Organ-sparing treatment of invasive transitional cell bladder carcinoma

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1 Journal of BUON 7: , Zerbinis Medical Publications. Printed in Greece ORIGINAL ARTICLE Organ-sparing treatment of invasive transitional cell bladder carcinoma C. Damyanov, B. Tsingilev, V. Tabakov, R. Simeonov Department of Urology, National Oncological Center, Sofia, Bulgaria Summary Purpose: To assess the effectiveness of two approaches of organ-sparing treatment in patients with invasive transitional cell bladder carcinoma. Patients and methods: During the period from June 1996 to June 2000, 33 patients with invasive transitional cell carcinoma (T2-4) of the bladder were treated. Patients were divided into two groups. Group A included 17 patients treated with CMV systemic chemotherapy (methotrexate 30 mg/m 2 and vinblastine 3 mg/m 2, day 1; and cisplatin 70 mg/ m 2, day 2) repeated every 3 weeks for 3 courses, combined with intravesical BCG. Complete responders (CR) received maintenance intravesical BCG, while partial responders (PR) were subjected to transurethral bladder resection (TURB) or partial bladder resection. Group B included 16 patients treated with maximal TURB followed by 2 CMV courses and radiotherapy. Results: Group A patients have been followed-up for a period of 7 to 48 months (median 21.6 months). After completing the 2nd chemotherapy course, 2 patients refused further treatment and were excluded from the group. On completing chemoimmunotherapy 11 (73%) patients showed objective response (CR+PR) and preservation of the bladder was achieved. Four (27%) patients were treatment failures. Group B patients have been followed for a period of 9 to 47 months (median 27.5 months). On completing treatment 12 of 16 (75%) patients showed an objective response with preservation of the bladder. Treatment failure was diagnosed in 4 (25%) patients. The 2 groups differed significantly in terms of side-effects, which were more pronounced in Group B patients. Of the late complications in Group B a serious problem was the development of severe radiationinduced fibrosis leading to microcystis and a cystectomy was indispensable in one of the patients. Conclusion: The applied 2 approaches of combined organ-sparing treatment of invasive bladder carcinoma seem equally effective. Future randomized studies are needed to define reliable criteria for patient selection. Key words: bladder cancer, bladder preservation, chemoimmunotherapy, chemotherapy, quality of life, radiotherapy Introduction Received ; Accepted Author and address for correspondence: Christo Damyanov, MD Department of Urology National Oncological Center 6, Plovdivsko pole Street 1756 Sofia Bulgaria Tel/Fax: noch_urol@netbg.com Radical cystectomy still remains the standard method of treatment for invasive bladder carcinoma. Despite the improved results from radical surgery, there is also a number of disadvantages which accompanies this therapeutic modality. The necessity of urine derivation, loss of sexual function, psychological adaptation, and the possible complications in the continent urine derivation present a serious problem [1]. The different methods of orthotopic bladder replacement represent a remarkable progress of modern surgery. However, it should be mentioned that these methods are not applicable to all patients eligible for cystectomy. The idea of finding an alternative to radical cystectomy providing a better quality of life has increasingly drawn the investigators attention. Various methods of organ-sparing treatment have been applied in the clinical practice over the last 10 years, using a variety of combinations of chemotherapy, radiotherapy, and surgery. We initiated a clinical study of 2 approaches of combined treatment in order to assess their organ-sparing possibilities in patients with invasive bladder cancer. This paper focuses on the initial results of this study.

2 242 Patients and methods Patient selection During the period from June 1996 to June 2000, 33 patients with advanced, histologically proven transitional cell bladder cancer entered the study. Eligibility criteria included T2-T4NXM0 tumors; World Health Organization (WHO) performance status 0-2; age up to 75 years; and normal liver and kidney function. The patients included in the study had refused radical surgical treatment. Patients were divided into 2 groups for combined organ-sparing treatment: Group A:17 patients treated with chemotherapy in combination with intravesical BCG and followed by surgery in those achieving a PR or in nonresponders. Group B:16 patients treated with maximal TURB followed by chemotherapy and radiotherapy. Nonresponders were offered surgery. Patient evaluation Pretreatment clinical evaluation included bimanual examination, intravenous pyelogram, computed tomography (CT) and/or ultrasound of the abdomen and pelvis, cystoscopy with biopsy, urinary cytology, electrocardiogram (ECG), chest X-rays, complete blood count, and serum biochemistry. Patients were staged according to the TNM staging system. Table 1 shows the clinical characteristics of the treated population. Treatment The treatment of Group A patients included 3 chemotherapy courses, repeated at 3-week intervals, with the following combination: methotrexate 30 mg/m 2 and Table 1. Patient characteristics Characteristic Group A (n=17) Group B (n=16) Males 16 (94) 14 (87) Females 1 (6) 2 (13) Age, years median (range) 55.7 (40-68) 64.4 (43-70) T2 6 (35) 7 (25) T3a 9 (53) 4 (25) T3b 2 (12) 4 (25) T4a 1 (6) N0 16 (94) 14 (87) N1 1 (6) 2 (13) G1 1 (6) 1 (6) G2 9 (53) 4 (25) G3 5 (29) 9 (56) G4 2 (12) 2 (13) vinblastine 3 mg/m 2, day 1; cisplatin 70 mg/m 2, day 2 with appropriate pre and posthydration (CMV). Following each chemotherapy course, 2 intravesical instillations were performed weekly using 4 ampoules (1 amp mg) of BCG vaccine (Calgevax). After completing the 3rd chemoimmunotherapy course, complete clinicoimaging re-evaluation, including serum biochemistry, cystoscopy, and urinary cytology was carried out, and, depending on the treatment response, further treatment strategy was determined. Complete responders remained under close observation and maintenance BCG instillations were performed (one instillation monthly for one year). Patients with PR were subjected to organ-sparing operation (TURB or partial bladder resection) followed by maintenance BCG instillations (one instillation monthly for one year). Cystectomy or radiotherapy were offered to nonresponders. Treatment of Group B patients started with maximal TURB, followed by 2 CMV courses. This was followed by a concomitant administration of cisplatin 70 mg/m 2 with radiotherapy of the bladder and the regional lymph basin by means of a four-field box technique up to 45 Gy. Complete responders received a boost dose to the bladder up to 64.8 Gy. Nonresponders were planned to undergo radical cystectomy. On completing the 3rd chemoimmunotherapy course of Group A patients, and radiotherapy of Group B patients, a comparative re-evaluation was carried out, including abdominopelvic CT and/or ultrasound, cystoscopy with biopsy and urinary cytology. Response criteria Criteria for objective evaluation of the treatment efficacy were defined as follows: CR: complete disappearance of all measurable lesions detected physically, biochemically, radiologically and cystoscopically (including biopsy). PR: 50% decrease of the overall tumor mass with no appearance of new lesion(s). Disease stabililization (SD): 50% decrease of the overall tumor mass with no appearance of new lesion(s). No response (NR): any other response different to those mentioned above, including tumor progression. Follow-up Patients in both groups were followed-up at 3-month intervals for the 1st and 2nd year, 6-month intervals for the 3rd year, and once a year thereafter with clinical examination, CT and/or ultrasound of the abdomen and pelvis, cystoscopy with biopsy, urinary cytology, complete blood count, and serum biochemistry.

3 243 Results The Group A patients have been followed-up for a period of 7 to 48 months (median 21.6 months). After completing of the 2nd chemoimmunotherapy course, 2 of the patients refused further treatment and were excluded from the study. On completing the 3rd chemoimmunotherapy course 2 of 15 (13%) patients achieved CR while 9 of 15 (60%) patients showed a PR, for an overall objective response rate of 73%. The 9 PR patients underwent resection of the residual tumor (8 by TURB and one by partial cystectomy). So, preservation of the urinary bladder was possible in 11 of 15 (73%) patients. Four of 15 (27%) patients showed NR to treatment. Three of them underwent radical cystectomy after the 3rd chemoimmunotherapy course, and one died of progressive disease. One of the patients with PR and subsequent TURB was diagnosed with liver and retroperitoneal lymph node metastases on the 29th month following completion of treatment, with no tumor recurrence in the bladder. This patient died 2 months later. Another patient of the same group developed a superficial recurrence in the bladder 3 months after treatment completion, which was successfully treated by TURB. The Group B patients have been followed-up for a period of 9 to 47 months (median 27.5 months). Twelve of 16 (75%) patients achieved CR after the complete course of treatment. NR with tumor persistence was diagnosed in 4 of 16 (25%) patients. Three of them died within the first year from starting treatment. The fourth patient underwent palliative TURB three times because of disease progression and severe hematuria. Metastasis to the renal pelvis was diagnosed in a CR patient on the 11th month after completing treatment. Radical nephroureterectomy was performed, but 5 months later liver and lumbar vertebral metastases developed. Another patient with CR was diagnosed with a superficial recurrence in the bladder on the 16th month, which was successfully treated by TURB. Table 2 summarizes the results from the treatment applied to both patient groups and Table 3 depicts response in relation with T category. Table 4 shows the side-effects from the treatment applied to both patient groups. Discussion A number of randomized studies in recent years showed considerable advantages of polychemotherapy compared to single-agent chemotherapy in bladder carcinoma [2]. Regimens such as MVAC, CISCA, Table 2. Treatment results Result Group A (n=17) Group B (n=16) Objective response (CR+PR) 11 (73) 12 (75) with bladder preservation Treatment failure 4 (27) 4 (25) Recurrence 2 (11.7) 2 (12.5) Table 3. Treatment results in relation to T category (n=31) CR PR nonresponders n(%) n(%) n(%) Group A Group B Group A Group B Group A GroupB T2 0 (0) 6 (37) 4 (26) 0 (0) 1 (7) 1 (6) T3 2 (13) 6 (37) 5 (33) 0 (0) 3 (20) 2 (12) T4 0 (0) 0 (0) 0 (0) 0 (0) 0 (0) 1 (6) Table 4. Side-effects Side-effect Group A (n=17) Group B (n=16) Urethral stricture 1 (5.8) 1 (6.2) Toxic hepatitis* 1 (5.8) Acute renal failure* 1 (5.8) Fever 1 (5.8) Leukopenia 3 (18.7) Cystitis 4 (25) Proctitis 2 (12.5) Hematuria 2 (11.5) Severe hematuria 3 (18.7) Full incontinence 2 (12.5) Microcystis 1 (6.2) *chemotherapy- induced, intercurrent infection, WHO grade I and CMV proved very effective in the treatment of transitional cell carcinoma of the bladder [2,3]. Neoadjuvant chemotherapy aims at improving the efficacy of the conventional local methods of treatment by achieving local tumor control and possible eradication of micrometastases. The multimodality concept in the treatment of bladder cancer is the basis of the organ-saving strategy, a subject of multiple clinical studies in the last years [4].There seem to be two main versions of organ-saving treatment: chemotherapy combined with surgical treatment or radiotherapy, and a combination of chemotherapy, radiotherapy and surgery [4-6].

4 244 In a study carried out in 1986 we combined neoadjuvant chemotherapy with intravesical BCG and surgery. The main idea behind this approach originated from the bladder cancer heterogeneity. Including intravesical BCG makes it possible to influence superficial tumors and carcinoma in situ (often concomitant with invasive tumors) which are largerly nonresponsive to chemotherapy, to reduce the postoperative recurrence rate and to increase the recurrence-free interval [7,8]. Chemoimmunotherapy in combination with surgery, administered to 44 patients with invasive T2-4 tumors, produced objective response in 22 (55%) of them. Eighteen (82%) of the responders with preserved bladder survived more than 5 years. The overall recurrence rate was 36% [7]. Despite the encouraging results from applying different versions of organ-sparing treatment, there are questions still open to discussion concerning patient selection, effectiveness of the various therapeutic regimens and impact on the patient survival. In an attempt to search for an answer of a number of problems concerning the organ-sparing treatment, we applied two therapeutic approaches to 33 patients with invasive bladder carcinoma. The selection of the combination of maximal TURB, chemotherapy, and radiotherapy in the Group B patients was based on literature data [9-12]. The results achieved to date show an identical therapeutic activity for both treatment schemes: objective response rate and preserved bladder in 73 % of the Group A patients and 75% of the Group B patients. This rate does not differ significantly from the rates reported in the relevant literature, which vary between 47 to 78%. In 6 Group A patients extending the 3 basic chemotherapy courses with 1-2 additional ones a better local response was achieved, indicating that 3 courses are probably insufficient in achieving maximal therapeutic response. On the other hand, it seems reasonable that patients not responding after the 2nd chemotherapy course should undergo radical cystectomy or radiotherapy. The recurrence rate was also identical in both groups (12% and 13% for Group A and B, respectively). One patient with complete local control and late distant metastatic disease was observed in each group (3 and 1 year posttreatment for the Group A and B patients, respectively). The two groups differed significantly in terms of the observed side-effects. In Group B patients side-effects were more frequent and of the late complications a serious problem was the development of severe fibrous changes leading to microcystis and necessitating cystectomy in one of the Group B patients. The severity and rate of the side-effects in Group B patients were higher than those reported in the literature describing patients having received the same scheme of treatment. We believe that this difference could be attributed to the radiotherapy equipment used. Side-effects observed in Group A patients were attributable to chemotherapy and intravesical BCG, and were milder compared to side-effects of Group B patients. The percentage of nonresponders in both groups raises the question of patient selection eligible for organpreserving treatment. This question is of utmost significance, both for treatment results and for its introduction as a routine method in clinical practice. To date, no sufficient data exist for a reliable and universally accepted methodology for patient selection [13,14]. Based on our experience and the literature data, we suggest that, until sufficient methods are worked out in the field of molecular diagnosis for selecting patients eligible for organ-sparing treatment, two basic parameters can be used: the clinical stage of the disease, and the presence of chemosensitivity after the initial two chemotherapy courses. In conclusion, both methods of organ-sparing treatment of patients with invasive bladder carcinoma showed identical efficiency in about 70% or more of the cases. Search for reliable criteria for patient selection eligible for such treatments is of great importance. Although organ-sparing therapy unequivocally contributes to improved quality of life, it remains to be proven whether its impact on survival does not differ significantly compared to other more radical therapeutic approaches. Future randomized trials could well provide a reliable answer. References 1. Vogelzang N, Scardino P, Shipley W, Coffey D (eds). Comprehensive Textbook of Genitourinary Oncology. Bladder-preserving treatments. Williams & Wilkins, Baltimore, Maryland, 1996, pp Sternberg C, Yagoda A, Sher H et al. M-VAC for advanced transitional cell carcinoma of the urothelium. Cancer 1989; 64: Logothetis C. Optimal delivery of perioperative chemotherapy; preliminary results of a randomized, prospective, comparative trial of preoperative and postoperative chemotherapy for invasive bladder carcinoma. J Urol 1996; 188: Kaufman D, Shipley D, Griffen P et al. Selective bladder preservation by combination treatment of invasive bladder cancer. N Engl J Med 1993; 329: Crawford E, Das S, Smith J. Preoperative radiation therapy in the treatment of bladder cancer. Urol Clin North Am 1987; 14: Shipley W, Prout G, Einstein A et al. Treatment of invasive bladder cancer by cisplatin and radiation in patients unsuited for surgery. JAMA 1987; 258: Damyanov C, Patrashkov T, Petkov Z, Tabakov V, Tsingilev

5 245 B. Bladder preservation in patients with invasive transitional cell carcinoma of the bladder treated with immunochemotherapy. J BUON 1998; 2: Damyanov C, Terziev T, Koleva P. Combined immunochemotherapy (CEP, M-VEP, BCG) in the treatment of invasive bladder tumors..anticancer Drugs 1994; 5: Tester W, Porter A, Heaney J. Neoadjuvant combined modality therapy with possible organ preservation for invasive bladder cancer.j Clin Oncol 1996; 14: Housset M, Maulard C, Chretien Y. Combined radiation and chemotherapy for invasive transitional-cell carcinoma of the bladder. J Clin Oncol 1993; 11: Rodel C, Grabenbauer G, Kuhn R. Prognostic factors in 400 patients with invasive bladder cancer treated by a combined modality bladder-sparing protocol.int J Radiat Oncol Biol Phys 2000; 48: Shipley W, Kaufmann D, Heney N. An update of combined modality therapy for patients with muscle invading bladder cancer. J Urol 1999; 162: Kaufmann D, Raghavan D, Carducci M et al. Phase 2 trial of gemcitabine plus cisplatin in patients with metastatic urothelial cancer.j Clin Oncol 2000; 18: Scher H, Herr H, Sternberg C. Neoadjuvant chemotherapy for bladder cancer; experience with M-VAC regimen. Br J Urol 1989; 64:

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