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  • 1
    Language: English
    In: The lancet oncology, 2015, Vol.16 (1), p.98-107
    Description: Summary Background Results of previous study showed promising but short-lived activity of sorafenib in the treatment of patients with unresectable advanced and metastatic osteosarcoma. This treatment failure has been attributed to the mTOR pathway and might therefore be overcome with the addition of mTOR inhibitors. We aimed to investigate the activity of sorafenib in combination with everolimus in patients with inoperable high-grade osteosarcoma progressing after standard treatment. Methods We did this non-randomised phase 2 trial in three Italian Sarcoma Group centres. We enrolled adults (≥18 years) with relapsed or unresectable osteosarcoma progressing after standard treatment (methotrexate, cisplatin, and doxorubicin, with or without ifosfamide). Patients received 800 mg sorafenib plus 5 mg everolimus once a day until disease progression or unacceptable toxic effects. The primary endpoint was 6 month progression-free survival (PFS). All analyses were intention-to-treat. This trial is registered with ClinicalTrials.gov , number NCT01804374. Findings We enrolled 38 patients between June 16, 2011, and June 4, 2013. 17 (45%; 95% CI 28–61) of 38 patients were progression free at 6 months. Toxic effects led to dose reductions, or short interruptions, or both in 25 (66%) of 38 patients and permanent discontinuation for two (5%) patients. The most common grade 3–4 adverse events were lymphopenia and hypophosphataemia each in six (16%) patients, hand and foot syndrome in five (13%), thrombocytopenia in four (11%), and fatigue, oral mucositis, diarrhoea, and anaemia each in two (5%). One patient (3%) had a grade 3 pneumothorax that required trans-thoracic drainage, and that recurred at the time of disease progression. This was reported as a serious adverse event related to the study drugs in both instances. No other serious adverse events were reported during the trial. There were no treatment-related deaths. Interpretation Although the combination of sorafenib and everolimus showed activity as a further-line treatment for patients with advanced or unresectable osteosarcoma, it did not attain the prespecified target of 6 month PFS of 50% or greater. Funding Italian Sarcoma Group.
    Subject(s): Hematology, Oncology and Palliative Medicine ; Niacinamide - analogs & derivatives ; Osteosarcoma - drug therapy ; TOR Serine-Threonine Kinases - metabolism ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Male ; Bone Neoplasms - pathology ; TOR Serine-Threonine Kinases - antagonists & inhibitors ; Young Adult ; Neoplasm Grading ; Time Factors ; Adult ; Female ; Bone Neoplasms - drug therapy ; Everolimus ; Sirolimus - analogs & derivatives ; Bone Neoplasms - enzymology ; Osteosarcoma - enzymology ; Kaplan-Meier Estimate ; Treatment Outcome ; Disease Progression ; Niacinamide - administration & dosage ; Disease-Free Survival ; Sirolimus - administration & dosage ; Phenylurea Compounds - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Adolescent ; Intention to Treat Analysis ; Italy ; Osteosarcoma - secondary ; Antimitotic agents ; Chemotherapy ; Osteosarcoma ; Stem cells ; Clinical trials ; Product development ; Antineoplastic agents ; Standards ; Cancer ; Index Medicus
    ISSN: 1470-2045
    E-ISSN: 1474-5488
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 2
    Language: English
    In: Journal of clinical oncology, 2012-06-10, Vol.30 (17), p.2112-2118
    Description: We compared two chemotherapy regimens that included methotrexate (MTX), cisplatin (CDP), and doxorubicin (ADM) with or without ifosfamide (IFO) in patients with nonmetastatic osteosarcoma of the extremity. Patients age ≤ 40 years randomly received regimens with the same cumulative doses of drugs (ADM 420 mg/m(2), MTX 120 g/m(2), CDP 600 mg/m(2), and IFO 30 g/m(2)) but with different durations (arm A, 44 weeks; arm B, 34 weeks). IFO was given postoperatively when pathologic response to MTX-CDP-ADM was poor (arm A) or given in the primary phase of chemotherapy with MTX-CDP-ADM (arm B). End points of the study included pathologic response to preoperative chemotherapy, toxicity, and survival. Given the feasibility of accrual, the statistical plan only permitted detection of a 15% difference in 5-year overall survival (OS). From April 2001 to December 2006, 246 patients were enrolled. Two hundred thirty patients (94%) underwent limb salvage surgery (arm A, 92%; arm B, 96%; P = .5). Chemotherapy-induced necrosis was good in 45% of patients (48% in arm A, 42% in arm B; P = .3). Four patients died of treatment-related toxicity (arm A, n = 1; arm B, n = 3). A significantly higher incidence of hematologic toxicity was reported in arm B. With a median follow-up of 66 months (range, 1 to 104 months), 5-year OS and event-free survival (EFS) rates were not significantly different between arm A and arm B, with OS being 73% (95% CI, 65% to 81%) in arm A and 74% (95% CI, 66% to 82%) in arm B and EFS being 64% (95% CI, 56% to 73%) in arm A and 55% (95% CI, 46% to 64%) in arm B. IFO added to MTX, CDP, and ADM from the preoperative phase does not improve the good responder rate and increases hematologic toxicity. IFO should only be considered in patients who have a poor histologic response to MTX, CDP, and ADM.
    Subject(s): Biological and medical sciences ; Medical sciences ; Diseases of the osteoarticular system ; Tumors of striated muscle and skeleton ; Tumors ; Osteosarcoma - drug therapy ; Femur - pathology ; Humans ; Child, Preschool ; Male ; Tibia - pathology ; Cisplatin - administration & dosage ; Humerus - pathology ; Disease-Free Survival ; Ifosfamide - administration & dosage ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Chemotherapy, Adjuvant - methods ; Adolescent ; Adult ; Female ; Methotrexate - administration & dosage ; Bone Neoplasms - drug therapy ; Child ; Doxorubicin - administration & dosage
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
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  • 3
    Language: English
    In: Journal of clinical oncology, 2005-08-20, Vol.23 (24), p.5795-5804
    Description: The aim of this study was to identify factors predicting initial and late resistance of GI stromal tumor (GIST) patients to imatinib and to document the dose-response relationship in the prognostic subgroups. This study is based on the European Organisation for Research and Treatment of Cancer-Italian Sarcoma Group-Australasian Gastrointestinal Trials Group randomized trial comparing two doses of imatinib in advanced disease. Initial resistance was defined as progression within 3 months of randomization, and late resistance was defined as progression beyond 3 months. Investigated cofactors include imatinib dose, age, sex, performance status, original disease site, site and size of lesions at trial entry, and baseline hematologic and biologic parameters. Initial resistance was recorded for 116 (12%) of 934 assessable patients and was independently predicted by the presence of lung and absence of liver metastases, low hemoglobin level, and high granulocyte count. Among 818 patients who were alive and progression free at 3 months, 347 subsequent progressions were recorded, and late resistance was independently predicted by high baseline granulocyte count, primary tumor outside of the stomach, large tumor size, and low initial imatinib dose. The impact of initial dose on late resistance was mainly significant in patients with a high baseline granulocyte count (〉 5.10(9)/L) and in patients with tumors of GI origin outside of the stomach and small intestine. Our study identifies patients for whom initial and/or long-term treatment needs to be improved and patients who require a high initial dose. Correlation of these results with immunohistochemistry and molecular parameters may further help to understand the biologic mechanisms of resistance.
    Subject(s): Gastroenterology. Liver. Pancreas. Abdomen ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; Biological and medical sciences ; Medical sciences ; Tumors ; Predictive Value of Tests ; Prognosis ; Humans ; Middle Aged ; Proportional Hazards Models ; Drug Resistance, Neoplasm ; Logistic Models ; Male ; Treatment Outcome ; Antineoplastic Agents - therapeutic use ; Piperazines - therapeutic use ; Imatinib Mesylate ; Disease Progression ; Gastrointestinal Stromal Tumors - drug therapy ; Pyrimidines - therapeutic use ; Gastrointestinal Stromal Tumors - pathology ; Adult ; Female ; Aged ; Benzamides ; Index Medicus
    ISSN: 0732-183X
    E-ISSN: 1527-7755
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 4
    Language: English
    In: Medical oncology (Northwood, London, England), 2019-07, Vol.36 (7), p.1-8
    Description: Rhabdomyosarcoma (RMS) is rare in adults and it is generally characterized by poor outcome. In a previous retrospective study, we demonstrated a better prognosis in adults treated with multimodality approach resembling pediatric protocols. Thereafter, we developed specific recommendations based on the principles adopted in pediatric oncology. The present analysis reports the results in a subsequent prospective series. The study included 95 consecutive patients (age 18–77 years) treated from 2002 to 2015 for embryonal and alveolar RMS. As in the previous series, patients were stratified by the appropriateness of their treatment according to therapeutic guidelines for childhood RMS. The 5-year event-free survival (EFS) and overall survival (OS) rates were 33.6% and 40.3%, respectively. The 5-year EFS was 40.8% for patients with the highest treatment score, and 15% for those with lower score, while OS was 44.4% and 24.5%, respectively. The developing of specific recommendations enabled an increase in the number of patients treated with intensive multimodal treatment resembling pediatric strategy (69.7% vs. 39.1% in the retrospective series). This study reinforced the idea that adherence to the principles of pediatric protocols, improves adult RMS outcomes. However, treating adults with pediatric-type strategy is not enough to achieve the results obtained in children. Issues in compliance and a more aggressive biology of adult RMS might have a role in the different outcome according to age. Improving the collaboration between pediatric and adult oncologists in promoting specific clinical and biological research is crucial to improve the outcome for this patient population.
