ABSTRACT
Bilharzial bladder cancer is a major health problem in Egypt, as well as some African and Asian countries it represents a distinct clinicopathologic disease. In order to investigate efficacy of chemotherapy in cases with advanced bilharizial bladder cancer as well as different clinicopathologic factors, that may impact response to chemotherapy, we conducted a phase III study, upon 58 patients, over the period from April 1999 to Dec. 2002. The 58 patients had pathologically proven bladder carcinoma on top of previous bilharzial cystitis presenting with either metastatic, inoperable, or recurrent disease. The 55 patient's evalvuable for response, 26 patients were randomized to receive single agent epidoxorubicin, claimed to be most active single agent in cases of bilharzial bladder cancer and the remaining 29 patients received the combination of epidoxorubicin with vincristine alternating with etoposide and ifosfamide. The clinicopathologic characteristics of the two groups were comparable, except for the higher frequency of grade 3 tumors in the combination chemotherapy group. Those who received single agent chemotherapy, had a response in only 4 cases response rate [15.38%] with only 2 cases achieving complete remission, those receiving combination chemotherapy had a response in 11 patients [response rate of 37.9%] with only 2 patients achieving complete responses. In terms of disease control rate [CR+PR+SD] epirubicin had a control rate of 46. 15%, with a mean TDP of 8 months and mean OS of 9 months, versus 62% for those receiving combination treatment with a mean TDP of 7 months and a mean OS. of 9.4 months. The 5 year actuarial PFS rate for patients who have achieved PR and CR in both treatment groups [15 patients] was 20.5%, SE = 5.8. Combination treatment group had a higher PFS of 36.2%, in contrast to 15.4% in the group receiving epidoxorubicin treatment, a difference that proved to be statistically significant [p=0.04]. Patients randomized to receive combination treatment had a higher 5 year overall survival rate of 37.9%, versus 25.5% in patient receiving epidoxorubicin treatment, however, this difference was not statistically significant [p=O.4]. Seventy six percent of patients receiving combination treatment expressed both MDR and p53 versus 33% and 50% respectively for those receiving single agent epidoxorubicin, yet such occurrence had no statistically significant correlation with response, but MOR affected OS and PFS for responding cases. Toxicity from treatment was in the form of vomiting, mucositis, diarrhea, leucopenia, anemia and were all comparable between both groups except for alopecia which was more prominent in those receiving single agent epidoxorubicin Among different clinicopathologic variables only the pathologic cell type seemed to affect response