bluuebunny/crossref_metadata_2025_split huggingface dataset:
Venous thromboembolism in advanced ovarian cancer patients undergoing front-line adjuvant chemotherapy.
Authors: Pant Alok , Schink Julian C. 
Published: March 2020

5570 Background: To define the incidence and prognostic significance of venous thromboembolism (VTE) in patients with advanced, epithelial ovarian cancer undergoing front-line adjuvant chemotherapy after extended period (28 day) post-operative prophylaxis. Methods: A retrospective analysis of patients with advanced, epithelial ovarian cancer who underwent surgery and chemotherapy at a single institution from January 2008 through December 2011 was performed. Exclusion criteria were prior history of VTE, VTE during the post-operative period, clear cell histology, use of anti-coagulation for a different indication, and lack of compliance with 28 days of post-operative prophylaxis with a low molecular weight heparin. Results: 128 patients met criteria for inclusion. Sixteen patients had a reported VTE during the time they were on front line chemotherapy (12.5%). Nine patients (7%) had a pulmonary embolus (PE) and 8 (6.3%) had a deep vein thrombus (DVT). The average BMI in the group that developed VTE was 28 and in the group without VTE was 26.5 (p = 0.23). Three out of 16 (23%) patients who developed VTE had undergone a suboptimal cytoreduction compared to 12/112 (11%) in the group with no VTE (p = 0.4). Six of the 16 (37%) patients who developed VTE during chemotherapy underwent a bowel resection and/or splenectomy during their cytoreductive surgery compared to 18 of 112 (16%) patients who did not develop VTE (p=0.079). Eight of the patients in the VTE group had indwelling venous catheters during chemotherapy (50%) compared to 39 (35%) in the group with no VTE (p = 0.27). In the group that developed VTE, there was a trend towards increased pre-operative CA-125, higher rates of bowel resection and/or splenectomy during surgery, decreased use of aspirin, and inferior survival. On multivariate analysis, patients who developed VTE had significantly longer post-operative hospital stays (7 vs 5 days [p = 0.009]) and lower rates of complete response (p = 0.01). Conclusions: A 12.5% risk of VTE merits consideration of prophylaxis during chemotherapy in this cohort. A randomized, controlled trial is needed to clarify whether the benefits of long term prophylaxis outweigh the risks and costs of such therapy.
Clinical management and resolution of stomatitis in BOLERO-2.
Authors: Perez Alejandra T. , Rugo Hope S. , Baselga José , Hart Lowell , Pritchard Kathleen I. , Arena Francis P. , Eakle J F , Geberth M , Hortobagyi Gabriel N. , Csõszi Tibor , Gnant Michael , Chouinard Edmond Emilien , Noguchi Shinzaburo , Srimuninnimit Vichien , Puttawibul Puttisak , Heng Daniel Yick Chin , Panneerselvam Ashok , Taran Tanya , Sahmoud Tarek , Burris Howard A. 
Published: March 2020

558 Background: In BOLERO-2, adding everolimus (EVE) to exemestane (EXE) more than doubled progression-free survival without affecting quality of life vs EXE alone in postmenopausal women with hormone-receptor–positive advanced breast cancer who had recurrence or progression on/after nonsteroidal aromatase inhibitor therapy. Although mTOR inhibitors are generally well tolerated, stomatitis is one of their most clinically relevant and potentially dose-limiting toxicities (Sonis Cancer2010). The incidence, grade, and clinical course of stomatitis among patients (pts) participating in the BOLERO-2 study are described. Methods: Pts were randomized 2:1 to receive EVE+EXE or placebo (PBO)+EXE. Stomatitis incidence, severity, consequent dose interruptions/adjustments, study drug discontinuations, and time to resolution were recorded. Results: The median duration of EVE+EXE treatment exposure was 30 wk (range, 1-123 wk). Stomatitis (any grade) occurred more frequently with EVE+EXE than with PBO+EXE (59% vs 12%, respectively). Grade 3 stomatitis occurred in 8% vs 1% of pts receiving EVE+EXE vs PBO+EXE, respectively; no grade 4 was reported. Onset of grade ≥2 stomatitis after treatment initiation was earlier in the EVE+EXE arm vs the PBO+EXE arm: median time was 15d vs 24d, respectively. In the EVE+EXE arm, 97% of pts with grade 3 stomatitis (n=38) improved to ≤1 after a median of 13 d. Complete resolution was observed in 82% of these pts after a median of 38 d. In the PBO+EXE arm, all pts with grade 3 stomatitis (n=2) improved to ≤1 after a median of 18 d. Complete resolution was observed after a median of 29 d. Overall, 24% of pts in the EVE+EXE arm required dose interruptions/adjustments vs 1% of pts in the PBO+EXE arm, and 3% of pts (n=13) discontinued EVE+EXE vs <1% of pts (n=1) discontinuing PBO+EXE, all related to stomatitis. Conclusions: The BOLERO-2 data foster a new era of combining targeted and endocrine therapies. In the study, treatment-emergent stomatitis was of mild to moderate intensity, occurred shortly after treatment initiation, and was generally reversible. Most incidents were successfully managed with palliative interventions and temporary dose modifications. Oral hygiene and other preventive measures are recommended. Clinical trial information: NCT00863655.
Results of a phase II clinical trial to evaluate a re-challenge of intraperitoneal catumaxomab for treatment of malignant ascites (MA) due to epithelial cancer (SECIMAS).
Authors: Pietzner Klaus , Vergote Ignace , Santoro Armando , Marme Frederik , Rosenberg Per , Friccius-Quecke Hilke , Sehouli Jalid 
Published: March 2020

5582 Background: Catumaxomab is approved in Europe for the i.p. treatment of MA. With a growing number of patients (pts) treated, the question arises, if a re-challenge is feasible and effective despite the immunogenicity of this non-humanised antibody. Methods: Pts were eligible if they received 4 i.p. applications of catumaxomab in the CASIMAS study and benefitted with a puncture free interval of > 60 days. Primary endpoint was to determine the proportion of pts who were able to receive at least 3 catumaxomab applications. Secondary endpoints were the development of human anti-drug antibodies (ADA) as well as the safety profile of a second catumaxomab cycle including a composite safety score (CSS) summarizing the worst CTCAE grades for the main adverse reactions (pyrexia, nausea, vomiting, abdominal pain). Efficacy endpoints were time to puncture (TTPu), overall survival (OS) and puncture-free survival (PuFS). Results: Median age was 59.0 years. 8 out of 9 screened pts were treated with a second cycle of catumaxomab. The primary tumor was ovarian cancer in 5 (62.5%), breast cancer in 2 (25%) and urachal cancer in 1 (12.5%) pts. All 8 (100%) pts received all 4 infusions within 20 days. Median CSS was 3.0 after the second cycle while it was 3.4 after the first cycle in the CASIMAS study for these 8 pts. Only less pts had AEs with CTC >3 (SECIMAS 25%; CASIMAS 70.1%). All 8 (100%) pts were ADA-positive at study entry. ADA levels were consistently higher in the plasma than in the ascites fluid. During treatment, highest ADA values were found on day 10 for ascites and day 11 for plasma up to values of > 1 mg/ml. PuFS was 47.5 days and TTPu 60 days after the second cycle, and 37 days and 102 days, respectively after the first cycle. Median OS was 406.5. Conclusions: This first experience with a re-challenge of catumaxomab in MA, demonstrates a tolerable safety profile without acute allergic reactions, in spite of the high immunogenicity of catumaxomab and the repeated application. Efficacy was not impaired despite ADA response and the advanced disease of the pts. A re-challenge seems feasible for selected pts suffering from recurrent MA after a first cycle of catumaxomab. Clinical trial information: NCT01065246.
