Gynecologic Oncology Group Study Research Articles

Minority Participation in Gynecologic Oncology Group (GOG) Studies

Cancer mortality rates have declined significantly in the United States since the 1990s. There has been about a 10% reduction in death in women alone. Despite this reduction, 5-year overall survival at each stage of diagnosis remains significantly lower for black patients compared with whites. The primary factors underlying cancer racial disparities are likely multifactorial and include clinical features, environmental factors, socioeconomic factors, and differences in tumor biology. Racial differences have been reported in incidence of several malignancies, including endometrial, ovarian, and cervical cancers and uterine sarcoma. A review of death rates in advanced/recurrent endometrial cancer showed that black women in the United States were 60% to 80% more likely to die of endometrial cancer when controlling for other variables such as performance status, disease stage, tumor grade and histology, and the treatment provided. Black patients with cervical cancer have the highest death compared with all racial or ethnic groups, and there is racial disparity in ovarian cancer death rates as well. The gap in racial disparity for mortality from all cancers have widened over the past few decades. The observed enrollment of black patients in clinical trials is substantially lower than that of white women. It has been suggested that enrollment of minority populations into clinical trials is critical to adequately describe true racial disparity for gynecologic malignancies. Without adequately studying minority populations, it is difficult to gain significant insight into the potential factors that contribute to well-described disparities and enhance understanding of the burden of gynecologic cancer in minority patients. The aim of this study was to evaluate minority participation in published Gynecologic Oncology Group (GOG) clinical trials. Articles published from 1985 to 2013 were reviewed. Minority enrollment was stratified by tumor site, tumor and study type, and year published. Data variables also included patient demographics and surgicopathology. Using the Centers of Disease Control and Prevention (CDC) age-adjusted incidence for race, expected and observed ratios of racial participation were calculated. Data were abstracted and reviewed from 445 GOG publications involving 67,568 patients. Racial breakdown was provided for 38% (n = 170) of these studies involving 45,259 patients and was as follows: 83% white (n = 37,617), 8% black (n = 3686), and 9% other (n = 3956). Ovarian trials (n = 202) were the most common studies accounting for 45% of those reviewed. The most common type of trials published, comprising 65% of all studies, was phase 2 studies (n = 290). There was a steady decline in the proportion of black patients enrolled when evaluating the quartiles of publication year. Inclusion of racial breakdown was not reported prior to 1994 (years 1985 to 1993; 0 publications). There was a 2.8-fold reduction in black enrollment over time. The percentage enrolled dropped from 16% in 1994 to 2002 to 5.8% from 2009 to 2013 (P < 0.01). Observed enrollment of black patients into GOG clinical trials utilizing CDC age-adjusted incidence was significantly less than expected. Compared with expected enrollment, observed black enrollment was15-fold lower in ovarian trials. Other tumor types with less than expected enrollment were endometrial (10-fold lower), cervical (4.5-fold lower), and sarcoma (5.2-fold lower); each comparison was P < 0.001. These findings show that observed enrollment of black patients into GOG studies based on age-adjusted incidence was lower than expected for a variety of tumor types. Despite emphasis on minority participation in clinical trials, there has been decrease in enrollment of black patients over time.

Comparison of diagnostic accuracy between endometrial curettage and pipelle aspiration biopsy in patients treated with progestin for endometrial hyperplasia: a Korean Gynecologic Oncology Group Study (KGOG 2019).

