Renal cell carcinoma

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Metastatic disease

Axitinib (Inlyta)

Regimen

• Axitinib (Inlyta) 5 mg PO BID x at least 2 weeks
  • Then if tolerated and BP not greater than 150/90, increased to 7 mg PO BID
    • Then if tolerated and BP not greater than 150/90, increased to 10 mg PO BID
  • Dose can be reduced to 2-3 mg PO BID if needed based on tolerability

References

1. Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. Epub 2011 Nov 4. link to original article contains verified protocol PubMed

Bevacizumab (Avastin)

Regimen

• Bevacizumab (Avastin) 10 mg/kg IV over 90 minutes (can subsequently be reduced to 60 and 30 minute infusions as tolerated) every 2 weeks

given for up to 104 weeks, until progression of disease, or unacceptable toxicity

References

1. Bukowski RM, Kabbinavar FF, Figlin RA, Flaherty K, Srinivas S, Vaishampayan U, Drabkin HA, Dutcher J, Ryba S, Xia Q, Scappaticci FA, McDermott D. Randomized phase II study of erlotinib combined with bevacizumab compared with bevacizumab alone in metastatic renal cell cancer. J Clin Oncol. 2007 Oct 10;25(29):4536-41. Epub 2007 Sep 17. link to original article contains verified protocol PubMed

Bevacizumab (Avastin) & Interferon alfa-2a (Roferon-A)

Regimen

• Bevacizumab (Avastin) 10 mg/kg IV every 2 weeks
• Interferon alfa-2a (Roferon-A) 9 million units SC 3 times per week
  • Dose can be reduced to 3 or 6 million units SC 3 times per week based on tolerability

Interferon alfa-2a given for up to 52 weeks, until progression of disease, or unacceptable toxicity; bevacizumab given until progression of disease or unacceptable toxicity

References

1. Escudier B, Bellmunt J, Négrier S, Bajetta E, Melichar B, Bracarda S, Ravaud A, Golding S, Jethwa S, Sneller V. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol. 2010 May 1;28(13):2144-50. Epub 2010 Apr 5. link to original article contains verified protocol PubMed

Erlotinib (Tarceva)

Regimen

• Erlotinib (Tarceva) 150 mg PO daily, 1 hour before or 2 hours after meals

given until progression of disease or unacceptable toxicity

References

1. 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 PubMed

Everolimus (Afinitor)

Regimen

• Everolimus (Afinitor) 10 mg PO daily
  • Dose can be reduced to 5 mg PO daily or every other day if needed based on tolerability

References

1. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Figlin RA, Hollaender N, Urbanowitz G, Berg WJ, Kay A, Lebwohl D, Ravaud A; RECORD-1 Study Group. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial. Lancet. 2008 Aug 9;372(9637):449-56. Epub 2008 Jul 22. link to original article contains verified protocol PubMed
2. Motzer RJ, Escudier B, Oudard S, Hutson TE, Porta C, Bracarda S, Grünwald V, Thompson JA, Figlin RA, Hollaender N, Kay A, Ravaud A; RECORD-1 Study Group. Phase 3 trial of everolimus for metastatic renal cell carcinoma : final results and analysis of prognostic factors. Cancer. 2010 Sep 15;116(18):4256-65. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar) & Doxorubicin (Adriamycin)

Regimen

• Gemcitabine (Gemzar) 1500 mg/m2 IV over 30 minutes on day 1
• Doxorubicin (Adriamycin) 50 mg/m2 IV push on day 1

14-day cycles, given until cumulative Doxorubicin (Adriamycin) dose of 300-450 mg/m2 (depending on cardiac function), progression of disease, or unacceptable toxicity

Supportive medications:

• EITHER Filgrastim (Neupogen) 5 mcg/kg SC on starting on day 2 or 3, given until day 10
  • OR Pegfilgrastim (Neulasta) 6 mg SC on day 2

References

1. Roubaud G, Gross-Goupil M, Wallerand H, de Clermont H, Dilhuydy MS, Ravaud A. Combination of gemcitabine and doxorubicin in rapidly progressive metastatic renal cell carcinoma and/or sarcomatoid renal cell carcinoma. Oncology. 2011;80(3-4):214-8. Epub 2011 Jul 1. link to original article contains verified protocol PubMed
2. Haas NB, Lin X, Manola J, Pins M, Liu G, McDermott D, Nanus D, Heath E, Wilding G, Dutcher J. A phase II trial of doxorubicin and gemcitabine in renal cell carcinoma with sarcomatoid features: ECOG 8802. Med Oncol. 2012 Jun;29(2):761-7. Epub 2011 Feb 6. link to original article contains verified protocol PubMed

Gemcitabine (Gemzar) & Sunitinib (Sutent)

