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 This is an original JCO publication from 2016. Please visit the JCO website to access the full article.


Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology Guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement

 

 Authors

Matthew I. Milowsky, R. Bryan Rumble, Christopher M. Booth, Timothy Gilligan, Libni J. Eapen, Ralph J. Hauke, Pat Boumansour, and Cheryl T. Lee

THE BOTTOM LINE

Guideline on Muscle-Invasive and Metastatic Bladder Cancer (European Association of Urology guideline): American Society of Clinical Oncology Clinical Practice Guideline Endorsement

Target Population

Patients with muscle-invasive (MIBC) or metastatic bladder cancer

Target Audience

Primary care providers, urologists, radiation and medical oncologists, and other providers

Methods

An ASCO Endorsement Panel was convened to consider endorsing the EAU guideline on MIBC and metastatic bladder cancer recommendations that were based on a systematic review of the medical literature. The ASCO Endorsement Panel considered the methodology used in the EAU guideline by considering the results from the AGREE II review instrument. The ASCO Endorsement Panel carefully reviewed the EAU guideline content to determine appropriateness for ASCO endorsement.

ASCO Key Recommendations for MIBC and Metastatic Bladder Cancer

Table 1 lists the EAU recommendations and ASCO-endorsed guidelines with qualifying statements (in bold italics).

1. Multidisciplinary input via tumor board discussions and/or directed consultations is critical to the optimal management of patients with MIBC and metastatic bladder cancer (eg, referral to a medical oncologist should be made for a discussion of neoadjuvant chemotherapy and referral to a radiation oncologist for a discussion of bladder preservation in patients with muscle-invasive disease). Implementation of these guidelines requires the integration of urology and medical and radiation oncology expertise to provide the highest level of care to patients.

2. Neoadjuvant chemotherapy is recommended for T2-T4a, cN0M0 bladder cancer and should always be cisplatin-based combination therapy.

3. Neoadjuvant chemotherapy is not recommended in patients who are ineligible for cisplatin-based combination chemotherapy, unless the goal is downstaging surgically unresectable tumors.

4. Any decision regarding bladder-sparing or radical cystectomy in elderly/geriatric patients with invasive bladder cancer should be based on tumor stage, bladder function, and the ability to tolerate major surgery, radiotherapy, and/or chemotherapy.

5. Radical cystectomy is recommended in T2-T4a, N0M0 and high-risk non-MIBC. Chemoradiotherapy-based organ preservation treatment may be offered to select patients with MIBC.

6. In patients being treated with bladder-preservation therapy with curative intent, combined chemoradiotherapy is superior to, and is recommended over, radiotherapy alone.

7. Although neoadjuvant chemotherapy is recommended, adjuvant chemotherapy may be offered to high-risk patients who have not received neoadjuvant treatment.*

8. First-line treatment of fit patients with metastatic disease: Use cisplatin-containing combination chemotherapy with gemcitabine plus carboplatin, MVAC (methotrexate, vinblastine, doxorubicin, and cisplatin), or high-dose MVAC with granulocyte colony-stimulating factor.

9. First-line treatment in patients ineligible (unfit) for cisplatin: use carboplatin combination chemotherapy or single agents.

10. In patients experiencing progression after platinum-based combination chemotherapy for metastatic disease, entry into a clinical trial is preferred. Alternatively, single-agent therapy may be offered (eg, paclitaxel, docetaxel, or vinflunine where available).

Additional Resources

More information that may include a Data Supplement, a Methodology Supplement, slide sets, and clinical tools and resources is available at www.asco.org/endorsements/MIBC and www.asco.org/guidelineswiki. Patient information is available at www.cancer.net.

A link to the guideline on MIBC and metastatic bladder cancer can be found at http://uroweb.org/guideline/bladder-cancermuscle-invasive-and-metastatic/.

