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Paclitaxel single agent
Abstract: European-Canadian randomized trial of paclitaxel in relapsed
ovarian cancer: high-dose versus low-dose and long versus short infusion.
PURPOSE: Taxol (paclitaxel; Bristol-Myers Squibb, Wallingford, CT) is
a new anticancer agent with activity in a number of human tumors, including
epithelial ovarian cancer. In nonrandomized trials, doses studied have ranged
from 135 mg/m2 to 250 mg/m2 administered over 24 hours with premedication
to avoid hypersensitivity reactions (HSRs). This study addressed two questions:
the dose-response relationship of Taxol in relapsed ovarian cancer and the
safety of a short infusion given with premedication. METHODS: Women with
platinum-pretreated epithelial ovarian cancer and measurable recurrent disease
were randomized in a bifactorial design to receive either 175 or 135 mg/m2
of Taxol over either 24 or 3 hours. Major end points were the frequency
of significant HSRs and objective response rate. Secondary end points were
progression-free and overall survival. RESULTS: Of 407 patients randomized,
391 were eligible and 382 assessable for response. Analysis was performed
according to the bifactorial design. Severe HSRs were rare (1.5% patients)
and were not affected by either dose or schedule. Response was slightly
higher at the 175-mg/m2 dose (20%) than at 135 mg/m2 (15%), but this was
not statistically significant (P = .2). However, progression-free survival
was significantly longer in the high-dose group (19 v 14 weeks; P = .02).
Significantly more neutropenia was seen when Taxol was administered as a
24-hour infusion. Response rates were similar in the 24- and 3-hour groups
(19% and 16%, respectively; P = .6). No survival differences were noted.
CONCLUSION: The 3-hour infusion of Taxol is safe when given with premedication
and is associated with less neutropenia. There is a modest dose effect with
longer time to progression at 175 mg/m2. The observation that longer infusion
produces more myelosuppression but does not yield higher response rates
should lead to further studies to determine the optimal dose and schedule
of this interesting new agent.
References
Eisenhauer EA, ten Bokkel Huinink WW, Swenerton KD, Gianni L, Myles J,
van der Burg ME, Kerr I, Vermorken JB, Buser K, Colombo N, et al. European-Canadian
randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus
low-dose and long versus short infusion. J Clin Oncol 1994; 2654 - 2666.
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Paclitaxel....... 175 mg / M2
IV (over 3 h) day 1
FREQUENCY every 21 days |
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