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Competing Interests: Competing interests: IR-C has reported advisory boards for Abbvie, Agenus, Advaxis, Blueprint, BMS, ESAÏ, Daichi Sankyo, PharmaMar, Genmab, Pfizer, AstraZeneca, Roche/Genentech, GSK, MSD, Deciphera, Mersana, Merck Sereno, Macrogenics, Novartis, Amgen, Tesaro and Clovis, and grants for traveling from Roche, MSD, AstraZeneca, Chugai and GSK; PG-C has reported Institution research grants from Advenchen Laboratories, Amgen Dompé, AROG Pharmaceuticals, Bayer, Blueprint Medicines, Boehringer Ingelheim, Daiichi Sankyo, Deciphera, Eisai, Eli Lilly, Epizyme Inc, Foghorn Ther Inc, Glaxo, Hutchinson MediPharam Lt, Inhibrx Inc, Karyopharm Pharmaceuticals, PTC Ther, Novartis, Pfizer, PharmaMar, Rain Oncology, and SpringWorks Ther; RJ has reported advisory boards for Adaptimmune, Astex, Athenex, Bayer, Borhringer Ingelheim, Blueprint, Clinigen, Eisai, Epizume, Daichii, Deciphera, Immunedesign, Immunicum, Karma Oncology, Lilly, Merck, Mundipharma, PharmaMar, Springworks, SynOx, Tracon, and Upto Date; RS has reported grants for traveling from ParmaMar; FA has reported advisory boards for MiMark; J-YB has reported advisory boards for Deciphera, Bayer and Roche, and grants for traveling from OSE Pharma (unrelated); JM-B has reported advisory boards for Asofarma, Tecnofarma, FarmaMar, GSK, Novartis, Amgen, Bayer, Roche, Lilly and Boehringer Ingelheim, and grants for traveling from PharmaMar; AC has reported advisory boards for AstraZeneca and EISAI, and grants for traveling from PharmaMar, Merck and AstraZeneca; APDT has reported advisory boards for GSK, Boehringer and Novartis Oncology, and grants for traveling from PharmaMar; MLH has reported advisory boards for Aadi; PH has reported advisory boards for Boehringer Ingelheim and PharmaMar, and grants for traveling from Boehringer Ingelheim, PharmaMar, and Lighthouse PTC; PP has reported advisory boards for PharmaMar and MSD, and grants for traveling from Amgen, PharmaMar, AstraZeneca, and MSD; ARAR has reported research support (institutional) from 23&Me, Abbisko, AbbVie, Adaptimmune, Amgen, AstraZeneca, Bayer, Biontech, Blueprint Medicine, Boehringer Ingleheim, Bristol Myers Squibb, Cogent Biosciences, Daiichi Sankyo, Deciphera, Frontier Biopharma, Gilead, GSK, Iterion Therapeutics, Karyopharm Therapeutics, MedImmune, Medison, Merck, Neoleukin, Novartis, Pfizer, Polaris, Roche/Genentech, Rain Therapeutics, and Symphogen, expert testimony/advisory boards for Boehringer Ingelheim and Medison, DSMB (self) for Inhibrx, and honorarium (self) from Journal of Clinical Oncology, Medison and UpToDate; JS has reported advisory boards for AstraZeneca, Eisai, MSD, GSK, Novocure, Intuitive Surgical Deutschland GmbH, Seagan, Bayer Vital, GmbH, Mundipharma GmbH, PharmaMar, Sanofi-Aventis Deutschland GmbH, Immunogen, Tubulis GmbH, and Daiichi Sankyo, and grants for traveling from AstraZeneca, Eisai, MSD, GSK, Novocure, Intuitive Surgical Deutschland GmbH, Seagan, Bayer Vital, GmbH, Mundipharma GmbH; PharmaMar, Sanofi-Aventis Deutschland GmbH, Immunogen, Tubulis GmbH, Daiichi Sankyo; WvH has reported advisory boards for Sanofi, Belpharma, Boehringer Ingelheim, MSD, and Novartis, and grants for traveling from Sanofi; MF has reported consulting fees from AstraZeneca, Novartis, GSK, and Incyclix, payment for honoraria for lectures, presentations, spearkers bureaus, manuscript writing or educational events from AstraZeneca, GSK, MSD, and Limbic, participation on a data safety monitoring board or advisory board for AGITG IDSMB, and ENDO-3, and research grants (institution) from AstraZeneca, Beigene and Novartis; SCr, FMF, DF, IZ, SCh, RH, J-WK, SIK, MMM, and FP have reported no conflicts of interest.

