Clinical Evaluation of Hydroxyurea in Advanced Lung Cancer

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Abstract
Hydroxyurea has been adequately evaluated in 27 patients with inoperable or advanced lung cancer (group A). The drug was also given to 13 patients with miscellaneous metastatic solid tumors (group B). Four different dosages of hydroxyurea were administered: 40 mg/kg/day p.o. (15 patients of group A and 7 patients of group B); 10 mg/kg/day i.v. (3 patients of group A and 1 patient of group B); 100 mg/kg/week (3 patients of group A and 2 patients of group B); 100 mg/kg i.v. on alternate days (6 patients of group A and 3 patients of group B). The total daily dose was given in two administrations with an interval of 12 hours. None of the patients had been previously treated with radiotherapy or chemotherapy; their performance status was not less than 40. Subjective and objective responses, evaluated on the Karnofsky's categories, were seen in patients with advanced lung cancer, but only one patient of the miscellaneous group showed an objective response to hydroxyurea. The therapeutic responses were achieved in group A with dosages of 40 mg/kg/day p.o. (5/15 cases) and of 100 mg/kg i.v. on alternate days (4/6 cases). Relief of symptoms and objective regressions were short-lived. No maintenance treatment in responsive cases was given. There was no definite change in the basic course of the disease. The other patients treated respectively with 10 mg/kg/day and with 100 mg/kg/week were very few and received a smaller total dose of hydroxyurea. Bone marrow toxicity occurred mainly with patients receiving higher doses of hydroxyurea (40 mg/kg by mouth and 100 mg/kg i.v. on alternate days respectively). In these patients progressive leukopenia and anemia developed in almost every case, often requiring multiple blood transfusions. Megaloblastosis was checked in 3 cases. Five patients after 2–3 weeks of treatment had nasal bleeding, which disappeared spontaneously after 3–6 days. Only 2 patients, while receiving hydroxyurea by mouth, complained of nausea and epigastric distress and the drug was discontinued temporarily. Two patients showed a mild hyperuricemia after the first week of treatment. The administration of intravenous hydroxyurea at the dose of 100 mg/kg on alternate days in lung cancer deserves a more extensive trial.