A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer Article

Alvarez, EA, Wolfson, AH, Pearson, JM et al. (2009). A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer . GYNECOLOGIC ONCOLOGY, 113(2), 195-199. 10.1016/j.ygyno.2008.12.033

cited authors

  • Alvarez, EA; Wolfson, AH; Pearson, JM; Crisp, MP; Mendez, LE; Lambrou, NC; Lucci, JA

authors

abstract

  • Objectives: This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix. Methods: Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m2, 30 mg/m2 and 40 mg/m2 given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD. Results: Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m2 dose level consisting of colonic and ureteral obstruction. At the 30 mg/m2 dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m2 dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months). Conclusions: The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m2. © 2009 Elsevier Inc. All rights reserved.

publication date

  • May 1, 2009

published in

Digital Object Identifier (DOI)

start page

  • 195

end page

  • 199

volume

  • 113

issue

  • 2