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Biomedical subjects

J T Soper

Publications and source records attributed to J T Soper.

At least 37 records · Page 2Linked to original sources
PubMed1995

Postsurgical surveillance of patients with FIGO stage I/II endometrial adenocarcinoma.

OBJECTIVE: To examine the effect of postsurgical surveillance on survival of patients with FIGO stage I/II endometrial adenocarcinoma. METHODS: We examined the records of 354 patients who underwent primary surgical therapy for FIGO stage I/II endometrial adenocarcinoma. In patients who developed recurrent disease, we determined whether symptoms or signs of disease were present at recurrence and whether there was evidence of disease on Pap smear or chest radiograph. RESULTS: Among the 354 patients in this study, 44 (12%) developed recurrent disease. Sites of recurrence included 12 (27%) isolated vaginal, 12 (27%) pelvic with vagina or abdomen, 4 (10%) isolated lung, 13 (29%) pelvic/abdominal with other distant sites, and 3 (7%) other distant sites. At diagnosis of recurrence 61% of patients had symptoms related to their cancer, 68% had physical exam findings suggestive of recurrence, and 84% had symptoms and/or signs. Findings consistent with recurrent cancer were detected by Pap smear in 25% and on chest radiograph in 20%. Among the 44 patients who developed recurrent disease, 8 (18%) remain alive without evidence of disease, including 6/12 (50%) with isolated vaginal disease and 2/34 (6%) with other patterns of recurrent disease (P = 0.01). Among the 12 patients with isolated vaginal recurrence, 1/3 (33%) in whom recurrent disease was diagnosed by Pap smear alone was salvaged compared to 5/9 (56%) who had symptoms or signs of vaginal recurrence. None of the three patients in whom an abnormal chest radiograph was the only evidence of recurrence survived. CONCLUSIONS: Because of the low recurrence rate of FIGO stage I/II endometrial cancer and the paucity of effective second-line treatment, surveillance Pap smears and chest radiographs appear to have little impact on survival. Although few asymptomatic potentially curable recurrences were detected due to surveillance examinations, the value of psychological reassurance associated with a normal examination is difficult to quantitate.

Adenocarcinoma↗
PubMed1995

Combinations of multiple serum markers are superior to individual assays for discriminating malignant from benign pelvic masses.

To determine whether measurement of the levels of multiple tumor markers in the preoperative serum of women presenting with a pelvic mass distinguished benign from malignant disease better than the assay of CA 125 alone, sera from 429 patients, 192 of whom had malignant histology, were assayed for 8 different markers: CA 125, macrophage colony-stimulating factor, OVX1, lipid-associated sialic acid (LASA), CA15-3, CA72-4, CA19-9, and CA54/61. The sensitivity and specificity of CA 125 alone (> 35 U/ml) was 78.1 and 76.8%, respectively. A panel consisting of CA 125, OVX1, LASA, CA15-3, and CA72-4 had a sensitivity of 83.3% and specificity of 84.0% when two or more markers were elevated. Using the concentrations of these five markers, logistic regression analysis had a sensitivity of 85.4% and a specificity of 83.1%. Considering the values of markers in different sequences, classification and regression tree analysis substantially improved the sensitivity to 90.6% and the specificity to 93.2%. When applied in clinical practice this approach could improve the management of women presenting with a pelvic mass and may also have application in screening for ovarian cancer.

Biomarkers, Tumor↗
PubMed1995

Relationship between race and interval to treatment in endometrial cancer.

