Phase II study of pirarubicin (THP) in patients with cervical, endometrial and ovarian cancer: Study of the clinical screening group of the European Organization for Research and Treatment of Cancer (EORTC)

Abstract From 1986 to 1990, a multicentric phase II study was conducted with pirarubicin, a new semi-synthetic anthracyclin [4′- O -tetrahydropyranyl-adriamycin (THP)]. 87 patients with advanced gynaecological cancers were treated: epidermoid cervical carcinoma ( n = 31), adenocarcinoma of the endometrium ( n = 28) and ovarian adenocarcinoma ( n = 28). THP was administered by short intravenous infusion, for 3 consecutive days, every 3 weeks. The initial dose of THP was 25 mg/m 2 day (25% of patients) which was then reduced to 20 mg/m 2 day. The average number of courses was 3.7 (range 1–10). The cumulative THP dose was 180 mg/m 2 (range 56–594) in cervix and endometrial tumours and 121 mg/m 2 (range 58–425) in ovarian tumours. Myelosuppression was the major observed toxicity with grade 3–4 leukopenia and thrombocytopenia in 62 and 19% of the patients, respectively. Severe general complications occurred in 6% of the patients with three fatalities due to infections. Gastro-intestinal side-effects were frequent and usually mild (7% of grade 3 vomiting). 48% of the patients showed alopecia, which was complete in 9 cases (10%). 3 patients experienced cardiac events. No significant antitumoral activity was observed in patients who had failed to respod to previous chemotherapy. Promising antitumoral activity was noticed in untreated cervico-uterine carcinomas with 19% partial responses and 12% complete responses (CR). THP activity was lower in endometrial carcinomas (9.5% CR). Results were found to be negligible in ovarian cancer patients, most of them being refractory to previous chemotherapy containing an anthracyclin compound. On the basis of these results, the definite role of THP in gynaecological cancers deserves to be studied in more favourable programmes (e.g. in combined protocols as first-line chemotherapy).