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m (Replaced content with "==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab <div class="tocc...")
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==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
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==CF & Trastuzumab -- original {{#subobject:ca9cd1|Regimen=1}}==
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CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
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{| class="wikitable" style="float:right; margin-left: 5px;"
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<div class="toccolours" style="background-color:#eeeeee">
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|-
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===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
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|[[#top|back to top]]
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{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|}
 
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CF & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, Trastuzumab
 
−
 
 
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===Regimen {{#subobject:b2731|Variant=1}}===
 
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{| class="wikitable" style="width: 100%; text-align:center;"
 
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! style="width: 25%" |Study
 
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! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
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! style="width: 25%" |Comparator
 
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! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
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|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext Bang et al. 2010 (ToGA)]
 
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| style="background-color:#1a9851" |Phase III (E)
 
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|[[#Cisplatin_.26_Fluorouracil_4|CF]]
 
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| style="background-color:#1a9850" |Superior OS
 
−
|-
 
−
|}
 
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''Patients had overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.''
 
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==CF & Trastuzumab -- modified {{#subobject:ca9cd1|Regimen=1}}==
 
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{| class="wikitable" style="float:right; margin-left: 5px;"
 
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|-
 
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|[[#top|back to top]]
 
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|}
 
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CF & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, Trastuzumab
 
−
 
 
−
===Regimen {{#subobject:b2731|Variant=1}}===
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
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! style="width: 25%" |Study
 
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! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
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! style="width: 25%" |Comparator
 
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! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
|-
 
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|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext Bang et al. 2010 (ToGA)]
 
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| style="background-color:#1a9851" |Phase III (E)
 
−
|[[#Cisplatin_.26_Fluorouracil_4|CF]]
 
−
| style="background-color:#1a9850" |Superior OS
 
−
|-
 
−
|}
 
−
====Biomarker eligiblity criteria====
 
−
*Gene: HER2
 
−
*Alteration: amplification
 
−
*Acceptable methods of measurement: IHC or FISH
 
−
 
 
−
====Chemotherapy====
 
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
 
−
*[[Fluorouracil (5-FU)]] 800 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
 
−
*[[Trastuzumab (Herceptin)]] as follows:
 
−
**Cycle 1: 8 mg/kg IV once on day 1
 
−
**Subsequent cycles: 6 mg/kg IV once on day 1
 
−
 
 
−
'''21-day cycles'''
 
−
 
 
−
===References===
 
−
# Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20728210 PubMed]
 
−
 
 
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==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
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|-
 
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|[[#top|back to top]]
 
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|}
 
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===Regimen {{#subobject:c0e636|Variant=1}}===
 
−
{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|Comparator
 
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
 
−
| style="background-color:#1a9851" |Phase III (E)
 
−
|[[#Anastrozole_monotherapy_3|Anastrozole]]
 
−
| style="background-color:#1a9850" |Superior PFS
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
 
−
 
 
−
====Hormonotherapy====
 
−
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
 
−
 
 
−
'''28-day cycles'''
 
−
 
 
−
===References===
 
−
# '''MONARCH 3:''' Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. [https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28968163 PubMed]
 
−
 
 
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==Abemaciclib & Anastrozole -- modified {{#subobject:213a4e|Regimen=1}}==
 
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{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
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|[[#top|back to top]]
 
−
|}
 
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===Regimen {{#subobject:c0e636|Variant=1}}===
 
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{| class="wikitable" style="color:white; background-color:#404040"
 
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|<small>'''FDA-recommended dose'''</small>
 
−
|-
 
−
|}
 
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{| class="wikitable" style="width: 100%; text-align:center;"  
 
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
−
!style="width: 20%"|Years of study
 
−
|-
 
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|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
 
−
| style="background-color:#1a9851" |Phase III (E)
 
−
|[[#Anastrozole_monotherapy_3|Anastrozole]]
 
−
| style="background-color:#1a9850" |Superior PFS
 
−
|2014-2015
 
−
|-
 
−
|}
 
−
====Chemotherapy====
 
−
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
 
−
 
−
====Hormonotherapy====
 
−
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
 
−
 
−
'''28-day cycles'''
 
−
 
−
===References===
 
−
# '''MONARCH 3:''' Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. [https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28968163 PubMed]
 
−
 
−
==Sunitinib monotherapy {{#subobject:cf6852|Regimen=1}}==
 
−
{| class="wikitable" style="float:right; margin-left: 5px;"
 
−
|-
 
−
|[[#top|back to top]]
 
−
|}
 
−
===Regimen {{#subobject:3c0a01|Variant=1}}===
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
−
! style="width: 20%" |Study
 
−
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
−
! style="width: 20%" |Comparator
 
−
! style="width: 20%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
−
! style="width: 20%" |[[Levels_of_Evidence#Toxicity|Toxicity]]
 
−
|-
 
−
| rowspan="2" |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878938/ Haas et al. 2016 (ECOG-ACRIN E2805)]
 
−
| rowspan="2" style="background-color:#1a9851" |Phase III (E)
 
−
|[[#Placebo|1. Placebo]]
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|
 
−
|-
 
−
|2. Sorafenib
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|
 
−
|-
 
−
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1611406 Ravaud et al. 2016 (S-TRAC)]
 
−
| style="background-color:#1a9851" |Phase III (E)
 
−
|[[#Placebo|Placebo]]
 
−
| style="background-color:#91cf60" |Seems to have superior DFS
 
−
| style="background-color:#d73027" |More toxicity
 
−
|-
 
−
|}
 
−
====Preceding treatment====
 
−
*[[Surgery]]
 
−
====Chemotherapy====
 
−
*[[Sunitinib (Sutent)]] 50 mg PO once per day on days 1 to 28
 
−
 
−
'''42-day cycles, given for up to 1 year'''
 
−
 
−
===References===
 
−
# '''ECOG-ACRIN E2805:''' Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016 May 14;387(10032):2008-16. Epub 2016 Mar 9. Erratum in: Lancet. 2016 May 14;387(10032):1998. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00559-6/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878938/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26969090 PubMed]
 
−
# '''S-TRAC:''' Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9. [https://www.nejm.org/doi/full/10.1056/NEJMoa1611406 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/27718781 PubMed]
 
−
## '''Update:''' Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant sunitinib for high-risk renal cell carcinoma after nephrectomy: subgroup analyses and updated overall survival results. Eur Urol. 2018 Jan;73(1):62-68. Epub 2017 Sep 26. [http://www.europeanurology.com/article/S0302-2838(17)30772-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28967554 PubMed]
 
−
 
−
 
−
==BEACOPP 4+4==
 
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−
===Variant #1, CI Ara-C (100 mg/m<sup>2</sup>) {{#subobject:bb27bc|Variant=1}}===
 
−
{| class="mw-collapsible mw-collapsed wikitable" style="width: 100%; text-align:center;"
 
−
!style="width: 25%"|Study
 
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
−
!style="width: 25%"|Comparator
 
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
−
|-
 
−
| rowspan="3" |[http://www.bloodjournal.org/content/58/6/1203.long Rai et al. 1981 (CALGB 7421)]
 
−
| rowspan="3" style="background-color:#1a9851" |Phase III
 
−
|7+3d (bolus Ara-C)
 
−
| style="background-color:#91cf60" |Seems to have superior CR rate
 
−
|-
 
−
|5+2d
 
−
| style="background-color:#1a9850" |Superior CR rate
 
−
|-
 
−
|5+2d (bolus Ara-C)
 
−
| style="background-color:#1a9850" |Superior CR rate
 
−
|-
 
−
| rowspan="2" |[http://www.bloodjournal.org/content/60/2/454.long Yates et al. 1982 (CALGB 7721)]
 
−
| rowspan="2" style="background-color:#1a9851" |Phase III
 
−
|7+3d, low-dose dauno (30 mg/m<sup>2</sup>)
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
|7+3a (30 mg/m<sup>2</sup>)
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
| rowspan="2" |[http://www.bloodjournal.org/content/69/5/1441.long Preisler et al. 1987 (CALGB 7921)]
 
