Journal of Clinical Oncology, Vol 10, 1748-1753, Copyright © 1992 by American Society of Clinical Oncology
Phase II study and long-term follow-up of patients treated with taxol for advanced ovarian adenocarcinoma
AI Einzig, PH Wiernik, J Sasloff, CD Runowicz and GL Goldberg
Division of Medical Oncology, Albert Einstein Cancer Center, Bronx, NY 10461.
PURPOSE: Based on the results of our phase I study that demonstrated the
antitumor activity of taxol in a previously treated patient with ovarian
cancer, a phase II study was conducted to evaluate the efficacy of taxol in
patients with metastatic ovarian cancer and to evaluate further the
toxicity of taxol in this group of patients. PATIENTS AND METHODS:
Thirty-four patients with metastatic ovarian cancer received taxol (180 to
250 mg/m2) as a 24-hour continuous infusion. A premedication regimen was
used to reduce the likelihood of an acute hypersensitivity reaction.
RESULTS: Six of 30 assessable patients demonstrated complete responses (one
patient) or partial responses (five patients; 20%; 95% confidence interval
[CI], 6% to 34%; range, 2 to 30 months). Additionally, one patient had a
less than partial objective response (2 months), and two patients had
stable disease for 6 and 15 months. Those responders had a median survival
of 27 months, and the nonresponders had a median survival of 6 months (P =
.0001). Myelosuppression was the most significant toxicity. Other adverse
effects included alopecia and peripheral neuropathy. CONCLUSION: Taxol has
significant activity in ovarian cancer and should be studied in combination
with other active agents earlier in this disease.
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