bluuebunny/crossref_metadata_2025_split huggingface dataset:
Male partner approval on the use of modern contraceptive methods: factors determining usage among couples in Kibaha district, Tanzania
Authors: Msovela Judith , Tengia–Kessy Anna , Rumisha Susan F. , Simba Daudi O. , Urassa David P. , Msamanga Gernard 
Published: April 2020

Abstract
Background
Men in developing countries play an important role in the adoption of family planning (FP), either as actual users or supporters of their partners. Notwithstanding the universal knowledge on the contraceptive methods, their approval and use have been low among men in Tanzania. This study determined the magnitude and factors that influence men to use or approve the use of modern contraceptive methods with their spouses.

Methods
A cross sectional, community-based study was conducted in Kibaha, Pwani region in 2014. A total of 365 randomly selected married and cohabiting men; aged 18 to 60 years who had at least a child below the age of 5 years were interviewed using a structured questionnaire. Descriptive statistics were performed and associations between status of men using modern FP with their partners and potential factors were tested using Chi-square and Fisher’s exact tests as appropriate. Logistic regression model was fitted to determine significant factors associated with male use of the methods with their partners.

Results
About 60 % of men (59.7%) reported to use modern FP methods. In the bivariate analysis, education level (odds ratio (OR) = 2.6, CI = 1.4–4.8; p = 0.002); men knowledge on any contraceptive method (OR = 24.1, CI = 7.3–79.9; p < 0.001); awareness of a nearby FP clinic (OR = 6.2, CI = 3.1–12.3; p < 0.001); number of children (OR = 2, CI = 1.1–3.6; p < 0.025) and presence of a provider during clinic visit (OR = 12.0, CI = 2.26–63.7; p < 0.004) were significantly associated with the use of FP. However, in the multivariable analysis, only knowledge on FP methods (adjusted odds ratios (AOR) =26.4; CI = 7.9–88.4, p < 0.001) and number of children a man had (AOR = 1.9; CI = 1.0–3.6, p = 0.039) remained significantly associated with the use of modern FP methods.

Conclusion
This study has shown that for men to use family planning methods with their partners, knowledge of FP methods and number of children are critical factors. Visiting a FP center alone or with a spouse, and availability of FP provider (during visit) also influence this practice. These findings emphasize a need to increase knowledge on contraception and family planning services access among men.
Megestrol acetate increases the incidence of deep venous thrombosis in patients with non small cell lung cancer
Authors: Hussain S. , Singh M. , Shi R. , Mansour R. , Mills G. , Marion J. 
Published: April 2020

18510 Background: To evaluate the incidence of deep venous thrombosis (DVT) in patients with non small cell lung cancer who take megestrol acetate as an appetite stimulant. Methods: A retrospective study of patients with non small cell lung cancer (NSCLC) was performed to determine the incidence of deep venous thrombosis. We reviewed medical records of patients with NSCLC who were treated with and without megestrol acetate as an appetite stimulant during the course of their treatment or follow up. Cochran-Mantel-Hansel statistics was performed. Results: We reviewed the charts of 179 patients with NSCLC. 86 patients received megestrol acetate during the course of treatment or follow up whereas 93 did not. Within the treatment group, 28 patients were female and 58 were male. In the control group 43 patients were female and 50 were male. There was no significant difference in the ECOG performance status of those in the treatment group from those in the control group. The frequency of DVT was 3.4 times higher in the treatment group as compared to the control group adjusting for gender (p < 0.02). Similarly, the frequency of DVT was 2.8 times higher in the treatment group as compared to the control group adjusting for stage (P < 0.045). Conclusions: After adjusting for gender or stage, the incidence of DVT appears to be higher for patients with NSCLC who took megestrol acetate as compared to those who did not. Even though megestrol acetate was being used as an appetite stimulant, the observed differences were not due to differences in the performance status of the two groups. Further prospective study of the risks and benefits of megestrol acetate as an appetite stimulant in patients with advanced NSCLC and other malignancies is warranted. No significant financial relationships to disclose.
The impact of physician’s sequence [1st vs 2nd] and posture [sitting vs standing] on cancer patients’ physician preference and perception of compassion
Authors: Bruera E. , Strasser F. , Kaur G. , Zhang T. K. , Cohen L. , Pace E. , Palmer J. 
Published: April 2020

