bluuebunny/crossref_metadata_2025_split huggingface dataset:
Temsirolimus (TEM) maintenance therapy after response of castration-resistant prostate cancer (CRPC) to docetaxel (TAX).
Authors: Emmenegger Urban , Booth Christopher M. , Berry Scott R. , Sridhar Srikala S. , Winquist Eric , Bandali Nesan , Chow Annabelle , Lee Christina R. , Xu Ping , Man Shan , Kerbel Robert S. , Ko Yoo-Joung 
Published: March 2020

e15177^ Background: There are no standard treatments for men who have demonstrated a good response to TAX without signs of progression. The mTOR pathway is involved in many aspects of CRPC, and mTOR inhibitors have shown significant anti-CRPC activity in preclinical testing. Therefore, we designed a phase II trial to explore whether maintenance therapy with TEM has the potential to prolong response to TAX without compromising quality of life. Methods: For this single-arm, multicenter phase II trial we recruited CRPC pts with documented treatment response by PSA (> 50% decline from baseline) or RECIST (1.0) criteria following ≥ 6 to 10 cycles of TAX (75 mg/m2 q3wks). Subjects received weekly TEM (25 mg iv x 4/cycle). The primary endpoint was time to treatment failure (TTF; RECIST or symptomatic progression). Secondary endpoints included safety (NCI-CTCAE v3.0), quality of life (FACT-P, PPI), changes in PSA, objective tumor response rate, and overall survival. We were also studying surrogate markers of TEM activity, including the enumeration of circulating endothelial cells (CEC) as a potential indicator of the antiangiogenic effects of TEM. Results: 19 pts have been enrolled to data after a median of 7 cycles of TAX. The mean age was 68 years (range 51-82), and the median baseline PSA 17.3 (0.02-380.7). 15 pts had received prior local radiation therapy, 6 surgery. 17 pts had bone metastases, 9 visceral and 8 nodal disease. Pts received a median of 4 cycles of TEM (maximum 23 and continuing), resulting in a median TTF of 5.8 (95%CI 3.8-9.2) months. No PSA responses were seen (time to PSA progression 1.8 months), but 1 PR. 8 pts achieved SD. 12 pts have been discontinued due to treatment failure (RECIST [4], symptomatic [7], combined [1]), and 3 for other reasons, including TEM-associated toxicity (lymphedema [1]). TEM has been generally well tolerated without unexpected adverse events or negative impact on quality of life. The median overall survival has not yet been reached. There is a trend for TEM to reduce viable CEC amid large inter/intrapatient CEC variability. Conclusions: TEM maintenance therapy in CRPC pts that have responded to TAX appears to be well tolerated and results in meaningful prolonged TTF.
The effect of BMI at time of surgery on long-term outcome after radical prostatectomy.
Authors: Payne Ondracek Rochelle , Hayn Matthew H. , Poch Michael Adam , Davis Warren , Curtis Alexandra , Kim Hyung Lae , Morrison Carl D , Mohler James , Marshall James Roger 
Published: March 2020

e15203 Background: Body mass index (BMI) at time of surgery was determined among 715 radical prostatectomy patients. The association of BMI with a range of treatment outcomes was considered. Methods: The associations of BMI at time of radical prostatectomy (RP) with disease stage and aggressiveness and long-term outcome were evaluated among 715 patients treated with RP at Roswell Park Cancer Institute between 1993 and 2005. Clinical and pathological aggressiveness indicators included clinical Gleason sum and tumor stage (2002 TNM), highest preoperative PSA, pathological Gleason sum and tumor stage (2002 TNM) and surgical margin status. Ten post-RP recurrence definitions were considered: 1) PSA ≥ 0.2 ng/ml; 2) PSA ≥ 0.4 ng/ml (with 1 confirming value); 3) 1 or more post RP treatments (ADT, radiation, chemotherapy); 4) PSA doubling time < 12 months; 5) PSA doubling time < 9 months; 6) PSA doubling time < 6 months; 7) NCCN definition of PSA failure; 8) AUA definition of PSA failure; 9) diagnosis of metastatic CaP; and 10) death from CaP. Results: Of the 715 men, 33 developed metastatic prostate cancer, and 17 died of prostate cancer. 246 men had BMI ≥ 30. BMI was not significantly associated with clinical or pathological aggressiveness criteria. These analyses showed that there is a trend towards higher risk of the development of metastasis or death for men with BMI ≥ 30, although the association with high BMI and these failure types is not significant. With adjustment for the most significant tumor aggressiveness features (clinical Gleason sum, pathological tumor stage, pathological Gleason sum, and surgical margin status) in proportional hazards regression, men with BMI ≥ 30 had consistently lower risk for all definitions of recurrence except metastasis and death, although no hazard ratios were significant. In contrast, men with higher BMIs had higher risk for metastasis and death from prostate cancer, although neither association is statistically significant. Conclusions: Men with higher BMIs show similar to slightly reduced risk for PSA-based recurrence definitions. Men with higher BMIs had slightly higher risk, though not significant, for metastasis and death. These results seem to support theories that PSA is diluted in men with higher BMIs.
Association of calcium channel blocker use with prostate cancer aggressiveness, progression-free survival, and overall survival.
Authors: Poch Michael Adam , Mehedint Diana , Curtis Alexandra , Attwood Kristopher , Wilding Gregory E. , Payne Ondracek Rochelle , Underwood Willie , Schwaab Thomas , Guru Khurshid , Mohler James , Heemers Hannelore 
Published: March 2020

