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Inefficiencies in phase II to phase III transition impeding successful drug development in glioblastoma
| Content Provider | Oxford Academic |
|---|---|
| Author | Balasubramanian, Adithya Gunjur, Ashray Hafeez, Umbreen Menon, Siddharth Cher, Lawrence M Parakh, Sagun Gan, Hui Kong |
| Copyright Year | 2021 |
| Abstract | BackgroundImproving outcomes of patients with glioblastoma (GBM) represents a significant challenge in neuro-oncology. We undertook a systematic review of key parameters of phase II and III trials in GBM to identify and quantify the impact of trial design on this phenomenon.MethodsStudies between 2005 and 2019 inclusive were identified though MEDLINE search and manual bibliography searches. Phase II studies (P2T) were restricted to those referenced by the corresponding phase III trials (P3T). Clinical and statistical characteristics were extracted. For each P3T, corresponding P2T data was “optimally matched,” where same drug was used in similar schedule and similar population; “suboptimally matched” if dis-similar schedule and/or treatment setting; or “lacking.” Phase II/III transition data were compared by Pearson Correlation, Fisher's exact or chi-square testing.ResultsOf 20 P3Ts identified, 6 (30%) lacked phase II data. Of the remaining 14 P3T, 9 had 1 prior P2T, 4 had 2 P2T, and 1 had 3 P2T, for a total of 20 P3T-P2T pairs (called dyads). The 13 “optimally matched” dyads showed strong concordance for mPFS (r2 = 0.95, P < .01) and mOS (r2 = 0.84, P < .01), while 7 “suboptimally matched” dyads did not (P > .05). Overall, 7 P3Ts underwent an ideal transition from P2T to P3T. “Newly diagnosed” P2Ts with mPFS < 14 months and/or mOS< 22 months had subsequent negative P3Ts. “Recurrent” P2Ts with mPFS < 6 months and mOS< 12 months also had negative P3Ts.ConclusionOur findings highlight the critical role of optimally designed phase II trials in informing drug development for GBM. |
| Related Links | https://academic.oup.com/noa/article-pdf/3/1/vdaa171/36154203/vdaa171.pdf |
| File Format | |
| e-ISSN | 26322498 |
| DOI | 10.1093/noajnl/vdaa171 |
| Journal | Neuro-Oncology Advances |
| Issue Number | 1 |
| Volume Number | 3 |
| Language | English |
| Publisher | Oxford Academic |
| Publisher Date | 2021-01-01 |
| Access Restriction | Open |
| Subject Keyword | Clinical Medicine Medical Oncology Medicine and Health Neurology Glioblastoma Phase 2 Clinical Trials Phase 3 Clinical Trials Drug Development Myelofibrosis Mos Pp39 Serine/threonine Kinase Clinical Trials Phase Iii Phase Ii Trial Design Glioma |
| Content Type | Text |
| Resource Type | Article |
| Subject | Surgery Oncology Neurology (clinical) |