18513 Background: Our group previously found in a cross-over RCT in 69 advanced cancer patients [P] that the sitting posture was preferred; we also found that patients consistently chose the physician [MD] they observed in 2nd order [ASCO 2003:2958]. The effect of sequence on MD preference and perception of compassion had not been reported before. The purpose of this study was to assess if P preferred MD seen in 2nd order after controlling for posture. Methods: Advanced cancer P were randomized to observe 2 9-minute videos of a P/MD interaction. Both videos were identical except for the posture of the MD [sitting versus standing]. After a 2–3 minute assessment P were crossed-over into viewing the opposite video. Investigators were blinded to the type of video observed. P were blinded to the purpose of the study and difference between videos. Results: 168 P [98%] were evaluable. The mean perception of compassion [0 = worst, 50 = best] was 29 ± 13 for the 1st MD versus 33 ± 11 for the 2nd MD [p < 0.001]. P also preferred sitting [33 ± 11] versus standing [29 ± 12, p < 0.001]. The overall impression [0 = worst, 10 = best] for the MD seen 2nd versus 1st was 6.5 ± 2.3 versus 5.7 ± 2.7 [p ≤ 0.001]. All differences in response were independent on posture. 119/168 P [71%] perceived a difference between the 2 MDs and this difference was considered ≥ moderately important in 95 P [80%]. 76/168 P preferred the 2nd MD [45%, 95% CI, 38–53], 38/168 P preferred the 1st MD [23%, 95% CI, 16–29], and 54/168 P had no preference [32%, 95% CI, 25–39]. 49/114 P who expressed a preference perceived their preferred MD had spent more time with the P [43%]. 87/168 P preferred their MD to sit [52%] but they considered posture more important than time in 23 cases [20%], friendliness in 18 [15%], patience in 16 [14%], caring in 15 [14%], and respect in 18 [16%]. Conclusions: P prefer MDs they see in 2nd order, they have an overall better impression of them and consider them more compassionate, and they perceive that they spent more time with their P, independently on the MD’s chosen posture. Most P also prefer MDs to sit but posture is rated as a relatively low priority in P/MD communication. These findings are important for clinical care and trial participation. No significant financial relationships to disclose.
Retrospective study of locally advanced bladder cancer in elderly patients
Authors: El Karak F. , Bringeon G. , Kepenekian G. , Flechon A. , Ghosn M. , Droz J. , Terret C. 
Published: April 2020

18523 Background: Bladder cancer is one of the most frequent tumors in elderly patients (pts). However, guidelines have not been established yet in this age group. Methods: We analyzed retrospectively pts aged 75 years or more, with muscle invasive or metastatic bladder cancer treated between January 2000 and June 2005, in three institutions in Lyon-France: Léon Bérard Center, Saint Luc Saint Joseph Hospital and Protestant Infirmary. Results: Data from 126 pts (81% male) were available: median age was 80 years (75–94). 99 pts had disease confined to the bladder, 19 confirmed metastatic cancer and 8 at least T2aM0 disease. 42% of pts had a history of superficial bladder cancer; 96% an urothelial carcinoma, 19% an associated in situ carcinoma. Of note, 33% of male pts had a concomitant prostate cancer. Median Performance Status, American Society of Anesthesia score and Charlson Comorbidity index were 1, 2 and 2.14 respectively. Cardiovascular comorbidities were the most common (42.8%). 87% of pts were taking medications; median number of drug intake was 4. We focused on pts with muscle invasive, non metastatic bladder cancer: 55 of 99 pts underwent surgery; 48 of them had external urinary diversion. Postoperative complications occurred in 34% of pts: evisceration (15%), sepsis, hemorrhage, acute cardiac failure, acute renal failure, pulmonary embolism (3.7% each), bowel obstruction and acute arterial thrombosis of lower limbs (1.8% each), and 2 immediate postoperative deaths. 16 pts received radiotherapy with a curative intent, 6 of them had chemoradiation. Mean irradiation dose and duration were respectively 56.4 Gy and 6.5 weeks. Toxicity occurred in 5 pts: 2 discontinuations for intolerance, 1 acute cardiac failure, 1 grade 3 thrombopenia, and 1 toxic death (intestinal perforation). The last 28 pts received palliative care. After a median follow up of 14 months, 33 operated pts and 3 pts treated by radiotherapy were still alive in complete remission. Disease free survival and median survival were 11.5 and 42 months in the surgical group respectively and 12 and 12 months in the radiotherapy group respectively. Conclusions: Treatment of locally advanced bladder cancer in the elderly carries significant morbidity and mortality. Oncogeriatric assessment benefit for individual management must be studied. No significant financial relationships to disclose.
An Internet-based survey evaluating attitudes of cancer patients towards pain intervention
Authors: Simone C. B. , Vapiwala N. , Hampshire M. K. , Metz J. M. 
Published: April 2020