A prospective multicenter trial has been started in Korea to evaluate the diagnostic accuracy of endometrial aspiration biopsy compared with dilatation and curettage in patients treated with progestin for endometrial hyperplasia. For conservative treatment of endometrial hyperplasia, orally administered progestins are most commonly used method with various treatment regimens and more recently, the levonorgestrel-releasing intrauterine system also has been used successfully to treat endometrial hyperplasia. However, there is no report about the accuracy of endometrial sampling during hormonal treatment for follow-up evaluation of endometrial hyperplasia. Patients with histologically confirmed endometrial hyperplasia are offered hormonal treatment with any one of the following three options: oral medroxyprogesterone acetate 10 mg/day for 14 days per cycle, continuous oral medroxyprogesterone acetate 10 mg/day or insertion of levonorgestrel-releasing intrauterine system. Histological surveillance is performed at 3 months or 6 months following initial treatment. Endometrial tissues are obtained via endometrial aspiration biopsy using a pipelle and dilatation and curettage. In the case of levonorgestrel-releasing intrauterine system, endometrial aspiration biopsy will be done with levonorgestrel-releasing intrauterine system in uterus and then, after the removal of levonorgestrel-releasing intrauterine system, dilatation and curettage will be done. The biopsy findings will be compared. The primary endpoint is to compare the pathological outcome of endometrial aspiration with dilatation and curettage. The secondary endpoint is the response rate with three types of progestin treatment at 6 months.

Triage of Atypical Glandular Cell by SOX1 and POU4F3 Methylation: A Taiwanese Gynecologic Oncology Group (TGOG) Study.

IntroductionInvasive procedures including loop electrosurgical excision, cervical conization, and endometrial sampling are often recommended when atypical glandular cells (AGC) are detected on Pap smear with unsatisfactory colposcopy. These invasive procedures may result in patient anxiety, increased medical expense, and increasing the risk of preterm delivery in subsequent pregnancies. This study was performed to assess methylation biomarkers in the triage of AGC on Pap smear for invasive procedures.MethodsWe conducted a multicenter study in 13 medical centers in Taiwan from May 2012 to May 2014. A total of 55 samples diagnosed “AGC not otherwise specified” (AGC-NOS) were included. All patients with AGC underwent colposcopy, cervical biopsy, endometrial sampling, and conization if indicated. Multiplex quantitative methylation-specific polymerase chain reaction (QMSPCR) was performed. Sensitivity, specificity, and accuracy were calculated for detecting CIN3+ and endometrial complex hyperplasia.ResultsIn 55 patients with AGC, the sensitivity for methylated (m) SOX1m, PAX1 m, ZNF582m,PTPRRm, AJAP1m, HS3ST2m, and POU4F3m for detecting CIN3+ and endometrial complex hyperplasia lesions was 100, 86, 71, 86, 86, 57, and 100%; specificity was 67, 79, 85, 50, 52, 96, and 52%, respectively. Testing for high risk-HPV had a sensitivity of 57% and specificity of 75% for CIN3+ and endometrial complex hyperplasia lesions.ConclusionMethylated (m) SOX1m and POU4F3m could be new methylation biomarkers for detection of CIN3+ and endometrial complex hyperplasia in AGC. Women with AGC and positive SOX1m / POU4F3m, colposcopy, cervical conization or endometrial sampling should be considered.

Outcome of patients with recurrent adult-type granulosa cell tumors – A Taiwanese Gynecologic Oncology Group study

ObjectiveThe aim of this study is to evaluate the long-term outcome of ovarian recurrent granulosa cell tumors (GCTs) in a large series of patients treated in Taiwanese Gynecologic Oncology Group (TGOG) centers and to define the prognostic parameters for survival. Materials and methodsA retrospective multi-institutional review of patients with recurrent ovarian GCTs treated in TGOG centers was conducted. The clinical and pathological characteristics, treatment, and outcomes of patients with ovarian recurrent GCTs were analyzed using Kaplan-Meier and Cox proportional hazards analyses to determine the predictors for survival. ResultsA total of 44 patients from 16 medical centers were identified between January 1994 and December 2010. The median disease-free survival (DFS), postrecurrence survival, and overall survival (OS) were 61.5 months (range, 3.7–219.3 months), 55.8 months (range, 4.6–193.7 months), and 115.3 months (range, 17.2–390.6 months), respectively. In multivariate analysis, DFS (> 61.5 months versus ≤ 61.5 months, hazard ratio (HR) 0.15, 95% confidence interval (CI) 0.03–0.78, p = 0.024) at the initial operation after diagnosis of relapse was the only predictor that correlated with OS. ConclusionDFS after the initial operation was the only important predictor for overall survival in patients with recurrent GCTs, regardless of treatment, suggesting that the natural behavior of the tumor is a critical factor for patients with recurrent GCTs.

