PARENT SESSION
9:00 AM to 11:00 AM
Saturday, April 20, 2002
NAHS Symposium 1
NAHS Current and Evolving Clinical Hyperthermia
Room: Nevada 1-2
Chair: Hurwitz, Mark²²75 Francis St., ASB1-L2, Boston, MA, Co-Chair: Jones, Ellen³³P.O. Box 3085, Durham, NC
Speakers: Jones, Ellen⁴; Prosnitz, Leonard⁵; Hurwitz, Mark⁶; Kalapurakal, John⁷; Myerson, Robert⁸⁴P.O. Box 3085, Durham, NC⁵P.O. Box 3085, Durham, NC⁶75 Francis St., ASB1-L2, Boston, MA⁷251 E. Huron St. LC-178, Chicago, IL⁸510 S. Kingshighway, St. Louis, MO

(S01-1) Phase I/II study of liposomal doxorubicin and whole abdomen hyperthermia in refractory ovarian cancer.

Jones, Ellen^*,1, Prosnitz, Leonard¹, Samulski, Thaddeus¹, Berchuck, Andrew², Clarke-Pearson, Daniel², Alvarez, Angeles², Soper, John², Dewhirst, Mark¹, ¹ Dept. of Radiation Oncology, Durham, NC² Division of Oncology, Dept. of OB/GYN, Durham, NC

ABSTRACT-
PURPOSE: A phase I/II study of liposomal doxorubicin (Doxil) was conducted in patients with recurrent ovarian cancer who did not respond to platinum- and paclitaxel-based regimens. Doxil is a standard chemotherapy agent FDA approved for use in recurrent ovarian cancer. It was selected for combination with whole abdomen hyperthermia based on preclinical data demonstrating preferential extravasation of liposomal drug in tumor tissue. PATIENTS AND METHODS: Thirty-one consecutive patients were enrolled on protocol. All had progressive disease after either cisplatin or carboplatin and paclitaxel, or at least one platinum-based and one paclitaxel-based regimen. Patients received intravenous Doxil 40 mg/m² every 4 weeks immediately followed by whole abdomen hyperthermia using an annular phased applicator (BSD Sigma 60 system). RESULTS: Three clinical responses (one complete response [CR], two partial responses [PRs]) were observed in 31 patients (9.7%), based on RECIST criteria. Overall, the treatment was well tolerated, and no unusual side effects were seen from the combination of hyperthermia and Doxil. Quality of life was assessed before, during, and after therapy. CONCLUSION: Liposomal doxorubicin and whole abdomen hyperthermia has activity against ovarian cancer refractory to platinum and paclitaxel. Overall quality of life improved for most patients during the course of therapy. Further studies with temperature sensitive liposomes or vascular targeting agents may yield improved clinical response. Quality of life assessments may be an important endpoint to include in clinical hyperthermia studies.

KEYWORDS: ovarian cancer, doxil, hyperthermia, quality of life