GUIDELINES FOR THE MANAGEMENT OF

Transcription

1 GUIDELINES FOR THE MANAGEMENT OF RENAL CANCER Date of endorsement: July 2011 Authors: Mr. RD Mills & Mr. WH Turner Ref: AngCN-SSG-U3 Page 1 of 14 Approved and Published: Aug 2011

2 Title: Guidelines for the Management of Renal Cancer Authors: Mr. RD Mills & Mr. WH Turner Document management Document ratification and history Approved by: Review period: Urology NSSG Joint Chair and Network CEO 2 years (or earlier in the light of new evidence) Date placed on electronic library: Aug 2011 Authors: Mr R.D. Mills and Mr W.T. Turner Document Owner: Anglia Cancer Network Tel: Version number as approved and published: 2 Unique identifier no.: AngCN-SSG-U3 For comments / amendments to these guidelines, please contact: Name Hospital Tel. No Rob Mills NNUH Robert.mills@nnuh.nhs.uk William Turner Addenbrookes William.turner@addenbrookes.nhs.uk For copies of guidelines, please refer to the Anglia Cancer Network website: Monitoring the effectiveness of the Process a) Process for Monitoring compliance and Effectiveness - Review of compliance as determined by audit. Any non compliance to be presented by PQ Manager to the AngCN Business Meeting on an annual basis the minutes of this meeting are retained for a minimum of five years. b) Standards/Key Performance Indicators This process forms part of a quality system working to, but not accredited to, International Standard BS EN ISO 9001:2008. The effectiveness of the process will be monitored in accordance with the methods given in the quality manual, AngCN-QM Equality and Diversity Statement This document complies with the Suffolk PCT Equality and Diversity statement an EqIA assessment is available on request to Anglia Cancer Network PQ Manager, Gibson Centre, Exning Road, Newmarket, CB8 7JG. Disclaimer It is your responsibility to check against the electronic library that this printed out copy is the most recent issue of this document. Page 2 of 14 Approved and Published: Aug 2011

3 CONTENTS Introduction...4 Referrals...4 Staging...4 Treatment...4 Partial nephrectomy... 5 Radical nephrectomy... 5 Adrenalectomy... 5 Lymphadenectomy... 6 Cytoreductive surgery... 6 High risk or metastatic disease... 6 Classification... 6 Follow up...6 Following radical nephrectomy... 6 Following partial nephrectomy... 7 Patients with hereditary renal cancer... 7 Recurrent disease...7 Local recurrence... 7 Distant recurrence... 7 Appendices...8 Appendix 1 TNM Classification 2002 (6th Edition)... 9 T Primary Tumour... 9 N Regional Lymph Nodes... 9 M1 Distant Metastasis... 9 ptnm Pathological Classification Appendix 2 Fuhrman Pathological Grading System Appendix Appendix 4 Kidney Cancer Pathway Page 3 of 14 Approved and Published: Aug 2011

4 Introduction The purpose of this manual is to collate the numerous guidelines that exist, into a working manual for the management of renal cancer within the Anglia Cancer Network. It should act as a summary guide for the management of patients with renal cancer based on the available published evidence. Its scope is to aid all health practitioners involved with the patient from primary care and referral through treatment to follow up. However, as constant modifications are being made, these guidelines should only be used to give an indication of current management. They should not be used to treat patients without checking that changes have not been made. These guidelines have been developed by discussion between clinicians within the Anglia Cancer Network Urology Site Specific Group but without the establishment of a formal guideline development group. These guidelines have been endorsed by the Anglia Cancer Network Urology Site Specific Group. They will be reviewed and updated on an annual basis or more frequently as required. The guidelines are intended as a working document for daily practice. For more detailed sources, and for educational material, please refer to guidelines produced by eg, NICE, BAUS, EAU, AUA. Referrals For referrals from Primary and Secondary Care, see AngCN kidney cancer pathway and DH suspected cancer guidance. Staging Haemoglobin, ESR or CRP, creatinine, electrolytes, bone and liver profile. CT of chest, abdomen and pelvis Bone scintigram if alkaline phosphatase elevated or bone pain. Nuclear medicine studies may be considered prior to partial nephrectomy. If clarification of venous involvement is required, consider US or MR Brain CT only if symptoms of cerebral metastases. 3D reconstruction of CT may be considered prior to partial nephrectomy. Biopsy is not normally necessary before surgery but should be considered in cases where imaging is unclear or where surgery is not appropriate and biological treatment is being considered. Treatment As a result of accumulated evidence confirming the oncological safety of nephronsparing surgery, and confirming the risk of CKD (with its inherent cardiovascular risks) following elective radical nephrectomy, and consistent with the 2009 AUA guidelines, all patients with presumed T1 tumours (solid mass < 7cm) should be considered for partial nephrectomy. Those deemed suitable for partial nephrectomy should then be discussed with the Specialist Multi-disciplinary Team at Addenbrooke s or the Norfolk and Norwich University Hospital. Page 4 of 14 Approved and Published: Aug 2011

