ADJUVANT CISPLATIN CHEMOTHERAPY FOLLOWING CYSTECTOMY FOR BLADDER-CANCER - RESULTS OF A PROSPECTIVE RANDOMIZED TRIAL

Between April 1984 and May 1989, 77 eligible patients with invasive, n onmetastatic (stage MO) transitional cell carcinoma of the bladder wer e stratified after radical cystectomy and pelvic lymph node dissection on the basis of nodal status (stage pNO versus pN1-2) and were random ly assigned to either observation or postoperative cisplatin chemother apy (3 courses of 90 mg./m.(2) cisplatin given for 3 consecutive days at monthly intervals). Patient eligibility included a creatinine clear ance of greater than 60 ml. per minute. There were 40 eligible patient s in the control group (median age 61 years) and 37 in the cisplatin g roup (median age 64 years). In regard to postoperative tumor stage and nodal status, there was no statistical difference between the 2 patie nt groups. In the cisplatin group 21 patients received the full dose, 9 required dose reduction and 7 refused treatment. Median followup was 5 years 9 months (range 3 to 8 years). Survival analysis showed no si gnificant difference (log rank p = 0.65) between the 40 patients in th e control group and the 37 in the cisplatin group. The survival rate a t 5 years was 54% (95% confidence interval 39 to 69%) in the control g roup and 57% (95% confidence interval 40 to 74%) in the treatment grou p. Patients with cancer confined to the bladder wall (stage pT3a or le ss) had a 5-year overall survival rate of 70% and those with tumor gro wth in the perivesical fat or into the prostate (stages pT3b plus pT4a ) had a 5-year overall survival rate of 40%. This difference in surviv al between the low stage subgroup (stages pT3a or less) and the high s tage subgroup (pT3b plus pT4a) is highly significant (p = 0.0043). How ever, no difference between the controls and the cisplatin group was f ound within either the low or high stage subgroups. The reasons for fa iling to show a survival benefit from adjuvant high dose cisplatin mon otherapy after radical cystectomy are discussed.