title: A phase I study of carboplatin concurrent with radiation in FIGO stage IIIB cervix uteri carcinoma.
abstract: OBJECTIVE
  Chemoradiation based on cisplatin, most commonly weekly, is the standard treatment of locally advanced cervical cancer; however, the nephrotoxic potential and the requirement for hydration of cisplatin somewhat restrains its use. The objective of this study was to determine the recommended dose of carboplatin when administered weekly during pelvic radiation (RT).
  
  
  METHODS
  Twenty-four histologically proven, International Federation of Gynecology and Obstetrics Stage IIIB patients were treated with standard pelvic RT concurrently with six weekly applications of carboplatin at the following dose levels: 100 mg/m(2), 116 mg/m(2), 133 mg/m(2), and 150 mg/m(2). Six patients per level were treated. Acute toxicity was assessed according to the Radiation Therapy Oncology Group Acute Radiation Morbidity Scoring Criteria. The recommended dose was defined as the one that was one level below the level at which dose-limiting toxicity was present in more than one-third of patients.
  
  
  RESULTS
  Between September 2001 and July 2002, 24 patients were accrued. All but two completed external beam radiotherapy and intracavitary treatment. The treatment was well tolerated. The median number of weekly applications of carboplatin was six, and the mean dose to points A and B was 85.6 Gy (range 75.2-91.6) and 62.9 Gy (range 58.2-74.6), respectively. RT was delivered within 41.7 days (range 33-70). Dose-limiting toxicity (leukopenia and/or neutropenia) was present in 50% of patients treated at the higher dose level (150 mg/m(2)). At the recommended dose of 133 mg/m(2), 33% of patients presented with Grade 3 leukopenia. At treatment completion, 75% of patients had a complete clinical response.
  
  
  CONCLUSIONS
  Carboplatin at 133 mg/m(2), weekly for 6 weeks, is a well tolerated and effective radiosensitizer in cervical cancer patients.
authors.affiliation: Unidad de Investigación Biomédica en Cancer, IIB, UNAM/Instituto Nacional de Cancerología, Tlalpan, Mexico. alduenas@Prodigy.Net.mx
authors.forename: Alfonso
authors.initials: A
authors.lastname: Duenas-Gonzalez
authors.forename: Lucely
authors.initials: L
authors.lastname: Cetina
authors.forename: Benito
authors.initials: B
authors.lastname: Sánchez
authors.forename: Ernesto
authors.initials: E
authors.lastname: Gomez
authors.forename: Lesbia
authors.initials: L
authors.lastname: Rivera
authors.forename: Jose
authors.initials: J
authors.lastname: Hinojosa
authors.forename: Carlos
authors.initials: C
authors.lastname: López-Graniel
authors.forename: Aaron
authors.initials: A
authors.lastname: Gonzalez-Enciso
authors.forename: Jaime
authors.initials: J
authors.lastname: de la Garza
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin