dr. debora marchiori clinica gynepro medical bologna · follow-up measure radical or partial...
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LINEE GUIDA UROLOGICHE TERAPIA DEL RCC
Dr. Debora MarchioriClinica Gynepro Medical
Bologna
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COSA SONO LE LINEE GUIDA….
Sono delle raccomandazion i di comportamento clinico relative ad un
quesito diagnostico-terapeutico
BIGNAMI ENCICLOPEDIA
SANTO PROTETTORE
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A COSA SERVONO LE LINEE GUIDA….
Servono a fornire un supporto basato sulle evidenze alla esperienza del
medico nelle decisioni cliniche
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�Raccomandazioni derivate da un processo direvisione sistematica della letteratura;
�Valutano il rapporto beneficio/danno;
�Assistono il medico nella decisione clinica;
COSA SONO LE LINEE GUIDA….
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�Esistono diverse linee guida per la stessa patologia;
�Non tutte le linee guida sono uguali;
�Non tutte le linee guida forniscono le stesse informazioni;
MA….
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COME INTERPRETARLE ?
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Le linee guida sono raccomandazioni fondate sugli studi disponibili:
La qualità di uno studio condotto su un determinato argomento, e quindi il livello della prova di efficacia, risiede nel minimizzare i bias e nella capacità di poter generalizzare un risultato
VALUTAZIONE dei LIVELLI di EVIDENZA:
�NCCN Categories of evidence and consensus
�Oxford Centre for Evidence-based Medicine Levels of Evidence
�SIGN
�Ecc…
Le raccomandazioni vengono quindi graduate in classi PER FORZA DI RACCOMANDAZIONE, generalmente indicate con le lettere maiuscola A, B, C, D.
METODOLOGIA
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� Formulazione di un quesito clinico con scelta e valutazione formale degli outcome ad esso correlati;
� Valutazione sistematica della letteratura scientifica e della qualità delle prove reperite;
� Valutazione di benefici e rischi associati all’intervento considerando le preferenze dei pazienti, la fattibilità e l’impiego di risorse necessario;
� Definizione formale della forza della raccomandazione;
MA…
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� Valide
� Le più usate dagli oncologi
ma…
� Non chiara l’esaustività e la sistematicità del processso di revisione
� Livello di evidenza non è adeguato alla quantità delle evidenze
� La qualità dell’evidenza non è separata dalla forza della raccomandazione
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Oxford Centre for Evidence-based
Medicine Levels of Evidence( marzo 2009)
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� Valide
� Le più usate dagli urologi
ma…
� La forza della raccomandazione è basata solo sulle evidenze
� Nessun dato sul rapporto rischio beneficio
� livello delle prove di efficacia e la forza delle raccomandazioni SPESSO SONO CONSEGUENTI
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Linee guidaTUMORI del RENEEdizione 2013
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Linee guidaTUMORI del RENEEdizione 2013
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QU
ALITA’delle E
VID
EN
ZE
FIDUCIA della QUALITA’dell’’EVIDENZA
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� Valide
� Le più usate dagli oncologi
ma…
� La forza della raccomandazione è basata sulle evidenze
� Dati relativi al rapporto rischio/beneficio
Linee guidaTUMORI del RENEEdizione 2013
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GUIDELINE FOR MANAGEMENT OF THE CLINICAL STAGE 1 RE NAL MASSPanel Members: Andrew C. Novick, MD, Chair; Steven C. Campbell, MD, PhD, Co-Chair; Arie Belldegrun, MD; Michael L. Blute, MD; George Kuoche Chow, MD; Ithaar H. Derweesh, MD; Jihad H. Kaouk, MD; Raymond J. Leveillee, MD, FRCS-G; Surena F. Matin, MD; Paul Russo, MD; Robert Guy Uzzo, MD
H LEM LE
H /M LE ma R/B bilanciato /non
chiaro
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� Valide
� Non sono le più usate dagli urologi
ma…
� La forza della raccomandazione è basata sulla valutazione complessiva delle evidenze su un determinato quesito e non sulla qualità dei singoli studi
� la raccomandazione viene formulata sulla base della qualità delle evidenze e l’opinione del panel sul rapporto rischio/beneficio
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PREMESSA
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STADIO del RCC e RUOLI:
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LINEE GUIDA trattamento RCC localizzato: Eau ed.2013
Indicazioni:
NEFRECTOMIA parziale vs radicale Studi clinic ben fatti ; no RCT
Assenza di studi di qualità
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LINEE GUIDA trattamento RCC localizzato:AIOM ed.2013
NEFRECTOMIA parziale vs radicale
Indicazioni:
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LINEE GUIDA trattamento RCC localizzato: Eau ed.2013
NEFRECTOMIA RADICALE laparoscopica vs open
TECNICHE:
assenza di studi di qualità
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NEFRECTOMIA RADICALE laparoscopica vs open
TECNICHE:
LINEE GUIDA trattamento RCC localizzato: AIOM ed.20 13
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LINEE GUIDA trattamento RCC localizzato: Eau ed.2013
TECNICHE:
NEFRECTOMIA PARZIALE laparoscopica vs open
assenza di studi di qualità
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NEFRECTOMIA PARZIALE laparoscopica vs open
Tecniche:
NEFRECTOMIA PARZIALE laparoscpica classica vs robotica
LINEE GUIDA trattamento RCC localizzato: AIOM ed.20 13
