Difference between revisions of "Urothelial carcinoma - historical"

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(Created page with "The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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)...")
 
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=Metastatic disease, subsequent lines of therapy=
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=Metastatic disease, platinum-refractory=
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==Atezolizumab monotherapy {{#subobject:451e68|Regimen=1}}==
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{| class="wikitable" style="float:right; margin-left: 5px;"
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|-
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|[[Bladder cancer#top|back to top]]
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|}
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===Regimen {{#subobject:feb2e2|Variant=1}}===
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
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! style="width: 20%" |Study
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! style="width: 20%" |Years of enrollment
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! style="width: 20%" |[[Levels of Evidence#Evidence|Evidence]]
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! style="width: 20%" |Comparator
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! style="width: 20%" |[[Levels of Evidence#Comparative efficacy|Comparative Efficacy]]
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|-
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|[https://www.nature.com/articles/nature13904 Powles et al. 2014 (PCD4989g)]
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|2013-2014
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| style="background-color:#ffffbe" |Phase 1
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| style="background-color:#d3d3d3" |
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| style="background-color:#d3d3d3" |
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|-
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5480242/ Rosenberg et al. 2016 (IMvigor210)]
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|2014
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| style="background-color:#91cf61" |Phase II (RT)
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| style="background-color:#d3d3d3" |
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| style="background-color:#88419d; color:white" |ORR: 15% (95% CI 11-20)
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|-
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|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)33297-X/fulltext Powles et al. 2017 (IMvigor211)]
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|2015-2016
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| style="background-color:#1a9851" |Phase III (E-switch-ood)
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|1. [[Bladder cancer#Docetaxel monotherapy|Docetaxel]]
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2. [[Bladder cancer#Paclitaxel monotherapy|Paclitaxel]]
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3. [[Bladder cancer#Vinflunine monotherapy|Vinflunine]]
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| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
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|-
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|}''Note: this regimen did not meet its primary endpoint in phase III; here for historical reference only.''
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====Biomarker eligibility criteria====
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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
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Patients are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
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====Immunotherapy====
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*[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1
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'''21-day cycles'''
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===References===
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#'''Phase 1:''' 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. [https://www.nature.com/articles/nature13904 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25428503 PubMed] NCT01375842
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#'''IMvigor210:''' 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. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00561-4/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5480242/ link to PMC article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/26952546 PubMed] NCT02108652
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#'''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. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)33297-X/fulltext link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/29268948 PubMed] NCT02302807
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==Durvalumab monotherapy {{#subobject:7ae7fb|Regimen=1}}==
 
==Durvalumab monotherapy {{#subobject:7ae7fb|Regimen=1}}==
 
{| class="wikitable" style="float:right; margin-left: 5px;"
 
{| class="wikitable" style="float:right; margin-left: 5px;"

Revision as of 23:54, 9 March 2021

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


Metastatic disease, platinum-refractory

Atezolizumab monotherapy

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Powles et al. 2014 (PCD4989g) 2013-2014 Phase 1
Rosenberg et al. 2016 (IMvigor210) 2014 Phase II (RT) ORR: 15% (95% CI 11-20)
Powles et al. 2017 (IMvigor211) 2015-2016 Phase III (E-switch-ood) 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

21-day cycles

References

  1. Phase 1: 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
  2. IMvigor210: 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
  3. 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

back to top

Regimen

Study Years of enrollment Evidence Efficacy
Massard et al. 2016 (Study 1108) 2014-2015 Phase I/II (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

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

  1. 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
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