A phase II study of high-dose epirubicin in ovarian cancer patients previously treated with cisplatin
Articolo
Data di Pubblicazione:
2000
Citazione:
A phase II study of high-dose epirubicin in ovarian cancer patients
previously treated with cisplatin / J.B. Vermorken, A. Kobierska, B. Chevallier, F. Zanaboni, A. Pawinski, G. Bolis. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - 11:8(2000 Aug), pp. 1035-1040. [10.1023/A:1008332517333]
Abstract:
Background; In vitro data demonstrated a dose-response relationship
for doxorubicin in ovarian cancer cell lines. However,
this dose-response question for anthracyclines has never been
adequately addressed in ovarian cancer patients. A phase I
study with epirubicin gave support to these in vitro findings
and recommended a dose of 150 mg/m2 for phase II testing.
Patients and methods: The present report concerns the final
analysis of an EORTC-Gynecological Cancer Cooperative
Group (GCCG) phase II study of high-dose epirubicin (HDE)
in cisplatin-pretreated patients with epithelial ovarian cancer.
A total of 100 eligible patients were included; 34 had progressed
during first-line therapy (group 1), 17 had persistent
disease after first-line therapy (group 2) and 49 had relapsed
following an initial response to first-line therapy (group 3). All
patients had measurable or evaluable disease, were aged < 75
years, had a WHO performance status 0-2, had adequate vital
organ function and gave consent. Epirubicin was administered
by rapid i.v. infusion at a dose of 150 mg/m2 and given at threeweek
intervals. Escalation to 180 mg/m2 was to be carried out
if white blood cell nadir count was >2.0 x 109/l and platelet
nadir count was > 75 x 109/l.
Results: A total of 361 HDE treatment cycles were administered,
the median number per patient being 4. Of the 85
patients who received at least two cycles of protocol treatment,
26 (31%) did not have any dose modification, 23 (26%) had
dose reduction, while 36 (43%) had the dose increased to 180
mg/m2, at least for one cycle. The response rate in all eligible
patients was 20% (95% confidence interval 13%-30%), 15% in
group 1, 12% in group 2 and 27% in group 3. Patients with a
cisplatin-free interval of > 12 months responded in 41%. The
median duration of response was nine months (range 19 weeks
to 3 years). Main toxicities were myelosuppression (leucopenia,
neutropenia), nausea, vomiting, alopecia and mucositis.
There were three cases of excessive toxicity leading to
early discontinuation of HDE treatment and in one patient
this contributed to death. No serious cardiotoxicity was recorded.
Conclusions: It is concluded that HDE is active in platinumpretreated
patients with epithelial ovarian cancer and should
be further studied in first-line in combination with paclitaxel
and a platinum compound.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
high-dose epirubicin ; ovarian cancer ; phase II
Elenco autori:
J.B. Vermorken, A. Kobierska, B. Chevallier, F. Zanaboni, A. Pawinski, G. Bolis
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