bluuebunny/crossref_metadata_2025_split huggingface dataset:
Development and psychometric properties of the Prostate Cancer Radiation Toxicity Questionnaire
Authors: Rodrigues G. , Bauman G. , Lock M. , D'Souza D. , Mahon J. 
Published: March 2020

15631 Background: The objective of this study was to construct a prostate cancer late radiation toxicity (PCRT) questionnaire with associated health-related quality of life (HRQoL) domains. Methods: A literature review of prostate cancer toxicity scales and HRQoL instruments generated a list of potential items for inclusion into the PCRT. An initial questionnaire was subjected to both patient (n=8) and expert (n=7) opinion. A pilot study (n=37) assessed patient feedback, ease of administration, and acceptance. Item reduction (n=100) based on response heterogeneity, factor analysis and Cronbach's alpha analysis was performed. Reliability testing (n=274) was performed using test- retest methodology and calculation of intraclass correlation coefficients (CC). Validity testing (n=274) consisted of discriminant and various construct validity tests (1. calculation of Pearson CC between the PCRT and different HRQoL instruments, and 2. comparison of mean brachytherapy versus external-beam radiation therapy domain scores by Student's t-test). Results: Construction of an initial 29 item (5 point Likert scale) questionnaire with genitourinary, gastrointestinal, and sexual symptom and bother items was performed. The pilot study demonstrated that the PCRT was comprehensive (94%) and easy to administer (1.3% missing data). Item reduction resulted in three HRQoL subscales: (4 item GU alpha = 0.639, 12 item GI = 0.859, 5 item sexual = 0.700). Test-retest reliability demonstrated intraclass correlation coefficients of 0.811 (GU), 0.842 (GI), and 0.740 (sexual). Discriminate validity analysis demonstrated Pearson CC of 0.449 (GU-GI), 0.200 (sexual-GU), and 0.09 (sexual-GI). Content validity analysis demonstrated significant correlations between analogous subscales between PCRT and the PCQoL (range 0.35–0.78). Smaller correlations exist between the PCRT and FACT-G (0.19–0.39) and SF-36 (0.03–0.34). Difference scores between brachytherapy and external-beam favoured brachytherapy [4.13 (GI, p=0.02), 3.50 (sexual, p=0.36), and 3.63 (GU, p=0.14)]. Conclusion: The HRQoL subscales generated from the PCRT have been shown to have good internal consistency with documented reliability and validity. No significant financial relationships to disclose.
Induction of complete remission in metastatic hormone-refractory prostate cancer: A combined anti-inflammatory therapy approach
Authors: Reichle A. , Walter B. , Berand A. , Vogelhuber M. , Bross K. , Wilke J. , Wieland W. , Andreesen R. , Rogenhofer S. 
