Ibandronate reduces radiotherapy-resistant metastatic bone pain in patients with solid tumors: A comparison of i.v. and oral formulations

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19517-19517
Author(s):  
K. Mystakidou ◽  
E. Stathopoulou ◽  
E. Parpa ◽  
I. Hatzipli ◽  
N. Touroutoglou ◽  
...  
Keyword(s):  
Solid Tumors ◽  
Bone Pain ◽  
Progressive Disease ◽  
Bone Lesion ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Primary Tumor Site ◽  
Significant Difference ◽  
Analgesic Use ◽  
Renal Safety

19517 Background: Bisphosphonates are used to treat metastatic bone disease (MBD). However, some bisphosphonates are associated with renal toxicity. Ibandronate (IA) is a single-nitrogen, noncyclic bisphosphonate with a renal safety profile similar to placebo in phase III trials. This study compares the effects of i.v. IA 6mg and oral IA 50mg on bone pain, analgesic intake and renal safety. Methods: Recruited patients fulfilled the following criteria: age ≥18, solid tumors with at least one bone lesion, normal renal (serum creatinine ≤1.5mg/dL) and hepatic function, WHO performance status 0, I or II, life expectancy ≥6 months, normal serum calcium or asymptomatic hypercalcemia. Patients were excluded if they were pregnant or lactating, taking nephrotoxic drugs or osteoclast activity modulators. Eligible patients (n=52) were recruited for a two-arm study, with 26 patients per group treated over 6 months. Groups were matched for age, gender, weight, height, blood pressure, site of primary tumor, site and number of bone metastases and number of irradiated sites. Intravenous IA 6mg was administered over 15 minutes every 4 weeks. Oral IA 50mg was administered as a single, daily tablet before breakfast. Studies were ceased on occurrence of new bone events. Primary endpoint was reduction in bone pain and reduced analgesic use. Results: There were no significant differences in patient demographics between the two treatment arms. The percentage of patients receiving i.v. IA that achieved stable or progressive disease was 15.4%; those receiving oral IA attained 11.5% stable or progressive disease. Pain (Brief Pain Inventory questionnaire) and analgesic intake were assessed at baseline, 3 and 6 months. Both i.v. and oral IA caused a significant and sustainable decrease in each of the pain indices (p<0.0005) with no significant difference between i.v. and oral groups. Both i.v. and oral IA treatment led to a trend in decrease of analgesic use. Conclusions: Oral and i.v. ibandronate have comparable efficacy for palliation of bone pain in MBD patients. No significant financial relationships to disclose.

Risk of bevacizumab-associated gastrointestinal perforation in patients with colorectal cancer and noncolorectal cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9622-9622
Author(s):  
D. T. Chu ◽  
S. Hapani ◽  
S. Wu
Keyword(s):  
Colorectal Cancer ◽  
Relative Risk ◽  
Solid Tumors ◽  
Random Effect ◽  
Angiogenesis Inhibitor ◽  
Phase Iii ◽  
Tumor Type ◽  
Increased Risk ◽  
Significant Difference ◽  
American Society

