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The Integration of Chemotherapy and Surgery for Bladder Cancer

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The Integration of Chemotherapy and Surgery for Bladder Cancer 45 Original Article The Integration of Chemotherapy and Surgery for Bladder Cancer Matthew D. Galsky, MD,* Harry W. Herr, MD,† and Dean F. Bajorin, MD,‡ New York, New York Key Words Surgical Management of Muscle-Invasive Bladder cancer, lymphadenectomy, neoadjuvant chemotherapy, TCC adjuvant chemotherapy Radical Cystectomy Abstract For patients with muscle-invasive disease found on a Despite surgery with curative intent, approximately 50% of patients transurethral resection of bladder tumor (TURBT) spec- with muscle-invasive transitional cell carcinoma of the bladder will imen, the standard approach in the United States is a develop distant metastases and succumb to their disease. Attempts radical cystectomy with pelvic lymph node dissection, to improve outcomes have focused on refining surgical techniques although organ-sparing programs may be appropriate in and integrating perioperative chemotherapy. This review summarizes the available literature addressing the role of pelvic lymph- a select subgroup of patients. A radical cystectomy in- adenectomy, neoadjuvant chemotherapy, and adjuvant chemo- volves a wide resection of all the perivesical fat and tis- therapy in the management of patients with muscle-invasive sue to achieve a negative margin. In men, the procedure transitional cell carcinoma of bladder. (JNCCN 2005;3:45–51) is performed in conjunction with a prostatectomy, and in women the urethra, uterus, fallopian tubes, ovaries, Transitional cell carcinoma (TCC) of the bladder exists anterior vaginal wall, and surrounding fascia are also re- as a spectrum of clinical states ranging from superficial to moved. invasive to metastatic disease. Each clinical state is asso- The prognosis after surgery with curative intent de- ciated with a unique prognosis, approach to treatment, and pends on the pathologic stage. In a recent report on 1,054 tumor biology. Although patients with superficial and patients with TCC undergoing radical cystectomy and muscle-invasive disease are often curable, the vast majority pelvic lymph node dissection, the 5-year disease-free sur- of patients with distant metastases will succumb to their vival for patients with node-negative organ-confined dis- disease. Clearly, the goal of treatment at each disease state ease exceeded 80%. This number dropped to 62% to 78% is to prevent progression to more advanced states and, for patients with extravesical disease (pT3) and to 50% ultimately, death. For patients with muscle-invasive dis- for patients with invasion of local organs (pT4).1 Lymph ease, the integration of chemotherapy and surgery has node involvement generally portends an even worse prog- been the focus of much investigation in an effort to op- nosis. Five-year survival rates of up to 57% have been re- timally achieve this goal. ported for patients with N1 disease compared with 0% to 27% for those with N2 to N3 disease.2,3 From the Genitourinary Oncology Service, Division of Solid Tumor Oncology, Department of Medicine,*‡ and Department of Urology,† Memorial Hospital for Cancer and Allied Diseases,* Memorial Sloan- Impact of Surgical Factors on Outcome Kettering Cancer Center, and the Joan and Stanford I. Weill Medical College of Cornel University,‡ New York, New York. The importance of an “adequate” pelvic lymph node dis- Submitted September 15, 2004; accepted for publication November 3, section and pathologic assessment should not be over- 2004. Dr. Bajorin receives research support from Eli-Lilly and Co and Bristol- looked. A standard pelvic lymph node dissection includes Myers Squibb. Dr. Galsky and Dr. Herr have no financial relationships to removal of all of the distal common iliac, external iliac, disclose. Correspondence: Matthew Galsky, MD, Memorial Sloan-Kettering obturator, and hypogastric nodes. This approach typi- Cancer Center, 1275 York Avenue, New York, NY 10021. E-mail: cally yields 10 to 14 lymph nodes.4 Several retrospective [email protected] studies have correlated improved survival with the ex- © Journal of the National Comprehensive Cancer Network | Volume 3 Number 1 | January 2005 46 Original Article Galsky et al. tent of lymphadenectomy. An analysis of 637 cases of variety of chemotherapeutic regimens administered invasive bladder TCC treated using radical cystec- before (neoadjuvant) or after (adjuvant) surgery. tomy and pelvic lymph node dissection explored the association between surgical and pathological vari- Trial Design and Statistical Considerations ables and survival.5 Improved survival and decreased Well-designed, interpretable trials exploring the role local recurrence was associated with an increased num- of perioperative chemotherapy in TCC should include