Published: March 2020

15636 Background: The present multi-centre phase II study was designed to support the hypothesis that networking agents binding to ubiquitous accessible targets in metastatic hormone-refractory prostate cancer (HRPC) may counteract neoplasia-specific aberrant cellular functions, thereby mediating objective response (primary endpoint). Method: Patients with metastatic HRPC, received both an anti- inflammatory and angiostatic therapy consisting of low-dose chemotherapy with capecitabine 1 g twice daily for 14 days every 3 weeks, day 15+, COX-2 blockade with etoricoxib 60 mg daily, day 1+, combined with two transcription modulators, pioglitazone 60 mg daily, day 1+, plus dexamethason 1 mg daily for 14 days, every 3 weeks, day 15+, until disease progression. The study was planned using the Simon optimal design. Results: Thirty-six consecutive patients (N= 22 (61%) chemo-naive, n= 14 (39%) with preceding chemotherapies, mean 2.1 regimen) with metastatic HRPC, confirmed PSA increase, assessable response, and ECOG 0–2 were enrolled between 1/03 to 5/06. Objective response occurred in 10 of 13 cases (N/n: 41%/7%) with PSA (and C-reactive protein) response >50% (N/n: 45%/21%). Median time to PSA response was 2.4 months (range 1.0 to 7.3 months). Two of three patients responding with PSA <4 ng/ml achieved complete remission after 9 and 16 months, 16 patients stable disease (N/n: 41%/64%), and 5 patients experienced progressive disease (N/n: 14%/14%). Median progression-free survival (PFS) was 3.6 months (range 0.5 to 28.5) and median overall survival (OS) 14.4 months (range 0.6 to 37.2). Multivariate analysis recognized pre-treatment with chemotherapy as negative predictor for both OS (hazard ratio 2.26 (CI 95%: 0.970; 5.277), p=0.05) and PFS (HR 2.47 (CI 95%: 1.146; 5.348), p= 0.02), and <50% PSA response as negative predictor for PFS (HR 0.38 (CI 95%: 0.171; 0.857), p= 0.01). Toxicities > WHO grade II were reported: Hand-foot syndrome (n=1), anemia (n=6), edema (n=1), cushing syndrome (n=1), hydronephrosis (n=1). Conclusions: This is the first study reporting continuous complete remissions in HRPC with a biomodulatory therapy approach. Further, the study may clinically support the upper mentioned hypothesis. No significant financial relationships to disclose.
A study of complementary therapies in men receiving radiation therapy for prostate cancer: A randomized feasibility trial
Authors: Beard C. , Dean-Clower E. , Dusek J. , Stason W. B. , DeCristofaro S. , Keshaviah A. , Purevjal I. , Rosenthal D. , Webster A. , Benson H. 
Published: March 2020

15638 Background: Prostate-cancer patients suffer from substantial distress with both their diagnosis and treatment. Several studies have looked at the use of complementary and alternative medicine (CAM) in patients with prostate cancer to alleviate their stress and effects of therapy. We elected to study Reiki and Relaxation Response Therapy (RRT) in prostate-cancer patients. Methods: Patients receiving an eight-week course of radiation for prostate cancer were eligible. Consented participants were randomly assigned to RRT, to Reiki, or to no CAM therapy during radiotherapy. Reiki was given twice weekly, RRT once weekly. The feasibility of enrolling 60 patients, their compliance with physiologic and psychological testing, and preliminary assessment of the effect of CAM are the study endpoints. Statistical analysis of feasibility is based on the assumption that at least 80% of patients would complete 14/16 Reiki sessions or 7/8 RRT sessions. Patients were tested for outcome measures at baseline, at randomization, halfway through radiation, at completion of radiation and 2 months later. The psychosocial outcome measures used were the STAI, CES-D, FACT-G, FACIT: Fatigue Scale, and EPIC: Hormone Section. Physiological assessment included salivary cortisol, blood samples for interleukin-6, tumor necrosis factor alpha, CD8, natural killer cells, heat shock protein 70 and a validated bowel-and-bladder-symptom questionnaire. Results: We have enrolled 62 of 108 eligible patients (60%) within 18 months. The number of enrollment has been increased to 62 as two patients changed their treatment location. To date five patients dropped out short of completion, 1 became ineligible, 32 have completed the study, 20 are still receiving CAM therapy or are in active follow-up and 2 are awaiting randomization and radiotherapy. Conclusions: Complementary therapy appears to be of much interest to prostate-cancer patients. At the completion of the trial, we will have more data on feasibility, compliance and preliminary results on the effect of CAM intervention in this population. No significant financial relationships to disclose.
Endometrial carcinoma (EC) in women 35 years of age or younger
Authors: Ali-Fehmi R. , Cote M. , Arabi M. H. , Munkarah A. , Schimp V. , Bryant C. , Morris R. 
