Renal cell carcinoma - historical

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main RCC page for current regimens.
Last updated on 2024-07-23:9 regimens on this page
9 variants on this page
 
=Metastatic disease, first-line=
==Interferon alfa-2a & Interleukin-2==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Negrier et al. 1998 	1992-1995 	Phase 3 (E-esc)	1. HD IL-22. Interferon alfa-2a	Longer EFS
Passalacqua et al. 2009 	1998-2003 	Phase 3 (C) 	IFN & IL-2; maintenance 	Did not meet primary endpoint of OS
Négrier et al. 2008 (LEONB-PERCY-DUO)	2000-2005 	Phase 3 (C) 	IFN & IL-2; IV IL-2 	Did not meet primary endpoint of OS
====Immunotherapy====
*Interferon alfa-2a (Roferon-A) as follows:
**Cycles 1 & 2: 1,800,000 units/m2 SC once per day on days 3, 5, 10, 12, 17, 19, 24, 26
**Cycle 3 onwards: 1,800,000 units/m2 SC once per day on days 3, 5, 10, 12, 17, 19, 24, 26
*Aldesleukin (Proleukin) as follows:
**Cycles 1 & 2: 1,000,000 units/m2 SC twice per day on days 1, 2, 8, 9, 15, 16, 22, 23
**Cycle 3 onwards: 1,000,000 units/m2 SC twice per day on days 1, 2, 8, 9, 15, 16, 22, 23
*Aldesleukin (Proleukin) as follows:
**Cycles 1 & 2: 1,000,000 units/m2 SC once per day on days 3 to 5, 10 to 12, 17 to 19, 24 to 26
**Cycle 3 onwards: 1,000,000 units/m2 SC once per day on days 3 to 5, 10 to 12, 17 to 19, 24 to 26
2-month cycle for 2 cycles, then 3-month cycles
===References===
#Négrier S, Escudier B, Lasset C, Douillard JY, Savary J, Chevreau C, Ravaud A, Mercatello A, Peny J, Mousseau M, Philip T, Tursz T; Groupe Français d'Immunothérapie. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. N Engl J Med. 1998 Apr 30;338(18):1272-8. link to original article EuroPMC
#LEONB-PERCY-DUO: Négrier S, Perol D, Ravaud A, Bay JO, Oudard S, Chabaud S, Fargeot P, Delva R, Deplanque G, Gravis G, Escudier B; French Immunotherapy Group. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res. 2008 Sep 15;14(18):5907-12. link to original article EuroPMC NCT00416871
#Passalacqua R, Buzio C, Buti S, Porta C, Labianca R, Pezzuolo D, Camisa R, Sabbatini R, Benecchi L, Messina C, Cengarle R, Vaglio A, Dalla Chiesa M, Tomasello G, Caminiti C. Phase III, randomised, multicentre trial of maintenance immunotherapy with low-dose interleukin-2 and interferon-alpha for metastatic renal cell cancer. Cancer Immunol Immunother. 2010 Apr;59(4):553-61. Epub 2009 Sep 25. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC
==Interferon alfa-2b monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Flanigan et al. 2001 (SWOG 8949) 	1991-1998 	Non-randomized part of RCT
Mickisch et al. 2001 (EORTC 30947)	1995-1998 	Non-randomized part of RCT
====Preceding treatment====
*Nephrectomy versus no preceding treatment
====Immunotherapy====
*Interferon alfa-2b (Intron-A)
===References===
#EORTC 30947: Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; EORTC Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. link to original article EuroPMC
#SWOG 8949: Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. link to original article EuroPMC
#ECOG E2898: NCT00005966
==Medroxyprogesterone acetate monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Ritchie et al. 1999 (MRC RE01) 	1992-1997 	Phase 3 (C)	IFN alfa-2a 	Seems to have shorter OSMedian OS: 6 vs 8.5 mo(HR 1.39, 95% CI 1.06-1.82)
Negrier et al. 2007 (PERCY Quattro)	2000-2004 	Phase 3 (C)	1. IFN alfa-2a2. IFN alfa-2a & IL-23. IL-2	Did not meet primary endpoint of OS
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
====Hormone replacement therapy====
*Medroxyprogesterone acetate (MPA) 300 mg PO once per day
12-week course
===References===
#MRC RE01: Ritchie A, Griffiths G, Parmar M; Medical Research Council Renal Cancer Collaborators. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Lancet. 1999 Jan 2;353(9146):14-7. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
#PERCY Quattro: Negrier S, Perol D, Ravaud A, Chevreau C, Bay JO, Delva R, Sevin E, Caty A, Escudier B; French Immunotherapy Intergroup. Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer. 2007 Dec 1;110(11):2468-77. link to original article EuroPMC NCT00416429
==Vinblastine monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Pyrhönen et al. 1999	1988-1994 	Phase 3 (C)	Vinblastine & IFN alfa-2a	Shorter OS
