611P - ESMO-magnitude of clinical benefit scale (MCBS) scores for phase III trials of adjuvant and curative therapies at the 2022 ASCO annual meeting (ASCO22)

Background

The ESMO-MCBS provides a standardized assessment of the clinical benefit of a study treatment, considering factors such as overall survival and quality of life. We examined the profile of scores for trials of adjuvant therapy or potentially curative therapies presented at ASCO22 to assess the applicability of the MCBS.

Methods

Abstracts and prior or subsequent (until April 10, 2023) full publications of phase 3 trials on adjuvant therapy or curative treatment presented at ASCO22 were assessed using the MCBS v1.1 evaluation form 1. Scores were calculated based on overall survival, disease free survival or pathological complete response data and graded as A, B or C. Grades A and B indicate a substantial magnitude of clinical benefit. Two independent reviewers performed the grading; discrepancies were resolved through discussion and consensus with a third investigator.

Results

Thirty-five trials were evaluated, of which 11 could not be scored due to insufficient data or endpoint not gradable of the remaining 24 trials, 12 could not be graded due to statistically non-significant results. The remaining 12 trials were scored based on abstract alone (n= 6), or subsequent publication (n=6). A meaningful clinical benefit was seen in 11 of 12 trials (92%) with a score of A (n=9) or B (n=2), whereas 1 study had a score C.

Conclusions

Applying the current ESMO-MCBS to adjuvant and curative phase 3 trials presented at ASCO22 has significant limitations, due to the number of trials not able to be scored. This is a particular problem for studies with non-significant results. Adapting the score to allow grading of all trials may better assist clinicians and patients to assess the value of contemporary research.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

E. Segelov: Non-Financial Interests, Personal, Member: ESMO-MCBS Working Group. All other authors have declared no conflicts of interest.