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1.
Support Care Cancer ; 32(3): 172, 2024 Feb 20.
Article in English | MEDLINE | ID: mdl-38379082

ABSTRACT

PURPOSE: This cross-sectional study aimed to investigate the prevalence and characteristics of supplement usage among cancer patients and explore its potential associations with anxiety, excessive daytime sleepiness, and overall quality of life. METHODS: Cancer patients receiving specific care at Hôtel Dieu de France University Hospital, Beirut, were enrolled between April and June 2023. In face-to-face interviews, participants were asked to complete a questionnaire consisting of sociodemographic information, supplement usage details, and cancer-related variables. Three validated surveys (Epworth Sleepiness Scale, GAD-7, and EORTC-QLQ-C15-PAL) were employed to assess excessive daytime sleepiness, anxiety, and overall quality of life. Statistical analyses, including chi-square tests, t-tests, and multiple regression models, were conducted to examine associations between supplement use and other variables. RESULTS: A total of 202 participants were interviewed. Fifty-two percent reported regular use of supplements following their cancer diagnosis, with vitamin D being the most commonly used supplement. Using multivariate logistic regression, supplement use was associated with being female, having lower educational levels, having a longer duration since cancer diagnosis, and having a poor overall quality of life. The multivariate logistic regression showed no significant correlation between supplement use and excessive daytime sleepiness and anxiety. CONCLUSION: This study highlights a high prevalence of supplement usage among cancer patients in Lebanon, indicating a rising interest in alternative therapies aimed at enhancing quality of life. Larger prospective studies are needed to assess the relation between supplement intake and excessive daytime sleepiness and anxiety and establish clear guidelines pertaining to supplement use in cancer patients.


Subject(s)
Disorders of Excessive Somnolence , Neoplasms , Humans , Female , Male , Cross-Sectional Studies , Quality of Life , Disorders of Excessive Somnolence/diagnosis , Disorders of Excessive Somnolence/epidemiology , Surveys and Questionnaires
2.
Future Oncol ; 19(12): 863-872, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37194701

ABSTRACT

Renal cell carcinoma (RCC) management has seen a revolution over the last decades. Six Lebanese oncologists discussed recent updates in RCC management and outlined the challenges and future directions in Lebanon. Sunitinib continues to be a first-line choice for metastatic RCC in Lebanon, except for intermediate- and poor-risk patients. Immunotherapy is not always accessible to patients or selected routinely as first-line therapy. More data are needed on the sequencing of immunotherapy and tyrosine kinase inhibitor treatments and on the use of immunotherapy beyond progression and/or after failure of immunotherapy in the first-line setting. For second-line management, the clinical experience with axitinib for low tumor growth rate and nivolumab after progression on tyrosine kinase inhibitors make those two agents the most widely used. Several challenges affect the Lebanese practice, limiting the accessibility and availability of the medications. Reimbursement remains the most critical challenge, especially with the socioeconomic crisis of October 2019.


Subject(s)
Carcinoma, Renal Cell , Kidney Neoplasms , Humans , Carcinoma, Renal Cell/drug therapy , Carcinoma, Renal Cell/pathology , Kidney Neoplasms/drug therapy , Kidney Neoplasms/pathology , Sunitinib/therapeutic use , Axitinib/therapeutic use , Nivolumab/therapeutic use
3.
Future Oncol ; 19(29): 1991-2002, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37795707

ABSTRACT

Aim: Chronic lymphocytic leukemia (CLL) is a highly heterogenous hemopathy. Genetic stratification of CLL patients has important prognostic and therapeutic values - mainly immunoglobulin heavy chain variable region gene (IGHV) mutational status and the presence of cytogenetic abnormalities. The genetics of CLL in Lebanon is scarcely described in the literature. Patients & methods: In this work, we studied the genetic biomarkers of 312 Lebanese CLL patients. Results: Prominent IGHV genes were IGHV4-34, IGHV1-69 and IGHV3-30; and CLL #1 and #5 presented major subsets. Some similarities as well as major differences were highlighted when comparing our data with previously published data. Conclusion: The distribution of IGHV alleles in our series differed from previously described distributions, suggesting involvement of antigenic selection and regional variables in CLL pathogenesis.


Subject(s)
Leukemia, Lymphocytic, Chronic, B-Cell , Humans , Leukemia, Lymphocytic, Chronic, B-Cell/diagnosis , Leukemia, Lymphocytic, Chronic, B-Cell/epidemiology , Leukemia, Lymphocytic, Chronic, B-Cell/genetics , Retrospective Studies , Genetic Markers , Genes, Immunoglobulin Heavy Chain/genetics , Lebanon/epidemiology , Immunoglobulin Variable Region/genetics , Prognosis , Mutation
4.
Int J Cancer ; 149(3): 505-513, 2021 08 01.
Article in English | MEDLINE | ID: mdl-33559295

ABSTRACT

In low-middle income countries (LMICs) and the Middle East and North Africa (MENA) region, there is an unmet need to establish and improve breast cancer (BC) awareness, early diagnosis and risk reduction programs. During the 12th Breast, Gynecological & Immuno-oncology International Cancer Conference - Egypt 2020, 26 experts from 7 countries worldwide voted to establish the first consensus for BC awareness, early detection and risk reduction in LMICs/MENA region. The panel advised that there is an extreme necessity for a well-developed BC data registries and prospective clinical studies that address alternative modalities/modified BC screening programs in areas of limited resources. The most important recommendations of the panel were: (a) BC awareness campaigns should be promoted to public and all adult age groups; (b) early detection programs should combine geographically distributed mammographic facilities with clinical breast examination (CBE); (c) breast awareness should be encouraged; and (d) intensive surveillance and chemoprevention strategies should be fostered for high-risk women. The panel defined some areas for future clinical research, which included the role of CBE and breast self-examination as an alternative to radiological screening in areas of limited resources, the interval and methodology of BC surveillance in women with increased risk of BC and the use of low dose tamoxifen in BC risk reduction. In LMICs/MENA region, BC awareness and early detection campaigns should take into consideration the specific disease criteria and the socioeconomic status of the target population. The statements with no consensus reached should serve as potential catalyst for future clinical research.


Subject(s)
Breast Neoplasms/diagnosis , Breast Neoplasms/prevention & control , Developing Countries/economics , Early Detection of Cancer/standards , Health Knowledge, Attitudes, Practice , Practice Guidelines as Topic/standards , Risk Reduction Behavior , Africa, Northern/epidemiology , Breast Neoplasms/economics , Breast Neoplasms/epidemiology , Breast Self-Examination , Congresses as Topic , Female , Humans , Income , Mammography , Middle East/epidemiology
5.
Am J Hematol ; 96(9): 1156-1165, 2021 09 01.
Article in English | MEDLINE | ID: mdl-34161616

ABSTRACT

Eliglustat, an oral substrate reduction therapy, is approved for eligible adults with Gaucher disease type 1. In the Phase 3 ENGAGE trial of previously untreated adults with Gaucher disease type 1, eliglustat-treated patients had statistically significant improvements in organ volumes and hematologic parameters compared with placebo in the 9-month primary analysis. We report final outcomes by time on eliglustat among all patients who participated in the ENGAGE trial and extension. No patient deteriorated clinically or withdrew due to adverse events; 39/40 patients entered the open-label extension period and 34/40 (85%) remained in the trial until completion or switching to commercial eliglustat after its approval (2.3-6 years). Clinically meaningful improvements in Gaucher disease manifestations were seen in all patients concomitant with reductions in pathological lipid substrate levels (glucosylceramide and glucosylsphingosine). Among patients with 4.5 years of eliglustat exposure, mean spleen volume decreased by 66% (from 17.1 to 5.8 multiples of normal [MN], n = 13), mean liver volume decreased by 23% (from 1.5 to 1.1 MN, n = 13), mean hemoglobin increased 1.4 g/dl (from 11.9 to 13.4 g/dl, n = 12), mean platelet count increased by 87% (from 67.6 to 122.6 × 109 /L, n = 12), median chitotriosidase decreased by 82% (from 13 394 to 2312 nmol/h/ml, n = 11), median glucosylceramide decreased by 79% (from 11.5 to 2.4 µg/ml, n = 11), median glucosylsphingosine decreased by 84% (from 518.5 to 72.1 ng/ml, n = 10), and mean spine T-score increased from -1.07 (osteopenia) to -0.53 (normal) (n = 9). The magnitude of improvement in Gaucher disease manifestations and biomarkers over time was similar among the full trial cohort. Eliglustat was well-tolerated and led to clinically significant improvements in previously untreated patients with Gaucher disease type 1 during 4.5 years of treatment.


