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21 patients with metastatic breast cancer, refractory to conventional agents, were treated with a combination of BCNU, vincristine, mitomycin-C and prednisone given every 4 weeks. Only three of the nineteen (15.8%) evaluable patients were observed to have a partial remission, whereas four experienced stabilization of tumor. The sites which responded included skin lesions in two patients and a pleural effusion in 1 patient. This combination resulted in moderate to severe thrombocytopenia in five patients, but was otherwise well tolerated. This pilot study therefore suggests that these four agents in the schedule and doses given do not appear to be superior to any of these agents used singly for advanced, refractory breast cancer.

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Fifty-six patients with advanced metastatic carcinoma of the breast, melanoma and lymphoma were treated with the new vinca alkaloid vindesine in a prospective Phase II study. The dose was 3 mg/M2 by I.V. bolus once a week for a minimum of two doses. Patients who failed to respond to four I.V. doses were treated with 48-h intravenous infusions at a dose of 1.5 mg/M2 per 24 h. Of the 26 evaluable patients with breast cancer, there were only two incomplete responses and four patients who experienced stabilization of disease. Of the 12 evaluable patients with melanoma, no responses were seen with four patients experiencing stabilization of disease. Of the 11 patients with non-Hodgkin's lymphomas, there was one complete remission which persisted for 26 months and two partial remissions. No additional responses were seen when the mode of administration was changed to 48-h infusion in three patients with breast cancer, five patients with melanoma and one patient with lymphoma. Significant toxicities included neutropenia in 24 patients and nausea and vomiting in two patients. There were no drug related deaths. Previously reported experience with vindesine in these tumors is reviewed as well.

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In a prospective evaluation, two preoperative courses of methotrexate, bleomycin, and cisplatin combined with 2,000 rad/10 fractions ("chemo-radiotherapy") yielded 78% responses rates in previously untreated advanced head and neck cancer. Similarly staged patients receiving preoperative irradiation of 5,000 rad alone had a 67% response rate. Treatment-related mortality in the chemo-radiotherapy patients was equal to that seen with standard combinations of surgery and preoperative or postoperative irradiation. At 24 months, disease-free survival is 47% with chemo-radiotherapy vs 33% with standard therapy; however, patients benefiting most from the former approach were those with T4 primary lesions or N3a neck nodes.

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The records of 177 patients with small cell carcinoma of the lung were reviewed to determine parameters associated with brain metastases. Complete autopsy, including examination of the brain, was done in each case. Of the 70 cases of brain metastases, only two patients (3%) were aged 70 years or more as compared with 19 (18%) aged 70 years or more who did not have brain metastases. Patients with brain metastases had a longer median survival as compared with those without brain metastases. Patients with brain metastases had involvement of the thyroid and kidney more frequently (23% and 34%, respectively) compared with patients without brain metastases (8% and 13%). Thus, patients who have brain metastases tend to (1) be less than 70 years of age; (2) have a longer survival; and (3) have a higher incidence of metastases to the thyroid and kidney.

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Forty patients with various types of myeloproliferative disorders were evaluated immunologically. Serum immunoglobulin levels were within the normal range in most patients and no monoclonal gammopathies were detected. Serum C'3 levels were decreased in 19 of 40 (48%) patients. The response of peripheral blood lymphocytes to phytohemagglutinin was decreased in 26 of 40 (65%) and to pokeweed mitogen in 18 of 28 (64%) patients studied. Lymphocytes from patients with polycythemia vera were least affected. Unstimulated lymphocytes from some patients demonstrated markedly increased thymidine uptake activity. Despite the diminished mitogenic response, only 2 of 33 patients (6%) were anergic by intradermal skin testing. There was no association between depressed lymphocyte response and recent chemotherapy except in chronic myelogenous leukemia where 6 of 8 patients were receiving cytotoxic therapy when studied. These observations suggest that most of our patients with myeloproliferative disorders have abnormal cellular responses in vitro, but that delayed hypersensitivity and humoral responses are minimally affected.

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Two cases of disseminated atypical tuberculosis are presented in which the infection anteceded by over four years the development of acute granulocytic leukemia on one and Hodgkin's Disease in the other patient. The presence of disseminated atypical mycobacteriosis in the absence of a clearcut underlying illness suggests a "preneoplastic state." It should alert the clinician to the possibility of a neoplastic disorder which may not become clinically manifest for several years.

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Teardrop-shaped erythrocytes (TD) are frequently observed in the peripheral blood of patients with agnogenic myeloid metaplasia (AMM). These deformed cells may result from the myelofibrosis or the extramedullary hematopoiesis in the spleen. To determine the influence of the spleen on TD formation, we reviewed the presplenectomy (pre-S) and postsplenectomy (post-S) peripheral blood smears from 13 patients with AMM. The splenectomy was performed for a variety of reasons, including symptomatic hypersplenism or splenomegaly. The average number of TDs per 1,000 RBCs in the pre-S smears was 42 (range, 15 to 112 TDs), compared with 11 TDs in the post-S smears (range, 6 to 20 TDs)(P = less than .001). Only one of the 13 patients failed to exhibit this decrease in TDs post-S. There was no definite correlation between the number of TDs and the weight of the spleen removed at surgery, the interval since surgery, or age and sex of the patient. Based on this fourfold decrease in the number of TDs post-S, we conclude that the spleen in AMM play an important role in TD formation.

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Pyrimethamine, a folate antagonist similar to methrotrexate without known hepatotoxcity in man, was administer orally, once a week, to seven patients with severe, long-standing psoriasis. Four patients obtained a good to excellent response; a fifth withdrew from the study early after a partial response; a sixth had minimal response to high doses, and the seventh was withdrawn due to a probable drug-induced hepatotoxic reaction. Hepatotoxic reaction was suspected in another patient with abnormal liver biopsy and experienced severe gastrointestinal toxic reactions and two developed significant thrombocytopenia, which resolved after oral treatment with folic acid or discontinuation of the drug. These did not recur at lower doses. Pyrimethamine appears to be effective in severe psoriasis, but offers no advantage, and several disadvantages over methotrexate. Pyrimethamine is probably hepatotoxic. It should be used with caution in patients with liver disease or impaired renal function; pretreatment liver biopsy is recommended.

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18 patients with metastatic or recurrent bronchogenic carcinoma and one patient with a squamous cell carcinoma of the trachea were treated with a combination of CCNU, hexamethylmelamine and methotrexate. Objective remissions were observed in 3/19 (16%): 1 complete, 1 partial (greater than 50%) and 1 incomplete (less than 50%). However, the patient with the complete response was the only drug death, on day 21. Remission duration in the other two patients was 3 and 9+ months respectively. One patient with oat cell carcinoma experienced no tumor progression for 5 months. This combination resulted in severe gastrointestinal toxicity in 5/19, severe thrombopenia in 12/19 and severe neutropenia in 6/19. We conclude that the combination as used here resulted in no increased clinical effectiveness and proved to be quite toxic.

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