Objective: To assess potential predictive variables for nodal metastasis and survival outcomes in patients with newly diagnosed, low-grade endometrial stromal sarcoma., Methods: We performed a single-institution, retrospective analysis of consecutive patients with newly diagnosed, low-grade endometrial stromal sarcoma who presented between January 1, 1980 and December 31, 2019 and underwent hysterectomy at our institution or presented within 3 months of primary surgery elsewhere before recurrence. Patients who presented to our institution only at recurrence were excluded. Patients with <3 months of follow-up were excluded from survival analyses., Results: We identified 127 consecutive patients for analysis. Median age at diagnosis was 48 years (range 19-88 years); 91 (74.6%) of 127 were pre-menopausal; and 74 (58.3%) of 127 had uterine-confined, stage I tumors. Of 56 patients (44.1%) who underwent lymph node sampling, 10 (17.9%) had nodal metastasis. Of the 10 with nodal metastasis, 1 (10%) did not have lymphadenopathy or extra-uterine disease, 4 (40%) had lymphadenopathy only, 1 (10%) had extra-uterine disease only, and 4 (40%) had both. Among the 29 patients without apparent extra-uterine disease or gross lymphadenopathy, there was one occult lymph node metastasis (3.4%). Gross lymphadenopathy at time of surgery was predictive for lymph node metastasis (p<0.001). Median follow-up was 69 months (range 4-336) for the 95 patients included in the survival analyses. The 5-year progression-free survival and disease-specific survival rates were 79.8% and 90.8%, respectively. Patients with stage I tumors had longer progression-free survival than those with stage II-IV disease (p<0.001); there was no difference in disease-specific survival (p=0.63). Post-operative observation versus adjuvant therapy with hormone blockade or radiation therapy did not result in progression-free survival differences for stage I or completely resected stage II-IV disease (p=0.50 and p=0.81, respectively). Similarly, there was no disease-specific survival difference for completely resected stage II-IV disease (p=0.3)., Conclusions: Lymph node dissection in patients with low-grade endometrial stromal sarcoma should be reserved for those with clinically suspicious lymphadenopathy. Disease stage correlated with progression-free survival but not disease-specific survival. Post-operative therapy did not improve progression-free survival or disease-specific survival., Competing Interests: Competing interests: Outside the submitted work, ML reports personal fees from JnJ/Ethicon and Takeda, and grants from KCI/Acelity. He is also an ad hoc speaker for Intuitive Surgical, Inc. NRA-R reports grants from Stryker/Novadaq and GRAIL. SC reports personal fees from AstraZeneca. MLH reports “other” from Sanofi and UpToDate, as well as personal fees from GSK, Lilly, Thrive/Exact Sciences, and Research To Practice., (© IGCS and ESGO 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Hypersensitivity with repeated exposure to platinum agents is common and can preclude continued treatment, even in patients with disease that remains platinum sensitive. We sought to compare the effects of prophylactic, extended carboplatin infusion versus standard infusion on the rate of carboplatin hypersensitivity reactions (HSRs) in women with recurrent ovarian cancer., Methods: This was a single-institution, randomized, nonblinded trial comparing a graded, 3-hour extended infusion of carboplatin with a standard 30-minute infusion in patients with recurrent ovarian cancer who were enrolled from January 2011 to April 2015. The study was designed to detect a decrease in the HSR rate from 20% (standard infusion) to 5% (extended infusion) assuming a type 1 error of 10% and power of 80% using a 1-sided test., Results: Of 146 enrolled patients, 114 were evaluable. Fifteen (13%) had an HSR-11% (6/56) in the extended-infusion and 16% (9/58) in the standard-infusion groups (P = 0.582). Planned treatment completion was achieved in 50 (89%) of 56 patients and 49 (84%) of 58 patients, respectively. Of 25 patients who received single-agent carboplatin, 8 (32%) had an HSR (53% of all patients who had an HSR [8/15]). Of 23 patients who received carboplatin with gemcitabine, 4 (17%) had an HSR (27% of all patients who had an HSR [4/15]). Of 8 patients who received carboplatin with paclitaxel, 3 (38%) had an HSR (20% of all patients who had an HSR [3/15]). There were no HSRs with pegylated liposomal doxorubicin, the most commonly given concurrent chemotherapy (46% of all patients)., Conclusions: A prophylactic, extended carboplatin infusion was not associated with a decreased HSR rate. The overall low HSR rate suggests that premedication may help reduce HSRs.