9622 Background: Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor. It is a widely used angiogenesis inhibitor in the treatment of colorectal cancer (CRC) and other solid tumors. Gastrointestinal (GI) perforation is a potentially fatal adverse event associated with bevacizumab, but the risk unclear. This study was conducted to determine the risk of developing GI perforation among CRC and non-CRC patients receiving bevacizumab. Methods: Databases from PUBMED and the Web Science from January 1966 until July 2008 and abstracts presented at the American Society of Clinical Oncology conferences from January 2000 to through July 2008 were searched to identify relevant studies. Eligible studies included prospective phase III clinical trials in which standard anti-neoplastic therapy was administered with and without the use of bevacizumab with available data for GI perforation. Summary incidence rate, relative risk (RR), and 95% confidence interval (CI) were calculated using fixed or random effect models based upon the heterogeneity of the included studies. Results: A total of 12084 patients with various solid tumors from 14 phase III trials were included for analysis. Among patients receiving bevacizumab, the incidence of GI perforation was 0.8% (95% CI: 0.6–1.1%), and RR was 2.0 (95% CI: 1.1–3.8, p = 0.028) in compared with controls. The risk of GI perforation was significantly increased in patients receiving bevacizumab at 5 mg/kg/week (RR 2.6, 95% CI: 1.0–6.6, p=0.04), but not at 2.5 mg/kg/week (RR=1.5, 95%CI: 0.7–3.3, p=0.3). Among 2151 patients with CRC, the incidence of GI perforation was 0.8% (95% CI: 0.5–1.6%); while for 2.999 patients with non-CRC malignancies, the incidence of GI perforation was 0.7% (95% CI: 0.5–1.1%); The relative risk of GI perforation varied with tumor type, with significantly increased risk observed in patients with CRC (RR = 3.1, 95% CI: 1.2–8.2, p<0.023), but not non-CRC (RR=1.5, 95% CI: 0.67–3.4, p=0.3). Conclusions: There is a significant difference in the risk of developing GI perforation in CRC and non-CRC patients receiving bevacizumab with a higher relative risk in patients with CRC. Further investigation into the etiology of this difference is recommended. No significant financial relationships to disclose.

Phase III study of paclitaxel (Pac) versus pegylated liposomal doxorubicin (PLD) for the treatment of advanced human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS): An Eastern Cooperative Oncology Group (ECOG) and AIDS Malignancy Consortium

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 20503-20503
Author(s):  
J. H. Von Roenn ◽  
S. Lee ◽  
M. Cianfrocca ◽  
A. Tulpule ◽  
D. Scadden ◽  
...  
Keyword(s):  
New York ◽  
Eastern Cooperative Oncology Group ◽  
Pegylated Liposomal Doxorubicin ◽  
Progression Free Survival ◽  
Multicenter Trial ◽  
Phase Iii ◽  
Disease Assessment ◽  
Comparable Efficacy ◽  
Efficacy Analysis ◽  
Significant Difference

20503 Background: PLD (doxorubicin HCL liposome injection, Doxil®, Tibotec Therapeutics, Raritan, NJ) and paclitaxel (Taxol®, Bristol Myers, Inc, New York, NY) are active in the treatment of HIV-associated KS; however, optimal therapy is undefined. Methods: A randomized phase III, multicenter trial was initiated to compare the efficacy of Pac (100 mg/m2) every 2 weeks to PLD (20 mg/m2) every 3 weeks for chemotherapy-naïve AIDS-related KS. Treatment continued until disease progression or unacceptable toxicity; concurrent antiretrovirals were permitted. 216 pts were required to detect at least a 3-month improvement in median progression free survival (PFS) for Pac compared with PLD (80% power, 2-sided alpha 0.05). Response was assessed using KS response and clinical benefit criteria, and global assessment of quality of life (QOL) using the Functional Assessment of Health Index (FAHI; version 3) plus 3 supplemental questions concerning pain, swelling, and satisfaction with physical appearance (measured at baseline and during/after treatment). Results: The trial was terminated early due to poor accrual; 46 pts were randomized to PLD, 43 to Pac. 11 pts were ineligible, 4 never started therapy and 6 lacked disease assessment or progression data, resulting in 68 pts for the efficacy analysis (34 in each arm) and 82 in the toxicity analysis. After a median follow-up of 35.8 months (mo.), there was no significant difference in PFS, response rate, or overall survival. Due to early termination, the study was not adequately powered to detect the hypothesized difference in PFS. There was no significant difference in QOL between the two arms. Grade 3–4 toxicity was comparable, including grade 4 neutropenia (34% vs. 27%) and infection (13% vs. 11%). Conclusions: Paclitaxel and PLD have comparable efficacy and toxicity in patients with HIV-associated KS. [Table: see text] [Table: see text]

Randomized phase III study comparing paclitaxel/cisplatin/gemcitabine (PCG) and gemcitabine/cisplatin (GC) in patients with locally advanced (LA) or metastatic (M) urothelial cancer without prior systemic therapy; EORTC30987/Intergroup Study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. LBA5030-LBA5030 ◽  
Author(s):  
J. Bellmunt ◽  
H. von der Maase ◽  
G. M. Mead ◽  
J. Heyer ◽  
N. Houede ◽  
...  
Keyword(s):  
Median Survival ◽  
Urothelial Cancer ◽  
Locally Advanced ◽  
International Study ◽  
Error Rates ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Logrank Test ◽  
Significant Difference ◽  
Phase Iii Study

