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The purpose of this prospective study was to determine the incidence of thyroid dysfunction in cancer patients receiving immunotherapy with interleukin-2 (IL-2) alone, and to assess the relationship of hypothyroidism t o clinical response. A cohort of 281 consecutive patients with metastatic melanoma or renal carcinoma were treated with IL-2 alone from July 1, 1989 until June 30, 1993. The majority (n = 216) received high-dose IL-2 and the remainder (n = 65) received low-dose therapy. Thyroid function was measured before, during, and after immunotherapy. Forty-one percent of initially euthyroid patients developed thyroid dysfunction after starting high-dose IL-2-alone therapy. The most common abnormality was hypothyroidism, occurring in 35% of patients, although moderate or severe hypothyroidism requiring thyroid hormone replacement occurred in 9% of patients. Hypothyroidism was related to duration of IL-2 therapy and was not associated with clinical response. Hyperthyroidism developed in 7% of previously euthyroid patients receiving high-dose IL-2. Overall, the incidence of thyroid dysfunction was similar in the high-and low-dose IL-2 regimens. In conclusion, thyroid dysfunction is a common sequela of IL-2 therapy. Thyroid function should be measured routinely in cancer patients receiving IL-Zbased treatment. It is recommended that thyroid hormone replacement be given to patients with moderate or severe hypothyroidism.

BACKGROUNDMalignant mixed tumors of the liver in adults are rare. To the authors' knowledge, twenty‐four cases of primary malignant mixed hepatic tumors have been reported in the literature since the first description by Walter in 1896. Many of the previously reported cases are now considered mixed hepatoblastoma, primary hepatocellular carcinomas with focal sarcomatous metaplasia, or epithelioid hemangioendothelioma.METHODSClinical, radiologic, histologic and immunohistochemic methods were used to characterize an unusual example of a mixed malignant tumor of the adult liver that the authors descriptively refer to as “ossifying malignant mixed epithelial and stromal tumor” of the liver.RESULTSIn contrast to previously reported cases, the tumor in question was morphologically distinct. It was composed of three distinct neoplastic phenotypes: malignant spindle cells, with adenocarcinomatous differentiation, and extensive osteoid formation. The tumor was treated by partial hepatectomy. The patient was alive 8 years postoperatively as of December 2001. The distinctive combination of morphologic features and prolonged survival are much different from previously reported cases of mixed malignant hepatic tumors, which were typically rapidly fatal.CONCLUSIONSThe authors believe that the clinical and pathologic features of this patient's tumor are sufficiently distinctive to exclude it from the well‐established categories of hepatic neoplasms. Histologically, the authors suggest the descriptive name “ossifying malignant mixed epithelial and stromal tumor of the liver” as a preliminary description for this tumor until the origin and relationship to other hepatic neoplasms are further characterized. Cancer 2002;94:1018–22. © 2002 American Cancer Society.DOI 10.1002/cncr.10345