Since 1979, 41 patients with locally advanced thyroid cancers have been prospectively treated in our institution according to a combination regimen of low-dose Adriamycin (doxorubicin) and external-beam radiation therapy. Two types of treatment regimen were used depending on tumor histologic type. Group 1 patients with well-differentiated papillary, follicular, or mixed type tumor (n = 22) received the combined regimen consisting of once weekly administration of Adriamycin (10 mg/m2) before radiation therapy (RT). Radiation therapy was carried out with a daily dose of 200 cGy for 5 days per week to a total tumor dose of 5600 cGy. Group 2 patients with anaplastic giant and spindle cell carcinoma of the thyroid (n = 19) received the combined regimen, consisting of once weekly administration of Adriamycin (10 mg/m2) before hyperfractionated RT. Radiation therapy was carried out with a fractional dose of 160 cGy per treatment twice a day for 3 days per week to a total dose of 5760 cGy in 40 days. Initial complete tumor response rates in the group 1 and 2 were 91% and 84%, respectively. Local tumor control rates at 2 years after combined therapy were 77% and 68%, respectively. The median survival time was 4 years for group 1 and 1 year for group 2. There was no disproportionately enhanced normal tissue morbidity seen with this combined approach. Patients in group 1 have a good quality of life, once the local disease is under control due to the indolent course of the disease. On the contrary, most patients in group 2 promptly developed distant metastases and died from the disease.

During therapeutic trials with E. coli L‐asparaginase in 131 children and 143 adults with neoplastic disease the following signs of toxicity have been observed: fever, nausea and vomiting, weight loss, somnolence, lethargy, confusion, hypolipidemia, hyperlipidemia, hypoproteinemia, abnormal liver function tests, fatty metamorphosis of the liver, pancreatitis (in rare instances), azotemia, granulocytopenia, lymphopenia, thrombocytopenia, and hypersensitivity reactions. While these effects have been moderately severe and reversible in most instances, some patients have shown dangerous degrees of toxicity. This has been the case most frequently in adult patients receiving a dose of 5000 IU/kg/day.

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The authors have devised a new treatment regimen consisting of combination Adriamycin and hyperfractionated radiation therapy for the treatment of anaplastic giant and spindle cell carcinoma of the thyroid gland. The regimen consists of a once weekly administration of low‐dose Adriamycin (doxorubicin) (10 mg/m2) and hyperfractionated radiation therapy. The radiation therapy is carried out with fractional dose of 160 rad per treatment twice a day for three days per week. The total tumor dose is 5760 rad delivered in 40 days. Since 1979, nine patients underwent the foregoing combination treatment regimen. Eight of nine achieved complete tumor regression in the primary treated area and six remained free of disease in the neck until time of death or last follow‐up. There was no disproportionately enhanced normal tissue morbidity seen with this combined approach. If an effective systemic treatment regimen can be devised for anaplastic carcinoma of the thyroid, the present Adriamycin and hyperfractionated radiation therapy may be capable of achieving improved survival time.

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