Regimen

• Gemcitabine (Gemzar) 750 mg/m2 IV over 90 minutes on days 1 & 8
• Sunitinib (Sutent) 37.5 mg PO on days 2-15

21-day cycles

References

1. Pandya SS, Mier JW, McDermott DF, Cho DC. Addition of gemcitabine at the time of sunitinib resistance in metastatic renal cell cancer. BJU Int. 2011 Oct;108(8 Pt 2):E245-9. doi: 10.1111/j.1464-410X.2011.10096.x. Epub 2011 Feb 14. link to original article contains verified protocol PubMed

High-dose (HD) IL-2

Regimen #1, McDermott, et al. 2005

• IL-2 - Aldesleukin (Proleukin) 600,000 units/kg IV every 8 hours x up to 14 doses per week, on days 1-5, 15-19

28-day cycles x up to 3 cycles

Supportive medications:

• Ciprofloxacin (Cipro) 250 mg PO BID on days 1-10, 15-24
• All antihypertensive therapy discontinued at least 24 hours before each cycle
• Acetaminophen (Tylenol) 650 mg PO every 4 hours
• Indomethacin (Indocin) 25 mg PO every 6 hours
• EITHER Ranitidine (Zantac) 150 mg PO OR Famotidine (Pepcid) 20 mg PO every 12 hours
• EITHER Hydroxyzine (Atarax) 25-50 mg PO every 6 hours OR Diphendyramine (Benadryl) 25 mg PO every (note: frequency was blank in reference) hours for pruritis
• Meperidine (Demerol) 25-50 mg PO every 6 hours for chills and rigors
• "An antidiarrheal agent, antiemetics, anxiolytics, diuretics, and vasopressors as needed"

Regimen #2, Yang, et al. 2003

• IL-2 - Aldesleukin (Proleukin) 720,000 units/kg IV every 8 hours x up to 15 doses
  • Then after 7-10 days of rest, IL-2 - Aldesleukin (Proleukin) 720,000 units/kg IV every 8 hours x up to 15 doses is given again

8-week cycles x up to 2 cycles

References

1. Yang JC, Sherry RM, Steinberg SM, Topalian SL, Schwartzentruber DJ, Hwu P, Seipp CA, Rogers-Freezer L, Morton KE, White DE, Liewehr DJ, Merino MJ, Rosenberg SA. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol. 2003 Aug 15;21(16):3127-32. link to original article contains verified protocol PubMed
2. McDermott DF, Regan MM, Clark JI, Flaherty LE, Weiss GR, Logan TF, Kirkwood JM, Gordon MS, Sosman JA, Ernstoff MS, Tretter CP, Urba WJ, Smith JW, Margolin KA, Mier JW, Gollob JA, Dutcher JP, Atkins MB. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005 Jan 1;23(1):133-41. link to original article contains verified protocol PubMed

Low-dose (LD) IL-2

Regimen

• IL-2 - Aldesleukin (Proleukin) 72,000 units/kg IV every 8 hours x up to 15 doses
  • Then after 7-10 days of rest, IL-2 - Aldesleukin (Proleukin) 72,000 units/kg IV every 8 hours x up to 15 doses is given again

8-week cycles x up to 2 cycles

References

1. Yang JC, Sherry RM, Steinberg SM, Topalian SL, Schwartzentruber DJ, Hwu P, Seipp CA, Rogers-Freezer L, Morton KE, White DE, Liewehr DJ, Merino MJ, Rosenberg SA. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol. 2003 Aug 15;21(16):3127-32. link to original article contains verified protocol PubMed

Subcutaneous IL-2

Regimen

• IL-2 - Aldesleukin (Proleukin) 250,000 units/kg SC x 5 days on week 1
  • Then IL-2 - Aldesleukin (Proleukin) 125,000 units/kg SC x 5 days per week during weeks 2-6

8-week cycles x up to 2 cycles

References

1. Yang JC, Sherry RM, Steinberg SM, Topalian SL, Schwartzentruber DJ, Hwu P, Seipp CA, Rogers-Freezer L, Morton KE, White DE, Liewehr DJ, Merino MJ, Rosenberg SA. Randomized study of high-dose and low-dose interleukin-2 in patients with metastatic renal cancer. J Clin Oncol. 2003 Aug 15;21(16):3127-32. link to original article contains verified protocol PubMed

Interferon alfa-2a (Roferon-A)

Regimen #1, Motzer, et al. 2009

• Interferon alfa-2a (Roferon-A) 3 million units SC 3 times per week on week 1
  • Then if tolerated, 6 million units SC 3 times per week on week 2
    • Then if tolerated, 9 million units SC 3 times per week on week 3 and beyond

given until progression of disease or unacceptable toxicity

Regimen #2, Hudes, et al. 2007

• Interferon alfa-2a (Roferon-A) 3 million units SC 3 times per week on week 1
  • Then if tolerated, 9 million units SC 3 times per week on week 2
    • Then if tolerated, 18 million units SC 3 times per week on week 3 and beyond
  • If higher doses cannot be tolerated, highest tolerable doses of 3, 4.5, or 6 million units can be used