Systemic therapy for recurrent, persistent, or metastatic cervical cancer: a clinical practice guideline.

Systemic therapy options are needed for women with recurrent, metastatic, or persistent cervical cancer. This systematic review and clinical practice guideline were developed to address that need, and to update a 2007 guideline from Cancer Care Ontario's Program in Evidence-Based Care. The literature between 2006 and April 2014 in the medline and embase databases, the Cochrane Database of Systematic Reviews (Issue 4, 2014), the Cochrane Central Register of Controlled Trials (Issue 3, 2014), relevant guideline databases, and conference proceedings of the American Society of Clinical Oncology (2007-2013) was searched. A working group developed draft guidelines and incorporated comments and feedback from internal and external reviewers. Four phase iii randomized controlled trials met the inclusion criteria for the review and provided the basis for draft recommendations. Feedback was obtained from Ontario practitioners and others abroad, which led to modifications to the draft recommendations. Three key recommendations were developed. The working group concluded that all patients should be offered the opportunity to participate in appropriate randomized clinical trials. Cisplatin-paclitaxel, cisplatin-vinorelbine, cisplatin-gemcitabine, and cisplatin-topotecan are recommended combinations for this patient population. The substitution of carboplatin for cisplatin in the foregoing combinations can also be recommended because carboplatin is associated with fewer adverse effects and greater ease of administration. Selection of combination chemotherapy will depend on the toxicity profile, patient preference, and other factors. Finally, bevacizumab in combination with cisplatin-paclitaxel or carboplatin-paclitaxel is recommended for a specific subset of the target population as outlined in Gynecologic Oncology Group study 0240.

Minority participation in Gynecologic Oncology Group (GOG) Studies

ObjectiveParticipation of minority populations in clinical trials is paramount to understanding and overcoming cancer racial disparities. The goal of this project is to evaluate minority participation in published GOG clinical trials. MethodsGOG publications from 1985 to 2013 were reviewed. Minority enrollment was stratified by tumor site, type of study, and year published. Based on Centers of Disease Control and Prevention (CDC) age-adjusted incidence for race, expected and observed ratios of racial participation were calculated. ResultsA total of 445 GOG publications involving 67,568 patients were reviewed. Racial breakdown was provided in 170 studies (38%) for a total of 45,259 patients: 83% White (n=37,617); 8% Black (n=3,686), and 9% Other (n=3,956). The majority of studies were Ovarian (n=202) and Phase 2 (n=290). When evaluating the quartiles of publication year, a steady decline in the proportion of Black patients enrolled was seen. Race was not reported in any publication prior to 1994. Compared to years 1994–2002, a 2.8-fold lower proportion of black enrollment was noted in years 2009–2013 (16% and 5.8%, respectively; p<0.01). Utilizing CDC age-adjusted incidence, observed enrollment of Black patients onto GOG clinical trials was significantly less than expected enrollment. Observed Black enrollment was 15-fold lower than expected for ovarian trials, 10-fold lower for endometrial, 4.5-fold for cervix, and 5.2-fold for sarcoma (each p<0.001). ConclusionsBased on age-adjusted incidence, observed enrollment of Black patients was lower than expected enrollment onto GOG studies. Despite national emphasis on minority enrollment on clinical trials, fewer Black patients were enrolled over time.

Delayed recurrences and survival after relapse in patients initially treated with intraperitoneal chemotherapy for advanced ovarian cancer: A Gynecologic Oncology Group study.

5577 Background: Randomized trials have shown that intraperitoneal (IP) therapy is superior to intravenous (IV) chemotherapy in advanced ovarian cancer patients with long-term survival outcomes. We...