e15204 Background: Epidemiological studies indicate that the use of calcium channel blockers (CCB) is inversely related to prostate cancer (PCa) incidence. The goal of this study was to examine the association between CCB use and PCa aggressiveness at the time of radical prostatectomy (RP) or outcome after RP. Methods: Information on medication use, PCa aggressiveness and outcome after RP was retrieved from a prospective database that contains clinical and follow-up (FU) data for all men that have undergone RP at the Department of Urology at Roswell Park Cancer Institute since 1992. The database was queried for anti-hypertensive medication use at the time of diagnosis for all patients with ≥ 1 year FU. Prostate cancer aggressiveness (risk status) and recurrence were defined using NCCN guideline definitions. Cox regression models were performed to compare the distribution of progression-free survival (PFS) and overall survival (OS) with adjustment for covariates. Chi-Square test was used to assess the relationship between CCB use and PCa aggressiveness. Results: 875 men were included in the study. At diagnosis, mean age was 60 (SD ± 7) years and mean serum PSA value was 7.4 (SD ±7.4) ng/ml. 48%, 37%, and 15% of patients had low risk, intermediate risk, or high risk PCa, respectively. 104 (12%) had a history of CCB use. CCB users and non-users were similar by PSA at diagnosis (p=0.97) and tumor aggressiveness (p=0.88). Patients taking CCB were more likely to be older (p=0.023), have a higher BMI (p=0.006) and use additional anti-hypertensive medications (p<0.01). Margin status after radical prostatectomy was similar (p=0.30) between the two groups. Median FU was 42 months. PFS (p=0.82, HR 95% CI: 0.63-1.44) and OS (p=0.72, HR 95% CI: 0.42-3.52) did not differ between the 2 groups. Adjusting for age and PCa aggressiveness did not alter the results observed for PFS (p=0.44, HR 95% CI: 0.62–1.41) and OS (p=0.50, HR 95% CI: 0.04-3.48). PCa aggressiveness was associated with PFS (p=0.001) in the multivariate model. Conclusions: CCB use does not affect PCa aggressiveness at time of diagnosis or improve PFS or OS.
Borderline ovarian tumors: Long-term survival and preservation of fertility.
Authors: Gercovich Natasha , Garcia Gerardi Carlos , Gil Deza Ernesto , Morgenfeld Eduardo L. , Rivarola Edgardo G. J. , Gercovich Felipe G. 
Published: March 2020

