Clinical pharmacology, metabolism, and tissue distribution of 90Y-labeled monoclonal antibody B72.3 after intraperitoneal administration.

B72.3 is a murine monoclonal antibody that recognizes a high-molecular-weight tumor-associated glycoprotein (TAG-72). Nine patients with TAG-72-positive ovarian carcinoma or papillary serous carcinoma of the peritoneum received an intraperitoneal infusion of 2, 4, or 10 mg B72.3 labeled with 0.5-1.2 (mean, 0.8) mCi 90Y. All patients had laparotomy, with multiple tissue and tumor samples removed 3-7 days later. The concentration of the total 90Y label in peritoneal fluid cleared with an extrapolated half-life of 68.6 +/- 4.5 hours. A low-molecular-weight 90Y-labeled species of metabolite was identified by high-performance liquid chromatography. The concentration of this low-molecular-weight species initially increased in the peritoneal fluid, with a half-life of 0.9 hour, and was rapidly cleared from the peritoneal cavity, with a half-life of 23.1 hours. Both the 90Y-labeled metabolite and the 90Y-labeled B72.3 were absorbed into the plasma, with half-lives of 16 +/- 2.2 hours and 25 +/- 5 hours, respectively. The clearance half-lives for these agents in plasma were 25 +/- 3 hours for the metabolite and 42 +/- 17 hours for B72.3. Approximately 8%-11% of the total injected 90Y label appeared in urine over 72 hours. Most of the label (about 70%) was present as the 90Y-labeled metabolite, but about 30% of the 90Y label in urine appeared identical to the authentic 90Y-labeled B72.3 standard when assayed by chromatography. Tissue distribution studies showed that normal tumor tissue and omentum contained the highest content of 90Y (about 0.017% of the injected dose per gram), followed in descending order by liver, normal lymph nodes, peritoneum, bone, and fascia. The lowest concentrations of 90Y were found in rectus abdominis muscle, bone marrow, and fat. There was substantial heterogeneity in the uptake of the 90Y label into tumor sites among patients and among different sites within the same patient. No correlation could be demonstrated between the TAG-72 content and the amount of 90Y label found in tumor sites. Preliminary radiation dosimetry estimates suggest that the tumor sites received about 82.8 cGy for each millicurie of 90Y administered. Thus, if an adequate total radiation dose can be achieved, 90Y-labeled B72.3 should be therapeutically useful for treating diffuse intraperitoneal disease.

Salvage surgery for chemorefractory gestational trophoblastic disease.

PURPOSE: To investigate and define better the role of salvage surgery for patients with chemorefractory gestational trophoblastic disease (GTD). PATIENTS AND METHODS: A retrospective review of medical records at The University of Texas M.D. Anderson Cancer Center identified 33 patients with chemorefractory GTD who underwent salvage surgery between 1962 and 1991. The end points selected for analysis were serologic response and survival. RESULTS: Initial salvage procedures consisted of 29 hysterectomies, four thoracotomies, and one nephrectomy (in conjunction with a hysterectomy). Fourteen patients (42%) had a serologic complete response (CR) to surgery (normalization of human chorionic gonadotropin [hCG]), 10 (30%) had a partial response (> 50% decrease in hCG level), and nine had no response (< or = 50% decrease in hCG level). Of 19 patients who received further chemotherapy, eight (42%) attained a CR. Four patients underwent a second salvage surgery: two thoracotomies, one craniotomy, and one partial hepatectomy. All achieved a CR. The probability of achieving a CR was influenced by the time from diagnosis to surgery, number of preoperative disease sites, preoperative World Health Organization (WHO) score, and histologic type. Survival was influenced by the type of antecedent pregnancy, number of preoperative regimens, number of preoperative disease sites, time from diagnosis to surgery, and preoperative WHO score. CONCLUSION: Based on the findings of this study, it appears that a select subset of patients with chemorefractory GTD who have a limited number of clinically detectable tumor foci may benefit from salvage surgery.

Phase II study of vinorelbine in advanced and recurrent squamous cell carcinoma of the cervix.