18540 Background: Pain is a common symptom among cancer patients (pts), but many pts experience inadequate medical management for pain. There are little data quantifying reasons that cancer pts fail to receive optimal analgesic treatment. This study evaluated those reasons and investigated the causes of pain in cancer pts. Methods: An Internet-based questionnaire assessing pt demographics and pain symptoms was piloted with pts and healthcare providers and posted on the OncoLink (http://www.oncolink.org) website. The questionnaire included 22 queries evaluating medication utilization, pain control and attitudes regarding pain medications. The questionnaire was IRB approved and held on a secure server. Between 11/05–1/06, 99 pts responded to the questionnaire. They were predominantly Caucasian (76%), female (78%) and pursued education beyond high school (66%). The most common diseases included cancer of the breast (51%), lung (8%) and brain (6%). Cancer treatment included surgery (75%), chemotherapy (63%) and radiation (45%). Results: Half (49%) of the respondents reported pain directly from their cancer and 42% complained of pain due to cancer treatment. This pain was primarily intermittent (42%) or chronic (35%). Most (77%) pts did not use medication specifically to help manage their pain. Analgesic usage trended less in women (19% vs. 36%, p = 0.10), Caucasians (19% vs. 38%, p = 0.06), and pts with higher education levels (17% vs. 26%, p = 0.29) but did not reach statistical significance. Reasons most commonly cited for not taking analgesics included the healthcare provider not recommending medications (86%), fear of becoming addicted or dependent (80%) and an inability to pay for medication (75%). Participants experiencing pain, but not taking analgesics, sought alternative measures for pain control such as physical therapy (84%), massage (7%) and acupuncture (4%). Conclusions: Although many cancer pts experience pain regularly, both from their cancer and cancer treatment, most pts in this study did not seek out analgesics. Pts do seek complementary therapies for pain control. Healthcare providers should regularly have open discussions with pts regarding pain symptoms. Further study will be needed to evaluate attitudes of pts towards pain based on disease condition. No significant financial relationships to disclose.
A randomized comparison of darbepoetin alfa with epoetin for chemotherapy induced anemia in nonhematological tumors
Authors: Kotsori A. A. , Alexopoulos C. G. 
Published: April 2020

18554 Background: Although once weekly (QW) Darbepoetin is nowadays used for chemotherapy induced anemia by many oncologists, a head to head comparison with thrice weekly (TIW) Epoetin regimen has not been published so far. Methods: We randomly compared QW Darbepoetin alfa with TIW Epoetin in 110 cancer patients with chemotherapy induced anemia (Hb ≤ 11 gr%). Epoetin was administered at 10.000 U TIW (20.000 U in nonresponders after 4 weeks, Group A). Darbepoetin was administered at 150 mcg QW (300 mcg as above, Group B). Evaluation was performed on week 4 and 8 including QoL assessment using FACT- An scale. Results: In group A, Hb increased from 10.11 ± 0.94 at baseline to 11.02 ± 1.39 at 4 weeks (p = .000) and to 12.09 ± 1.78 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .000). In group B, Hb increased from 10.26 ± 0.81 at baseline to 10.91 ± 1.89 at 4 weeks (p = .003) and to 11.66 ± 2.25 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .001). In all 110 patients, Hb increased from 10.2 ± 0.87 at baseline to 10.95 ± 1.71 at 4 weeks (p= .000) and to 11.82 ± 2.08 at 8 weeks (p = .000). It also increased between week 4 and 8 (p = .000). Fifteen of 27 (55.6%) responding patients in group A had to double Epoetin dose versus 18 of 39 (46.2%) in group B (P = .61). Three patients in group A required transfusions compared with 9 in group B (p= .35). On an intent to treat analysis, RR, at 4 weeks, was 46.7% for Epoetin versus 40% for Darbepoetin (p =.56). At 8 weeks, it was 55.6% and 56.9%, respectively (p = NS). QoL analysis showed that mean physical, social, functional and emotional well-being scores as well as mean fatigue and non-fatigue subscale scores were not significantly different between the two groups. Conclusions: Once weekly Darbepoetin is equally effective and more convenient therapy than thrice weekly Epoetin. No significant financial relationships to disclose.
The impact of ”laying on of hands” on well being in patients with advanced cancer
Authors: Pohl G. , Seemann H. , Zojer N. , Ochsner C. , Luhan C. , Schemper M. , Heinzl H. , Ludwig H. 
Published: April 2020

