Treatment Pathways: When Chemotherapy Alone Is the Right Choice in Metastatic SCAC
A panelist discusses how given PODIUM-303's benefits across all subgroups, the primary patient population that should receive chemotherapy alone rather than the combination with retifanlimab would be those with contraindications to checkpoint inhibitors, specifically patients with autoimmune diseases such as irritable bowel disease, organ transplant recipients or those with severe rheumatoid arthritis requiring immunosuppressants, where the risks of checkpoint inhibitor administration outweigh potential benefits, while noting that no validated biomarker currently exists to exclude patients from retifanlimab treatment.
Treatment Pathways: When Chemotherapy Alone Is the Right Choice in Metastatic SCAC
The broad efficacy demonstrated across all subgroups in the POD1UM-303 trial makes it challenging to identify specific patient populations who should receive chemotherapy alone rather than the combination regimen of carboplatin, paclitaxel and retifanlimab. The consistent benefit patterns observed throughout the trial support the widespread application of combination therapy as the preferred first-line approach for metastatic squamous cell anal carcinoma (SCAC). However, clinical judgment remains essential in determining the most appropriate treatment strategy for individual patients based on their unique risk-benefit profiles and contraindications to specific therapeutic components.
The primary population warranting chemotherapy alone consists of patients with absolute contraindications to checkpoint inhibitor therapy, particularly those with active autoimmune diseases where immunotherapy risks outweigh potential benefits. Patients with inflammatory bowel disease, organ transplant recipients requiring ongoing immunosuppression and individuals with severe rheumatoid arthritis represent clear examples of populations where checkpoint inhibitor administration could exacerbate underlying autoimmune conditions. Similarly, any patient requiring chronic immunosuppressive therapy for autoimmune disease management should be considered for chemotherapy alone rather than combination therapy with retifanlimab.
Current evidence does not support excluding patients based on biomarker status, including PD-L1 expression levels. While PD-L1-negative patients may demonstrate less robust overall survival signals, the progression-free survival benefits observed in POD1UM-303 suggest that biomarker-based exclusions are not warranted at this time. The absence of validated biomarkers that definitively predict lack of benefit from retifanlimab reinforces the broad applicability of combination therapy. Clinical decision-making should focus primarily on identifying patients with specific contraindications to checkpoint inhibition rather than attempting to exclude patients based on molecular or demographic characteristics, ensuring that the maximum number of appropriate patients can access this effective treatment combination.
Patients Express Concerns Over Costs, Risks of Gene Therapies for Sickle Cell Disease
December 12th 2024Research at the annual meeting of the American Society of Hematology evaluated patient and caregiver perspectives on gene therapies for sickle cell disease, which offer great potential but have had slow uptake.
Read More
Evolving Role of Statins in Managing CV Risk in HIV | ID Week 2024
October 18th 2024Statins have had an evolving role in the management of cardiovascular risk in people living with HIV, explained Michelle Cespedes, M.D., M.S., professor of medicine, Icahn School of Medicine at Mount Sinai and Mount Sinai Health System.
Read More