    Subject(s): Multimodal treatment ; Pathology ; Childhood tumors in adults ; Medicine & Public Health ; Hematology ; Treatment score ; Rhabdomyosarcoma ; Soft tissue sarcoma ; Oncology ; Internal Medicine ; Adults ; Pediatrics ; Medical prognosis ; Index Medicus ; PATIENTS ; RECOMMENDATIONS ; ADULTS ; RADIOLOGY AND NUCLEAR MEDICINE ; PEDIATRICS ; MEDICAL PERSONNEL ; RHABDOMYOSARCOMAS ; CONNECTIVE TISSUE ; CHILDREN
    ISSN: 1357-0560
    ISSN: 1559-131X
    E-ISSN: 1559-131X
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 5
    Language: English
    In: Clinical cancer research, 2009-09-15, Vol.15 (18), p.5910-5916
    Description: Purpose: To study the safety, tolerability, and pharmacokinetics of the selective tyrosine kinase inhibitor nilotinib as a single agent or in combination with imatinib in patients with advanced imatinib-resistant gastrointestinal stromal tumors. Experimental Design: A phase I intercohort dose-escalation trial was done in patients who received either ( a ) single agent nilotinib 400 mg twice daily or ( b ) escalating doses of nilotinib (200 mg once daily, 400 mg qd, or 400 mg bid) plus imatinib 400 mg bid (10- and 14-hour interval daily), or ( c ) nilotinib 400 mg bid plus imatinib 400 mg qd. Safety, pharmacokinetics, and tumor assessments were done. Results: Oral clearance (CL/F) of nilotinib was similar across the combination groups (mean CL/F, 19.1-25.6 L/h), and lower than in the single-agent cohort (mean CL/F, 35.6 L/h). A linear relationship between nilotinib daily dose and peak concentration was observed in the combination cohorts. Observed adverse events (AE) were mostly nonhematologic. Frequently reported AEs were rash (40%), fatigue (38%), abdominal pain (36%), and nausea (36%). Severe AEs (grade 3 or 4) included abdominal pain (13%) and rash (9%), the latter mainly with the combination. Thirty-eight patients had stable disease and two patients achieved partial response with a median progression-free survival of 134 days for the entire group. Conclusions: Nilotinib alone or in combination with imatinib was well tolerated overall and showed clinical activity in imatinib-resistant gastrointestinal stromal tumor patients. This phase I trial identified single-agent nilotinib 400 mg bid or combined with imatinib 400 mg qd as possible phase II doses for further evaluation. (Clin Cancer Res 2009;15(18):5910–6)
    Subject(s): pharmacokinetics ; imatinib ; gastrointestinal stromal tumors ; phase I ; nilotinib ; Biological and medical sciences ; Medical sciences ; Antineoplastic agents ; Pharmacology. Drug treatments ; Humans ; Middle Aged ; Antineoplastic Combined Chemotherapy Protocols - pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols - adverse effects ; Male ; Dose-Response Relationship, Drug ; Young Adult ; Drug-Related Side Effects and Adverse Reactions ; Aged, 80 and over ; Adult ; Female ; Piperazines - pharmacokinetics ; Drug Tolerance ; Treatment Outcome ; Piperazines - therapeutic use ; Imatinib Mesylate ; Piperazines - adverse effects ; Disease Progression ; Disease-Free Survival ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Gastrointestinal Stromal Tumors - drug therapy ; Pyrimidines - therapeutic use ; Pyrimidines - adverse effects ; Pyrimidines - pharmacokinetics ; Aged ; Benzamides ; Drug Resistance, Neoplasm - drug effects ; Index Medicus ; gastrointestinal stromal tumors (GIST) ; Phase I ; pharmacokinetics (PK)
    ISSN: 1078-0432
    E-ISSN: 1557-3265
    Source: HighWire Press (Free Journals)
    Source: Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 6
    Language: English
    In: Pain medicine (Malden, Mass.), 2014-05, Vol.15 (5), p.758-761
    Description: Setting In the last few years, the use of opioids for cancer pain has rapidly increased and new molecules have been developed. Currently, rapid‐onset opioids are widely used in clinical practice for breakthrough cancer pain (BTcP). However, the tolerability of these molecules is still a matter of debate. Patients We describe two cases of rapid‐onset opioids misuse that have been recently observed at our palliative care unit. Discussion The reported cases are explicative as they occurred in patients suffering from different types of cancer and with different causes of BTcP. Further investigations are needed to identify factors predicting addiction to this new class of molecules.