OBJECTIVE: To determine whether the poor prognosis of black women with endometrial adenocarcinoma is due to racial differences in the interval between the onset of abnormal uterine bleeding and hysterectomy. METHODS: Clinical records of all 219 patients (176 white, 39 black, four other) who underwent surgical treatment of endometrial cancer during 1990-1993 at our institution were reviewed to obtain information regarding clinicopathologic features. In addition, the interval between the onset of abnormal uterine bleeding and hysterectomy was noted. RESULTS: Compared with white patients, black women with endometrial cancer had a significantly higher incidence of unfavorable features, including non-endometrioid histology (38 versus 12%), stage III or IV disease (51 versus 19%), grade 3 differentiation (49 versus 18%), and poor survival (P = .003). There was no significant difference in the median interval from onset of abnormal uterine bleeding to hysterectomy between blacks (11.1 weeks) and whites (13.7 weeks), nor was the interval to treatment related to stage, grade, histologic type, myometrial invasion, or survival. In contrast, patients with a history of hormone use had a longer median interval from the onset of abnormal bleeding to treatment compared with patients who had not used hormones (19 versus 10 weeks) (P < .01), and hormone use was associated with favorable clinicopathologic features and survival. Although black women were less likely to have used hormones than white women (13 versus 44%) (P < .001), racial differences in stage, grade, and survival persisted after correcting for hormone use. CONCLUSION: This study confirms that black women with endometrial cancer have a poorer outcome than white women; however, this does not appear to be due to a difference in the interval from onset of abnormal uterine bleeding to hysterectomy.

Adenocarcinoma↗
PubMed1995

Cervical carcinoma: determination of recurrent tumor extent versus radiation changes with MR imaging.

PURPOSE: To evaluate the effectiveness of magnetic resonance (MR) imaging for assessment of the present and extent of tumor recurrence as determined with pathologic and surgical findings. MATERIALS AND METHODS: MR findings were retrospectively examined in 37 patients with a history of cervical carcinoma. Inter- and intraobserver variability was analyzed. Surgical or pathologic results were acquired in 34 of these patients; the remaining three patients were clinically followed up for at least 4 years. RESULTS: MR imaging allowed correct detection of recurrent tumor in 18 of 21 patients who had histologically documented recurrence. It helped correctly exclude recurrent disease in 15 of 16 patients. Sensitivity and specificity for detection of recurrence was 86% and 94%, respectively. Good intra- and interobserver agreement was demonstrated. CONCLUSION: MR imaging is a useful modality for differentiation of recurrent cervical carcinoma from radiation changes. Determination of the extent of recurrence with MR imaging may offer clinical assistance in the selection of optimal therapy.

Adenocarcinoma↗
PubMed1995

Anaphylactoid reactions with intraperitoneal cisplatin.

OBJECTIVE: To report the occurrence of anaphylactoid reactions to intraperitoneal cisplatin in 3 patients. CASE SUMMARIES: While conducting a protocol evaluating the efficacy of intraperitoneal cisplatin and hyperthermia in the treatment of recurrent ovarian cancer, 3 patients were noted to exhibit anaphylactoid reactions. A 43-year-old woman received cisplatin 60 mg/m2 in 15 minutes during her sixth cycle of therapy. She developed pruritus, edema, and urticaria over both hands. The reaction subsided after treatment with diphenhydramine and dexamethasone. A 57-year-old woman received 400 mL (62.4 mg) of a cisplatin solution concentrated to deliver cisplatin 100 mg/m2 during her first attempted therapy. At this point, she developed whole body urticaria and pruritus with edema of the extremities. The reaction was aborted with diphenhydramine and dexamethasone. Despite premedication with dexamethasone prior to a second attempt at therapy, she again experienced similar symptoms after receiving 500 mL (78 mg) of cisplatin solution. A 55-year-old woman received 2 cycles of therapy with cisplatin 100 mg/m2 without difficulty. During her third cycle, she again received cisplatin 100 mg/m2 over 30 minutes and developed palmar pruritus, urticaria, and edema. Symptomatology resolved with diphenhydramine. Despite premedication with diphenhydramine and dexamethasone, she experienced generalized pruritus and urticaria, as well as headache and chest pain/tightness, after her next infusion. For both the second and third patients, symptomatology failed to resolve until the intraperitoneal cisplatin solution was withdrawn. DISCUSSION: Anaphylactoid reactions have been described previously with cisplatin administration. No dose-rate effect has been reported, however. We observed 5 reactions in 3 patients that appear to be related to a high dose-infusion time ratio, indicating that dose and rate of infusion may be important factors in precipitating anaphylactoid reactions with cisplatin. CONCLUSIONS: We conclude that a high dose combined with a short infusion time increases the risk of anaphylactoid reactions with the administration of intraperitoneal cisplatin. There was no indication that the increase in anaphylactoid reactions was associated with the use of hyperthermia.

