bluuebunny/crossref_metadata_2025_split huggingface dataset:
Incidence of bone fracture in Japanese patients receiving long-term hormone therapy for prostate cancer.
Authors: Uemura Hiroji , Fusayasu Hideo , Ohtake Shinji , Hayashi Narihiko , Yokomizo Yumiko , Miyoshi Yasuhide , Kubota Yoshinobu , Izumi Kouji 
Published: March 2020

e16098 Background: For patients with advanced prostate cancer, long-term treatment of androgen deprivation has been conventionally performed. Among the adverse events such as hormonal therapy, bone fracture due to osteoporosis or metastatsis is one of indispensable events. We assessed the frequency of bone fractures in Japanese patients received hormonal therapy. Methods: Between 2000 and 2010, 1,108 Japanese patients were treated with hormonal therapy including GnRH agonist plus anti-androgens or GnRH agonist alone at Yokohama City University Hospital. Of those patients, 48 patients (4.3%) had bone fractures during their treatment. In this retrospective study, we examined the association of bone fracture with the long-term hormonal therapy by investigating the duration of hormonal therapy, fracture sites, and the occurrence of fracture in castration resistant prostate cancer (CRPC) patients. Results: The median age of the patients with fracture was 77 (60-85) years; the median duration from the start of hormonal therapy to fracture was 29.4 (5.4-110.4) months. Eight patients with CRPC had pathological fractures at bone metastases. With respect of fracture sites, 22 patients (46%) had spinal fractures and 10 patients (21%) had fracture of lower legs. Of 8 CRPC patients, 7 patients had spinal fracture after long-term hormonal therapy (median: 38.6 months, range: 15.7-99.1 months). Conclusions: Japanese patients with prostate cancer treated with hormonal therapy have lower risk for bone fracture compared with those in western countries and USA, and interestingly, it is recognized that vertebral body is vulnerable to fracture in Japanese, especially in CRPC patients treated for long-term hormonal therapy. Because bone fracture in patients with prostate cancer endanger their prognosis, the bone management how to prevent bone fracture is very important during hormonal therapy. For the purpose of it, more detailed analysis in this retrospective study should be required.
Outcome analysis of locally advanced adenocarcinoma/adenosquamous carcinoma and squamous cell carcinoma of cervix after definitive radiotherapy.
Authors: Chen Jenny Ling-Yu , Huang Chao-Yuan , Kuo Sung Hsin , Cheng Jason C. 
Published: March 2020

e16503 Background: To compare tumor characteristics, treatment response, failure patterns, and clinical outcome of patients with cervix locally advanced adenocarcinoma (AC)/adenosquamous carcinoma (ASC) and squamous cell carcinoma (SCC). Methods: Medical records for 36 patients with stage IIB–IVA histologically proven cervix AC/ASC and 199 patients with SCC who received definitive radiotherapy (RT) or concurrent chemoradiotherapy (CCRT) between 1995 and 2009 were retrospectively reviewed. The clinicopathologic features, radiation dose, treatment response, recurrent pattern, metastases pattern, and survival outcome between histologic groups were evaluated. Results: Compared with the SCC subgroup of patients, patients with AC/ASC were significantly younger (mean age, 56 vs. 62 years, p=0.007), more of them without clinical symptoms were diagnosed by abnormal Papanicolaou smear findings (16.7% vs. 5.5%, p = 0.019), and less responded to treatment (complete response, 72.2% vs. 86.9%, p = 0.024). After a median follow-up of 59.3 months, patients with AC/ASC had worse 5-year recurrence-free survival (RFS) (33.7% vs. 58.7%, p = 0.046), worse 5-year distant metastasis-free survival (40.2% vs. 70.3%, p = 0.002), and trends toward worse 5-year local recurrence-free survival (62.4% vs. 75.7%, p = 0.127) and worse 5-year overall survival (OS) (40.1% vs. 58.0%, p = 0.062) than those with SCC. In univariate analysis, early FIGO stage and complete treatment response were found to be significantly associated with both RFS and OS. Histology of non-AC/ASC and Point A biologically equivalent doses in 2-Gy fractions >85Gy were significantly associated with better RFS, and CCRT was significantly associated with better OS. In multivariate analysis, complete treatment response remained significant factor for predicting better RFS, and early FIGO stage, CCRT and complete treatment response remained significant factors for predicting better OS. Conclusions: Cervix AC/ASC may behave more aggressively than does SCC. For this subgroup of cervical cancer, more comprehensively effective treatment is warranted.
Beyond the bevacizumab resistance, combined effects of erlotinib in heavily pretreated patients with recurrent ovarian cancers.
Authors: Kikuchi Yoshihiro , Takano Masashi , Ikeda Yuji , Kikuchi Ryoko , Kudoh Kazuya , Sasaki Naoki , Sakamoto Masaru , Kita Tsunekazu , Terao Yasuhisa , Takeda Satoru 
Published: March 2020

e16505 Background: In heavily pretreated ovarian cancer patients, bevacizumab (B) combined with conventional chemotherapy has been reported to improve the response. However, responses to B are usually transient and resistance inevitably develops. The vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR) are valid targets in many solid tumors, and their inhibitors have synergistic effects in preclinical studies. Methods: In 13 patients with heavily pretreated ovarian cancers, after development of B resistance erlotinib (E) (150 mg/day, 3 week, one week rest) and B (2 mg/kg/week, 3 week, one week rest) were administered with cytotoxic agents until development of disease progression or unmanageable adverse effects (AE). The primary endpoint in this study was response rate (RR) and progression-free survival (PFS). Results: Of 13 patients, 3 patients were not evaluable for response evaluation criteria in solid tumors (RECIST). Of 10 patients, 3 (30%) patients had partial responses (PR), 4 (40%) had stable diseases (SD), resulting in 70% clinical benefit rate (CBR). The PFS lasts more than 6 months in 4 (40%) patients. Although main AEs by E were rash, diarrhea and mucositis, all cases were manageable and tolerable. Conclusions: E administration after development of B resistance can reverse effects of B in 70% of heavily pretreated patients with recurrent ovarian cancers. AE of E was manageable and tolerable. These results warrant further studies in such clinical settings.
Is adjuvant chemotherapy after secondary debulking surgery for recurrent ovarian cancer necessary?
Authors: Takekuma Munetaka , Mori Keita , Komeda Satomi , Kuji Shiho , Tanaka Aki , Takahashi Nobutaka , Abe Masakazu , Hirashima Yasuyuki 
Published: March 2020

e16507 Background: Secondary debulking surgery (SDS) for recurrent ovarian cancer is recognized as a valuable options. However, to our knowledge, the value of chemotherapy after SDS has not been reported. Methods: Between November 2003 and November 2011, 30 patients with recurrent ovarian cancer underwent SDS at our hospital. We statistically analyzed which variables influenced survival. Results: After SDS, the median follow-up was 22.9 months, and the median survival was 26.7 months (range, 0.1-61 months). Twenty-five patients (83.3%) had no residual tumor after SDS. With Fisher's exact method, the patients who had serum CA125 levels ≥ 40 U/ml tended to show disease progression after SDS (p = 0.13). Adjuvant chemotherapy after SDS had no significant clinical benefit with regard to disease progression (p = 0.25). Moreover, log-rank test showed median progression free survival to be 31.8 months for patients who had serum CA125 levels < 40 U/ml as compared with 8.9 months for patients who had serum CA125 levels ≥ 40 U/ml (p = 0.0351). For patients who received adjuvant chemotherapy after SDS, the median progression free survival was 13.0 months, versus 8.0 months for patients not given adjuvant chemotherapy after SDS (p = 0.5871). Conclusions: We suggest that a serum CA125 level < 40 U/ml should be used as a selection criterion for offering SDS. Adjuvant chemotherapy after SDS does not appear to prolong survival. We advocate that a randomized trial to verify the necessity of chemotherapy after SDS be initiated to confirm this finding.
Centralized independent disease status adjudication for maintenance treatment evaluation in advanced ovarian cancer setting: A critical analysis of the MIMOSA trial experience.
Authors: Scartoni Simona , Pfisterer Jacobus , Sabbatini Paul , Berek Jonathan S. , Bertolotti Monica , Contini Mariapaola , Cristina Goso , Otranto Isabella , Melani Lorenzo , Poggiali Giulia , Maggi Carlo Alberto , Capriati Angela , Simonelli Cecilia ,   on behalf of Mimosa Investigators
Published: March 2020

