bluuebunny/crossref_metadata_2025_split huggingface dataset:
Lymph node density and number of adjuvant chemotherapy cycles for node-positive resected bladder cancer: University of Iowa experience
Authors: Abu Hejleh T. , O'Donnell M. , Vaena D. 
Published: August 2020

e16126 Background: Although its survival benefit is unclear, adjuvant chemotherapy (CT) is commonly utilized for node-positive bladder cancer after radical cystectomy (RC) and lymph node (LN) dissection. The ideal number of CT cycles is also unknown. Previous studies in patients with metastatic disease administered up to 6 cycles. Lymph node density (LND) (ratio of positive LN/total LN) has been shown to be more important than nodal TNM stage in predicting outcomes after RC, and suggested a 20% LND cutoff for prognosis. This finding also accounted for adjuvant chemotherapy (yes vs. no). We evaluated the long-term outcomes of node-positive pts after RC, according to the number of cycles of adjuvant CT received and adjusting for LND. Methods: The study was IRB approved. Patients still alive were required to give informed consent and accrual is ongoing. Pathological and survival variables of pathologically node-positive pts who underwent RC at the University of Iowa in the last 5 yrs and then received adjuvant CT were retrospectively evaluated. Results: 22 pts have been evaluated to date. Median age was 62 (37–86). Median number of LNs resected was 19.5 and median LND was 19% (3–47). Median survival was 17 mo (10–67). 21 pts received a platinum-gemcitabine combination. The table shows the pt distribution according to no. of CT cycles, LND and number of > 2 yr survivors. Median survival was 17 mo both for pts with LND ≤ 20% and >20% . Median survival of pts with ≤ 4 cycles of CT was 16.5 mo (11–67), with 4 patients still alive at 14–67 months. Median survival of pts who received > 4 cycles of adjuvant CT was 17 mo (10–44), with 3 pts still alive at 29–39 months. Conclusions: The pt distribution table suggests that patients with high LND may have been sicker, and thus less able to receive as many CT cycles. This study is limited by its retrospective nature and small current sample. Accrual is ongoing and updated data will be available. Prospective adjuvant trials could stratify or randomize patients based on LND. [Table: see text] No significant financial relationships to disclose.
Combined brachytherapy and external beam radiation for prostate cancer in a community setting
Authors: Kubicek G. J. , Kubicek G. J. , Brown S. , Redfield S. 
Published: August 2020

e16147 Background: Prostate cancer is the most common male malignancy, and there is no one standard treatment modality. One treatment option is the combination of external beam radiotherapy and permanent transperineal brachytherapy seed implant Methods: Retrospective review of prostate cancer and side effect outcomes at a single institution in the community setting. All patients were treated with a combination of low dose rate transperineal brachytherapy seed placement and external beam radiation. Results: A total of 897 patients were analyzed, 781 had a minimum follow-up of one year. Median pre-treatment PSA was 8.1 (range 0.3 to 106) and the median Gleason score was 6. With a median follow-up of 3.6 years, 33 (3.4 %) patients had biochemical failure based on the phoenix definition of Nadir + 2. Not including impotence, acute toxicity greater than or equal to Grade 2 was seen in 115 patients (102 GU and 13 GI) and 193 patients had late toxicity greater than or equal to Grade 2 (155 GU and 38 GI). 563 patients received hormone therapy prior to or concurrent with the radiation. Conclusions: This is the largest series reporting on the outcome of combination brachytherpay implant and external beam radiation in the treatment of prostate cancer. Combination treatment using brachytherapy and external beam radiation is well tolerated, with a low rate of biochemical failure and should be considered one of the treatment options for prostate cancer. No significant financial relationships to disclose.
Phase III efficacy and safety trial of a new leuprolide acetate 3.75 mg depot formulation in prostate cancer patients
Authors: Shore N. D. , Savulsky C. , Mis R. , Karlin G. , Marberger M. , Leuratti C. , Kaisary A. 
Published: August 2020

e16152 Background: Androgen suppression is the standard palliative treatment for metastatic, localized or locally advanced prostate cancer. This phase III, open-label, international multicenter clinical study was conducted to investigate the efficacy and safety profile of a new formulation of leuprolide acetate (Lutrate 3.75mg Depot) in suppressing testosterone levels in prostate cancer patients. Methods: 160 patients with prostate cancer who could benefit from androgen deprivation therapy received single intramuscular injections of Lutrate 3.75 mg Depot every 28 days for a total of six doses. Plasma testosterone was determined at specific times throughout the study. The primary endpoint was the proportion of successful patients over the total number of evaluable patients. Patients’ success was defined as testosterone suppression (<0.5 ng/ml) at day 28 and continuance of castration until day 168, with no missing data at the monthly assessments. An exact two-sided binomial test (5% significance level) with two-sided 95% confidence interval (CI) estimated with exact method was performed to test the null hypothesis of 86% successful patients versus the alternative hypothesis of 94% . Results: The proportion of successful patients over the total number of evaluable patients was 96.8% (152/157); the exact binomial test was satisfied (p=0.000094, 90% CI: 92.7–99.0 %). The 78.7% (122/157) of evaluable patients achieved testosterone suppression by day 21. At day 28, 96.8% of the patients achieved castrate levels and 73.1% achieved testosterone levels ≤0.2 ng/ml. At conclusion of the trial, all patients (100%)maintained castration and 92.8% had testosterone levels ≤0.2 ng/ml. The most common treatment-related adverse event were hot flashes (45%), associated with testosterone suppression. Fatigue, hyperhydrosis, night sweats and headache occurred in ≤6.3% of patients. The most frequently reported local adverse reaction was pain at the injection site, experienced by 8.1% of patients. Conclusions: The results of this study demonstrate that Lutrate 3.75 mg Depot is as effective as presently marketed one-month leuprolide acetate formulations in establishing and maintaining testosterone concentration below castration levels in prostate cancer patients. [Table: see text]
Serum selenium and risk of prostate cancer in Japanese men
Authors: Nozawa M. , Yoshida M. , Saito Y. , Nakagawa M. , Ozeki T. , Yoshikawa M. , Aono Y. , Uemura H. 
Published: August 2020

e16166 Background: Epidemiologic studies suggest that low selenium levels are associated with an increased incidence of prostate cancer, although results are conflicting. We examined the association between serum selenium levels and risk of prostate cancer in men who received a prostate biopsy in our hospital. Methods: Our prospective study included 82 patients who received a prostate biopsy based on elevated PSA levels over 4.0ng/ml. Serum from each patient was sampled to determine the selenium level at the time of biopsy. Of these, 47 patients were diagnosed with prostate cancer (case group) and no malignant lesions in the biopsy specimen were detected in the remains, 35 patients (control group). Results: The mean serum selenium levels in the case and control group were 120.4 (SD, 14.4) ng/mL and 118.5 (SD, 16.1) ng/mL, respectively (p = 0.588). Serum selenium levels at biopsy were not associated with risk of prostate cancer diagnosis. In the case group, the mean serum selenium levels in patients diagnosed with 6 or less in Gleason score and 7 or more were 121.0 (SD, 9.9) ng/mL (n = 14) and 120.1 (SD, 16.1) ng/mL (n = 33), respectively (p = 0.851). Serum selenium levels at biopsy were not associated with Gleason score in the case group. An inverse association between serum selenium and PSA levels at biopsy was observed (p = 0.030). No correlation was observed between serum selenium level and age at biopsy. Conclusions: From this study, serum selenium level cannot predict the result of prostate biopsy. The inverse association between serum selenium and PSA levels may suggest that low selenium levels are associated with an increased incidence of prostate cancer. No significant financial relationships to disclose.
Differential mitochondrial scoring associated with chemotherapeutic effect on ovarian cancer
Authors: Isonishi S. , Matsumoto R. , Hirama M. , Ochiai K. , Tachibana T. , Ishikawa H. , Yasuda M. , Tanaka T. 
Published: August 2020

