GUIDELINES FOR THE MANAGEMENT OF BLADDER CANCER For approvals and version control see Document Management Record on page 9 Ref: AngCN-SSG-U4 Page 1 of 11 Approved and Published: Aug 2012
TABLE OF CONTENTS 1 Introduction... 3 2 Referrals... 3 2.1 Investigations, staging and treatment guidelines...3 2.2 Initial tumour resection...3 2.3 New non-muscle invasive Tumours...3 2.4 Recurrent non-muscle invasive Tumours...5 2.5 Muscle-invasive Tumours...5 2.6 Cystectomy...5 2.7 High risk disease post-cystectomy (vascular/lymphovascular invasion, pn+, M+, positive margins)...6 3 Radiotherapy (RT)... 6 3.1 Radical RT...6 3.2 Palliative RT...6 4 Chemotherapy... 6 5 Follow up after radical treatment...7 5.1 Cystectomy...7 5.2 Radiotherapy...7 5.3 Metastatic disease...7 6 Upper Tract Transitional Cell Carcinoma... 7 6.1 Investigation...7 6.2 Treatment...7 6.3 Follow-up...7 7 Clinical Trials Portfolio... 8 8 Evidence of Agreement... 9 Page 2 of 11 Approved and Published: Aug 2012
1 Introduction The purpose of this manual is to collate the numerous guidelines that exist, into a working manual for the management of bladder cancer within the Anglia Cancer Network. It should act as a summary guide for the management of patients with bladder cancer based on the available published evidence. Its scope is to aid all health practitioners involved in 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 e.g. NICE, BAUS, EAU, AUA. 2 Referrals For referrals from Primary and Secondary Care, see AngCN bladder cancer pathway Appendix 1 Bladder Pathway and DH suspected cancer guidance. 2.1 Investigations, staging and treatment guidelines Outpatient assessment of haematuria clinical history and examination FBC, C & E, PSA in men urine culture and consider cytology upper tract imaging (at local discretion) Classification and treatment for patients with bladder cancer. 2.2 Initial tumour resection TURBT under GA or regional anaesthesia Single dose of intravesical chemotherapy At the discretion of the treating consultant, those with very small papillary tumours, those with small indeterminate lesions, or those with obviously solid invasive tumours, may not receive intravesical chemotherapy All tumours classified by Stage (TNM) and Grade LMDT review 2.3 New non-muscle invasive Tumours ptag1 or ptag2 Flexible cystoscopy at three months At three month flexible cystoscopy, assign the patient to a recurrence risk group, as follows. Page 3 of 11 Approved and Published: Aug 2012
Initial resection Three month cystoscopy Recurrence risk group Solitary tumour and negative Low risk of recurrence Solitary tumour and positive Medium risk of recurrence or Multifocal tumour and negative Medium risk of recurrence Multifocal tumour and positive High risk of recurrence Subsequent management is recommended as follows: Recurrence risk group Plan Low flexible cystoscopy at one year from diagnosis then annually for seven years from diagnosis then if no recurrence, annual GP symptom review and urinalysis for life Medium intravesical chemotherapy after three month flexible cystoscopy if recurrence then three monthly flexible cystoscopy until one year from diagnosis then six monthly flexible cystoscopy until three years from diagnosis then annual flexible cystoscopy until seven years from diagnosis then if no recurrence, annual GP symptom review and urinalysis for life High six doses of intravesical chemo then 3 monthly flexible cystoscopy until one year from diagnosis then six monthly flexible cystoscopy until three years from diagnosis then annual flexible cystoscopy until seven years from diagnosis then if no recurrence, annual GP symptom review and urinalysis for life pt1 (all grades), ptag3 and ptis (Carcinoma in situ) Patients with high risk superficial bladder cancer (as designated in the 2008 Urology Measures, ptag3, pt1g3, T1G2, carcinoma in situ, and extensive, multifocal or recurrent G2) should be referred for discussion at the SMDT. To simplify the referral process, it has been agreed that the SMDT only requires a copy of the LMDT s outcome form and just the histology slide that demonstrates the relevant pathology. Relevant imaging should be sent where appropriate. The SMDT will confirm an Action Plan for each of these referred patients, For those patients who need to be counselled about the options of BCG and cystectomy, the SMDT will arrange an outpatient appointment at the Cancer centre for the patient to see one of the following Urologists who perform Radical Cystectomy: CUH NNUH Alexandra Colquhoun David Neal William Turner Edwin Ho Vivek Kumar Robert Mills Mark Rochester Krishna Sethia Page 4 of 11 Approved and Published: Aug 2012
