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Sub-category:
Ovarian Cancer
Category:
Gynecologic Cancer
Meeting:
2008 ASCO Annual Meeting
Session Type and Session Title:
Poster Discussion, Gynecologic Cancer
Abstract No:
5523
Citation:
J Clin Oncol 26: 2008 (May 20 suppl; abstr 5523)
Author(s):
N. S. Horowitz, R. T. Penson, S. M. Campos, J. Lee, D. L. Kendall, C. N. Krasner, S. T. Berlin, M. Roche, L. R. Duska, U. A. Matulonis
Abstract:
Background: More efficacious, less toxic combinations are needed to treat platinum-sensitive recurrent ovarian cancer. Pemetrexed (Pem) is a multitargeted antifolate that has a manageable toxicity profile and has been combined with carboplatin in other cancers. Methods: Phase II study of carboplatin AUC 5 with Pem 500 mg/m2 both administered IV on day 1, with Decadron, B12, and folate premedication, and given every 21 d for six cycles with the possibility of receiving 8 if benefit derived. Eligibility included platinum sensitive (>6 mos without progression after last platinum regimen), measurable (by RECIST) recurrent ovarian, peritoneal, or fallopian tube cancer, PS < 2, < 2 prior regimens for recurrence, and normal bone marrow, liver/renal function. Primary objective was response rate. Other endpoints included toxicities, time to progression (TTP), and survival. A RR of > 31% was considered worthy of further phase III testing. Results: 45 patients have been enrolled, and accrual is complete. 1 pt was ineligible. 3 pts withdrew before 2 cycles were completed because of grade 3 fatigue/weakness, grade 3 diarrhea and a carboplatin reaction, respectively and were not evaluated for response. 27 pts completed at least 6 cycles. No dose reductions (DR's) were required because of toxicities in 28 of 41 pts who received at least 2 cycles. 13 pts had DR's as a result of myelosuppression or GI toxicity; 11 had one DR and 2 had two DR's. 44 pts are evaluable for toxicities. Grade 3 and 4 toxicities are as follows: neutropenia (19 pts), platelets (11 pts), leukopenia (7 pts), anemia (4 pts), fatigue (4 pts), nausea (2 pts), diarrhea (2 pts), dizziness (2 pts), and 1 pt each experienced hypokalemia, vomiting, constipation, anorexia, memory impairment, pulmonary embolism. 14 pts had a carboplatin allergy. No significant rashes nor mucositis occurred. 41 pts were evaluable for RR, TTP, and survival. Overall RR was 61%; 1CR (2%), 24 PR's (59%), 14 SD (34%), and 2 PD (5%). Median TTP was 4.6 months (95% CI 3.2 -5.9) while median PFS was 7.7 months (95% CI 6.7 - 10.1). Conclusions: Carboplatin/Pem is a well-tolerated regimen with significant activity in platinum-sensitive recurrent ovarian cancer. Further testing of this regimen in this population is warranted.
Abstract Disclosures
Abstracts that were granted an exception in accordance with ASCO's Conflict of Interest Policy
and are designated with a caret symbol (^) here and in the print version.
 Associated Presentation(s):
Other Abstracts in this Sub-Category:
Abstracts by N. S. Horowitz :
Presentations by N. S. Horowitz :
Educational Book Manuscripts by N. S. Horowitz :
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