Use of hypnotics among women diagnosed with cervical cancer - A population-based cohort study.

OBJECTIVE: Previous studies suggest that sleeping problems are frequent after cervical cancer. However, the evidence on the use of hypnotics is sparse. We investigated if women diagnosed with cervical cancer have an increased risk of using hypnotics and identified risk factors for prolonged use. METHODS: In this nationwide register-based cohort study, 4264 women diagnosed with cervical cancer from 1997 to 2013 and 36,632 cancer-free women were followed in registers until 2016. Prolonged use of hypnotics was defined as more than three prescriptions with no more than three months in between. Data were analysed using Cox proportional hazards regression models and multistate Markov models separately for women with localized and advanced cervical cancer. RESULTS: The rate of first use of hypnotics was substantially increased during the first year after cervical cancer diagnosis compared to cancer-free women (HRlocalized 4.4, 95% CI 3.9-5.1; HRadvanced 8.9, 95% CI 7.5-10.6) and remained markedly increased for up to five years after diagnosis. Dependent on stage of disease and age, 1.4 to 4.7 excess women per 100 with cervical cancer were prolonged users of hypnotics compared to cancer-free women one year after diagnosis. Risk factors for prolonged use of hypnotics were higher age, short education, previous use of antidepressants or anxiolytics, and advanced disease. CONCLUSIONS: Women diagnosed with cervical cancer are at increased risk of prolonged use of hypnotics. For the majority, treatment with hypnotics is initiated within the first year after cancer diagnosis, but the rate of first use is increased for up to five years.

Gynaecological cancer leads to long-term sick leave and permanently reduced working ability years after diagnosis.

PURPOSE: The aim of the study was to investigate overall patterns in labour market affiliation, risk for permanently reduced work ability and prevalence of long-term sickness absence among women diagnosed with gynaecological cancer. METHODS: We followed 8451 women diagnosed with ovarian, endometrial or cervical cancer, and 72,311 women with no history of cancer in nationwide registers for up to 19 years (mean 7.5 years). We computed hazards ratios for permanently reduced working ability and annual proportions of long-term sick leave. RESULTS: Patterns of labour market affiliation varied by cancer diagnosis and stage. The hazard of permanently reduced working ability was increased for survivors of all three cancers but most pronounced for women diagnosed with advanced ovarian cancer. The highest hazard ratios were found 2-5 years after diagnosis, and they persisted for years in all groups and throughout the follow-up period of 19 years in women diagnosed with advanced cervical cancer. In the subgroups of women who continued to be potentially active on the labour market, long-term sick leave was more prevalent among cancer survivors than women with no history of cancer up to 10 years after diagnosis. CONCLUSIONS: Women diagnosed with localised as well as advanced gynaecological cancer are at prolonged risk for permanently reduced working ability and long-term sick leave. IMPLICATIONS FOR CANCER SURVIVORS: Gynaecological cancer can have long-term as well as permanent consequences for working ability, and survivors who remain active on the labour market might have to take more sick leave even years after cancer diagnosis than other women at their age.

Survival after a nationwide adoption of robotic minimally invasive surgery for early-stage cervical cancer - A population-based study.

AIM: Lately, the safety of minimally invasive surgery (MIS) in the treatment of cervical cancer (CC) has been questioned. This study aimed to evaluate the risk of recurrence and survival after a nationwide adoption of robotic MIS for the treatment of early-stage CC in Denmark. METHODS: Population-based data on all Danish women with early-stage CC, who underwent radical hysterectomy January 1st 2005-June 30th 2017 were retrieved from the Danish Gynecologic Cancer Database and enriched with follow-up data on recurrence, death and cause of death. The cohort was divided into two groups according to the year of robotic MIS introduction at each cancer centre. Chi-squared or Fischer test, the Kaplan Meier method and multivariate Cox regression were used for comparison between groups. RESULTS: One thousand one hundred twenty-five patients with CC were included; 530 underwent surgery before (group 1) and 595 underwent surgery after (group 2) the introduction of robotic MIS. The 5-year rate of recurrence was low: 8.2% and 6.3% (p = 0.55) in group 1 and 2, respectively. In adjusted analyses, this corresponded to a five-year disease-free survival, hazard ratio (HR) 1.23 [95% confidence interval (CI) 0.79-1.93]. No difference in site of recurrence (P = 0.19) was observed. The cumulative cancer-specific survival was 94.1% and 95.9% (P = 0.10) in group 1 and 2, respectively, corresponding to a HR 0.60 [95% CI 0.32-1.11] in adjusted analyses. CONCLUSION: In this population-based cohort study, the Danish nationwide adoption of robotic MIS for early-stage CC was not associated with increased risk of recurrence or reduction in survival outcomes.

