Difference between revisions of "Editing test page"

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m (Text replacement - "{| class="wikitable" style="width: 100%" to "{| class="wikitable sortable" style="width: 100%")
m (test edits)
Tag: visualeditor
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|}
 
|}
 
====Biomarker eligiblity criteria====
 
====Biomarker eligiblity criteria====
 +
 
*Gene: HER2
 
*Gene: HER2
 
*Alteration: amplification
 
*Alteration: amplification
Line 47: Line 48:
  
 
====Chemotherapy====
 
====Chemotherapy====
−
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
+
 
 +
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> '''<u>IV once on day 1</u>''' [http://google.com Hello this is a link]
 +
*
 
*[[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>)
 
*[[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:
 
*[[Trastuzumab (Herceptin)]] as follows:
 
**Cycle 1: 8 mg/kg IV once on day 1
 
**Cycle 1: 8 mg/kg IV once on day 1
 
**Subsequent cycles: 6 mg/kg IV once on day 1
 
**Subsequent cycles: 6 mg/kg IV once on day 1
 +
 +
<br />
 +
 +
===== New heading =====
 +
 +
# This is the content of the page.
 +
  
 
'''21-day cycles'''
 
'''21-day cycles'''
  
 
===References===
 
===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://pubmed.ncbi.nlm.nih.gov/20728210 PubMed]
+
 
 +
#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://pubmed.ncbi.nlm.nih.gov/20728210 PubMed]
  
 
==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}==
 
==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}==
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|}
 
|}
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
! style="width: 25%" |Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|Comparator
+
! style="width: 25%" |Comparator
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
 
|[https://doi.org/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
 
|[https://doi.org/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
Line 81: Line 92:
 
|}
 
|}
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
 
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
  
 
====Hormonotherapy====
 
====Hormonotherapy====
 +
 
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
 
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
  
Line 89: Line 102:
  
 
===References===
 
===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://doi.org/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28968163 PubMed]
+
 
 +
#'''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://doi.org/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28968163 PubMed]
  
 
==Abemaciclib & Anastrozole -- modified {{#subobject:213a4e|Regimen=1}}==
 
==Abemaciclib & Anastrozole -- modified {{#subobject:213a4e|Regimen=1}}==
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|}
 
|}
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 20%"|Study
+
! style="width: 20%" |Study
−
!style="width: 20%"|Years of enrollment
+
! style="width: 20%" |Years 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]]
 
|-
 
|-
 
|[https://doi.org/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
 
|[https://doi.org/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
Line 116: Line 130:
 
|}
 
|}
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
 
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
  
 
====Hormonotherapy====
 
====Hormonotherapy====
 +
 
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
 
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
  
Line 124: Line 140:
  
 
===References===
 
===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://doi.org/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28968163 PubMed]
+
 
 +
#'''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://doi.org/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://pubmed.ncbi.nlm.nih.gov/28968163 PubMed]
  
 
==Sunitinib monotherapy {{#subobject:cf6852|Regimen=1}}==
 
==Sunitinib monotherapy {{#subobject:cf6852|Regimen=1}}==
Line 157: Line 174:
 
|}
 
|}
 
====Preceding treatment====
 
====Preceding treatment====
 +
 
*[[Surgery]]
 
*[[Surgery]]
 +
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[Sunitinib (Sutent)]] 50 mg PO once per day on days 1 to 28
 
*[[Sunitinib (Sutent)]] 50 mg PO once per day on days 1 to 28
  
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===References===
 
===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://pubmed.ncbi.nlm.nih.gov/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://pubmed.ncbi.nlm.nih.gov/27718781 PubMed]
+
#'''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://pubmed.ncbi.nlm.nih.gov/26969090 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://pubmed.ncbi.nlm.nih.gov/28967554 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://pubmed.ncbi.nlm.nih.gov/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://pubmed.ncbi.nlm.nih.gov/28967554 PubMed]
  
  
 
===Regimen {{#subobject:90ba4d|Variant=1}}===
 
===Regimen {{#subobject:90ba4d|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
−
!style="width: 20%"|Study
+
! style="width: 20%" |Study
−
!style="width: 20%"|Years of enrollment
+
! style="width: 20%" |Years 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]]
 
![[Overall response rate|ORR]]
 
![[Overall response rate|ORR]]
 
!Comparator [[Overall response rate|ORR]]
 
!Comparator [[Overall response rate|ORR]]
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===Regimen variant #1, CI Ara-C (100 mg/m<sup>2</sup>) {{#subobject:bb27bc|Variant=1}}===
 
===Regimen 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;"  
 
{| class="mw-collapsible mw-collapsed wikitable" style="width: 100%; text-align:center;"  
−
!style="width: 25%"|Study
+
! style="width: 25%" |Study
−
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
−
!style="width: 25%"|Comparator
+
! style="width: 25%" |Comparator
−
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
! 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" |[http://www.bloodjournal.org/content/58/6/1203.long Rai et al. 1981 (CALGB 7421)]
Line 250: Line 271:
  
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[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>)
 
*[[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
 
*[[Daunorubicin (Cerubidine)]] 45 mg/m<sup>2</sup> IV once per day on days 1 to 3
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</div>
 
</div>
 
====Subsequent treatment====
 
====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
 
*Rowe et al. 2004: Patients with persistent disease at day 14 (greater than 5% blasts) underwent an identical second cycle of 7+3i
  
