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Efficacy and toxicity of belotecan with and without cisplatin in patients with recurrent ovarian cancer.

AbstractOBJECTIVE:
This study was performed to determine the safety and efficacy of belotecan, a new camptothecin analogue and potent topoisomerase I inhibitor, with and without platinum in patients with recurrent ovarian cancer.
METHODS:
Fifty-three patients with recurrent or persistent ovarian cancer were enrolled between March 2005 and March 2008. Eligible patients received 0.5 mg/m of intravenous (IV) belotecan on days 1 to 5, every 3 weeks belotecan monotherapy (B) or 50 mg/m of IV cisplatin on day 1 plus 0.3 mg/m of IV belotecan on days 1 to 5, every 3 weeks (belotecan plus cisplatin combination therapy [BP]).
RESULTS:
Of the 53 treated patients, 34 received BP and 19 received B. Thirty-four patients had platinum-sensitive (PS) disease and 19 had platinum-resistant disease. The overall response of the 53 patients was 37.7% (20/53). According to regimen, the response rate in the BP group was 47.1% (16/34) and that of the B group was 21.1% (4/19). BP had better response (66.7%, 14/21) than B (15.4%, 2/13) for PS disease (P = 0.004), but it was not superior in terms of progression-free survival (BP, 6 month; B, 7 months). Grade 3 or 4 toxicity was less common in B than in BP.
CONCLUSION:
Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer. These results warrant further prospective randomized trials. Both BP and B seems to be effective and safe regimens for patients with PS or platinum-resistant recurrent ovarian cancer.
AuthorsEun Ji Nam, Jae Wook Kim, Jae Hoon Kim, Sunghoon Kim, Sang Wun Kim, Si Young Jang, Dae Woo Lee, Yong Wook Jung, Young Tae Kim
JournalAmerican journal of clinical oncology (Am J Clin Oncol) Vol. 33 Issue 3 Pg. 233-7 (Jun 2010) ISSN: 1537-453X [Electronic] United States
PMID19745693 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)
Chemical References
  • Antineoplastic Agents, Phytogenic
  • Organoplatinum Compounds
  • belotecan
  • Cisplatin
  • Camptothecin
Topics
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic (therapeutic use)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Camptothecin (administration & dosage, analogs & derivatives, therapeutic use)
  • Carcinoma (drug therapy, mortality)
  • Cisplatin (administration & dosage)
  • Disease-Free Survival
  • Drug Resistance, Neoplasm
  • Female
  • Hematologic Diseases (chemically induced)
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local (drug therapy)
  • Organoplatinum Compounds (administration & dosage)
  • Ovarian Neoplasms (drug therapy, mortality)
  • Salvage Therapy
  • Survival Analysis
  • Treatment Outcome

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