Phase II study of esorubicin (4'-deoxydoxorubicin) in advanced or metastatic squamous carcinoma of the uterine cervix: a Gynecologic Oncology Group Study.

Twenty-eight patients with advanced, measurable squamous carcinoma of the uterine cervix were treated with 62 courses of esorubicin at doses ranging from 20-35 mg/m2 every three weeks. All patients were evaluable for response and toxicity. All patients had received prior therapy including radiation therapy in 28, chemotherapy in 23, and surgery in 11. All patients were Gynecologic Oncology Group (GOG) performance status 0, 1 or 2. There were no responses seen. Severe (grade 3 or 4) leukopenia, thrombocytopenia, and anemia were seen in 13, 3, and 9 patients, respectively. Gastrointestinal toxicity as well as alopecia were the other adverse effects. Mucositis and phlebitis were not seen. Neither clinical congestive cardiomyopathy nor decrement in left ventricular ejection fraction was observed. Lack of response in association with moderate toxicity using this dose and schedule of esorubicin in squamous carcinoma of the cervix previously treated with chemotherapy makes further study as a salvage agent unwarranted.