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Biomedical subjects

E Surwit

Publications and source records attributed to E Surwit.

9 recordsLinked to original sources
PubMed1994

Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial.

BACKGROUND: Retinoids enhance differentiation of most epithelial tissues. Epidemiologic studies have shown an inverse relationship between dietary intake or serum levels of vitamin A and the development of cervical dysplasia and/or cervical cancer. Pilot and phase I investigations demonstrated the feasibility of the local delivery of all-trans-retinoic acid (RA) to the cervix using a collagen sponge insert and cervical cap. A phase II trial produced a clinical complete response rate of 50%. PURPOSE: This randomized phase III trial was designed to determine whether topically applied RA reversed moderate cervical intraepithelial neoplasia (CIN) II or severe CIN. METHODS: Analyses were based on 301 women with CIN (moderate dysplasia, 151 women; severe dysplasia, 150 women), evaluated by serial colposcopy, Papanicolaou cytology, and cervical biopsy. Cervical caps with sponges containing either 1.0 mL of 0.372% beta-trans-RA or a placebo were inserted daily for 4 days when women entered the trial, and for 2 days at months 3 and 6. Patients receiving treatment and those receiving placebo were similar with respect to age, ethnicity, birth-control methods, histologic features of the endocervical biopsy specimen and koilocytotic atypia, and percentage of involvement of the cervix at study. Treatment effects were compared using Fisher's exact test and logistic regression methods. Side effects were recorded, and differences were compared using Fisher's exact test. RESULTS: RA increased the complete histologic regression rate of CIN II from 27% in the placebo group to 43% in the retinoic acid treatment group (P = .041). No treatment difference between the two arms was evident in the severe dysplasia group. More vaginal and vulvar side effects were seen in the patients receiving RA, but these effects were mild and reversible. CONCLUSIONS: A short course of locally applied RA can reverse CIN II, but not more advanced dysplasia, with acceptable local side effects. IMPLICATIONS: A derivative of vitamin A can reverse or suppress an epithelial preneoplasia, lending further support to the notion that chemoprevention of human cancer is feasible.

Administration, Intravaginal↗
PubMed1994

Comparative exposure ratios: a non-parametric, multifactor technique for case-control studies.

The odds ratio in a two-by-two table is widely used in case-control studies to measure association between disease and a binary risk factor. In this article we propose a more general measure of association, the comparative exposure ratio (CER), which is the ratio of the number of case-control pairs where the case has greater exposure divided by the number where the control has greater exposure. In simple cases, the CER is an odds ratio or a weighted combination of odds ratios. In more general cases, a CER continues to measure association even when an odds ratio computation is not feasible. Moreover, CERs improve on odds ratios in several ways: they do not require binary risk factors, or a choice of the scale of measurement of continuous risk factors; they make it possible to investigate multiple risk factors simultaneously, without multivariate parametric assumptions; they also can be used to detect patterns that might indicate possible causal pathways. We illustrate how various choices of the definition of 'greater exposure' make the CER a powerful and flexible tool. We give expressions for confidence intervals for CERs, and verify in a pilot simulation that they are valid. Finally, we illustrate with a case-control study of cervical dysplasia how exploratory inference using CERs can be carried out.

Case-Control Studies↗
PubMed1994

Phase II trial of amonafide in patients with advanced metastatic or recurrent endometrial adenocarcinoma. A Southwest Oncology Group study.

Amonafide, a benzisoquinoline-1,3-dione was administered to 38 patients with recurrent or metastatic, bidimensionally measurable endometrial cancer. There were 34 patients with no prior cytotoxic chemotherapy, performance status of 0-2, and normal bone marrow, renal, and hepatic function were eligible for response and toxicity evaluation. Amonafide, 300 mg/m2, was administered intravenously over 1 hour daily for 5 consecutive days. Courses were repeated every 21 days. The major grade 3 or 4 toxicities were hematologic with granulocytopenia in 18 patients (53%), thrombocytopenia in 6 patients (18%), and anemia in 8 patients (24%). Infectious complications occurred in 3 patients (9%). Other side effects included cardiac dysrhythmias, hypotension, pain and phlebitis at the site of injection, nausea, vomiting, and flu-like symptoms. The overall objective response rate was 6% (95% confidence interval of 1-20%); 2 patients had a complete response (6%), 9 patients had stable disease (26%) and 21 patients had progressive disease (62%). Two patients had insufficient follow-up for response determination and are assumed to be nonresponders. The median survival of the eligible patients was 8 months. With the toxicity observed and the low response rate, amonafide at this dose and schedule has no efficacy in the treatment of endometrial cancer.

Adenine↗
PubMed1993

Results of a Southwest Oncology Group phase III trial of carboplatin plus cyclophosphamide versus cisplatin plus cyclophosphamide in advanced ovarian cancer.

