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A Pilot Study Evaluating a Novel Regimen Comprised of Carboplatin, Paclitaxel, and Bevacizumab for Advanced-Stage Ovarian Carcinoma
  1. III John V. Brown, MD*,
  2. John P. Micha, MD*,
  3. Mark A. Rettenmaier, MD*,
  4. Lisa N. Abaid, MD, MPH*,
  5. Katrina L. Lopez, PhD and
  6. Bram H. Goldstein, PhD*
  1. *Gynecologic Oncology Associates, Hoag Cancer Center; and
  2. The Women's Cancer Research Foundation, Newport Beach, CA.
  1. Address correspondence and reprint requests to Bram H. Goldstein, PhD, Gynecologic Oncology Associates, 351 Hospital Rd, Suite 507, Newport Beach, CA 92663. E-mail: bram{at}gynoncology.com.

Abstract

Objectives: The purpose of this study was to assess the toxicity, progression-free survival, and response rate of advanced stage ovarian carcinoma patients treated with a novel regimen comprising paclitaxel, carboplatin, and bevacizumab.

Methods: All eligible patients were treated with intravenous paclitaxel (80 mg/m2) on days 1, 8, and 15; carboplatin (area under the curve, 5) on day 1; and bevacizumab (10 mg/kg) on days 1 and 15; Q28 days for 6 cycles. Bevacizumab was administered during cycles 2 through 6.

Results: Twenty patients received a combined total of 102 cycles of primary induction chemotherapy (median, 6; range, 2-6) and were evaluable for toxicity assessment. Six (5.9%) cycles were associated with grades 3 and 4 neutropenia, which resulted in the removal of 2 patients. Only 1 (0.98%) cycle was associated with grade 3 thrombocytopenia. Moreover, one patient developed a colorectal fistula and was subsequently removed from the study. Grade 3 hypertension was encountered and successfully managed in 3 participants. In the group of 13 patients who were evaluated for response, the overall response rate was 61.6% (30.8% complete response). Four patients exhibited stable disease, and 1 patient had progressive disease. The patient group's mean progression-free survival was 5.8 months.

Conclusions: The tolerable hematologic toxicity and reasonable response rate after paclitaxel, carboplatin, and bevacizumab suggest that this regimen has moderate activity and can be safely administered to an advanced-stage ovarian carcinoma population. We were further encouraged by the reasonable incidence of hypertension. However, because 4 patients were removed from the study because of either grade ≥2 neutropenia or thrombocytopenia, we suggest that colony-stimulating factors and cautious patient observation should be considered with this regimen.

  • Gynecologic oncology
  • Ovarian cancer
  • Paclitaxel
  • Carboplatin
  • Bevacizumab

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Footnotes

  • This study was supported by a grant from the Women's Cancer Research Foundation.