LBA5030 Background: GC is a standard alternative to M-VAC for LA/M urothelial cancer (UC) based on comparable efficacy and a more favorable toxicity profile. Based on a phaseII trial, it has been suggested that the PCG triplet might provide improved response and survival. To evaluate the role of paclitaxel when added to GC, a randomized, international study (EORTC30987/Intergroup Study) comparing GC with PCG in LA/M UC was initiated in 2001, with the main endpoint being overall survival (OS). Methods: Chemo naive patients with histologic evidence of LA or M transitional UC, with GFR>60ml/min were eligible. After stratification for institution, PS(WHO 0–1) and presence/absence of metastatic disease, patients were randomized to receive PCG(armA) or GC(armB). PCG treatment included: paclitaxel(P) 80mg/m2 d1&8, cisplatin(C) 70mg/m2 d1 and gemcitabine(G) 1000mg/m2 d1&8, every 21d. GC: C70mg/m2 d1 or 2, G1000mg/m2 d1,8,15 every 28d. To detect an increase in median survival from 14 to 18m(HR=0.778) based on a two sided logrank test at error rates a=0.05 and β=0.20, 498 deaths were required. The planned sample size was of 610 pts. Results: From June 01 to May 04, 627pts (82% primary bladder) were included, (312 PCG, 315 GC). Median age was 61y with 81% males and similar baseline prognostic characteristics on both arms. PS 1 in 47%PCG and 46%GC pts. On PCG 47% had visceral and 83% M; on CG 49%-83% respectively. Overall response rate (RR): 57,1% for PCG (CR15%) and 46,4% for GC (CR10%), p=0.02. Median PFS: 8.4m and 7.7m for PCG and GC, p=0.10. 478 pts have died; the EORTC IDMC has released the study because the required number of events will occur prior to presentation. Median survival is 15.7m for PCG and 12.8m for CG, with no significant difference in OS (p=0.10, HR0.86, CI95% 0.72–1.03, p=0.12 adjusted for risk factors). Both treatments were overall well tolerated, with more thrombopenia and bleeding on GC (12%vs7%) and more febrile neutropenia on PCG (13%vs4%). Conclusions: This large, multicenter, Phase III study shows that PCG provided a better RR when compared with GC in LA/M UC; however the predefined endpoint for PFS and OS improvement was not reached. [Table: see text]

Impact of skeletal-related events on pain and analgesic use in patients with solid tumors and bone metastases.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20514-e20514
Author(s):  
Lesley Fallowfield ◽  
Charles S. Cleeland ◽  
Roger Von Moos ◽  
Donald Patrick ◽  
Jean-Jacques Body ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Solid Tumors ◽  
Severe Pain ◽  
Proportional Hazards Model ◽  
Oral Morphine ◽  
Cox Proportional Hazards Model ◽  
Phase Iii ◽  
Control Group ◽  
Skeletal Related Events ◽  
Analgesic Use