Intravesical BCG for those patients recommended by the SMDT to have BCG An induction course of six weekly doses of BCG, with GA cystoscopy and biopsy six weeks after 1 st course, then Lamm's maintenance schedule (three instillations at three months, six months, then six monthly for a further three years), with three monthly flexible cystoscopy and cytology for two years, then six monthly for two years, then annually for life. It is recognised that not all patients will complete a full maintenance course due to side effects. In this case alterations to the doses and/or frequency maybe required. 2.4 Recurrent non-muscle invasive Tumours Initial ptag1 or ptag2 disease For single recurrence, resect/biopsy and diathermy, single post operative dose of intravesical chemotherapy if larger than 3 mm max diameter for multiple recurrences, resect/biopsy and diathermy, single post operative dose of intravesical chemotherapy LMDT review Consider full (6 week) course of intravesical chemotherapy / BCG Flexible cystoscopy at three months For large recurrences (>1cm), multiple (>5) or if worsening recurrence history and if patient is fit for radical surgery refer to SMDT to discuss cystectomy. For other patients treated with BCG (ptag3, pt1g2/3 or Cis) If recurrence, resect/biopsy & diathermy Discuss at LMDT If candidate for Radical Surgery to refer to SMDT for discussion of option of cystectomy 2.5 Muscle-invasive Tumours If a new tumour looks solid at initial flexible cystoscopy, arrange MRI before TURBT At TURBT, resect/debulk tumour and consider sending separate bladder tumour base for analysis TUR/cup biopsy of prostatic urethra to assess indication for urethrectomy Document bimanual examination of clinical stage LMDT discussion of histology Refer for discussion at SMDT if muscle-invasive or high risk superficial (as above) MRI pelvis and abdomen, if not done already Chest X-ray, alkaline phosphatase (bone scan, if elevated alkaline phosphatase or otherwise indicated) Discussion of cases at SMDT Assess suitability for neo-adjuvant chemotherapy. To consider options of Radical Cystectomy and Radical radiotherapy If not a suitable candidate for neo-adjuvant chemotherapy, arrange to see in CUH or NNUH Uro- Oncology Clinic if a surgical candidate, and with an Oncologist either locally, or at CUH or NNUH as appropriate. 2.6 Cystectomy Discuss the following: Neo-adjuvant chemotherapy Alternatives to cystectomy are radiotherapy or continued endoscopic management Page 5 of 11 Approved and Published: Aug 2012
Diversion/reconstruction options (all those possible for particular patient): Conduit Bladder substitute Catheterisable reservoir only if urethrectomy necessary Check GFR and estimate of differential renal function if any upper tract dilatation, consider if normal upper tracts Consider nephrostomy drainage if upper tract obstruction 2.7 High risk disease post-cystectomy (vascular/lymphovascular invasion, pn+, M+, positive margins) Review histology in SMDT Consider adjuvant chemotherapy 3 Radiotherapy (RT) 3.1 Radical RT Fit patients with muscle invasive disease: ideally those with no ureteric obstruction with small tumours away from trigone Younger fitter patients with limited lymphadenopathy (but no metastases) can be offered radical radiotherapy if good response to neo-adjuvant chemotherapy Patient keen on bladder preservation Preference over radical surgery: Concomitant disease increasing the risks of surgery e.g. cardiovascular disease Inability to manage a stoma 3.2 Palliative RT Palliative radiotherapy is to control symptoms, particularly pelvic pain (not cystitis) and haematuria in the following circumstances: frail patients metastatic disease 4 Chemotherapy Gem/CIS (Gemcitabine and cisplatin) is the current choice for network. See Network Approved Chemotherapy Regimen list and protocol. Restage with CT/MR and EUA towards the end of, or after chemotherapy Page 6 of 11 Approved and Published: Aug 2012
