It has been suggested that oral supplements of folic acid interfere with the intestinal absorption of zinc and may have toxic side effects. The concentrations of Zn and folate in blood were monitored ...in a group of women with cervical dysplasia randomly assigned to receive 10 mg/d of either folic acid (pteroylglutamic acid) or ascorbate. Fifty subjects were evaluated after 2 mo; 21 of the same subjects were evaluated again after 4 mo. No untoward clinical effects were observed. Significant elevation of erythrocyte folate above the baseline value was observed in the supplemented group but not in the placebo group (p less than 0.001). The concentration of Zn in plasma and erythrocytes did not change significantly in either the folate-treated or placebo groups after 2 and 4 mo. It is concluded that carefully controlled clinical intervention trials of this type do not impose a risk of depleting the concentration of Zn in erythrocytes and plasma.
In cancer of the ovary, a tumor marker is much needed to assist the conventional methods for monitoring the disease course. All published reports of the CA125 serum immunoassay to date have indicated ...that rising or falling CA125 levels correlated with disease progression or regression in patients with ovarian malignancies. Our experience with CA125 at the University of Alabama at Birmingham shows that rising CA125 levels are highly suggestive of progressive disease. However, the significance of our findings with CA125 is that, contrary to other reports, falling CA125 levels are not a reliable indicator for regressive disease. Thus, falling CA125 levels are not clinically useful whereas rising CA125 levels may be interpreted as indicative of poor tumor response to therapy, and of the presence of persistent or recurrent disease either prior to second-look laparotomy or during post-treatment follow-up.
This study (Alabama Breast Cancer Project) reports the ten-year surgical results of a prospective randomized trial comparing Halsted radical mastectomy (RM) with modified radical mastectomy (MRM) for ...breast cancer. We entered 311 patients in the study between 1975 and 1978. Patients with histologically positive axillary lymph nodes were randomized after operation to receive melphalan or intermittent intravenous cyclophosphamide, methotrexate, and fluorouracil for one year. After a median follow-up of ten years, there was no significant difference in the survival of the two groups (RM, 71%; MRM, 64%). Local recurrence after RM was significantly lower than after MRM. A subset of patients with more advanced cancers (T3 and T2 with clinically positive axillary nodes) experienced significantly better survival at ten years following RM compared with MRM (59% vs 38%, respectively). These results indicate that overall survival is similar for patients treated by either RM or MRM. However, there is subset of patients with more advanced cancers whose ultimate survival can be favorably influenced by RM.
Gehan's two-stage procedure is commonly used in phase II clinical trials to enable one to stop a trial early if the observed response rate in the first stage does not warrant further study and to ...obtain an adequate estimate of response rate if the trial passes the first stage. However, when the response rate of interest is relatively high (0.3 or more), Gehan's procedure can be inefficient since the trial may hardly be halted even though the actual response rate is low. In this paper, we extend Gehan's two-stage procedure to a more efficient multiple-stage procedure, which allows early termination of a phase II trial at multiple stages and provides precise estimate of the response rate if the trial reaches the final stage. The proposed multiple-stage procedure is suitable for phase II clinical trials that have high response rate objectives.
This retrospective study analyzes 580 term and near-term singleton pregnancies complicated by breech presentation from 1976 through 1982. Vaginal delivery was achieved in 174 patients (30%), 135 of ...which were selectively allowed a trial of labor. Six infant deaths occurred (1%); all were neonatal deaths directly related to lethal congenital anomalies, for a corrected neonatal mortality rate of 0%. No significant difference was found in the incidence of low Apgar scores, traumatic birth injury, or requirement for neonatal resuscitation between those infants delivered by cesarean section and those delivered vaginally. Although no maternal deaths occurred, cesarean section was associated with a 38-fold increase in significant maternal morbidity. These data suggest that with careful patient selection and fetal monitoring, vaginal delivery of the term or near-term breech infant remains a real alternative to routine cesarean delivery of all breech infants. A selection and management protocol is proposed.
Between October, 1969, and August, 1981, 125 pelvic exenterations were performed by gynecologic oncologists at the University of Alabama in Birmingham. One hundred twenty patients underwent an ...exenterative procedure that required urinary diversion and a gastrointestinal anastomosis. Gastrointestinal complications accounted for 60% of all nonmalignant indications for reoperation after exenteration. The common factor in the majority of gastrointestinal complications was the presence of an anastomosis in previously irradiated small bowel. Other preoperative factors, such as significant medical disease, previous laparotomy, or malnutrition, had little apparent effect on the rate of gastrointestinal complications. Avoidance of a small bowel anastomosis by means of a colon conduit, use of an omental pedicle to bring new blood supply into the pelvis, and hyperalimentation have reduced the risk of small bowel obstruction and fistula to 2.2%, while alteration in surgical technique has decreased the rectovaginal fistula rate to 5.3%.