Subject(s)
Enzyme Inhibitors/therapeutic use , Gaucher Disease/drug therapy , Pyrrolidines/therapeutic use , Adult , Double-Blind Method , Enzyme Inhibitors/adverse effects , Female , Gaucher Disease/pathology , Humans , Liver/drug effects , Liver/pathology , Male , Organ Size/drug effects , Placebo Effect , Pyrrolidines/adverse effects , Spleen/drug effects , Spleen/pathology , Treatment Outcome , Young Adult
6.
Future Oncol ; 17(22): 2951-2960, 2021 Aug.
Article in English | MEDLINE | ID: mdl-34044583

ABSTRACT

Real-world evidence (RWE) can provide insights into patient profiles, disease detection, treatment choice, dosing strategies, treatment sequencing, adverse event management and financial toxicity associated with oncology treatment. However, the full potential of RWE is untapped in emerging economies due to structural and behavioral factors. Structural barriers include lack of regulatory engagement, real-world data availability, quality and integrity. Behavioral barriers include entrenched healthcare professional behaviors that impede rapid RWE understanding and adoption. These barriers can be addressed with close collaboration of healthcare stakeholders; of whom, regulators need to be at the forefront given their ability to facilitate use of RWE in healthcare policy and legislation.


Lay abstract Traditionally, randomized clinical trials have been used to provide insights on new medical therapies and continue to remain the gold standard for approval. The-increasing availability of patient level data in the real-world, it is now possible to generate evidence regarding the usage and potential benefits or risks of a medical therapy derived from analysis of real-world data. This evidence is collectively referred to real-world evidence (RWE). randomized clinical trials and RWE are complementary and the area of Oncology especially benefits from RWE to guide clinical decision making across the patient journey. Key benefits include cancer screening and diagnosis, optimal treatment choices (including personalized medicine) and disease management such as dosing and treatment of side effects. In recent times, RWE generation in oncology has been prolific in the USA and western Europe. With expansive biopharmaceutical investments into infrastructure harnessing patient-level data and greater local regulatory guidance, oncology patients in emerging economies may now also have the opportunity to benefit from clinical decision making informed by RWE.


Subject(s)
Clinical Decision-Making/methods , Evidence-Based Medicine/methods , Medical Oncology/methods , Neoplasms/therapy , Developing Countries , Humans , Randomized Controlled Trials as Topic
7.
Future Oncol ; 17(31): 4071-4079, 2021 Nov.
Article in English | MEDLINE | ID: mdl-34337969

ABSTRACT

Aims: This paper reports the results of a survey assessing the acceptance of the COVID-19 vaccine among patients with cancer. Patients and methods: In total, 111 adult patients with cancer from a single institution were asked to complete a questionnaire designed to assess their knowledge about the vaccine, their readiness to be vaccinated and the determinants of their decision. Results: 61.3% of the patients considered themselves more vulnerable to COVID-19 than the general population. Television, radio and newspapers were the major sources of information about the vaccine. A total of 55% of the patients were ready to be vaccinated and 14.4% refused the vaccine. The main reason for refusal was incompatibility with patients' disease or treatment. Conclusion: Most of the patients in this institutional sample accepted the COVID-19 vaccine. Better communication of information with patients is needed to decrease vaccine hesitancy.


Lay abstract Major cancer societies consider vaccinating patients with cancer against COVID-19 a priority. The investigators conducted a survey assessing perceptions of the vaccine among patients with cancer. A total of 111 patients were asked to complete a questionnaire evaluating their knowledge about the vaccine, their readiness to be vaccinated and the determinants of their decision. Most (61.3%) patients considered themselves more susceptible to COVID-19 than the general population. Television, radio and newspapers were the major sources of information about the vaccine. The majority of patients (55%) were ready to be vaccinated and 14.4% refused the vaccine. The main reason for refusal was incompatibility with patients' disease or treatment. Better communication with patients is needed to decrease vaccine hesitancy.