Preoperative risk assessment for lymph node metastasis in endometrial cancer (PALME study): Results of the Korean Gynecologic Oncology Group study

Preoperative risk assessment for lymph node metastasis in endometrial cancer (PALME study): Results of the Korean Gynecologic Oncology Group study

Laparoscopic retroperitoneal lymphadenectomy for bulky para-aortic ovarian cancer recurrence

posed of mtDNA and formylated peptides, are released after cellular injury and activate innate immune responses.mtDNA is found in variable amounts in serumand the tumormicroenvironment of epithelial ovarian cancer (EOC) patients. Because EOC is associated with cellular necrosis, we reasoned that extracellular mtDNA may be a molecular marker of prognosis. The prognostic significance of CA-125, the serummarkermost closely associated with EOC, is widely published. Methods: Serum frompatientswith advanced-stage EOC collected before primary surgical debulking (n= 41) was analyzed for mtDNA using quantitative polymerase chain reaction with cytochrome B primers specific for mtDNA. Defining the top 15% concentration of serum mtDNA as the high (hi) category and the remainder as low (lo), survival was determined for each category. Comparison using Cox regression model was performed. Progression-free survival (PFS) was the primary clinical endpoint. Log rank test was then used to correlate published CA-125 data with serum mtDNA. Results: Patientswithin the serummtDNA grouphadmarkedly reduced PFS (4.5 vs. 16.1 months; P=0.00145) and overall survival (8.3 vs. 50.1 months; P=0.00098) compared to the mtDNA group. Table 1A lists the patient characteristics, including disease stage, histology, grade, and mean patient age at diagnosis. Comparing pretreatment serum mtDNA levels to published results on serum CA-125 levels from a Gynecology Oncology Group study that analyzed 1299 patientswith EOC, serum mtDNA was substantially better in predicting prognosis for PFS (HR= 4.3) and OS (HR= 5.4), as shown in Table 1B. Conclusions: Comparing pretreatment serum mtDNA levels in a small cohort of the top 15% with published data on serum CA-125 levels, we observed significantly greater effect sizes with serum mtDNA in predicting prognosis in EOC, with the greatest effect in the high serum mtDNA category.

A phase I trial of pegylated liposomal doxorubicin (PLD), carboplatin, bevacizumab, and veliparib (ABT-888) in recurrent, platinum-sensitive ovarian, primary peritoneal, and fallopian tube cancer: A Gynecologic Oncology Group study

Objectives: To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of two different regimens of ABT-888 when administered with carboplatin and PLD in recurrent platinum-sensitive epithelial ovarian, primary peritoneal, and fallopian tube cancer. A second component of the study was to examine the tolerability of these treatment regimens in combination with bevacizumab (10 mg/kg on days 1 and 15) at the MTD.

A phase II trial of trebaninib (AMG 386), a selective angiopoietin 1/2 neuralizing peptibody in patients with persistent/recurrent carcinoma of the endometrium: A Gynecologic Oncology Group study

A phase II trial of trebaninib (AMG 386), a selective angiopoietin 1/2 neuralizing peptibody in patients with persistent/recurrent carcinoma of the endometrium: A Gynecologic Oncology Group study

A randomized trial comparing concurrent chemoradiotherapy with single-agent cisplatin versus cisplatin plus gemcitabine in patients with advanced cervical cancer: An Asian Gynecologic Oncology Group study