e16514 Background: We reported mitochondrial (MT) scoring system related to platinum response in ovarian cancer (OC) (Oncol Rep2008). We investigated whether the system could be useful to evaluate cellular drug sensitivity and patients’ prognosis. Methods: Ultrathin sections of surgical specimens prepared from 41 OC patients were examined by electron microscopy. Ovarian carcinoma cell line 2008 and its platinum- or taxane-resistant variant C13 or PX24 were used as control cells. Seven independent MT features including diameter and pattern of cresta structure were examined. Clinical response and in vitro sensitivity to platinum (P), taxane (T), irrinotecan (CPT), and doxorubicine (D) were examined while the MT scoring was performed independently. Results: Of 41 cases, 37 were available for clinical evaluation (stage II-IV, received 6 cycles of TP chemotherapy). Fifteen cases were responsive, while 22 were resistant. Total MT score in 15 responsive cases was 5.13 ± 1.13 (M ± SE) and was 11.41 ± 0.43 in 22 resistant cases (p < 0.001). Receptor operative characteristics (ROC) analysis revealed that resistant total “cut-off” score was ≥ 10 points (p < 0.05; AUC = 0.86). Except for D, the scoring system well related to P, T, and CPT sensitivity (p; <0.001, <0.001, 0.006). ROC analysis revealed resistant “cut-off” score for P, T and CPT were ≥ 11, 5, and 10 points (p < 0.05; AUC > 0.80). With a median follow up of 20 months, 11 patients have relapsed. The progression-free survival (PFS) curves show a difference in favor of low scoring group of patients (N = 14) compared to high scoring group (N = 19) (hazard ratio 3.99, p = 0.045), corresponding to an absolute difference in 6-months PFS 16% (89 vs 73%). Conclusions: This MT scoring system excellently related to clinically diagnosed P sensitivity as well as cellular sensitivity to P, T and CPT. Each drug has its own specific “cut-off” score, suggesting that the MT function might be differentially involved in drug sensitivity. No significant financial relationships to disclose.
Susceptibility of ascites tumor cells to ex-vivo killing by the oncolytic virus JX-963 in epithelial ovarian cancer
Authors: Davies C. , Garson K. , LeBoeuf F. , Bell J. , Weberpals J. 
Published: August 2020

e16537 Background: Epithelial ovarian cancer (EOC) has a poor prognosis, and novel therapies are urgently needed. One-third of patients with EOC will develop clinical ascites, an adverse prognostic factor. The ascitic fluid is rich in tumor cells which can be purified and used as a valuable source of patient material for in vitro analysis. In this study, we describe a method to evaluate the efficacy of ascitic tumor cell killing by the oncolytic virus, JX-963 (vaccinia strain) currently approved for use in a NCIC-CTG phase I trial. Methods: Research ethics approval and patient consent was obtained for this study. 15 samples were collected prospectively with relevant clinicopathologic information. Infection with JX-963 was performed using viral doses ranging from a multiplicity of infection (MOI) of 0.5 to 8. Following a seven-day infection period, viability was assessed using the Alamar Blue metabolic assay and tracked by virally encoded green fluorescent protein (eGFP) expression, immunohistochemistry (IHC) and flow cytometry. Results: A standardized protocol was developed for the collection and purification of EOC cells from patient ascites for subsequent infection and quantification of viral killing. Qualitative analysis using phase contrast imaging of the total cell content showed greater opaque dead cell aggregates with increasing MOI over time. Although variable between individual samples, there was a strong correlation between escalating MOI and enhanced cell death in all patient ascites samples, when quantified by Alamar Blue assay and confirmed by flow cytometry and IHC. Similar cell killing profiles by JX-963 were observed for ascites tumor cells derived from both chemotherapy-naïve patients and chemotherapy-exposed (>1 prior line of chemotherapy) patients. Conclusions: EOC cells from patient ascites show effective but differential susceptibility to viral oncolysis by the JX-963 virus that appears to be independent of prior exposure to chemotherapy. The relevance of this work is that in an individual patient, this assay will allow the testing of panels of oncolytic viruses to identify candidate viral therapeutics which may predict response to treatment. No significant financial relationships to disclose.
Carbon ion radiotherapy for malignant melanoma of female genital organs
Authors: Kiyohara H. , Kato S. , Ohno T. , Ohkubo Y. , Tamaki T. , Kamada T. 
Published: August 2020