Subject(s)
COVID-19 Vaccines , Neoplasms/psychology , Patient Acceptance of Health Care/psychology , Adult , Aged , Aged, 80 and over , COVID-19/prevention & control , COVID-19/psychology , Female , Health Knowledge, Attitudes, Practice , Hospitals, University , Humans , Lebanon/epidemiology , Male , Middle Aged , Patient Acceptance of Health Care/statistics & numerical data , SARS-CoV-2/immunology , Surveys and Questionnaires , Vaccination/psychology , Vaccination Refusal/psychology , Young Adult
8.
Hematol Oncol ; 38(5): 648-653, 2020 Dec.
Article in English | MEDLINE | ID: mdl-32779823

ABSTRACT

The coronavirus disease (COVID-19) pandemic has posed several challenges to the hematology community to re-organize the medical care of patients with hematologic malignancies. Whereas the oncology societies favored a more or less conservative approach which considered the possibility of delaying treatment administration on a case-by-case basis, the hematology community guidelines were less stringent and recommended adequate individualized regimens. As countries are de-escalating the lockdown and the medical community is unable to foresee the end of the current outbreak will and whether the pandemic would eventually come back as a seasonal infection, there is interest in screening of patients with hematology malignancies with COVID-19 instead of limiting access to curative treatments. The rapidly accumulating knowledge about COVID-19 allows a better understanding of the diagnostic tools that may be potentially used in screening. Herein, we briefly review the pathophysiology of COVID-19, the rationale of screening of patients with hematologic malignancies, tools for screening, and available guidelines.


Subject(s)
COVID-19/complications , COVID-19/diagnosis , Hematologic Neoplasms/complications , SARS-CoV-2 , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , Antineoplastic Agents, Immunological/therapeutic use , COVID-19/etiology , COVID-19/virology , Clinical Decision-Making , Colony-Stimulating Factors/administration & dosage , Colony-Stimulating Factors/adverse effects , Colony-Stimulating Factors/therapeutic use , Disease Management , Disease Susceptibility/immunology , Hematologic Neoplasms/therapy , Humans , Immunocompromised Host , Mass Screening , Molecular Diagnostic Techniques , Molecular Targeted Therapy/adverse effects , Molecular Targeted Therapy/methods , Practice Guidelines as Topic
9.
Breast J ; 26(1): 69-80, 2020 01.
Article in English | MEDLINE | ID: mdl-31872557

ABSTRACT

Compared with other breast cancer subtypes, patients with triple-negative breast cancer (TNBC), and irrespective to their disease stage, were always recognized to have the worst overall survival data. Although this does not seem different at the present time, yet the last few years have witnessed many breakthrough genomic and molecular findings, that could dramatically improve our understanding of the biological complexity of TNBC. Based on genomic analyses, it was consistently evident that TNBC comprises a heterogeneous group of cancers, which have numerous diverse molecular aberrations. This-in return-has provided a platform for a new generation of clinical trials using many innovative therapies, directed against such novel targets. At the present time, two PARP inhibitors and one anti-PD-L1 monoclonal antibody (in combination with chemotherapy) have been approved in certain subpopulations of metastatic TNBC (mTNBC) patients, which have finally brought this disease into the era of personalized medicine. In the current review, we will explore the genomic landscape of TNBC, through which many actionable targets were graduated. We will also discuss the results of the key-practice changing-clinical studies, and some upcoming personalized treatment options for patients with mTNBC, that may be clinically adopted in the near future.


