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Adjuvant therapies for RCC Dr. Camillo Porta S.C. di Oncologia Medica I.R.C.C.S. Policlinico San Matteo, Pavia
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Back to the basics: terminology Adjuvant therapy: – additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back NCI Dictionary of Cancer Terms
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The natural history of RCC Presentation at diagnosis1: – 45% with localized disease – 25% with locally advanced disease – 20–30% metastatic disease 33% of patients treated for localized disease will develop metastatic disease2 1. National Cancer Institute. SEER cancer statistics fact sheet: cancer of the kidney and renal pelvis. Accessed 2009; 2. Flanigan RC et al. Curr Treat Options Oncol 2003;4:385–90.
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Completed RCTs of adjuvant Tx Closed adjuvant trialsNAuthor (year)Outcome of the study RT vs. observation72Kjaer (1987)negative MPA vs. observation136Pizzocaro (1987)negative Aut. tumor vaccine + BCG vs. observation43Adler (1987)negative Aut. tumor vaccine ± BCG vs. observation120Galligioni (1996)negative UFT vs. observation71Naito (1997)negative IFN- vs. observation247Pizzocaro (2001)negative IFN- NL vs. observation283Messing (2003)negative HD IL-2 vs. observation69Clark (2003)negative Autologous tumor vaccine vs. observation553Jocham (2004)positive in terms of PFS (p=0.02) s.c. IL-2 + IFN- + 5-FU vs. observation203Atzpodien (2005)negative s.c. IL-2 + IFN- vs. observation310Passalacqua (2007)negative Aut. tumour-derived HSP-96-peptide complex vs. observation 918Wood C (2008)negative Thalidomide vs. observation46*Margulis (2009)negative *trial stopped due to inefficacy s.c. IL-2 + IFN- + 5-FU vs. observation550Aitchinson (2012)negative Girentuximab (anti-CAIX MoAb) vs. observation 856Belldegrun (2013)negative
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Completed RCTs of adjuvant Tx Closed adjuvant trialsNAuthor (year)Outcome of the study RT vs. observation72Kjaer (1987)negative MPA vs. observation136Pizzocaro (1987)negative Aut. tumor vaccine + BCG vs. observation43Adler (1987)negative Aut. tumor vaccine ± BCG vs. observation120Galligioni (1996)negative UFT vs. observation71Naito (1997)negative IFN- vs. observation247Pizzocaro (2001)negative IFN- NL vs. observation283Messing (2003)negative HD IL-2 vs. observation69Clark (2003)negative Autologous tumor vaccine vs. observation553Jocham (2004)positive in terms of PFS (p=0.02) s.c. IL-2 + IFN- + 5-FU vs. observation203Atzpodien (2005)negative s.c. IL-2 + IFN- vs. observation310Passalacqua (2007)negative Aut. tumour-derived HSP-96-peptide complex vs. observation 918Wood C (2008)negative Thalidomide vs. observation46*Margulis (2009)negative *trial stopped due to inefficacy s.c. IL-2 + IFN- + 5-FU vs. observation550Aitchinson (2012)negative Girentuximab (anti-CAIX MoAb) vs. observation 856Belldegrun (2013)negative
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Meta-analysis of RCTs of adjuvant Tx Massari F, et al. Clin Genitourin Cancer 2013 (E-pub ahead of print)
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Ongoing RCTs of targeted agents as adjuvant Tx Ongoing adjuvant trials SORCE (MRC/EORTC) Sorafenib 1 year (+ 2 years placebo) vs. Sorafenib 3 years vs. placebo 3 years 1656Leibovich score of 3 to 8. Primary end-point: DFS Closed at enrolment; no data available yet ASSURE (ECOG) Sunitinib 1 year vs. Sorafenib 1 year vs. placebo 1 year 1923T3b-4 N0, T1-4 N+, or T1-4 with positive margins or vascular invasion) Primary end-point: DFS Closed at enrolment; no data available yet S-TRAC (Pfizer) Sunitinib 1 year vs. placebo 1 year 856High risk according to UISS. Primary end-point: DFS Closed at enrolment; no data available yet EVEREST (SWOG) Everolimus vs. placebo (days 1-42; treatment repeats every 6 weeks for 9 courses) 1218Pathologically intermediate high-risk or very high-risk. Primary end-point: DFS Not yet enrolling (US only) VEG113387 PROTECT study (GSK) Pazopanib 1 year vs. placebo 1 year 1500Intermediate and high risk. Primary end-point: DFS Closed at enrolment; no data available yet NCT01599754 (SFJ Pharmaceuticals) Axitinib 3 yeas vs. placebo 3 years 592pT2 or higher, pNx pN0 or pN1, M0, Fuhrman G3-4 and ECOG PS 0-1 Primary end-point: DFS Enrolling (Japan only)
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What theoretically hampers the adjuvant use of antiangiogenics?
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Adjuvant Tx for RCC: conclusions To date, no treatment emerged as a standard of care in this setting Presently, patients should be thus offered just obser- vation Enrollment into well-desigend and adequately con- ducted RCTs is mandatory
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Thank You for Your kind attention!!! c.porta@smatteo.pv.it
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