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Treatment of cervical carcinoma in a renal transplant patient with a single pelvic kidney presents several management dilemmas. Standard treatment modalities are complicated by the patient's immunosuppressed state and the location of the transplanted kidney in the standard pelvic field, as well as other surgical risks. No information on the best approach to this clinical situation is available in the English language literature. We present this case to discuss factors considered in selecting a treatment plan and possible reasons for the rapid recurrence and demise of this patient.

Purpose. The primary goal of this trial was to evaluate the clinical activity and the toxicity of a combination of cisplatin and carboplatin for women with advanced-stage epithelial ovarian cancer. Patients and methods. Fifty-one consecutive evaluable patients with untreated stage III and IV epithelial ovarian cancer received 360 mg/m 2 carboplatin on Day 1 and 50 mg/m 2 cisplatin on Day 2 administered intravenously every 28 days for six cycles. Drug doses were adjusted for hematologic toxicity based on nadir counts during the prior therapy course. Dose levels included 300-400 mg/m 2 carboplatin and 50-75 mg/m 2 cisplatin. Second-look surgery was optional. Endpoints were clinical response, surgical response, progression-free survival, and survival. Results. Of 8 patients with measurable disease, 3 (37.5%) had a clinical compete response, and 3 (37.5%) had a clinical partial response, for an overall clinical response rate of 75%. Of 39 patients who began chemotherapy with abnormal serum levels of CA 125, 31 (79%) achieved normalization of CA 125 at the completion of chemotherapy. Thirteen patients underwent second-look laparotomy. Of these, 7 (54%) had a pathological compete response, and 2 (15%) had a partial response. The median progression-free survival was 14 months, and the overall median survival was 32.5 months. Neutropenia and thrombocytopenia were the main dose-limiting toxicities. In addition, 9 patients developed grade 2 and 3 developed grade 3 ototoxicity. Conclusion. This regimen is very active against advanced-stage epithelial ovarian cancer. The degree of ototoxicity observed is worrisome, but such toxicity may be ameliorated by limiting the dose of cisplatin and increasing the dose of carboplatin.

The surgical staging scheme for uterine corpus cancer adopted in 1988 by the International Federation of Gynecology and Obstetrics assigns patients with tumor spread to retroperitoneal lymph nodes to stage IIIC. However, a recommended approach to the detection of lymph node metastasis is not delineated. As part of an ongoing project to assess the value of surgical staging procedures, we reviewed the techniques of lymph node evaluation in 295 at-risk patients. Cases included clinical stage I patients whose preoperative biopsies demonstrated grade 2 or 3 adenocarcinoma or papillary serous, clear cell, or mixed carcinoma. We arbitrarily divided the retroperitoneal space into 10 lymphatic zones: left and right para-aortic, common iliac, external iliac, hypogastric, and obturator. Eighty-two percent of patients had some type of node sampling that involved a mean of three zones. Thirty-three of 244 sampled cases (13.5%) had nodal metastases: 20 had gross involvement and 13 had microscopic. We stratified patients into three groups: (1) those who had no node sampling (n = 51), (2) those with some nodes biopsied (n = 193), and (3) those whose node sampling included a minimum of one para-aortic plus at least one right and left pelvic specimen (n = 51). Retroperitoneal recurrences thought to originate from lymph node sites were identified for the "node-negative" patients in each group: Group 1, 4/51 (8%); Group 2, 9/173 (5%); and Group 3, 0/38 (0%). Lymphatic site failures were seen in 8 of 33 (24%) patients with biopsy-proven metastases. We found that failure to systematically sample pelvic and para-aortic nodes results in a small, but real, risk of undetected extrauterine metastasis. A selective approach to sampling that includes biopsy from both para-aortic and bilateral pelvic lymphatic zones appears to provide an accurate estimate of true node negativity. Further evaluation of this approach is warranted.