e20514 Background: Skeletal-related events (SREs) including pathological fracture (PF), surgery (SB) or radiotherapy to bone (RB), or spinal cord compression (SCC) occur frequently in patients (pts) with advanced cancer and bone metastases and may cause debilitating clinical sequelae for pts. Pooled results from 3 clinical trials showed denosumab was superior to zoledronic acid (ZA) for prevention of SREs. We now evaluate the burden of SREs through pt-reported pain and analgesic use. Methods: Randomized (1:1) pts in the phase III, double-blind, placebo-controlled trials received denosumab (120 mg SC) or ZA (4 mg IV, adjusted for renal function) monthly. In this posthoc analysis, data from pts with solid tumors in the 2 treatment arms were pooled. At baseline (BL) and each monthly visit, pain was assessed via the Brief Pain Inventory (BPI; 0 no pain to 10 severe pain), and pts’ analgesic use with the Analgesic Quantification Algorithm (AQA; 0 no analgesics to 7 > 600 mg oral morphine equivalent/day). Pain and analgesic use for pts with SREs were assessed from 6 months before to 6 months after the 1st on-study SRE. A control group was comprised of all pts without SREs; the index time was defined as the median time to each SRE type. SRE impact was assessed using a stratified Cox proportional hazards model adjusting for SREs, as time-dependent covariates, and other baseline characteristics, and reported as HR and 95% CI. Results: 1,925 pts had an on-study SRE (first SRE type: 923 PF; 829 RB, 119 SCC, 54 SB), and 3,618 pts did not. A greater proportion of pts with SREs had a BPI worst pain score > 4 (moderate/severe pain) or an AQA score ≥ 3 (strong opioid use) than did pts with no SREs. The development of SRE was associated with significantly greater risk of pain progression from no/mild pain at BL to moderate/severe pain on study (PF 1.29 [1.07, 1.57], P = 0.009; RB 2.51 [2.03, 3.10], P < 0.001; SCC 3.07 [1.83, 5.13], P < 0.001; and SB 2.75 [1.19, 6.33], P = 0.018). Conclusions: Pts who experienced on-study SREs had increased pain severity requiring stronger analgesic use. Effective treatments that delay or prevent SREs can reduce pain and the need for palliation with opioids. Clinical trial information: NCT00321464, NCT00321620, and NCT00330759.

scholarly journals The Efficacy and Safety of Bilastine in the Treatment of Perennial Allergic Rhinitis in Patients with Moderate and Severe Forms of the Disease. Comparison of bilastine 20 mg with desloratadine 5 mg Сергей

2019 ◽  
pp. 58-67
Author(s):  
S. Ryazantsev ◽  
I. Gogunska ◽  
I. Lymar ◽  
L. Romanyuk ◽  
B. Bil ◽  
...  
Keyword(s):  
Symptomatic Treatment ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Open Label ◽  
Prick Test ◽  
Treatment Groups ◽  
Persistent Symptoms ◽  
Parallel Group ◽  
Significant Difference ◽  
Rhino Conjunctivitis

Background: Bilastine is a new non-sedating H1 antihistamine approved for the symptomatic treatment of allergic rhinoconjunctivitis (ARC) and urticaria in adults and children over 12 years of age. In this paper, bilastine was compared with desloratadine in the treatment of various forms of allergic rhino-conjunctivitis classified according to the ARIA recommendations.Materials and Methods: This was an international, multi-centre, open-label, prospective randomized, parallel-group, phase III study which enrolled a total of 226 patients with ARC. The diagnosis of the allergic rhino-conjunctivitis was established on the basis of nasal and non-nasal symptoms and confirmed by the skin prick test. Patients were randomized to one of the two treatment groups: bilastine 20 mg daily or desloratadine 5 mg daily.Results: The results for the primary and secondary endpoints showed a comparable reduction in TSS, NSS, and NNSS from the baseline to the end of the treatment between the treatment groups, with slightly better effects for bilastine. Additional tests carried out in the subgroup of patients with moderate / severe persistent (MSP) ARC demonstrated comparable results for the bilastine and desloratadine groups regarding the mean change in TSS from the baseline until the 28th day, except for the sneezing score, for which bilastine showed the higher response (-1.60 ± 0.60 vs. -1.39 ± 0.63), and a statistically significant difference between the treatment groups regarding AUC for TSS ( -26.07 [95% CI: -48.6, -3.53] p = 0.024), NNSS (-10.51 [95% CI:-19.42, -1.59] p = 0.021), the sneezing score (-4.79 [95% CI:-9.06, -0.51] p = 0.028) and the ocular redness score (-5.50 [95% CI: -8.91, -2.08] p = 0.02).Conclusion: In general, bilastine and desloratadine showed a comparable efficacy profile in the treatment of ARC; however, the results obtained in the subgroup of patients with moderate / severe persistent symptoms indicate that bilastine has a stronger therapeutic effect 

scholarly journals An international, multicentre, double-blind, randomized study (DISSCO): effect of diacerein vs celecoxib on symptoms in knee osteoarthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (12) ◽  
pp. 3858-3868
Author(s):  
Jean-Pierre Pelletier ◽  
Jean-Pierre Raynauld ◽  
Marc Dorais ◽  
Louis Bessette ◽  
Eva Dokoupilova ◽  
...  
Keyword(s):  
Pain Score ◽  
Phase Iii ◽  
Comparable Efficacy ◽  
Womac Pain ◽  
Double Blind ◽  
Once Daily ◽  
Womac Pain Score ◽  
Knee Oa ◽  
Symptomatic Knee ◽  
Significant Difference

