Alliance 2025 Almanac article accompanying the Outstanding CE Outcomes Award

Introduction

Although developments in cancer immunotherapy (immuno-oncology or I-O) continue to improve targeted treatments for patients with cancers such as melanoma and non-small cell lung cancer (NSCLC), there is an ongoing need for education that improves the measurement of pathological response to treatment and promotes best practices in utilizing biomarker testing to help inform the treatment selection. For instance, pathological response is defined by the amount of tumor cells that persist in the surgical specimen after treatment, but its measurement also utilizes scoring systems to assign categories such as “pathological complete response” or “major pathological response”. These categories influence decisions about treatment options and have been correlated with clinical outcomes in patients receiving neoadjuvant immunotherapy for NSCLC and melanoma.

However, differences in their use and the optimal response thresholds need to be updated as clinical trials mature, both of which may vary by tumor type. Also, as new scoring systems have been developed for multiple tumor types, there is an ongoing need for pathologists, laboratory professionals and other members of multidisciplinary cancer care teams to be aware of the differences when interpreting and reporting pathological response measurements and making decisions about treatment options based on the results.

Moreover, biomarker testing can help identify patients who are more likely to respond to immunotherapies, allowing for more targeted and effective treatment selection. With the rapid pace of new advances that can make it difficult to stay abreast of current guidelines and recommended practices, though, ongoing education is needed to increase understanding of the role that biomarker testing can play. Education is also necessary to increase understanding of considerations for selecting the most appropriate methods for biomarker testing and ensuring that the testing is done effectively, efficiently and equitably.

This article highlights outcomes from an education program undertaken to address knowledge/practice gaps in these areas: Insufficient knowledge and skills in accurately measuring and interpreting pathological response for patients with NSCLC and melanoma in accordance with treatment advances, and insufficient knowledge and skills in conducting appropriate biomarker testing in accordance with recommended guidelines. The program also addressed the need for pathologists to take a more active role in promoting best practices and overcoming barriers to optimizing biomarker testing.

Methods

Designed by the American Society for Clinical Pathology and Q Synthesis, the education used a multifaceted approach, combining microlearning, expert discussion, and peer collaboration to address the identified knowledge and practice gaps. The education program comprised four main components aligned with measuring and interpreting pathological response and conducting appropriate biomarker testing for patients with NSCLC and melanoma: a microlearning series, a podcast, a peer learning collaborative and a pair of implementation guides. Divided into four 30-minute online, on-demand segments, the microlearning series focused on two aspects of NSCLC and melanoma and covered knowledge/skills such as:

• How to measure and score pathological response in resectable NSCLC and melanoma
• Best practices for specimen collection and handling to ensure the accurate measurement of pathological response
• Knowledge of when certain biomarker tests may or may not be needed
• Considerations for selecting appropriate methods of biomarker testing

These short, focused modules allowed learners to engage efficiently with the complexity of topics associated with pathological response scoring and biomarker testing.

In the podcast, pathology experts discussed the impact of advances in immunotherapies for patients with NSCLC and melanoma, and a cancer patient shared their perspective on the importance of having a timely, accurate diagnosis. The peer learning collaborative engaged a cohort of pathologists in facilitated live, virtual discussions aimed at helping them examine practices at their institution around the role of biomarker testing in informing treatment selection and how to assess pathological response. The collaborative moved beyond knowledge delivery by creating a space for participants to reflect on institutional practices, share insights, and co-develop solutions. This collaboration lead to practical improvements, such as refined workflows and clearer testing protocols. The participants also used their experiential learning to develop a pair of implementation guides to help others apply recommendations for I-O biomarker testing and pathological response. The finalized guides were then published online to make them accessible to the broader pathology/laboratory community.

Results

The education has reached more than 5,100 learners, including pathologists, oncologists, other physicians, laboratory professionals, pathologists’ assistants, physician assistants and other members of multidisciplinary cancer care teams. As shown by the examples in Table 1, the program achieved several goals aimed at increasing knowledge/skills, competence and performance around the measurement of pathological response and application of best practices in biomarker testing.

Overall knowledge gain, measured by a pretest and posttest administered with the microlearning series, was statistically significant with mean scores increasing 41%, t(7748) = 109.9, p < 0.01, η² = 0.6. Among the areas with the highest gains were knowledge of methods for appropriate biomarker testing for resectable NSCLC, knowledge of best practices for specimen collection and handling to ensure the accurate measurement of pathological response for resectable NSCLC, and knowledge of scoring systems to assess pathological response in patients with resectable NSCLC and melanoma undergoing neoadjuvant immunotherapy.

Discussion and Conclusions

The examples of knowledge gain and application to practice show how the education program strengthened knowledge and skills needed to improve the measurement of pathological response to immunotherapy for patients with NSCLC and melanoma. Furthermore, the development of the implementation guides by the participants in the peer learning collaborative was an integrated mechanism for disseminating lessons learned based on their application of scientific, technical content to their own practices. They were able to promote best practices for biomarker testing by sharing their collective experience with the broader pathology/laboratory community as they honed their knowledge and applied it to improve biomarker testing and the monitoring of patient response to immunotherapy in their institutions.

The program’s multifaceted approach to addressing knowledge gaps around the role of biomarker testing in informing the selection of targeted immunotherapy and measuring patient response to treatment with an emphasis on peer collaboration and discussion  empowered learners to implement practice changes that promoted best practices.  The need to apply this type of foundational knowledge and skills to clinical practice continues to grow with new advances in immunotherapy.

Acknowledgments

This project was funded by an independent educational grant from Bristol Myers Squibb.