Objective: The aim of the study was to evaluate the activity and tolerability of iniparib monotherapy in women with BRCA1 or BRCA2-associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer., Methods and Materials: Eligible patients had advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer, germline BRCA1 or BRCA2 mutation, measurable disease, and at least 1 previous treatment regimen of platinum/taxane chemotherapy. Patients received iniparib 8 mg/kg intravenously on days 1 and 4 weekly, with imaging every 8 weeks. Treatment continued until disease progression or adverse events (AEs) prohibited further therapy. Common Terminology Criteria for AEs v3.0 was used to grade AEs. The primary endpoint was tumor response. The study was conducted with a Simon 2-stage design with 12 and 23 patients planned in the first and second stage, respectively. The study was designed to distinguish between 10% and 30% responding with types 1 and 2 error of 0.10., Results: Twelve patients were treated on study, with median exposure to iniparib of 7.5 weeks. The median number of previous chemotherapeutic regimens was 7. Treatment-related AEs (≥10%) included asthenia (83.3%), constipation (25%), diarrhea (25%), nausea (25%), abdominal pain (16.7%), and decreased hemoglobin (16.7%). All treatment-related AEs were grades 1 or 2 with the following 2 exceptions: 1 grade 3 diarrhea and 1 grade 3 hypertension. One patient had stable disease lasting 2 cycles; the remaining 11 patients had progressive disease. The study did not proceed to second stage enrollment., Conclusions: Iniparib did not show significant activity in this heavily pretreated ovarian cancer population, all of whom had BRCA1 or BRCA2 mutations.

Objectives: The Gynecologic Cancer InterGroup aimed to provide an overview of uterine and ovarian leiomyosarcoma management., Methods: Published articles and author experience were used to draft management overview. The draft manuscript was circulated to international members of the Gynecologic Cancer InterGroup for review and comment, and appropriate revisions were made., Results: The approach to management of uterine and ovarian leiomyosarcoma management is reviewed., Conclusions: Uterine and ovarian leiomyosarcomas are rare and aggressive cancers that require specialized expertise for optimal management.

Objective: To evaluate overall survival (OS) and progression-free survival (PFS) after adjuvant therapy in stage I to stage IV uterine carcinosarcoma with rhabdomyosarcoma differentiation., Methods: Memorial Sloan-Kettering Cancer Center medical records from 1990 to 2012 were reviewed. Patients who received chemotherapy with or without radiation therapy (RT), or RT alone, for completely resected stage I to stage IV uterine carcinosarcoma with rhabdomyosarcoma differentiation were included., Results: Of 53 patients, International Federation of Gynecology and Obstetrics stage distribution was as follows: I, 13 (24.5%); II, 8 (15.1%); III, 13 (24.5%); and IV, 19 (35.9%). Forty-one (77.4%) of 53 patients received adjuvant chemotherapy, and 34% of the patients who received chemotherapy also received pelvic RT or intravaginal brachytherapy (IVRT). Twelve (22.6%) of the 53 patients received only pelvic RT with/without IVRT. Paclitaxel-carboplatin was the most commonly used adjuvant chemotherapy treatment. The median PFS for the entire cohort was 13.4 months (95% confidence interval [CI], 10.5-17.0). The median OS for the entire cohort was 23.0 months (95% CI, 16.9-34.3). The median PFS periods by stage were 15.9 months for stages I/II versus 11.2 months for stages III/IV (P = 0.012). Median OS was not reached in the early-stage cohort. The median OS for the late-stage cohort was 20.9 months (P = 0.004). The median PFS periods by treatment were 10.4 months for pelvic RT with/without IVRT group versus 13.1 months for chemotherapy with/without pelvic RT with/without IVRT group (P = 0.498). The median OS periods by treatment were 23.6 months for chemotherapy with/without pelvic RT with/without IVRT group versus 16.9 months for pelvic RT with/without IVRT group (P = 0.501)., Conclusion: The results suggest that chemotherapy alone or in combination with RT is associated with longer PFS and OS compared to RT alone. Only the stage of disease significantly affected PFS and OS.