Abstract Objective The objective of this study was to investigate whether diacerein has comparable efficacy with celecoxib in pain reduction for treatment in symptomatic knee OA patients. Methods This randomized double-blind multicentre non-inferiority trial evaluated diacerein vs celecoxib treatment in patients with Kellgren–Lawrence grade 2–3 and pain scoring ≥4 (10-cm VAS). Patients were randomized to 6 months of treatment with diacerein 50 mg (n = 187) once daily for 1 month and twice daily thereafter, or celecoxib 200 mg (n = 193) once daily. The primary outcome was the change in WOMAC pain score (0–50 cm) at 6 months, and the secondary outcomes were WOMAC sub-scores, VAS pain score, and the OMERACT–OARSI responder rate. Results In the per protocol population, the adjusted mean change from baseline in the WOMAC pain score was –11.1 ( 0.9) with diacerein (n = 140) and –11.8 (0.9) with celecoxib (n = 148). The intergroup difference was 0.7 (95% CI: −1.8, 3.2; P = 0.597), meeting the non-inferiority margin. Supportive analysis of the intention-to-treat population gave similar results. Other outcomes showed no significant difference between treatment groups. The incidence of treatment-related adverse events was low and balanced between groups, but a greater incidence of diarrhoea occurred with diacerein (10.2% vs 3.7%). Diarrhoea was considered mild-to-moderate in all but one case with complete resolution. Conclusions Diacerein was non-inferior to celecoxib in reducing knee OA pain and improving physical function. Diacerein also demonstrated a good safety profile. Trial registration A multicentre study on the effect of DIacerein on Structure and Symptoms vs Celecoxib in Osteoarthritis is a National Institutes of Health (NCT02688400) and European Clinical Trial Database (2015–002933-23) registered phase III (Canada) or IV (Europe) study.

scholarly journals Imaging Assessment of Tumor Response in the Era of Immunotherapy

Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1041
Author(s):  
Jun Nakata ◽  
Kayako Isohashi ◽  
Yoshihiro Oka ◽  
Hiroko Nakajima ◽  
Soyoko Morimoto ◽  
...  
Keyword(s):  
Positron Emission Tomography ◽  
Solid Tumors ◽  
False Positive ◽  
Progressive Disease ◽  
Tumor Response ◽  
Metabolic Response ◽  
Evaluation Criteria ◽  
Emission Tomography ◽  
Response Criteria ◽  
Positron Emission

Assessment of tumor response during treatment is one of the most important purposes of imaging. Before the appearance of immunotherapy, response evaluation criteria in solid tumors (RECIST) and positron emission tomography response criteria in solid tumors (PERCIST) were, respectively, the established morphologic and metabolic response criteria, and cessation of treatment was recommended when progressive disease was detected according to these criteria. However, various types of immunotherapy have been developed over the past 20 years, which show novel false positive findings on images, as well as distinct response patterns from conventional therapies. Antitumor immune response itself causes 18F-fluorodeoxyglucose (FDG) uptake in tumor sites, known as “flare phenomenon”, so that positron emission tomography using FDG can no longer accurately identify remaining tumors. Furthermore, tumors often initially increase, followed by stability or decrease resulting from immunotherapy, which is called “pseudoprogression”, so that progressive disease cannot be confirmed by computed tomography or magnetic resonance imaging at a single time point. As a result, neither RECIST nor PERCIST can accurately predict the response to immunotherapy, and therefore several new response criteria fixed for immunotherapy have been proposed. However, these criteria are still controversial, and also require months for response confirmation. The establishment of optimal response criteria and the development of new imaging technologies other than FDG are therefore urgently needed. In this review, we summarize the false positive images and the revision of response criteria for each immunotherapy, in order to avoid discontinuation of a truly effective immunotherapy.

