Metastatic Breast Tumour Regression Following Treatment by a Gene-Modified Vaccinia Virus Expressing MUC1 and IL-2.

MUC1 is expressed by glandular epithelial cells. It is overexpressed in the majority of breast tumours, making it a potential target for immune therapy. The objectives of the present study were to evaluate the anti-tumour activity and tolerance of repeated administration of TG1031 (an attenuated recombinant vaccinia virus containing sequences coding for human MUC1 and the immune stimulatory cytokine IL-2) in patients with MUC1-positive metastatic breast cancer. This was an open-label, randomised study comparing two dose levels, 5 x 10E6 and 5 x 10E7, with 14 patients in each arm. The treatment was administered intramuscularly every 3 weeks for the first 4 doses and every 6 weeks thereafter, until progression. Two patients had a partial tumour regression ( > 50%), and 15 patients had stable disease as their best overall response until at least the 5th injection. Partial regression lasted for 11 months in one patient and for 12 months in the second patient who then underwent surgical resection of her hepatic metastases. The most frequent adverse events included inflammation at injection site: 7 patients, itching or pain at injection site: 5 patients, and moderate fever: 6 patients. One responding patient developed antinuclear, anti-DNA, and increased anti-TPO antibodies after the fifth injection, and which resolved at the end of treatment. The treatment regimes were well tolerated with a low toxicity profile. Although clinical efficacy remains limited, this study demonstrates the potential use of MUC1-based immune therapy in breast cancer.

Late Relapse in Hodgkin's Disease: Report of Five Cases and a Review of the Literature.

During the past 15 years the treatment of Hodgkin's disease (HD) with chemo/radiotherapy has been shown to appreciably improve the long-term prognosis of patients, even those with more advanced disease. In the past it was accepted that the probability of primary relapse 5 years after achieving complete remission (CR) was small and a 5-year disease-free period was sufficient to be considered as a cure. During the past 15 years, however, more data has been published relating to late relapses in these patients after an initial "cure" has been achieved. This report briefly examines our own experience with five patients initially "cured" who relapsed 5 to 11 years after achieving CR and also reviews recent literature on the subject. The phenomenon of late relapse has thus become a more important issue in the management of patients with HD.