Increased risk for depression persists for years among women treated for gynecological cancers - a register-based cohort study with up to 19 years of follow-up.

OBJECTIVE: Little is known about long-term risk of depression in women treated for gynecological cancers. We aim to investigate risk for depression among these women compared to women without a history of cancer. METHODS: We followed 16,833 women diagnosed with gynecological cancers between 1998 and 2013 and 138,888 reference women in nationwide registers for up to 19 years. Women with a history of severe psychiatric disorders, and those who had redeemed a prescription for antidepressants three years before study entry were excluded from analyses. Regression analyses were applied to compare the risk for antidepressant use among patients compared to reference women, and to investigate associations between socio-demographic as well as clinical risk factors and use of antidepressants. RESULTS: We found an increased risk for antidepressant use among women treated for ovarian (HR 4.14, 95% CI 3.74-4.59), endometrial (HR 2.19, 95% CI 1.97-2.45), and cervical cancer (HR 3.14, 95% CI 2.74-3.61) one year after diagnosis. This increased risk persisted years after diagnosis in all three groups, with the longest (up to eight years) found for ovarian cancer. Advanced disease was strongly associated with antidepressant use followed by short education, and comorbidity. CONCLUSIONS: Women diagnosed with gynecological cancer have an increased risk for depression compared to reference women. The risk remains increased for years after diagnosis throughout and beyond standard oncological follow-up care. Advanced disease, short education, and comorbidity are factors associated with antidepressant use in this patient group.

Correction: Tumour-reactive T cell subsets in the microenvironment of ovarian cancer.

Since the publication of this paper, the authors noticed that the funding information was not complete. The correct funding information is now shown in the Acknowledgements section. Acknowledgements The studies were supported by grants from the OvaCure Foundation, the Danish Cancer Society Research Foundation, the Anticancer Fund, Aase og Ejnar Danielsens Foundation and the Independent Research Fund Denmark (grant number DFF-4183-00597).

Tumour-reactive T cell subsets in the microenvironment of ovarian cancer.

BACKGROUND: Solid malignancies are frequently infiltrated with T cells. The success of adoptive cell transfer (ACT) with expanded tumour-infiltrating lymphocytes (TILs) in melanoma warrants its testing in other cancer types. In this preclinical study, we investigated whether clinical-grade TILs could be manufactured from ovarian cancer (OC) tumour specimens. METHODS: Thirty-four tumour specimens were obtained from 33 individual patients with OC. TILs were analysed for phenotype, antigen specificity and functionality. RESULTS: Minimally expanded TILs (Young TILs) were successfully established from all patients. Young TILs contained a high frequency of CD3+ cells with a variable CD4/CD8 ratio. TILs could be expanded to clinical numbers. Importantly, recognition of autologous tumour cells was demonstrated in TILs in >50% of the patients. We confirmed with mass spectrometry the presentation of multiple tumour antigens, including peptides derived from the cancer-testis antigen GAGE, which could be recognised by antigen-specific TILs. Antigen-specific TILs could be isolated and further expanded in vitro. CONCLUSION: These findings support the hypothesis that patients with OC can benefit from ACT with TILs and led to the initiation of a pilot clinical trial at our institution . TRIAL REGISTRATION: clinicaltrials.gov: NCT02482090.

Association between oropharyngeal cancers with known HPV and p16 status and cervical intraepithelial neoplasia: a Danish population-based study.