Regimen #3, Escudier, et al. 2010

• Interferon alfa-2a (Roferon-A) 9 million units SC 3 times per week
  • Dose can be reduced to 3 or 6 million units SC 3 times per week based on tolerability

Interferon alfa-2a given for up to 52 weeks, until progression of disease, or unacceptable toxicity

References

1. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. link to original article contains verified protocol PubMed
2. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. Epub 2009 Jun 1. link to original article contains verified protocol PubMed content property of HemOnc.org
3. Escudier B, Bellmunt J, Négrier S, Bajetta E, Melichar B, Bracarda S, Ravaud A, Golding S, Jethwa S, Sneller V. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol. 2010 May 1;28(13):2144-50. Epub 2010 Apr 5. link to original article contains verified protocol PubMed

Pazopanib (Votrient)

Regimen

• Pazopanib (Votrient) 800 mg PO daily, 1 hour before or 2 hours after meals

References

1. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarbá JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. J Clin Oncol. 2010 Feb 20;28(6):1061-8. Epub 2010 Jan 25. link to original article contains verified protocol PubMed

Sorafenib (Nexavar)

Regimen

• Sorafenib (Nexavar) 400 mg PO BID
  • Can be decreased to 400 mg PO daily or 400 mg PO every other day if needed due to toxicity

References

1. Hutson TE, Bellmunt J, Porta C, Szczylik C, Staehler M, Nadel A, Anderson S, Bukowski R, Eisen T, Escudier B; Sorafenib TARGET Clinical Trial Group. Long-term safety of sorafenib in advanced renal cell carcinoma: follow-up of patients from phase III TARGET. Eur J Cancer. 2010 Sep;46(13):2432-40. Epub 2010 Jul 23. link to original article contains verified protocol PubMed
2. Beck J, Procopio G, Bajetta E, Keilholz U, Negrier S, Szczylik C, Bokemeyer C, Bracarda S, Richel DJ, Staehler M, Strauss UP, Mersmann S, Burock K, Escudier B. Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings. Ann Oncol. 2011 Aug;22(8):1812-23. Epub 2011 Feb 15. link to original article contains verified protocol PubMed
3. Rini BI, Escudier B, Tomczak P, Kaprin A, Szczylik C, Hutson TE, Michaelson MD, Gorbunova VA, Gore ME, Rusakov IG, Negrier S, Ou YC, Castellano D, Lim HY, Uemura H, Tarazi J, Cella D, Chen C, Rosbrook B, Kim S, Motzer RJ. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet. 2011 Dec 3;378(9807):1931-9. Epub 2011 Nov 4. link to original article contains verified protocol PubMed

Sunitinib (Sutent)

Regimen

• Sunitinib (Sutent) 50 mg PO on days 1-28
  • Dose may be decreased to 37.5 mg or 25 mg depending on tolerability

42-day cycles, given until progression of disease or unacceptable toxicity

References

1. 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. Motzer RJ, Hutson TE, Tomczak P, Michaelson MD, Bukowski RM, Oudard S, Negrier S, Szczylik C, Pili R, Bjarnason GA, Garcia-del-Muro X, Sosman JA, Solska E, Wilding G, Thompson JA, Kim ST, Chen I, Huang X, Figlin RA. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol. 2009 Aug 1;27(22):3584-90. Epub 2009 Jun 1. link to original article contains verified protocol PubMed
3. Gore ME, Szczylik C, Porta C, Bracarda S, Bjarnason GA, Oudard S, Hariharan S, Lee SH, Haanen J, Castellano D, Vrdoljak E, Schöffski P, Mainwaring P, Nieto A, Yuan J, Bukowski R. Safety and efficacy of sunitinib for metastatic renal-cell carcinoma: an expanded-access trial. Lancet Oncol. 2009 Aug;10(8):757-63. Epub 2009 Jul 15. link to original article contains verified protocol PubMed

Temsirolimus (Torisel)

Regimen

• Temsirolimus (Torisel) 25 mg IV over 30 minutes every week

Supportive medications:

• Diphenhydramine (Benadryl) "or similar H1 blocker" 25-50 mg IV 30 minutes prior to temsirolimus

References

1. Hudes G, Carducci M, Tomczak P, Dutcher J, Figlin R, Kapoor A, Staroslawska E, Sosman J, McDermott D, Bodrogi I, Kovacevic Z, Lesovoy V, Schmidt-Wolf IG, Barbarash O, Gokmen E, O'Toole T, Lustgarten S, Moore L, Motzer RJ; Global ARCC Trial. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med. 2007 May 31;356(22):2271-81. link to original article contains verified protocol PubMed