Cisplatin combined with cyclophosphamide has been considered a very active treatment for advanced ovarian cancer. Unfortunately, cisplatin is associated with dose-limiting neurotoxicity, as well as possible neuropathy, ototoxicity, and occasional renal dysfunction. Carboplatin, a cisplatin analogue, is active against advanced ovarian cancer, with a presumed lower incidence of emesis, ototoxicity, neuropathy, and renal dysfunction. The Southwest Oncology Group initiated a phase III randomized trial, in which 342 patients with stage III (suboptimal disease) and stage IV ovarian cancer were randomly assigned to treatment with six courses of intravenous cisplatin 100 mg/m2 plus cyclophosphamide 600 mg/m2 or carboplatin 300 mg/m2 plus cyclophosphamide 600 mg/m2. The median survival for the cisplatin arm was 17.4 months; for the carboplatin arm, median survival was 20.0 months. The null hypothesis of a 30% survival superiority with the cisplatin arm was rejected at the p = 0.02 level. Clinical response rates were 52% for the cisplatin arm and 61% for the carboplatin arm. There was less thrombocytopenia in the cisplatin arm (p < 0.001); however, there was less nausea and emesis (p < 0.001 for courses one to five), renal toxicity (p < 0.001), anemia (p < 0.001), hearing loss (p < 0.001), and neuromuscular toxicity (p < 0.001) in the carboplatin arm. Carboplatin/cyclophosphamide proved to have a significantly better therapeutic index than cisplatin/cyclophosphamide in these patients with advanced ovarian cancer.

Adult↗
PubMed1985

Phase I trial of carboplatin-cyclophosphamide and iproplatin-cyclophosphamide in advanced ovarian cancer: a Southwest Oncology Group study.

The Southwest Oncology Group has carried out a phase I clinical trial of carboplatin plus cyclophosphamide and iproplatin plus cyclophosphamide in 20 patients with stages III and IV ovarian cancer prior to initiating a phase III trial to compare these platinum analog-cyclophosphamide combinations with standard cisplatin-cyclophosphamide therapy. Myelosuppression proved the dose-limiting toxicity of both the carboplatin (300 mg/m2) plus cyclophosphamide (600 mg/m2) and iproplatin (180 mg/m2) plus cyclophosphamide (600 mg/m2) regimens. Evaluating up to six courses of therapy (repeated at 4-week intervals), the median nadir WBC and platelet counts associated with carboplatin-cyclophosphamide therapy were 1800 (range, 900-4000) and 69 000 per microliter, respectively, and those associated with iproplatin-cyclophosphamide therapy were 1400 (1100-1600) and 140 000 per microliter, respectively. Although the starting doses of carboplatin and iproplatin required a median decrease of 25%, the median doses of each administered through six courses of therapy were 300 and 180 mg/m2, respectively. Neither nephrotoxicity nor neuropathy were experienced by the patients, but mild to moderate nausea and vomiting occurred in more than 75% of those treated with either drug combination. Alopecia of mild to severe degree was observed in 40% of patients. Although the results of this phase I trial are still preliminary, we can recommend for future phase III trials 300 mg/m2 carboplatin and 180 mg/m2 iproplatin when combined with 600 mg/m2 cyclophosphamide repeated a 4-week intervals for six treatment courses.

Adult↗
PubMed1983

Treatment of locally advanced cancer of the cervix with transperineal interstitial irradiation. Report on 106 cases.

The survival of patients with locally advanced cancer of the cervix (stage IIB, IIIB, and IVA) treated with conventional intracavitary radium remains unsatisfactory. Over 50% of these patients are local failures and die with uncontrolled tumor in the pelvis. In 1978, we began performing transperineal interstitial implants to the parametria in patients with advanced disease. One hundred six evaluable patients (34 IIB, 67 IIIB, and five IVA) received one (99) or two interstitial implants (7) following 40-50 Gy of external supervoltage external irradiation. In addition, seven patients underwent exploratory staging laparotomies concurrently with the first implant procedure. Mean follow-up is 23 months and range is 12-60 months. Control of the pelvic tumor has been documented in 85%, 75%, and 40% of stage IIB, IIIB and IVA patients, respectively. Seven patients developed distant metastases and three died of intercurrent disease with no evidence of pelvic relapse. Nineteen patients (18%) developed radiation-related complications: proctitis or cystitis (six), rectal stenosis (six), ulceration and necrosis of the vaginal wall (one), and recto- or vesicovaginal fistula (six). It is noteworthy that 7/11 patients (64%) who had radioactive sources placed on the surface of the vaginal obturator as a substitute for an intrauterine tandem developed severe complications. We conclude that transperineal interstitial irradiation is both safe and an effective modality in the treatment of advanced cancer of the cervix.

Brachytherapy↗
PubMed1976

Radical hysterectomy with or without preoperative radium for stage IB squamous cell carcinoma of the cervix.

A retrospective study of 119 patients ranging from 30 to 69 years of age was undertaken to evaluate the effectiveness of preoperative radium treatment for patients with Stage IB (FIGO 1971) squamous cell carcinoma of the cervix undergoing radical hysterectomy. Results in 61 patients who had radical hysterectomy without preoperative radium treatment were compared to those in 58 patients who had received radium preoperatively. The patients receiving radium systems had an uncorrected 5-year survival rate of 89.7%, while the patients without preoperative radium treatment had a 75.1% 5-year rate of survival. This difference in survival rate was judged to be secondary to the greater incidence of lymphatic invasion and residual tumor in the surgical specimens of the patients who did not receive preoperative radium. The occurrence of significant gastrointestinal and urinary tract complications was identical in the 2 groups.

Adult↗