18566 Background: To determine whether the impact of “laying on of hands” on well being of patients with advanced cancer is more efficient when performed by a person with “healing powers” as compared to an actor. Methods: A total of 80 patients was registered to participate in a randomized, single-blind phase III trial to evaluate the difference in efficacy of “laying on of hands” by either a “healer” or a sham person (actor). Both arms were designed to consist of a total of 40 patients, divided into 5 groups including 8 patients each. Each patient should receive treatment for 5 minutes, 3 times a week. A “Well-being scale” was used to measure differences in treatment outcomes. The primary and secondary endpoint evaluated the difference in the total sum score of the “Well-being scale” between the two arms on day 10 or day 5, respectively. Results: The first run was unblinded by the “healer”. Hence, only the second run was available for comparison. There was no significant difference in sum-score values between the “healer” and the actor (p = 0.34) with regard to the primary endpoint or the secondary endpoint (p = 0.94). After the second run, the “healer” quit and a major protocol violation occurred. Despite this major obstacle, the study was completed by the actor as a descriptive, explorative study. There was a significant decrease in total sum score values after each single treatment (day 1, 3 and 5, p < 0.0001, respectively) for all patients. In addition, a significant improvement in symptoms could be found on day 5 (p < 0.001) after treatment and day 10 (p = 0.0002) as compared to day 1 before treatment. Conclusions: “Laying on of hands” resulted in a significant improvement of cancer or cancer-therapy associated symptoms. The magnitude of improvement obtained was similar when “treatment” was provided by a self declared “healer” or an actor, although the comparison was hampered by protocol vialotions by the “healer”. No significant financial relationships to disclose.
An attempt to correlate “comprehensive geriatric assessment” (CGA), treatment assignment and clinical outcome in elderly cancer patients: Preliminary results of a phase II open study
Authors: Mantovani G. , Astara G. , Massa E. , Madeddu C. , Tanca F. M. , Sanna E. , Spiga C. , Deiana L. , Saba F. 
Published: April 2020

18599 Background: The aim of our study was to verify the feasibility of using the CGA as an effective instrumental tool for treatment assignment and verify its influence on clinical outcome in elderly cancer patients (pts). Methods: The study design was a prospective Phase II open study. Elderly (age ≥65 years) cancer pts were assigned to 3 different CGA categories (“Fit”, “Intermediate” and “Frail”): accordingly, an appropriate treatment was administered and the clinical outcome was assessed. “Fit” pts were assigned standard chemotherapy, “intermediate” pts tailored (chemo) therapy, “frail” pts monochemotherapy (as “supportive” therapy) or only “supportive” therapy. The primary endpoint of the study was to correlate CGA with treatment and clinical outcome which was based on: objective clinical response (RECIST), ECOG PS, toxicity (NCI CTC v.3), survival, quality of life. Patients who completed at least 3 months of treatment were evaluable. Results: At January 2006, 72 pts were enrolled (mean age 74.4 years, range 65–91, M/F 39/33), 35 of whom (34 stage IV) were evaluable: 5 were “fit”, 16 “intermediate” and 14 “frail”. At baseline no difference was found between the CGA categories in the clinical characteristics (M/F ratio, stage, tumor site) except for ECOG PS which was significantly higher in frail pts (ANOVA test). The objective clinical response to the assigned treatment was: 1 PR, 1 SD and 3 PD for “fit” pts; 1 PR, 9 SD and 6 PD for “intermediate” pts; 4 PR, 4 SD and 6 PD for “frail” pts. Comprehensively, the ORR was 17.1% and the median survival was 4.15 months; 25 out of 35 pts are alive. As for the correlation of CGA categories with treatment and clinical outcome, no difference was found in the clinical outcome variables after 3 months of treatment (ANOVA test). Our results are preliminary as the study is still in progress: the required accrual is at least 32 pts for each CGA category. Conclusions: The CGA assessment is strongly recommended as an essential component of the clinical evaluation of elderly pts. Large prospective clinical trials in this field are awaited. Work Supported by: MIUR, Rome, Italy: NRP No. 2004067078. No significant financial relationships to disclose.
Complete rescue from established emesis by the NK-1 receptor antagonist, casopitant mesylate, in cisplatin-induced delayed emesis in the ferret
Authors: King A. G. 
Published: April 2020

