title: Pathologic response and toxicity assessment of chemoradiotherapy with cisplatin versus cisplatin plus gemcitabine in cervical cancer: a randomized Phase II study.
abstract: OBJECTIVE
  To compare gemcitabine and cisplatin (GC) with cisplatin (C) concurrent with radiotherapy in International Federation of Gynecology and Obstetrics Stage IB2, IIA, and IIB cervical carcinoma in a preoperative setting. The main endpoints were the pathologic response rate and toxicity.
  
  
  METHODS
  A total of 83 patients were randomized to either C or GC. Treatment consisted of six doses of cisplatin at 40 mg/m(2) every week for Arm 1 (C) and six doses of gemcitabine at 125 mg/m(2) plus cisplatin at 40 mg/m(2) every week for or Arm 2 (GC) Both regimens were administered concurrent with 50 Gy of external beam radiotherapy in 2-Gy fractions for 5 weeks. After chemoradiotherapy, patients underwent radical hysterectomy.
  
  
  RESULTS
  All 83 patients were studied for toxicity and 80 for response. The complete pathologic response rate in the C arm and GC arm was 55% (95% confidence interval, 35.5-73%) and 77.5% (95% confidence interval, 57-90%; p = 0.0201). Among those with a partial response, 7 patients each had high and intermediate-high risk factors for recurrence in their surgical specimens in the C arm vs. 2 and 3 patients, respectively, with these characteristics in the CG arm. The number of weekly doses and the dose intensity of GC were lower than for C. The time to complete external beam radiotherapy also favored the C arm. The CG combination produced greater GI and hematologic toxicity.
  
  
  CONCLUSIONS
  The radiosensitizing combination of GC achieved a greater pathologic response rate than C in the treatment of cervical cancer.
authors.affiliation: Unidad de Investigación Biomédica en Cáncer, Instituto Nacional de Cancerología-Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, San Fernando no. 22, Tlalpan 14080, Mexico City, Mexico. aduenasg@incan.edu.mx
authors.forename: Alfonso
authors.initials: A
authors.lastname: Dueñas-González
authors.forename: Lucely
authors.initials: L
authors.lastname: Cetina-Perez
authors.forename: Carlos
authors.initials: C
authors.lastname: Lopez-Graniel
authors.forename: Aarón
authors.initials: A
authors.lastname: Gonzalez-Enciso
authors.forename: Ernesto
authors.initials: E
authors.lastname: Gómez-Gonzalez
authors.forename: Lesbia
authors.initials: L
authors.lastname: Rivera-Rubi
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Montalvo-Esquivel
authors.forename: David
authors.initials: D
authors.lastname: Muñoz-Gonzalez
authors.forename: Juan
authors.initials: J
authors.lastname: Robles-Flores
authors.forename: Elisa
authors.initials: E
authors.lastname: Vazquez-Govea
authors.forename: Jaime
authors.initials: J
authors.lastname: de La Garza
authors.forename: Alejandro
authors.initials: A
authors.lastname: Mohar
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018196:Carcinoma, Adenosquamous / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D016001:Confidence Intervals; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D008875:Middle Aged; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000627:therapeutic use*; D011879:Radiotherapy Dosage; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D011838:Radiation-Sensitizing Agents; D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine