This site is intended for US health care professionals only.
In stage ll and lllA muscle-invasive bladder cancer (MIBC)
Neoadjuvant Therapy+Surgery Together
Preoperative systemic cisplatin-based therapy may benefit certain patients with MIBC1–3

Find out why.

down-arrow
Neoadjuvant cisplatin-based chemotherapy is a systemic therapy given before surgery to help downstage the tumor and may reduce the risk of recurrence.1,4–6
When considering surgery
When considering neoadjuvant therapy
What is stage ll and lllA MIBC?
What is the role of the multidisciplinary team in MIBC?8
The multidisciplinary approach in MIBC creates a platform to discuss potential risks and benefits of all accepted forms of therapy.8
After taking into account patient preference, the urologist and medical oncologist should determine if the patient is a good candidate for neoadjuvant therapy + surgery.8
For an Optimized Treatment Strategy, the Following Topics Are Critical for Discussion8
Surgical
intervention
Neoadjuvant
therapy
Patient
preference
Lifestyle
considerations
Potential risks
and benefits
Patient comorbidity and tumor characteristics

See why neoadjuvant therapy may be considered for select patients.

down-arrow
Why neoadjuvant therapy?
The risk of recurrence after surgery is a clinical concern.
In a retrospective single-institution study of 2,315 patients with urothelial carcinoma, soft tissue recurrence outside of the urinary tract was assessed in 617 patients after undergoing radical cystectomy between 2000 and 2014. Disease characteristics, including consensus T-stage and histology, were studied. In addition, select treatment factors studied were use of intravesical therapy, preoperative systemic chemotherapy, adjuvant chemotherapy, and salvage chemotherapy.9

The majority of soft tissue recurrences outside of the urinary tract took place ≤3 years after surgery.9
Visual Representation of Various Stages of Muscle Invasive Bladder Cancer (MIBC)
For illustrative purposes only: A visual representation of various stages of MIBC.7 Based off AJCC, 8th edition.

Recurrence by Tumor (T) Stage and Lymph Node Involvement9

Recurrence by Tumor (T) Stage and Lymph Node Involvement9

Early
recurrence
(n=559)
Late
recurrence*
(n=58)
pT2
Early
recurrence
(n=559)
Late
recurrence*
(n=58)
121
(22%)
19
(33%)
pT3
Early
recurrence
(n=559)
Late
recurrence*
(n=58)
241
(43%)
15
(26%)
pT4
Early
recurrence
(n=559)
Late
recurrence*
(n=58)
143
(26%)
5
(8.6%)
Lymph node involvement (n=594)
Early
recurrence
(n=559)
Late
recurrence*
(n=58)
237
(44%)
11
(20%)
*Defined as more than 3 years after radical cystectomy.

What is the potential benefit of neoadjuvant chemotherapy?

According to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®):

National Comprehensive Cancer Network® (NCCN®) recommends cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy for certain patients with stage ll or lllA bladder cancer.1

What are select recognized end points in oncology trials in MIBC?10–14
Pathologic Complete Response (pCR)15
Defined as the lack of detectable evidence of tumor in tissue samples removed during surgery or biopsy after treatment with radiation or chemotherapy
Event-Free Survival (EFS)12

Defined as the time from randomization to any of the following: Disease progression that precludes surgery, local or distant recurrence, or death from any cause

Overall Survival (OS)12

Defined as the time from randomization until death from any cause and is measured in the intent-to-treat population

down-arrow
Considerations for surgery and neoadjuvant therapy
When considering surgery
The AUA recommends this strategy8:

A cisplatin-based neoadjuvant chemotherapy should be offered to eligible radical cystectomy patients prior to cystectomy.

Radical cystectomy with bilateral pelvic lymphadenectomy should be offered to surgically eligible patients with resectable nonmetastatic (M0) muscle-invasive bladder cancer.

AUA = American Urological Association.

These topics should be discussed with your appropriate patients with MIBC8:

Risks and benefits
of surgery

Lifestyle changes
associated with surgery

Potential benefits
of cisplatin-based neoadjuvant therapy

Identify if your patients with MIBC are appropriate for cisplatin-based neoadjuvant therapy.

When considering neoadjuvant therapy

For some patients, NCCN recommends neoadjuvant chemotherapy over adjuvant-based chemotherapy.1

NCCN recommends that patients meet these criteria.