Adult↗
PubMed1994

Multivariable analysis of DNA ploidy, p53, and HER-2/neu as prognostic factors in endometrial cancer.

BACKGROUND: Several molecular-genetic alterations in endometrial cancers, including aneuploidy and aberrant expression of p53 and HER-2/neu, have been associated with poor prognosis. To determine the importance of molecular-genetic factors relative to more traditional surgical-pathologic prognostic factors, a multivariable analysis was performed. METHODS: Immunohistochemical staining for p53, HER-2/neu, estrogen receptor, progesterone receptor, and epidermal growth factor receptor was performed on frozen sections from 100 primary endometrial cancers. DNA ploidy was determined using computerized image analysis of Feulgen-stained touch preparations. In addition, information regarding surgical-pathologic features of the cancers was obtained. Univariable analysis was performed followed by multivariable analysis using Cox's proportional hazards model to identify variables predictive of poor prognosis. RESULTS: With univariable analysis, race, histologic type, stage, grade, myometrial invasion, estrogen receptor, progesterone receptor, ploidy, p53 and HER-2/neu were predictive of the presence of persistent or recurrent disease. In the multivariable analysis, only International Federation of Gynecology and Obstetrics stage (P = 0.005), grade (P = 0.005), myometrial invasion (P = 0.024), and ploidy (P = 0.028) were significant. CONCLUSIONS: Among molecular-genetic prognostic factors, DNA ploidy was the most strongly predictive of persistent or recurrent disease.

Aged↗
PubMed1994

OVX1 as a marker for early stage endometrial carcinoma.

BACKGROUND: Endometrial carcinoma is generally diagnosed only after the onset of postmenopausal bleeding. Although most patients with Stage I disease can be cured, the prognosis worsens significantly when the tumor is no longer confined to the uterine corpus. Serum CA 125 is elevated in only 10-20% cases of Stage I and II endometrial carcinoma. A serum tumor marker that can detect early stage endometrial cancer might aid in management of the disease. METHODS: An OVX1 double-determinant radioimmunoassay was used to detect an epitope on a high-molecular-weight mucinlike glycoprotein found in the sera of 45 patients with endometrial cancer. RESULTS: Apparently healthy persons had serum OVX1 antigen levels of 2.23 plus or minus 2.48 U/ml (mean +/- standard deviation). Elevated levels of OVX1 antigen (> 7.2 U/ml) were found in 5% of 184 healthy persons and in 64% of 45 patients with endometrial cancer. OVX1 antigen was elevated in 64% of 36 patients with Stage I, 50% of 2 patients with Stage II, 60% of 5 patients with Stage III, and each of 2 patients with Stage IV endometrial cancer, but only 8.6% of 58 patients with endometriosis. Elevation of serum OVX1 was found more frequently in patients with deep myometrial invasion and with poorly differentiated tumors (P < 0.01). CONCLUSIONS: The OVX1 antigen deserves further evaluation as a marker for early detection of endometrial cancers and as a prognostic factor for women with apparent early stage disease.

Antigens, Neoplasm↗
PubMed1994

Overexpression of p53 is not a feature of benign and early-stage borderline epithelial ovarian tumors.

Since overexpression of mutant p53 protein is a common feature of invasive epithelial ovarian cancers, we investigated whether overexpression of the p53 tumor suppressor gene product occurs in benign and borderline epithelial ovarian tumors. Immunohistochemical staining for p53 was performed in frozen samples of 17 benign tumors and in 49 borderline tumors (4 frozen, 45 paraffin embedded). Overexpression of p53 was observed in 0/17 (0%) benign ovarian tumors and 2/49 (4%) borderline tumors. Overexpression of p53 in borderline tumors was only seen in advanced stage cases; overexpression was seen in 2/8 (25%) stage III cases, but not in any of 41 stage I/II cases. In conclusion, overexpression of p53 is not a feature of benign epithelial ovarian tumors or early-stage borderline ovarian tumors. Similar to invasive epithelial ovarian cancers, however, a fraction of metastatic borderline tumors also overexpress p53.