e15508 Background: Borderline ovarian tumors, also called low-malignancy potential tumors, are infrequent tumors present predominantly in pre-menopause women. Their evolution after surgical treatment is generally very good. The main objective of this paper is to show the evolution of a group of borderline tumors treated at our institution. Methods: Between January 1, 2000 and January 1, 2010, 36 patients diagnosed with ovarian borderline tumors were examined by two independent pathologists, according to the guidelines established by the USA Association of Directors of Anatomic and Surgical Pathology. These patients were followed at IOHM and comprise this paper’s study group. Results: Population Characteristics: Mean Age: 41 years (Range: 20-85). Affected Ovary (Right: 17 pts; Left: 14 pts; Both: 5 pts). Pathology: Mucinous (17 pts), Serous (16 pts), Clear, Brenner and Endometroid Cells (1 pt each). Stages: IA (24 pts), IB (5 pts), IC (2pts), IIIA (4 pts), IIIC (1 pt). Five patients presented non-invasive peritoneal implants and three presented positive peritoneal liquid. All patients were surgically treated: 28 with total anexohisterectomy (TAH) and 8 with unilateral ooforectomy. No patient was given any chemotherapy or radiotherapy treatment. Four patients did not attend follow-up consultations and were lost after 4, 6, 12 and 29 months with no evidence of disease (NED). Thirty-two patients were followed bi-annually during the first five years and annually thereafter. One patient became pregnant after the surgery. All patients are alive and NED with an average follow up of 50 months (range: 29-133). Conclusions: 1) Although half the cases in the study were under 35 years old, there were 12 tumors present in patients over 50 years of age and 1 borderline tumor present in an 85 year old patient. 2) Surgically treated ovarian borderline tumors have a high chance of being curable without the need of chemotherapy or radiotherapy. 3) Conservative surgery in young patients allows a conservation of fertility, provided they are subject to an adequate follow-up.
Menopausal and sexual symptoms following radiotherapy in survivors of advanced cervical cancer.
Authors: Pushpalatha Kameshwarachari , Sharma Dayanand , Julka Pramod Kumar , Kumar Sunesh , Rath G K 
Published: March 2020

e15518 Background: With ever-increasing number of cancer survivors nearing 12 million, a majority of women will face vaginal health issues related to their disease and/or treatment. Hypothesis is that there is direct damage to ovarian follicles as a result of ionizing radiation leading to follicular atrophy and decrease in ovarian follicular reserve. Cancer treatment with radiotherapy induces menopause-causing estrogen-deprivation symptoms. Hence this study was conducted to investigate the frequency of radiation-induced menopausal and sexual symptoms in cervical cancer survivors Methods: A cross-sectional study was conducted between Feb-June 2011 on cohort of 55 advanced cervical cancer patients treated with pelvic radiation of 50.4 Gy in 28 fractions over 5.5 weeks and concurrent Cisplatin, followed by intracavitary boost of 15 Grays. Women aged 55 or older and/or postmenopausal at the time of the survey were excluded. By using a questionnaire, frequency of menopause was tried to elicit along with associated sexual symptoms like hot flushes, vaginal dryness, mood swings, dyspareunia, loss of libido, botheration. Results: The average age and parity were 38.8 years and 3.6 respectively. Amenorrhoea was found in all patients. 27 (49%) patients were asymptomatic. Among 28 (50.9%) symptomatic patients, we found hot flushes in 21 (38.2%), vaginal dryness in 38 (69%), mood swings in 12 (21.8%), dyspareunia in 27 (49%), loss of libido in 26 (47.2%), bothersome in 28 (50.9%). Conclusions: Menopausal symptoms were associated with other health-related issues known to compromise the quality of life. These results highlight the need to better acknowledge and define the utility of hormonal therapy in this population. Recommendations need to be provided to treating gynaecologists and Oncologists to identify, treat and promote vaginal health. Vaginal health issues can be reduced by dedicating a small duration of time to educate the cancer survivors on hormonal/non-hormonal vaginal health strategies.
Nonpegylated liposome-encapsulated doxorubicin (NPLED) and cyclophosphamide in the treatment of platinum-resistant ovarian cancer: Final results of a phase II study.
Authors: Sambataro Daniela , Caruso Melania , Di Blasi Concetta , Lavenia Giuseppe , Asero Salvatore , Amadio Placido , Mattina Marco , Burrafato Giovanni , Longhitano Laura , Rapisardi Stefania , Cordio Stefano Sergio , Ettore Giuseppe , Bordonaro Roberto 
Published: March 2020

e15544 Background: Platinum resistant-refractory ovarian cancer (PRROC) patients have a poor outcome; single-agent therapy is still the gold standard, with overall response rate lesser than 20% and progression-free-survival is not higher than 4 months. Methods: We tested safety and activity of a two-drugs-regimen containing NPLED and cyclophosphamide in a phase II open label study. From October 2007 to October 2011 thirty-two patients with platinum-resistant/refractory disease were enrolled. Enrolled patients were pretreated with a median number of 2 lines of chemotherapy, ranging from 1 to 5. NPLED and cyclophosphamide were administered at the dose of 60 mg. and 600 mg p.s.m. respectively. Results: Patients received a median number of three cycles of chemotherapy. A total of 145 cycles were administered: as G3 toxicities we registered emesis (6%), diaorrhea (3%), asthenia, and alopecia. No grade 4 adverse events occurred. Among the 30 patients evaluable for response we observed 5 (17%) partial responses and 10 (33%) stable diseases. The median progression-free-survival was 13 weeks and the median survival was 46 weeks. Conclusions: These results are similar to other data reported in literature. In conclusion we may affirm that the association of NPLED and cyclophosphamide is active and safe when administered in PRROC, but it don’t modify the prognosis of this subset of patients.
ADXS11-011 immunotherapy: Preliminary safety data from two P2 studies in women with CIN 2/3 and with recurrent/refractory cervical cancer.
Authors: Petit Robert G. , Aqua Keith A. , Basu Partha 
Published: March 2020