5 Other patients with complex renal cancer (defined below) should also be discussed with the Specialist Multi-disciplinary Team at Addenbrooke s or the Norfolk and Norwich University Hospital. Those whose tumours have or may have extended to the renal vein, IVC or the heart Those with nodes of greater than 2 cm or with limited distant metastatic disease which might be amenable to resection Those who have bilateral disease or who will require dialysis Patients with von Hippel-Lindau disease or hereditary papillary tumours Patients with non-renal cell cancer, other than those with upper tract TCC, eg sarcoma Partial nephrectomy Indications Tumour less than 7 cm with normal contralateral kidney Tumour in anatomically or functionally solitary kidney Bilateral synchronous presumed renal cell cancer Possible metachronous cancers (hereditary renal cancer) Relative indications Systemic disease that might affect renal function in the future, eg diabetes, stone disease Patients who do not need to be discussed with an SMDT should be managed locally by radical surgery, or conservatively, if: not suitable surgical candidates (eg very frail or very elderly) patient preference (active monitoring) Partial nephrectomy should take place at either Addenbrooke s or the Norfolk and Norwich University Hospital. Radical nephrectomy Patients with T2 or T3a disease, and with an apparently normal contralateral kidney should be considered, in their LMDT, for radical nephrectomy. This can be an open operation or a laparoscopic nephrectomy. The latter may be contraindicated if the tumour is very large, there is extensive nodal enlargement or the renal vein is involved Adrenalectomy Adrenalectomy is indicated where there is high risk of adrenal metastasis, evidenced by large (T3) tumours in the upper half of the kidney or where the adrenal is suspicious for metastasis on pre-operative imaging. Page 5 of 14 Approved and Published: Aug 2011

6 Lymphadenectomy Left to individual surgeon preference. Cytoreductive surgery The role of nephrectomy in metastatic disease is controversial. The decision about such surgery should be made jointly at an SMDT and should involve clinical oncologists with specific expertise in renal cancer. High risk or metastatic disease Patients with high risk surgical pathology or with metastatic disease should be referred to an oncologist with specific expertise in renal cancer. Palliative nephrectomy for local symptoms is sometimes indicated in patients with metastatic disease. For selected patients renal embolisation may have a role. For patients whose metastatic disease is asymptomatic a period of observation may be indicated. When a patient has not undergone surgical resection, biopsy should be considered before immunotherapy is offered. Classification For details of pathology guidelines for renal cancer, see the ACN Pathology guidelines. Tumour should be classified using the 2002 TNM classification system. (6th Edition) (see Appendix 1). The Fuhrman pathological grading system is favoured (see Appendix 2). Histopathology reporting should accord with the Royal College of Pathologists guidelines. In addition, reporting should allow prognostication by the Leibovich (Mayo) scoring system (see Appendix 2). Follow up All stages six weeks post surgery visit to: exclude complications of surgery physical examination, serum haemoglobin, creatinine, with alkaline phosphatase optional. Following radical nephrectomy Page 6 of 14 Approved and Published: Aug 2011

7 Further follow-up depends on classification of recurrence risk: Low recurrence risk (T1, Fuhrman 1 or 2) o no further follow-up Intermediate recurrence risk (T2, Fuhrman 1 or 2) o 6 monthly visits with FBC, C & E and CXR to 3 years, with CT chest/abdomen at 6, 12, 24 and 36 months (omit CXR at these points) High recurrence risk (all T3 or 4, all Fuhrman 3 or 4) o 6 monthly visits with FBC, C & E and CXR to 5 years, with CT chest/abdomen at 6, and 12, months, then annually to 5 years (omit CXR at these points) Following partial nephrectomy 6 monthly visits with FBC, C & E and CXR to 5 years, with CT chest/abdomen at 6, and 12, months, then annually to 5 years (omit CXR at these points) Patients with hereditary renal cancer follow up also in the medical genetics unit. Recurrent disease Local recurrence discussion in SMDT with clinical oncologists with specific expertise in renal cancer restaging consider period of observation to assess disease cadence then consider excision if isolated recurrence Distant recurrence discussion in SMDT with clinical oncologists with specific expertise in renal cancer restaging consider period of observation to assess disease natural history then consider excision if isolated recurrence if widespread recurrence, discuss with clinical oncologists with specific expertise in renal cancer Page 7 of 14 Approved and Published: Aug 2011

