Difference between revisions of "Urothelial carcinoma - historical"

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Bladder cancer|main bladder cancer page]] for current regimens.
 
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only.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 [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. Is there a regimen missing from this list? See the [[Bladder cancer|main bladder cancer page]] for current regimens.
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]]  |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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{{TOC limit|limit=3}}
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=Nonmuscle invasive bladder cancer=
 
=Nonmuscle invasive bladder cancer=
 
==Intravesicular Doxorubicin monotherapy {{#subobject:8034b6|Regimen=1}}==
 
==Intravesicular Doxorubicin monotherapy {{#subobject:8034b6|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:49ccdb|Variant=1}}===
 
===Regimen {{#subobject:49ccdb|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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|-
 
|-
 
|}
 
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''Inferior to BCG, included for reference purposes only.''
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Doxorubicin (Adriamycin)]] 50 mg intravesicularly once on day 1
 
*[[Doxorubicin (Adriamycin)]] 50 mg intravesicularly once on day 1
 
'''7-day cycle for 5 cycles, then 30-day cycle for 11 cycles (approximately 1 year)'''
 
'''7-day cycle for 5 cycles, then 30-day cycle for 11 cycles (approximately 1 year)'''
 +
</div></div>
 
===References===
 
===References===
 
#Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. [https://doi.org/10.1016/s0022-5347(17)40002-4 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/2106041 PubMed]
 
#Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. [https://doi.org/10.1016/s0022-5347(17)40002-4 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/2106041 PubMed]
 
#'''SWOG 8216:''' Lamm DL, Blumenstein BA, Crawford ED, Montie JE, Scardino P, Grossman HB, Stanisic TH, Smith JA Jr, Sullivan J, Sarosdy MF, Crissman JD, Coltman CA. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. N Engl J Med. 1991 Oct 24;325(17):1205-9. [https://doi.org/10.1056/NEJM199110243251703 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/1922207 PubMed]
 
#'''SWOG 8216:''' Lamm DL, Blumenstein BA, Crawford ED, Montie JE, Scardino P, Grossman HB, Stanisic TH, Smith JA Jr, Sullivan J, Sarosdy MF, Crissman JD, Coltman CA. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. N Engl J Med. 1991 Oct 24;325(17):1205-9. [https://doi.org/10.1056/NEJM199110243251703 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/1922207 PubMed]
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==Intravesicular Thiotepa monotherapy {{#subobject:5b9d6c|Regimen=1}}==
 
==Intravesicular Thiotepa monotherapy {{#subobject:5b9d6c|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:97d2e7|Variant=1}}===
 
===Regimen {{#subobject:97d2e7|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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|-
 
|-
 
|}
 
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''Inferior to BCG, included for reference purposes only.''
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Thiotepa (Thioplex)]] 50 mg intravesicularly x 15 treatments
 
*[[Thiotepa (Thioplex)]] 50 mg intravesicularly x 15 treatments
 +
</div></div>
 
===References===
 
===References===
 
#Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. [https://doi.org/10.1016/s0022-5347(17)40002-4 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/2106041 PubMed]
 
#Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. [https://doi.org/10.1016/s0022-5347(17)40002-4 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/2106041 PubMed]
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=Locally advanced or metastatic disease, first-line, platinum-eligible=
 
=Locally advanced or metastatic disease, first-line, platinum-eligible=
 
==Cisplatin monotherapy {{#subobject:1af7a9|Regimen=1}}==
 
==Cisplatin monotherapy {{#subobject:1af7a9|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #1, 70 mg/m<sup>2</sup> {{#subobject:71bd05|Variant=1}}===
 
===Regimen variant #1, 70 mg/m<sup>2</sup> {{#subobject:71bd05|Variant=1}}===
 
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''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.''
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''Note: To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Cisplatin (Platinol)]] 70 mg/m<sup>2</sup> IV once on day 1
 
*[[Cisplatin (Platinol)]] 70 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''28-day cycle for up to 6 cycles'''
 
'''28-day cycle for up to 6 cycles'''
−
 
+
</div></div><br>
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen variant #2, 80 mg/m<sup>2</sup> {{#subobject:8gbd05|Variant=1}}===
 
===Regimen variant #2, 80 mg/m<sup>2</sup> {{#subobject:8gbd05|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
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|-
 
|-
 
|}
 
|}
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''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.''
+
''Note: To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
 
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''28-day cycles'''
 
'''28-day cycles'''
−
 
+
</div></div>
 
===References===
 
===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. [https://doi.org/10.1002/1097-0142(19830901)52:5%3C767::AID-CNCR2820520502%3E3.0.CO;2-P link to original article] [https://pubmed.ncbi.nlm.nih.gov/6347356 PubMed]
 
#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. [https://doi.org/10.1002/1097-0142(19830901)52:5%3C767::AID-CNCR2820520502%3E3.0.CO;2-P link to original article] [https://pubmed.ncbi.nlm.nih.gov/6347356 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. [https://doi.org/10.1200/JCO.1985.3.4.539 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3884746 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. [https://doi.org/10.1200/JCO.1985.3.4.539 link to original article] [https://pubmed.ncbi.nlm.nih.gov/3884746 PubMed]
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#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. [https://doi.org/10.1200/JCO.1992.10.7.1066 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/1607913 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. [https://doi.org/10.1200/JCO.1992.10.7.1066 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/1607913 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. [https://doi.org/10.1200/JCO.1997.15.7.2564 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9215826 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. [https://doi.org/10.1200/JCO.1997.15.7.2564 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9215826 PubMed]
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=Metastatic disease, platinum-refractory=
 