Patients with MIBC who are candidates for surgery

NCCN recommends cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy for certain patients with stage II or IIIA bladder cancer.1

Neoadjuvant cisplatin-based therapy + radical cystectomy + pelvic lymph node dissection is a recommended treatment option for:

  • Stage ll = cT2, N0, M01
  • Stage lllA = cT3, N0, M0: cT4a, N0, M0; cT1–4a, N11
  • Patients willing to accept urinary diversion8
Patients with MIBC who are cisplatin-eligible

Factors to consider1,16:

  • Hearing
  • Performance status
  • Renal function
  • Neuropathy
  • Heart failure
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
Consider Neoadjuvant Therapy
for your appropriate stage ll and lllA patients with MIBC.1
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Bladder Cancer V.3.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed May 26, 2023. To view the most recent and complete version of the guidelines, go online to NCCN.org. 2. Advanced Bladder Cancer (ABC) Meta-analysis Collaboration. Neoadjuvant chemotherapy in invasive bladder cancer: update of a systematic review and meta-analysis of individual patient data. Eur Urol. 2005;48(2):202–206. doi:10.1016/j.eururo.2005.04.006 3. Grossman HB, Natale RB, Tangen CM, et al. Neoadjuvant chemotherapy plus cystectomy compared with cystectomy alone for locally advanced bladder cancer. N Engl J Med. 2003; 349(9):859–866. doi:10.1056/NEJMoa022148 4. National Cancer Institute. Dictionary of Cancer Terms. Neoadjuvant therapy. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/neoadjuvant-therapy. Accessed June 28, 2023. 5. Mayo Clinic. Adjuvant therapy: treatment to keep cancer from returning. https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/adjuvant-therapy/art-20046687. Updated May 5, 2022. Accessed July 5, 2023. 6. Cleveland Clinic. Metastasis (metastatic cancer). https://my.clevelandclinic.org/health/diseases/22213-metastasis-metastatic-cancer. Published June 22, 2022. Accessed May 10, 2023. 7. American Cancer Society. Bladder cancer early detection, diagnosis, and staging. https://www.cancer.org/cancer/types/bladder-cancer/detection-diagnosis-staging/staging.html. Updated January 30, 2019. Accessed August 9, 2023. 8. Chang SS, Bochner BH, Chou R, et al. Treatment of non-metastatic muscle-invasive bladder cancer: AUA/ASCO/ASTRO/SUO guideline. J Urol. 2017;198(3):552–559. doi:10.1016/j.juro.2017.04.086 9. Dason S, Cha EK, Falavolti C, et al. Late recurrences following radical cystectomy have distinct prognostic and management considerations. J Urol. 2020;204(3):460–465. doi:10.1097/JU0000000000001028 10. Martini A, Jia R, Ferket BS, et al. Tumor downstaging as an intermediate endpoint to assess the activity of neoadjuvant systemic therapy in patients with muscle-invasive bladder cancer. Cancer. 2019;125(18):3155–3163. doi:10.1002/cncr.32169 11. Travis WD, Dacic S, Wistuba I, et al. IASLC multidisciplinary recommendations for pathologic assessment of lung cancer resection specimens after neoadjuvant therapy. J Thorac Oncol. 2020;15(5):709–740. doi:10.1016/j.jtho.2020.01.005  12. US Food & Drug Administration. Clinical trial endpoints for the approval of cancer drugs and biologics: guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-trial-endpoints-approval-cancer-drugs-and-biologics. Updated May 7, 2020. Accessed February 2, 2023. 13. Kilickap S, Demirci U, Karadurmus N, et al. Endpoints in oncology clinical trials. J BUON. 2018;23(7):1–6. 14. Delgado A, Guddati AK. Clinical endpoints in oncology - a primer. Am J Cancer Res. 2021;11(4):1121–1131. 15. National Cancer Institute. Dictionary of Cancer Terms. Pathologic complete response. https://www.cancer.gov/search/results?swKeyword=pathologic+complete+response. Accessed August 22, 2023. 16. Galsky MD, Hahn NM, Rosenberg J, et al. Treatment of patients with metastatic urothelial cancer “unfit” for cisplatin-based chemotherapy. J Clin Oncol. 2011;29(17):2432–2438. doi:10.1200/JCO.2011.34.8433

This site is intended for residents of the United States, its territories, and Puerto Rico. Copyright © 2023 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.


US-MIB-00002 11/23

Terms of UsePrivacy PolicyCookie Preferences