ObjectiveA recent randomized trial demonstrated that concurrent chemoradiotherapy (CCRT) with weekly cisplatin and gemcitabine, followed by two adjuvant cycles of cisplatin and gemcitabine improved survival for advanced cervical cancer patients. An Asian Gynecologic Oncology Group (AGOG) study was designed to determine whether only adding gemcitabine in the chemoradiation phase without adjuvant chemotherapy could improve survival. MethodsBetween March 2009 and March 2013, 74 eligible patients with International Federation of Obstetrics and Gynecology stage III/IVA cervical cancer or stage I/II with positive pelvic/para-aortic nodal metastasis were enrolled. Thirty-seven patients were randomized to arm C (weekly cisplatin 40mg/m2) and 37 patients were randomized to arm CG (weekly cisplatin 40mg/m2 and gemcitabine 125mg/m2), for six cycles. Six eligible patients were excluded before the beginning of treatment. ResultsAn interim analysis showed superimposable progression-free (PFS) and overall survival (OS), a decision of closing accrual was made. A 3-year PFS was similar in both arms (arm C 65.1% vs. arm CG 71.0%, p=0.71), and a 3-year OS was 74.1% in arm C vs. 85.9% in arm CG (p=0.89), but crossed over at 5years. Grade 2–4 hematological toxicities, including neutropenia (p=0.028) and thrombocytopenia (p=0.001), were more frequent in arm CG than arm C. ConclusionsDespite limitation in power, it suggests that only adding gemcitabine at the CCRT phase does not provide substantially superior results, but treatment toxicities could increase. Further studies are required to determine the role of post-CCRT adjuvant chemotherapy in advanced cervical cancer.

Primary surgery versus primary radiation therapy for FIGO stages I–II small cell carcinoma of the uterine cervix: A retrospective Taiwanese Gynecologic Oncology Group study

Objective: To evaluate the role of surgery, radiation therapy and chemotherapy in the management of small cell carcinoma of the uterine cervix (SCCC) through a retrospective study of Taiwanese Gynecologic Oncology Group. Methods: We reviewed the medical records and histological files of 144 patients with FIGO stages IA–IIB SCCC treated in 11 main hospitals in Taiwan from 1987 to 2009. Results: There were 110 patients receiving primary surgery and 34 primary radiation therapy. Most patients in each group also received chemotherapy as part of primary treatment. A lower loco-regional failure rate was observed in patients who received primary radiation therapy than in those who had primary surgery (6% vs. 27%; P=0.009). The 5-year overall survival (OS) was 89% for 13 surgically treated patients with cervical tumor ≤2cm and no lymphovascular space involvement (LVSI) in whom recurrence was noted in 2 of 4 patients without receiving adjuvant chemotherapy and none in the 9 patients who had chemotherapy. Excluding these 13 patients, primary radiation therapy with at least 5cycles of platinum-based chemotherapy (n=14, including 12 stages IB2–IIB) resulted in a 5-year OS of 78%, better than that of 46% by primary surgery (n=97, including 40 stages IB2–IIB) (P=0.046). Conclusions: None of the 9 patients with cervical tumor ≤2cm and no LVSI showed disease recurrence after primary surgery and adjuvant chemotherapy. For most patients with stages I–II, primary radiation therapy with aggressive chemotherapy was associated with better survival than surgery.

Introduction: moving beyond chemotherapy

Epithelial ovarian cancer and related cancers arising in extrauterine Mullerian epithelium are generally chemosensitive—particularly to the platinum drugs, cisplatin and carboplatin, that form the backbone of first-line treatments upon diagnosis even at early stages. Doublets of platinums with paclitaxel have represented the standard-of-care since the late 1990s, with further notable advances taking place by intraperitoneal administration (in Gynecologic Oncology Group studies) after optimal surgical cytoreduction is achieved, and by divided doses of paclitaxel (in a Japanese GOG study). Adding another agent to improve on these results has otherwise proven to be quite challenging. Nevertheless, continued forays into introducing ‘targeted therapies’ are beginning to bear fruit, and form part of this Translational Cancer Research ( TCR ) supplement. The purpose of this supplement is to provide a summary of the advances in tumor biology and a glimpse into where targeted therapeutics are moving, and their successes to date.

