In 1979, the protocol guidelines on clinical assessment of response to therapy in advanced breast cancer were proposed by the Chemotherapy Committee and the Endocrine Therapy Committee of the Japan Mammary Cancer Society, in accordance with guidelines presented by the UICC (1977) and by the Breast Cancer Task Force of the NCI (1978). After amending some clauses, these protocol guidelines were finally published in 1982 by the Japan Mammary Cancer Society. A discussion was presented on the consistency of the present guidelines with the criteria for the evaluation of cancer chemotherapy for solid tumors, that was proposed by Koyama-Saito's Committee and was later adopted by the Japan Society for Cancer Therapy. The newly organized committee of the Japan Mammary Cancer Society is now carrying out further work to clarify several questionable points which have arisen in the present protocol guidelines.

Assessment of response to therapy in advanced breast cancer

Intracellular K+, Na+ and Cl− concentrations and membrane potential in human moncytes

Sixteen adults patients with insulin-dependent diabetes mellitus and 16 healthy controls, matched for sex and age, were asked to collect their urine during the night and during the day at rest, at weekly intervals on four occasions. Subjects with heart failure, kidney disease, hypertension, abnormal urinanalysis (Albustix positive) or poorly controlled diabetes prior to entry in the study, were excluded.



A high variability in the albumin excretion rates (AER) was observed in both diabetic and control groups but the variance was significantly greater in diabetics. Moreover the variance in AER was higher in daytime as compared to overnight urine collections in both groups. Overnight urine collections are more precise than daytime urine collections for the determination of AER.

Variability of albumin excretion in insulin-dependent diabetics.

Extracorporeal removal or modulation of circulating immune complexes (CIC) from plasma of animals and humans with malignant disease may be associated with induction of immune-mediated anti-tumor responses. Immunoadsorption columns containing heat-killed and formalin-fixed Staphylococcus aureus or staphylococcal protein A have been used for this purpose but treatments have often been associated with cardiopulmonary toxicity. Recently, an immunoadsorption device containing highly purified protein A covalently attached to a silica matrix (PROSORBA column) was used to treat 142 patients with refractory malignancies and 22 of 104 patients evaluated for anti-tumor response had objectively measurable reduction in tumor burden. In contrast to earlier experience with other devices, the procedures used in this trial were well tolerated and could be performed on an outpatient basis. The most common side effects observed among 1,306 treatments were chills (28% of treatments), low grade fever (28%), and musculoskeletal pain (16%). Side effects were mild to moderate and required no treatment or only symptomatic treatment. Treatment schedules were interrupted due to side effects for only six patients and there were no treatment-related deaths. Of 64 patients available for long-term follow-up evaluation (mean of 11 months), none exhibited evidence of long-term treatment-related side effects. None of the patient deaths in that period were associated with short or long-term treatment-related side effects. Protein A-silica (PROSORBA columns) can be used safely for development of further experimental treatments of malignant disease.

Minimal toxicity during protein A immunoadsorption treatment of malignant disease: an outpatient therapy.

The Fc-receptor (Fc-R) function of monocytes isolated from 19 control subjects and from 30 patients presenting with a rheumatoid arthritis (RA) was assessedin vitro by a classical rosette assay using IgG-coated sheep red blood cells. In RA patients, the percentage of monocytes forming rosettes was significantly lower than in controls (34.4±20.4 versus 67.4±4.5%;P<0.001). The blockade observed was reversed by a prior trypsin treatment of RA monocytes, the percentage of recovery being correlated with the IgG plasma levels. Besides, IgG purified from the serum of four RA patients bound a mean of 7.3, 5.2, 1.6, and 1.6 times more than normal IgG did onto concanavalin A (Con A), peanut agglutinin (PNA), phytohemagglutinin (PHA), and pokeweed mitogen (PWM), respectively. Although similar amounts of125I-labeled normal and RA IgG were bound to normal monocytes, RA IgG inhibited more efficiently than normal IgG the Fc-R function of normal monocytes, for all concentrations tested (10 to 100 µg/100 µl). A prior treatment of RA IgG by α-mannosidase, but not by β-galactosidase, significantly reduced their inhibitory properties. The incubation of monocytes withD-mannose or mannan reduced their capacity to form rosettes. The percentage of monocytes forming rosettes in the presence of both mannan and normal IgG was significantly lower than that measured in the presence of normal IgG only. On the contrary, the rosetting capacity of monocytes in the presence of both RA IgG and mannan was the same as that calculated in the presence of RA IgG only. The inhibitory effect of RA IgG was not related to their abnormal circular dichroism. Our data suggest that the greater ability of RA IgG to block the Fc-R function of monocytes probably depends on the presence of a greater number of accessible mannosyl residues on the glycosidic side chains located in the Fc domain of the molecules.

In vitro studies on the Fc-receptor function of mononuclear phagocytes in rheumatoid arthritis: relation between the Fc-receptor blockade and the concanavalin A-binding capacity of autologous immunoglobulin G.

. Plasma of twelve patients presenting with a metastic mammary adenocarcinoma was perfused ex vivo over columns of protein A covalently linked to crystalline silica. The plasma of seven patients (group A) was perfused over columns of protein A exhibiting a normal Fc-binding capacity and the plasma of five (group B) over columns of protein A in which the Fc-binding capacity was destroyed. In group A, all patients experienced acute, easily manageable, side effects (hypotension, chills, mild fever, leucocytosis and pain in tumour sites) during or immediately after the immunoadsorption procedures, and three exhibited an objective partial regression after two to five sessions. In contrast, none of the patients from group B developed any acute side effects and all showed evident progression of their disease during the treatment. Tumour cells in all stages of destruction, sometimes surrounded by extensive fibrosis, were seen in biopsies of patients A. However, focal areas of active tumour proliferation were always present in these patients. These data confirm that ex vivo perfusion over protein A columns of plasma from patients with cancer can induce a tumoricidal response in some instances and show that the Fc-binding capacity of protein A is most probably responsible for the necrolytic response and the side effects.

Ex vivo perfusion of plasma over protein A columns in human mammary adenocarcinoma. Role of the Fc-binding capacity of protein A in the side effects and the tumoricidal response.

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Ex vivo perfusion of plasma over protein A columns in human mammary adenocarcinoma. Role of the Fc-binding capacity of protein A in the side effects and the tumoricidal response.