ASCO believes that cancer clinical trials are vital to inform medical decisions and improve cancer care and that all patients should have the opportunity to participate.

*The word “offered” should be interpreted as having a detailed discussion with the patient about the risks and benefits of adjuvant chemotherapy. The discussion should include a thorough review of the absolute risk of recurrence in light of the pathologic findings, acknowledging the limitations of the data in the adjuvant setting.

SUMMARY OF RECOMMENDATIONS

Clinical DomainEAU Recommendation with ASCO Qualifying Statements in Bold Italics
Primary Assessment of Presumably Invasive Bladder TumorsCystoscopy should describe all macroscopic features of the tumour (site, size, number and appearance) and mucosal abnormalities. A bladder diagram is recommended when feasible.
Biopsy of the prostatic urethra is recommended when there is positive cytology without evidence of tumour in the bladder, or when abnormalities of the prostatic urethra are visible. Additionally, prostatic urethral biopsy should be considered for cases of bladder neck tumour or when bladder CIS is present or suspected.
If biopsy is not performed during the initial procedure, it should be completed at the time of the second resection
In women undergoing subsequent orthotopic neobladder construction, procedural information is required (including histological evaluation) of the bladder neck and urethral margin, either prior to or at the time of cystectomy.
The pathological report should specify the grade, histology, depth of tumour invasion, and whether the lamina propria and muscle tissue are present in the specimen.
Comorbidity ScalesAny decision regarding bladder-sparing or radical cystectomy in elderly/geriatric patients with invasive bladder cancer should be based on tumour stage, bladder function, and the ability to tolerate major surgery, radiotherapy and/or chemotherapy.
The ASA score does not address comorbidity and should not be used in this setting.
Treatment Failure in Non–Muscle Invasive Bladder CancerIn all T1 tumors at high risk of progression (i.e., high grade, multifocality, CIS, and tumor size, as outlined in the EAU guidelines for non-muscle-invasive bladder cancer), immediate radical treatment is an option.
In all T1 patients failing intravesical therapy, radical treatment should be offered.
Neoadjuvant ChemotherapyNeoadjuvant chemotherapy is recommended for T2-T4a, cN0M0 bladder cancer and should always be cisplatin-based combination therapy.
Neoadjuvant chemotherapy is not recommended in patients who are ineligible for cisplatinbased combination chemotherapy, unless the goal is downstaging surgically unresectable tumors.
Pre- and Postoperative RadiotherapyPre-operative radiotherapy is not recommended to improve survival.
Not endorsed by ASCO based on the evidence that the EAU reviewed
Radical Cystectomy and Urinary DiversionFor patients that are not receiving neoadjuvant chemotherapy, cystectomy for MIBC should be performed within 3 months of diagnosis to lower the risk of progression and cancerspecific mortality
Before cystectomy, the patient should be fully informed about the benefits and potential risks of all possible alternatives, and the final decision should be based on a balanced discussion between patient and surgeon.
In addition to ileal conduit diversion, an orthotopic bladder substitute should be offered to male and female patients lacking any contraindications and who have no tumor in the urethra or at the level of urethral dissection.
Preoperative radiotherapy is not recommended for patients undergoing cystectomy with urinary diversion.
Pre-operative bowel preparation is not mandatory. “Fast track” measurements may reduce the time of bowel recovery.
Radical cystectomy is recommended in T2-T4a, N0 M0, and high-risk non-MIBC. Chemoradiation based organ preservation treatment may be offered to select patients with MIBC.
Lymph node dissection should be an integral part of cystectomy.
The urethra can be preserved if margins are negative. If no bladder substitution is attached, the urethra must be surveyed regularly in males.
Laparoscopic cystectomy and robot-assisted laparoscopic cystectomy are both management options. However, current data have not sufficiently proven the advantages or disadvantages for oncological and functional outcomes.
Nonresectable Tumor: Palliative Cystectomy for Muscle-Invasive Bladder CarcinomaIn patients with inoperable locally advanced tumors (T4b), primary radical cystectomy is a palliative option and cannot be offered as curative treatment.
In patients with symptoms palliative cystectomy may be offered.
Bladder-Sparing Treatments for Localized DiseaseTransurethral resection of bladder tumor (TURB) alone is not a curative treatment option in most patients.
Radiotherapy alone is not recommended as primary therapy for localised bladder cancer.
Chemotherapy alone is not recommended as primary therapy for localized bladder cancer
Neoadjuvant chemotherapy followed by radical cystectomy or bladder-preserving chemoradiotherapy treatments are the preferred curative therapeutic approaches as they are more effective than radiotherapy alone.
Bladder-preserving multimodality treatment could be offered as an alternative to cystectomy in appropriately selected patients, and may be appropriate in some patients for whom cystectomy is not an option.
Adjuvant ChemotherapyAdjuvant cisplatin based combination chemotherapy may be offered to patients with pT3/4 and/or or pN+) disease if no neoadjuvant chemotherapy has been given.
While neoadjuvant chemotherapy is recommended, adjuvant chemotherapy may be offered to high-risk patients that did not receive neoadjuvant treatment. *
Metastatic Disease

