Non-clear cell renal cell carcinoma

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 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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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:

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

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.

Targeted therapy

Continued indefinitely

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

  1. 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
  2. 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

21-day cycle for up to 36 cycles (2 years)

References

  1. 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.

Targeted therapy

42-day cycles

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

  1. 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
  2. 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
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