Explore the vast range of titles available.

Background: Recently, a Risk of Ovarian Malignancy Algorithm (ROMA) utilising human epididymis secretory protein 4 (HE4) and CA125 successfully classified patients as presenting a high or low risk for epithelial ovarian cancer (EOC). We validated this algorithm in an independent prospective study. Methods: Women with a pelvic mass, who were scheduled to have surgery, were enrolled in a prospective study. Preoperative serum levels of HE4 and CA125 were measured in 389 patients. The performance of each of the markers, as well as that of ROMA, was analysed. Results: When all malignant tumours were included, ROMA (receiver operator characteristic (ROC)-area under curve (AUC)=0.898) and HE4 (ROC-AUC)=0.857) did not perform significantly better than CA125 alone (ROC–AUC=0.877). Using a cutoff for ROMA of 12.5% for pre-menopausal patients, the test had a sensitivity of 67.5% and a specificity of 87.9%. With a cutoff of 14.4% for post-menopausal patients, the test had a sensitivity of 90.8% and a specificity of 66.3%. For EOC vs benign disease, the ROC–AUC of ROMA increased to 0.913 and for invasive EOC vs benign disease to 0.957. Conclusion: This independent validation study demonstrated similar performance indices to those recently published. However, in this study, HE4 and ROMA did not increase the detection of malignant disease compared with CA125 alone. Although the initial reports were promising, measurement of HE4 serum levels does not contribute to the diagnosis of ovarian cancer.

PurposeBreast cancer is the most common malignancy among young women of reproductive age. Adjuvant treatment with tamoxifen reduces the risk of recurrence in hormone-sensitive breast cancer. However, the use of tamoxifen is considered contraindicated during pregnancy, because of a limited number of case reports demonstrating potential adverse effects on the fetus. The objective of this report is to give a more broad overview of the available data on the effect of tamoxifen exposure during pregnancy.MethodsA literature review was performed using PubMed and the databases of the Netherlands Pharmacovigilance Centre Lareb and of the International Network on Cancer, Infertility, and Pregnancy.ResultsA total of 238 cases of tamoxifen use during pregnancy were found. Of the 167 pregnancies with known outcome, 21 were complicated by an abnormal fetal development. The malformations described were non-specific and the majority of cases concerned healthy infants despite exposure to tamoxifen.ConclusionThere seems to be an increased risk of fetal abnormalities when taking tamoxifen during pregnancy (12.6% in contrast to 3.9% in the general population), but the evidence is limited and no causal relationship could be established. The possible disadvantage of postponing or discontinuing tamoxifen for the maternal prognosis is unclear. Patients should be counseled about the use of tamoxifen during pregnancy instead of presenting it as being absolutely contraindicated.

Background and Objective As a result of changes in physiology during pregnancy, the pharmacokinetics (PK) of drugs can be altered. It is unclear whether under- or overexposure occurs in pregnant cancer patients and thus also whether adjustments in dosing regimens are required. Given the severity of the malignant disease and the potentially high impact on both the mother and child, there is a high unmet medical need for adequate and tolerable treatment of this patient population. We aimed to develop and evaluate a semi-physiological enriched model that incorporates physiological changes during pregnancy into available population PK models developed from non-pregnant patient data. Methods Gestational changes in plasma protein levels, renal function, hepatic function, plasma volume, extracellular water and total body water were implemented in existing empirical PK models for docetaxel, paclitaxel, epirubicin and doxorubicin. These models were used to predict PK profiles for pregnant patients, which were compared with observed data obtained from pregnant patients. Results The observed PK profiles were well described by the model. For docetaxel, paclitaxel and doxorubicin, an overprediction of the lower concentrations was observed, most likely as a result of a lack of data on the gestational changes in metabolizing enzymes. For paclitaxel, epirubicin and doxorubicin, the semi-physiological enriched model performed better in predicting PK in pregnant patients compared with a model that was not adjusted for pregnancy-induced changes. Conclusion By incorporating gestational changes into existing population pharmacokinetic models, it is possible to adequately predict plasma concentrations of drugs in pregnant patients which may inform dose adjustments in this population.

BackgroundSafety of sentinel lymph node (SLN) biopsy for breast cancer during pregnancy is insufficiently explored. We investigated efficacy and local recurrence rate in a large series of pregnant patients.Patients and methodsWomen diagnosed with breast cancer who underwent SLN biopsy during pregnancy were identified from the International Network on Cancer, Infertility and Pregnancy, the German Breast Group, and the Cancer and Pregnancy Registry. Chart review was performed to record technique and outcome of SLN biopsy, locoregional and distant recurrence, and survival.ResultsWe identified 145 women with clinically N0 disease who underwent SLN during pregnancy. The SLN detection techniques were as follows: 99mTc-labeled albumin nanocolloid only (n = 96; 66.2%), blue dye only (n = 14; 9.7%), combined technique (n = 15; 10.3%), or unknown (n = 20; 13.8%). Mapping was unsuccessful in one patient (0.7%) and she underwent an axillary lymph node dissection (ALND). Mean number of SLNs was 3.2 (interquartile range 1-3; missing n = 15). Positive SLNs were found in 43 (29.7%) patients and 34 subsequently underwent ALND. After a median follow-up of 48 months (range 1–177), 123 (84.8%) patients were alive and free of disease. Eleven patients experienced a locoregional relapse, including 1 isolated ipsilateral axillary recurrence (0.7%). Eleven (7.6%) patients developed distant metastases, of whom 9 (6.2%) died of breast cancer. No neonatal adverse events related to SLN procedure during pregnancy were reported.ConclusionsSLN biopsy during pregnancy has a comparably low axillary recurrence rate as in nonpregnant women. Therefore, this method can be considered during pregnancy instead of standard ALND for early-stage, clinically node-negative breast cancer.

