dr. m salvi unifi, aouc careggi - overgroup...• attualmente la nephron sparing surgery costituisce...
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Chirurgia radicale VS. Chirurgia conservativa
Dr. M SalviUNIFI, AOUC Careggi
• La procedura chirurgica standard è la Nefrectomia Radicale comprensiva dell’asportazione della fascia di Gerota. La surrenectomia èraccomandata
Godley Paet al; Curr Opin Oncol 1999
• In casi selezionati di lesioni completamente esofitiche <4cm può essere considerato un approccio conservativo; tuttavia la sicurezza oncologica di tale approccio è in fase di definizione
Van Poppel Het al; J Urol 1998
La terapia chirurgica è l’unico trattamento curativo per il RCC
2000
• La nefrectomia radicale rimane l’approccio terapeutico gold standard per il trattamento del Carcinoma Renale localizzato
Robson CJ et al; J Urol 1969
• La surrenectomia non è raccomandata eccetto che nei tumori polari superiori di diametro >/= 7cm
• La Nefrectomia parziale costituisce un approccio curativo riconosciuto per il trattamento di carcinomi renali cT1a. Il suo ricorso per tumori di diametro 4‐7cm dovrebbe essere limitato a centri terziari di riferimento
Uzzo RG et al; J Urol 2001
• L’approccio OPEN rimane il gold standard per l’esecuzione di nefrectomie parzialiNovick AC et al; Clin Cancer Res 2004
Fare clic per modificare lo stile del sottotitolo dello schema
Quale trattamento per la malattia localizzata oggi?
• La terapia chirurgica è l’unico trattamento curativo per il Carcinoma Renale
• Attualmente la Nephron Sparing Surgery costituisce il gold standard per RCC <T2 ogniqualvolta sia tecnicamente eseguibile
• La nefrectomia laparoscopica costituisce il gold standard per il trattamento di RCC ≥T2 o RCC<T2 non trattabili con NSS
In alcuni pazienti con tumore renale localizzato la chirurgia conservativa non è attuabile a causa di:
1. Crescita tumorale infiltrativa2. Resezione parziale non tecnicamente eseguibile per posizione
sfavorevole della neoformazione
1. Comorbiltà del paziente non compatibili con chirurgia conservativa
Nefrectomia per RCC <cT2
• Studi non randomizzati (>20 studi osservazionali) dimostrano una sopravvivenza causa specifica sovrapponibile tra RN e NSS con una migliore conservazione della funzione renale e conseguentemente una migliore sopravvivenza globale per NSS
• Con NSS riduzione del rischio di morte cancro specifica e per ogni causa pari al 19% e 29%
(kim SP . J.Urol 2012)• Il solo studio randomizzato (sottodimensionato e con molti bias ) esistente non
dimostra alcun vantaggio (Van Poppel Eur. Urol.2011)
Nefrectomia radicale VS. Nephron Sparing Surgery
LIMITS• QoL and renal function outcomes have not been addressed• the required sample size of 1300 patients was not reached• 55 patients switched treatment: 16 patients (5.9%) randomised to RN received NSS, and
39 patients (14.6%) randomised to NSS received RN
In the intention‐to‐treat analysis, overall survival was better in the RN arm compared with the NSS arm (hazard ratio[HR]:1.50; 95% confidence interval [CI], 1.03–2.16; p = 0.03). This difference, however, could not be attributed to differences in kidney cancer mortality.
• 34 studies met the inclusion criteria• There were highrisks of bias and low‐quality evidence• Open radical nephrectomy and open partial nephrectomy showed similar cancer‐
specific and overall survival but when both open and laparoscopic approaches are considered together, the evidence showed improved survival for partial nephrectomy for tumours <4 cm
• Open and laparoscopic partial nephrectomy achieved equivalent survival
Nephron‐sparing improves preservation of renal function,decreased overall mortality, and reduced frequency of cardiovascular events
Outcomes
GFR<60 ml/min
80%
35%
GFR<45 ml/min
95%
64%
CARDIOVASCULAR EVENTS 21.6% (RN ) VS 15.1% (NSS)
• OBJECTIVE: To review systematically all the relevant published literature comparing perioperative and QoL outcomes of surgical management of localised RCC (T1–2N0M0)
• Studies of low methodological quality marked by high risks of bias
Conclusions: Partial nephrectomy results in significantly better preservation of renal function over radical nephrectomy
• Retrospective review of patients undergoing renal surgery for localized RCC stratified by surgical extent and preoperative CKD stage based on GFR level
• 1306 patients
Compared with RN, NSS is associated with a lower rate of GFR decline for preoperative CKD stage‐I and ‐II patients, but only CKD stage‐II patients demonstrated a decreased risk of developing significant renal impairment
• phase 3 international randomized trial was conducted in patients with a small (<5 cm) renal mass and normal contralateral kidney who were enrolled from March 1992 to January 2003
• median follow‐up of 6.7 yr
• eGFR <60 was reached by 85.7% with RN and 64.7% with NSS, with a difference of 21.0%(95% CI, 13.8–28.3); eGFR <30 was reached by 10.0% with RN and 6.3% with NSS, with a difference of 3.7% (95% CI, –1.0 to 8.5); and eGFR <15 was reached by 1.5% with RN and 1.6% with NSS, with a difference of –0.1% (95% CI, –2.2 to 2.1)
Surveillance, Epidemiology and End Results –Medicare data 5,496 patients >66 years of age who underwent PN or RN for T1a (≤4cm) RCC from 1995–2007 The effects of procedure type on overall mortality by age were assessed.