Subject(s)
Neoplasm Recurrence, Local/drug therapy , Precision Medicine/methods , Triple Negative Breast Neoplasms/drug therapy , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/pharmacology , Female , Humans , Molecular Targeted Therapy/methods , Triple Negative Breast Neoplasms/classification , Triple Negative Breast Neoplasms/genetics
10.
BJU Int ; 123(3): 456-464, 2019 03.
Article in English | MEDLINE | ID: mdl-30098093

ABSTRACT

OBJECTIVES: To obtain routine clinical practice data on cabazitaxel usage patterns for patients with metastatic castration-resistant prostate cancer (mCRPC) and to describe physician-assessed cabazitaxel effectiveness, health-related quality of life (HRQoL) and safety. PATIENTS AND METHODS: CAPRISTANA was an international, observational cohort study examining cabazitaxel use for the treatment of patients with mCRPC. Effectiveness was assessed by overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF) and disease control rate. HRQoL was assessed using the Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P) and the three-level European Quality of Life questionnaire (EQ-5D-3L). Safety was assessed by adverse event (AE) reporting. RESULTS: A total of 189 patients were treated across 54 centres between April 2012 and June 2016. At baseline, 58.7% had ≥1 comorbidity, 93.7% had an Eastern Cooperative Oncology Group performance status ≤1, and 60.1% had a Gleason score at diagnosis of ≥8. Patients received a median of 6 cabazitaxel cycles; 84.7% received cabazitaxel as second-line therapy. The median OS, PFS and TTF were 13.2, 5.6 and 4.4 months, respectively. Cabazitaxel led to disease control in 52.9% of patients. HRQoL was maintained (40.3%) or improved (32.2%) in 72.5% of patients based on total FACT-P scores. Interestingly, 53.6% of patients reported pain improvement and a further 21.2% maintained pain control based on FACT-P prostate cancer-specific pain scores. The most common treatment-related grade ≥3 AEs were neutropenia (7.9%) and anaemia (2.1%). CONCLUSION: Patients in CAPRISTANA treated with cabazitaxel had similar disease outcomes and safety profiles compared with large phase III clinical trials. Most patients had maintained or improved HRQoL scores; >70% of patients had maintained or improved pain control.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols , Docetaxel/therapeutic use , Prostatic Neoplasms, Castration-Resistant/drug therapy , Taxoids/therapeutic use , Adult , Aged , Aged, 80 and over , Docetaxel/adverse effects , Follow-Up Studies , Humans , Male , Middle Aged , Neutrophils/drug effects , Progression-Free Survival , Prostatic Neoplasms, Castration-Resistant/mortality , Prostatic Neoplasms, Castration-Resistant/pathology , Quality of Life , Survival Rate
11.
Future Oncol ; 15(8): 909-923, 2019 Mar.
Article in English | MEDLINE | ID: mdl-30669875

ABSTRACT

AIM: The literature lacks direct evidence comparing the different regimens evaluated in the second-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). METHODS: We conducted a network meta-analysis (NMA) of the randomized controlled Phase III trials reporting on the second-line drug treatment options in R/M SCCHN. RESULTS: The eligible trials included 11 regimens among which six targeted therapies, two immune checkpoint inhibitors and three chemotherapy regimens. Only nivolumab has shown statistically significant superiority over methotrexate in terms of overall survival (HR: 0.64; 95% CI: 0.43-0.96) and objective response rate (OR: 2.51; 95% CI: 1.07-5.86). CONCLUSION: Based on the efficacy and safety outcomes of this network meta-analysis, nivolumab seems the most favorable regimen inthe management of R/M SCCHN.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Head and Neck Neoplasms/drug therapy , Neoplasm Recurrence, Local/drug therapy , Squamous Cell Carcinoma of Head and Neck/drug therapy , Clinical Trials, Phase III as Topic , Head and Neck Neoplasms/mortality , Head and Neck Neoplasms/pathology , Humans , Methotrexate/therapeutic use , Neoplasm Recurrence, Local/mortality , Neoplasm Recurrence, Local/pathology , Network Meta-Analysis , Nivolumab/therapeutic use , Progression-Free Survival , Randomized Controlled Trials as Topic , Squamous Cell Carcinoma of Head and Neck/mortality , Squamous Cell Carcinoma of Head and Neck/pathology , Survival Analysis
12.
Future Oncol ; 15(26): 3025-3032, 2019 Sep.
Article in English | MEDLINE | ID: mdl-31424958

