LISBON, Portugal--Doxorubicin coupled with cisplatin(Drug information on 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(Drug information on 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.
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