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
====Chemotherapy====
*Vinblastine (Velban) 0.1 mg/kg IV once on day 1
21-day cycles
===References===
# Pyrhönen S, Salminen E, Ruutu M, Lehtonen T, Nurmi M, Tammela T, Juusela H, Rintala E, Hietanen P, Kellokumpu-Lehtinen PL. Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol. 1999 Sep;17(9):2859-67. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
=Metastatic disease, second-line=
==Cyclophosphamide & Fludarabine (FC), then allo HSCT==
FC: Fludarabine & Cyclophosphamide
===Regimen===
Study 	Dates of enrollment	Evidence
Childs et al. 2000 (NIH 97-H-0196)	1998-02 to 1999-08 	Non-randomized, fewer than 20 pts
===References===
#NIH 97-H-0196: Childs R, Chernoff A, Contentin N, Bahceci E, Schrump D, Leitman S, Read EJ, Tisdale J, Dunbar C, Linehan WM, Young NS, Clave E, Epperson D, Mayo V, Barrett AJ. Regression of metastatic renal-cell carcinoma after nonmyeloablative allogeneic peripheral-blood stem-cell transplantation. N Engl J Med. 2000 Sep 14;343(11):750-8. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC
==Interferon alfa-2a monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Aass et al. 2005 (EORTC 30951)	1998-2001 	Phase 3 (C)	IFN alfa-2a & Isotretinoin	Seems to have shorter OS
====Immunotherapy====
*Interferon alfa-2a (Roferon-A) as follows:
**Cycle 1: 3,000,000 units SC once per day on days 1 to 7
**Cycle 2: 6,000,000 units SC once per day on days 1 to 7
**Cycle 3 onwards: 9,000,000 units SC once per day on days 1 to 7
7-day cycles
===References===
# EORTC 30951: Aass N, De Mulder PH, Mickisch GH, Mulders P, van Oosterom AT, van Poppel H, Fossa SD, de Prijck L, Sylvester RJ. Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005 Jun 20;23(18):4172-8. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00002737
==Interferon alfa-2a & Isotretinoin==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Aass et al. 2005 (EORTC 30951)	1998-2001 	Phase 3 (E-esc)	IFN alfa-2a	Seems to have longer OS (primary endpoint)Median OS: 17.3 vs 13.2 mo
====Immunotherapy====
*Interferon alfa-2a (Roferon-A) as follows:
**Cycle 1: 3,000,000 units SC once per day on days 1 to 7
**Cycle 2: 6,000,000 units SC once per day on days 1 to 7
**Cycle 3 onwards: 9,000,000 units SC once per day on days 1 to 7
*Isotretinoin (Accutane) 1 mg/kg PO once per day on days 1 to 7 (rounded up to the nearest 10 mg)
7-day cycles
===References===
# EORTC 30951: Aass N, De Mulder PH, Mickisch GH, Mulders P, van Oosterom AT, van Poppel H, Fossa SD, de Prijck L, Sylvester RJ. Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell Carcinoma: the European Organisation for Research and Treatment of Cancer Genito-Urinary Tract Cancer Group (EORTC 30951). J Clin Oncol. 2005 Jun 20;23(18):4172-8. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT00002737
==Interferon alfa-2c monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
De Mulder et al. 1995 (EORTC 30885)	1988-1990 	Phase 3 (C)	IFN alfa-2c & IFN gamma	Did not meet efficacy endpoints
====Immunotherapy====
*Interferon alfa-2c (Berofor) 2,000,000 units/m2 SC once per day on days 1 & 4 (twice per week)
7-day cycles
===References===
# EORTC 30885: De Mulder PH, Oosterhof G, Bouffioux C, van Oosterom AT, Vermeylen K, Sylvester R; EORTC Genitourinary Group. EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma. Br J Cancer. 1995 Feb;71(2):371-5. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC
==Megestrol monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Ravaud et al. 2008	2002-2005 	Phase 3 (C)	Lapatinib 	Did not meet primary endpoint of TTP
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
====Hormone replacement therapy====
*Megestrol (Megace)
===References===
# Ravaud A, Hawkins R, Gardner JP, von der Maase H, Zantl N, Harper P, Rolland F, Audhuy B, Machiels JP, Pétavy F, Gore M, Schöffski P, El-Hariry I. Lapatinib versus hormone therapy in patients with advanced renal cell carcinoma: a randomized phase III clinical trial. J Clin Oncol. 2008 May 10;26(14):2285-91. link to original article dosing details not described in manuscript EuroPMC
Category:Renal cell carcinoma regimens
Category:Historical regimens
Category:Disease-specific pages
Category:Genitourinary cancers