e16548 Background: Malignant melanoma of the female genital organs is a very rare tumor and resistant to conventional photon radiotherapy. We report six cases of female genital malignant melanoma those were well controlled locally by carbon ion radiotherapy (CIRT). Methods: Between November 2004 and October 2008, six patients with unresectable female genital malignant melanoma were treated with CIRT. Age of the patients ranged from 55 to 80 years (median; 69 years). Four patients had previously untreated locally invasive tumors and other two had locally recurrent tumors after surgery and adjuvant chemotherapy. The tumor located in the vagina (4 patients), both the cervix and the vagina (1 patient), or both the vagina and the vulva (1 patient). Two patients had inguinal lymph node metastasis and two had distant metastases at CIRT. All patients received a total dose of 57.6 gray equivalent (GyE) in 16 fractions over 4 weeks of CIRT. Three patients received chemotherapy using dacarbazine, ACNU, and vincristine after CIRT. Results: The follow-up durations after CIRT were from 9 to 20 months (median; 13 months). No patient developed severe acute toxicity during CIRT. No late toxicity of greater Grade 2 was experienced, while Grade 1 proctitis was observed in a patient. All tumors completely responded to CIRT. No patient developed in-field recurrence. The four patients without distant metastasis were alive with no evidence of disease for 9–20 months after CIRT. The two patients with distant metastases died from metastatic disease 13 and 18 months after CIRT, respectively. Conclusions: CIRT achieved favorable local tumor control without developing severe acute and late toxicity in the treatment of unresectable malignant melanoma of the female genital organs. No significant financial relationships to disclose.
A feasibility study of intravenous (IV) paclitaxel, intraperitoneal (IP) carboplatin, and IP paclitaxel in patients with epithelial ovarian carcinoma, fallopian tube carcinoma, or peritoneal carcinoma
Authors: Nagao S. , Oishi R. , Iwasa N. , Shimizu M. , Hasegawa K. , Goto T. , Fujiwara K. 
Published: August 2020

e16549 Background: This is a feasibility study for a future trial to assess the feasibility of intravenous (IV) paclitaxel, intraperitoneal (IP) carboplatin and IP paclitaxel (TCipTip therapy) in patients with epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. Methods: The patients eligible for this study had histologically confirmed, stage IC-IV epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. IV paclitaxel was administered at 135 mg/m2 followed by IP carboplatin administration based on the area under the curve =6 on day1, and IP paclitaxel was administered at 60 mg/m2 on day 8. To ensure the safety, the three initial patients received 45 mg/m2 of IP paclitaxel on day 8. The toxicity grade was determined by CTCAE version 3. This study has been approved by the institutional review committee. Results: During November 2007 and December 2008, 10 patients were entered in this study. The patients included 7 epithelial ovarian carcinoma (stage IC, 2; stage IIIC, 5), 2 stage IIIC primary peritoneal carcinoma, and 1 stage IIA fallopian tube carcinoma. There were 7 serous adenocarcinoma, 2 endometrioid adenocarcinoma, 1 clear cell adenocarcinoma. The incidences of grade 3/4 hematological toxicities were 48% for neutropenia, 28% for thrombocytopenia, and 48% for anemia. Grade 3/4 neurotoxicity, abdominal pain nor IP catheter related toxicity was not observed. IP paclitaxel at 2nd or 3rd cycle was skipped in 4 patients by grade 3/4 neutropenia (grade 3, 3; grade 4, 1 ). Conclusions: TCipTip therapy is feasible for patients with epithelial ovarian carcinoma, fallopian tube carcinoma or peritoneal carcinoma. No significant financial relationships to disclose.
Hematologic toxicities before and during bevacizumab chemotherapy in women with gynecologic malignancy
Authors: Bottsford-Miller J. N. , Shafer A. , Deal A. , Filip L. , Fowler W. 
Published: August 2020