e16510^ Background: Progression free survival (PFS) is an accepted surrogate of Overall Survival (OS) often used as the primary endpoint in phase III trials evaluating maintenance treatment in advanced ovarian cancer (AOC). Methods: We compare the centrally assessed PFS (PFS-CA) vsthe locally assessed PFS (PFS-LA) data collected in the Mimosa Trial, a randomized, double blind, placebo controlled, Phase III study of Abagovomab maintenance therapy in AOC patients in complete response after standard chemotherapy. PFS was assessed at pre-fixed time points by pelvis/abdomen CT scan, which were centrally and blinded reviewed by trained radiologists for radiological assessment (RA) of recurrence status and date (PFS-RA). An independent blinded committee, including one radiologist and one oncologist, reviewed all the CT scans and any additional imaging records AND/OR clinical data (when locally required for patients’management) to adjudicate the recurrence status and date (PFS-CA). PFS-CA was used for the primary analysis; sensitivity analyses were carried out on PFS-LA as well as on the strictly defined PFS-RA data. Results: 888 patients were randomized 2:1 to receive Abagovomab or placebo. In the ITT population (n = 886) time to PFS-CA was 403 and 402 days in Abagovomab and placebo group, respectively; in the sensitivity analyses time to PFS-LA was 407 and 409, and finally time to PFS-RA was 414- 487 days respectively, without any statistically significant differences between groups or PFS assessments. Conclusions: No differences were seen in PFS assessed centrally or locally when RA and clinical data are considered, whereas a slightly longer PFS was observed when it was assessed exclusively by the independent radiological review although this is not statistically different. The centralised independent assessment of recurrence status for ovarian cancer patients treated in the remission setting appears not to add value to the local blinded assessment. Clinical trial information: NCT00418574.
The impact of an automatically generated survivorship care plan on patient reported outcomes (ROGY Care): Results of a pragmatic cluster randomized controlled trial among endometrial cancer patients.
Authors: van de Poll-Franse Lonneke V. , Nicolaije Kim A.H. , Ezendam Nicole P.M. , Vos M. Caroline , Boll Dorry , Pijnenborg Johanna MA , Roukema Jan A. , Kruitwagen Roy F.P.M. 
Published: March 2020

e16517 Background: More patient tailored information for cancer survivors is needed. Evidence on effects of implementing Survivorship Care Plans (SCPs), is limited. Aim of this pragmatic cluster randomized trial is to assess the impact of SCPs in routine clinical practice. Primary endpoint is patient satisfaction with information. Secondary endpoints are QoL and health care use. Methods: We built an SCP-application in the web-based Registrationsystem Oncological GYnecology (ROGY), used in our area since 2006. By clicking the SCP-icon in ROGY, a personalized SCP is automatically generated. Twelve hospitals were randomized to usual care or SCP care. In usual care, gynecologists did not have access to the SCP-icon. In SCP care, SCPs are personally discussed and handed to patients. All newly diagnosed endometrial cancer patients (age ≥ 18) were asked to complete a questionnaire after surgery, 6, 12 and 24 months after diagnosis. The questionnaire included the EORTC INFO25 and asked whether patients actually received an SCP. We expected 150 endometrial cancer patients: 75 per arm. We hypothesized that patients receiving SCP care are more satisfied with the information. Results: 201 patients (74%) returned a questionnaire after surgery: 109 SCP arm, 92 usual care arm. Of the patients in the SCP arm, 69% reported receiving an SCP. Analyses according to randomization arm showed that patients in both arms reported similar scores on all scales of the INFO25, including satisfaction with care (87% vs. 82%, SCP vs usual care, p=0.20). Analyses according to actual care received showed that patients who received SCP care reported significantly higher scores (4-18 points) on all scales of the INFO25, including satisfaction with care (91% vs. 78%, SCP vs usual care, p=0.046) compared to those who did not receive SCP care. Conclusions: Even in a situation where SCPs are automatically generated, still one third does not receive an SCP. But, those who receive SCP care report better information provision and satisfaction. Follow-up measures will show whether this ultimately results in better QoL and decreased health care use. Clinical trial information: NCT01185626.
Novel approach to outpatient endometrial biopsy to detect endometrial cancer.
Authors: De Leon Maria B. , Howard Wu , Del Priore Giuseppe 
Published: March 2020