Adult↗
PubMed1994

5-day methotrexate for women with metastatic gestational trophoblastic disease.

The objective of this study was to analyze the toxicity and the efficacy of single-agent 5-day methotrexate for women with metastatic gestational trophoblastic disease. The study is a retrospective analysis of 52 patients who received repetitive 5-day cycles of intramuscular methotrexate as primary therapy for metastatic trophoblastic disease between 1975 and 1990. The majority of patients were low-risk by both clinical and World Health Organization prognostic index score criteria. Sixty percent achieved primary remission with a median of 3 cycles of single-agent methotrexate. Therapy was changed because of toxicity and drug-resistance by hCG criteria in 11 (21%) and 10 (19%) patients, respectively. Pretherapy hCG > 10,000 mIU/ml was associated with the development of drug-resistance. Remission was achieved in all patients, with only 2 (4%) requiring multiagent therapy. The use of repetitive 5-day cycles of methotrexate is efficacious therapy of low-risk metastatic trophoblastic disease. Future studies are needed to define a cost-effective and minimally toxic therapy that retains a high primary remission rate in these patients.

Analysis of Variance↗
PubMed1994

A Gynecologic Oncology Group phase II study of amonafide (NSC #308847) in squamous cell carcinoma of the cervix.

Twenty evaluable patients with squamous cell carcinoma of the cervix, who had previously received a cisplatin-containing regimen, were treated with amonafide 300 mg/m2 over 1 hour for 5 consecutive days every 3 weeks. One partial response (5%) was seen. Hematologic toxicity was substantial with severe or life-threatening events occurring as follows: leukopenia, 5 patients (25%); thrombocytopenia, 4 patients (20%); granulocytopenia, 2 patients (10%). One patient experienced acute bilateral open-angle glaucoma immediately after treatment, and another developed gastric ulceration with life-threatening gastrointestinal bleeding. In view of the low response rate and high toxicity, amonafide does not warrant further investigation as second-line chemotherapy in squamous cell carcinoma of the cervix.

Adenine↗
PubMed1994

Management of early-stage epithelial ovarian cancer.

"Early" epithelial ovarian carcinoma encompasses a spectrum of patients with diseases that have markedly different survivals, ranging from indolent lesions truly confined to the ovary to high-grade lesions that have a significant chance of occult metastasis at the time of diagnosis. The basic principles of management rest on an adequate primary surgical procedure that removes all gross disease and accurately assesses the sites at risk for metastasis with a comprehensive staging laparotomy. After a comprehensive staging laparotomy, patients can be stratified into low-risk and high-risk groups. Those with low-risk disease have such a low risk of recurrence that the toxicity of adjuvant therapy is not warranted. Although patients with high-risk disease have a high enough of a risk of recurrence to justify consideration of adjuvant therapy, their ultimate prognosis may be determined more by an accurate determination of the stage of disease rather than by currently available, marginally effective or ineffective therapy. Patients who are thought to have early stage disease on the basis of inadequate staging procedures either should undergo a restaging laparotomy or receive therapy for the possibility of occult advanced disease.

Carcinoma↗
PubMed1994

Serum progesterone for the exclusion of early pregnancy in women at risk for recurrent gestational trophoblastic neoplasia.

