Objectives: The purposes of this study were to determine the efficacy of pegylated liposomal doxorubicin (PLD), using a dose of 40 mg/m2 given every 3 weeks, in the treatment of platinum-refractory epithelial ovarian cancer (EOC) and to evaluate the toxicities. Methods: Fourteen patients with platinum-resistant EOC were treated with intravenous PLD 40 mg/m2 every 3 weeks. Tumor responses were assessed every 2–3 cycles by CT scan. Results: All 14 patients were evaluable for toxicity, but only 13 patients were evaluable for response because 1 patient who had grade 3 palmar-plantar erythrodysesthesia (PPE) refused to continue with the treatment. Three partial responses were observed in 13 patients. The overall response rate was 23% (95% confidence interval 10–38%). The median time to response was 2 months, and the median duration of response was 3 months. The median survival of the 13 patients was 14.5 months, and the median progression-free survival was 6 months. In this study, we had only 4 cases of grade 3 toxicity (2 cases of grade 3 leukopenia and 2 cases of grade 3 PPE). All toxicities that occurred were manageable. Conclusion: This is the first report of the use of a slightly modified dose schedule for PLD at a dose of 40 mg/m2 every 3 weeks, which is active in platinum-refractory EOC with manageable toxicities.

1.
Parkin DM, Pisani P, Ferlay J: Global cancer statistics. CA Cancer J Clin 1999;49:33–64.
2.
Seewaldt VL, Greer BE, Cain JM, et al: Paclitaxel (Taxol) treatment for refractory ovarian cancer: Phase II clinical trial. Am J Obstet Gynecol 1994;170:1666–1670.
3.
Neijt JP, ten Bokkel Huiniuk WW, van der Berg ME: Long-term survival in ovarian cancer. Mature data from the Netherlands Joint Study Group for Ovarian Cancer. Eur J Cancer 1991;27:1367–1372.
4.
Lasic DD: Doxorubicin in sterically stabilized liposomes. Nature 1996;380:561–562.
5.
Muggia FM, Hainsworth ID, Jeffers S, et al: Phase II study of liposomal doxorubicin in refractory ovarian cancer: Antitumor activity and toxicity modification by liposomal encapsulation. J Clin Oncol 1997;15:987–993.
6.
Israel VP, Garcia AA, Roman L, et al: Phase II study of liposomal doxorubicin in advanced gynecologic cancers. Gynecol Oncol 2000;78:143–147.
7.
Hensley ML, Hoppe B, Leon L, et al: The costs and efficacy of liposomal doxorubicin in platinum-refractory ovarian cancer in heavily pretreated patients. Gynecol Oncol 2001;82:464–469.
8.
Safra T, Groshen S, Jeffers S, et al: Treatment of patients with ovarian carcinoma with pegylated liposomal doxorubicin: Analysis of toxicities and predictors of outcome. Cancer 2001;91:90–100.
9.
Markman M, Kennedy A, Webster K, et al: Phase 2 trial of liposomal doxorubicin (40 mg/m2) in platinum/paclitaxel-refractory ovarian and fallopian tube cancers and primary carcinoma of the peritoneum. Gynecol Oncol 2000;78:369–372.
10.
Gordon AN, Granai CO, Rose PG, et al: Phase II study of liposomal doxorubicin in platinum- and paclitaxel-refractory epithelial ovarian cancer. J Clin Oncol 2000;18:3093–3100.
11.
WHO Handbook for Reporting Results of Cancer Treatment. WHO Offset Publication No. 48. Geneva, World Health Organization, 1979.
12.
Markman M, Reichman B, Hakes T, et al: Responses to second-line cisplatin-based intraperitoneal therapy in ovarian cancer: Influence of a prior response to intravenous cisplatin. J Clin Oncol 1991;9:1801–1805.
13.
Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457.
14.
Gehan EA: The determination of the number of patients required in a preliminary and follow-up trial of a new chemotherapeutic agent. J Chronic Dis 1961;13:346–353.
15.
Omura GA, Bundy BN, Berek JS, et al: Randomized trial of cyclophosphamide plus cisplatin with or without doxorubicin in ovarian carcinoma: A Gynecologic Oncology Group study. J Clin Oncol 1989;7:457–465.
16.
A’Hern RP, Gore ME: Impact of doxorubicin on survival in advanced ovarian cancer. J Clin Oncol 1995;13:726–732.
17.
Stebbing J, Gaya A: Pegylated liposomal doxorubicin (CaelyxTM) in recurrent ovarian cancer. Cancer Treatment Rev 2002;28:121–125.
18.
Maluf FC, Spriggs D: Anthracyclines in the treatment of gynecologic malignancies. Gynecol Oncol 2002;85:18–31.
19.
Williams CJ, Stewart L, Parmar M, et al: Meta-analysis of the role of platinum compounds in advanced ovarian carcinoma. The Advanced Ovarian Cancer Trialists Group. Semin Oncol 1992;19(1 suppl 2):120–128.
20.
Conte PF: Role of anthracyclines in first line combination chemotherapy of ovarian carcinoma. Bull Cancer 1993;80:152–155.
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