Difference between revisions of "Urothelial carcinoma - historical"
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Revision as of 11:05, 26 July 2022
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main bladder cancer page for current regimens.
9 regimens on this page
10 variants on this page
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Locally advanced or metastatic disease, first-line, platinum-eligible
Cisplatin monotherapy
Regimen variant #1, 70 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Soloway et al. 1983 | 1978-NR | Randomized (C) | Cisplatin & Cyclophosphamide | Did not meet primary endpoint of ORR |
Khandekar et al. 1985 | 1978-1981 | Randomized (C) | CAD | Might have inferior ORR |
Troner et al. 1987 | NR | Phase 3 (C) | CAD | Did not meet endpoint of ORR |
Loehrer et al. 1992 | 1984-1989 | Phase 3 (C) | MVAC | Inferior OS |
For historic reference. To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.
Chemotherapy
- Cisplatin (Platinol) 70 mg/m2 IV once on day 1
28-day cycle for up to 6 cycles
Regimen variant #2, 80 mg/m2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Hillcoat et al. 1989 | 1982-1986 | Phase 3 (C) | Cisplatin & Methotrexate | Did not meet efficacy endpoints |
For historic reference. To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
28-day cycles
References
- Soloway MS, Einstein A, Corder MP, Bonney W, Prout GR Jr, Coombs J; National Bladder Cancer Collaborative Group A. A comparison of cisplatin and the combination of cisplatin and cyclophosphamide in advanced urothelial cancer: a National Bladder Cancer Collaborative Group A study. Cancer. 1983 Sep 1;52(5):767-72. link to original article PubMed
- Khandekar JD, Elson PJ, DeWys WD, Slayton RE, Harris DT. Comparative activity and toxicity of cis-diamminedichloroplatinum (DDP) and a combination of doxorubicin, cyclophosphamide, and DDP in disseminated transitional cell carcinomas of the urinary tract. J Clin Oncol. 1985 Apr;3(4):539-45. link to original article PubMed
- Troner M, Birch R, Omura GA, Williams S; Southeastern Cancer Study Group. Phase III comparison of cisplatin alone versus cisplatin, doxorubicin and cyclophosphamide in the treatment of bladder (urothelial) cancer: a Southeastern Cancer Study Group trial. J Urol. 1987 Apr;137(4):660-2. link to original article PubMed
- Hillcoat BL, Raghavan D, Matthews J, Kefford R, Yuen K, Woods R, Olver I, Bishop J, Pearson B, Coorey G, Levi J, Abbott RL, Aroney R, Gill PG, McLennan R. A randomized trial of cisplatin versus cisplatin plus methotrexate in advanced cancer of the urothelial tract. J Clin Oncol. 1989 Jun;7(6):706-9. link to original article contains protocol PubMed
- Loehrer PJ Sr, Einhorn LH, Elson PJ, Crawford ED, Kuebler P, Tannock I, Raghavan D, Stuart-Harris R, Sarosdy MF, Lowe BA, Blumenstein B, Trump D. A randomized comparison of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1992 Jul;10(7):1066-73. Erratum in: J Clin Oncol 1993 Feb;11(2):384. link to original article contains verified protocol PubMed
- Update: Saxman SB, Propert KJ, Einhorn LH, Crawford ED, Tannock I, Raghavan D, Loehrer PJ Sr, Trump D. Long-term follow-up of a phase III intergroup study of cisplatin alone or in combination with methotrexate, vinblastine, and doxorubicin in patients with metastatic urothelial carcinoma: a cooperative group study. J Clin Oncol. 1997 Jul;15(7):2564-9. link to original article PubMed
Metastatic disease, platinum-refractory
Atezolizumab monotherapy
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Regimen
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Powles et al. 2014 (PCD4989g) | 2013-2014 | Phase 1 | ||
Rosenberg et al. 2016 (IMvigor210 previously treated) | 2014 | Phase 2 (RT) | ORR: 15% (95% CI 11-20) | |
Powles et al. 2017 (IMvigor211) | 2015-2016 | Phase 3 (E-switch-ooc) | 1. Docetaxel 2. Paclitaxel 3. Vinflunine |
Did not meet primary endpoint of OS |
Note: this regimen did not meet its primary endpoint in phase III; here for historical reference only.
