Real-world safety and effectiveness of MVASI in metastatic colorectal cancer patients in Canada.
Bibliographic record
Abstract
e15555 Background: MVASI is a biosimilar to the reference product, bevacizumab, and is the first biosimilar approved by Health Canada for the first-line (1L) treatment of metastatic colorectal cancer (mCRC). This study addresses the limited real-world evidence by describing the safety and effectiveness of MVASI as 1L therapy in mCRC. Methods: Retrospective data were collected in two waves of sites across Canada, at least 1 year (wave 1) or 2 years (wave 2) after commercial availability of MVASI at each site. Adult patients treated with ≥ 1 MVASI cycles as their 1L therapy for mCRC were included. Baseline demographic and clinical characteristics were collected 6 months prior to MVASI initiation (index date). Medical history, adjuvant treatment, and CRC diagnosis were collected within 5 years of pre-index date. Outcomes were gathered between index and chart review dates. Results: Among the 75 patients in wave 1, 36 (48.0%) were male and the median age was 62 years. Of the 164 patients in wave 2, 98 (59.8%) were male and the median age was 67 years. Most patients in wave 1 (42/69; 60.9%) and wave 2 (87/141; 61.7%) had a RAS mutation. The median time from mCRC diagnosis to MVASI initiation among wave 1 and 2 patients was 3.1 (IQR [2.1, 4.2]) and 2.3 months (IQR [1.6, 3.7]), respectively. At least one safety event of interest (EOI) was recorded for 26/75 (34.7%) wave 1 and 70/164 (42.7%) wave 2 patients (Table 1). The median progression free survival (PFS) for wave 1 and 2 patients were 9.47 and 21.38 months, respectively. Median overall survival (OS) for wave 1 patients was not estimable and was 26.45 months for wave 2 patients. Conclusions: In this real-world study, mCRC patients treated with 1L MVASI were generally representative of the Canadian mCRC population treated with 1L bevacizumab. Compared with clinical trials of MVASI and reference bevacizumab, the EOI profile and the OS data are similar, but lower rates of individual EOIs are observed in this real-world setting. The shorter PFS observed in wave 1 may be due to higher rates of comorbidities at baseline and longer time from mCRC diagnosis to index. [Table: see text]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.008 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".