Objective: We propose a new staging system for stage I endometrial cancer and compare its performance to the 1988 and 2009 International Federation of Gynecology and Obstetrics (FIGO) systems., Methods: We analyzed patients with 1988 FIGO stage I endometrial cancer from January 1993 to August 2011. Low-grade carcinoma consisted of endometrioid grade 1 to grade 2 lesions. High-grade carcinoma consisted of endometrioid grade 3 or nonendometrioid carcinomas (serous, clear cell, and carcinosarcoma). The proposed system is as follows:IA. Low-grade carcinoma with less than half myometrial invasionIB. High-grade carcinoma with no myometrial invasionIC. Low-grade carcinoma with half or greater myometrial invasionID. High-grade carcinoma with any myometrial invasion, Results: Data from 1843 patients were analyzed. When patients were restaged with our proposed system, the 5-year overall survival significantly differed (P < 0.001): IA1, 96.7%; IA2, 92.2%; IB1, 92.2%; IB2, 76.4%; IC1, 83.9%; IC2, 78.6%; ID1, 81.1%; and ID2, 68.8%. The bootstrap-corrected concordance probability estimate for the proposed system was 0.627 (95% confidence interval, 0.590-0.664) and was superior to the concordance probability estimate of 0.530 (95% confidence interval, 0.516-0.544) for the 2009 FIGO system., Conclusions: By incorporating histological subtype, grade, myometrial invasion, and whether lymph nodes were removed, our proposed system for stage I endometrial cancer has a superior predictive ability over the 2009 FIGO staging system and provides a novel binary grading system (low-grade including endometrioid grade 1-2 lesions; high-grade carcinoma consisting of endometrioid grade 3 carcinomas and nonendometrioid carcinomas).

Objective: Long-term survival for patients with advanced endometrial carcinoma is poor, and limited options exist for the management of recurrent disease. Our goal was to investigate the activity of doxorubicin in the second-line setting in patients who progressed after paclitaxel/carboplatin adjuvant treatment., Methods: We conducted a retrospective analysis of patients with recurrent endometrial carcinoma who were treated at Memorial Sloan-Kettering Cancer Center from 1995 to 2009 and who received paclitaxel/carboplatin adjuvant chemotherapy followed by second-line doxorubicin therapy at time of recurrence. The median progression-free survival (PFS) and overall survival times following paclitaxel/carboplatin and following second-line doxorubicin therapy were estimated using the Kaplan-Meier method. Toxicity was assessed by the treating physician at each visit and graded using version 4.0 of Common Terminology Criteria for Adverse Events. Patient presentation, treatment, patterns of recurrence, and patient outcomes were summarized., Results: Seventeen patients were included in study analyses. The median PFS from completion of paclitaxel/carboplatin was 8.0 months (95% confidence interval [CI], 4.5-13.6 months). At the time of recurrence, all 17 patients were treated with doxorubicin as second-line therapy. No patient achieved objective response of stable disease. The median PFS of this cohort following doxorubicin treatment was 2.1 months (95% CI, 0.95-2.7) months. Median overall survival was 5.8 months (95% CI, 1.0-15.0 months). There is only 1 patient still alive; her median follow-up time is 49.4 months. Predominant doxorubicin-related grade 2 toxicities included nausea/vomiting (18.8%), fatigue (18.8%), and neutropenia (12.5%). No grade 3 or 4 toxicities occurred., Conclusions: Among patients with advanced endometrial carcinoma who had received adjuvant paclitaxel/carboplatin, treatment with doxorubicin at time of disease recurrence failed to achieve any objective responses and was associated with a very short (2 months) time to progression. Doxorubicin may be considered inactive as second-line therapy in this endometrial carcinoma population.

Objective: To describe the incidence of low-volume ultrastage-detected metastases in sentinel lymph nodes (SLNs) identified at surgical staging for endometrial carcinoma and to correlate it with depth of myoinvasion and tumor grade., Methods: We reviewed all patients who underwent primary surgery for endometrial carcinoma with successful mapping of at least one SLN at our institution from September 2005 to December 2011. All patients underwent a cervical injection for mapping. The SLN ultrastaging protocol involved cutting an additional 2 adjacent 5-μm sections at each of 2 levels, 50-μm apart, from each paraffin block lacking metastatic carcinoma on routine hematoxylin and eosin (H&E) staining. At each level, one slide was stained with H&E and with immunohistochemistry (IHC) using anticytokeratin AE1:AE3.Micrometastases (tumor deposits >0.2 mm and ≤2 mm) and isolated tumor cells (≤0.2 mm) were classified as low-volume ultrastage-detected metastases if pathologic ultrastaging was the only method allowing detection of such nodal disease., Results: Of 508 patients with successful mapping, 413 patients (81.3%) had endometrioid carcinoma. Sixty-four (12.6%) of the 508 patients had positive nodes: routine H&E detected 35 patients (6.9%), ultrastaging detected an additional 23 patients (4.5%) who would have otherwise been missed (4 micrometastases and 19 isolated tumor cells), and 6 patients (1.2%) had metastatic disease in their non-SLNs. The incidence rates of low-volume ultrastage-detected nodal metastases in patients with grades 1, 2, and 3 tumors were 3.8%, 3.4%, and 6.9%, respectively. The frequency rates of low-volume ultrastage-detected metastases in patients with a depth of myoinvasion of 0, less than 50%, and 50% or more were 0.8%, 8.0%, and 7.4%, respectively. Lymphovascular invasion was present in 20 (87%) of the cases containing low-volume ultrastage-detected metastases in the lymph nodes., Conclusions: Sentinel lymph node mapping with pathologic ultrastaging in endometrial carcinoma detects additional low-volume metastases (4.5%) that would otherwise go undetected with routine evaluations. Our data support the incorporation of pathologic ultrastaging of SLNs in endometrial carcinoma with any degree of myoinvasion. The oncologic significance of low-volume nodal metastases requires long-term follow-up.

