Journal
CLINICAL CANCER RESEARCH
Volume 27, Issue 14, Pages 3916-3925Publisher
AMER ASSOC CANCER RESEARCH
DOI: 10.1158/1078-0432.CCR-21-0446
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Funding
- Medicenna
- American Cancer Society (ACS) [RSG-15-003-01-CCE]
- UCLA SPORE in Brain Cancer [NIH/NCI 1P50 CA211015-01A1]
- NIH/NCI [1R21 CA223757-01]
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The study compared different neuro-oncology criteria in an immunotherapy trial for recurrent glioblastoma and found a strong correlation between PFS and OS using mRANO, while iRANO required confirmation of progression 3 months later, resulting in more than half of the patients being censored.
Purpose: The current study compared the standard response assessment in neuro-oncology (RANO), immunotherapy RANO (iRANO), and modified RANO (mRANO) criteria as well as quantified the association between progression-free (PFS) and overall survival (OS) in an immunotherapy trial in recurrent glioblastoma (rGBM). Patients and Methods: A total of 47 patients with rGBM were enrolled in a prospective phase II convection-enhanced delivery of an IL4R-targeted immunotoxin (MDNA55-05, NCT02858895). Bidirectional tumor measurements were created by local sites and centrally by an independent radiologic faculty, then standard RANO, iRANO, and mRANO criteria were applied. Results: A total of 41 of 47 patients (mean age 56 +/- 11.7) were evaluable for response. PFS was significantly shorter using standard RANO compared with iRANO (log-rank, P < 0.0001; HR = 0.3) and mRANO (P < 0.0001; HR = 0.3). In patients who died and had confirmed progression on standard RANO, no correlation was observed between PFS and OS (local, P = 0.47; central, P = 0.34). Using iRANO, a weak association was observed between confirmed PFS and OS via local site measurements (P = 0.017), but not central measurements (P = 0.18). A total of 24 of 41 patients (59%) were censored using iRANO and because they lacked confirmation of progression 3 months after initial progression. A strong correlation was observed between mRANO PFS and OS for both local (R-2 = 0.66, P < 0.0001) and centrally determined reads (R-2 = 0.57, P = 0.0007). Conclusions: No correlation between radiographic PFS and OS was observed for standard RANO or iRANO, but a correlation was observed between PFS and OS using the mRANO criteria. Also, the iRANO criteria was difficult to implement due to need to confirm progression 3 months after initial progression, censoring more than half the patients.
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