e16522 Background: Currently there is no consensus on the best device and technique for obtaining endometrial biopsies to rule out cancer. Outpatient methods available include aspiration devices (Pipelle) and disruption devices (Tao brush). This study evaluated a new device which combines Global endometrial Disruption using a brush with a built in suction Process (GDP-Tao). Methods: After IRB approval, endometrial specimens were collected using the GDP-Tao from fresh uteri after completion of hysterectomies. Endometrial pathology results from the new device were compared to the final hysterectomy diagnosis by blinded review. Results: Patients (n = 33) were 29-86 years old (median 56), 67% obese, 52% menopausal. Uterine sounds were 2.5-11cm (median 6.6 cm), weight 45-3500g (median 238g), 15% of cervical os were stenotic but all allowed the device to pass without other instrumentation with overall diagnostic rate of 91% (30/33) 15/15 pathologically confirmed malignant specimens were correctly identified by the new device including 2 GDP-Tao specimens with atypical hyperplasia (AH) and hysterectomy pathology with AH and focal adenocarcinoma. Classifying any atypia from the GDP-Tao as “positive” then the detection rate for malignancy was 100% (PPV). 11/11 samples were benign in GDP-Tao and final pathology. There were 3 non-diagnostic (ND) samples from GDP-Tao with final pathology of benign endometrium. One specimen was ND due to absence of tissue from prior endometrial ablation. There was one device result of “proliferative endometrium” with final pathology of focal complex atypical hyperplasia and one device result of “rare atypical cells” with final diagnosis of endometrial polyp. Sensitivity and specificity were 94% and 92%, and negative predictive value was 82% for the identification of both atypical hyperplasia and malignancy. When stratified by uterine size, benign or malignant, the results were similar. Conclusions: Our validation study showed encouraging data thatthis new endometrial sampling device, which combines tissue disruption and aspiration into a single process, provides a reliable mean of obtaining adequate sample to accurately detect endometrial cancer with a high negative and positive predictive value.
Impact of treatment strategies on local control and survival in uterine carcinosarcomas.
Authors: Yalcin Selim , Dizdar Omer , Kucukoztas Nadire , Rahatli Samed , Ozen Ozlem , Dursun Polat , Haberal Nihan , Tarhan Cagla , Yildiz Ferah , Altundag Ozden , Ayhan Ali 
Published: March 2020

e16526 Background: Carcinosarcoma is a biphasic neoplasm composed of a mixture of malignant epithelial and mesenchymal components. Uterine carcinosarcomas comprise only 3% of all uterine malignancies, however they account for a disproportionally higher rate of mortality from uterine cancer because of their agressive nature. No standardized treatment has yet been established. The purpose of this study was to determine the clinical characteristics, patterns of recurrence and survival outcomes in patients with uterine carcinosarcoma treated in our institution. Methods: Records of the patients with uterine carcinosarcoma were retrospectively evaluated and 29 pts with carcinosarcoma diagnosed between 2007 and 2012 were identified. All patients were initially treated surgically by the same surgeon with comprehensive staging, i.e. total abdominal hysterectomy, bilateral salphingooopherectomy , bilateral pelvic and paraaortic lymph node dissection and omentectomy. Demographic features, tumor characteristics, treatment regimens and patient outcomes in terms of relapse-free survival (RFS) and overall survival (OS) were analyzed. Results: Median age was 63 (range 43-78). 13 patients (45%) had stage I disease, 5 patients (17%) had stage III and 11 patients (38%) had stage IV disease at diagnosis. Median tumor size was 6 cm (range 1.7-20 cm) and lymphovascular invasion was present in 17 patients 59%). Twenty patients (69%) received chemotherapy (90% with paclitaxel and carboplatin) for 6 cycles. One patient received radiotherapy. Median follow up was 13 mos. Seventeen patients (59%) relapsed and 20 patients (69%) died on follow up. Two patients had vaginal cuff recurrence, 4 had pelvic, 4 had abdominal and 7 had distant recurrences. All recurrences were fatal. 3 year RFS was 31%. 3 year OS was 15%. Conclusions: Our data show that uterine carcinosarcomas tend to be more at more advanced stage at diagnosis and despite the use of chemotherapy and radiotherapy, overall prognosis is poor. Surgery remains the mainstay of treatment. More effective adjuvant strategies are needed to reduce relapse and death rates because recurrences are generally fatal.
Efficacy and safety outcomes in heavily pretreated patients (pts) with relapsed ovarian cancer (ROC) after single-agent trabectedin.
Authors: Salutari Vanda , Ferrandina Gabriella , Vincenzi Bruno , Marinaccio Marco , Naglieri Emanuele , Loizzi Vera , Carpano Silvia , Lorusso Domenica , De Vincenzo Rosa Pasqualina , Maria Grazia Distefano , Amadio Giulia , Tonini Giuseppe , Scambia Giovanni 
Published: March 2020