BACKGROUND: Persistent infection with high-risk genotypes of human papillomavirus (HPV) is the main risk factor in the development of uterine cervical precancerous lesions and cervical cancer (CC), and cases of HPV-induced oropharyngeal squamous cell carcinoma (OPSCC) is increasing in the Western world. We investigated the association between HPV and p16 status and previous results of cervical examinations, including cytological and histological tests, in females with OPSCC. MATERIAL AND METHODS: We included females diagnosed with an OPSCC in Eastern Denmark from 2000 to 2014. OPSCCs were assessed for p16-overexpression and HPV DNA PCR. History of cervical tests was obtained from the Danish Pathology Registry. The cytology and histological results were categorized in accordance with the 2014 Bethesda System (TBS) and WHO. Hence, we divide the cervical results into two groups. Group I were negative for intraepithelial lesion or malignancy and group II had epithelial cell abnormalities and subdivided after increasingly neoplastic severity from A-D. Chi2-tests and Fischer's exact tests were performed to compare the two groups. RESULTS: A total of 417 women with OPSCC were identified; 203 with HPV-positive tumors (49%) of which cervical cytology or histology were available in 172 women (85%). Among these, 22 (13%) patients had a cervical history of ≥ IIC. A total of 171 out of 214 women in the HPV-negative group (80%) were examined with cytology and 17 had a history of ≥ IIC. No significant difference in diagnoses of (pre)cancerous lesions between the OPSCC HPV-positive and negative groups were observed (χ2 test p = .28, Fischer's exact test p = .29). CONCLUSION: HPV status in oropharyngeal tumors was not correlated with a history of ≥ IIC in cervical examinations. The effect on cervical dysplasia may be masked by a higher incidence of smoking among the OPSCC HPV-negative group.

International Study of Primary Mucinous Ovarian Carcinomas Managed at Tertiary Medical Centers.

OBJECTIVE: We sought to describe a large, international cohort of patients diagnosed with primary mucinous ovarian carcinoma (PMOC) across 3 tertiary medical centers to evaluate differences in patient characteristics, surgical/adjuvant treatment strategies, and oncologic outcomes. METHODS: This was a retrospective review spanning 1976-2014. All tumors were centrally reviewed by an expert gynecologic pathologist. Each center used a combination of clinical and histologic criteria to confirm a PMOC diagnosis. Data were abstracted from medical records, and a deidentified dataset was compiled and processed at a single institution. Appropriate statistical tests were performed. RESULTS: Two hundred twenty-two patients with PMOC were identified; all had undergone primary surgery. Disease stage distribution was as follows: stage I, 163 patients (74%); stage II, 8 (4%); stage III, 40 (18%); and stage IV, 10 (5%). Ninety-nine (45%) of 219 patients underwent lymphadenectomy; 41 (19%) of 215 underwent fertility-preserving surgery. Of the 145 patients (65%) with available treatment data, 68 (47%) had received chemotherapy-55 (81%) a gynecologic regimen and 13 (19%) a gastrointestinal regimen. The 5-year progression-free survival (PFS) rates were 80% (95% confidence interval [CI], 73%-85%) for patients with stage I to II disease and 17% (95% CI, 8%-29%) for those with stage III to IV disease. The 5-year PFS rate was 73% (95% CI, 50%-86%) for patients who underwent fertility-preserving surgery. CONCLUSIONS: Most patients (74%) presented with stage I disease. Nearly 50% were treated with adjuvant chemotherapy using various regimens across institutions. The PFS outcomes were favorable for those with early-stage disease and lower but acceptable for those who underwent fertility preservation.

Risk of recurrence, prognosis, and follow-up for Danish women with cervical cancer in 2005-2013: A national cohort study.

BACKGROUND: In developed countries, women attend follow-up after treatment for cervical cancer to detect recurrence. The aim of this study was to describe the Danish population of women with early-stage cervical cancer at risk for recurrence and death due to recurrence. METHODS: Data were extracted from 3 nationwide databases to find women diagnosed with stage 1A1 to 1B1 cervical cancer in 2005-2013. Recurrences were determined from data on oncological or surgical treatment more than 3 months after the initial diagnosis and were cross-checked with patient journals. RESULTS: In all, 1523 patients were diagnosed with stage 1A1 to 1B1 cervical cancer. Eighty women experienced recurrences: 8 at International Federation of Gynecology and Obstetrics (FIGO) stage 1A1, 0 at FIGO stage 1A2, and 72 at FIGO stage 1B1. The 5-year recurrence rate was 6.4%; 67.5% of the women had symptomatic recurrences, and 28.8% had asymptomatic recurrences. At significantly greater risk for recurrence were women at stage 1B1, regardless of their lymph node (LN) status at diagnosis (hazard ratio with a positive LN, 5.10; 95% confidence interval [CI], 1.65-15.76; P = .0047; hazard ratio with a negative LN, 3.14; 95% CI, 1.25-7.93; P = .0153; hazard ratio with LN data missing, 6.33; 95% CI, 1.80-22.26; P = .004), women older than 50 years (hazard ratio, 1.81; 95% CI, 1.12-2.94; P = .0158), and women with lymphatic and lymphovascular space invasion (LVSI; hazard ratio, 1.92; 95% CI, 1.11-3.30; P = .0188). In a multivariate analysis, significantly inferior survival was found after recurrence for patients with lymphatic LVSI (hazard ratio, 2.23; 95% CI, 1.04-4.80; P = .0401), a symptomatic diagnosis of recurrence (hazard ratio, 2.52; 95% CI, 1.08-5.90; P = .0332), and multiple sites of recurrence (hazard ratio, 2.72; 95% CI, 1.32-5.61; P = .0066). CONCLUSIONS: This study has identified a group of women at FIGO stage 1A1 in no need of specialized, hospital-based follow-up. Many of the recurrences at FIGO stage 1B1 are asymptomatic, and this may show a need for follow-up in this group. Further prospective investigation is needed. Cancer 2018;124:943-51. © 2017 American Cancer Society.