Impact of wait times on survival of women with uterine cancer.
Authors: Elit Lorraine , O'Leary Erin , Seow Hsien , Pond Gregory Russell 
Published: March 2020

5586 Background: Reducing cancer wait times have been a priority investment for Cancer Care Ontario since 2005. Our objective was to determine whether wait time from histologic diagnosis of uterine cancer to time of definitive surgery by hysterectomy impacted on all cause survival. Methods: Cases were identified in the Ontario Cancer Registry using ICD-09 codes 179 and 182. Excluded were women without histologic/cytologic confirmation of cancer prior to surgery, with no definitive surgery, or with wait times of ≤14 days or >2 years. Survival was calculated using the Kaplan-Meier method from the day of hysterectomy. Factors were evaluated for their prognostic ability on survival using Cox proportional hazards regression. Wait time was evaluated as a continuous variable and dichotomized at selected cutpoints in the univariable analyses and in a multivariable model adjusting for significant patient factors identified using forward stepwise selection. Results: The final study population included 8,744 women. 51.9% had surgery by a gynaecologist and 69.9% had endometrioid adenocarcinoma. The optimal model is shown below. Multivariable analysis of factors prognostic for survival. Longer wait times remained a statistically significant negative prognostic factor for survival regardless of definition, univariably (p<0.002) and multivariably after adjusting for other significant factors (p<0.001). The final multivariable model is shown. 5-year (95%CI) survival for women with more than 12 week wait times was 61.4 (57.8-64.8)% versus 71.9 (69.9-73.8)% for women with less than 6 week wait time. Conclusions: The longer a woman waits from diagnosis of uterine cancer to definitive surgery negatively impacts her overall survival. [Table: see text]
A retrospective assessment of outcomes of chemotherapy-based versus radiation-only adjuvant treatment for completely resected stage I–IV uterine carcinosarcoma (UCS) with rhabdomyosarcoma (RMS) differentiation.
Authors: Makker Vicky , Kravetz Sara Jane , Gallagher Jacqueline , Orodel Oana , Iasonos Alexia , DeLair Deborah , Zhou Qin , Aghajanian Carol , Hensley Martee Leigh 
Published: March 2020

5595 Background: UCS with RMS differentiation are aggressive cancers with poor survival, and without an established standard treatment (txt). We aimed to determine the progression-free survival (PFS) and overall survival (OS) in patients (pts) who received either platinum-based chemo with or w/o radiation therapy (pelvic or IVRT), or RT alone (pelvic or IVRT). Methods: MSKCC EMR from 1990 to 2012 was reviewed for pt age, diag. date, primary surgery, residual disease at completion of primary surgery, FIGO stage, txt details, dates of progression, death, site(s) of first recurrence. Univariate analysis for PFS/OS utilized Kaplan Meier method. Differences between PFS/OS and categorical variables of stage + txt type were assessed using log-rank test. All analyses utilized SAS version 9.2. Pts who received chemo with or w/o RT or RT alone were included in the analysis. Results: 53 pts met study criteria. 41/53 (77.4%) pts received chemo: 30/41 (73.2%) paclitaxel-carboplatin (TC); 3/41 (7.3%) ifosfamide (I)-platinum; 3/41 (7.3%) weekly cisplatin followed by TC; 2/41 (4.9%) other platinum-doublets; 3/41 (7.3%) IT. 34% of the chemo pts also received pelvic or IVRT. 12/53 (22.6%) pts received only pelvic RT+/-IVRT. FIGO stage: I =16 (30%); II =5 (9%); III =14 (26%); IV =18 (34%). Median PFS for the entire cohort: 11.7 mos (95% CI 6.4, 14.1). Median OS for the entire cohort: 21.8 mos (95% CI 14.9, 31.8). Median PFS by stage: 14.3 mos for early stage (stages I and II) vs 9.9 mos for late stage (stages III and IV), p=0.0217. Median OS by stage: not reached in the early stage cohort. Median OS for the late stage: 19.9 mos, p=0.0106. Median PFS by txt: 10.7 mos for the Pelvic RT+/- IVRT group vs 13.5 mos for chemo+/-Pelvic RT+/- IVRT group, p=0.5126. Median OS treatment: 23.9 mos for the chemo+/-Pelvic RT+/- IVRT group vs 17.4 mos for the Pelvic RT+/- IVRT group, p = 0.5191. Conclusions: PFS and OS outcomes in our cohort of pts with UCS with RMS differentiation were similar to survival outcomes among pts treated with platinum-based chemo on GOG 150 and GOG232B. The role of adjuvant RT in addition to chemo warrants further investigation.
