Abstract 611P
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.
Resources from the same session
26P - Subcutaneous trastuzumab versus intravenous trastuzumab for treatment of patients with HER2-positive breast cancer: A time, motion and cost-benefit assessment in a day care oncology unit in China
Presenter: Bei Sun
Session: Poster Display
Resources:
Abstract
27P - The biological characteristics of HER2-low in TNBC using mRNA profiling and molecular subtypes
Presenter: Asako Tsuruga
Session: Poster Display
Resources:
Abstract
28P - One-week ultra-hypofractionated partial breast RT in early breast cancer: 3DCRT vs IMRT
Presenter: Nurilla Zaynutdinov
Session: Poster Display
Resources:
Abstract
30P - Stereotactic body radiotherapy using cyberknife versus interstitial brachytherapy in accelerated partial breast irradiation on left-sided breast: A comparison of preliminary clinical result and dosimetric characteristics
Presenter: Ting-Na Wei
Session: Poster Display
Resources:
Abstract
31P - Prognostic implication of breast edema on preoperative breast MRI in breast cancer
Presenter: Ki-tae Hwang
Session: Poster Display
Resources:
Abstract
32P - Efficacy of olanzapine in the prophylaxis of delayed chemotherapy-induced nausea and vomiting in breast cancer patients receiving dose-dense AC with a steroid-sparing regimen: A single-center pilot study
Presenter: Manami Tada
Session: Poster Display
Resources:
Abstract
34P - Social support as the mediator of the association between unmet needs and happiness among women with early breast cancer
Presenter: Nithiya Sinarajoo
Session: Poster Display
Resources:
Abstract
35P - Prospective study assessing the efficacy and safety of a scalp cooling device for the prevention of alopecia in breast cancer patients undergoing (neo)adjuvant chemotherapy
Presenter: Winnie Yeo
Session: Poster Display
Resources:
Abstract
37P - To excise or not to excise: Preventive management of early breast cancer in atypical ductal hyperplasia patients
Presenter: Clarisse Hing
Session: Poster Display
Resources:
Abstract
38P - Exploring prognostic factors in patients achieving PCR after neoadjuvant therapy for triple-negative breast cancer: A retrospective study based on SEER data
Presenter: Lv Wenjie
Session: Poster Display
Resources:
Abstract