Difference between revisions of "Papillary renal cell carcinoma"

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Note: these are regimens tested in histology-specific populations, please see the '''[[Renal cell carcinoma|main RCC page]]''' for other regimens.
 
Note: these are regimens tested in histology-specific populations, please see the '''[[Renal cell carcinoma|main RCC page]]''' for other regimens.
 
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=Guidelines=
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'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
 +
==NCCN==
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*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1440 NCCN Guidelines - Kidney Cancer].''
 
=Metastatic disease, first-line=
 
=Metastatic disease, first-line=
 
==Cabozantinib monotherapy {{#subobject:8agz0a|Regimen=1}}==
 
==Cabozantinib monotherapy {{#subobject:8agz0a|Regimen=1}}==
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|rowspan=2 style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ic)
 
|rowspan=2 style="background-color:#1a9851" |Randomized Phase 2 (E-switch-ic)
 
|1. [[#Sunitinib_monotherapy|Sunitinib]]
 
|1. [[#Sunitinib_monotherapy|Sunitinib]]
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| style="background-color:#91cf60" |Seems to have superior PFS<br>Median PFS: 9 vs 5.6 mo<br>(HR 0.60, 95% CI 0.37-0.97)
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| style="background-color:#91cf60" |Seems to have superior PFS (primary endpoint)<br>Median PFS: 9 vs 5.6 mo<br>(HR 0.60, 95% CI 0.37-0.97)
 
|-
 
|-
 
|2. [[#Crizotinib_monotherapy_999|Crizotinib]]<br>3. [[#Savolitinib_monotherapy_777|Savolitinib]]
 
|2. [[#Crizotinib_monotherapy_999|Crizotinib]]<br>3. [[#Savolitinib_monotherapy_777|Savolitinib]]
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
*[[Cabozantinib (Cometriq)|Cabozantinib (Cabometyx)]] 60 mg PO once per day
+
*[[Cabozantinib (Cometriq)|Cabozantinib (Cabometyx)]] 60 mg PO once per day on days 1 to 28
−
'''Continued indefinitely'''
+
'''28-day cycles'''
 
</div></div>
 
</div></div>
 +
 
===References===
 
===References===
−
# '''SWOG S1500:''' Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. [https://doi.org/10.1016/s0140-6736(21)00152-5 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8687736/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33592176/ PubMed] [https://clinicaltrials.gov/study/NCT02761057 Clinical Trials Registry]
+
# '''SWOG S1500:''' Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. [https://doi.org/10.1016/s0140-6736(21)00152-5 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8687736/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33592176/ PubMed] [https://clinicaltrials.gov/study/NCT02761057 NCT02761057]
 
==Erlotinib monotherapy {{#subobject:862d0a|Regimen=1}}==
 
==Erlotinib monotherapy {{#subobject:862d0a|Regimen=1}}==
 
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<div class="toccolours" style="background-color:#eeeeee">
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
*[[Erlotinib (Tarceva)]] 150 mg PO once per day
+
*[[Erlotinib (Tarceva)]] 150 mg PO once per day on days 1 to 28
−
'''Continued indefinitely'''
+
'''28-day cycles'''
 
</div></div>
 
</div></div>
 +
 
===References===
 
===References===
−
# '''SWOG S0317:''' Gordon MS, Hussey M, Nagle RB, Lara PN Jr, Mack PC, Dutcher J, Samlowski W, Clark JI, Quinn DI, Pan CX, Crawford D. Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol. 2009 Dec 1;27(34):5788-93. Epub 2009 Nov 2. [https://doi.org/10.1200/jco.2008.18.8821 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2793000/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19884559/ PubMed] [https://clinicaltrials.gov/study/NCT00060307 Clinical Trials Registry]
+
# '''SWOG S0317:''' Gordon MS, Hussey M, Nagle RB, Lara PN Jr, Mack PC, Dutcher J, Samlowski W, Clark JI, Quinn DI, Pan CX, Crawford D. Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol. 2009 Dec 1;27(34):5788-93. Epub 2009 Nov 2. [https://doi.org/10.1200/jco.2008.18.8821 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2793000/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19884559/ PubMed] [https://clinicaltrials.gov/study/NCT00060307 NCT00060307]
 
==Sunitinib monotherapy {{#subobject:b4a97a|Regimen=1}}==
 
==Sunitinib monotherapy {{#subobject:b4a97a|Regimen=1}}==
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
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|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7260692/ Choueiri et al. 2020 (SAVOIR)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7260692/ Choueiri et al. 2020 (SAVOIR)]
−
|2017-2018
+
|2017-07 to 2018-11
 
| style="background-color:#1a9851" |Phase 3 (C)
 
| style="background-color:#1a9851" |Phase 3 (C)
−
|[[#Savolitinib_monotherapy_777|Savolitinib]]
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|[[#Savolitinib_monotherapy_999|Savolitinib]]
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
| style="background-color:#ffffbf" |Did not meet primary endpoint of PFS
 
|-
 
|-
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'''42-day cycles'''
 
'''42-day cycles'''
 
</div></div>
 
</div></div>
 +
 
===References===
 
===References===
 
# '''Retrospective:''' Choueiri TK, Plantade A, Elson P, Negrier S, Ravaud A, Oudard S, Zhou M, Rini BI, Bukowski RM, Escudier B. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol. 2008 Jan 1;26(1):127-31. [https://doi.org/10.1200/jco.2007.13.3223 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18165647/ PubMed]
 