e15546 Background: ADXS11-001 immunotherapy is a live attenuated Listeria monocytogenes (Lm) bioengineered to secrete a HPV-16-E7 fusion protein targeting HPV transformed cells. The Lm vector serves as its own adjuvant and infects APC where it naturally cross presents, stimulating both MHC class 1 and 2 pathways resulting in specific T-cell immunity to tumors. Here we describe the preliminary survival data associated with ADXS11-001 administration in Lm-LLO-E7-015, a randomized phase II study being conducted in India in 110 patients with recurrent/refractory cervical cancer who have been treated previously with chemotherapy, radiotherapy or both. Methods: Patients are randomized to either 3 doses of ADXS11-001 at 1 x 109 CFU or 4 doses of ADXS11-001 at 1 x 109 CFU with cisplatin chemotherapy. Naprosyn and oral promethazine are given as premedications and a course of ampicillin is given 72h after infusion thereby clearing any residual vector. Patients receive CT scans at baseline and Days 84, 184, 273, 365 and 545. The primary endpoint is 12 month survival. Results: As of January 26, 2012, 88 patients have received 200 doses of ADXS11-001; with the percentage of patients alive at 6 months at 62% (34/55); at 9 months at 41% (15/37) and at 12 months at 40% (6/15). Tumor responses have been observed in both treatment arms with 3 complete responses (elimination of tumor burden) and 4 partial responses (≥30% reduction in tumor burden) by RECIST. One serious (Gr3) adverse event and 77 mild-moderate (Gr 1-2) adverse events possibly related to study treatment have been reported in 35% (31/88) of patients. The non-serious adverse events consisted predominately of transient, non-cumulative flu-like symptoms associated with infusion that responded to symptomatic treatment, or resolved on their own within hours of treatment. Conclusions: This immunotherapy can be safely administered to patients with advanced cancer alone and in combination with chemotherapy. ADXS11-001 is well tolerated and presents a predictable and manageable safety profile. Early signs of clinical benefit merit further investigation. Updated findings will be presented at the meeting.
Does HE4 have a role in the recurrence of ovarian cancer?
Authors: Montera Roberto , Plotti Francesco , Muzii Ludovico , Terranova Corrado , Angelucci Michela , Oronzi Irma , Damiani Patrizio , Dugo Nella , Guzzo Federica , De Oronzo Maria Antonietta , Ricciardi Roberto , Aloisi Alessia , Luvero Daniela , Portuesi Rosa Alba Valentina , Scaletta Giuseppe , Capriglione Stella , Linciano Francesca , Gennari Paolo , Benedetti Panici Pierluigi , Angioli Roberto 
Published: March 2020