PURPOSE: To evaluate the efficacy and toxicity of intravenous vinorelbine as single-agent chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the cervix. PATIENTS AND METHODS: Between August 1993 and July 1995, 35 patients with advanced or recurrent squamous cell carcinoma of the cervix were entered onto this study. Patients had received no prior therapeutic chemotherapy. The initial dose of vinorelbine 30 mg/m2 was administered as a weekly intravenous infusion. Subsequent doses were unchanged, reduced, escalated, or omitted according to observed toxicity. Patients were evaluated for response and toxicity using standard Gynecologic Oncology Group (GOG) and World Health Organization criteria, respectively. RESULTS: Thirty-three of 35 patients were assessable for response and 35 of 35 for toxicity. The overall response rate was 18% (one complete response [CR], five partial responses [PR]). The mean response duration was 5.2 months and the median survival from treatment for all patients was 11.0 months. The major toxicity was leukopenia, with 61% of patients who had grade 3 or 4. Gastrointestinal and neurotoxicity were infrequent and mild. CONCLUSION: Vinorelbine has moderate activity in advanced or recurrent squamous cell carcinoma of the cervix. Further studies of combination regimens with this agent are justified in this patient population.

Adenovirus-mediated expression of p53 or p21 in a papillary serous endometrial carcinoma cell line (SPEC-2) results in both growth inhibition and apoptotic cell death: potential application of gene therapy to endometrial cancer.

Papillary serous endometrial carcinoma is an aggressive tumor characterized by late-stage presentation, i.p. spread, and poor prognosis. It is histologically similar to serous papillary carcinoma of the ovary. Preclinical studies have shown that adenovirus-mediated expression of p53 in ovarian cancer cell lines causes growth inhibition and apoptosis in vitro and in vivo. Such studies provide the rationale for Phase I Adp53 gene therapy clinical trials in ovarian cancer. In the present study, we compared the efficacy of adenoviral vectors containing p53 (Adp53) or p21 (Adp21) in a papillary serous endometrial tumor cell line (SPEC-2) that contains mutated p53. Growth assays revealed that both Adp53 and Adp21 were efficacious in decreasing cell proliferation as assessed by anchorage-dependent and anchorage-independent growth assays. However, as compared with Adp53, the effects of Adp21 tended to be more transient and less marked. Strikingly, Adp21, but not Adp53, induced a G1 arrest in SPEC-2 endometrial adenocarcinoma cells. In contrast, as assessed by induction of hypodiploid peaks, free DNA ends detected by a terminal deoxynucleotidyl transferase-based assay, and annexin V positivity, p53 was more effective than p21 in inducing cell death by apoptosis. Compatible with the more efficient induction of apoptosis, Adp53, but not Adp21, induced a marked increase in expression of the preapoptotic molecule BAX without a concomitant change in expression of the antiapoptotic mediator Bcl-2. The differential effects of Adp53 and Adp21 on cell cycle progression and apoptosis may be related to the reversibility of p21-induced cell cycle arrest and the irreversibility of p53-induced apoptosis. Thus, at least in the papillary serous endometrial carcinoma cell line SPEC-2, Adp53 may be more effective than Adp21 as a gene therapeutic. Nevertheless, these preclinical studies suggest that papillary serous endometrial carcinoma is a potential target for p53- or p21-mediated gene therapy.

Structure of the genes encoding transcription factor IIB and TATA box-binding protein from Drosophila melanogaster.

To investigate the structure and regulation of the genes encoding components of the basal RNA polymerase II transcriptional machinery, the Drosophila melanogaster genes encoding transcription factor IIB (TFIIB) and the TATA-box-binding protein (TBP) were isolated and characterized. In the TBP gene, a single intron bisects the sequences that encode the two repeated DNA-binding domains of TBP, which supports the notion that TBP evolved from an earlier form that possessed only a single domain. The transcription start points (tsp) were determined, and there was a good correlation between the tsp that were used in vivo and transcription reactions in vitro. The TFIIB and TBP genes have several similar features, which include high A + T content (68 to 74%) upstream from the tsp, multiple copies of an ATTATTATT sequence motif in the proximal promoter region, the absence of a consensus TATA-box element, and small introns (55 to 64 nucleotides). These genes should be useful in the combined genetic and biochemical analysis of TFIIB and TBP in D. melanogaster.

Adjuvant chemotherapy for high-risk endometrial cancer.

Identification of histopathologic factors that predict the risk of tumor recurrence allows for selection of women with endometrial cancer who might benefit from adjuvant therapy. Most studies of adjuvant treatment have focused on external-beam irradiation or oral progestational agents and have failed to document a survival advantage for treated patients. Although recurrent or metastatic endometrial tumors often respond to salvage treatment with cytotoxic agents, there is relatively little experience with postoperative systemic chemotherapy used in an adjuvant setting. A few nonrandomized trials-using doxorubicin/platinum-based regimens-have suggested that adjuvant chemotherapy may be beneficial in some patient subsets. Data from larger-scale, randomized trials do not exist. Additional clinical experience is needed before a definite role for adjuvant chemotherapy can be established.

Treatment of endometrial carcinoma with radiation therapy alone.

PURPOSE: To review the results of treatment with radiotherapy alone in 152 patients with adenocarcinoma of the endometrium who had medical or surgical contraindications to hysterectomy. METHODS AND MATERIALS: We reviewed the records of all patients who were treated with radiotherapy alone for uterine carcinoma at The University of Texas M. D. Anderson Cancer Center between 1960 and 1986. One hundred fifty-two cases were analyzed. Most patients had multiple medical problems. One hundred sixteen patients were treated with intracavitary radiotherapy alone. A combination of external beam and intracavitary radiotherapy was used for 10 patients with Stage I disease who had unusually large cavities, 10 patients with Stage II disease, and 13 of 15 patients with Stage III or IV disease. Histologic material was reviewed in 91 cases. RESULTS: Ten years after treatment, these patients were twice as likely to have died of intercurrent illness as of uterine cancer. The 5-year disease-specific survival rate of patients with Stage I disease was 87%. The disease-specific survival of patients with Stage II disease was 88%, which was not significantly different from that of Stage I patients. Stage III and IV patients had a significantly poorer disease-specific survival rate of 49% at 5 years. Intrauterine recurrence occurred in 14% of the patients with Stage I or II disease. Salvage treatment was attempted in 5 of the 10 patients who had isolated intrauterine recurrences of Stage I disease and was successful in all cases. Extrauterine pelvic recurrence developed in only 3% of Stage I and II patients. Of 82 Stage I and II carcinomas that were available for pathologic review, 17 (21%) were clear-cell or papillary serous variants. The disease-specific survival rate of patients with Stage I or II papillary serous carcinomas was 43%, significantly poorer than that of patients with endometrioid carcinomas. Seven patients experienced acute anesthesia-related complications; none were fatal. Five patients had serious late complications of radiation therapy. CONCLUSION: Radical radiotherapy achieved acceptable DSS and local control rates in patients with medically or surgically inoperable uterine carcinoma. However for patients with localized disease, such treatment is justified only when the operative risk exceeds the 10-15% uterine recurrence rate expected with radiation alone.

Low-stage clear-cell carcinoma of the endometrium.

Clear-cell carcinoma (CCC) of the endometrium is a relatively rare malignancy that is considered to be one of the most aggressive types of endometrial carcinoma. To evaluate the behavior of low-stage (stages I and II) CCC of the endometrium, we retrospectively reviewed 17 such cases seen at The University of Texas M.D. Anderson Cancer Center from 1963 to 1990. Patients' ages ranged from 52 to 81 years. Fifteen cases were pure CCC, and two cases were predominantly CCC with a focus of endometrioid adenocarcinoma FIGO grade I. All patients have been followed-up for at least 3 years. At the time of the study, six patients were alive without disease, one patient was alive with disease, five had died of other causes, and five had died of disease. The estimated survival rate was 71%. Estimated 5-year survival rates for endometrioid adenocarcinoma FIGO grade III and uterine papillary serous carcinoma are 73 and 39%, respectively. We conclude that patients with low-stage CCC of the endometrium have a survival rate similar to that of patients with endometrioid adenocarcinoma FIGO grade III and better than that of patients with uterine papillary serous carcinoma of similar stages.

High-stage endometrioid carcinoma of the ovary. Prognostic significance of pure versus mixed histologic types.

We retrospectively reviewed 80 cases of endometrioid carcinoma of the ovary: 68 pure endometrioid tumors and 12 predominantly endometrioid carcinomas (> 50%) mixed with either papillary serous or undifferentiated carcinoma. Each group had 11 cases of stage III or IV tumors, which were studied to determine whether the overall prognosis was affected by grade, histology, number of mitoses, residual tumor after surgery, and patient's age. Prognosis was significantly affected only by a mixed histologic pattern. The 5- and 10-year survival rates and the median survival time for pure endometrioid carcinomas were much better than those for mixed endometrioid carcinomas (63% and 45% and > 86 months versus 8% and 0% and 18 months, respectively). Recurrent tumors in cases of mixed endometrioid carcinoma were pure serous or undifferentiated carcinomas, whereas those in cases of pure endometrioid carcinoma were either endometrioid or high-grade carcinoma. Our results show that the presence of even a small component of serous or undifferentiated carcinoma in an otherwise predominantly endometrioid carcinoma significantly affects the prognosis. Thus pathologists should thoroughly sample all endometrioid carcinomas, especially high-stage tumors, to ensure that no serous or undifferentiated component is present.

Analysis of 96 patients with advanced ovarian carcinoma treated with high-dose chemotherapy and autologous stem cell transplantation.

The purpose of this study was to identify characteristics significant to survival and progression-free survival in patients with advanced ovarian cancer receiving high-dose chemotherapy. In all, 96 patients received autologous stem cell transplantation. Regimens included paclitaxel with carboplatin (PC), topotecan, melphalan, cyclophosphamide (TMC) and cyclophosphamide, BCNU, thiotepa (CBT). At the time of transplantation, 43% of patients were in clinical CR, 34% were in clinical PR, 18% had progressive disease and 5% had stable disease. There were no treatment-related deaths. The 6-year survival by Kaplan-Meier was 38%. For patients who received transplantation for remission consolidation, the 6-year survival was 53% with a PFS of 29%. On univariate analysis, the CBT regimen, clear cell histology and disease status other than CR prior to treatment were statistically significant adverse prognostic factors. This analysis has demonstrated that patients in clinical remission are most likely to benefit from autologous transplantation, with the exception of patients with clear cell histology. The TMC combination appeared to be superior to the PC and CBT combinations. Comparative studies of different consolidation approaches will be necessary to determine if autologous transplantation is the preferred treatment for this patient population.

Retroperitoneal teratoma presenting as an abdominal-pelvic mass.

Nonovarian teratomas are relatively common neoplasms in children, but are rarely seen in adults. A case of a large retroperitoneal teratoma in a 42-year-old woman is presented. The 21.5-kg tumor originated in the retroperitoneal space inferior to the origin of the superior mesenteric artery, and displaced the contents of the entire abdominal cavity. The duodenum, pancreas, and transverse colon mesentery were incorporated into the tumor's pseudocapsule. Evaluation and operative management are described. Diagnosis and pathogenesis of nonovarian teratomas are reviewed.

Retroperitoneal nerve sheath tumors: an unusual cause of pelvic mass.

Solitary nerve sheath tumors can arise in peripheral, cranial, or sympathetic nerves at virtually any anatomic site. Although origin along the nerves of the retroperitoneal space is not uncommon, these tumors rarely present as pelvic masses. We describe two patients found to have benign nerve sheath tumors of the sacral plexus. Neurilemomas (schwannomas) and neurofibromas are thought to result from a proliferation of perineural cells. These tumors are characteristically firm, smooth, and asymptomatic. They range in size from 1-2 mm to over 20 cm. Surgical excision can usually be accomplished by enucleation of the tumor without damage to the adjacent nerve. Resection of sacral plexus tumors requires knowledge of pelvic retroperitoneal anatomy to avoid injuries to the nearby vascular and urinary structures.

Biologic course of cervical human papillomavirus infection.

To determine the natural course of cervical human papillomavirus infection, we prospectively studied all new patients referred to the colposcopy clinic at the Naval Hospital Bethesda, from April 1981 to August 1983, whose screening cervical cytology demonstrated features consistent with human papillomavirus infection as the only abnormality. Histologic confirmation of human papillomavirus infection was required for entry into the study. All patients were evaluated by repeat cytology, colposcopy, endocervical curettage, and colposcopically directed biopsy as indicated at intervals of three to six months. Patients who developed classic features of cervical intraepithelial neoplasia were treated by standard modalities, whereas patients with evidence of human papillomavirus infection without associated cervical intraepithelial neoplasia were not treated. Confirmation of the resolution of human papillomavirus infection required negative cytology and colposcopy on two consecutive evaluations. Of the 45 patients for whom complete follow-up data are available, five (11.1%) had cervical intraepithelial neoplasia at the time of their initial evaluation, 15 (33.3%) progressed to cervical intraepithelial neoplasia over an average of 10.9 months, 18 (40%) resolved over an average of 13.7 months, and seven (15.6%) persisted with neither progression nor resolution for an average of 21 months. These data suggest that about one-third of patients who have histologically confirmed human papillomavirus cervical infection can be expected to develop cervical intraepithelial neoplasia within a year.

Ovarian malignant mixed müllerian tumors treated with platinum-based chemotherapy.

OBJECTIVE: To characterize the clinical course of patients diagnosed with ovarian malignant mixed müllerian tumors treated with platinum-based chemotherapy. METHODS: Thirty-six patients received this treatment at The University of Texas M. D. Anderson Cancer Center in the period 1979-1993. The mean age was 59 years. Stage distribution was as follows: stage IA, one (3%) patient; stage IIIB, two (5.5%); stage IIIC, 21 (58%); and stage IV, two (5.5%). Ten (28%) patients were unstaged. Chemotherapy regimens included cisplatin, doxorubicin, and cyclophosphamide in 16 patients; cisplatin-ifosfamide in five; cisplatin-cyclophosphamide in four; carboplatinum in three; cisplatin-doxorubicin in three; and various other combinations in the remaining five. RESULTS: Of 16 patients evaluated for clinical response, seven (44%) had a complete response and four (25%) had a partial response, for a total clinical response rate of 69%. Nine patients were evaluated for surgical response: five (56%) had a complete response and one (11%) had a partial response, for a total surgical response rate of 67%. The median survival for the cohort was 18 months. At the time of this analysis, five (14%) patients were alive and disease-free, 25 (69%) had died of disease, five (14%) were alive with disease, and one had been lost to follow-up. CONCLUSION: This study suggests that the clinical course of patients with ovarian malignant mixed müllerian tumors treated with platinum-based chemotherapy is similar to the clinical course experienced by patients with high-grade epithelial carcinoma of the ovary.

Intraoperative lymphatic mapping for vulvar cancer.

OBJECTIVE: To determine the feasibility of intraoperative lymphatic mapping in patients with vulvar cancer. METHODS: Isosulfan blue was injected intradermally at the junction of tumor and normal skin in nine patients. We then attempted to identify the dye in the superficial lymphatic channels and in a superficial groin lymph node. RESULTS: The sentinel node was identified in seven of 12 groins in seven of the nine subjects studied. Six of the successful cases had unilateral lesions. The cases in which a sentinel node was not identified were both patients with midline lesions, including one whose scar was injected following a prior wide local excision of a perineal tumor and one who appeared to have direct drainage to the deep pelvic nodes. There were no technique-related complications. In no case was there a positive non-sentinel node in the presence of a negative sentinel node. CONCLUSION: Intraoperative lymphatic mapping is technically feasible in patients with vulvar cancer, particularly those with unilateral disease. Further experience is needed to evaluate the reliability of the technique in identification of groin node metastases.

Closure of complex vulvar defects using local rhomboid flaps.

Because primary closure under tension is frequently associated with wound breakdown and prolonged healing, we have used local rhomboid flaps as a technique for vulvar reconstruction when primary closure is not adequate. We evaluated the range of clinical applications, perioperative and long-term complication rates, length of hospital stay, and patient reaction to the rhomboid flap repair. Fifteen rhomboid flaps were constructed in 13 patients who underwent extensive vulvar resections between 1989-1994. Partial primary closure was combined with flap construction in 11 patients. Flap size ranged from 2.5 x 2.5 to 6 x 6 cm. Two women had minor wound separations. There were no other early or delayed vulvar complications. The six women with partners were able to resume sexual activity postoperatively. Rhomboid flaps provide excellent design flexibility for closure of large complex vulvar defects with minimal morbidity and acceptable cosmetic and functional results.

Treatment of poor-prognosis sex cord-stromal tumors of the ovary with the combination of bleomycin, etoposide, and cisplatin.

OBJECTIVE: To investigate the clinical activity of the combination of bleomycin, etoposide, and cisplatin for metastatic ovarian sex cord-stromal tumors of all types and poorly differentiated Sertoli-Leydig cell tumors confined to the ovary. METHODS: The regimen was administered as follows: bleomycin 10-15 mg/day by continuous intravenous (IV) infusion on days 1-3; etoposide 100 mg/m2 IV per day on days 1-3; cisplatin 100 mg/m2 IV on day 1. End points for analysis included response, progression-free survival, and survival. RESULTS: Nine patients were entered in this trial. The median age was 37 years (range 12-69). Histologic types included adult granulosa cell tumor in five patients, juvenile granulosa cell tumor in one, poorly differentiated Sertoli-Leydig cell tumor in two, and mixed tumor in one. Stage distribution was as follows: stage Ia, two; stage IIc, one; stage IIIc, one; recurrent, five. Of the six patients with measurable disease, two (33%) had a complete response (one surgical and one clinical), and three (50%) had a partial response, for an overall response rate of 83%; one patient had no response. Toxicity was acceptable; two patients had mild bleomycin pulmonary toxicity. Of the three patients with nonmeasurable disease, one relapsed, one developed progressive disease, and one remains in remission. Of the seven patients with metastatic disease, only one (14%) had a durable remission. Median progression-free survival was 14 months. Median survival time was 28 months. At the time of analysis, two patients were alive disease-free, three were alive with disease, and four were dead of disease. CONCLUSION: Although the overall response rate to the combination of bleomycin, etoposide, and cisplatin was high, the regimen apparently lacks durable activity in this group of tumors. More active drugs and modalities should continue to be investigated.