    Subject(s): Abuse ; Breakthrough Cancer Pain ; Rapid‐Onset Opioids ; Fentanyl - administration & dosage ; Chemoradiotherapy - methods ; Fentanyl - adverse effects ; Opioid-Related Disorders - etiology ; Oxycodone - administration & dosage ; Humans ; Nasopharyngeal Neoplasms - therapy ; Male ; Tramadol - adverse effects ; Young Adult ; Breakthrough Pain - drug therapy ; Gastrointestinal Stromal Tumors - therapy ; Analgesics, Opioid - adverse effects ; Analgesics, Opioid - administration & dosage ; Nasopharyngeal Neoplasms - complications ; Tramadol - administration & dosage ; Gastrointestinal Stromal Tumors - complications ; Oxycodone - adverse effects ; Breakthrough Pain - etiology ; Coma - chemically induced ; Palliative Care - methods ; Drug abuse ; Care and treatment ; Pain ; Opioids ; Cancer pain ; Drug therapy ; Cancer ; Index Medicus
    ISSN: 1526-2375
    E-ISSN: 1526-4637
    Source: Academic Search Ultimate
    Source: SPORTDiscus with Full Text
    Source: Oxford Journals 2016 Current and Archive A-Z Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 7
    Language: English
    In: Head & neck, 2017-03, Vol.39 (3), p.E45-E50
    Description: ABSTRACT Background Sinonasal localization of Ewing's sarcoma in adults is an exceedingly rare event. Methods The clinical records of 5 patients with primary sinonasal Ewing's sarcoma treated from 1992 to 2012 were retrospectively analyzed. All pathologic slides were reviewed by 2 experienced pathologists. All patients underwent multimodality treatments. Results Median age was 36 years (range, 25–52 years). At referral, 2 patients had the original diagnosis changed by review of the histologic slides. Tumors were classified as T4aN0M0 (4 patients) and T2N0M0 (1 patient). Median follow‐up was 110 months (range, 70–139 months). Only 1 patient, who started treatment elsewhere based on an incorrect histologic diagnosis, experienced multiple recurrences and eventually died of widespread metastasis. Conclusion Correct pathologic diagnosis can have a crucial impact on treatment planning and outcome. Multimodality therapy is the key for long‐term successful results. Because of the rarity of the tumor, referral to highly experienced care centers is strongly recommended. © 2016 Wiley Periodicals, Inc. Head Neck 39: E45–E50, 2017
    Subject(s): multimodality treatment ; chemotherapy ; sinonasal cancer ; transnasal endoscopic surgery ; Ewing's sarcoma ; Paranasal Sinus Neoplasms - therapy ; Radiotherapy Dosage ; Antineoplastic Combined Chemotherapy Protocols - administration & dosage ; Follow-Up Studies ; Sarcoma, Ewing - therapy ; Paranasal Sinus Neoplasms - diagnostic imaging ; Humans ; Middle Aged ; Magnetic Resonance Imaging - methods ; Tomography, X-Ray Computed - methods ; Male ; Survival Rate ; Sarcoma, Ewing - mortality ; Sampling Studies ; Chemoradiotherapy, Adjuvant - methods ; Paranasal Sinus Neoplasms - mortality ; Sarcoma, Ewing - diagnostic imaging ; Time Factors ; Neoplasm Invasiveness - pathology ; Adult ; Female ; Retrospective Studies ; Neoplasm Staging ; Sarcoma ; Analysis ; Adults
    ISSN: 1043-3074
    E-ISSN: 1097-0347
    Source: Alma/SFX Local Collection
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  • 8
    Language: English
    In: Annals of surgical oncology, 2006-01, Vol.13 (1), p.110-117
    Description: We explored the outcome of patients with primary adult soft tissue sarcoma (STS) of the extremities undergoing re-excision after previous unplanned surgery. A total of 597 consecutive adult patients with primary extremity STS were treated with conservative surgery at our institution over a 20-year time span. A total of 318 patients were referred after unplanned excisions, and the remaining 279 underwent primary resection at our center. The two groups significantly differed in tumor size and depth. The assessed end points were sarcoma-specific mortality, local recurrence, and distant metastasis. Univariable and multivariable analyses, adjusted for other prognostic factors, were performed in the competing risks framework. The adjusted 10-year cumulative incidences in re-excised and primarily operated patients were, respectively, 18.7% and 16.4% (P = .535) for local relapse, 17.6% and 20.2% (P = .541) for metastasis, and 20.4% and 22.4% (P = .645) for mortality. Among patients who underwent re-excision, evidence of microscopic residual disease on pathologic examination had a significant prognostic effect on multivariable analysis for distant metastases (P = .002). A trend for survival was detected as well. At a referral center with a liberal policy of re-excisions in adult primary STS of the extremities, the outcome of patients who underwent re-excision was similar to that of patients who had primary resections. Evidence of microscopic residual disease at re-excision was a marker of clinical aggressiveness.
