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Biomedical subjects

B N Bundy

Publications and source records attributed to B N Bundy.

50 records · Page 3Linked to original sources
PubMed1987

Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study.

The surgical pathologic features of 621 patients with Stage I carcinoma of the endometrium are presented. All patients were treated with primary surgery consisting of total abdominal hysterectomy, bilateral salpingo-oophorectomy, selective pelvic and paraaortic lymphadenectomy and peritoneal cytology. An appreciable number of patients (144-22%) with Stage I cancers have disease outside of the uterus (lymph node metastasis, adnexal disease, intraperitoneal spread and/or malignant cells in peritoneal washings). Multiple prognostic factors particularly grade and depth of invasion are related to extrauterine disease. This study adds credence to the primary surgical approach with individualized postoperative therapy as indicated.

Female↗
PubMed1987

Mitoxantrone in the treatment of advanced non-squamous carcinoma of the cervix (a phase II trial of the gynecologic oncology group).

Twenty-five evaluable patients with advanced non-squamous carcinoma of the uterine cervix were treated with mitoxantrone 12 mg/m2 every three weeks. All patients had good performance status and measurable disease and only 11 had received prior chemotherapy. One complete and one partial response were noted among 15 patients with no prior chemotherapy while no responses were seen in 11 previously treated patients. The major toxicity was myelosuppression; other toxicity was mild. The median progression-free interval was 2.1 months and median survival 4.3 months. Mitoxantrone displays minimal activity in patients with advanced non-squamous carcinoma of the cervix.

Adenocarcinoma↗
PubMed1987

Positive groin lymph nodes in superficial squamous cell vulvar cancer. A Gynecologic Oncology Group Study.

The term microinvasive carcinoma is inappropriate when applied to all vulvar cancers less than or equal to 5 mm thick because approximately 50% of vulvar carcinomas are no thicker than 5 mm and 20% of those superficial tumors metastasize to the lymph nodes. The significant predictors of groin node metastases in patients with superficial vulvar cancer are tumor thickness, histologic grade (proportion of undifferentiated tumor pattern), capillary-like space involvement with the tumor, clitoral or perineal location, and clinically suspicious nodes, according to the linear logistic model analysis of clinicopathologic data in 272 women. No lymph node metastases occurred in approximately one fourth of patients with a combination of low-risk factors: no clinically suspicious nodes, negative capillary-like space, and nonmidline vulvar cancers that were either grade 1 and 1 to 5 mm thick or grade 2 and 1 to 2 mm thick. In contrast, all 10 patients with clinically suspicious nodes and grade 4 tumors had positive groin nodes. The risk of lymph node metastases is best determined by simultaneous evaluation of all risk factors rather than a single factor such as tumor thickness.

Carcinoma, Squamous Cell↗
PubMed1987

Phase III study on the treatment of women with cervical cancer, stage IIB, IIIB, and IVA (confined to the pelvis and/or periaortic nodes), with radiotherapy alone versus radiotherapy plus immunotherapy with intravenous Corynebacterium parvum: a Gynecologic Oncology Group Study.

A report on a study conducted under the auspices of the Gynecologic Oncology Group on the treatment of women with advanced carcinoma of the uterine cervix (stages IIB, IIIB, IVA) with radiotherapy alone versus radiotherapy plus immunotherapy (intravenous Corynebacterium parvum) is presented. There were 283 patients considered evaluable for analysis. Of these, 135 patients were randomized to radiotherapy plus C. parvum (120 patients received at least one course) and 148 were randomized to radiotherapy only. The two treatment regimens were similar for those adverse effects commonly associated with radiation therapy but for hematologic toxicity and fever and/or chills were significantly more frequent among those patients who received C. parvum. There was no statistical difference in the treatment regimens with regard to survival or progression-free interval. Of the 42 patients with positive periaortic nodes, 19% were alive at 3 years. No therapeutic value was demonstrated by combining C. parvum therapy with traditional radiation therapy in advanced cervical cancer. Because of the greater frequency of adverse effects in those patients receiving C. parvum, the further use of C. parvum at this dose and schedule does not appear to be indicated for treating cervical cancer patients.

Adenocarcinoma↗
PubMed1987

Experience with the use of generalized data base management systems in cooperative group clinical trials (a project of the Gynecologic Oncology Group).

