Papillary renal cell carcinoma
Revision as of 01:20, 18 April 2021 by Jwarner (talk | contribs) (→Sunitinib monotherapy {{#subobject:b4a97a|Regimen=1}})
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Ali Raza Khaki, MD Stanford University Palo Alto, CA  arkhaki
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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
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Metastatic disease, first-line
Cabozantinib monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Pal et al. 2021 (SWOG S1500) | 2016-2019 | Randomized Phase II (E-switch-ic) | 1. Sunitinib | Seems to have superior PFS |
| 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
- Cabozantinib (Cabometyx) 60 mg PO once per day
Continued indefinitely
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 12:S0140-6736(21)00152-5. Epub ahead of print. link to original article contains verified protocol PubMed NCT02761057
Erlotinib monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| Gordon et al. 2009 (SWOG S0317) | 2005-2006 | Phase II | ORR: 11% (95% CI 3-24%) |
Targeted therapy
- Erlotinib (Tarceva) 150 mg PO once per day, given 1 hour before or 2 hours after meals
Continued indefinitely
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. link to original article contains verified protocol link to PMC article PubMed NCT00060307
Pembrolizumab monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Efficacy |
|---|---|---|---|
| McDermott et al. 2021 (KEYNOTE-427) | 2016-NR | Phase II | ORR: 27% |
Note: this reference describes 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-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. link to original article contains protocol PubMed NCT02853344
Sunitinib monotherapy
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Regimen
| Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Pal et al. 2021 (SWOG S1500) | 2016-2019 | Randomized Phase II (C) | 1. Cabozantinib | Seems to have inferior PFS |
| 2. Crizotinib 3. Savolitinib |
Not reported | |||
| Choueiri et al. 2020 (SAVOIR) | 2017-2018 | Phase III (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
- Sunitinib (Sutent) 50 mg PO once per day on days 1 to 28
42-day cycles
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. link to original article 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. link to original article link to PMC article contains verified protocol PubMed 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 12:S0140-6736(21)00152-5. Epub ahead of print. link to original article contains verified protocol PubMed NCT02761057