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CARCINOMA of the rectum is one of the more common malignant diseases in this country, estimated to afflict some 45,500 persons during 1991. 1 It has certainly been one of the most frustrating of therapeutic challenges. Recent national studies have shown 5-year and 10-year survival rates to be 35 percent and 22 percent, respectively. 2 Attempts to improve the results of surgery with adjuvant chemotherapy have produced only equivocal findings. 3 4 5 Because of the tendency of rectal carcinoma to recur locally, and because of the well-established palliative effect of the irradiation of locally recurrent disease, both preoperative and postoperative radiation therapy have been . . .

Based on reports of substantial antitumor efficacy of the combination of mitoxantrone (DHAD), 5-fluorouracil (FU) and leucovorin (LV), a clinical trial was performed to attempt augmentation of the dose of DHAD with filgrastim support. The doses and schedules, all intravenous, were DHAD (total dose divided over days 1 and 2), level I, 16 mg/m2; II, 20 mg/m2; III, 24 mg/m2; IV, 32 mg/m2; and LV, 300 mg, followed by FU, 350 mg/m2, on days 1-3. Filgrastim was given at 5 micrograms/kg/day subcutaneously on days 4-13. The planned cycle length was 21 days. Three or 4 patients were to be entered at each dose level and the maximum tolerated dose (MTD) was defined as the dose immediately below that which resulted in 2 patients with dose-limiting toxicity (DLT) in cycle 1. Once an apparent MTD was identified, an additional 6 patients were to be entered. Twenty patients (pts) were entered: level I: 3 pts; II: 3 pts; III: 10 pts: IV: 4 pts. The major toxicity was found to be cumulative thrombocytopenia with platelet counts < or = 20,000/microL occurring after cycle 1 at all levels beyond level I and five pts (25%) were removed from treatment solely because of platelet toxicity. Additional serious toxicities included grade 4 stomatitis in one patient (level IV) and cardiac toxicity in 2 patients with prior doxorubicin exposure. Ten pts had measurable and 8 had evaluable disease, and in 17 pts assessed, 5 (29%) achieved an objective response. The response rates in this study are lower than reported in the literature for the combination of DHAD, 5FU, LV and this may be related to the fact that only 40% of the patients were removed from protocol treatment because of disease progression. On the basis of limited DHAD-dose augmentation, toxicities observed, and modest response rate, the filgrastim-supported DHAD, 5FU, LV regimen as utilized in this study cannot be recommended for further development for treatment of women with metastatic breast cancer.

Twelve hundred ninety-six patients with resected colon cancer that either was locally invasive (Stage B 2 ) or had regional nodal involvement (Stage C) were randomly assigned to observation or to treatment for one year with levamisole combined with fluorouracil. Patients with Stage C disease could also be randomly assigned to treatment with levamisole alone. The median follow-up time at this writing is 3 years (range, 2 to 5 1/2). Among the patients with Stage C disease, therapy with levamisole plus fluorouracil reduced the risk of cancer recurrence by 41 percent (P<0.0001). The overall death rate was reduced by 33 percent (P ≈ 0.006). Treatment with levamisole alone had no detectable effect. The results in the patients with Stage B 2 disease were equivocal and too preliminary to allow firm conclusions. Toxic effects of levamisole alone were infrequent, usually consisting of mild nausea with occasional dermatitis or leukopenia, and those of levamisole plus fluorouracil were essentially the same as those of fluorouracil alone — i.e., nausea, vomiting, stomatitis, diarrhea, dermatitis, and leukopenia. These reactions were usually not severe and did not greatly impede patients' compliance with their regimen. We conclude that adjuvant therapy with levamisole and fluorouracil should be standard treatment for Stage C colon carcinoma. Since most patients in our study were treated by community oncologists, this approach should be readily adaptable to conventional medical practice. (N Engl J Med 1990; 322:352–8.) THIS year, cancer of the colon will afflict over 100,000 persons in the United States. 1 As a cause of death due to cancer, it is second only to lung cancer. There is no established means of preventing colon cancer, and there is no reliable and cost-effective means of screening to ensure early diagnosis. In the main, symptomatic patients must be treated as they present themselves, and in half of them cure has unfortunately not been possible. However, in about 80 percent of patients the diagnosis is made at a stage when all apparent diseased tissue can be surgically removed. In . . .

Objective: A phase II multi-institutional clinical trial conducted to evaluate the efficacy and tolerability of docetaxel and carboplatin as first-line therapy for women with metastatic breast cancer. Methods: Patients had histologically confirmed metastatic breast cancer with at least one measurable lesion. Prior adjuvant chemotherapy was permitted, provided that at least 12 months had elapsed between any prior taxane and platinum therapy. Patients received docetaxel 75 mg/m 2 with carboplatin AUC 6 mg/ml·min every 21 days until disease progression or prohibitive toxicity. Results: All 53 patients enrolled were evaluable for response and toxicity. Median number of cycles delivered was 6. Overall response rate was 60%, with 3 complete responses (6%) and 29 partial responses (54%). Median time to disease progression was 9.6 months. Median survival time was 20.4 months. Myelosuppression was the predominant toxicity, with grade 3 or 4 neutropenia occurring in 94% of patients and 15% of patients experiencing febrile neutropenia. The overall incidence (grades 1–3) of neurosensory toxicity was 57% and neuromotor toxicity was 25%, respectively, with grade 3 toxicity occurring in 4% of patients each. Conclusions: The combination of docetaxel and carboplatin is highly active in metastatic breast cancer. Prophylactic growth factor support is recommended in any further evaluation of this combination in the treatment of patients with breast cancer.

A patient with recurrent bacterialmeningitis wholackedcirculating C8, serum IgA, and secretory IgAis reported. The combinedabsence of C8and IgAdeficiency has not been previously noted. Although the association of disseminated neisserial infectionand absence of the terminalcomplement components is now well established, the deficiency of bactericidal capability as well as mucosal humoral defense may have been additive in predisposing the patient to recurrent meningitis. The pedigree was uninformative regarding possible linkage of these two uncommon genetic errors.