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Indicazioni:
LINEE GUIDA trattamento RCC localizzato / localment e avanzato : Eau ed.2013
SURRENALECTOMIA
LINFOADENECTOMIA ESTESA
assenza di studi di qualità
studi di buona qualità di cui almeno 1 RTCstudi di buona qualità di cui almeno 1 RTC
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LINEE GUIDA trattamento RCC localizzato / localment e avanzato AIOM ed.2013
SURRENALECTOMIA
LINFOADENECTOMIA
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LINEE GUIDA trattamnto : Eau /AIOM ed.2013 ( RCC localizzato non candidato alla chirurgia )
Indicazioni:
SORVEGLIANZA ATTIVA
assenza di studi di qualità
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LINEE GUIDA trattamento: Eau /AIOM ed.2013 ( RCC localizzato non candidato alla chirurgia )
Indicazioni:
TERAPIE ABLATIVE
assenza di studi di qualità
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Indicazioni:
LINEE GUIDA trattamento: Eau /AIOM ed.2013 ( RCC avanzato )
NEFRECTOMIA CITORIDUTTIVA
studi di buona qualità di cui almeno 1 RTC
studi di buona qualità di cui almeno 1 RTC
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Indicazioni:
LINEE GUIDA trattamento: Eau /AIOM ed.2013 ( RCC avanzato )
METASTASECTOMIA
assenza di studi di qualità
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� evidence-based medicine isn't necessarily the best medicine;
� guidelines can be very successful when they address more controversial topics, because those are the issues where you're likely to have more variability in opinions;
� no CPG is perfectly suited for any patient, nor is any patient a perfect fit for a practice guideline;
� never forget to be a doctor, to emphasize clinical judgment, and to pay attention to the individual patient.
Do Clinical Practice Guidelines Contribute to Bette r Patient Care?
MEDSCAPE Oncology: An Expert Interview with Drs. Joseph O. Jacobson and Antonio C. Wolff
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LINEE GUIDA PER IL FOLLOW UP DEL PAZIENTE
DAL PUNTO DI VISTA DELL’UROLOGO
Dr. Debora MarchioriClinica Gynepro Medical
Bologna
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PREMESSA
� follow up nei pazienti sottoposti a chirurgia permette:1. valutazione delle complicanze post operatorie; 2. monitoraggio funzionalità renale;3. monitoraggio della recidiva;
�Timing non definito�Setting non definito
APPROCCIO RISK ADAPTED
Non trial clinici ma solo follow up a lungo termine
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NO DATA ON TIMING….!!!
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Linee guidaTUMORI del RENEEdizione 2013
�No raccomandazioni
�Follow up basati sul rischio
�Nessun dato confermato con RCT sulla durata ottimale del follow up
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Follow-Up Measure Radical or Partial Nephrectomy Physical Exam and History • History & physical exam directed at detecting signs/symptoms of metastatic spread or local recurrence
Laboratory Testing • Basic laboratory testing to include BUN/creatinine, UA and eGFR;
• CBC, LDH, LFTs, ALP and calcium level tests may be used at the discretion of the physician;
• Progressive renal insufficiency should prompt a nephrology referral
CNS Scan • Acute neurological signs should prompt neurologic cross sectional (CT or MRI) scan1 of the head or spine based on
localized symptomatology
Bone Scan • Elevated ALP, clinical symptoms such as bone pain, and/or radiographic findings suggestive of a bony neoplasm
should prompt a bone scan;
• A bone scan should not be performed in the absence of these symptoms
Follow-Up Measure Low Risk Moderate to High Risk Abdominal Scan1/Imaging2 Partial Nephrectomy—Obtain a baseline abdominal scan1 (CT or
MRI) within three to twelve months following surgery;
• If the initial postoperative scan is negative, abdominal
imaging2 (US, CT OR MRI) may be performed yearly for
three years based on individual risk factors
• A baseline abdominal scan1 (CT or MRI) within
three to six months following surgery with
continued imaging2 (US, CT or MRI) every six
months for at least three years and annually
thereafter to year five.
• Imaging2 beyond five years may be performed at
the discretion of the clinician.
• Perform site specific imaging as symptoms
warrant.
Radical Nephrectomy—Patients should undergo abdominal
imaging2 (US, CT or MRI) within three to twelve months
following renal surgery;
• If the initial postoperative imaging is negative, abdominal
imaging2 beyond twelve months may be performed at the
discretion of the clinician
Chest Imaging/scan • Obtain a yearly chest x-ray for three years and only as
clinically indicated beyond that time period
• Obtain a baseline chest scan (CT) within three to
six months following surgery with continued
imaging3 (CXR or CT) every six months for at least
three years and annually thereafter to year five.
• Imaging3 beyond five years is optional and should
be based on individual patient characteristics and
tumor risk factors
1In t
h
e co nt ext of th i s do cume nt, “s can” dictates th e us e of CT or MRI . h
E.O.
E.O.
O; C
O; C
R; C
R; C
O; C
CL.P
E.O.
S;A.
R; C
Legenda:S: standard; R:reccomandation;E.O: expert opinion; O: option;CL.P; clinical principle
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FOLLOW del RCC e RUOLI:
UROLOGOONCOLOGO MEDICO
PRIMA
PAZIENTE METASTATICO
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Martedì 24 giugno 11.30-12.30 :
Spazio siuro giovani
- I "mai più" e i "mai più senza" nel percorso diagnostico terapeutico dei tumori del rene: report
dell'evento Young Specialist in Renal Care -