An outcomes management program in gynecologic oncology.

OBJECTIVE: To evaluate the effectiveness of an outcomes-management program designed to provide high-quality patient care, generate data for outcomes research, and decrease costs in a managed-care environment. METHODS: An outcomes-management program was launched in June 1994, based on the elimination of wasteful or ineffective therapies through the systematic development of practice guidelines and collaborative care paths, with concomitant definition of desired outcomes. Over 3 months, care paths were developed for our most common surgical procedures. A matched control outcomes study was undertaken for the most commonly performed gynecologic oncology procedure: total abdominal hysterectomy and oophorectomy with pelvic and para-aortic node sampling for endometrial cancer. Thirty consecutive women treated on the care path were compared with 29 matched controls accrued during the period of care-path planning and with 73 controls from the period preceding care-path planning. Patient satisfaction with care-path treatment was assessed by a survey sent 2 weeks after discharge. RESULTS: Median length of hospital stay decreased significantly, from 6 days before care-path planning to 4 days after care-path implementation (P < .001). Median laboratory costs decreased by 74% (P < .001), medication costs by 35% (P < .001), room costs by 29% (P < .001), and total hospital costs by 20% (P < .002). Incremental improvements were observed during care-path planning. There were no readmissions for complications in the care-path group. According to the survey results, patient satisfaction with care was very high among care-path patients. CONCLUSIONS: A physician-driven outcomes-management program in an academic setting permits the delivery of high-quality care and supports outcomes research while decreasing costs.

Prognostic factors in stage IB squamous cervical cancer patients with low risk for recurrence.

About one-half of cervical cancer patients whose tumors recur after radical surgery have negative lymph nodes and clear resection margins. We evaluated 95 patients with squamous cell tumors who underwent radical hysterectomy and pelvic lymphadenectomy between January 1975 and December 1985 and who were thought to be at low risk for recurrence to see whether other clinical or histopathologic factors were predictive of tumor recurrence. Detailed retrospective record review and complete pathology review were accomplished for each case. The 5-year actuarial survival rate was 89%. Nine patients developed recurrent disease (9.5%), of whom eight died. Several clinical features were evaluated as possible prognostic factors: patient age (P = .26), patient race (P = .60), cervical diameter (P = .24), extent of gross cervical involvement (P = .36), and presence of contact bleeding (P = .82). Histopathologic features were examined: depth of invasion (P = .31), number of mitoses (P = .42), character of the tumor-stromal border (P = .15), histologic differentiation (P = .02), lymph-vascular space invasion (P = .56), and width of tumor (P = .23). Depth of invasion did correlate with increasing tumor width (P less than .001). Once node- and margin-positive patients are excluded, differentiation may be the only feature useful in identifying patients at risk for recurrence. Because almost one-half of our patients had poorly differentiated tumors, sole use of this feature as a criterion for adjuvant therapy would have resulted in overtreatment of low-risk patients.

End colostomy using the end-to-end anastomosis instrument.

Gastrointestinal stapling instruments have achieved wide-spread application in intestinal surgery. Reported advantages of stapled bowel procedures compared to classic hand-sutured procedures include reduced tissue trauma, shorter operating time, and improved blood supply to the stapled bowel segment. A technique for creation of an end colostomy using the end-to-end anastomosis stapler (EEA instrument) is described. This technique was used in 11 gynecologic oncology patients who required colostomy. Postoperative stomal function was normal in all cases. No patient developed stomal necrosis, peristomal hematoma, or abscess. No delayed complications have been observed. Colostomy creation with the EEA instrument is a safe, simple and rapid procedure. Possible advantages of the stapled colostomy are enhanced blood flow to the stomal site, reduced incidence of peristomal infection, and improved appliance fit.