LISBON, Portugal--Doxorubicin coupled with cisplatin (Platinol)
confers a distinct survival edge over the anthracycline alone
in women with advanced inoperable or recurrent endometrial carcinoma,
according to the latest findings of the Gynaecological Cancer
Cooperative Group (GCCG) of the European Organization for Research
and Treatment of Cancer (EORTC).
The results of this new EORTC trial mount a direct challenge to
the contrasting data recently reported by the Gynecological Oncology
Group (GOG), said Dr. Matti S. Aapro, of the European Oncology
Institute, Milan, and Clinique de Genolier, Switzerland.
Speaking at the congress of the European Society of Medical Oncology,
Dr. Aapro described candidates for the EORTC trial as women with
measurable, pathologically proven lesions in nonirradiated areas
who had received no prior chemotherapy and had good performance
status. Over the last 6 years, he said, more than 160 such women
have been randomized to receive either doxorubicin, 60 mg/m²,
plus cisplatin, 50 mg/m², every 4 weeks, or the same dose
of doxorubicin alone every 4 weeks.
The combination regimen was not without serious drawbacks, Dr.
Aapro acknowledged, citing a 47% incidence of severe neutropenia
(versus 32% with doxorubicin alone), an 11% incidence of severe
thrombocytopenia (versus 6% for single-drug therapy), and a 38%
incidence of nausea and vomiting (versus 14% for doxorubicin alone).
On the other hand, although the rate of study discontinuation
due to drug toxicity was greater in the combination therapy group,
the rate of withdrawal because of disease progression was strikingly
higher among women treated with doxorubicin alone.
Complete responses were observed in 10 (17%) of 59 eligible women
in the combination arm, compared with 6 (11%) of 54 in the single-agent
arm, and partial responses were documented in 17 (29%) of the
combination therapy patients but in only 3 (6%) of those on doxorubicin
alone. No change was discerned in 13 (22%) of the patients receiving
doxorubicin plus cisplatin and in 12 (22%) of the women treated
with doxorubicin alone.