Background. 4'-O-tetrahydropyranyladriamycin
(Pirarubicin, Meiji Seika (USA) Inc., New York, NY) may be less toxic than doxorubicin.
A Phase I1 trial of Pirarubicin was done in 26 patients who had not previously had chemotherapy and who had measurable and incurable head and neck carcinoma. All patients received an intravenous bolus dose of 60 mg/mz Pirarubicin in the first cycle without any prophylactic antiemetic. The cycles were repeated every 3 weeks. Based on tumor response, nadir counts, or complications of myelosuppression, the doses were escalated or de-escalated by 10 mg/m2, if necessary, in the second cycle to achieve mild leukopenia (3000-4000 leukocytes/& Results. Leukopenia was mild, moderate (2000- 2999 Ieukocytes/pl), severe (1000-1999 leukocytes/pl), and life threatening (less than 1000 leukocytes/pl) in 13%, 31%, 27%, and 9% of the first two courses, respectively. The median interval to nadir leukopenia was 13 days (range, 7-21 days), with a median of 8 days (range, 5-13 days) to recover to normal. One patient with a leukocyte count of 800/p1 and an absolute granulocyte count (AGC) of 488/~1 died of sepsis 15 days after the first course. All patients had at least one course that resulted in leukopenia. One episode each of mild (100,000-150,000 platelets/pl) and severe (25,000-49,999 platelets/pl) thrombocytopenia occurred in the first two courses. Leukocyte, granulocyte, and platelet counts were not done routinely after the second cycle. Six patients who received four or more courses with cumulative doses of Methods.