Difference between revisions of "Non-clear cell renal cell carcinoma"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
− | {{#lst: | + | {{#lst:Editorial board transclusions|rcc}} |
''Are you looking for a regimen but can't find it here? It is possible that we've moved it to the [[Renal_cell_carcinoma_-_historical|historical regimens page]]. For placebo or observational studies in this condition, please visit [[Renal cell carcinoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ''Are you looking for a regimen but can't find it here? It is possible that we've moved it to the [[Renal_cell_carcinoma_-_historical|historical regimens page]]. For placebo or observational studies in this condition, please visit [[Renal cell carcinoma - null regimens|this page]]. If you still can't find it, please let us know so we can add it!'' | ||
<br>There are several related dedicated pages: | <br>There are several related dedicated pages: | ||
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|} | |} | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
+ | =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== | ||
+ | *''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= | ||
==Everolimus monotherapy {{#subobject:b3af63|Regimen=1}}== | ==Everolimus monotherapy {{#subobject:b3af63|Regimen=1}}== | ||
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====Targeted therapy==== | ====Targeted therapy==== | ||
*[[Everolimus (Afinitor)]] 10 mg PO once per day | *[[Everolimus (Afinitor)]] 10 mg PO once per day | ||
− | |||
'''Continued indefinitely''' | '''Continued indefinitely''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#fff2ae"> | ||
+ | ====Dose and schedule modifications==== | ||
+ | *ESPN: Dose can be reduced to 5 mg PO once per day or every other day if needed based on tolerability | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
#'''ESPN:''' Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. [https://doi.org/10.1016/j.eururo.2015.10.049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879109/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26626617/ PubMed] [https://clinicaltrials.gov/study/NCT01185366 NCT01185366] | #'''ESPN:''' Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. [https://doi.org/10.1016/j.eururo.2015.10.049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879109/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26626617/ PubMed] [https://clinicaltrials.gov/study/NCT01185366 NCT01185366] | ||
− | #'''ASPEN:''' Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. [https://doi.org/10.1016/S1470-2045(15)00515-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6863151/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26794930/ PubMed] [https://clinicaltrials.gov/study/NCT01108445 NCT01108445] | + | #'''ASPEN:''' Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. [https://doi.org/10.1016/S1470-2045(15)00515-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6863151/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26794930/ PubMed] [https://clinicaltrials.gov/study/NCT01108445 NCT01108445] |
==Pembrolizumab monotherapy {{#subobject:18jguz|Regimen=1}}== | ==Pembrolizumab monotherapy {{#subobject:18jguz|Regimen=1}}== | ||
<div class="toccolours" style="background-color:#eeeeee"> | <div class="toccolours" style="background-color:#eeeeee"> | ||
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!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
|- | |- | ||
− | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078262/ McDermott et al. 2021 (KEYNOTE-427)] | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078262/ McDermott et al. 2021 (KEYNOTE-427<sub>nccRCC</sub>)] |
|2016-NR | |2016-NR | ||
| style="background-color:#91cf61" |Phase 2 | | style="background-color:#91cf61" |Phase 2 | ||
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|- | |- | ||
|} | |} | ||
− | ''Note: this reference | + | ''Note: this reference described the non-clear cell cohort of KEYNOTE-427.'' |
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Immunotherapy==== | ====Immunotherapy==== | ||
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</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | #'''KEYNOTE-427:''' McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, Wiechno P, Gafanov RA, Tomczak P, Pouliot F, Donskov F, Alekseev BY, Shin SJ, Bjarnason GA, Castellano D, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. Epub 2021 Feb 2. [https://doi.org/10.1200/jco.20.02365 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078262/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33529058/ PubMed] [https://clinicaltrials.gov/study/NCT02853344 NCT02853344] | + | #'''KEYNOTE-427<sub>nccRCC</sub>:''' McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, Wiechno P, Gafanov RA, Tomczak P, Pouliot F, Donskov F, Alekseev BY, Shin SJ, Bjarnason GA, Castellano D, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. Epub 2021 Feb 2. [https://doi.org/10.1200/jco.20.02365 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc8078262/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33529058/ PubMed] [https://clinicaltrials.gov/study/NCT02853344 NCT02853344] |
==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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====Targeted therapy==== | ====Targeted therapy==== | ||
*[[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 | ||
− | |||
'''42-day cycles''' | '''42-day cycles''' | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#fff2ae"> | ||
+ | ====Dose and schedule modifications==== | ||
+ | *Per some references, dose may be decreased to 37.5 mg or 25 mg PO once per day depending on tolerability | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
#'''ESPN:''' Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. [https://doi.org/10.1016/j.eururo.2015.10.049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879109/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26626617/ PubMed] [https://clinicaltrials.gov/study/NCT01185366 NCT01185366] | #'''ESPN:''' Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. [https://doi.org/10.1016/j.eururo.2015.10.049 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4879109/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26626617/ PubMed] [https://clinicaltrials.gov/study/NCT01185366 NCT01185366] | ||
− | #'''ASPEN:''' Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. [https://doi.org/10.1016/S1470-2045(15)00515-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6863151/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26794930/ PubMed] [https://clinicaltrials.gov/study/NCT01108445 NCT01108445] | + | #'''ASPEN:''' Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. [https://doi.org/10.1016/S1470-2045(15)00515-X link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc6863151/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/26794930/ PubMed] [https://clinicaltrials.gov/study/NCT01108445 NCT01108445] |
[[Category:Non-clear cell renal cell carcinoma regimens]] | [[Category:Non-clear cell renal cell carcinoma regimens]] | ||
− | |||
[[Category:Histology-specific pages]] | [[Category:Histology-specific pages]] | ||
[[Category:Renal cell carcinomas]] | [[Category:Renal cell carcinomas]] |
Latest revision as of 11:26, 13 May 2024
Page editor | Section editor | ||
---|---|---|---|
Teja Ganta, MD Icahn School of Medicine at Mount Sinai New York, NY, USA |
Ali Raza Khaki, MD Stanford University Palo Alto, CA, USA |
Are you looking for a regimen but can't find it here? It is possible that we've moved it to the historical regimens page. For placebo or observational studies in this condition, please visit this page. If you still can't find it, please let us know so we can add it!