Classification of Ovarian Cancer Surgery Facilitates Treatment Decisions in a Gynecological Multidisciplinary Team.

OBJECTIVE: Proper planning of intervention and care of ovarian cancer surgery is of outmost importance and involves a wide range of personnel at the departments involved. The aim of this study is to evaluate the introduction of an ovarian surgery classification (COVA) system for facilitating multidisciplinary team (MDT) decisions. MATERIALS AND METHODS: Four hundred eighteen women diagnosed with ovarian cancers (n = 351) or borderline tumors (n = 66) were selected for primary debulking surgery from January 2008 to July 2013. At an MDT meeting, women were allocated into 3 groups named "pre-COVA" 1 to 3 classifying the expected extent of the primary surgery and need for postoperative care. On the basis of the operative procedures performed, women were allocated into 1 of the 3 corresponding COVA 1 to 3 groups. The outcome measure was the predictive value of the pre-COVA score compared with the actual COVA performed. RESULTS: The MDT meeting allocated 213 women (51%) to pre-COVA 1, 136 (33%) to pre-COVA 2, and 52 (12%) to pre-COVA 3. At the end of surgery, 168 (40%) were classified as COVA 1, 158 (38%) were classified as COVA 2, and 28 (7%) were classified as COVA 3. Traced individually, 212 (51%) patients were correctly preclassified at the MDT meeting and distributed into 110 (52%) COVA 1, 71 (52%) COVA 2, and 17 (32%) COVA 3. Analyzing the subgroup of patients with cancer, 164 (47%) were correctly preclassified. Regarding the International Federation of Gynecology and Obstetrics (FIGO) stages, the pre-COVA classification predicted the actual COVA group in 79 (49%) FIGO stages I to IIIB and in 85 (45%) FIGO stages IIIC to IV. CONCLUSIONS: The COVA classification system is a simple and useful tool in the MDT setting where specialists make treatment decisions based on advanced technology. The use of pre-COVA classification facilitates well-organized patient care-relevant procedures to be undertaken. Pre-COVA accurately predicts the final COVA in 51% classified women.

Robot-assisted surgery in gynecological oncology: current status and controversies on patient benefits, cost and surgeon conditions - a systematic review.

INTRODUCTION: Robot-assisted surgery has become more widespread in gynecological oncology. The purpose of this systematic review is to present current knowledge on robot-assisted surgery, and to clarify and discuss controversies that have arisen alongside the development and deployment. MATERIAL AND METHODS: A database search in PubMed and EMBASE was performed up until 4 March 2016. The search strategy was developed in collaboration with an information specialist, and by application of the PRISMA guidelines. Human participants and English language were the only restrictive filters applied. Selection was performed by screening of titles and abstracts, and by full text scrutiny. From 2001 to 2016, a total of 76 references were included. RESULTS: Robot-assisted surgery in gynecological oncology has increased, and current knowledge supports that the oncological safety is similar, compared with previous surgical methods. Controversies arise because current knowledge does not clearly document the benefit of robot-assisted surgery, on perioperative outcome compared with the increased costs of the acquisition and application. CONCLUSIONS: The rapid development in robot-assisted surgery calls for long-term detailed prospective cohorts or randomized controlled trials. The costs associated with acquisition, application, and maintenance have an unfavorable impact on cost-benefit evaluations, especially when compared with laparoscopy. Future developments in robot-assisted surgery will hopefully lead to competition in the market, which will decrease costs.

[The development of a generic guideline for multidisciplinary team conferences in Denmark].