Impact of socioeconomic status and degree of ethnic isolation on cervical cancer incidence among Hispanics and Asians in California.
Authors: Froment Marie-Anne , Roux Audrey , DeRouen Mindy C. , Gomez Scarlett Lin , Kidd Elizabeth A. 
Published: March 2020

5605 Background: The incidence of cervical cancer in the United States has declined since the introduction of the pap smear. However, differences exist based on ethnicity and socioeconomic status (SES).This study aimed to evaluate the impact of nativity, neighborhood SES and enclave (degree of ethnic isolation) on the incidence of cervical cancer in California. Methods: Using data from the California Cancer Registry, comprising three of the National Cancer Institute’s Surveillance Epidemiology and End Results (SEER) program registries, information on all primary invasive cervical cancer diagnosed in California from January 1, 1990, through December 31, 2004 was obtained. We analyzed the influence of enclave, SES, and nativity on cervical cancer incidence. Results: Among the 22,189 invasive cervical cancer cases diagnosed between 1990 and 2004, 50% were non-Hispanic white (NHW), 39% Hispanic and 11% Asian women. Seventy percent (70%) of the invasive cervical cancer cases were squamous cell carcinoma (SCC), 19% were adenocarcinoma and 11% other histologies. Approximately half (51%) of patients presented with localized disease, 33% regional disease, 10% distant disease and 6% unknown. By ethnic group, US born women showed lower rates of SCC compared to foreign-born women. Seventy-six percent (76%) of invasive cervical cases were observed in high enclave neighborhoods, and seventy percent (70%) were noted in low SES neighborhoods. Hispanics living in low SES and high enclave had 12.7 times (95% CI; 11.2-14.3) higher rate of cervical cancer than those living in high SES, low enclave neighborhoods. For Asian women incidence rates were 6 times (95% CI; 4.9-7.5) higher in the low SES, high enclave neighborhoods compared to those living in high SES, low enclave neighborhoods. Conclusions: More efforts should be done to reach out to and increase pap smear screening for women living in high enclave neighborhoods to help decrease the incidence of invasive cervical cancer cases in these groups of women.
Male workers’ influence on partners uptake of pap smear screening in a teaching hospital in Nigeria.