ABSTRACT

Aim: This study assessed the efficacy of anti-PD-1/PD-L1 agents in real life when used in second line or beyond. Materials & methods: Patients with advanced non-small-cell lung cancer progressing after standard chemotherapy and receiving immunotherapy in the second line or beyond were included. Results: One hundred and ten patients were included with PD-L1 expression above 50%, between 1-49 and <1% in 38.6, 27.3 and 34.1% of patients, respectively. Checkpoint inhibitors were used as second, third and fourth line in 74.7, 21.8 and 3.5%, respectively. Partial response was observed in 25.6% of patients. Median progression-free survival was 4 months and median overall survival was 8.1 months. Conclusion: Immunotherapies are emerging as important tools in the oncologic field with good responses in real-life practice.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Immunotherapy , Lung Neoplasms/drug therapy , Lung Neoplasms/immunology , Aged , Antineoplastic Agents, Immunological/administration & dosage , Antineoplastic Agents, Immunological/adverse effects , B7-H1 Antigen/antagonists & inhibitors , Biomarkers, Tumor , Female , Humans , Immunotherapy/adverse effects , Immunotherapy/methods , Lung Neoplasms/mortality , Lung Neoplasms/pathology , Male , Middle Aged , Prognosis , Retreatment , T-Lymphocyte Subsets/drug effects , T-Lymphocyte Subsets/immunology , T-Lymphocyte Subsets/metabolism , Treatment Outcome
13.
Clin Oral Investig ; 23(1): 235-243, 2019 Jan.
Article in English | MEDLINE | ID: mdl-29607456

ABSTRACT

OBJECTIVES: This study explores whether the chemotherapy regimen has a role in inducing oral health problems and malnutrition in elderly patients with other cancers than head and neck malignancies. MATERIAL AND METHODS: An observational cross-sectional study was designed to compare the relationships between oral health and nutritional status between four groups of elderly differing in cancer or chemotherapy regimen. Data were collected using a questionnaire including the Mini-Nutritional Assessment (MNA), the Geriatric Oral Health Assessment Index (GOHAI) and questions about perception of xerostomia. The oral examinations recorded the number of functional dental units (PFU) and the presence of oral lesions. RESULTS: The sample comprised 46 patients receiving chemotherapy, 48 patients on a non-chemotherapy regimen, 45 persons in complete remission not under treatment and 53 non-cancer patients. Oral health perception was significantly worse in chemotherapy patients. They reported limiting the kinds of food they consumed, the discomfort felt when eating and took medications for oral pain. Oral lesions were frequent in chemotherapy participants. Nutritional status was related to the cancer treatment regimen (OR = 4.17; p value = 0.017), the presence of oral lesions (OR = 4.51; p value = 0.003), perception of xerostomia (OR = 3.54; p value = 0.012), the number of PFU (OR = 2.51; p value = 0.046) and GOHAI score (OR = 1.617; p value = 0.019). CONCLUSION: The presence of oral lesions and the chemotherapeutic regimen were highly associated with nutritional status in older patients with cancer. CLINICAL RELEVANCE: Dental professionals should be asked to intervene preventively and per-therapy to optimise oral health status in elderly patients with other cancers than head and neck malignancies.


Subject(s)
Geriatric Assessment , Malnutrition/etiology , Neoplasms/drug therapy , Oral Health , Aged , Aged, 80 and over , Cross-Sectional Studies , Female , Humans , Lebanon , Male , Nutrition Assessment , Quality of Life , Risk Factors , Xerostomia/etiology
14.
Intern Med J ; 48(11): 1382-1388, 2018 11.
Article in English | MEDLINE | ID: mdl-29660234

ABSTRACT

BACKGROUND: The evaluation of chronic kidney disease (CKD) in cancer patients seems to rely mostly on the Cockcroft-Gault (CG) formula or the creatinine levels to adjust treatment dosages which is a practice refuted by internists. AIMS: We evaluate the overall agreement of the CG, modification of diet in renal disease (MDRD) and CKD-epidemiology collaboration equations (CKD-EPI) equation with the newly devised Janowitz and Williams' (JW) equation. METHODS: The renal function was estimated in 235 cancer patients according to the CG, MDRD, body surface area (BSA)-adjusted MDRD, CKD-EPI, BSA-adjusted CKD-EPI and JW formulae. RESULTS: JW equation was more in agreement with CG and CKD-EPI estimations than the other equations. Taking JW equation as reference, receiver operating characteristic curve analysis showed that CG eGFR had the higher area under the curve when compared with other equations. Hierarchical cluster analysis showed more proximity between CG and JW equations than the other equations. CONCLUSION: The newly proposed JW eGFR estimation was more in agreement with CG equation than the other equations.