Published: March 2020

16000 Background: Although the majority of women with EC are postmenopausal, 25% are under the age of 50 years at the time of diagnosis. The aim of this study is to describe the demographic and survival data for women presenting with EC at age 35 years or younger (YOY). Design: Patients with a diagnosis of EC were identified from the Surveillance, Epidemiology, and End Results (SEER) cancer database from 1988 to 2003. Demographic and pathologic data were collected. Chi-square and t-tests were used to examine differences between the younger and older women, and survival analyses were performed using Kaplan Meier and Cox regression models. Results: Of the 61,364 women diagnosed with EC in the study period, 931 patients 1.5% were 35 YOY. Compared to women 36 years of age or older at diagnosis, the young-onset women were more diverse in terms of race/ethnicity (p<0.0001), with white women comprising 48% of the younger population, and 80.4% of the older population. Hispanic 23.7%, black 8.3%, and other race/ethnicities 18.4% were more common in the younger age group. The mean age in the young population was 31.5 years. Mean age at diagnosis was greater for the young whites compared to the other racial groups combined (32.0 years vs. 31.0 years, p<<zemphx>0.0001). Younger women were more likely to be diagnosed in earlier stages and grades compared to their older counterparts (both p<0.0001). The overall stage by AJCC in younger women was 75.4%, 6.6%, 4.1% and 5.2% (stages I-IV, respectively), with 8.7% unstaged. In the younger women, 54.6%, 26.3%, and 9.5% of grade 1, 2, and 3 tumors were reported, respectively. Type II tumors comprised 4% (N=36) of the study population. The overall mean survival was significantly better for younger (75.4 months, 95% CI 71.8–79.0) compared to older women (66.6 months, 95% CI 66.2–67.0). The survival difference was seen for every AJCC stage of disease. Conclusions: The changing race and ethnicity demographics in the US, coupled with the increase in obesity, suggest that EC incidence may be on the rise in younger women. Early stage, well-differentiated EC represents the most common type of EC in the younger patients. As treatment standards differ for younger women who hope to preserve their fertility, it is important to follow the long-term outcomes in this group. No significant financial relationships to disclose.
Outpatient intraperitoneal chemotherapy for ovarian cancer chemotherapy—A comparison of reimbursement for intraperitoneal versus intravenous therapy
Authors: Schink J. C. , Bamlett-Sherman T. , Anastos L. M. 
Published: March 2020

16027 Background: The GOG 172 trial produced compelling evidence that IP chemotherapy produced superior outcomes to IV chemotherapy for women with advanced ovarian cancer (AOC). In January 2006 these results were published along with an NCI Clinical Alert documenting the improved overall survival resulting from IP treatment. However, broad adoption of IP chemotherapy may hinge in part on adequate reimbursement, thus requiring support from governmental and third party payors. This analysis is designed to compare reimbursement for outpatient IP versus IV chemotherapy, assuming that the net effect might affect overall adoption of this important new therapy. Methods: A prospective trial of outpatient IP chemotherapy was initiated 1/2006 for women with AOC. A group of 28 AOC patients received 119 IP treatments between 1/2006 and 10/2006. Reimbursement for these treatments, net of related costs, was compared with that for standard IV chemotherapy. The IP regimen includes: aprepitant, palonosetron and dexamethasone on day 1; followed by docetaxel 70 mg/M2 then amifostine 910 mg/M2 (all IV) then cisplatin 100 mg/M2 IP; concluding with paclitaxel 60 mg/M2 IP on day 8. The IV regimen was carboplatin AUC 5 and taxane (paclitaxel 175 mg/M2 or docetaxel 70 mg/M2). The nursing administration codes for IP were 96445 on days 1 and 8; by comparison, the codes for IV were 96413 for infusions up to 1h, and 96415 for each additional hour. Data on precertification, total drug and administration charges, drug costs, and reimbursement were assimilated and used to compare reimbursement net of select costs. Results: Reimbursement for IP code 96445 was significantly higher than for IV codes 96413 and 96415, with the respective mean billed $2,469 for IP vs $834 for IV. Reimbursement rates for 96445 ranged from 25% to 100% (median 97%, mean 87%). Mean total charges for IP regimen was 1.28 times higher than for IV regimen, and reimbursement rates were comparable. Conclusions: IP chemotherapy for AOC is more effort intense and requires more chemotherapy drug and supportive care medications, resulting in higher charges and higher net revenue when administered on an outpatient basis. No significant financial relationships to disclose.