scholarly journals Is jumbo biopsy forceps comparable to cold snare for diminutive colorectal polyps? – a meta-analysis

2021 ◽  
Vol 09 (01) ◽  
pp. E9-E13
Author(s):  
Sachin Srinivasan ◽  
Peter D. Siersema ◽  
Madhav Desai
Keyword(s):  
Meta Analysis ◽  
Complete Removal ◽  
Colorectal Polyps ◽  
Comparable Efficacy ◽  
Incomplete Resection ◽  
Complication Rates ◽  
Biopsy Forceps ◽  
Significant Difference ◽  
Leave One Out ◽  
Endoscopic Assessment

Abstract Background and study aims Diminutive colorectal polyps are increasingly being detected and it is not clear whether jumbo biopsy forceps (JBF) has comparable efficacy to that of cold snare polypectomy (CSP) for management of these lesions. Methods An electronic literature search was performed for studies comparing resection rates of JBF and CSP for diminutive polyps (≤ 5 mm). The primary outcome was incomplete resection rate (IRR). Secondary outcomes included failure of tissue retrieval and complication rates (post-polypectomy bleeding, perforation etc.). Leave-one-out analysis was performed to examine the disproportionate role of any of the studies. Meta-analysis outcomes and heterogeneity (I2) were computed using Comprehensive meta-analysis software. Results A total of 4 studies (3 randomized controlled trials and 1 retrospective study) with 407 patients and 569 total polyps (mean size of 3.62 mm) was included for analysis. IRR of JBF was slightly higher than that of CSP (10.2 % vs 7.2 %) but this was not statistically significantly different (Pooled OR 1.76; 95 % CI 0.94–3.28; I2 = 0). Leave-one-out analysis showed no significant difference in the pooled OR comparison either. Two of the 4 studies reported 0 % failure of tissue retrieval for JBF and 1 % and 4.3 % for CSP. There were no complications for either group from the 2 studies that reported this outcome. The quality of the included studies was moderate to high. Conclusions This systematic review with only limited data shows that JBF and CSP are not statistically different in completely removing diminutive polyps, although careful endoscopic assessment is needed to ensure complete removal of all polyp tissue.

scholarly journals Determination of Efficacy of Single and Double 4.7 mg Deslorelin Acetate Implant on the Reproductive Activity of Female Pond Sliders (Trachemys scripta)

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 660
Author(s):  
Edoardo Bardi ◽  
Martina Manfredi ◽  
Raffaella Capitelli ◽  
Emanuele Lubian ◽  
Alessandro Vetere ◽  
...  
Keyword(s):  
Phase Ii ◽  
Egg Production ◽  
Reproductive Activity ◽  
Trachemys Scripta ◽  
Phase Iii ◽  
Control Group ◽  
Sexual Hormones ◽  
Significant Difference ◽  
Group 6 ◽  
Plasmatic Concentration

The use of long-acting gonadotropin-releasing hormone (GnRH) agonists to suppress fertility has been poorly investigated in reptiles, and the few available studies show inconsistent results. The efficacy of single and double intramuscular 4.7 mg deslorelin acetate implants in captive pond sliders (Trachemys scripta) was investigated, with 20 animals divided into three groups: a single-implant group (6 animals), a double-implant group (6 animals), and a control group (no implant). During one reproductive season (March to October), plasmatic concentration of sexual hormones (estradiol, progesterone, and testosterone) and ovarian morphometric activity via computed tomography were monitored about every 30 days. A significative decrease in the number of phase II ovarian follicles was detected in the double-implant group compared with the control group, but no significant difference was noted in the number of phase III and phase IV follicles, egg production, and plasmatic concentration of sexual hormones. Results show that neither a single nor a double deslorelin acetate implant can successfully inhibit reproduction in female pond sliders during the ongoing season, but the lower number of phase II follicles in the double-implant group can possibly be associated with reduced fertility in the following seasons.

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