Radical wide excision and selective inguinal node dissection provide a more conservative and less morbid surgical option for women with vulvar carcinoma than en bloc radical vulvectomy with bilateral inguinofemoral lymphadenectomy. We have expanded our initial experience with this approach to 76 patients with T1 (n = 33) and T2 (n = 43) squamous carcinomas with invasion >1 mm and clinically negative groin nodes treated between 1978 and 1994. Lateral tumors (n = 53) were more frequent than midline lesions (n = 23). Tumors were excised with a measured gross margin of 2 cm, and dissection was carried to the deep perineal fascia. The mean largest tumor dimension was 26 mm; the mean depth of invasion was 4.4 mm. Superficial inguinal lymphadenectomy, unilateral or bilateral depending on lesion location, was performed. Perioperative complications occurred on the vulva in 8% of cases and in the groin in 11%. Delayed complications, all related to groin treatment, were seen in 29%. The median follow-up interval was 38 months. Seven patients (9%) had inguinal lymph node metastases identified at their primary operation. Most received additional therapy; one has died of disease. Nine women (12%) developed recurrent disease in the vulva: all were controlled by additional resection. Four (5%) developed recurrence in a previously negative groin: three of these are dead of disease. Actuarial 4-year survival is 81%. Radical wide excision and selective inguinal lymphadenectomy can be safely offered to women with T1 and T2 vulvar cancers. Patients with known positive nodes or vulvar failure can be salvaged by further therapy. Women with unanticipated groin failure usually die of disease. These experiences are similar to those observed in more radically resected patients.

Bilateral gracilis myocutaneous flaps were originally used as part of a technique for creating a neovagina following total pelvic exenteration. Based upon this experience, we began using single flaps for primary repair and closure of large surgical defects in the perineal area that require alternate tissue sources to replace lost skin, mucosa, or adjacent deep tissues. Eighteen single gracilis flaps were used for major vulvovaginal reconstructions in 17 women during the past 5 years. Women undergoing unilateral flap reconstructions included 6 with anorectal cancers and 11 with vulvovaginal tumors. Most patients were being treated for recurrence after failed primary therapy (n = 7) or were receiving multimodal treatment for advanced local disease (n = 7). All cases involved complex resections followed by simultaneous reconstruction: mean total operative time was 377 min with a mean estimated blood loss of 1010 cc. Reconstruction involved external flap placement on the vulva or perineum in 7 cases and internal placement to replace excised portions of the vagina in the other 11. Mean flap size was 6.6 x 11.4 cm. Necrosis of flap skin occurred in 3 patients; minor wound separations or flap edge necrosis was seen in 5 cases. Hospital stay averaged 18.4 days. Nine women had recurrent disease and died over 4-30 months; the remaining 8 are alive and disease free with a median follow-up of 25 months. The single gracilis flap provides a versatile method for providing anatomic reconstruction of large perineal defects in women who have undergone extensive resection.

Objective: To characterize the clinical course of patients diagnosed with ovarian malignant mixed mullerian 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 IIIII, 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; cisplatindoxorubicin 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 mullerian tumors treated with platinum-based chemotherapy is similar to the clinical course experienced by patients with high-grade epithelial carcinoma of the ovary.

The purpose of this study was to determine the maximum tolerated dose (MTD) and feasibility of treatment with sequential intra-arterial FUDR and cisplatin administered with concurrent whole pelvis radiation (XRT) to women with advanced cervical cancer. Sixteen patients with squamous carcinoma of the cervix were prospectively treated in a Phase I study. All tumors were stages IIb, IIIb, or IVa with diameters of > or = 7 cm. Patients underwent surgical staging with pelvic and paraortic lymphadenectomy with placement of bilateral intra-arterial catheters in the anterior division of the internal iliac arteries. The catheters terminated in separate subcutaneous ports. No patient had metastasis in the high common iliac or paraortic nodes. Patients received a planned course of 40-50 Gy whole pelvis XRT followed by indicated brachytherapy. During the first 2 weeks of whole pelvis XRT, patients received a 1-hr infusion of FUDR and during the second 2 weeks a 1-hr infusion of cisplatin, each delivered daily by external pump with the daily whole pelviS XRT fraction. Additional cisplatin was infused during brachytherapy. Five dose levels ranging from 6.5 to 27 mg/m2 daily for FUDR and from 2 to 8 mg/m2 daily for cisplatin were used. The MTD of FUDR and CDDP was dose level 4 (22.5 and 6.75 mg/m2, respectively). Dose-limiting toxicity was grade 3/4 nausea seen in three of four patients at dose level 5. No patient had neuro- or ototoxicity. There was no grade 4 myelosuppression. Eight patients had a complete response, and six had a partial response. Disease progressed in two. Mean follow-up was 22.4 months. At this writing, 10 patients had no evidence of disease, 2 were alive with disease, and 4 had died of disease. Median survival has not been reached. This is a well-tolerated regimen with significant activity that warrants further investigation at dose level 4.