18601 Background: Postoperative and chemotherapy-induced nausea and vomiting (PONV, CINV) can be major complications in patients undergoing surgery or cancer treatment with emetogenic drugs. Nausea and vomiting may extend beyond the postoperative recovery period or in a delayed manner following chemotherapy. Prophylaxis with 5-HT3 receptor antagonists may fail in some patients, requiring the use of rescue medications. Selective NK-1 receptor antagonists provide incremental improvement in efficacy when used in combination with 5-HT3 antagonists and dexamethasone, both in preclinical animal models and in the clinical setting. Methods: The anti-emetic and anti-nausea properties of a potent and selective NK-1 receptor antagonist, casopitant mesylate ( GW679769 ), were evaluated in the ferret using single-dose rescue treatment in a cisplatin-based delayed emesis model. In the delayed model (72 hr), a single dose of saline, ondansetron, or casopitant mesylate was administered ip at 44.8 hrs post cisplatin (5 mg/kg, ip). This time corresponds to peak emetic frequency in this model. Results: Ondansetron (1 mg/kg) significantly delayed further emetic events for ∼8 hours post injection. Emetic frequency after this latency period then paralleled the saline treated group. In contrast, casopitant mesylate resulted in an immediate dose-dependent rescue from further emetic events, with minor effects on latency. Complete rescue from further emetic events were achieved at casopitant mesylate doses ≥0.5 mg/kg. Casopitant mesylate rescue treatment also reduced nausea-like behaviors in a dose-dependent manner; however, higher doses were required to achieve statistical significance. Conclusions: Single-dose ondansetron rescue treatment failed to reduce nausea-like behaviors. These unique results, along with previously described anti-emetic prophylactic activity, support the ongoing clinical evaluation of casopitant mesylate, which is currently in phase III trials for the prevention of PONV and CINV from moderately and highly emetogenic chemotherapy. It is also in clinical development for depression and anxiety. [Table: see text]
Autologous tumor-derived HSPPC-96 vs. physician’s choice (PC) in a randomized phase III trial in stage IV melanoma
Authors: Richards J. , Testori A. , Whitman E. , Mann G. B. , Lutzky J. , Camacho L. , Parmiani G. , Hoos A. , Gupta R. , Srivastava P. 
Published: April 2020

8002 Background: Vitespen (Oncophage; formerly HSPPC-96) is an autologous, tumor-derived, heat shock protein (gp96)-peptide complex vaccine that has shown signals of clinical activity in patients (pts) with metastatic melanoma, and colon and renal cancers. Methods: This phase 3 trial compares vitespen v. PC in AJCC stage IV melanoma. Pts had ECOG PS 0/1 and ≥7 g tumor tissue for vaccine production. Randomization was 2:1 favoring vitespen, and stratified by ECOG PS and AJCC substage (M1a, -b, -c). Vitespen was administered s.c. weekly for 4 weeks, then biweekly until vaccine depletion or disease progression (DP). PC treatment was any regimen including IL-2 and/or dacarbazine/temozolomide and/or tumor resection. Pts were evaluated every 3 months for 1st year, every 6 months for 2nd year, then annually until DP. Primary endpoint was overall survival (OS). OS data, based on ITT, were analyzed using 1-sided log-rank tests. Results: From Jan 2002-Sept 2004, 322 pts at 76 centers (US, Europe, Russia/Ukraine, Australia) were enrolled. 215 pts were randomized to vitespen, 107 pts to PC. Mean age was 55 y; 59% were male; ECOG was 0 in 71% of pts; 19% of pts were M1a, 24% M1b, 57% M1c. 62% of pts in vaccine arm received vitespen; median number of vaccines was 6 (range, 0–74). As of Sept 2005, 18 pts were in tumor evaluation phase, 53 in survival follow-up, 251 off-study (death, withdrew consent, lost to follow-up). Median follow-up time for vaccine and PC arms was 250 and 289 d, respectively. Estimated median survival for vaccine and PC arms was 281 and 322 d, respectively (P = .078). M1a pts in the vaccine arm survived longer than those in the PC arm (626 v. 383 d, P = .177). Survival was comparable in both arms for M1b pts (297 v. 320 d, P = .478), and longer in the PC arm for M1c pts (299 v. 226 d, P = .015). Impact of number of doses was examined using landmark analyses to correct potential biases. Pts who received ≥10 doses of vaccine survived longer than those who received PC (377 v. 478 d, P = .072). Conclusions: Vitespen confers qualitative survival benefit over PC for M1a melanoma pts. If 10 doses of vaccine can be administered, vitespen also appears to confer survival benefit over PC for M1b pts. A phase 3 trial evaluating vitespen in M1a and M1b pts is planned. [Table: see text]