Outcome of 3-day bleomycin, etoposide and cisplatin chemotherapeutic regimen for patients with malignant ovarian germ cell tumours: A Taiwanese Gynecologic Oncology Group study

BackgroundThe combination of bleomycin, etoposide and cisplatin (BEP) is currently the most widely used treatment for malignant ovarian germ cell tumours (MOGCTs). The aim of this study was to evaluate the efficacy and adverse effects of the 3-day BEP regimen in Taiwan. The prognostic factors of the MOGCT patients were also analysed. Patients and methodsTwo hundred and thirty-nine cases of MOGCTs were identified from the Taiwanese Gynecologic Oncology Group database, and 204 of those who received postoperative BEP chemotherapy were then analysed. ResultsThe estimated rate of no evidence of disease was 94.0% for 204 patients with adjuvant BEP regimen. Seven grade 3/4 haematological adverse effects including four subjects with neutropenia, one with pancytopenia and two with neutropenic fever were recorded in the 853 total courses of chemotherapeutic cycles. The rates of haematological and non-haematological adverse effects were 0.82% and 2.3%, respectively. No treatment-related mortality was noted. In the analysis of prognostic factors, only tumour stage had a significant impact on disease recurrence (95% confidence interval (CI), 4.2–94.4, p<0.001) and disease-related mortality (95% CI, 2.2–163.9, p=0.007). ConclusionsThe current 3-day adjuvant BEP regimen was effective and safe for patients with MOGCTs.

Final Overall Survival Analysis of the Phase III Randomized Trial of Chemotherapy with and Without Bevacizumab for Advanced Cervical Cancer: a Nrg Oncology - Gynecologic Oncology Group Study

ABSTRACT Aim: On August 14, 2014, the United States Food and Drug Administration approved bevacizumab for women with advanced cervical cancer. This regulatory milestone was due to GOG protocol 240 having met its primary endpoint with the arms administering chemotherapy plus bevacizumab resulting in significantly improved overall survival (OS) compared to chemotherapy alone. These results were publically announced following a data freeze on Dec 12, 2012 when 271 deaths had occurred. We now report the planned final analysis of OS. Methods: Phase III randomized clinical trial using a 2x2 factorial design to determine whether chemotherapy plus bevacizumab and/or the non-platinum chemotherapy doublet (topotecan plus paclitaxel) improves OS in women with recurrent/persistent and metastatic cervical cancer. The primary endpoints were OS and toxicity with secondary endpoints being PFS and response. We calculated that we would need to enroll approximately 450 patients with approximately 346 deaths expected to provide the study with 90% power to detect a reduction in the risk of death of at least 30% with either experimental treatment, with the one-sided type I error rate limited to 2.5% for each regimen. Results: The median age was 49 yrs and groups were well-balanced for disease status (70-73% recurrent), prior chemoradiation (74-75%), and in-field pelvic recurrence (53-54%). Gastrointestinal (GI) perforations were reported in 3.2% of patients receiving bevacizumab, all of whom had prior radiotherapy. GI-vaginal fistula occurred in 8.2% of patients treated with bevacizumab vs. 0.9% of those treated with chemotherapy alone. Grade 3+ venous thromboembolic events were reported in 10.6% (chemotherapy plus bevacizumab) vs 5.4% (chemotherapy alone). On March 7, 2014, 348 deaths had occurred and the regimens administering bevacizumab continued to demonstrate a significant improvement in OS over chemotherapy alone: 16.8 mos vs 13.3 mos; HR 0.765 (95% CI: 0.62, 0.95; p = 0.0068). Conclusions: The benefit conferred by the incorporation of bevacizumab is sustained beyond 50 months as evidenced by the survival curves remaining separated. Bevacizumab is the first targeted agent to be granted regulatory approval in the U.S. for treatment of a gynecologic cancer. Disclosure: K.S. Tewari: Contracted research: Endocyte, Amgen, Genentech Speaker's Bureau: Vermillion Advisory Board: Genentech, Caris Extramural funding: National Cancer Institute, Intuitive Surgical Inc.; R.T. Penson: Advisory Board: Genentech; A. Oaknin: Advisory Board: Roche; B.J. Monk: Advisory Board: Genentech/Roche. All other authors have declared no conflicts of interest.