Biomarker eligibility criteria
Patients are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 5% of the tumor area), as determined by an FDA-approved test
Patients are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
Immunotherapy
- Atezolizumab (Tecentriq) 1200 mg IV once on day 1
21-day cycles
References
- PCD4989g: Powles T, Eder JP, Fine GD, Braiteh FS, Loriot Y, Cruz C, Bellmunt J, Burris HA, Petrylak DP, Teng SL, Shen X, Boyd Z, Hegde PS, Chen DS, Vogelzang NJ. MPDL3280A (anti-PD-L1) treatment leads to clinical activity in metastatic bladder cancer. Nature. 2014 Nov 27;515(7528):558-62. link to original article PubMed NCT01375842
- IMvigor210 previously treated: Rosenberg JE, Hoffman-Censits J, Powles T, van der Heijden MS, Balar AV, Necchi A, Dawson N, O'Donnell PH, Balmanoukian A, Loriot Y, Srinivas S, Retz MM, Grivas P, Joseph RW, Galsky MD, Fleming MT, Petrylak DP, Perez-Gracia JL, Burris HA, Castellano D, Canil C, Bellmunt J, Bajorin D, Nickles D, Bourgon R, Frampton GM, Cui N, Mariathasan S, Abidoye O, Fine GD, Dreicer R. Atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy: a single-arm, multicentre, phase 2 trial. Lancet. 2016 May 7;387(10031):1909-20. Epub 2016 Mar 4. link to original article link to PMC article contains protocol PubMed NCT02108652
- IMvigor211: Powles T, Durán I, van der Heijden MS, Loriot Y, Vogelzang NJ, De Giorgi U, Oudard S, Retz MM, Castellano D, Bamias A, Fléchon A, Gravis G, Hussain S, Takano T, Leng N, Kadel EE 3rd, Banchereau R, Hegde PS, Mariathasan S, Cui N, Shen X, Derleth CL, Green MC, Ravaud A. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211): a multicentre, open-label, phase 3 randomised controlled trial. Lancet. 2018 Feb 24;391(10122):748-757. Epub 2017 Dec 18. link to original article contains protocol PubMed NCT02302807
Durvalumab monotherapy
Regimen
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Massard et al. 2016 (Study 1108) | 2014-2015 | Phase 1/2 (RT) | ORR: 31% (95% CI 18 to 47) |
Note: this regimen was intended for patients "who had progressed on, been ineligible for, or refused any number of prior therapies".
Immunotherapy
- Durvalumab (Imfinzi) 10 mg/kg IV over 60 minutes once on day 1
14-day cycle for up to 26 cycles (1 year). Patients could receive another 12 months of treatment if they experienced disease progression, had not received other anticancer treatment, and did not meet criteria for discontinuation.
References
- Study 1108: Massard C, Gordon MS, Sharma S, Rafii S, Wainberg ZA, Luke J, Curiel TJ, Colon-Otero G, Hamid O, Sanborn RE, O'Donnell PH, Drakaki A, Tan W, Kurland JF, Rebelatto MC, Jin X, Blake-Haskins JA, Gupta A, Segal NH. Safety and efficacy of durvalumab (MEDI4736), an anti-programmed cell death ligand-1 immune checkpoint inhibitor, in patients with advanced urothelial bladder cancer. J Clin Oncol. 2016 Sep 10;34(26):3119-25. Epub 2016 Jun 6. link to original article contains protocol link to PMC article PubMed NCT01693562
- Update: Powles T, O'Donnell PH, Massard C, Arkenau HT, Friedlander TW, Hoimes CJ, Lee JL, Ong M, Sridhar SS, Vogelzang NJ, Fishman MN, Zhang J, Srinivas S, Parikh J, Antal J, Jin X, Gupta AK, Ben Y, Hahn NM. Efficacy and Safety of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma: Updated Results From a Phase 1/2 Open-label Study. JAMA Oncol. 2017 Sep 14;3(9):e172411. Epub 2017 Sep 14. link to original article link to PMC article PubMed