    Subject(s): Neoplasm, Residual - pathology ; Reoperation ; Prognosis ; Neoplasm, Residual - surgery ; Humans ; Middle Aged ; Neoplasm Recurrence, Local ; Male ; Treatment Outcome ; Combined Modality Therapy ; Sarcoma - pathology ; Regression Analysis ; Soft Tissue Neoplasms - surgery ; Sarcoma - surgery ; Soft Tissue Neoplasms - pathology ; Adult ; Female ; Chemotherapy, Adjuvant ; Radiotherapy, Adjuvant ; Extremities ; Index Medicus
    ISSN: 1068-9265
    E-ISSN: 1534-4681
    Source: Alma/SFX Local Collection
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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  • 9
    Language: English
    In: Clinical sarcoma research, 2017, Vol.7 (1), p.20-6
    Description: Ossifying fibromyxoid tumor (OFMT) is a rare soft tissue neoplasm of uncertain lineage and intermediate biological potential. It is more common in middle-aged men, usually arising from the deep tissues of the extremities. It is now established that it is a translocation related tumor, most often marked by translocation of PHF1 gene. Surgery is the mainstay of treatment and proves usually curative, although, in rarer cases the disease shows malignant features and tendency to recur both locally and at distant sites. In such cases, no standard treatment exists. We report on a case of malignant advanced OFMT of the hand with lung metastases responding to isolated limb perfusion with human recombinant tumor necrosis factor and melphalan and chemotherapy with epirubicin and ifosfamide. To our knowledge, this is the first report of activity of soft tissue sarcoma-oriented chemotherapy in advanced OFMT.
    Subject(s): Soft tissue sarcoma ; Ossifying fibromyxoid tumor ; Chemotherapy ; Epirubicin ; Ifosfamide ; Isolated limb perfusion
    ISSN: 2045-3329
    E-ISSN: 2045-3329
    Source: BioMedCentral Open Access
    Source: Academic Search Ultimate
    Source: PubMed Central
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  • 10
    Language: English
    In: Sarcoma, 2017-12-01, Vol.2017, p.3739159-5
    Description: Background. To report on the activity of high-dose prolonged-infusion ifosfamide (HDIFX) chemotherapy in a retrospective series of patients affected by myxoid liposarcoma treated at Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy. Patients and Methods. Patients with an advanced myxoid liposarcoma treated with HDIFX (14 g/sqm, i.v., prolonged infusion of 14 days every 28 days) as a single agent between May 2002 and April 2017 were retrospectively reviewed. All pathologic diagnoses were centrally reviewed and molecularly confirmed. Response was evaluated by RECIST, and survival functions were computed by the Kaplan-Meier method. Results. Eleven patients with advanced myxoid liposarcoma were treated with HDIFX (male/female = 9/2, median age 33 years, range 31–75). Among these, 1/11 received HDIFX in first line, 5/11 in second line, 3/11 in third line, and 2/11 in fourth line for a median course number of 3 (range 2–7). No RECIST objective responses were observed. Overall median progression-free survival was 1,9 months. Median overall survival was 37 months. At a median follow-up of 115 months, 1 patient is alive. Conclusions. In this series of patients affected by advanced myxoid liposarcoma, chemotherapy with HDIFX was essentially inactive.
    Subject(s): Chemotherapy ; Dosage and administration ; Ifosfamide ; Cancer
    ISSN: 1357-714X
    E-ISSN: 1369-1643
    Source: Academic Search Ultimate
    Source: PubMed Central
    Source: © ProQuest LLC All rights reserved〈img src="https://exlibris-pub.s3.amazonaws.com/PQ_Logo.jpg" style="vertical-align:middle;margin-left:7px"〉
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