Pyomyositis, an unusual infection of large skeletal muscles, developed in a woman with a history of bulky stage IIIB cervical cancer. Three years prior, the woman had undergone aggressive neoadjuvant intra-arterial chemotherapy followed by pelvic irradiation. The overwhelming majority of pyomyositis cases is caused by Staphylococcus aureus. Group B beta-hemolytic streptococcus, an organism that rarely causes this infection, was isolated in this case. Although surgical drainage is the most common approach, successful percutaneous drainage was accomplished. Pyomyositis has only recently been reported in non-tropical climates. The presentation, diagnosis, risk factors, and management of pyomyositis are discussed.

Enterovesical fistula is a rare complication of pelvic radiotherapy. Recurrent disease is the cause of fistulization in most patients. We identified 14 patients who developed enterovesical fistula in the absence of tumor recurrence. These women were at high risk for radiation morbidity due to prior surgery, pelvic inflammatory disease, adjuvant hyperbaric oxygen, or locally high doses of radiotherapy caused by suboptimal geometry and technique. All patients underwent radiographic imaging including barium enema, intravenous pyelogram, and upper gastrointestinal study with small bowel follow-through. The range of radiation morbidity was great: some patients had small fistulae, others had extensive fistulization and radionecrosis. Six patients had colovesical fistulae, five had enterovesical fistulae, and three had fistulae involving both the small and large bowel. Twelve patients underwent 13 surgical procedures. Healing or successful repair of the fistula was achieved in 1 of 3 patients treated with diversion (loop colostomy), 2 of 4 patients treated with isolation of the fistulized bowel loop and urinary conduit, and 5 or 6 treated with bowel resection with or without urinary conduit. Two of three perioperative deaths occurred in the isolation group managed without urinary conduit and were related to ongoing sepsis. Surgical procedures which resect necrotic fistualized bowel and result in complete separation of the gastrointestinal and genitourinary tracts provided the best results in patients with radiation-induced enterovesical fistulae. CT scan of the abdomen and pelvis is recommended in the evaluation of the majority of patients with suspected enterovesical fistula.

Objectives: Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to reduce the acute toxicity of combined therapy with extended-field irradiation, brachytherapy, and cisplatin chemotherapy in patients with cervical cancer with para-aortic or high common iliac disease. This report presents the results of part 2. Materials and Methods: Radiation Therapy Oncology Group 0116 was a 2-part trial. Part 1 delivered extended-field irradiation, brachytherapy, and cisplatin; part 2 added amifostine and required 16 evaluable patients to assess an improved toxicity profile. Eligibility included evidence for high common iliac or para-aortic metastasis. Patients were treated for a total dose of 45 Gy in 25 fractions with intracavitary irradiation. Intensity-modulated radiation therapy was not allowed. The final point A dose was 85 Gy low-dose rate equivalent. High-dose rate techniques were allowed. The positive para-aortic and iliac nodes were to be boosted to 54 to 59.4 Gy. Amifostine at 500 mg was to be delivered with every fraction of radiotherapy. Results: The study opened on August 1, 2001, and closed March 3, 2007, after accruing 45 patients, 18 for the second part with amifostine. This analysis reports the primary end point for the patients entered on part 2 of the study. Three patients were excluded, one was ineligible, and 2 withdrew. The median follow-up was 22.9 months (range, 6.5-45.4 months). The median dose of amifostine delivered was 5000 mg (range, 500-13,500 mg). Thirteen patients (87%) experienced an acute grade 3/4 toxicity (excluding grade 3 leukopenia). This compared to an 81% rate in part 1 of the trial. The estimated median survival was 34.8 months with a 20% late grade 3/4 toxicity rate. Conclusions: Amifostine, as delivered in this study, did not reduce acute toxicity in this patient population.

