S1314, Co-expression Extrapolation (COXEN) Program to Predict Chemotherapy Response in Patients With Bladder Cancer
Summary
The primary focus of this study is to see if looking at tumor biomarkers using a program called coexpression extrapolation or "COXEN" may predict a patient's response to chemotherapy before surgery.
Timeline
- Start
- 2014-08-28
- Primary completion
- 2020-02
- Completion
- 2022-12-01
Outcome
Mixed primary results
registry analysis (superiority test); Gemcitabine & Cisplatin; p = 0.1; Odds Ratio (OR) 2.63 (95% CI 0.82 to 8.36); Regression, Logistic NCT02177695 ↗
registry analysis (superiority test); Dose Dense MVAC; p = 0.82; Odds Ratio (OR) 1.12 (95% CI 0.42 to 2.95); Regression, Logistic NCT02177695 ↗
registry analysis (superiority test); Gemcitabine & Cisplatin; p = 0.02; Odds Ratio (OR) 2.33 (95% CI 1.11 to 4.89); Regression, Logistic NCT02177695 ↗
registry analysis (superiority test); Dose Dense MVAC; p = 0.76; Odds Ratio (OR) 0.90 (95% CI 0.46 to 1.75); Regression, Logistic NCT02177695 ↗
Publications
- Bai Z, Osman M, Brendel M, Tangen CM, Flaig TW, Thompson IM, Plets M, Scott Lucia M, Theodorescu D, Gustafson D, Daneshmand S, Meeks JJ, Choi W, Dinney CPN, Elemento O, Lerner SP, McConkey DJ, Faltas BM, Wang F. Predicting response to neoadjuvant chemotherapy in muscle-invasive bladder cancer via interpretable multimodal deep learning. NPJ Digit Med. 2025 Mar 22;8(1):174. doi: 10.1038/s41746-025-01560-y.
- Flaig TW, Tangen CM, Daneshmand S, Alva AS, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr, Lerner SP. Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695). Eur Urol. 2023 Sep;84(3):341-347. doi: 10.1016/j.eururo.2023.06.014. Epub 2023 Jul 4.
- Flaig TW, Tangen CM, Daneshmand S, Alva A, Lerner SP, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr. A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695). Clin Cancer Res. 2021 May 1;27(9):2435-2441. doi: 10.1158/1078-0432.CCR-20-2409. Epub 2021 Feb 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Doxorubicin | Other / unclassified | 30 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Methotrexate | Small molecule | 30 mg/m2 | Intravenous |
| Subject | Vinblastine | Small molecule | 3 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |