Phase I study of conformal radiotherapy with concurrent gemcitabine in locally advanced bladder cancer

Journal Article · Tue Feb 01 04:00:00 EST 2005 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2004.05.074· OSTI ID:20633052

Sangar, Vijay K ^[1]; McBain, Catherine A ^[2]; Lyons, Jeanette ^[2]; Ramani, Vijay ^[1]; Logue, John ^[2]; Wylie, James ^[2]; Clarke, Noel W ^[2]; Cowan, Richard A ^[2]

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1. Department of Urology, Christie Hospital NHS Trust, Manchester (United Kingdom)
2. Department of Clinical Oncology, Christie Hospital NHS Trust, Manchester (United Kingdom)

Purpose: A prospective phase I trial was conducted to determine the maximal tolerated dose of gemcitabine given once weekly during hypofractionated conformal radiotherapy to patients with locally advanced transitional cell carcinoma of the bladder. Eight male patients, median age 69 years, with Stage T2 (n = 4) or T3 (n = 4) N0M0, were enrolled in cohorts of 3. Treatment comprised conformal radiotherapy (52.5 Gy in 20 fractions) within 4 weeks, with concurrent gemcitabine once weekly for four cycles. The weekly gemcitabine dose was escalated from 100 mg/m{sup 2} in increments of 50 mg/m{sup 2} per cohort. Dose-limiting toxicity was defined as any acute Radiation Therapy Oncology Group (RTOG) toxicity Grade 3 or greater arising in >1 of 3 patients in each cohort. Tumor response was assessed cystoscopically and radiologically at 3 months. Results: All 8 patients completed radiotherapy, and 6 of 8 completed chemoradiotherapy. No acute toxicity greater than RTOG Grade 1 was seen with gemcitabine at 100 mg/m{sup 2}. Dose-limiting toxicity was observed at 150 mg/m{sup 2} with Grade 3 toxicity seen in 2 of 2 patients (one bladder, one bowel). An additional 3 patients received 100 mg/m{sup 2} with minimal toxicity. No hematologic toxicity was encountered. A complete response was seen in 7 (87.5%) of 8 patients, all of whom were disease free at a median follow-up of 19.5 months (range, 14-23 months). No late toxicity (greater than RTOG Grade 0) has been observed. Conclusion: The maximal tolerated dose for gemcitabine given once weekly with concurrent hypofractionated conformal bladder radiotherapy was 150 mg/m{sup 2}, with a maximal recommended dose of 100 mg/m{sup 2}. This dose regimen has now entered Phase II clinical trials.

• OSTI ID: 20633052
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 2 Vol. 61; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
BLADDER
CARCINOMAS
CLINICAL TRIALS
PATIENTS
RADIATION DOSES
RADIOTHERAPY
TOXICITY