Since 2005 multidisciplinary team conferences (MDT) has been a crucial pivot for the Danish national integrated cancer pathways. Despite the formal decision to implement MDT-conferences, many aspects of this complex organization have never been addressed. In 2014, The Danish Multidisciplinary Cancer Groups (DMCG) provided a workgroup with the task of drafting a Danish national guideline for keeping MDT-conferences. This article presents the process of the workgroup, the background for the final content of the guideline as well as minutes from different parts of the guideline.

Survival after stage IA endometrial cancer; can follow-up be altered? A prospective nationwide Danish survey.

OBJECTIVE: To present Danish national survival data on women with early stage endometrial cancer and use these data to discuss the relevance of postoperative follow-up. DESIGN: Prospective study. SETTING: Danish Endometrial Cancer Study (DEMCA). POPULATION: Five hundred and seventy-one FIGO stage IA (1988 classification) endometrial cancer patients prospectively included between 1986 and 1999. All patients had total abdominal hysterectomy and bilateral salpingo-oophorectomy without adjuvant therapy. METHODS: The patient and the disease characteristics were drawn from the DEMCA database with cross-references to the national death registry and the national pathology database. Statistical methods included Kaplan-Meier, log-rank and Cox regression analysis. MAIN OUTCOME MEASURES: Survival rates in relation to histopathology. RESULTS: The five year overall survival rate was 88.9% and five year disease-specific survival was 97.3%. Patients with low- (91.8%) and high-risk histopathology (8.2%) were compared. The age-adjusted overall and disease-specific survival differed significantly between women with low- and high-risk histopathology (p = 0.039 and p = 0.004, respectively). The disease-specific survival adjusted for age between patients with well-differentiated endometrioid tumors differed from those with moderately differentiated tumors (p = 0.008, hazard ratio = 3.75, 95% confidence interval 1.41-10.00). Recurrence data were available on 464 patients. Twenty-three (3.9%) experienced recurrence. Of these recurrences, 15 of 23 (65%) were vaginal. Death from recurrence was observed in nine of 23 (39%) patients, and five of these nine had vaginal recurrences. CONCLUSIONS: Women with FIGO stage IA endometrial cancer have a very high disease-specific five year survival. Survival was related to histopathology. Follow-up at a highly specialized tertiary care center for patients with an extremely good prognosis may be questioned.

The value of gynecologic cancer follow-up: evidence-based ignorance?

INTRODUCTION: To explore the extent of evidence-based data and cost-utility of follow-up after primary treatment of endometrial and ovarian cancer, addressing perspectives of technology, organization, economics, and patients. METHODS: Systematic literature searches according to the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions were conducted separately for each of the 4 perspectives. In addition, the organizational analysis included a nationwide questionnaire survey among all relevant hospital departments, and the operating costs were calculated. RESULTS: None of the identified studies supported a survival benefit from hospital-based follow-up after completion of primary treatment of endometrial or ovarian cancer. The methods for follow-up were of low technology (gynecologic examination with or without ultrasound examination). Other technologies had poor sensitivity and specificity in detecting recurrence. Small changes in applied technologies and organization lead to substantial changes in costs. Substantial differences especially in frequency and applied methods were found between departments. The literature review did not find evidence that follow-up affects the women's quality of life. CONCLUSIONS: The main purpose of follow-up after treatment of cancer is improved survival. Our review of the literature showed no evidence of a positive effect on survival in women followed up after primary treatment of endometrial or ovarian cancer. The conception of follow-up among physicians, patients, and their relatives therefore needs revision. Follow-up after treatment should have a clearly defined and evidence-based purpose. Based on the existing literature, this purpose should presently focus on other end points rather than early detection of relapse and improved survival. These end points could be quality of life, treatment toxicity, and economy.

[Inguinal endometriosis]. / Ingvinal endometriose.

Inguinal endometriosis is a rare manifestation of endometriosis. Four cases are presented. In three of these cases proper diagnosis was delayed due to differential diagnostic difficulties as the symptoms in these cases were interpreted as hernia. In two cases the patient underwent hernia surgery. In inguinal lump cases in fertile women, endometriosis should be considered if accompanied by dysmenorrhoea or deep dyspareunia. In such cases MRI (magnetic resonance imaging) scans often yield further diagnostic information. If surgery is needed, it should be performed in a gynaecological setting to facilitate full surgical intervention including abdominal laparoscopy and excision.

Late urologic morbidity in 177 consecutive patients after radiotherapy for cervical carcinoma: a longitudinal study.