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|ORR > 20%
 
|ORR > 20%
 
|≤ 0.01
 
|≤ 0.01
−
|style="background-color:#1a9850"|Likely to have true ORR >20%
+
| style="background-color:#1a9850" |Likely to have true ORR >20%
 
|-
 
|-
 
|ORR > 20%
 
|ORR > 20%
 
|> 0.01 and ≤ 0.10
 
|> 0.01 and ≤ 0.10
−
|style="background-color:#91cf60"|Might have true ORR >20%
+
| style="background-color:#91cf60" |Might have true ORR >20%
 
|-
 
|-
 
|ORR > 20%
 
|ORR > 20%
 
|> 0.10
 
|> 0.10
−
|style="background-color:#d9ef8b"|Potentially has true ORR >20%
+
| style="background-color:#d9ef8b" |Potentially has true ORR >20%
 
|-
 
|-
 
|ORR < 20%
 
|ORR < 20%
 
|N/A
 
|N/A
−
|style="background-color:#ffffbf"|Unlikely to have true ORR >20%
+
| style="background-color:#ffffbf" |Unlikely to have true ORR >20%
 
|-
 
|-
 
|}
 
|}
−
 
−
 
  
 
[[Category:Null pages]]
 
[[Category:Null pages]]

Revision as of 21:02, 26 October 2020


CF & Trastuzumab -- original

back to top

CF & Trastuzumab: Cisplatin, Fluorouracil, Trastuzumab

Regimen

Study Evidence Comparator Efficacy
Bang et al. 2010 (ToGA) Phase III (E) CF Superior OS

Patients had overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.

CF & Trastuzumab -- modified

back to top

CF & Trastuzumab: Cisplatin, Fluorouracil, Trastuzumab

Regimen

Study Evidence Comparator Efficacy
Bang et al. 2010 (ToGA) Phase III (E) CF Superior OS

Biomarker eligiblity criteria

  • Gene: HER2
  • Alteration: amplification
  • Acceptable methods of measurement: IHC or FISH

Chemotherapy


New heading
  1. This is the content of the page.


21-day cycles

References

  1. 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. link to original article contains verified protocol PubMed

Abemaciclib & Anastrozole -- original

back to top

Regimen

FDA-recommended dose
Study Evidence Comparator Comparative Efficacy
Goetz et al. 2017 (MONARCH 3) Phase III (E) Anastrozole Superior PFS

Chemotherapy

Hormonotherapy

28-day cycles

References

  1. 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. link to original article contains verified protocol PubMed

Abemaciclib & Anastrozole -- modified

back to top

Regimen

FDA-recommended dose
Study Years of enrollment Evidence Comparator Comparative Efficacy
Goetz et al. 2017 (MONARCH 3) Phase III (E) Anastrozole Superior PFS 2014-2015

Chemotherapy

Hormonotherapy

28-day cycles

References

  1. 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. link to original article contains verified protocol PubMed

Sunitinib monotherapy

back to top

Regimen

Study Evidence Comparator Efficacy Toxicity
Haas et al. 2016 (ECOG-ACRIN E2805) Phase III (E) 1. Placebo Seems not superior
2. Sorafenib Seems not superior
Ravaud et al. 2016 (S-TRAC) Phase III (E) Placebo Seems to have superior DFS More toxicity

Preceding treatment

Chemotherapy

42-day cycles, given for up to 1 year

References

  1. 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. link to original article link to PMC article PubMed
  2. 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. link to original article contains verified protocol PubMed
    1. 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. link to original article PubMed


Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy ORR Comparator ORR
Hutson et al. 2013 (A4061051) 2010-2011 Phase III (E-switch-ic) Sorafenib Might have superior PFS (*) 32% 15%

BEACOPP 4+4

Regimen variant #1, CI Ara-C (100 mg/m2)

Study Evidence Comparator Comparative Efficacy
Rai et al. 1981 (CALGB 7421) Phase III 7+3d (bolus Ara-C) Seems to have superior CR rate
5+2d Superior CR rate
5+2d (bolus Ara-C) Superior CR rate
Yates et al. 1982 (CALGB 7721) Phase III 7+3d, low-dose dauno (30 mg/m2) Seems not superior
7+3a (30 mg/m2) Seems not superior
Preisler et al. 1987 (CALGB 7921) Phase III 10+3d Seems not superior
TAD Seems not superior
Wiernik et al. 1992 Phase III 7+3i Seems to have inferior OS
Rowe et al. 2004 Phase III 7+3d + GM-CSF
7+3i
7+3i + GM-CSF
7+3m
7+3m + GM-CSF 		Seems not superior
Fernandez et al. 2009 (ECOG E1900) Phase III (C) 7+3d (high-dose) Inferior OS
Dombret et al. 2015 (AZA-AML-001) Phase III (C) Azacitidine Might have inferior OS

Note: this was the lower bound of the allowable daunorubicin dose in AZA-AML-001.

Chemotherapy

7-day course

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

Efficacy p-value Narrative description
ORR > 20% ≤ 0.01 Likely to have true ORR >20%
ORR > 20% > 0.01 and ≤ 0.10 Might have true ORR >20%
ORR > 20% > 0.10 Potentially has true ORR >20%
ORR < 20% N/A Unlikely to have true ORR >20%
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