title: Tolerability of Concurrent Chemoradiation Therapy With Gemcitabine (GemX), With and Without Prior Neoadjuvant Chemotherapy, in Muscle Invasive Bladder Cancer.
abstract: The aim of this study is to assess the tolerability of concurrent chemoradiation therapy with gemcitabine (GemX) in muscle invasive bladder cancer following neoadjuvant chemotherapy (neoGemX) by use of patient- and provider-reported outcomes.
  
  
  
  Seventy-eight patients were treated with GemX. Thirty-eight received prior neoadjuvant chemotherapy (NAC). Patients were prospectively assessed during treatment and at 6 weeks and 12 months after treatment completion. Radiation therapy was given to a total dose of 52.5 Gy in 20 fractions with weekly concurrent gemcitabine chemotherapy, 100 mg/m2. Toxicity was assessed by the care provider and by a patient-reported outcome questionnaire collecting scores on the late effects in normal tissues-subjective, objective, management, and analytic scales and was statistically compared at baseline and 12 months, as well as between the neoGemX and GemX groups.
  
  
  
  The median duration of follow-up was 15.9 months. The radiation therapy completion rate was 95%, and 96% of patients completed at least 3 cycles of gemcitabine. Bowel toxicity of grade 3 or greater was reported in 7 of 38 patients (18%) in the neoGemX group and 5 of 25 (20%) in the GemX group. Three GemX and two neoGemX patients had grade 3 or greater urinary toxicity. Forty-nine patients completed questionnaires and were included in the analysis. Scores on the late effects in normal tissues-subjective, objective, management, and analytic scales showed an expected peak by week 4 of treatment. There was no statistically significant difference between mean scores at baseline and 12 months after treatment completion or between the neoGemX and GemX groups.
  
  
  
  This study demonstrates that GemX, alone or following NAC, has manageable toxicity and acceptable treatment completion rates. Allowing for small patient numbers and the nonrandomized nature of this study, these results do not suggest any additional toxicity from the use of NAC prior to GemX.
authors.affiliation: University Hospitals of Morecambe Bay, Lancaster, UK; Rosemere Cancer Centre, Preston, UK. Electronic address: Catherine.thompson@mbht.nhs.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Thompson
authors.affiliation: General Hospital Polonnaruwa, Ministry of Health, Polonnaruwa, Sri Lanka.
authors.forename: Nuradh
authors.initials: N
authors.lastname: Joseph
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Sanderson
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: John
authors.initials: J
authors.lastname: Logue
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: James
authors.initials: J
authors.lastname: Wylie
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Tony
authors.initials: T
authors.lastname: Elliott
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Lyons
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Carmel
authors.initials: C
authors.lastname: Anandadas
authors.affiliation: Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; Division of Molecular and Clinical Cancer Sciences, School of Medical Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK.
authors.forename: Ananya
authors.initials: A
authors.lastname: Choudhury
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D059248:Chemoradiotherapy / Q000401:mortality* / Q000706:statistics & numerical data; D017024:Chemotherapy, Adjuvant / Q000401:mortality / Q000706:statistics & numerical data; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004361:Drug Tolerance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009130:Muscle, Smooth / Q000473:pathology; D020360:Neoadjuvant Therapy / Q000401:mortality / Q000706:statistics & numerical data; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000401:mortality* / Q000473:pathology / Q000517:prevention & control; D000069473:Radiation Dose Hypofractionation; D011832:Radiation Injuries / Q000401:mortality* / Q000473:pathology / Q000517:prevention & control; D011836:Radiation Tolerance; D015996:Survival Rate; D016896:Treatment Outcome; D006113:United Kingdom / Q000453:epidemiology; D001749:Urinary Bladder Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D000093542:Gemcitabine