Objective: The purpose of this study was to describe the location of disease at the time of death of patients with endometrial cancer who died of their disease., Methods: All patients with a diagnosis of endometrial cancer from January 1993 through December 2010 were included. Histologic classification was either endometrioid or high-risk (HR) endometrial cancer. Patients who died were divided into 3 groups: dead of disease (DOD), dead of other causes (DOO), and dead lost to follow-up. Patterns of disease spread at death were documented from the most recent examination and imaging studies., Results: We identified 2513 patients. The median age at diagnosis was 62 years. Histologic findings were endometrioid endometrial cancer, 1949 patients (78%); and HR endometrial cancer, 54 patients (22%). The 1988 International Federation of Gynecology and Obstetrics stages were: stage I, 1763 patients (70%); stage II, 145 patients (6%); stage III, 416 patients (17%); and stage IV, 189 patients (8%). At the time of this study, 1867 patients (74%) had no evidence of disease, 232 patients (9%) were alive with disease, and 414 patients (16%) were dead. Of the 16% of patients who were dead, 224 (9%) of the 2513 patients were DOD, 84 (3%) of the 2513 patients were dead of other disease, and 106 (4%) of the 2513 patients were dead lost to follow-up. Of the 224 patients who were DOD, the locations of the disease at the time of death were pelvic, 23 patients (10%); abdominal, 83 patients (37%); and distant, 118 patients (53%). There was no significant difference in the pattern of location of disease between the endometrioid and HR histologies (P = 0.36)., Conclusions: These data suggest that death from endometrial cancer is largely due to abdominal (liver) and distant (lung) metastases, and this pattern of disease seems similar in the endometrioid and HR histologies. Most of the patients who died of their disease had metastases beyond the pelvis at the time of death.

Objective: Estimates of progression-free survival (PFS) from single-arm phase 2 consolidation/maintenance trials for recurrent ovarian cancer are usually interpreted in the context of historical controls. We illustrate how the duration of second-line therapy (SLT), the time on the investigational therapy (IT), and patient enrollment plan can affect efficacy measures from maintenance trials and might result in underpowered studies., Methods: Efficacy data from 3 published single-arm consolidation therapies in second remission in ovarian cancer were used for illustration. The studies were designed to show an increase in estimated median PFS from 9 to 13.5 months. We partitioned PFS as the sum of the duration of SLT, treatment-free interval, and duration of IT. We calculated the statistical power when IT is given concurrently with SLT or after SLT by varying the start of IT. We compared the sample sizes required when PFS includes the time on SLT versus PFS that starts after SLT at initiation of IT., Results: Required sample sizes varied with duration of SLT. If IT starts with initiation of SLT, only 34 patients are needed to provide 80% power to detect a 33% hazard reduction. In contrast, 104 patients are required for a single-arm study for 80% power, if IT begins 7.5 months after SLT initiation., Conclusions: Designs of nonrandomized consolidation trials that aim to prolong PFS must consider the effect of the duration of SLT on the end point definition and on required sample size. If IT is given concurrently with SLT, and after SLT, then SLT duration must be restricted per protocol eligibility, so that a comparison with historical data from other single-arm phase 2 studies is unbiased. If IT is given after SLT, the duration of SLT should be taken into account in the design stage because it will affect statistical power and sample size.

