Phase I study of conformal radiotherapy with concurrent gemcitabine in locally advanced bladder cancer.
AuthorsSangar, Vijay K
McBain, Catherine A
Ramani, Vijay A C
Logue, John P
Wylie, James P
Clarke, Noel W
Cowan, Richard A
AffiliationDepartment of Urology, Christie Hospital NHS Trust, Manchester M20 4XB, UK.
MetadataShow full item record
AbstractPURPOSE: 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(2) in increments of 50 mg/m(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(2). Dose-limiting toxicity was observed at 150 mg/m(2) with Grade 3 toxicity seen in 2 of 2 patients (one bladder, one bowel). An additional 3 patients received 100 mg/m(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(2), with a maximal recommended dose of 100 mg/m(2). This dose regimen has now entered Phase II clinical trials.
CitationPhase I study of conformal radiotherapy with concurrent gemcitabine in locally advanced bladder cancer. 2005, 61 (2):420-5 Int. J. Radiat. Oncol. Biol. Phys.
JournalInternational Journal of Radiation Oncology, Biology, Physics
- Prospective quality-of-life assessment in patients receiving concurrent gemcitabine and radiotherapy as a bladder preservation strategy.
- Authors: Herman JM, Smith DC, Montie J, Hayman JA, Sullivan MA, Kent E, Griffith KA, Esper P, Sandler HM
- Issue date: 2004 Jul
- Combined-modality therapy with gemcitabine and radiotherapy as a bladder preservation strategy: results of a phase I trial.
- Authors: Kent E, Sandler H, Montie J, Lee C, Herman J, Esper P, Fardig J, Smith DC
- Issue date: 2004 Jul 1
- Phase II study of conformal hypofractionated radiotherapy with concurrent gemcitabine in muscle-invasive bladder cancer.
- Authors: Choudhury A, Swindell R, Logue JP, Elliott PA, Livsey JE, Wise M, Symonds P, Wylie JP, Ramani V, Sangar V, Lyons J, Bottomley I, McCaul D, Clarke NW, Kiltie AE, Cowan RA
- Issue date: 2011 Feb 20
- Gemcitabine, cisplatin, and hyperfractionated accelerated radiotherapy for locally advanced non-small cell lung cancer.
- Authors: Zwitter M, Kovac V, Smrdel U, Strojan P
- Issue date: 2006 Sep
- Dose escalation of gemcitabine is possible with concurrent chest three-dimensional rather than two-dimensional radiotherapy: a phase I trial in patients with stage III non-small-cell lung cancer.
- Authors: Zinner RG, Komaki R, Cox JD, Glisson BS, Pisters KM, Herbst RS, Kies M, Liao Z, Hong WK, Fossella FV
- Issue date: 2009 Jan 1