ber of lymph nodes removed (and examined by the the following elements: randomization between pathologist) in patients with node-negative and node- chemotherapy plus definitive local therapy versus lo- positive disease. The 5-year survival rate for patients cal therapy alone, use of cisplatin-based chemother- with 0 to 6, 6 to 10, 11 to 14, and more than 14 lymph apy, and adequate sample size. Regarding sample size, nodes examined was 33%, 44%, 73%, and 79%, re- considering that up to 50% of patients will be cured spectively. This conclusion was corroborated by a re- with cystectomy alone, the potential benefit of port in which Surveillance, Epidemiology and End chemotherapy is limited to the remaining 50% who Results (SEER) data on 1,923 patients who under- have micrometastatic disease. If the proportion of pa- went radical cystectomy were analyzed and yielded tients who experience complete response in the peri- similar results.6 operative setting is the same as that for patients with The influence of surgical factors on outcome has overt metastases (approximately 20%), then a sur- been shown to be independent of the impact of peri- vival benefit may be restricted to only 10% of the en- operative chemotherapy. In a recent analysis of a ran- tire population. A trial with adequate power to detect domized cooperative group study exploring neoadjuvant an absolute survival difference of 10% would require chemotherapy, a multivariate model adjusted for peri- randomization of 1,000 patients.9 A smaller sample operative chemotherapy, age, pathologic stage, and size would be required if the benefit from chemother- nodal status showed that negative margins and 10 apy were greater. or more nodes removed were significantly associated Neoadjuvant Chemotherapy with longer post-cystectomy survival.7 These same sur- Administering chemotherapy before surgery has sev- gical factors were significant predictors of local re- eral advantages. Patients may be better able to toler- currence. ate chemotherapy in the preoperative setting. Systemic Historically, no standard definition of an “ade- therapy is initiated sooner, theoretically against a quate” cystectomy and lymphadenectomy has been smaller volume of micrometastases. In addition, this outlined. To address this issue, the consecutive cys- approach allows a response evaluation of the primary tectomy experience of 16 surgeons from four tertiary tumor, which is of prognostic significance. In a study referral centers was reviewed.8 Based on the results of patients treated with neoadjuvant cisplatin-based achieved in 1,091 cases of cystectomy, a positive mar- therapy followed by definitive surgery, at a median fol- gin rate on fewer than 10% of all cases was felt to be low-up of 25 months, 91% of patients who experi- acceptable. A standard lymphadenectomy was advised enced a response to chemotherapy (defined as for all reasonably fit candidates. Specifically, retrieval pathologic stage T1 or less) were alive compared with and examination of at least 10 to 14 lymph nodes was 37% of those with no response.10 recommended, acknowledging that some interindi- A potential disadvantage of the neoadjuvant ap- vidual variation will exist. proach is a result of the marked discordance between clinical response (based on repeat staging cys- toscopy/TURBT) and pathologic response (based on Integrating Perioperative Chemotherapy pathologic review of the cystectomy specimen). In a A significant proportion of patients undergoing cys- study exploring neoadjuvant MVAC (methotrexate, tectomy with curative intent will have micrometastases vinblastine, doxorubicin, and cisplatin) 57% of pa- and ultimately die of the disease. Given the chemosen- tients achieved a clinical complete response while sitivity of TCC in patients with overt metastases, sev- only 30% had a pathologic complete response.11 eral clinical trials have sought to administer Although neoadjuvant therapy may afford the con- chemotherapy in the perioperative setting to try to sideration of organ preservation in a select subgroup eradicate subclinical disease. These trials have used a of patients, the majority will still require cystectomy. © Journal of the National Comprehensive Cancer Network | Volume 3 Number 1 | January 2005 Original Article 47 Chemotherapy and Surgery in Bladder Cancer Hence, cystectomy refusal in patients experiencing a vival for patients receiving neoadjuvant chemother- complete clinical response becomes problematic. apy (P = .048; HR, 0.85; 95% CI, 0.72–1.0).17 Another theoretical disadvantage of neoadjuvant A U.S. intergroup trial has confirmed the bene- chemotherapy is the risk of delaying potentially cur- fits of neoadjuvant chemotherapy.18 Intergroup 0080 ative surgery during administration of possibly inef- randomized 317 patients with T2 to T4a TCC of the fective chemotherapy. bladder to receive
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