Authors: Olowokere Idowu Emmanuel , Roberts Olumuyiwa Adebola 
Published: March 2020

5606 Background: Cervical cancer remains a major global health issue still claiming the lives of African women despite the availability of screening facilities. Male involvement has paid off in enhancing uptake of contraception in Africa as reported by several empirical studies. It may be worthwhile in encouraging women uptake of the screening services. This formed the basis for this study. Methods: The study adopted a cross sectional descriptive survey that involved 350 respondents. Their involvement was assessed using a structured questionnaire with cronbach reliability coefficient of 0.78. The study was analyzed using SPSS version 16 by computing the frequency, means and standard deviations. Chi-square was employed to test the significance of associations at p < 0.05. Results: The results showed that all (n = 350) male medical staff of the hospital were aware about cervical cancer and pap smear screening test for premalignant lesions of the cervix compared to 90% and 77% observed in paramedics and non-medical groups respectively. At least, an episode of Pap smear screening test had been done by the partners of 52.4% of the medical staff; while only 30.2% and 13% of the partners of paramedics and non-medical workers respectively had undergone the test. Among those whose partners had participated in screening; 78.9% (n = 95) of the men initiated the screening. Eighty two percent (82%, n = 95) paid for their wives’ transportation while 78.9% (n = 95) have at least once followed their partners to the screening centre. Chi square result showed that men with higher level of education are likely to support their partners to participate in screening for cervical cancer (p < 0.005). There was no significant association between religion and male support for Pap smear uptake (p < 0.407). Conclusions: The study showed that the medical male workers were more involved in facilitating partners screening for cervical cancer. This may not be unconnected with their knowledge of the consequences of late identification of the disease. The study therefore concluded that knowledge of cervical cancer and its consequences by men will enhance their involvement in encouraging partners to utilize screening facilities.
Long-term survival following robot-assisted surgical treatment of early cervical cancer.
Authors: Jackson Amanda Lynn , Kilgore Joshua , Ko Emily Meichun , Craven Renatta , Gehrig Paola A. , Soper John T. , Boggess John 
Published: March 2020

5607 Background: To determine progression-free survival (PFS) and overall survival (OS) for patients with early stage cervical cancer surgically treated using robotic-assisted laparoscopy compared to open radical hysterectomy. Methods: A retrospective analysis of women that underwent a robotic-assisted surgery (RAS) for early stage cervical cancer was performed. Surgical procedures included radical hysterectomy, parametrectomy, and trachelectomy from 2005 to May 2012. Patient demographics, clinicopathologic data, and disease status were analyzed. Comparison was made to open radical hysterectomies (ORH) from 2000 to May 2012. Survival statistics were analyzed using the Kaplan-Meier method. Results: 147 patients underwent RAS; 97 patients underwent ORH in our comparison group. Surgery was aborted in 8 RAS and 5 ORH due to extent of disease. The robotic surgical treatments included 121 (82.3%) radical hysterectomies, 14 (9.5%) trachelectomies, and 12 (8.2%) parametrectomies. In the RAS, the mean age was 44.3 (range 17-75); the mean body mass index (BMI) was 27.7 (range 16-50). Most patients presented with clinical stage IBI disease (79.9%). Squamous cell histology was most common (55.4%) followed by adenosquamous (36.7%). No significant differences were found between the RAS and ORH with regards age, BMI, surgical stage, grade, short and long-term complications, and comorbidities. The mean follow up time was 24.7 (range 0-82.1) months. Recurrence was documented in 3 patients after RAS and 11 patients after ORH; 3 deaths were recorded in the RAS group and 10 in the ORH. One patient had persistent adenocarcinoma in situ after robotic trachelectomy. Compared to ORH, there was a significantly better PFS in RAS (HR .312, CI 0 .099-0.98, p = 0.046) while no difference was seen in OS (p = 0.172). Conclusions: The results demonstrate that RAS is associated with lower rates of recurrence and no difference in overall survival. These findings provide further evidence that robotic-assisted surgical treatment is not associated with inferior results when compared to laparotomy or traditional laparoscopy. As robotic-assisted surgery is associated with a less steep learning curve, it may become the surgical approach of choice.
Comparative analysis of bone marrow micrometastases with sentinel lymph node status in early-stage breast cancer.