First-line treatment for fit patients:

  • First-line treatment for fit patients: Use cisplatin-containing combination chemotherapy with GC, MVAC, or HD-MVAC with G-CSF
  • Carboplatin and non-platinum combination chemotherapy is not recommended

First-line treatment in patients ineligible (unfit) for cisplatin:

  • Use carboplatin combination chemotherapy or single agents.
  • For cisplatin-ineligible (unfit) patients, with PS2 or impaired renal function, as well as those with 0 or 1 poor Bajorin prognostic factors and impaired renal function, treatment with carboplatin-containing combination chemotherapy, preferably with gemcitabine/carboplatin is indicated.

Second-line treatment:

  • In patients progressing after platinum-based combination chemotherapy for metastatic disease, entry into a clinical trial is preferred. Alternatively, single-agent therapy may be offered (e.g. paclitaxel, docetaxel, or vinflunine where available).
  • Zoledronic acid or denosumab may be offered for treatment of bone metastases* .
BiomarkersCurrently, no biomarkers can be recommended in daily clinical practice because they have no impact on predicting outcome, treatment decisions, or monitoring therapy in muscle-invasive bladder cancer.
Health-Related Quality of LifeThe use of validated questionnaires is recommended to assess HRQoL in patients with MIBC.
Unless a patient’s comorbidities, tumour variables and coping abilities present clear contraindications, a continent urinary diversion should be offered to patients undergoing cystectomy.
Pre-operative patient information, patient selection, surgical techniques, and careful postoperative follow-up are the cornerstones for achieving good long-term results.
Patients should be encouraged to take active part in the decision-making process. Clear and exhaustive information on all potential benefits and side-effects should be provided, allowing them to make informed decisions.
Follow-Up

Local recurrence, poor prognosis: Treatment should be individualized depending on the local extent of tumor.

  • Radiotherapy, chemotherapy and possibly surgery are options for treatment, either alone or in combination.

Distant recurrence, poor Prognosis:

  • Chemotherapy is the first option, and consider individualized cases for metastatectomy when oligometastatic disease is present

Secondary urethral tumor: Staging and treatment should be done as for primary urethral tumor.

  • Local conservative treatment is possible for non-invasive tumor.
  • In isolated invasive disease, urethrectomy should be performed.
  • Urethral washes and cytology should be considered in high risk patients.
* The word “offered” should be interpreted as having a detailed discussion with the patient about the risks and benefits and limitations of the available data to facilitate shared decision making.

 

ASCO Guideline Disclaimer: The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. (“ASCO”) to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action.  The use of words like “must,” “must not,” “should,” and “should not” indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary.  ASCO provides this information on an “as is” basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.


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