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Cisplatin as second-line therapy in ovarian carcinoma treated initially with single-agent paclitaxel: a Gynecologic Oncology Group study.

AbstractOBJECTIVES:
The platinum compounds are the most active agents in the treatment of ovarian carcinoma. Phase II trials demonstrated the activity of paclitaxel in patients with disease clinically resistant to platinum-based front-line therapy, and phase III studies confirmed that a combination of paclitaxel plus a platinum was superior to cyclophosphamide plus a platinum. This study evaluated the activity of platinum in patients with bulky advanced disease treated with single-agent paclitaxel as front-line therapy on a Gynecologic Oncology Group protocol. Those patients who had persistent (stable) or progressive disease while receiving paclitaxel, or a recurrence of disease within 6 months of completing six cycles of paclitaxel therapy, received single-agent cisplatin.
METHODS:
Thirty-nine eligible patients with ovarian carcinoma persistent, progressive, or recurrent after initial treatment with paclitaxel 200 mg/m(2) over 24 h every 3 weeks received cisplatin 100 mg/m(2) every 3 weeks until disease progression or unacceptable toxicity.
RESULTS:
Among 37 patients evaluable for response, 8 complete (22%) and 13 partial (35%) responses resulted. Twelve (32%) patients exhibited stable disease, while 4 (11%) had increasing disease. Median progression-free survival was 11.0 months. Median survival was 15.0 months. All but two patients were clinically resistant to paclitaxel (progression during or within 6 months after completion of paclitaxel). Grade 2 or worse adverse effects among 39 patients evaluable for toxicity included neutropenia (23), thrombocytopenia (3), anemia (10), nausea and vomiting (23), azotemia (7), neurotoxicity (9), fever (2), and tinnitus (1).
CONCLUSION:
These data provide evidence that cisplatin is active as second-line therapy in patients clinically resistant to paclitaxel. The overall response rate is high (57%) with excellent progression-free and overall survival in the second-line setting.
AuthorsJ Tate Thigpen, John A Blessing, George Olt, Samuel S Lentz, Jeffrey Bell
JournalGynecologic oncology (Gynecol Oncol) Vol. 90 Issue 3 Pg. 581-6 (Sep 2003) ISSN: 0090-8258 [Print] United States
PMID13678728 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, U.S. Gov't, P.H.S.)
Chemical References
  • Antineoplastic Agents
  • Paclitaxel
  • Cisplatin
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents (adverse effects, therapeutic use)
  • Cisplatin (adverse effects, therapeutic use)
  • Disease Progression
  • Disease-Free Survival
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy)
  • Ovarian Neoplasms (drug therapy)
  • Paclitaxel (therapeutic use)

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