The objective of this study is to assess the therapeutic importance of surgical castration, adjuvant hormonal treatment and lymphadenectomy in endometrial stromal sarcoma (ESS). A retrospective and multicentric search was performed. Clinicopathologic data were retrieved from cases that were confirmed to be ESS after central pathology review. The protocol was approved by the Ethical Committee. ESS was confirmed histopathologically in 34 women, but follow-up data were available in only 31 women. Surgical treatment ( n =31) included hysterectomy with or without bilateral salpingo-oophorectomy (BSO) in 23 out of 31 (74%) and 8 out of 31 (26%) cases, respectively. Debulking surgery was performed in 6 out of 31 cases (19%). Stage distribution was as follows: 22 stage I, 4 stage III and 5 stage IV. Women with stage I disease recurred in 4 out of 22 (18%) cases. Among stage I women undergoing hormonal treatment with or without BSO, 3 out of 15 (20%) and 1 out of 7 (14%) relapsed, respectively. Among stages III–IV women receiving adjuvant hormonal treatment or not, 1 out of 5 (20%) and 3 out of 4 (75%) relapsed, respectively (differences=55.0%, 95% CI=−6.8–81.2%). Kaplan–Meier curves show comparable recurrence rates for stage I disease without adjuvant hormonal treatment when compared to stages III–IV disease treated with surgery and adjuvant hormonal treatment. Furthermore, women taking hormones at diagnosis have a better outcome when compared to women not taking hormonal treatment. Three out of 31 (9%) patients had a systematic lymphadenectomy whereas 3 out of 31 (9%) had a lymph node sampling. In one case, obvious nodal disease was encountered at presentation. Isolated retroperitoneal recurrence occurred in 1 out of 31 (3%) of all cases and in 1 out of 8 (13%) recurrences. This single woman later also developed lung and abdominal metastases. Leaving lymph nodes in situ does not appear to alter the clinical outcome of ESS. Although numbers are low, the retrospective data suggest that the need for surgical castration (BSO) in premenopausal women with early-stage disease should be discussed with the patient on an individual basis. The data support the current practice in some centres to administer adjuvant hormonal treatment.

Introduction/Background*Due to the rarity of cancer during pregnancy, physicians not always have up to date knowledge on all possibilities of treatment during pregnancy. To support physicians with decision on optimal cancer treatment for their pregnant patients, the Advisory Board on Cancer, Infertility and Pregnancy (ABCIP) was founded under the umbrella of the International Network for Cancer, Infertility and Pregnancy (INCIP).MethodologyMedical experts from a variety of disciplines and countries were informed on this new initiative, and asked whether they were interested in actively participating in the ABCIP. Several national advisory boards were founded, as well as an overarching international board. Funding was acquired to build a website to facilitate accessibility for physicians requesting advice and a forum for online discussions and communication between the board members. Based on available literature, default texts were drafted to use in the recommendation letters.Result(s)*An online platform was created at www.ab-cip.org, where physicians are able to submit questions regarding their pregnant patients with cancer, using only anonymous patient data. A total of 73 experts from a variety of disciplines and countries are joined in the national and international boards. Of this group, experts from eight countries already expressed their interest in setting up their own national advisory board. Incoming requests are discussed by the experts on a secure forum on the website. The website generates a recommendation letter, based on available literature and expert opinion of the board members, to send back to the requesting physician. In the first month after foundation, seven requests for advice were already submitted and discussed.Abstract 705 Figure 1Conclusion*The ABCIP provides easily accessible, free of charge recommendations to physicians from all over the world with questions regarding their pregnant patients with a cancer diagnosis or patients with a cancer diagnosis who wish to become pregnant in the future.

