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A phase I study of concurrent cisplatin chemotherapy in patients with carcinoma of the cervix receiving pelvic radiotherapy
  1. C. Nyongesa*,
  2. P. Ruff,
  3. B. Donde* and
  4. J. Kotzen*
  1. *Division of Radiation Oncology, Department of Radiation Sciences, University of Witwatersrand, Johannesburg, South Africa
  2. Division of Medical Oncology, Department of Medicine, University of Witwatersrand, Johannesburg, South Africa
  1. Address correspondence and reprint requests to: Catherine N. Nyongesa, MBChB, MMED, FC, Division of Radiation Oncology, Department of Radiation Sciences, University of the Witwatersrand, South Africa. Email: catherinenyongesa{at}yahoo.com

Abstract

The purpose of this study was to evaluate the maximum tolerated dose (MTD) of weekly cisplatin in a sample population of South African patients with cervical carcinoma, when given in combination with radical pelvic irradiation. Patients with cervical carcinoma stage IB2–IIIB (without hydronephrosis) received up to six cycles of cisplatin at weekly intervals. Groups consisting of three patients each were treated at each of the three predetermined dose levels of cisplatin (20, 25, and 30 mg/m2). Eighteen patients were treated and evaluated for toxicity. All the patients who received 20 mg/m2 (n = 3) and 25 mg/m2 (n = 3) cisplatin had no dose-limiting toxicity (DLT). Four of the 12 patients who were given cisplatin 30 mg/m2 experienced DLT with rising serum creatinine and declining creatinine clearance. The minimum creatinine clearance was 22 mL/min. The highest serum creatinine was 174 μmol/L. This study showed that a weekly dose of 25 mg/m2 of cisplatin was the MTD when used in combination with pelvic irradiation for this sample of patients. This dose is lower than the recommended dose of cisplatin 40 mg/m2/week. The patients in this study may have reduced tolerance to higher doses of cisplatin, when compared to patients from Western countries.

  • cancer of the cervix
  • cisplatin
  • concomitant radiotherapy

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Footnotes

  • This article was presented in part at the following forums: The University of Witwatersrand, Faculty of Health Sciences Research Day on August 4, 2004; at the Kenya Society of Hematology and Oncology (KESHO) conference, Nairobi, Kenya, on August 22, 2004; at the South African Society of Clinical & Radiation Oncology (SASCRO) and South African Society of Medical Oncology (SASMO) Congress on March 20, 2005, and at the African Organization for Research and Training in Cancer (AORTIC) Conference on November 15, 2005, at Dakar Senegal. It was submitted in full as a research protocol for Master of Medicine degree in Radiation Oncology at the University of Witwatersrand in August 2005.