Subject(s)
Acute Kidney Injury/diagnosis , Glomerular Filtration Rate , Kidney Function Tests/standards , Neoplasms/drug therapy , Renal Insufficiency, Chronic/diagnosis , Acute Kidney Injury/chemically induced , Adult , Aged , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Area Under Curve , Creatinine/blood , Female , Humans , Male , Middle Aged , Neoplasms/complications , Predictive Value of Tests , Renal Insufficiency, Chronic/chemically induced , Renal Insufficiency, Chronic/diet therapy
15.
Am J Hematol ; 92(11): 1170-1176, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28762527

ABSTRACT

Eliglustat, an oral substrate reduction therapy, is a first-line treatment for adults with Gaucher disease type 1 (GD1) who are poor, intermediate, or extensive CYP2D6 metabolizers (>90% of patients). In the primary analysis of the Phase 3 ENGAGE trial (NCT00891202), eliglustat treatment for 9 months resulted in significant reductions in spleen and liver volumes and increases in hemoglobin concentration and platelet count compared with placebo. We report 18-month outcomes of patients who entered the trial extension period, in which all patients received eliglustat. Of 40 trial patients, 39 entered the extension period, and 38 completed 18 months. Absolute values and percent change over time were determined for spleen and liver volume, hemoglobin concentration, platelet count, bone mineral density, bone marrow burden, and Gaucher disease biomarkers. For patients randomized to eliglustat in the double-blind period, continuing treatment with eliglustat for 9 more months resulted in incremental improvement of all disease parameters. For patients randomized to placebo in the double-blind period, eliglustat treatment during the 9-month, open-label period resulted in significant decrease of spleen and liver volumes and significant increase of hemoglobin and platelets, with a similar rate of change to patients who had received eliglustat in the double-blind period. Eliglustat treatment was also associated with improvement in bone marrow burden score, bone mineral density, and established biomarkers of Gaucher disease, including reduction of the bioactive lipid, glucosylsphingosine. These findings underscore the efficacy of eliglustat in treatment-naïve patients. Eliglustat was well-tolerated, and there were no new safety concerns with longer-term exposure.


Subject(s)
Enzyme Inhibitors/therapeutic use , Enzyme Replacement Therapy , Gaucher Disease/drug therapy , Pyrrolidines/therapeutic use , Enzyme Inhibitors/administration & dosage , Enzyme Inhibitors/adverse effects , Follow-Up Studies , Gaucher Disease/diagnosis , Gaucher Disease/enzymology , Glucosylceramidase/antagonists & inhibitors , Humans , Liver/pathology , Organ Size , Pyrrolidines/administration & dosage , Pyrrolidines/adverse effects , Spleen/pathology , Treatment Outcome
16.
Support Care Cancer ; 25(2): 599-605, 2017 02.
Article in English | MEDLINE | ID: mdl-27738795

ABSTRACT

INTRODUCTION: One major health care issue encountered in elderly cancer patients is the alteration of the quality of life. The purpose of our study is to evaluate the administration of chemotherapy in the last month of life (CLML) and to evaluate the impact of the palliative care consult (PCC) in the elderly patients. METHODS: We conducted a retrospective observational study that included elderly patients diagnosed with an end-stage cancer and who were deceased between the 1st of January 2012 and the 31st of December 2015. Patient medical records were reviewed for patients' characteristics and management during the last month of life. RESULTS: This study enrolled 231 patients that fulfilled the eligibility criteria. CLML was administered in 91 patients (39.4 %) among which 43 patients (47.3 %) had their treatment within the last 2 weeks of life. Seventy-seven patients (33.3 %) had a palliative care consult (PCC) with a median duration of follow up of 13 days (range 2-56 days). Overall, PCC failed to decrease CLML administration, the duration of hospitalization, and ICU admissions. However, CLML administration decreased by 69 % among patients that had their PCC before receiving treatment (OR = 0.31; 95 % CI 0.15-0.63). PCC also led to a change in the pattern of treatment administered in the last month of life with less cytotoxic therapy (OR = 0.27 CI 95 % 0.09-0.9, p = 0.02) and higher rates of oral agents being prescribed (OR = 3.8; 95 % CI 1.3-11.3, p = 0.014). CONCLUSION: Our elderly patients seem to receive aggressive management similar to the general oncology population. Early PCC was shown throughout our results to decrease the aggressiveness of cancer treatment in elderly patients which seems to improve the quality of care of our patients.


