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Phase 2 Trial of Paclitaxel, 13-cis Retinoic Acid, and Interferon Alfa-2b in the Treatment of Advanced Stage or Recurrent Cervical Cancer
  1. Mihae Song, MD*,
  2. Robert S. DiPaola, MD,
  3. Bernadette M. Cracchiolo, MD, MPH,
  4. Darlene G. Gibbon, MD,
  5. Mira Hellmann, MD,
  6. Wilberto Nieves-Neira, MD,
  7. Ami Vaidya, MD§,
  8. Allison R. Wagreich, MD,
  9. Weichung J. Shih, PhD and
  10. Lorna Rodriguez-Rodriguez, MD, PhD
  1. *Department of Obstetrics, Gynecology and Reproductive Sciences, Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ;
  2. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ;
  3. Rutgers New Jersey Medical School, Newark, NJ; and
  4. §John Theurer Cancer Center, Hackensack, NJ.
  1. Address correspondence and reprint requests to Lorna Rodriguez-Rodriguez, MD, PhD, 195 Little Albany St, New Brunswick, NJ, 08903. E-mail: rodriglo@cinj.rutgers.edu.

Abstract

Objective Overexpression of bcl-2 is a mechanism of drug resistance in cervical cancer. Agents that down-regulate bcl-2 may decrease tumor cell threshold and sensitize tumor cells to chemotherapy. The objective of this multi-institutional phase 2 trial was to evaluate the efficacy and toxicity of paclitaxel and bcl-2 modulators (13-cis retinoic acid and interferon alfa-2b) in patients with advanced-stage or recurrent cervical cancer.

Materials and Methods Patients had biopsy-proven metastatic, first relapse, or persistent cervical cancer with no prior chemotherapy except for chemosensitizing agents. The treatment consisted of oral 13-cis retinoic acid, 1 mg/kg, and subcutaneous interferon alfa-2b, 6 mU/m2, days 1 to 4, and intravenous paclitaxel, 175 mg/m2, day 4 until disease progression or adverse events prohibited treatment. The primary endpoint was overall response rate.

Results Thirty-three patients were enrolled between March 2001 and June 2009. Thirty-one patients were eligible for evaluation of treatment response. Twenty-seven patients (82%) received prior concurrent chemoradiation or radiotherapy alone before study enrollment. The overall response rate was 30% (6 complete responses and 4 partial responses). Furthermore, 7 patients (21%) had stable disease. Grade 3 or 4 adverse events included neutropenia (n =16 [48%]), febrile neutropenia (n = 1 [3%]), and anemia (n = 1 [3%]). There were no treatment-related deaths. The median progression-free survival was 3.4 months (95% confidence interval, 2.0–7.4 months), and overall survival was 11.2 months (95% confidence interval, 7.5–26.2 months). Of 6 patients with complete responses, 5 patients survived more than 2 years.

Conclusions Combination therapy with paclitaxel, 13-cis retinoic acid, and interferon alfa-2b is feasible and safe in treating patients with advanced and recurrent cervical cancer.

  • Cervical cancer
  • Paclitaxel
  • 13-cis retinoic acid
  • Interferon alfa-2b

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Footnotes

  • This trial was supported by National Cancer Institute grants CA 66077, and the following shared resources: Laboratory Support Services and Biometrics, Biospecimen Repository Service, and the Office of Human Research Services.

  • The authors declare no conflicts of interest.

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