Cisplatin and the combination of cisplatin, doxorubicin, and cyclophosphamide have documented activity in women with advanced or recurrent endometrial adenocarcinoma. However, response duration has been short and toxicity is substantial. To determine if similar activity could be obtained with less morbidity, we prospectively treated 33 patients with 360 mg/m2 carboplatin given intravenously every 28 days. Mean patient age was 69 years (range 40-86); all had a Zubrod functional status of 2 or less. Seventeen patients had advanced primary tumors, and 16 had recurrent disease. Prior treatment included surgical resection in 29 cases, hormonal agents in 7, and radiotherapy in 22. No patient had received prior chemotherapy. Mean treatment was 5.7 cycles. Nine of 27 patients (33%) with measurable disease had objective responses, including three complete and six partial responses. Nonresponders included 10 patients with stable disease and 8 whose disease progressed while on treatment. Median time to response was 3 months. Median progression-free survival for responders and nonresponders was 5 and 4 months, respectively. At analysis, 20 patients had died of disease, 7 were alive with disease, and 6 were clinically free of disease. Disease-free patients include 1 with a complete response and 5 who began treatment without measurable disease. Median follow-up for surviving patients was 18 months (range 4-32). Treatment toxic effects were minimal and largely limited to myelosuppression; 3 patients had grade 3 thrombocytopenia, 1 had grade 3 neutropenia, and 5 had grade 3 anemia. Carboplatin has define activity in endometrial carcinoma and offers a well-tolerated palliative therapeutic alternative.

Objective. The aim of this study was to evaluate the role of secondary cytoreductive surgery in patients with recurrent epithelial ovarian cancer with an apparent solitary intra-abdominal focus. Methods. We conducted a retrospective review of patients with epithelial ovarian cancer who underwent secondary cytoreduction for recurrence at the University of Texas M. D. Anderson Cancer Center between 1985 and 1994. Eligible patients included those who had a laparotomy to resect a tumor that was apparently solitary. Cytoreductive surgery was defined as optimal if the diameter of the largest residual tumor was ≤2 cm and suboptimal if >2 cm. Results. Twenty-five patients met our eligibility criteria. Their mean age was 55 years (range, 35–73 years). The median time from primary diagnosis to recurrence was 37.6 months. Tumor was found to be confined to a solitary site in 15 patients (60%), to two sites in 6 (24%), and to three or more sites in 4 (16%). Surgical procedures included cytoreduction in 10 patients, intestinal resection in 8, splenectomy in 3, and limited biopsies in 4. Secondary cytoreduction was optimal in 18 of 25 patients (72%). The median postsecondary cytoreduction survival was 25.1 months for patients who had suboptimal secondary cytoreduction compared with 56.9 months for those who had optimal cytoreduction ( P = 0.08). Conclusions. Secondary cytoreductive surgery for recurrent ovarian cancer at an apparently solitary intra-abdominal site resulted in optimal residual tumor in a high proportion of patients. Although there was no survival advantage for patients whose tumor was optimally debulked, there was a trend toward improved survival. A large prospective randomized trial of secondary cytoreduction for recurrence is recommended.

5505 Background: Vulvar cancer is a good target for SN strategy because lymphatic drainage is predictable and the morbidity of regional lymphadenectomy is significant. GOG 173 is a validation study of SN biopsy in a multi-institutional setting. Methods: Eligible patients have squamous carcinoma, nonsuspicious lymph nodes and tumor diameter between 2 cm and 6 cm. No surgeon skill verification was required. Use of radiocolloid for SN identification was an optional adjunct to blue dye until 2001 when it became mandatory. All patients underwent completion inguinal femoral lymphadenectomy. The study goal is to enroll 120 patients with nodal metastases to validate the sensitivity of SN > 88% (which would lead to a false negative predictive rate of th-75th percent: 3–14) as of 12/2008. 445 patients have data review completed. Of 403 evaluable patients, the median age was 66.9 years and 92.8% were white. 109 patients (27.1%) had lateralized lesions and unilateral groin dissections and 294 (72.9%) had midline involvement and bilateral dissections, resulting in 697 groins evaluated. SN was successfully identified in 78.8% (67/85) of patients using blue dye only and in 96.2% (306/318) using combination of radiolocalization and blue dye. For 294 patients with midline lesion treated by bilateral dissection, 159 (54.1%) had SN identified on both sides,114 (38.8%) on one side, and 21 (7.1%) not identified on either side. SN identification was successful in 373 (92.6%) patients. Nodal metastases were identified in 117 patients (31.4%). Conclusions: The combination of blue dye and radiocolloid appear superior to blue dye alone. Confirmed results for the entire cohort will be reported. No significant financial relationships to disclose.

