Non-clear cell renal cell carcinoma
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There are several related dedicated pages:
- General RCC page: Renal cell carcinoma
- Histology-specific:
- Biomarker-specific:
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 |
Last updated on 2024-07-23: 3 regimens on this page
3 variants on this page
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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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors PubMed NCT01108445
Pembrolizumab monotherapy
Regimen
Study | Dates of enrollment | Evidence | Efficacy |
---|---|---|---|
McDermott et al. 2021 (KEYNOTE-427nccRCC) | 2016 to not reported | 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 dosing details in abstract have been reviewed by our editors 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 (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 dosing details in manuscript have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors PubMed NCT01108445