e15550 Background: Human epididymis protein 4 (HE4) has been recently described as a new marker for early ovarian cancer, with higher sensitivity (76.9%) compared to CA125. This is the third study in literature on the role of HE4 in recurrence of ovarian cancer and the first evaluating the sensitivity of HE4 and CA125 in these patients Methods: Plasma was obtained 24 hours before secondary cytoreductive surgery from consecutive patients with suspicious recurrence ovarian cancer operated from November 2010 to April 2011 at University Campus Bio-Medico of Rome. CA125 levels were evaluated by a one-step "sandwich" radioimmunoassay. HE4 levels were determined using the HE4 enzymatic immune assay. The CA125 cut-off was less than 35 U/mL. Two cut-off were considered for HE4: less than 150 pmol/L (according to the manufacturer's indications) and less than 70 pmol/L. Results: Fourteen patients were histologically confirmed as recurrence ovarian cancer. Mean Ca125 plasma concentration was 31.95 ± 22.09 U/mL (range 1.1 – 64.3). Mean HE4 plasma concentration was 225.83± 286.82 pmol/L (range 21.61- 633.6). The sensitivity of CA125 was 35.7 %. The sensitivity of HE4 was 71.4% and 28.6% above the cut-off of 70 pmol/L and 150 pmol/L, respectively. The dual marker combination of CA125 and HE4 at 70 pmol/L cut-off yielded the highest sensitivity (85.7%) to detect recurrence ovarian cancer. Conclusions: Even if a standard cut-off point has not been determined, this study suggested that HE4 may potentially be a more sensible marker for recurrence ovarian cancer than CA125 and the association between CA125 and HE4 at cut-off of 70 pmol/L seems to yield the highest sensitivity.
Surgical primary treatment of stage IVA cervical cancer: A multicenter retrospective study.
Authors: Damiani Patrizio , Plotti Francesco , Zullo Marzio Angelo , De Cicco Nardone Carlo , Montera Roberto , Cafà  Ester Valentina , Guzzo Federica , Ricciardi Roberto , Aloisi Alessia , Montone Eva , Hyseni Entela , Luvero Daniela , Capriglione Stella , Lopez Salvatore , Scaletta Giuseppe , Miranda Andrea , Benedetti Panici Pierluigi , Angioli Roberto 
Published: March 2020

e15551 Background: The aim of the present study is to describe feasibility, surgical technique, perioperative data, early and late complications of anterior and total pelvic exenteration after neoadjuvant chemotherapy as primary treatment for stage IVa cervical cancer. Methods: It is a retrospective study which included 73 consecutive patients affected by stage IVa cervical cancer who required anterior or total pelvic exenteration referred to 3 international gynaecologic oncology centres. The steps of this extirpative surgical procedure were: 1) staging laparotomy; 2) frozen section biopsy of the paraaortic lymph nodes; 3) systematic lymphadenectomy, radical hysterectomy with adnexectomy and total or anterior pelvic exenteration; 4) continent urinary diversions and low colorectal anastomosis if it was possible. Results: The treatment of patients affected by FIGO stage IVA cervical cancer remains one of the most complex procedures gynecologic oncologists are faced with. Our study focused on clinical and operative data , in terms of overall survival (OS) and disease free survival (DFS) at 5 years. 5-year OS of our series was 43%. Conclusions: The surgical treatment of stage IVA cervical cancer appears therefore a suitable and valid alternative. Stage IVA cervical cancer patients in good general condition, with a disease resectable with clear surgical margins, should be considered for primary exenteration in referral centers where the surgical experience to perform this procedure is available.
Laparoscopic lymphocele fenestration as first-line measure for gynecologic cancer patients after retroperitoneal lymph node dissection: 10-year analysis of safety, feasibility, efficacy, and recurrence rate.
Authors: Runnebaum Ingo B. , Radosa Marc P. , Diebolder Herbert , Winzer Harald , Anschuetz Julia , Camara Oumar 
Published: March 2020

e15566 Background: The occurrence of lymphoceles is a notorious complication occurring after retroperitoneal lymph node dissection (LND) frequently treated by repetitive percutaneous needle punctures associated with a high risk of wound infection or bowel injury. Methods: We analyzed 10 years of single-center experience with laparoscopic lymphocele fenestration as a first-line measure in gynecologic cancer 102 consecutive patients with a history of retroperitoneal LND (53.4 years; range: 22–80) who underwent laparoscopic lymphocele fenestration at our department between January 2001 and December 2010 for a symptomatic lymphocele. Results: A total of 132 lymphoceles have been fenestrated in 102 patients by laparoscopy, onaverage 5.3 months (SD: 6.3 months) after the initial LND. Mean follow-up of the patients was 60.4 months. Mean duration of surgery was 115.6 minutes and the average intra-operative blood loss per patient was 146 ml. Overall conversion rate to laparotomy was 7.8 %. The rate of intraoperative and postoperative minor and major complications was significantly higher in patients after pelvic plus paraaortic LND (23.8 %) compared to those after pelvic LND alone (3.6 %; p>0.01). Two-year cumulative risk of lymphocelerecurrence was only 4.2 % with a total of 7 recurrences of lymphoceles observed. Conclusions: Laparoscopic lymphocele fenestration was safe and feasible as well as efficacious as a surgical first-line treatment option for symptomatic lymphocele following retroperitoneal LND in gynecological cancer patients with a particularly low recurrence rate.