16010 Background: Intraperitoneal interferon therapy has been shown to have response rates as high as 45% in patients with recurrent ovarian cancer. Continued exposure has also been associated with the effectiveness of interferon treatment. The purpose of this study was evaluate the optimum dose and toxicity profile of PEG INTRON given subcutaneously (SC) on a weekly schedule to women with platinum-resistant ovarian cancer. Methods: Women with platinum-resistant ovarian, peritoneal, or fallopian tube cancer were eligible. Those whose tumors tested positive for IL-8, bFGF, or VEGF were randomized to three PEG INTRON treatment doses, 1.0, 1.25, or 1.5 micrograms/kg/wk SC for a total of 4 weekly injections per cycle. Re-evaluation for tumor response by imaging, physical exam and CA-125 was performed every 2 -3 cycles (8 - 12 weeks). Up to 12 cycles of treatment was allowed. Treatment was continued until progression of disease or unacceptable toxicity. Results: Thirty patients were enrolled, only 17 received treatment; 11 tested negative, 1 refused testing, 1 tested positive but refused treatment. Median age was 56 years (35–73). Of those treated, 94% (16/17) had a performance status of 0. All were heavily pretreated (3–8 prior chemo regimens). One patient received 9 cycles (1.25 micrograms/kg, total dose = 80 mcg) with stable disease. In the remaining 16 patients, 14 (75%) were taken off study due to disease progression; 3 after completing 2 treatment cycles and 11 after No significant financial relationships to disclose.

5589 Background: Systemic therapy for advanced malignant mixed müllerian tumor of the uterus (MMMT) after surgery has been disappointing. Currently, the most common treatment regimen is ifosfamide and platinum. Moderate success has been documented using paclitaxel in MMMT of the ovary. The purpose of this study is to evaluate carboplatin and paclitaxel in patients with advanced (IIIb-IVb) and recurrent MMMT of the uterus. Methods: A single arm, prospective, non-randomized phase II trial opened in October 2001. The planned sample size is 37 evaluable patients, with time to progression and response rate as the primary endpoints. Patients receive carboplatin (AUC 5) and paclitaxel (175 mg/m2) every 21 days. Patients treated adjuvantly receive a total of 6 cycles or until progression or toxicity. Patients with disease present at study entry are treated until progression or toxicity. Results: To date, 18 patients have been enrolled. Seven patients received adjuvant treatment and 11 patients had documented disease at study entry. In the adjuvant group, the median progression-free interval was 15.8 months and median overall survival from treatment initiation was 20.2 months. Four of these 7 patients (57%) continue to be followed with a median follow-up of 19.2 months. In the patients with documented disease, the median progression- free interval was 7.8 months and the median overall survival from treatment initiation was 12.4 months. In this group, there were 3 complete and 4 partial responses (63.6% response rate). Over 45% of patients with disease at study entry are alive with a median follow-up of 14.0 months. Four patients experienced grade 4 granulocytopenia. Only two (11%) had treatment-limiting toxicity, one with grade 3 neuropathy and one with grade 3 fatigue. Conclusions: Carboplatin and paclitaxel appear to have improved tolerability and response rate (63.6%) compared to previous reports of ifosfamide and cisplatin (33% RR) in treating MMMT of the uterus. This regimen seems extremely promising and we are awaiting the final results of this trial. No significant financial relationships to disclose.

5014 Objective: To evaluate the safety and feasibility of laparoscopic extraperitoneal para-aortic lymphadenectomy and to correlate histopathologic findings and preoperative PET-CT imaging in patients with locally advanced cervical cancer. Methods: We performed a prospective study of patients with locally advanced cervical cancer. Patients enrolled underwent laparoscopic extraperitoneal para-aortic lymphadenectomy prior to chemoradiation at our tertiary cancer center from April 2004 to June 2005. All patients had a preoperative CT scan and PET-CT scan. Results: 12 patients were enrolled. One patient did not undergo surgery. No patient had evidence of metastatic disease to the para-aortic area by preoperative CT scan. The median age was 48 years (range, 35–67). 10 patients were diagnosed with squamous cell carcinoma, one patient with adenocarcinoma, and one patient with transitional cell carcinoma. The stage distribution was: IB2 (3), IIA (1), IIB (4), IIIA (1), IIIB (3). The median BMI was 26 (range, 18.6–29.7). Two (18%) of 11 patients had a positive preoperative PET-CT imaging study for disease in the para-aortic lymph nodes. The median time of surgery was 162 minutes (range, 52–247). The median blood loss was 25 mL (range, 10–100). There were no intraoperative complications. No patient required intraoperative blood transfusions. The median length of postoperative stay was 1 day (range, 1–2). There were two patients who developed postoperative lymphocysts requiring drainage. The median number of lymph nodes removed was 11 (range, 4–17). A total of 2 (18%) of 11 patients had evidence of histologically confirmed lymph node metastases. Of these, only one patient had evidence of disease by PET-CT scan. Only one of the two patients with a positive PET-CT scan for disease in the para-aortic nodes, actually had disease confirmed histopathologically. The sensitivity and specificity of PET-CT scan is 50% and 89%, respectively. Conclusions: Laparoscopic extraperitoneal para-aortic lymphadenectomy is safe, feasible and appears to increase the precision of identifying occult metastasis. Further patient accrual will be needed to evaluate the ultimate utility of PET-CT imaging in this setting. No significant financial relationships to disclose.

RT, and transfusion during RT) and three descriptive tumor variables (clinical tumor diameter, clinical lymph node status, and FIGO stage) were recorded. Tumor diameters were recorded in 94% of patients and were categorized as 4 cm (1035 pts; 38%), 4–4.9 cm (549 pts; 14%), 5–5.9 cm (499, 18%), 6–6.9 cm (301; 11%), or 7 cm (360 pts; 13%). The median follow-up of surviving patients was 163 months. Comparisons between actuarial curves were made using the log-rank method. A proportional hazards regression model was used to evaluate the relative importance of predictive factors.

Uterine papillary serous carcinoma (UPSC) is an aggressive malignancy that accounts for a disproportionate number of intraabdominal failures among endometrial carcinoma patients. The histologic appearance and tendency toward intraabdominal spread resemble those of papillary serous adenocarcinoma of the ovary. Because approximately 70% of untreated ovarian carcinoma patients respond to platinum-based chemotherapy, it has been suggested that UPSC patients might respond to similar treatment regimens. Twenty patients with UPSC were treated with cisplatin, doxorubicin (Adriamycin), cyclophosphamide (PAC) chemotherapy between January 1982 and December 1989. They included 9 patients with advanced primary disease, 5 with recurrence, and 6 who received PAC as adjuvant therapy. Patients received a mean of five cycles of PAC. Only 2 of 11 patients with measurable disease greater than 2 cm achieved complete clinical responses of 12 and 31 months duration; there were no partial responses. Actuarial 5-year survival for all patients was 23%. The mean progression-free interval was 9 months. Patients with clinical stages I or II disease had a higher survival rate than those with stage III or IV disease (P = 0.003). Survival did not correlate with depth of myometrial invasion (P = 0.81) or size of residual tumor following initial surgery (P = 0.16). Estrogen or progesterone receptors were detected in 10 of 11 tumors tested. Seven of 9 patients tested had elevated serum levels of CA-125 (greater than 35 U/ml). Correlation between CA-125 value and clinical course was demonstrated in 3 of 5 patients who had serial measurements. Of all patients, 3 are currently alive; 1 has documented disease. Moderate to severe toxicity was seen in 14 patients (70%). There was one possible treatment-related death from cardiomyopathy. UPSC, despite its histologic and clinical similarities to ovarian carcinoma, was relatively resistant to PAC chemotherapy in this mixed group of patients.

