Feasibility study of liposomal doxorubicin consolidation therapy after platinum/paclitaxel-based chemotherapy for suboptimally debulked stage IIIC/IV ovarian cancer patients.

Academic Article

Abstract

  • 5044 Background: To assess the utility of liposomal doxorubicin (Doxil) as a consolidation strategy in patients with advanced ovarian cancer who have attained a clinically defined complete response (CR) to initial platinum/paclitaxel-based chemotherapy. METHODS: Patients diagnosed with suboptimally debulked Stage IIIC/IV ovarian cancer who attained a clinically defined complete response (CA-125 < 35, normal CT scan, and normal pelvic exam) at the completion of platinum/paclitaxel-based chemotherapy were eligible for this protocol. Patients were treated with Doxil at a dose of 40 mg/m(2) every 28 days for four cycles. Primary endpoints included toxicity, quality of life (QoL), and time to progression. RESULTS: Of the 30 patients enrolled, 26 patients are evaluable, three patients are currently being treated, and one patient was ineligible due to inaccurate staging. 22 of the 26 evaluable patients (85%) completed all four cycles of consolidation therapy. Three patients were removed from the study after their 3(rd) course due to palmar-plantar erythrodysesthesia (PPE) and one for recurrent disease after her 3(rd) course. 13 patients required a 25% dose modification (11 patients for grade 2/3 PPE and 2 patients for grade 3 myelosuppression). A subset of patients completed a baseline and post-treatment QoL questionnaire and no difference was detected between the baseline and post-treatment QoL scores (p=0.179). Of the 26 patients who completed consolidation therapy, 10 remain clinically without evidence of disease with a median follow-up of 15 months from completion of primary chemotherapy (range, 7-20 months). Sixteen patients have recurred following treatment with a median time to recurrence of 10 months (range, 3-18 months). CONCLUSIONS: Consolidation therapy with Doxil chemotherapy administered to women with advanced ovarian cancer who attain a clinically defined complete response to initial chemotherapy appears feasible. PPE is the most common toxicity leading to dose modification and study discontinuation. Impact on progression-free survival awaits additional follow-up. No significant financial relationships to disclose.
  • Published In

    Pubmed Id

  • 16658606
  • Author List

  • Straughn JM; Rocconi RP; Leath CA; Kilgore LC; Huh WK; Alvarez RD
  • Start Page

  • 5044
  • Volume

  • 22
  • Issue

  • 14_suppl