A statistically significant survival benefit for PN compared to RN was observed at one (age 68: HR 1.6 [CI 1.2–2.3]; age 75: HR 1.5 [CI 1.1–
1.9]; age 85: HR 1.7 [CI 1.1–2.5]) and three (age 68: HR 1.4 [CI 1.03–2.0]; age 75:
HR 1.3 [CI 1.1–1.6]; age 85: HR 1.5[CI 1.02–2.3]) years while these trends become insignificant in patients <68 and >85 years of age.However, the survival benefit diminished over time, and little significant benefit with PN was observed at 5 and 10 years following surgery regardless of age (≥66 years).
In patients for whom increased perioperative risks of PN are nontrivial and for whom long‐term benefits of PN are uncertain, such as the elderly or infirm, RN may in fact be the superior option.
PN is traditionally associated with a higher risk of perioperative complications than RN . In particular, the risk of complications rises with increasing tumor anatomic complexity. In fact, NSS for renal masses of moderate and high complexity can be associated with a >20% risk of complications when documented using standardized reporting protocols
Arguably, the RN vs PN debate is most pertinent for elderly/frail patients with tumors of higher complexity, since these patients are more likely to harbor aggressive disease and thus are least appropriate for active surveillance
Open VLP
Robot
Vantaggi Tecniche mini‐invasive:
• Minori perdite ematiche• Minor dolore post‐operatorio• Minore ospedalizzazione
Mac Lennan et al., Eur Urol 2012
Quale approccio?
….perchè robot?
Chirurgia robotica: perché?
Potenziali vantaggi della laparoscopia robot‐assistita vs. laparoscopia tradizionale:
1. Visione tridimensionale in HD2. Ampia scala di movimenti con gli strumenti endo‐wrist3. Bilanciamento dei movimenti della mano chirurgica4. Curva di apprendimentoridotta
Lavery et al, JSLS 2011
Chirurgia robotica: perché?
Potenziali vantaggi della laparoscopia robot‐assistita vs. laparoscopia tradizionale:
1. Visione tridimensionale in HD2. Ampia scala di movimenti con gli strumenti endo‐wrist3. Bilanciamento dei movimenti della mano chirurgica4. Curva di apprendimentoridotta
Lavery et al, JSLS 2011
Although academic and urban locations are established factors that affect the receipt of PN
for RCC, the availability of robot‐assisted surgery at a hospital was also independently associated with higher use of PN
• Despite Guidelines, at most, a quarter of patients undergo optimum surgical treatment (Tan et al., JAMA 2014; Hollenbeck BK et al., J. Urol 2006)
• Significant variation in PN with academic medical centres and high‐volume surgeons associated with greater use in localized RCC (Weight CJ et al., BJU Int 2013; Miller DC et al., Med Care 2008)
La chirurgia robotica ha avuto un elevato impatto sulla gestione del RCC
Globally, 983 patients were evaluated at 19 centers
We Chose Enucleation
NSS
>500 procedure nefrectomia parziale per RCC con tecnica «Enucleazione semplice»
198 patients who underwent SE were retrospectively matched to 198 patients who underwent SPN
• SE was associated with similar WIT (18 vs 17.8 min)• PSM was significantly lower in patients treated with SE (1.4% vs 6.9%;p=0.02)
retrospectively analyzed 475 patients who underwent TE or RN for pT1 RCC, N0, M0, between 1995 and 2007
The 5‐ and 10‐year PFS estimates were 91.3 and 88.7% after RN and 95.3 and 92.8% after TE (P= NS), respectively. The 5‐ and 10‐year CSS estimates were 92.1 and 89.4% after RN and 94.4% (5‐ and 10‐year CSS) after TE (P=NS), respectively
CSS
0 2 4 6 8 10 12
Stratificazione per tipo di intervento (Apr. 2010‐Dic. 2014)
POLO DI CHIRURGIA ROBOTICA
DELLA REGIONE TOSCANA
Dept. Of Urology, AOUC Careggi, Florence
RAPN
POLO DI CHIRURGIA ROBOTICA
DELLA REGIONE TOSCANA
Dept. Of Urology, AOUC Careggi, Florence
Open VS. Simple Laparoscopic VS. Robot‐assisted procedures
0
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Change of perspective
Oncological perspective: cT1 b tumors
According to the statement of guidelines, today the widening of NSS indications are focused on the feasibility of the surgical excision, rather than the simple largest diameter.
Surgical perspective: High risk nephrometry tumors
Tumor diameter 6.9 cmc T1bPADUA 9
Tumor diameter 4 cmc T1aPADUA 10
90.8%96.1%88.0%
5‐yy
Perioperative variables TOTAL
96
Age, yrs mean ± SD 64 ± 13Clinical diameter (cm) mean ± SD (range) 4,8 ± 1,6 (3-10)Tumor size score / Clinical stage no. (%)
≤ 4 cm
4.1–7 cm
>7 cm
28 (29.2%)
59 (61.5%)
9 (9.3%)WIT (min) mean ± DS (range) 19,2 ± 5,7 (9-38)
EBL (cc) mean ± DS 196 ± 125Operative time (min) mean ± DS 126 ± 46LOS (days, including the day of surgery) median (IQR) 6 (5-7)
Postoperative overall complications no. (%) 25/96 (26.1%)Major (Clavien 3-4) complications no. (%) 9 (9.4%)Positive Surgical margins no. (%) 3/84 (3.6%)Patients with TRIFECTA no. (%) 54/84 (64.3%)
Simple enucleation for the treatment of highly complex renal tumors: perioperative, functional and oncological results
Carini et al 2015, in press
96 Patients with PADUA score 10‐13 RCC
70.8% ≥ cT1b
76 OSE20 ERASE
‐ 14 ml/min eGFR after 54 months
Grazie per l’attenzione
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