Long-term survival following resection of pulmonary metastases has been well documented. Variables that are believed to have an effect on survival are site of primary tumor, number and size of metastases, resectability, laterality of the metastases, doubling time, and disease-free interval. Published information regarding resection of pulmonary metastases in patients with gynecologic primary tumors is limited. We reviewed 45 patients whose pulmonary metastases from uterine sarcomas were resected at Memorial Sloan Kettering Cancer Center between 1960 and 1989. All cases met carefully defined criteria at time of thoracotomy: prior hysterectomy for uterine sarcoma, no extrathoracic tumor, known disease thought to be resectable, histology consistent with uterine sarcoma, and no medical contraindication to thoracotomy. Seventy-one percent had unilateral lesions, fifty-one percent had one lesion, and seventy percent had nodules greater than 2 cm. Thirty-six percent had incomplete resection at thoracotomy. Actuarial 5- and 10-year survival from hysterectomy for uterine sarcoma was 65 and 50%, respectively, with a mean follow-up of 89 months. Five- and ten-year survival from resection of pulmonary metastases was 43 and 35%, respectively, with a mean follow-up of 25 months. Unilateral vs bilateral disease was a significant predictor of survival after pulmonary resection (P = 0.02). Metastases size, number of metastases, disease-free interval, and patient age were not significant. Among this carefully selected group of patients undergoing resection of pulmonary metastases from uterine sarcomas, long-term survival was achieved by a substantial proportion of patients. No single risk factor is sufficiently accurate to exclude an individual patient from consideration for pulmonary resection.

Objective The Affordable Care Act mandates the Prospective Payment System (PPS)-Exempt Cancer Hospitals Quality Reporting program. These 11 hospitals (which are paid fee-for-service rather than on a DRG system) began reporting measures (2 general safety, 2 breast, 1 colon) in 2013. Given this reporting mandate, we set out to determine whether the PPS-exempt gynecologic oncology programs could identify quality measures specific to the care of our patients. Methods A list of 12 quality measures specific to gynecologic oncology was created (from sources including the National Quality Forum and the SGO). Measures already in use were not included. The list was ranked by the gynecologic oncology program directors at the PPS-exempt hospitals. Descriptive statistics (including mean and SD for rankings) were utilized. Results Despite mandatory reporting of quality measures for PPS-exempt cancer hospitals, little consensus exists regarding specific gynecologic cancer measures. Documentation of debulking status, cancer survival, and offering minimally invasive surgery (for endometrial cancer) and intraperitoneal chemotherapy (for ovarian cancer) are important, but with widely variable responses (when ranked 1–12, standard deviations are 2–3). General issues regarding adherence to guidelines for the use of GCSF, documentation of functional status, and tracking of patient satisfaction scores were ranked the lowest. Three of the directors reported that their compensation is partially linked to quality outcomes. Conclusions There is wide variability in ranking of quality measures, and may relate to provider or institutional factors. Despite the mandatory reporting in PPS-exempt cancer hospitals, work remains to define gynecologic cancer quality measures.

Background Canfosfamide is a novel glutathione analog activated by glutathione S-transferase P1-1. This study evaluated the safety and efficacy of canfosfamide in combination with pegylated liposomal doxorubicin (PLD) in patients with platinum resistant ovarian cancer. Patients with platinum resistant ovarian carcinoma and measurable disease received canfosfamide at 960 mg/m2 in combination with PLD at 50 mg/m2, intravenously day 1 in every 28 day cycles until tumor progression or unacceptable toxicities. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS). Results Canfosfamide plus PLD combination therapy was administered at 960/50 mg/m2, respectively. Thirty-nine patients received a median number of 4 cycles (range 1.0-18.0). The ORR was 27.8% (95% CI, 14.2-45.2) with a disease stabilization rate of 80.6% (95% CI, 64.0-91.8) in the evaluable population. The CA-125 marker responses correlated with the radiological findings of complete response or partial response. The median PFS was 6.0 months (95% CI, 4.2-7.9) and median survival was 17.8 months. The combination was well tolerated. Myelosuppression was managed with dose reductions and growth factor support. Grade 3 febrile neutropenia was observed in 2 patients (5.1%). Non-hematologic adverse events occurred at the expected frequency and grade for each drug alone, with no unexpected or cumulative toxicities. Conclusions Canfosfamide in combination with PLD is well tolerated and active in platinum and paclitaxel refractory or resistant ovarian cancer. A randomized phase 3 study was conducted based on this supportive phase 2 study. Trial Registration This study was registered at www.clinicaltrials.gov: NCT00052065.