PURPOSE: To provide longitudinal data on urologic morbidity after radiotherapy and brachytherapy for cervical carcinoma. METHODS AND MATERIALS: Five-year longitudinal urologic morbidity data were recorded from 177 consecutive patients of median age 59 years (range: 22-86 years) with cervical carcinoma receiving radiotherapy with curative intent at the Copenhagen University Hospital, Denmark. FIGO stages (%) were as follows: Stage I (15), Stage II (30), Stage III (54), and Stage IV (1). Late morbidity was calculated as cumulative incidence based on actuarial estimates. RESULTS: The 5-year cumulative incidence based on actuarial estimates of urologic morbidity Grades 1 + 2 + 3, Grades 2 + 3, and Grade 3 were 62%, 32%, and 5%, respectively. Frequencies of urologic morbidity in the 54 recurrence-free survivors at the end of follow-up indicated some reversibility in the case of Grades 1 and 2 morbidity. CONCLUSION: With the longitudinal design used in the present study, a rate of mild and moderate morbidity higher than that found in most of the previously reported literature was observed, giving cause for concern and underlining the importance of further longitudinal studies on this subject, specifically studies that relate to the background urologic morbidity in the female population, as well as to the fact that urologic morbidity might regress.

Evaluation of urologic morbidity after radiotherapy for cervical carcinoma by urodynamic examinations and patient voiding schemes: a prospective study.

PURPOSE: To assess urologic morbidity in a 5-year period by urodynamic examinations and patient voiding schemes after radiotherapy and brachytherapy for cervical carcinoma. METHODS AND MATERIALS: Thirty-six consecutive patients designated to receive radiotherapy with curative intent entered the study on urodynamic changes after radiotherapy for cervical carcinoma. Patients in the study had urodynamic examinations performed on admission and 3, 9, 18, 24, 30, 36, 48, and 60 months after radiotherapy. In addition, the patients were instructed to record 24-h voiding schemes before each consultation. Each voiding scheme contained information about exact time of voiding and amount voided, as well as time of involuntary voiding, if present. RESULTS: No changes were observed in the urodynamic parameters: volume of residual urine, maximum bladder capacity, maximum flow rate, or volume of first bladder sensation. Detrusor instability and frequent small voiding did develop in 15%-20% of patients during follow-up. Incontinence after therapy was, however, a rare observation. CONCLUSION: In a prospective design combining urodynamic examinations and patient voiding schemes, and with modern application techniques, presence of minor urologic morbidity was found to be much more rare than previously reported. Nevertheless, detrusor instability and frequent small voiding did develop in 15%-20% of patients during follow-up. Future studies should be concerned about possible bias from urologic morbidity unrelated to therapy.

Clinical use of serum TRA-1-60 as tumor marker in patients with germ cell cancer.

TRA-1-60 antigen has been related to the presence of embryonal germ cell carcinoma (EC) and carcinoma in situ. Our study further investigated the clinical efficacy of TRA-1-60 as a serum tumor marker for germ cell cancer in the testis. Three groups of patients with germ cell tumors were included: Group 1, 34 patients with disseminated disease (24 nonseminomatous germ cell tumors [NSGCT] and 10 seminomatous germ cell tumors [SGCT]); this group of patients were followed during the course of chemotherapy with measurements of TRA-1-60, HCG and AFP; Group 2, 28 patients with Stage I NSGCT (22 with embryonal carcinoma [EC]-component and 6 without EC-component, median follow-up 15 months); and Group 3, 40 patients with Stage I pure SGCT (median follow-up 15 months). Seventy-eight percent of patients with disseminated EC-positive NSGCT had increased levels of TRA-1-60 before chemotherapy. After chemotherapy, levels of TRA-1-60 had dropped significantly (p < 0.01). Levels of TRA-1-60 did not normalize in 15% of NSGCT and 30% of SGCT patients after chemotherapy. This was not associated with recurrent disease. Approximately one-third of patients with Stage I NSGCT had increased values of TRA-1-60 during follow-up without having a relapse. Contrary to earlier reports TRA-1-60 is not at present useful as a tumor marker in patients with germ cell tumors. Although detecting a few early relapses the rate of false positive elevations in the tumor marker makes it unreliable in the clinical setting. Our study did confirm that elevated levels of TRA-1-60 were present in approximately 80% of patients with disseminated EC-positive NSGCT before start of chemotherapy and chemotherapy induced a significant decrease in levels of TRA-1-60. Thus, the TRA-1-60 antigen might still prove clinically useful provided that the reliability of the assay can be increased.