OBJECTIVE: To evaluate the utility of the serum progesterone level for discriminating pregnancy from gestational trophoblastic neoplasia. METHODS: Serum progesterone levels were measured in 61 women with histories of trophoblastic disease who developed a re-elevation in hCG during surveillance and underwent a work-up to differentiate pregnancy from gestational trophoblastic neoplasia. Progesterone levels were analyzed in the context of diagnostic outcome (pregnancy versus gestational trophoblastic neoplasia) to identify optimal threshold levels of progesterone to be used for classifying outcome. RESULTS: Of the 61 women, 37 proved to be pregnant and 24 had gestational trophoblastic neoplasia. Progesterone less than 2.5 ng/mL was predictive of trophoblastic malignancy, with a sensitivity of 83% (20 of 24 subjects were classified correctly as having gestational trophoblastic neoplasia) and a specificity of 95% (35 of 37 patients with progesterone levels at or above 2.5 ng/mL were correctly classified as pregnant). Progesterone of at least 10 ng/mL was associated with viable pregnancy in 97% of the cases. Furthermore, the progesterone level predicted outcome regardless of the serum hCG value. CONCLUSION: The serum progesterone level is useful for discriminating early pregnancy from gestational trophoblastic neoplasia.

Adolescent↗
PubMed1994

Evaluation of prognostic factors and staging in gestational trophoblastic tumor.

OBJECTIVE: To evaluate factors influencing survival and compare current classification systems in women treated for malignant gestational trophoblastic tumor. METHODS: A consecutive series of 454 women treated between 1968-1992 was reviewed retrospectively to identify potential clinical prognostic factors using univariate analysis of life tables. All patients were evaluated using clinical classification, World Health Organization, and recently modified International Federation of Gynecology and Obstetrics (FIGO) staging systems, applied retrospectively. Multivariate Cox regression analysis was used to model potential independent prognostic factors within subsets of the patient population. RESULTS: Factors identified by univariate analysis as potential prognostic influences included age, duration of disease, type of antecedent pregnancy, clinicopathologic diagnosis, site of metastases, number of metastatic sites and foci, tumor size, and prior therapy. The pre-therapy hCG level was not significantly associated with survival (P < .04). Multivariate Cox modeling consistently identified prior therapy, type of antecedent pregnancy, number of metastatic sites, and duration of disease as independent prognostic factors. Clinicopathologic diagnosis and hCG level were of borderline significance only in some models of the total patient population. All classification systems were able to identify low- and high-risk subsets of patients with approximately equal efficiency. The addition of FIGO substages enhanced discrimination between prognostic groups in patients with stage III disease. CONCLUSIONS: Existing systems for the classification of malignant gestational trophoblastic tumor are based in part on factors that are not independently prognostic, such as hCG level or tumor size. These systems discriminate between low- and high-risk patients with approximately equal efficiency. The clinical classification system is currently preferred for determining initial therapy in women with malignant gestational trophoblastic tumors.

Chorionic Gonadotropin↗
PubMed1994

Surgical therapy for gestational trophoblastic disease.

Current successful therapy for women with gestational trophoblastic disease (GTD) is based upon the use of sensitive assays for human chorionic gonadotropin to monitor disease status and individualized application of chemotherapy based upon recognized risk factors. However, surgical therapy continues to play a role in the management of GTD. Suction dilation and curettage and hysterectomy are used for primary therapy for hydatidiform mole. Hysterectomy may be used as an adjunct to the primary management of selected patients with malignant GTD. Other extirpative procedures, such as thoracotomy, may be integrated into the management of drug-resistant disease.

Antineoplastic Agents↗
PubMed1994

Preoperative coagulation testing on a gynecologic oncology service.

