (SM) is a rare clonal disorder marked by abnormal mast cell accumulation in various organs, causing symptoms that range from skin manifestations to severe systemic complications. Diagnosis of SM follows the World Health Organization (WHO) criteria, which require one major criterion and one minor criterion or at least three minor criteria. The major criterion is detecting mast cell clusters (≥15 mast cells) in an extracutaneous organ, while minor criteria include abnormal mast cell morphology, aberrant cell surface markers (CD2, CD25, CD30), presence of the KIT D816V mutation (seen in over 90% of cases), and persistently elevated serum tryptase levels above 20 ng/mL.
SM subtypes include indolent systemic mastocytosis (ISM), aggressive systemic mastocytosis (ASM), and mast cell leukemia, with the classification guiding treatment strategies. Common treatments involve symptom management with antihistamines, leukotriene inhibitors, and medications such as omalizumab and aspirin. KIT-targeted therapies (e.g., Avapratinib, imatinib, midostaurin) are often used, especially for patients with the KIT D816V mutation, providing a targeted approach.
For ISM, low-dose avapritinib (25 mg daily) is typically effective for symptom relief without major side effects. In ASM, treatment begins with a higher dose (200 mg daily) to control disease progression, with common dose adjustments to manage side effects. Standard reductions include lowering to 100 mg if needed, or 50 mg if side effects persist. If symptoms recur, a drug break may be taken, resuming at 100 mg as necessary.
Accurate diagnosis and classification, particularly given the overlap with other myeloproliferative and hematologic disorders, are critical to effective treatment and prognosis for SM. This approach balances efficacy and quality of life, aiming to control disease while minimizing adverse effects.
This two-part panel on sarcoma therapies was presented by Dr. D’Amato and Dr. Druta, focusing on medical treatments and novel gene therapies in synovial sarcoma.
FDA-Approved Targeted Therapies for Sarcoma
FDA-approved treatments for sarcomas include primarily tyrosine kinase inhibitors (TKIs) and other targeted agents:
Non-FDA Approved Targeted Therapies
Several non-approved therapies are used off-label, mostly TKIs like Regorafenib, Sorafenib, Sunitinib, and Lenvatinib, alongside CDK4/6 inhibitors such as Palbociclib and Abemaciclib, which are being explored for efficacy in sarcoma subtypes.
Newly Approved Targeted Therapies
The newest FDA-approved therapies include:
TCR Gene Therapy for Synovial Sarcoma
Dr. Druta highlighted afamitresgene autoleucel (afami-cel), the first FDA-approved T-cell receptor (TCR) gene therapy for synovial sarcoma. Afami-cel consists of autologous CD4+ and CD8+ T-cells transduced with a lentiviral vector encoding an enhanced-affinity TCR specific for the MAGE-A4 antigen, a cancer-testis antigen selectively expressed in synovial sarcoma cells.
Eligibility and Efficacy
Afami-cel is indicated for patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy, possess specific HLA types (e.g., HLA-A*02:01), and have tumors expressing MAGE-A4. The phase 1 trial reported a median overall survival of 16.9 months and a median response duration of 28 weeks, with afami-cel showing a strong response in synovial sarcoma compared to other solid tumors.
Biomarkers in Localized Colorectal Carcinoma
Biomarkers in Metastatic Colorectal Carcinoma
Biomarkers in Immunotherapy for GI Cancers
Pathology Reporting Essentials - An optimal pathology report must be:
Case Studies and Lessons
Part 1: Diagnostic and Treatment Challenges in Head and Neck SCC
Led by Dr. Rabinowits, Dr. Danan, this segment explored cases of head and neck squamous cell carcinoma (SCC), discussing diagnostic challenges, treatment strategies, and follow-up.
Case 1: Metastatic p16+ SCC in the Neck with Unknown Primary.
Initial presentation involved a neck mass with p16+ squamous cell carcinoma of unknown primary origin. A later biopsy confirmed an oropharyngeal lesion that was p16+ and HPV+. The panel discussed that a modified surgery with adjuvant therapy offers an effective approach in cases where the primary lesion is identified in the oropharynx, emphasizing the role of HPV status in guiding treatment.
Case 2: Recurrent Tonsillar p16+ SCC. This patient had a history of tonsillar p16+ SCC diagnosed seven years prior and now presented with a recurrence at the original site. Circulating tumor cells (CTCs) were highlighted as a promising biomarker for monitoring recurrence and assessing therapeutic response in patients with SCC, as they can potentially offer insights into residual disease and relapse risk.
Case 3: Neck Mass with p16- SCC and Unclear History of Non-Melanoma Skin Cancer. The neck mass showed p16- SCC, and the patient had an uncertain history of non-melanoma skin cancer. The panel highlighted the utility of next-generation sequencing (NGS) to detect UV signature mutations, which can confirm a diagnosis of cutaneous SCC when histological features and history are ambiguous.
Part 2: Advanced Thyroid Cancer
Presented by Dr. Salgado, this session reviewed the management of high-risk and advanced thyroid cancers, with a focus on treatment options for papillary thyroid carcinoma, medullary carcinoma, and anaplastic thyroid carcinoma.
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