=Metastatic disease, platinum-refractory=
 
==Atezolizumab monotherapy {{#subobject:451e68|Regimen=1}}==
 
==Atezolizumab monotherapy {{#subobject:451e68|Regimen=1}}==
−
 
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:feb2e2|Variant=1}}===
 
===Regimen {{#subobject:feb2e2|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"
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| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of OS
 
|-
 
|-
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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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|}
 +
''Note: this regimen did not meet its primary endpoint in phase 3; here for historical reference only.''
 +
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====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 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
 
Patients are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
−
 
 
*[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1
 
*[[Atezolizumab (Tecentriq)]] 1200 mg IV once on day 1
−
 
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div>
 
===References===
 
===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. [https://www.nature.com/articles/nature13904 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25428503 PubMed] NCT01375842
 
#'''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. [https://www.nature.com/articles/nature13904 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25428503 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. [https://doi.org/10.1016/S0140-6736(16)00561-4 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5480242/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26952546 PubMed] NCT02108652
 
#'''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. [https://doi.org/10.1016/S0140-6736(16)00561-4 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5480242/ link to PMC article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/26952546 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. [https://doi.org/10.1016/S0140-6736(17)33297-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29268948 PubMed] NCT02302807
 
#'''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://doi.org/10.1016/S0140-6736(17)33297-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29268948 PubMed] NCT02302807
−
 
 
==Durvalumab monotherapy {{#subobject:7ae7fb|Regimen=1}}==
 
==Durvalumab monotherapy {{#subobject:7ae7fb|Regimen=1}}==
−
 
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:b2af36|Variant=1}}===
 
===Regimen {{#subobject:b2af36|Variant=1}}===
 
{| class="wikitable sortable" style="width: 80%; text-align:center;"  
 
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''Note: this regimen was intended for patients "who had progressed on, been ineligible for, or refused any number of prior therapies".''
 
''Note: this regimen was intended for patients "who had progressed on, been ineligible for, or refused any number of prior therapies".''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Immunotherapy====
 
====Immunotherapy====
−
 
 
*[[Durvalumab (Imfinzi)]] 10 mg/kg IV over 60 minutes once on day 1
 
*[[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.
 
'''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.
−
 
+
</div></div>
 
===References===
 
===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. [https://doi.org/10.1200/JCO.2016.67.9761 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569690/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27269937 PubMed] NCT01693562
 
#'''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. [https://doi.org/10.1200/JCO.2016.67.9761 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569690/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27269937 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. [https://doi.org/10.1001/jamaoncol.2017.2411 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5824288/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28817753/ PubMed]
 
##'''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. [https://doi.org/10.1001/jamaoncol.2017.2411 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc5824288/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28817753/ PubMed]
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[[Category:Bladder cancer regimens]]
 
[[Category:Bladder cancer regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Historical regimens]]
 
[[Category:Disease-specific pages]]
 
[[Category:Disease-specific pages]]
 
[[Category:Genitourinary cancers]]
 
[[Category:Genitourinary cancers]]

Revision as of 00:16, 1 March 2023

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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


Nonmuscle invasive bladder cancer

Intravesicular Doxorubicin monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Martínez-Piñeiro et al. 1990 1980-1988 Phase 3 (C) 1. BCG Inferior RFS
2. Thiotepa Not reported
Lamm et al. 1991 (SWOG 8216) 1983-1985 Phase 3 (C) BCG Seems to have inferior DFS

Chemotherapy

7-day cycle for 5 cycles, then 30-day cycle for 11 cycles (approximately 1 year)

References

  1. Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. link to original article contains partial protocol PubMed
  2. SWOG 8216: Lamm DL, Blumenstein BA, Crawford ED, Montie JE, Scardino P, Grossman HB, Stanisic TH, Smith JA Jr, Sullivan J, Sarosdy MF, Crissman JD, Coltman CA. A randomized trial of intravesical doxorubicin and immunotherapy with bacille Calmette-Guérin for transitional-cell carcinoma of the bladder. N Engl J Med. 1991 Oct 24;325(17):1205-9. link to original article contains dosing details in manuscript PubMed

Intravesicular Thiotepa monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Martínez-Piñeiro et al. 1990 1980-1988 Phase 3 (C) 1. BCG Inferior RFS
2. Doxorubicin Not reported

Chemotherapy

References

  1. Martínez-Piñeiro JA, Jiménez León J, Martínez-Piñeiro L Jr, Fiter L, Mosteiro JA, Navarro J, García Matres MJ, Cárcamo P. Bacillus Calmette-Guérin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol. 1990 Mar;143(3):502-6. link to original article contains partial protocol PubMed

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

Note: To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.

Chemotherapy

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

Note: To our knowledge, this regimen was not tested as an experimental arm in a RCT prior to becoming a standard comparator arm.

Chemotherapy

28-day cycles

References

  1. 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
  2. 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
  3. 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
  4. 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 dosing details in abstract PubMed
  5. 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 dosing details in manuscript PubMed
    1. 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

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) 1a. Docetaxel
1b. Paclitaxel
1c. Vinflunine 		Did not meet primary endpoint of OS

Note: this regimen did not meet its primary endpoint in phase 3; 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. 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
  2. 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 dosing details in abstract 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 dosing details in abstract 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

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 dosing details in abstract link to PMC article PubMed NCT01693562
    1. 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
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