adjuvant therapies for rcc dr. camillo porta s.c. di oncologia medica i.r.c.c.s. policlinico san...
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Adjuvant therapies for RCC
Dr. Camillo PortaS.C. di Oncologia MedicaI.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 TxClosed adjuvant trials N Author (year) Outcome of the study
RT vs. observation 72 Kjaer (1987) negative
MPA vs. observation 136 Pizzocaro (1987) negative
Aut. tumor vaccine + BCG vs. observation 43 Adler (1987) negative
Aut. tumor vaccine ± BCG vs. observation 120 Galligioni (1996) negative
UFT vs. observation 71 Naito (1997) negative
IFN- vs. observation 247 Pizzocaro (2001) negative
IFN- NL vs. observation 283 Messing (2003) negative
HD IL-2 vs. observation 69 Clark (2003) negative
Autologous tumor vaccine vs. observation 553 Jocham (2004) positive in terms of PFS (p=0.02)
s.c. IL-2 + IFN- + 5-FU vs. observation 203 Atzpodien (2005) negative
s.c. IL-2 + IFN- vs. observation 310 Passalacqua (2007) negative
Aut. tumour-derived HSP-96-peptide complexvs. observation
918 Wood C (2008) negative
Thalidomide vs. observation 46* Margulis (2009) negative*trial stopped due to inefficacy
s.c. IL-2 + IFN- + 5-FU vs. observation 550 Aitchinson (2012) negative
Girentuximab (anti-CAIX MoAb) vs. observation
856 Belldegrun (2013) negative
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Completed RCTs of adjuvant TxClosed adjuvant trials N Author (year) Outcome of the study
RT vs. observation 72 Kjaer (1987) negative
MPA vs. observation 136 Pizzocaro (1987) negative
Aut. tumor vaccine + BCG vs. observation 43 Adler (1987) negative
Aut. tumor vaccine ± BCG vs. observation 120 Galligioni (1996) negative
UFT vs. observation 71 Naito (1997) negative
IFN- vs. observation 247 Pizzocaro (2001) negative
IFN- NL vs. observation 283 Messing (2003) negative
HD IL-2 vs. observation 69 Clark (2003) negative
Autologous tumor vaccine vs. observation 553 Jocham (2004) positive in terms of PFS (p=0.02)
s.c. IL-2 + IFN- + 5-FU vs. observation 203 Atzpodien (2005) negative
s.c. IL-2 + IFN- vs. observation 310 Passalacqua (2007) negative
Aut. tumour-derived HSP-96-peptide complexvs. observation
918 Wood C (2008) negative
Thalidomide vs. observation 46* Margulis (2009) negative*trial stopped due to inefficacy
s.c. IL-2 + IFN- + 5-FU vs. observation 550 Aitchinson (2012) negative
Girentuximab (anti-CAIX MoAb) vs. observation
856 Belldegrun (2013) negative
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Meta-analysis of RCTsof adjuvant Tx
Massari F, et al. Clin Genitourin Cancer 2013 (E-pub ahead of print)
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Ongoing RCTs oftargeted agents as adjuvant Tx
Ongoing adjuvant trials
SORCE (MRC/EORTC)Sorafenib 1 year (+ 2 years placebo) vs. Sorafenib 3 years vs. placebo 3 years
1656 Leibovich 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
1923 T3b-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
856 High 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)
1218 Pathologically 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
1500 Intermediate and high risk.Primary end-point: DFS
Closed at enrolment;no data available yet
NCT01599754 (SFJ Pharmaceuticals)Axitinib 3 yeas vs. placebo 3 years
592 pT2 or higher, pNx pN0 or pN1, M0, Fuhrman G3-4 and
ECOG PS 0-1Primary end-point: DFS
Enrolling(Japan only)
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What theoretically hampersthe 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