Roswell Park Management Information System (RPMIS) is a formatted video-based system of programs for file creation, data entry, editing, updating, retrieval, and report generation. It has been utilized in more than 800 intrainstitutional research studies at Roswell Park. The Gynecologic Oncology Group (GOG) is a multiinstitutional, multidisciplinary cooperative group. Its clinical trials encompass the planning, initiation, execution, analysis, and presentation of results of management and treatment of patients with gynecologic cancer. The GOG Statistical Office, located at Roswell Park Memorial Institute, is responsible for data management and analysis of all patients entered into GOG protocols. Present annual accrual is approximately 2000 patients per year; 38 protocols are actively accruing patients while follow-up continues on 14 studies that are closed to patient entry. A previous paper (J Med Syst 7:235-242, 1983) described a time study comparing use of RPMIS and a paper batch processing system in GOG data management. The time study results and potential advantages of RPMIS warranted a gradual total conversion to this system. Presently GOG maintains 43 separate, self-contained applications of RPMIS and routinely develops a new system in conjunction with each new study initiated. This paper documents GOG experience with RPMIS during the past 4 years.

Clinical Trials as Topic↗
PubMed1987

Biopsy of the scalene fat pad in carcinoma of the cervix uteri metastatic to the periaortic lymph nodes.

Fifty-five patients with squamous cell carcinoma of the cervix uteri metastatic to high common iliac or periaortic lymph nodes underwent biopsy of the left scalene fat pad as part of a prospective clinical trial. Patients without metastasis to the scalene nodes were subsequently treated with extended field radiation therapy and were then eligible for a randomized trial of systemic chemotherapy. Only four patients were found to have micrometastases to the scalene fossa. This figure is appreciably lower than that reported in previous literature. While geographic failure continues to be a problem for this group of patients, routine use of left scalene fat pad biopsy before treatment is not recommended.

Adipose Tissue↗
PubMed1986

Adriamycin chemotherapy for malignant mixed mesodermal tumor of the ovary. A Gynecologic Oncology Group Study.

Malignant mixed mesodermal tumor (MMMT) of the ovary is a rare, but usually fatal, cancer for which there exists no proven postsurgical therapy. The Gynecologic Oncology Group has evaluated adriamycin in this disease at a dose of 75/m2. Among 10 evaluable cases with measurable disease there was one partial response and no complete responses. Of 21 cases with nonmeasurable tumor four remain clinically free of cancer from 2 to 45 months. There were two treatment-related deaths. We conclude that adriamycin alone as first-line chemotherapy in patients with MMMT of the ovary is not sufficiently active to be clinically useful.

Doxorubicin↗
PubMed1986

Radiation therapy versus pelvic node resection for carcinoma of the vulva with positive groin nodes.

From 1977 to 1984, 114 eligible patients with invasive squamous cell carcinoma of the vulva and positive groin nodes after radical vulvectomy and bilateral groin lymphadenectomy were randomized to receive either radiation therapy or pelvic node resection. Fifty-three of the 59 patients randomized to radiation therapy received a 4500- to 5000-rad tumor dose in five to 6.5 weeks bilaterally to the groins and to the midplane of the pelvis even if only unilateral positive groin nodes had been detected; no radiation was given to the central vulvar area. Fifty-three of the 55 patients randomized to further surgery had pelvic node resection performed on the side containing positive groin nodes either unilaterally or bilaterally. Acute and chronic morbidity was similar for both regimens. The two major poor prognostic factors were clinically suspicious or fixed ulcerated groin nodes and two or more positive groin nodes. The difference in survival for the 114 evaluable patients was significant, favoring the adjunctive radiation therapy group (P = .03). The estimated two-year survival rates were 68% for the radiation therapy group and 54% for pelvic node resection group. The most dramatic survival advantage for radiation therapy was in patients who had either of the two major poor prognostic factors present; at this time, the benefit of radiation therapy for the remaining patients is uncertain. In this randomized prospective study, the addition of adjunctive groin and pelvic irradiation therapy after radical vulvectomy and inguinal lymphadenectomy proved superior to pelvic node resection.

Carcinoma, Squamous Cell↗
PubMed1983

GOG meets RPMIS. Experience with computerized data management in a cooperative group setting.

The Gynecologic Oncology Group (GOG) is a multiinstitutional, multidisciplinary cooperative group. Its clinical trials encompass the planning, initiation, execution, analysis, and presentation of results of management and treatment of patients with gynecologic cancer. The GOG Statistical Office, located at Roswell Park Memorial Institute, is responsible for data management and analysis of all patients entered into GOG protocols. Present annual accrual is approximately 1,600 patients; 37 protocols are active, while follow-up continues on 9 studies that are closed to patient entry. RPMIS is a formatted video-based system of programs for file creation, data entry, editing, updating, retrieval, and report generation. It has been utilized in more than 500 intrainstitutional research studies at Roswell Park. In the past, data management for the GOG had been based on computer entry via punched cards, and on hand-filled reports. The switch to RPMIS used required major reorganization of the data-handling process and was first attempted on a limited basis. As the advantages of RPMIS became evident, the whole data management operation was gradually converted to the new system. In this paper, batch processing and RPMIS utilization are compared and contrasted in terms of time saved, human engineering, quality control, and satisfaction of information requests.

Antineoplastic Agents↗