There are several related dedicated pages:
- General RCC page: Renal cell carcinoma
- Histology-specific:
- Biomarker-specific:
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
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Kidney Cancer.
Metastatic disease, first-line
Everolimus monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tannir et al. 2015 (ESPN) | 2010-2013 | Randomized Phase 2 (E-switch-ic) | Sunitinib | Did not meet primary endpoint of PFS |
Armstrong et al. 2016 (ASPENRCC) | 2010-2013 | Randomized Phase 2 (E-switch-ic) | Sunitinib | Might have inferior PFS (primary endpoint) |
Note: ASPEN should not be confused with the trial by the same name in Waldenström macroglobulinemia.
Dose and schedule modifications
- ESPN: Dose can be reduced to 5 mg PO once per day or every other day if needed based on tolerability
References
- ESPN: Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. link to original article link to PMC article contains dosing details in manuscript PubMed NCT01185366
- ASPEN: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. link to original article link to PMC article contains dosing details in manuscript PubMed NCT01108445
Pembrolizumab monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
McDermott et al. 2021 (KEYNOTE-427nccRCC) | 2016-NR | Phase 2 | ORR: 27% |
Note: this reference described the non-clear cell cohort of KEYNOTE-427.
Immunotherapy
- Pembrolizumab (Keytruda) 200 mg IV once on day 1
21-day cycle for up to 36 cycles (2 years)
References
- KEYNOTE-427nccRCC: McDermott DF, Lee JL, Ziobro M, Suarez C, Langiewicz P, Matveev VB, Wiechno P, Gafanov RA, Tomczak P, Pouliot F, Donskov F, Alekseev BY, Shin SJ, Bjarnason GA, Castellano D, Silverman RK, Perini RF, Schloss C, Atkins MB. Open-Label, Single-Arm, Phase II Study of Pembrolizumab Monotherapy as First-Line Therapy in Patients With Advanced Non-Clear Cell Renal Cell Carcinoma. J Clin Oncol. 2021 Mar 20;39(9):1029-1039. Epub 2021 Feb 2. link to original article contains dosing details in abstract link to PMC article PubMed NCT02853344
Sunitinib monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Tannir et al. 2015 (ESPN) | 2010-2013 | Randomized Phase 2 (E-switch-ic) | Everolimus | Did not meet primary endpoint of PFS |
Armstrong et al. 2016 (ASPENRCC) | 2010-2013 | Randomized Phase 2 (E-switch-ic) | Everolimus | Might have superior PFS (primary endpoint) Median PFS: 8.3 vs 5.6 mo<br)(HR 0.71, 80% CI 0.52-0.97) |
Note: ASPEN should not be confused with the trial by the same name in Waldenström macroglobulinemia.
Dose and schedule modifications
- Per some references, dose may be decreased to 37.5 mg or 25 mg PO once per day depending on tolerability
References
- ESPN: Tannir NM, Jonasch E, Albiges L, Altinmakas E, Ng CS, Matin SF, Wang X, Qiao W, Dubauskas Lim Z, Tamboli P, Rao P, Sircar K, Karam JA, McDermott DF, Wood CG, Choueiri TK. Everolimus versus sunitinib prospective evaluation in metastatic non-clear cell renal cell carcinoma (ESPN): a randomized multicenter phase 2 trial. Eur Urol. 2016 May;69(5):866-74. Epub 2015 Nov 26. link to original article link to PMC article contains dosing details in manuscript PubMed NCT01185366
- ASPEN: Armstrong AJ, Halabi S, Eisen T, Broderick S, Stadler WM, Jones RJ, Garcia JA, Vaishampayan UN, Picus J, Hawkins RE, Hainsworth JD, Kollmannsberger CK, Logan TF, Puzanov I, Pickering LM, Ryan CW, Protheroe A, Lusk CM, Oberg S, George DJ. Everolimus versus sunitinib for patients with metastatic non-clear cell renal cell carcinoma (ASPEN): a multicentre, open-label, randomised phase 2 trial. Lancet Oncol. 2016 Mar;17(3):378-88. Epub 2016 Jan 13. link to original article link to PMC article contains dosing details in manuscript PubMed NCT01108445