We determined the therapeutic effect of fluorouracil (5-FU) in combination with folinic acid (FA) in patients with measurable recurrent or metastatic carcinoma of the colon or rectum by comparing it to standard 5-FU therapy in a prospective randomized controlled trial. Patients were randomized to receive either FA, 200 mg/m2/d for five consecutive days, or nothing. All patients received 5-FU, 370 mg/m2/d for five days on the first course, with subsequent dose modifications to maintain equal toxicity in the two arms. One hundred thirty patients were entered on trial and only five were excluded from the analysis because they did not meet the eligibility criteria or they refused therapy after randomization. The two treatment arms were balanced for 11 clinical characteristics. Patients were evaluated for response at the end of every two treatment courses and toxicity after every course of therapy. Median follow-up was 1.45 years. Dose-limiting toxicity was mucositis and diarrhea on this treatment schedule, although neutropenia was apparent. The response rate was 33% (21 of 63 patients) in the 5-FU and FA arm and was 7% (four of 61 patients) in the 5-FU arm (P less than .0005). Time to disease progression was significantly different in the combination arm as compared with the single-agent arm (P = .023). Overall survival was significantly longer for patients treated with 5-FU and FA as compared with those receiving 5-FU alone (P = .05). The median survival was 12.6 months for patients receiving the combination, and 9.6 months for those receiving 5-FU alone. Our results indicate that the combination of 5-FU and FA is effective treatment for patients with metastatic or recurrent carcinoma of the rectum and colon who have not received prior chemotherapy.

Weight gain during adjuvant chemotherapy has been reported by several authors. Because increased body weight at diagnosis is associated with an increased risk of disease recurrence, we have assessed the prevalence of weight gain in a series of patients receiving adjuvant treatment, as well as the association of weight gain with type of treatment and risk of recurrence. We first assembled an inception cohort of 237 patients who had all undergone pretreatment evaluation and treatment at one institution, and had already been followed for at least 12 months. Body weight at the start and completion of treatment was recorded, as was type of treatment and status at last followup. Ninety-six percent of patients gained weight during treatment and none lost weight (mean increase 4.3 kg). Weight gain was strongly associated with treatment, and was least in patients receiving single agent chemotherapy, greatest in patients treated with ovarian ablation and prednisone, and intermediate in those receiving combination chemotherapy. There was no association between weight gain and disease recurrence.

A retrospective chart review was conducted of men with the diagnosis of carcinoma of the breast seen at this institution between January 1967 and March 1981. Eighty-nine patients were available for analysis. These cases were evaluated to determine whether the natural history of this disease was similar to that of women with carcinoma of the breast and to identify prognostic variables in carcinoma of the male breast. The results of this review would suggest that many similarities exist between breast cancer in women and in men. The most common presenting symptom is a lump, the patterns of recurrence are similar for both men and women, and survival is determined by initial T stage and the presence or absence of nodes. Local postoperative radiotherapy does not influence overall survival in male breast cancer but does decrease the incidence of chest wall recurrence. Survival after recurrence is short and is similar to that observed for women with recurrent carcinoma of the breast. The differences observed in the present series were that the median age at presentation of 63.6 years is somewhat greater than that usually observed in women; no cases of lobular carcinoma were observed; and in the 44 patients who developed recurrences to date, none had evidence of liver metastases as the initial site of recurrence. In most respects the natural history of male breast cancer is similar to that of carcinoma of the breast in women. Since carcinoma of the male breast is a relatively rare malignancy. it is reasonable to recommend management of this disease be based on the greater base of knowledge available for carcinoma of the female breast.

No abstract

No abstract