8 Appendices Appendix 1 TNM Classification 2002 (6th Edition) Appendix 2 Fuhrman Pathological Grading System and Leibovich Prognosis Score Appendix 3 Clinical Trials Appendix 4 Kidney Cancer Pathway Page 8 of 14 Approved and Published: Aug 2011

9 Appendix 1 TNM Classification 2002 (6th Edition) T Primary Tumour TX T0 T1 Primary tumour cannot be assessed No evidence of primary tumour Tumour 7cm or less in greatest dimension, limited to the kidney T1a T1b Tumour 4cm or less Tumour more than 4cm but not more than 7cm T2 T3 Tumour more than 7cm in greatest dimension, limited to the kidney Tumour extends into major veins or directly invades adrenal gland or perinephric tissues but not beyond Gerota fascia T3a T3b T3c Tumour directly invades adrenal gland or peri-nephric tissues 1 but not beyond Gerota fascia Tumour grossly extends into renal veins(s) 2 or vena cava or its wall below diaphragm Tumour grossly extends into renal veins(s) 2 or vena cava or its wall above diaphragm T4 Tumour directly invades beyond Gerota fascia Notes: 1 Includes renal sinus (peripelvic) fat 2 Includes segmental (muscle-containing) branches N Regional Lymph Nodes NX N0 N1 N2 Regional lymph nodes cannot be assessed No regional lymph node metastasis Metastasis in a single regional lymph node Metastasis in more than one regional lymph node M1 Distant Metastasis MX M0 M1 Distant metastasis cannot be assessed No distant metastasis Distant metastasis Page 9 of 14 Approved and Published: Aug 2011

10 ptnm Pathological Classification The pt, pn and pm categories correspond to the T, N and M categories. pn0 Histological examination of a regional lymphadenectomy specimen will ordinarily include 8 or more lymph nodes. If the lymph nodes are negative but the number ordinarily examined is not met, classify as pn0. G - Histopathological Grading GX Grade of differentiation cannot be assessed G1 Well differentiated G2 Moderately differentiated G3-4 Poorly differentiated/undifferentiated Stage Grouping Stage I T1 N0 M0 Stage II T2 N0 M0 Stage III T3 N0 M0 T1, T2, T3 N1 M0 Stage IV T4 N0, N1 M0 Any T N2 M0 Any T Any N M1 Summary Kidney T1 7cm; limited to the kidney T1a T1b 4cm > 4cm T2 T3 > 7cm; limited to the kidney Adrenal or perinephric invasion; major veins T3a T3b T3c Adrenal or perinephric invasion Renal veins(s); vena cava below diaphragm Vena cava above diaphragm T4 N1 N2 Beyond Gerota fascia Single More than one Page 10 of 14 Approved and Published: Aug 2011

11 Appendix 2 Fuhrman Pathological Grading System Grade Nuclear size Nuclear shape Nucleoli Other features 1 10um Round and uniform Inconspicuous or absent 2 15um Irregular Present Examined at x400 magnification 3 20um Obviously irregular Large Examined at x100 magnification 4 20+um Bizarre or multilobulated Large Clumped chromatin, spindle cells Leibovich Score Table 1 Scoring Algorithm to Predict Metastases after Radical Nephrectomy in Patients with Clear Cell Renal Cell Carcinoma Feature Score Primary tumor status (pathologic T stage) a pt1a 0 pt1b 2 pt2 3 pt3a 4 pt3b 4 pt3c 4 pt4 4 Regional lymph node status (N stage) a pnx 0 pn0 0 pn1 2 pn2 2 Tumor size (cm) < Nuclear grade Histologic tumor necrosis No 0 Yes 1 a According to the 2002 American Joint Committee on Cancer TNM staging system.[19] Page 11 of 14 Approved and Published: Aug 2011

