Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 4727
© 2005 American Society of Clinical Oncology

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Abstract

Phase I/II trial for evaluation of the role of gemcitabine as a radiosensitizer in locally advanced bladder cancer in Egypt

Menufia Univ, Menufia, Egypt; Univ Of Cairo, Cairo, Egypt; Univ of Alexandria, Alexandria, Egypt

4727

Bladder cancer is the first common malignancy among men in Egypt. Most of our patients diagnosed late, locally advanced bladder cancer with more than 30% are squamous carcinoma. Conventional treatment is usually ineffective. Gemcitabine is a novel drug which has potent radiosensitive effect. However, its radiosensitive role in bladder cancer has not been studied well. Aim: To examine the feasibility, dose limiting toxicity and maximum tolerated dose and to study its effect on the response rates and the survival function. Patients and Methods: Patients attended Menufia University Hospitals between 1999–2002 diagnosed with cystoscopic biopsy as T3-T4 bladder cancer. Eligible Pts had Kernofisky PS of more than 60%, no prior cancer therapy, no evidences of metastatic disease, adequate renal and hepatic function and normal baseline hematological parameters. Pts were randomized into two treatment groups; Group I 30 Pts received conventional radical radiotherapy using the conformal radiotherapy to pelvis and bladder with total dose 60 GY/6 weeks. Group II received in addition to the radiotherapy GEM in a starting dose of 30 mg/m2 thrice weekly every other day half an hour before the radiation session through the six weeks of RT. Follow up of pts included CT scan, Cystoscopy and biopsy for responding pts. Follow up range was 6- 27 month. Results: There was no dose limiting toxicity at 30 mg/m2 3 times weekly in the 1 st 3 pts. At dose 50 mg/m2 there was no dose limiting toxicityin another 3 pt. The dose was escalated to 60 mg/m2 3 times weekly in another 3 pts, two pts developed grade 3 diarrhea. Thus, we offer the rest of patients 50 mg/m2. The CR for group I was 13, 3% (4/30) while it was 40% for group II, the difference was statistically significant (p = 0.050). The overall response rate for group I was 50% (15/30) and 66.7% (20/30) for group II (p = 0.19). As regard the progression free survival it was 11.1 ± 5.74 and 14 ± 3.24 for Group I and II consequently. However the difference was statistically insignificant with (P 0.114.) Conclusion: In Egyptian population with advanced bladder cancer, the maximum tolerated dose of GEM as a radiosensetizer is 50 mg /m2 thrice weekly, diarrhea is the dose limiting toxicity.

No significant financial relationships to disclose.