Dihydro-5-azacytidine in malignant mesothelioma

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Abstract
BACKGROUND Malignant mesothelioma is a disease that is refractory to chemotherapy. Therefore, the objective of this multi‐institutional, cooperative group Phase II trial was to determine the efficacy of dihydro‐5‐azacytidine (DHAC), a pyrimidine analogue, in the treatment of malignant mesothelioma. METHODS Forty‐one patients with histologically confirmed malignant mesothelioma received 120‐hour continuous infusions of DHAC (1,500 mg/m2/day every 21 days) until maximal response, intolerable toxicity, or disease progression. RESULTS One patient had a complete response, two had objective partial responses, and four had regression of evaluable disease. The overall response rate was 17%. The one complete responder remains without disease progression at 6 years. Chest pain and nausea were the most common toxicities. Supraventricular tachycardia and pericardial effusion occurred in 20% and 15% of patients, respectively. In most patients, gastrointestinal effects were manageable. There was no significant hematologic toxicity. CONCLUSIONS In malignant mesothelioma, a disease that is refractory to chemotherapy, dihydro‐5‐azacytidine has definite antitumor activity. Its modest hematologic toxicity profile favors its use in combination with other agents. Caution regarding cardiac arrhythmias and pericardial effusion is necessary. Cancer 1997; 79:2237‐42. © 1997 American Cancer Society.