# '''Retrospective:''' Choueiri TK, Plantade A, Elson P, Negrier S, Ravaud A, Oudard S, Zhou M, Rini BI, Bukowski RM, Escudier B. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol. 2008 Jan 1;26(1):127-31. [https://doi.org/10.1200/jco.2007.13.3223 link to original article] [https://pubmed.ncbi.nlm.nih.gov/18165647/ PubMed]
−
# '''SAVOIR:''' Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. Erratum in: JAMA Oncol. 2020 Sep 1;6(9):1473. [https://doi.org/10.1001/jamaoncol.2020.2218 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7260692/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469384/ PubMed] [https://clinicaltrials.gov/study/NCT03091192 Clinical Trials Registry]
+
# '''SAVOIR:''' Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. Erratum in: JAMA Oncol. 2020 Sep 1;6(9):1473. [https://doi.org/10.1001/jamaoncol.2020.2218 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7260692/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32469384/ PubMed] [https://clinicaltrials.gov/study/NCT03091192 NCT03091192]
−
# '''SWOG S1500:''' Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. [https://doi.org/10.1016/s0140-6736(21)00152-5 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8687736/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33592176/ PubMed] [https://clinicaltrials.gov/study/NCT02761057 Clinical Trials Registry]
+
# '''SWOG S1500:''' Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. [https://doi.org/10.1016/s0140-6736(21)00152-5 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8687736/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33592176/ PubMed] [https://clinicaltrials.gov/study/NCT02761057 NCT02761057]
 
[[Category:Papillary renal cell carcinoma regimens]]
 
[[Category:Papillary renal cell carcinoma regimens]]
−
[[Category:Disease-specific pages]]
 
 
[[Category:Histology-specific pages]]
 
[[Category:Histology-specific pages]]
 
[[Category:Renal cell carcinomas]]
 
[[Category:Renal cell carcinomas]]

Latest revision as of 11:35, 13 May 2024

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Page editor Section editor
Tejaganta.jpg
 Teja Ganta, MD
Icahn School of Medicine at Mount Sinai
New York, NY, USA
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 Ali Raza Khaki, MD
Stanford University
Palo Alto, CA, USA
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Note: these are regimens tested in histology-specific populations, please see the main RCC page for other regimens.

3 regimens on this page
3 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

Metastatic disease, first-line

Cabozantinib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Pal et al. 2021 (SWOG S1500) 2016-2019 Randomized Phase 2 (E-switch-ic) 1. Sunitinib Seems to have superior PFS (primary endpoint)
Median PFS: 9 vs 5.6 mo
(HR 0.60, 95% CI 0.37-0.97)
2. Crizotinib
3. Savolitinib 		Not reported

Note: SWOG S1500 was also open to previously treated patients (maximimum of one line of therapy) but almost all patients were untreated at time of study enrollment.

Targeted therapy

28-day cycles

References

  1. SWOG S1500: Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. link to original article contains dosing details in manuscript link to PMC article PubMed NCT02761057

Erlotinib monotherapy

Regimen

Study Dates of enrollment Evidence Efficacy
Gordon et al. 2009 (SWOG S0317) 2005-2006 Phase 2 ORR: 11% (95% CI 3-24%)

Targeted therapy

28-day cycles

References

  1. SWOG S0317: Gordon MS, Hussey M, Nagle RB, Lara PN Jr, Mack PC, Dutcher J, Samlowski W, Clark JI, Quinn DI, Pan CX, Crawford D. Phase II study of erlotinib in patients with locally advanced or metastatic papillary histology renal cell cancer: SWOG S0317. J Clin Oncol. 2009 Dec 1;27(34):5788-93. Epub 2009 Nov 2. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00060307

Sunitinib monotherapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Pal et al. 2021 (SWOG S1500) 2016-2019 Randomized Phase 2 (C) 1. Cabozantinib Seems to have inferior PFS
2. Crizotinib
3. Savolitinib 		Not reported
Choueiri et al. 2020 (SAVOIR) 2017-07 to 2018-11 Phase 3 (C) Savolitinib Did not meet primary endpoint of PFS

Note: SWOG S1500 was also open to previously treated patients (maximimum of one line of therapy) but almost all patients were untreated at time of study enrollment.

Biomarker eligibility criteria

  • SAVOIR: Chromosome 7 gain, MET amplification, MET kinase domain variations, or HGF amplification without any co-occurring FH or VHL variations

Targeted therapy

42-day cycles

References

  1. Retrospective: Choueiri TK, Plantade A, Elson P, Negrier S, Ravaud A, Oudard S, Zhou M, Rini BI, Bukowski RM, Escudier B. Efficacy of sunitinib and sorafenib in metastatic papillary and chromophobe renal cell carcinoma. J Clin Oncol. 2008 Jan 1;26(1):127-31. link to original article PubMed
  2. SAVOIR: Choueiri TK, Heng DYC, Lee JL, Cancel M, Verheijen RB, Mellemgaard A, Ottesen LH, Frigault MM, L'Hernault A, Szijgyarto Z, Signoretti S, Albiges L. Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Aug 1;6(8):1247-1255. Erratum in: JAMA Oncol. 2020 Sep 1;6(9):1473. link to original article link to PMC article contains dosing details in manuscript PubMed NCT03091192
  3. SWOG S1500: Pal SK, Tangen C, Thompson IM Jr, Balzer-Haas N, George DJ, Heng DYC, Shuch B, Stein M, Tretiakova M, Humphrey P, Adeniran A, Narayan V, Bjarnason GA, Vaishampayan U, Alva A, Zhang T, Cole S, Plets M, Wright J, Lara PN Jr. A comparison of sunitinib with cabozantinib, crizotinib, and savolitinib for treatment of advanced papillary renal cell carcinoma: a randomised, open-label, phase 2 trial. Lancet. 2021 Feb 20;397(10275):695-703. Epub 2021 Feb 12. link to original article contains dosing details in manuscript link to PMC article PubMed NCT02761057
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