Patients who have undergone supracervical hysterectomy or uterine morcellation for presumed benign uterine disease and are found to have malignancy on final pathology represent a management dilemma. Our goal was to analyze our experience and make observations regarding staging, treatment, and outcomes. We performed a retrospective case series of patients referred to our institution with uterine malignancy who previously underwent supracervical hysterectomy or uterine morcellation at the time of original surgery for presumed benign uterine disease. Between January 2000 and March 2006, 17 patients with uterine malignancy were identified. Following initial surgery, 15 (88%) patients had presumed stage I disease and 2 (12%) patients had stage III disease. Two (15%) of 13 patients who underwent completion surgery were upstaged; both had leiomyosarcoma (LMS) originally resected with morcellation. Ten of 11 patients whose stage was confirmed with secondary surgery remain disease free. None of the patients who initially underwent supracervical hysterectomy without morcellation were upstaged by secondary surgery. The median follow-up interval was 30 months (range, 2-90 months). Reoperation for completion surgery and staging is important when uterine malignancy is found incidentally after morcellation or supracervical hysterectomy for presumed benign uterine disease. Approximately 15% of patients will be upstaged by reexploration, particularly those with LMS who underwent morcellation. Patients who undergo completion surgery with restaging and are not upstaged appear to have a good prognosis. Surgical staging is valuable for prognosis and may alter postoperative treatments.

This phase I study sought to determine the toxicity profile, pharmacokinetics, and antitumor activity of giving carboplatin every 3 weeks and paclitaxel weekly in patients with relapsed ovarian cancer. Eligible patients with relapsed epithelial ovarian cancer and prior treatment with platinum- and paclitaxel-based therapy were treated with an escalating regimen of carboplatin (day 1) at an area under the curve (AUC) of 4-6 and 1-h infusions of paclitaxel (days 1, 8, and 15) at 50-80 mg/m(2) cycled at 3-week intervals. Pharmacokinetic studies were performed on the first day of cycles 1 and 2. All patients had a platinum-free interval of greater than 6 months from the most recent platinum treatment. A total of 77 cycles were administered to 16 patients, with a similar median number of cycles per patient at each dose level varying from 4.6 to 5.3. Febrile neutropenia and grade 4 thrombocytopenia were the dose-limiting toxicities at dose levels 3 and 4 after the third cycle, with no mucositis, nausea, vomiting, or peripheral neuropathy observed greater than grade 2. The maximum tolerated dose of carboplatin was an AUC of 5 and 80 mg/m(2) for paclitaxel. Pharmacokinetic analysis showed a marginal statistical difference with regard to reduced systemic paclitaxel concentration after cycle 2 compared with cycle 1 (P= 0.06). Of nine patients evaluable for a radiographic response, the response rate was 66.6% with a complete response of 33.3%. All five patients with nonmeasurable disease achieved a biochemical response. The combination of carboplatin given every 3 weeks at an AUC of 5 and 1-h weekly paclitaxel at 80 mg/m(2) is a feasible and reasonably well-tolerated regimen and may have significant antitumor activity in relapsed ovarian cancer patients.

The aim of this study was to assess the efficacy and tolerability of paclitaxel and carboplatin (TC) in the treatment of patients with advanced or recurrent endometrial cancer. Patients eligible for this retrospective analysis had endometrial cancer with either advanced or recurrent measurable disease (untreated primary stage III/IV or stage III/IV patients with persistent, measurable disease [> or =2 cm] after surgery), Eastern Cooperative Oncology Group (ECOG) performance status > or =3, and received at least one cycle of TC. Response rates were determined using Response Evaluation Criteria in Solid Tumors criteria. Institutional Review Board approval was obtained prior to the initiation of this study. Eighty-five eligible patients, with a median age of 62 years (range 36-80) were identified. Fifty-seven (67%) of patients were treated at the time of recurrence. Prior radiation therapy had been used in the treatment of 36 (42%) patients, while 13 (15%) patients had received prior chemotherapy. Median follow-up time was 11.7 months (range 1.1-96.7 months), and the median number of cycles of therapy received was six (range 1-18). The overall response rate (ORR) was 43%, with a complete response rate of 5% and a partial response rate of 38%. Chemotherapy-naive patients had an ORR of 47%. Only seven (8%) patients had to discontinue therapy due to toxicity. Median progression-free survival was 5.3 months (95% CI, 4.6-7.4), with a median overall survival of 13.2 months (95% CI, 11.7-18.2). We conclude that TC is an active and tolerable regimen in the treatment of patients with advanced or recurrent endometrial cancer.