Primary cytoreductive surgery or neoadjuvant chemotherapy: A retrospective analysis of 214 patients with stage IIIc and IV ovarian, tubal and peritoneal cancer from the Norwegian Radium Hospital
Authors: Silins I. , Elstrand M. B. , Davidson B. , Tropé C. 
Published: March 2020

16035 Background: We evaluated clinical prognostic factors in ovarian carcinoma for their association with upfront treatment in advanced stage ovarian cancer patients with effusions. Methods: Our study consists of a retrospective analysis of 214 patients with stage IIIc and IV primary ovarian cancer, primary peritoneal carcinoma and tubal cancer, treated at the Norwegian Radium Hospital (NRH) in the period 1998–2003. One-hundred and thirty-eight patients underwent primary cytoreduction, 51 patients received neoadjuvant chemotherapy followed by delayed debulking and 25 patients received only chemotherapy. Results: Residual disease of less than 1 cm was achieved in 31.9 % of primary surgery patients and in 47.1 % of delayed surgery patients. Standard taxane/platinum treatment was given to 79.7 % and 67.1 % patients in the surgery and neoadjuvant treatment group, respectively. Hazard ratio for relapse was significantly higher for upfront treatment with neoadjuvant chemotherapy (1.69, CI 95 % 1.12–2.55) compared to primary surgery and for suboptimal debulking surgery and/or suboptimal chemotherapy (1.66, CI 95 % 1.14–2.41) compared to optimal treatment. The incidence of disease-related death was also significantly higher for the neoadjuvant chemotherapy group (1.83, CI 95 % 1.21–2.79) and for patients treated suboptimally (1.50, CI 95 % 1.03–2.19). Median cancer-specific survival was 31 months for the primary surgery group and 15 months for the neoadjuvant treatment group. Conclusions: In this retrospective analysis, the two most important prognostic factors for advanced ovarian, tubal and peritoneal cancer with malignant pleural and/or abdominal effusion were surgical treatment as first-line therapy and combination of optimal tumor debulking (<1cm) and taxane/platinum chemotherapy. The role of neoadjuvant chemotherapy is still controversial. No significant financial relationships to disclose.
Combination gemcitabine and cisplatin for recurrent ovarian cancer
Authors: Richardson D. L. , Kim K. , Seamon L. G. , O'Malley D. M. , Eaton L. A. , Cohn D. E. , Copeland L. J. , Fowler J. M. 
Published: March 2020

16037 Background: Recent evidence suggests gemcitabine combined with a platinum drug is active in recurrent ovarian cancer. In an effort to decrease dose-limiting myelosuppression associated with gemcitabine plus carboplatin, cisplatin can be substituted for carboplatin. Our objective is to describe a single institutional experience with day 1 and day 15 (D1/15) gemcitabine (1000 mg/m2) and cisplatin (30 mg/m2) for the treatment of recurrent ovarian cancer. Methods: A retrospective chart review was performed of all patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer who were treated with gemcitabine and cisplatin from 8/2001 through 8/2006 at a single institution. Sixty-seven patients met inclusion criteria. Results: The median number of prior chemotherapy regimens was 2 (range 1–6). The median platinum-free treatment interval was 10 months (range 0–40). While 34 (51%) patients were platinum sensitive, 24 (36%) patients were platinum resistant, and 9 patients (13%) were platinum refractory. Patients were treated with a median of 6 cycles (range 1–31) of gemcitabine plus cisplatin. Fifteen (22%) patients had a complete clinical response with a median progression free survival (PFS) of 16 months (range 5–40); 15 (22%) patients had a partial clinical response (median PFS 6 months, range 2–15). Stable disease was noted in 19 patients, with a median PFS of 24 months (range 4–36). Three (38%) out of eight patients with refractory ovarian cancer had a complete clinical response, and 1 patient had a partial response. Non-hematologic toxicities were most common, occurring in 23% of the patient population (neuropathy, fatigue and pain). Grade 3 and 4 hematologic toxicities were rare, occurring in less than 10% of patients. Conclusions: Gemcitabine plus cisplatin (D1/15) is a well tolerated and active regimen in patients with recurrent ovarian cancer, regardless of previous response to platinum-based chemotherapy. No significant financial relationships to disclose.
Preoperative evaluation of epithelial ovarian cancer with multidetector computed tomography and its correlation with surgical outcome
Authors: SH C. , Thulkar S. , Srivastava D. , Kumar L. , Hariprasad R. , Kumar S. , Sharma M. 
Published: March 2020

16051 Background: In the management of epithelial ovarian cancer (EOC), optimum debulking surgery (residual tumour of 1 cm or less) is the most important prognostic factor and is associated with higher survival We conducted a prospective study to evaluate the role of Multidetector (MD) CT scan to predict optimal debulking in advanced EOC. Methods: Between December, 2004 and October, 2006, 38 previously untreated patients (median age-50 years, range 26 to 70) were evaluated with contrast- enhanced MD CT scan of abdomen and pelvis. All CT scans were performed on four-slice MD CT scanner with thin slice image acquisition. Multiplanar coronal, sagital or oblique images were constructed and all images were reviewed by at least 2 radiologists. The extent of disease was determined and mapped for all areas of abdomen and pelvis. Patients underwent primary debulking surgery in which total abdominal hysterectomy, bilateral salphingo-oophorectomy, omentectomy and optimal cytoreduction was done. CT scan films were reviewed and compared with surgical findings. A CT scan scoring system was developed to predict the optimum debulking using 10 parameters: ascites, pelvic, peritoneal deposits, large bowel, small bowel, omentum, diaphragm, liver, lymphadenopathy and lesser sac. Each factor was assigned a score of 0 to 2. The statistical analysis was done using SPSS version 11 and EpiInfo 6 software. Results: The mean interval between CT scan and surgery was 11 days. 18 of 38 patients had a CT score = 7; all 18 had sub-optimal debulking. Of remaining 20 patients with CT score <7, 17(44.7%) had optimum and 3 had sub-optimal cytoreduction. The sensitivity and specificity was 85.7% (95% CI 62.6–96.2) and 100% (95% CI 77.1–100), respectively. It had positive predictive value of 100% and negative predictive value of 85% with accuracy of 92% in identification of patients who would not benefit from surgery. Presence of tumor at gall bladder fossa, porta hepatis, ligament teres, spleen , stomach, pancreas, lesser sack and pelvic side walls was associated with sub-optimal debulking. Conclusions: Pre-operative CT scan scoring helps to identify patients who are likely to have sub-optimal debulking and may be candidates for neoadjuvant chemotherapy No significant financial relationships to disclose.
Correlation between immunohistochemical biomarker expression and in vitro drug response factors in stage III-IV ovarian cancer
Authors: Tawfik O. , Peterson L. , Parker R. , Mechetner E. , Davis M. , Chapman J. , Khan Q. , Ma J. 