OBJECTIVE: To determine the prevalence and clinical significance of abnormalities of preoperative coagulation tests in gynecologic oncology patients. METHODS: Three hundred fifty-one patients presenting for inpatient surgical procedures on the gynecologic oncology service at Duke University Medical Center from January 1, 1990 to December 31, 1990, underwent preoperative coagulation testing. Twenty-nine patients had only prothrombin time (PT) and partial thromboplastin time (PTT) measured; the remaining 322 had preoperative measurement of PT, PTT, fibrinogen, and fragment D-dimer. Outcomes assessed were perioperative hemorrhage resulting in death or reoperation, postoperative hematomas, and need for intraoperative and postoperative transfusion. RESULTS: Twelve of 351 patients (3.4%) had abnormally elevated PT or PTT; six of these were attributable to risk factors unrelated to malignancy. One hundred fifty-six of 322 subjects (48.4%) had abnormal levels of fibrinogen, mostly elevations above 360 mg/dL, and 88 of 322 subjects (27.3%) had positive tests for D-dimer. Fifty-seven (17.7%) had both elevated fibrinogen and positive D-dimer. One hundred eighty-eight of 322 subjects had at least one abnormal test result. There were no perioperative deaths or reexplorations because of hemorrhage. There was one postoperative hematoma. The combination of an elevated fibrinogen and a positive D-dimer test was a significant predictor of perioperative transfusion in a logistic regression model incorporating stage, preoperative hematocrit, and age (odds ratio 1.96, 95% confidence interval 1.03-3.76). However, the attributable risk associated with this abnormality was only 7.7% in patients at highest risk of transfusion. CONCLUSION: Although abnormalities in coagulation are common in patients undergoing surgery for gynecologic malignancy, preoperative testing for occult coagulopathy provides little clinically useful information.

Adult↗
PubMed1994

The negative prognostic implications of thrombocytosis in women with stage IB cervical cancer.

OBJECTIVE: To determine the association between pretreatment platelet count and survival in women with stage IB cervical cancer. METHODS: Clinical records were reviewed for 219 women with stage IB cervical cancer treated by radical hysterectomy from 1971-1984. Univariate and multivariate analyses were performed to identify clinicopathologic variables associated with poor survival. Survival as a function of the preoperative platelet count was analyzed further and corrected for known prognostic factors. RESULTS: The cumulative 5-year survival of women with a preoperative platelet count greater than 300,000/microL (n = 85) was 65%, as compared to 84% for a count equal to or less than 300,000/microL (n = 134) (P = .004). Univariate Cox regression analysis revealed non-white race, large lesion size (greater than 4 cm), platelet count greater than 300,000/microL, and the presence of nodal metastases to be factors related to poor prognosis. A comparison of patients with platelet counts of 300,000/microL or less and patients with platelet counts greater than 300,000/microL revealed no difference with regard to race, nodal metastases, and median age. However, a larger percentage of women with a platelet count greater than 300,000/microL had large lesion size (29 of 60, versus 32 of 114 with a count of 300,000/microL or less). In a multivariate analysis, after adjusting for age, race, the presence of nodal metastases, and lesion size, high platelet count was still associated with poor prognosis (P = .04). CONCLUSION: An elevated platelet count is an independent prognostic factor for poor survival in patients with early-stage cervical cancer.

Adult↗
PubMed1994

Alternating weekly chemotherapy with etoposide-methotrexate-dactinomycin/cyclophosphamide-vincristine for high-risk gestational trophoblastic disease.

OBJECTIVE: To evaluate the response rate and toxicity of alternating weekly therapy with etoposide-methotrexate-dactinomycin/cyclophosphamide-vincristine for women with high-risk gestational trophoblastic disease. METHODS: Twenty-two women with gestational trophoblastic disease received 126 cycles of the study regimen. Response was evaluated by serial hCG monitoring. Toxicity was assessed using standard criteria. RESULTS: Six women (27%) were treated for primary therapy and 16 (73%) for secondary therapy. The median prognostic index score was 11 (range 7-19). Only 23% of the patients and 11% of the 126 treatment cycles had grade 4 neutropenia, despite the heavily pretreated patient population. Only 2% of the cycles were associated with neutropenic sepsis or required platelet transfusions. Nonhematologic toxicity was modest. Among 16 women who received chemotherapy alone, there were 11 (69%) complete and three (19%) partial responses. When adjuvant therapies are included, the overall complete and partial response rates were 77 and 14%, respectively. Six (35%) of 17 complete responders developed recurrences. Five patients with partial response or relapse were salvaged with additional therapy. Fifteen of the 22 patients (68%) have sustained remissions. CONCLUSION: The regimen of alternating weekly etoposide-methotrexate-dactinomycin/cyclophosphamide-vincristine is effective and well-tolerated chemotherapy for patients with high-risk gestational trophoblastic disease.

Antineoplastic Combined Chemotherapy Protocols↗