PurposeAs a further step to elucidate the actual diverse spectrum of oncofertility practices for breast cancer around the globe, we present and discuss the comparisons of oncofertility practices for breast cancer in limited versus optimum resource settings based on data collected in the Repro-Can-OPEN Study Part I & II.MethodsWe surveyed 39 oncofertility centers including 14 in limited resource settings from Africa, Asia & Latin America (Repro-Can-OPEN Study Part I), and 25 in optimum resource settings from the United States, Europe, Australia and Japan (Repro-Can-OPEN Study Part II). Survey questions covered the availability of fertility preservation and restoration options offered to young female patients with breast cancer as well as the degree of utilization.ResultsIn the Repro-Can-OPEN Study Part I & II, responses for breast cancer and calculated oncofertility scores showed the following characteristics: (1) higher oncofertility scores in optimum resource settings than in limited resource settings especially for established options, (2) frequent utilization of egg freezing, embryo freezing, ovarian tissue freezing, GnRH analogs, and fractionation of chemo- and radiotherapy, (3) promising utilization of oocyte in vitro maturation (IVM), (4) rare utilization of neoadjuvant cytoprotective pharmacotherapy, artificial ovary, and stem cells reproductive technology as they are still in preclinical or early clinical research settings, (5) recognition that technical and ethical concerns should be considered when offering advanced and innovative oncofertility options.ConclusionsWe presented a plausible oncofertility best practice model to guide oncofertility teams in optimizing care for breast cancer patients in various resource settings.

The focus of this study was to document postoperative complications after vulvectomy and inguinofemoral lymphadenectomy using separate incisions. Data from 172 consecutive patients with newly diagnosed carcinoma of the vulva were studied. One hundred and one patients primarily treated with modified radical vulvectomy and complete inguinofemoral lymphadenectomy using separate groin incisions (n = 187) were included in this study. One or more complications were documented in 77 of the 101 (76%) patients. Complications after groin dissection were observed in 66% of the patients. The main complications were wound breakdown (17%) and/or infection (39%) of the groin, lymphocyst formation (40%), and lymphedema (28%). In 98 of 187 (52%) groin dissections, one or more complications were documented. The presence of lymph node metastases, postoperative radiation, age older than 65 years, and removal of the vena saphena magna were not significant risk factors for the occurrence of complications. The occurrence of early complications after groin dissection was significantly related to the late-complication lymphedema (P = 0.002). Our results confirm relatively high rates of wound breakdown, infection, lymphocyst formation, and lymphedema even with separate groin incisions. The occurrence of early complications was related to lymphedema. No other risk factors could be identified.

Background: To investigate the value of neoadjuvant chemotherapy (NACT), followed by interval debulking surgery (IDS), in endometrial cancer with transperitoneal spread (stage IV). Methods: Patients with endometrial cancer with transperitoneal spread, as determined by laparoscopy (±pleural effusion), were treated with NACT. Efficacy was determined according to the Response Evaluation Criteria in Solid Tumors, residual tumour at IDS and histopathological assessment of tumour regression. Results: A total of 30 patients (median age: 65 years; range:44–81 years) received 3–4 cycles of NACT (83% paclitaxel/carboplatin). Histopathological subtypes were as follows: serous (90%), clear cell (3%) and endometrioid (6%) carcinoma. Response according to RECIST was as follows: 2 (7%) complete remission, 20 (67%) partial remission, 6 (20%) stable disease and 2 (7%) progressive disease (PD). Patients with PD were not operated upon. A total of 24 patients (80%) had optimal cytoreduction ( R ⩽1 cm), of whom 22 (92%) were without residual tumour. Four patients were considered inoperable and were excluded from further analysis. The median progression-free survival and overall survival times were 13 and 23 months, respectively. Histopathological features of chemoresponse in both uterus and omentum were related to a better PFS ( P =0.017, hazard ratio (HR) =0.785) and overall survival ( P =0.014, HR=0.707). In particular, the absence of tumour infiltration and necrosis were associated with prognosis. Conclusion: The use of NACT resulted in a high rate (80%) of optimal IDS for the treatment of endometrial cancer with transperitoneal spread.

Introduction/Background*Physicians encounter pregnant women with cancer only incidentally, leading to lack of expertise or confidence to inform and treat these patients according to up to date guidelines and expert opinions. In the Netherlands, a national multidisciplinary tumor board (MDT) for cancer and pregnancy was founded in 2012, and consists of 33 physicians from all over the country. Requests to discuss patients in the MDT were received by e-mail and a recommendation letter was generated based on available literature and expert opinion of the board members.MethodologyAll requests and recommendations were gathered in a database and analyzed for tumor type, stage, gestational age and recommendation given. A survey was sent out to 93 physicians who requested recommendations of the MDT, containing questions regarding the their experiences with the MDT and the impact on treatment decisions.Result(s)*From December 2012 to May 2021, 209 recommendations were formulated, mostly regarding pregnant patients with breast cancer (n=65), cervical cancer (n=32), haematological malignancies (n= 32), rare cancer types (n=30) and melanoma (n=21). Questions were asked regarding possibilities of ionized imaging, chemotherapy, hormonal therapy or immunotherapy during pregnancy and possible effects on the child, the sequence of the different treatment components and questions on fertility. Response rate of the questionnaire was 54%. Overall satisfaction with the recommendations of the MDT was high, and 94% of the respondents informed their patients about consulting the MDT and felt supported by the received recommendations.Abstract 290 Figure 1Conclusion*A national MDT for cancer and pregnancy is frequently consulted and highly appreciated by physicians. Next to that, it increases expertise of its members about this rare coincidence of cancer and pregnancy. We highly recommend to establish an (inter)national MDT in each country. Figure 1 shows the important steps necessary to establish an MDT for cancer in pregnancy based on our experience.