−
| rowspan="2" style="background-color:#1a9851" |Phase III
 
−
|10+3d
 
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| style="background-color:#ffffbf" |Seems not superior
 
 
|-
 
|-
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|TAD
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
−
| style="background-color:#ffffbf" |Seems not superior
+
{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
 +
|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
 
|-
 
|-
−
|[http://www.bloodjournal.org/content/79/2/313 Wiernik et al. 1992]
+
|Click to learn more!
−
| style="background-color:#1a9851" |Phase III
 
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|[[#7.2B3i|7+3i]]
 
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| style="background-color:#fc8d59" |Seems to have inferior OS
 
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|-
 
−
|[http://www.bloodjournal.org/content/103/2/479.long Rowe et al. 2004]
 
−
| style="background-color:#1a9851" |Phase III
 
−
|7+3d + GM-CSF<br> [[#7.2B3i|7+3i]]<br> 7+3i + GM-CSF<br> [[#7.2B3m|7+3m]]<br> 7+3m + GM-CSF
 
−
| style="background-color:#ffffbf" |Seems not superior
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480917/ Fernandez et al. 2009 (ECOG E1900)]
 
−
| style="background-color:#1a9851" |Phase III (C)
 
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|[[#7.2B3d_.28high-dose.29|7+3d (high-dose)]]
 
−
| style="background-color:#d73027" |Inferior OS
 
−
|-
 
−
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504945/ Dombret et al. 2015 (AZA-AML-001)]
 
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| style="background-color:#1a9851" |Phase III (C)
 
−
|[[#Azacitidine_monotherapy|Azacitidine]]
 
−
| style="background-color:#fee08b" |Might have inferior OS
 
 
|-
 
|-
 
|}
 
|}
−
''Note: this was the lower bound of the allowable daunorubicin dose in AZA-AML-001.''
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|2017-2019
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<div class="toccolours" style="width:100%; overflow:auto;">
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
−
 
+
|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
−
====Chemotherapy====
+
| style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75)
−
*[[Cytarabine (Ara-C)]] 100 mg/m<sup>2</sup>/day IV continuous infusion on days 1 to 7 (total dose: 700 mg/m<sup>2</sup>)
 
−
*[[Daunorubicin (Cerubidine)]] 45 mg/m<sup>2</sup> IV once per day on days 1 to 3
 
−
 
 
−
'''7-day course'''
 
−
</div>
 
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====Subsequent treatment====
 
−
*Rowe et al. 2004: Patients with persistent disease at day 14 (greater than 5% blasts) underwent an identical second cycle of 7+3i
 
−
 
 
−
albjablja;ldkjgs
 
−
 
 
−
{| class="wikitable" style="width: 100%; text-align:center;"
 
−
!Efficacy
 
−
!p-value
 
−
!Narrative description
 
−
|-
 
−
|ORR > 20%
 
−
|≤ 0.01
 
−
|style="background-color:#1a9850"|Likely to have true ORR >20%
 
−
|-
 
−
|ORR > 20%
 
−
|> 0.01 and ≤ 0.10
 
−
|style="background-color:#91cf60"|Might have true ORR >20%
 
−
|-
 
−
|ORR > 20%
 
−
|> 0.10
 
−
|style="background-color:#d9ef8b"|Potentially has true ORR >20%
 
−
|-
 
−
|ORR < 20%
 
−
|N/A
 
−
|style="background-color:#ffffbf"|Unlikely to have true ORR >20%
 
 
|-
 
|-
 
|}
 
|}
−
 
+
''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
−
 
+
<div class="toccolours" style="background-color:#fdcdac">
−
 
+
====Biomarker eligibility criteria====
−
[[Category:Null pages]]
+
*CheckMate 816: No sensitizing EGFR or ALK mutations
 +
</div></div>

Latest revision as of 12:58, 18 July 2024

Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC 		Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations
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