Published: March 2020

16055 Background: The reliability of molecular biomarkers as predictors of treatment outcome remains unclear and, in relation to drug resistance even less is known. Immunohistochemical (IHC) expression of biomarkers and in vitro drug resistance (IVDR) relative to clinical outcome were evaluated in patients with stage III-IV epithelial ovarian cancer (OC) who received combination carboplatin (CAR) plus paclitaxel (TAX) chemotherapy. Methods: We correlated clinical outcome with histopathology and biomarker expression of MIB-1, p53, BCL2, EGFR, ER and PR in 98 OC patients with tumors tested for IVDR by extreme drug resistance (EDR) assay. IVDR was determined following exposures to single agents CAR, cisplatin (CP), TAX, taxotere (TXT), gemcitabine (GCB), topotecan (TP), liposomil doxorubicin, and cytoxan (CT). Percentage cell growth inhibition (PCI) for each drug was compared with PCI from untreated control cultures. Results: Tumors with prior chemotherapy (n=29) were more resistant to CAR (unpaired t-test, p=0.046), and CT (p=0.038), and more sensitive to liposomil doxorubicin (p=0.009), compared to treatment naive tumors (n=53). For 65 tumors, there was a positive relationship between MIB-1 vs p53 (r=0.419; p=0.001), and between ER vs PR (r=0.339; p=0.011). Correlation between biomarkers and drug response showed a significantly inverse relationship between MIB-1 vs liposomil doxorubicin, p53 vs liposomil doxorubicin, EGFR vs CAR, CP, GCB and TAX; and between ER vs TXT and CT, and PR vs CT and TP. With a 53% (33/61) response rate to CAR+TAX, time to progression (TTP) for responders (R) with EGFR+ tumors was longer (median TTP 15.6 mo); and shorter for R with EGFR- tumors (p=0.008). For R and non-R, BCL2+ tumors had longer overall survival (OS) (median OS 23.3 mo; p=0.006). No other significant correlations were seen. Conclusion: Prior chemotherapy increased IVDR to CAR and CT, and increased sensitivity to liposomil doxorubicin. Increased expression of proliferation biomarkers, particularly EGFR, correlated with resistance to several chemotherapeutic agents. EGFR expression in responders was associated with longer TTP. The significance of in vitro correlates of prognostic biomarker expression and IVDR for predicting chemoresistance warrants prospective studies to assess its value in clinical settings. [Table: see text]
Concurrent chemoradiotherapy for locally advanced cervical cancer: Analysis of a single institutional 10-year experience
Authors: Aoki Y. , Nagai Y. , Toita T. , Hirakawa M. , Toma M. , Yagi C. , Nashiro T. , Inamine M. , Kamiyama K. 
Published: March 2020

16056 Background: The purpose of this study was to report the feasibility and efficacy of concurrent chemoradiotherapy (CCRT) for the locally advanced cervical cancer in our institute. Methods: We retrospectively reviewed 147 patients (stage Ib: 9, II: 82, III: 80, and IVa: 7) with squamous cell carcinoma of the cervix treated with CCRT. Cisplatin (20mg/m2/day) was administered for 5 days every 3 weeks for a median of three courses (range: 1–5 courses) during radiotherapy (RT). The patients with paraaortic and/or common iliac lymphadenopathy were excluded. RT consisted of pelvic external beam RT (EBRT) with 40Gy/20 fractions followed by high-dose rate brachytherapy (HDR-BT) with 18Gy/3 fractions and pelvic EBRT with 10Gy/5 fractions using a midline block. Late complications were graded by the RTOG/EORTC criteria. Results: The 5-year actuarial overall survival (OS), disease-free survival (DFS), and pelvic relapse-free survival were 78.5%, 70.7%, and 78.0%, respectively. The 5-year OS by the disease stage was as follows: stage Ib 100%, II 82.0%, III 62.3%, and IVa 35.7%. Multivariate analysis identified pelvic lymphadenopathy, tumor diameter > 7cm, and pretreatment hemoglobin < 9.0g/dl as an independent prognostic factor for both OS and DFS. Only one patient suffered from grade 3 enterocolitis, but no grade 4 complication developed. Conclusions: Our experience suggests that CCRT using HDR-BT for locally advanced cervical cancer could achieve favorable local control without suffering from severe late complications. No significant financial relationships to disclose.