e16565 Background: Many women undergoing chemotherapy for gynecologic malignancy experience hematologic toxicity that delays therapy or requires supportive intervention. In animal models anti-VEGF antibodies increase erythropoietin levels. We examined the hematologic toxicities experienced by patients prior to (PR) and during bevacizumab (BR) treatment. Methods: Retrospective, single-institution study of women with gynecologic malignancy treated at the University of North Carolina with bevacizumab as part of their therapy from January 2005 to June 2007. Data collected included prior therapies, blood product and growth factor use, and interruptions in therapy. Comparisons were made between individual patients’ hematologic parameters during the PR and BR. Median differences between hematologic nadirs were compared using Wilcoxon Signed Rank Tests. Differences in proportions were compared by Chi-Square or Fisher's Exact tests. Results: 43 patients ware identified, 40 with complete data. Most women were Caucasian (88%) and had ovarian or primary peritoneal carcinoma (77%); median (range) age was 53 (23–73). 32 (74%) received three or more different chemotherapy drugs before starting bevacizumab. The median difference in HCT nadir (31.2 vs. 33, p = 0.01) and ANC nadir (1.2 vs. 1.4, p = 0.04) during the PR and BR were significant in favor of the bevacizumab regimens. The median nadir differences for WBC (2.7 vs. 3.1, p = 0.1) and PLT (129 vs. 150, p = 0.07) were non-significant favoring BR. For HCT toxicity grades, 22 (55%) had the same grade during their PR and BR, 15 (38%) had a lower grade during BR, and 3 (7%) had a higher grade during BR (p = 0.001). Similar trends were seen for WBC (p = 0.27), ANC (p = 0.1), and PLT (p = 0.15). During BR there was a trend toward fewer patients receiving darbepoetin (66% vs. 44%, p = 0.07) and filgastrim (29% vs. 14%, p = 0.1). Conclusions: Patients receiving bevacizumab had no worse hematologic toxicity compared to their prior regimens and may have had less severe anemia. While not statistically significant, there were trends toward less growth factor use with bevacizumab. Patients who have had prior hematologic toxicity should be considered for bevacizumab. The effect of bevacizumab on hematologic toxicity should be evaluated with prospective data. No significant financial relationships to disclose.
Carcinoma of uterine cervix: Top ranking in our country
Authors: Uddin D. , Begum K. N. , Akthar H. , Faruqui M. 
Published: August 2020

e16580 Background: Carcinoma of cervix is worldwide, the most frequent gynecological cancer particularly in developing countries like ours. Carcinoma of the cervix uterine is the second commonest gynecological cancer in the developed countries and top ranking in the developing countries like ours. Methods: One hundred and fifty women having carcinoma of the cervix uteri were prospectively studied in the department of Gynaecology and Obstetrics and Radiotherapy department of Rajshahi Medical College Hospital from January 2004 to December 2007. The cases were diagnosed clinically and confirmed by histopathological examination. Results: In all 150 patients of carcinoma of the cervix were selected for this study. There mean age was 50.12 yrs. Most of the patients (78%) had marriage between the age of 10–15 years; 8% married below 10 years and 14% between 16–20 years of age.In this study the all were multipara; 30% patients had 6 pregnancies throughout life. 10% had more than 10 pregnancies, 8% had 8 pregnancies, 4% had 9 pregnancies, 14% had 5 pregnancies and 16% had 4 pregnancies.The study shows that the distribution of patients according to the staging of the carcinoma. 54 (36%) were of III A stage. 39 (26%) in II B stage, 21 (14%) in III B stage, 9 (6%) in IV A stage, 6 (4%) in I B stage, and 3 (2%) in IV B stage. No patient presented with O or IA stage. Conclusions: The study showed that the majority of the patients were between the ages of 40–50. HPV types 16/18 has a significant role for the development of the disease. Religious practices are of important role for its causation. It is less frequent in Jew and most frequent in Hindu. Histopathologically 90%-95% are squamous cell carcinoma and 1–5% are adnocarcinoma.From the findings it is observed that early marriage, creation of awareness about sex hygiene, discourage to have multiple sexual partners and marriages, discourage to have multiple pregnancies and providing adequate health care and health education to the women could reduce the development of carcinoma of cervix. No significant financial relationships to disclose.