12 Table 2. Estimated Metastases Free Survival after Radical Nephrectomy in Patients with Clear Cell Renal Cell Carcinoma by Score Estimated metastasis free survival rate (% ± SE) Year 1 Year 3 Year 5 Year 7 Year 10 No. of patients Score (%) Rate No. Rate No. Rate No. Rate No. Rate No (22.0) 99.7 ± (19.2) 99.3 ± (9.7) 96.1 ± (14.7) 90.2 ± (12.0) 86.1 ± (10.9) 66.9 ± (5.6) 59.3 ± (5.9) 39.7 ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± SE: standard error. Page 12 of 14 Approved and Published: Aug 2011

13 Appendix 3 The Manual for Cancer Services 2004 states that one of the responsibilities of the MDT Lead Clinician is To ensure mechanisms are in place to support entry of eligible patients into clinical trials. The infrastructure to support clinical trials activity is the responsibility of the West Anglia, Norfolk & Waveney and Ipswich locality of the Mid-Anglia Cancer Research Networks (WACRN, NWCRN and MACRN) which provide facilities enabling patient entry into clinical trials in all of its units. The Anglia Cancer Network Urology SSG is committed to participation in high quality research studies and clinical trials. Whenever possible, patients should be considered for inclusion in local and national research studies and clinical trials. There is an NSSG agreed single list of clinical trials and research studies supported by the individual MDTs. This is updated at least annually. Further details and protocols are available as follow: Trust Contact Telephone Addenbrooke s West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network Bedford West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network Hinchingbrooke West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network Ipswich Anglia East Cancer To be To be confirmed Network confirmed James Paget Anglia East Cancer Natalie.barber@nnuh.nhs.uk Network King s Lynn West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network Norfolk & Norwich Anglia East Cancer Natalie.barber@nnuh.nhs.uk Network Papworth West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network Peterborough West Anglia Cancer Roy.harris@addenbrookes.nhs.uk Research Network West Suffolk West Anglia Cancer Research Network Roy.harris@addenbrookes.nhs.uk Page 13 of 14 Approved and Published: Aug 2011

14 Appendix 4 Kidney Cancer Pathway KIDNEY CANCER PATHWAY (E&W) Final Oncology OPA Decision to Treat (DTT) Systemic Therapy Radiotherapy Recurrence detected Urgent GP suspected cancer referral (2WW) OPA/ Haematuria Clinic Staging CT / MRI Where indicated DMSA (Unit) LOCAL MULTIDISCIPLINARY TEAM (LMDT) MEETING Decision to refer to SMDT OPA Patient informed of diagnosis Decision to Treat (DTT) SPECIALIST MULTIDISCIPLINARY (SMDT) MEETING Uro-Oncology Clinic (UOC) Decision to Treat (DTT) Cryotherapy Venous inv Surgery Partial Nephrectomy Active Monitoring L/SMDT / OPA to assess fitness for subsequent treatment Earliest clinically appropriate date, decision to treat (DTT) Follow Up Metasteses excision Radiotherapy Renal Oncology Where indicated DMSA (Unit) Palliative Radiotherapy Palliative Care Other Referrals i.e. non urgent 18ww referral Palliative Care Nephrectomy Active Monitoring Palliative Care Consultant upgrade points e.g. referral meets NICE criteria; at first seen, during or after diagnostic tests; on or before MDT date & decision to treat date +62 days from these upgrade point dates Consider Clinical Trial and Follow Up Referral to extended MDT services at any point in pathway e.g. Palliative care specialists, Specialist Nurses and AHPs, education about adverse effects of treatment; access to help and advice from all specialists; staff alert to psychosocial needs; therapists/local healthcare teams, Community Matron, Pharmacists (medicines usage review), Social Services, Mental Health Services, Housing benefits (Social Care and other agencies), GPs, Expert Patient Programme, Smoking Cessation, Alcohol Service (NORCAS), Voluntary organisations, information on prescription, Homeshield (over 60s) Day 0 (Referral) By Day 14 (1st seen) By Day 28 (LMDT Meeting) By Day 42 (DTT) By Day 62 (treatment) Day 0 (DTT) By Day 31 (2nd treatment) Key: Unit / Centre Centre Access to specialist services GFOCW Elapsed time for follow up or presentation of recurrence, mets or predetermined gap between treatments Page 14 of 14 Approved and Published: Aug 2011