Stephen L. Curry

Extraperitoneal versus transperitoneal selective paraaortic lymphadenectomy in the pretreatment surgical staging of advanced cervical carcinoma (A Gynecologic Oncology Group study)

Abstract Two-hundred and eighty-eight patients with predominately stage IIB or IIIB cervical carcinoma underwent pretreatment surgical staging including selective paraaortic lymphadenectomy (SPAL), followed by pelvic irradiation with or without paraaortic irradiation (RT). Four patients were excluded from analysis (two received no RT and two were insufficiently documented). Of the remaining 284 patients, 128 underwent extraperitoneal (EP) SPAL and 156 transperitoneal (TP) SPAL procedures. Age, race, and stage (clinical and surgical), cell type, paraaortic nodal status, and peritoneal cytology findings were similar in both groups. Complications presumed to arise from operative staging were infection, which was similar for both groups, and vascular injury, which was higher in the TP group, although not statistically significant. Complications subsequent to RT fell into two categories: local—pelvic necrosis, vesicovaginal and rectovaginal fistulas, proctitis, etc., and regional—enterovaginal fistula, bowel obstruction, enteritis, bowel perforation, etc. The frequency of local complications was similar for both EP and TP patients. Utilizing univariant analysis, among regional complications, both bowel obstruction and nonobstructive enteric injuries were observed significantly more often in TP patients than in EP patients (11.5% vs 3.9%, P = 0.03, for both types). Multivariant analysis confirmed these observations. This report supports the conclusions that in advanced cervical carcinoma (1) EP- and TP-SPAL are of similar sensitivity in detecting nodal spread, (2) no significant differences in the frequency of surgical complications could be detected between EP- and TP-SPAL groups, and (3) TP-SPAL is associated with a higher frequency of certain postirradiation regional enteric complications.

Hormonal contraception and trophoblastic sequelae after hydatidiform mole (A Gynecologic Oncology Group study)

A prospective randomized study was undertaken to determine whether the administration of oral contraceptives after the evacuation of a hydatidiform mole affects the human chorionic gonadotropin serum level in a way that leads to an increased frequency in the diagnosis of postmolar trophoblastic disease. Between 1981 and 1988, 266 patients were randomly assigned to either oral contraceptives or barrier contraception after evacuation of a hydatidiform mole. Patients were followed up until serum levels of human chorionic gonadotropin were normal or until specific criteria for the diagnosis of postmolar trophoblastic disease were met. Twenty-three percent of patients receiving oral contraceptives had postmolar trophoblastic disease, whereas those using a barrier method had a rate of 33%. The median time to spontaneous regression in the oral contraceptives group was 9 weeks, whereas the median time to regression in the barrier group was 10 weeks. Twice as many patients in the barrier group became pregnant in the immediate follow-up period. We conclude that oral contraceptives are the preferred method of contraception after evacuation of a hydatidiform mole.

Single‐dose actinomycin‐D treatment for nonmetastatic gestational trophoblastic disease: A prospective phase II trial of the gynecologic oncology group

The Gynecologic Oncology Group (GOG) conducted a prospective trial of single‐dose Actinomycin‐D (ACT‐D) given intravenously (IV) at 1.25 mg/m2 every 2 weeks to patients with nonmetastatic gestational trophoblastic disease (NMGTD) in order to determine the efficacy of pulse scheduling and the frequency and severity of associated toxicity. Of 31 evaluable patients, 29 (94%) achieved remission after receiving a median of four courses of therapy. Two patients who failed to respond to pulse therapy were subsequently cured by alternative treatment. There were 93 toxic events in 133 cycles of therapy. Ninety‐two percent of adverse effects were graded as mild or moderate, and 8% were graded as severe. No life‐threatening toxicity occurred. Although single‐dose ACT‐D efficacy and toxicity is comparable to conventional therapy for NMGTD, the advantages of easier administration, greater patient convenience, and improved cost‐effectiveness make it superior to other alternatives. On this basis it is recommended as the treatment of choice for NMGTD.

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.

Phase II trial of piperazinedione in patients with advanced or recurrent uterine sarcoma: A Gynecologic Oncology Group study

TWENTY PATIENTS WITH ADVANCED OR RECURRENT UTERINE SARCOMA no longer amenable to control with surgery and/or radiotherapy were entered into study by Gynecologic Oncology Group institutions to receive piperazinedione 9 mg/m2 intravenously every 3 weeks. One patient was deemed to be ineligible for study. Among the 19 evaluable patients, only one response was observed, a partial response in a patient with leiomyosarcoma. Adverse effects consisted primarily of myelosuppression and were tolerable. Piperazinedione at the dose and schedule tested appears to have little activity against uterine sarcomas.

Uterine thickness determination using real-time ultrasonography: A guide for intracavitary brachytherapy in the treatment of endometrial carcinoma

Two patients with medically inoperable stage I endometrial carcinoma were treated with intracavitary implants alone using Simon capsules, tandems, and ovoids. In both cases, uterine thickness was measured during the implant procedure by realtime ultrasonography. Tumor doses in both patients were then calculated to the midmyometrium and to the serosal surface of the uterus. These estimates, rather than the usual milligram-hours or points A and B, were used to make treatment decisions.

Hematologic monitoring in patients with cancer: a study of the gynecologic Oncology Group

A retrospective review of four Gynecologic Oncology Group protocols involving aggressive chemotherapy was carried out to assess the following, (a) Whether granulocyte determinations, which require a differential count resulting in extra cost and time, added pertinent clinical information to that obtained from the white blood cell count alone, (b) If, there is a predictable relationship between the white blood cell count and the platelet count as a reflection of bone marrow toxicity, and (c) whether one can predict when maximum myelosuppression will occur during a treatment program. This data revealed that the white blood count and granulocyte levels are closely related; that rarely is life-threatening throm-bocytopenia noted in the absence of leukopenia; and that myelosuppression can occur during any course of treatment and is not predictable. Thus, for these treatment regimens in gynecologic malignancies, the white blood count is sufficient for monitoring toxicity and adjusting future courses of chemotherapy. Only when the white blood count is severely depressed is it necessary to monitor the granulocyte and platelet counts.

Ultrasound for diagnosing and preventing malplacement of intrauterine tandems

Postoperative B-mode ultrasound was used to evaluate final tandem position in 50 consecutive placements (28 patients). In 34% (17 of 50), the tandem was found to be suboptimally positioned; in 24% (12 of 50), it penetrated the myometrium; and in 10% (five of 50), it frankly perforated the uterus. The uterine fundus was the region most commonly perforated, and the anterior myometrium was the site most frequently penetrated. In all cases in which postoperative ultrasound showed malpositioning, the clinical and radiographic assessment indicated proper intracavitary placement. Ultrasound affected clinical management in 42% (21 of 50) of the placements involving 61% (17 of 28) of the patients. To improve tandem placement, we used intraoperative realtime ultrasound to guide 73 consecutive surgical insertions. Ultrasound clearly visualized the procedure, allowing tandems to be positioned with confidence even in the most difficult cases. The immediate feedback from intraoperative ultrasound eliminated malplacements and thus the need for a second anesthesia to reposition the tandem.