Authors: Arora Madan L. , Mistry Shams , Shaik Mohammed , Tyagi Neha , Korant Alpesh K. , Saha Supriya Kumar , Johnston Gregory , Abadeer Benjamin , Dhar Vikrom K. , Wiese David , Saha Sukamal 
Published: March 2020

570 Background: A definitive relationship between bone marrow (BM) micrometastases (M) and sentinel lymph node (SLN) status has not been established in Breast Cancer (BRCa). Hence, a retrospective study was done to examine the relationship between BMM and SLN status in BRCa patients (pts). Methods: T1/T2 BRCa pts underwent SLN biopsy and definitive surgery for primary tumors. At the operation, BM aspiration from bilateral post-superior iliac spines was performed. BM samples were examined using a Cytokeratin Detection Kit using CAM 5.2 monoclonal antibody and visualization achieved with a Ventana iView V-Red detection system. An Automated Cellular Imaging System was applied to identify metastatic BRCa cells. Pts with +ve BM underwent repeat BM analysis 6 months after completing initial treatments. Data was collected for T-stages, SLN, BM, ER/PR receptor and Her-2/neu statuses and analyzed using Chi-Square Analysis or Fischer’s Exact Test. Results: We analyzed 458 consecutive pts, of which SLN metastasesv(mets) were detected in 22.9% and BMM were detected in 8.1%. BMM were found 23% bilaterally and 77% unilaterally. BMM were detected in 11.4% of SLN +ve pts versus 7.1% of SLN -ve ptsv(p=0.15) and 6.8% of T1 pts versus 12.3% of T2 ptsvv(p=0.07). BMM were found in 8.7% of ER/PR +ve pts versus 4.5% of ER/PR –ve ptsvv(p=0.1) and 9.5% of HER2/neu +ve pts versus 7.7% of HER2/neu –ve ptsv (p=0.5) (Table). Repeat BM analysis detected BMM only in 6.6% pts. Conclusions: Bilateral BM aspirate resulted in a significant increase in detection of micrometastases. BM metastases may occur independently of lymphatic metastasis. Therefore, evaluation for the presence of BMM may help identify high risk pts with node negative disease in early stage BRCa. [Table: see text]
Effect of fertility concerns on tamoxifen use in young survivors of breast cancer.
Authors: Llarena Natalia , Nunez Omar , Kane Anna , Jeruss Jacqueline Sara 
Published: March 2020

572 Background: For premenopausal patients with ER+ breast cancer, a 5-year course of tamoxifen results in a 47% reduction in annual recurrence risk and a 26% reduction in annual mortality. Despite these benefits, adherence rates for tamoxifen are low, particularly among younger women. We hypothesize that fertility concerns are causally related to the poor tamoxifen adherence rates observed among young breast cancer survivors. Methods: With IRB approval, a retrospective analysis of 535 women with breast cancer between 2000-2012 was undertaken. Patients were younger than age 46, premenopausal and had ER+ breast cancer. 138 patients did not complete a 5-year course. Patient and provider factors that influenced tamoxifen initiation and adherence were reviewed: (1) evidence of referral to a fertility specialist; (2) documentation of discussion about tamoxifen-related fertility concerns; (3) agreement to take tamoxifen; (4) duration of tamoxifen use. Phone interviews conducted with 27 patients focused on lack of initiation or early discontinuation. The Log-rank (Mantel-Cox) test was used to compare Kaplan-Meier curves and generate hazard ratios. Results: Of the 138 patients who did not complete 5 years of therapy, 38 (27.5%) failed to initiate or discontinued tamoxifen secondary to fertility concerns. Only 114 (21.3%) charts documented referral to a fertility specialist. Patients who expressed a desire to maintain fertility or to have children in the future (115 patients, 21.5%) were more likely to discontinue tamoxifen treatment (HR=2.7, p=0.001). Other critical factors included being unmarried (HR=1.9, p=0.011) and lack of college education (HR=2.5, p=0.0008). Major themes from phone interviews: (1) patients felt they were not adequately informed about fertility preservation and had to pursue information independently; (2) patients did not initiate/resume tamoxifen postpartum because of inadequate physician guidance. Conclusions: Concerns about fertility have a significant negative impact on the initiation and adherence to tamoxifen for young breast cancer patients. Efforts to improve tamoxifen adherence among young cancer patients should include prioritization of fertility preservation as part of the treatment plan.