Methylated ZNF582 gene as a marker for triage of women with Pap smear reporting low-grade squamous intraepithelial lesions — A Taiwanese Gynecologic Oncology Group (TGOG) study

ObjectiveOur previous work revealed that host genes ZNF582, PTPRR, PAX1, and SOX1 are highly methylated in cervical intraepithelial neoplasias grade 3 or worse (CIN3+). In this study, we used a standardized testing assay to evaluate the clinical efficacy of these biomarkers in the triage of cytological diagnoses of low-grade squamous intraepithelial lesions (LSILs), and compared the performance with human papillomavirus (HPV) testing. MethodsThis 2-year multicenter prospective study examined a population of 230 women from 12 medical centers who were diagnosed with LSILs on cervical cytology. Cervical scrapings were obtained prior to a colposcopy-directed biopsy for quantitative methylation analysis of ZNF582, PTPRR, PAX1, and SOX1, and HPV testing. Using logistic regression and receiver operating characteristic curve analyses, the abilities of methylated genes and HPV to predict CIN3+ were assessed. ResultsFifteen (6.5%) of the 230 women with a cytological diagnosis of LSIL were confirmed to have CIN3+ after a colposcopy-directed biopsy. Among the 4 methylated genes, ZNF582 was found to be the best biomarker for detecting CIN3+. The sensitivities for methylated ZNF582 and HPV testing were 73% and 80%, and the specificities were 71% and 28%, respectively. The odds ratio for predicting CIN3+ using methylated ZNF582 was 6.8 (95% confidence interval (CI) 2.1–22.1), which was much better than HPV testing (OR=1.6, 95% CI 0.4–5.8). ConclusionThis is the first study to show that ZNF582 methylation analysis of cervical swabs may be a promising choice in the positive triage of cytological diagnoses of LSILs.

2A phase II study to determine the response to second curettage as initial management for persistent “low-risk” non-metastatic gestational trophoblastic neoplasia: A Gynecologic Oncology Group study

2A phase II study to determine the response to second curettage as initial management for persistent “low-risk” non-metastatic gestational trophoblastic neoplasia: A Gynecologic Oncology Group study

3Geriatric assessment and tolerance to chemotherapy in elderly women with ovarian, primary peritoneal or fallopian tube cancer: A Gynecologic Oncology Group study

3Geriatric assessment and tolerance to chemotherapy in elderly women with ovarian, primary peritoneal or fallopian tube cancer: A Gynecologic Oncology Group study

Prognostic factors and treatment outcomes for patients with surgically staged uterine clear cell carcinoma focusing on the early stage: A Taiwanese Gynecologic Oncology Group study

ObjectiveThe aim of this study was to investigate the clinical and pathological characteristics of uterine clear cell carcinoma (UCCC) and the treatment of this disease in relation to patient outcomes. MethodsThe clinicopathological data for and the management of all patients with UCCC who presented between 1991 and 2010 at 11 member hospitals of the Taiwanese Gynecologic Oncology Group (TGOG) were retrospectively reviewed. ResultsThere were no significant differences in 5-year overall survival (OS) rates between patients with pure UCCC (n=100) and non-pure UCCC (n=53) at the same surgical stage, with OS rates of 92.6%, and 87.7% for stage I; 83.3% and 83.3% for stage II; 64.0% and 67.8% for stage III; and 16.7% and 0% for stage IV (n=1), respectively. Tumor stage and age independently influenced the OS rate of UCCC. For the patients with early stage UCCC, the adjuvant therapy modality was the only significant prognostic factor for recurrence-free survival. The patients with early stage UCCC who received adjuvant therapy had excellent 5-year recurrence-free survival and OS rates compared to those who received radiotherapy (100% vs. 74%, p=0.01; 100% vs. 72%, p=0.03). ConclusionsThe 5-year survival rates of patients with pure UCCC and non-pure UCCC were similar. The prognosis for surgical staging of patients with stage I/II UCCC was encouraging. Postoperative adjuvant platinum-based chemotherapy is recommended for patients with early stage UCCC who are at a high risk of recurrence.