e16538 Background: Trabectedin is a marine-derived antineoplastic agent, initially isolated from the tunicate Ecteinascidia turbinata and currently produced synthetically. In combination with pegylated liposomal doxorubicin, trabectedin is approved in Europe for the treatment of pts with platinum-sensitive (PS) ROC. The aim of this multicenter, retrospective study was to evaluate the efficacy and safety of single agent trabectedin in the palliative treatment of heavily pretreated patients with ROC. Methods: Patients with measurable ROC and at least 2 prior treatments were eligible. Patients received single agent trabectedin (1.3 mg/m2, n = 56; 1.1 mg/m2, n=42) as a 3-hour i.v. infusion every 3 weeks. An analysis of the overall response rate (ORR; primary end point) as per RECIST, time to progression (TTP) and overall survival (OS) were performed. Results: Overall, 98 pts were enrolled: median age at diagnosis of recurrence was 53 years (range: 29-79). Forty-four pts (44.9%) were fully PS, while 23 (23.5%) were partially PS and 31 (31.6%) were platinum-resistant. Median number of previous chemotherapy regimens was 4 (range: 2-6). The ORR was 28.6% (5 complete and 23 partial responses); 32 pts (32.6%) experienced stabilization of disease, which lasted ≥6 months in 2 pts, while 38 (38.8%) pts progressed during treatment. The ORR was higher in PS pts (38.6%) compared to partially PS (26.1%) and platinum resistant cases (16.1%), although the statistical significance was not reached (p=0.071). No difference in the ORR was found according to number of prior treatments or trabectedin dose. After a median follow-up of 8 months, median TTP and OS were 5 and 13 months, respectively. The most common grade 3/4 toxicities were transient and non-cumulative anemia and neutropenia in 6.1% and 17.5% of cases, respectively. AST and ALT were increased in 7.1% and 13.3% of pts. Cardiac toxicity was documented in 4 anthracycline pretreated pts, of whom one died due to acute arrhythmia. Conclusions: Single agent trabectedin represents a valid approach in the palliative treatment of pts with heavily pretreated ROC with meaningful clinical benefit and acceptable and manageable safety profile.
Quality of life in patients of carcinoma cervix treated with chemoradiotherapy: A prospective study.
Authors: Lachi Pavankumar , Malik Monica , Adavikolanu Kesava Ramgopal , Kothwal Syedakram , M Deepajoseph , Syed Fayaz ahmed , Pamidighantam Suresh , K.V Jagannathraonaidu 
Published: March 2020

e16545 Background: The standard of care in locally advanced carcinoma cervix is concurrent chemoradiotherapy. The aim of the study is to prospectively assess quality of life (QoL) in patients of carcinoma cervix treated with chemoradiotherapy. Methods: Between June 2011 and June 2012, 20 patients of carcinoma cervix were included in the study. All patients received conformal external beam radiotherapy (EBRT) on Linear accelerator to a total dose of 50Gy, 2 Gy per fraction, 25 fractions to the pelvis and intracavitary brachytherapy by High dose rate brachytherapy, 7 Gy per fraction, 3 fractions to a total dose of 21 Gy. Patients received concurrent chemotherapy with Cisplatin 40 mg/m2 weekly for five weeks. QoL was assessed using EORTC QLQ-C30 and QLQ-C24 questionnaires at baseline and at six months following completion of treatment. The collected data was analyzed using standard statistical software package (SPSS version 20.0). Results: Median age of the patients in the study was 52years ( range 34 – 69 years), 13 (65%) patients were stage II and seven (35%) were stage III. Mean duration of treatment is 37 days (range 34- 70 days). Local control rate at six months was 95%. Compliance with completion of QoL scores was high. A statistically significant improvement (p = 0.001) was seen at six months post treatment in Global health score and in function scales like physical function, role function, emotional function, social function and cognitive function. There was a significant improvement in symptom scales of urologic and vaginal symptoms. The difference in sexual function at six months showed a trend towards significance (p = 0.052). Conclusions: Patients of carcinoma cervix have a significant improvement in quality of life following treatment with radiotherapy and chemotherapy.