5 Follow up after radical treatment 5.1 Cystectomy Clinic six weeks post surgery to: exclude complications of surgery physical examination, serum haemoglobin, and creatinine Further follow-up depends on classification of recurrence risk: Low recurrence risk (worst pathology, T1 or better) Clinic three monthly for two years, then six monthly for two years, then annually for life FBC, C&E and CXR at each visit, PSA if prostate cancer at cystectomy Upper tract FU with US and Nuclear Medicine High recurrence risk (worst pathology, T2 or worse) As for low risk, with CT in first 6-12 weeks, and consideration of adjuvant chemotherapy 5.2 Radiotherapy GA cystoscopy at three months, then three monthly flexible cystoscopy for two years, then six monthly for two years, then annually for life 5.3 Metastatic disease discussion in SMDT staging/restaging consider chemotherapy and Palliative Care referral 6 Upper Tract Transitional Cell Carcinoma 6.1 Investigation as for Haematuria Clinic, and retrograde ureterogram/ureteroscopy and biopsy bone scintigram if elevated alkaline phosphatase or bone pain consider Nuclear medicine assessment of differential renal function 6.2 Treatment Open or laparoscopic nephroureterectomy Local excision or laser ablation are options for low volume pta G1 or G2 disease, after SMDT discussion Consider adjuvant chemotherapy if high risk disease, after SMDT discussion 6.3 Follow-up Check cystoscopy at three, six and 12 months, then annually if clear, until five years flexible ureterorenoscopy for life following local excision or laser ablation Imaging of remaining (contralateral) upper tract if symptomatic Page 7 of 11 Approved and Published: Aug 2012
7 Clinical Trials Portfolio 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 within the Anglia Cancer Network is the responsibility of the two Cancer s (West Anglia Cancer (WACRN) and Anglia East Cancer (AECRN) which provides facilities enabling patient entry into clinical trials in all of its units. The Anglia Cancer Network Urology SSG 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 Email Bedford West Anglia Cancer CUH West Anglia Cancer Hinchingbrooke West Anglia Cancer Ipswich Anglia East Cancer 01603 natalie.barber@nnuh.nhs.uk 289860 James Paget Anglia East Cancer 01603 natalie.barber@nnuh.nhs.uk 289860 King s Lynn West Anglia Cancer Norfolk & Anglia East Cancer 01603 natalie.barber@nnuh.nhs.uk Norwich 289860 Papworth West Anglia Cancer Peterborough West Anglia Cancer elisa.barter@pbh-tr.nhs.uk West Suffolk West Anglia Cancer Page 8 of 11 Approved and Published: Aug 2012
8 Evidence of Agreement These Clinical Guidelines have been agreed by: For comments / amendments to these guidelines, please contact: Name Hospital Tel. No Email Robert Brierly IHT 01473 712233 Robert.Brierly@ipswichhospital.nhs.uk For copies of guidelines, please refer to the Anglia Cancer Network website: The Chair of the Network Board Name: Paul Watson Organisation: NHS Suffolk Date agreed: 28 July 2012 The Chair/Joint Chairs of the Urology NSSG Name: Robert Brierly Organisation: IHT Date agreed: 19 July 2012 Name: Kumar Vivekanandan Organisation: NNUHFT Date agreed: 19 July 2012 The NSSG Members This document was discussed at the Urology NSSG Meeting on 19 July 2012 and was agreed to by all members. Document management Document history Review 2 years period: Date placed on electronic library: Authors: Robert Brierly Document Owner: Version number as approved and published: 2 Unique identifier no.: Aug 2012 Anglia Cancer Network Tel: 01638 608208 www.angliacancernetwork.nhs.uk AngCN-SSG-U4 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 Page 9 of 11 Approved and Published: Aug 2012
This document complies with the Suffolk PCT Equality and Diversity statement an EIA 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. Please notify any changes required to the Anglia Cancer Network PQ Manager Page 10 of 11 Approved and Published: Aug 2012
Appendix 1 Bladder Pathway BLADDER CANCER PATHWAY (E&W) Final Flexi cysto FU Other Referrals i.e. non urgent 18ww referral (via cystoscopy) Result ptag1/2 OPA and OP instillations MMC Result ptag3/cis OPA BCG BCG Urgent GP suspected cancer referral (2WW) One-stop Haematuria Clinic TURBT LOCAL MULTIDISCIPLINARY TEAM (LMDT) MEETING Histology presented Decision to refer to SMDT Result pt1g2/3 OPA then 2nd look TURBT Result <pt1 Result >pt2 OPA Decision to treat (DTT) Options for Cystectomy Cystectomy +/- EUA beforehand Cystectomy +/- EUA beforehand Direct referrals for staging where appropriate Staging +/- CT/MRI/ GFR Result >pt2 OPA Decision to treat (DTT) SPECIALIST MULTIDISCIPLINARY (SMDT) MEETING OPA Decision to treat (DTT) Radiotherapy Neoadjuvant Chemotherapy SMDT / OPA to assess fitness for subsequent treatment Earliest clinically appropriate date, decision to treat (DTT) Radiotherapy +/- EUA beforehand Chemotherapy Palliative Care 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 Tertiary Referral (to SMDT) 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 11 of 11 Approved and Published: Aug 2012