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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the NCCN Guidelines. Is there a regimen missing from this list? See the main RCC page for current regimens.

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-2
2. Interferon alfa-2a 		Superior 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

References

  1. 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 PubMed
  2. 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 PubMed NCT00416871
  3. 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 PubMed

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

Immunotherapy

References

  1. 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 PubMed
  2. 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 PubMed
  3. 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 inferior OS
Negrier et al. 2007 (PERCY Quattro) 2000-2004 Phase 3 (C) 1. IFN alfa-2a
2. IFN alfa-2a & IL-2
3. 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

References

  1. 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 contains dosing details in abstract PubMed
  2. 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 PubMed 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 Inferior 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

21-day cycles

References

  1. 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 contains dosing details in manuscript PubMed

Metastatic disease, second-line

Cyclophosphamide & Fludarabine (FC), then allo HSCT

FC: Fludarabine & Cyclophosphamide

Regimen

Study Evidence
Childs et al. 2000 Non-randomized, fewer than 20 pts

Chemotherapy

Immunotherapy

One course

References

  1. 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 contains dosing details in manuscript PubMed

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 inferior 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

  1. 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 contains dosing details in manuscript PubMed 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 superior 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

  1. 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 contains dosing details in manuscript PubMed 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

7-day cycles

References

  1. 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 contains dosing details in manuscript PubMed

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

References

  1. 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 PubMed
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