Subject(s)
Neoplasms/psychology , Palliative Care/methods , Quality of Life/psychology , Terminal Care/methods , Aged , Female , Humans , Male , Neoplasms/therapy , Retrospective Studies
17.
Invest New Drugs ; 34(4): 474-80, 2016 08.
Article in English | MEDLINE | ID: mdl-27159981

ABSTRACT

Background Treatment options for patients with metastatic castration-resistance prostate cancer are unsatisfactory. Docetaxel monotherapy offers promising results with a tolerable toxicity profile. However, enhancing the clinical index of Docetaxel-based therapy remains the ultimate goal. Methods We conducted a phase II, open label, multinational prospective trial to evaluate the efficacy of weekly Docetaxel combined with Zoledronic acid and Celecoxib. Eligible patients received 25 mg/m(2) Docetaxel weekly for 3 consecutive weeks every 4 weeks, 4 mg Zoledronic acid every 4 weeks, and 200 mg oral Celecoxib twice daily. Enrollment was terminated prematurely upon the publication of reports of cardiac toxicity associated with cyclooxygenase (COX) 2 inhibitors. Results Our study enrolled 22 patients with a median of 4.7 cycles per patient. The median overall survival (OS) was 9.8 months (range 0.7 to 24.1 months) with 36 % and 4.5 % survival rates at 1 and 2 years, respectively. Our patients had a biologic response in 40.1 % of cases and a palliative response in 72.7 %. Among the eight patients with measurable disease, three had partial responses, two had stable disease, and three had progressive disease, leading to a response rate (RR) of 62.5 %. The observed toxicities were mild and limited to grade 3 events. Nine patients had anemia (40.1 %), 5 had sensory neuropathy (22.7 %) and 2 had stomatitis (9.1 %). Conclusion The combination of Docetaxel, Celecoxib, and Zoledronic acid failed to improve OS or to offer an acceptable biologic response. We do not believe that there is compelling evidence to include either Celecoxib or Zoledronic acid in further phase II/III trials.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Bone Density Conservation Agents/therapeutic use , Celecoxib/therapeutic use , Cyclooxygenase 2 Inhibitors/therapeutic use , Diphosphonates/therapeutic use , Imidazoles/therapeutic use , Prostatic Neoplasms, Castration-Resistant/drug therapy , Taxoids/therapeutic use , Aged , Aged, 80 and over , Antineoplastic Agents/adverse effects , Antineoplastic Agents/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Bone Density Conservation Agents/adverse effects , Celecoxib/adverse effects , Cyclooxygenase 2 Inhibitors/adverse effects , Diphosphonates/adverse effects , Docetaxel , Humans , Imidazoles/adverse effects , Kaplan-Meier Estimate , Male , Middle Aged , Taxoids/adverse effects , Treatment Outcome , Zoledronic Acid
18.
Support Care Cancer ; 24(4): 1603-8, 2016 Apr.
Article in English | MEDLINE | ID: mdl-26391890

ABSTRACT

PURPOSE: The use of chemotherapy in the last month of life (CLML) of cancer patients is considered an aggressive approach to be avoided. We examined the practice of CLML in Lebanese cancer patients, and we investigated patient and tumor characteristics that justify this practice. To our knowledge, this is the first study describing CLML of Middle Eastern patients with advanced cancer. METHODS: We conducted this study at Hotel-Dieu de France University Hospital (HDF), Lebanon. Cases eligible for this study were all individuals diagnosed with cancer who died at HDF between the 1st of January and the 31st of December 2014. Demographic and clinical characteristics of the patients were obtained from the hospital registration records. Data concerning the management plan, primary malignancy and stage, chemo-sensitivity, line, type, and timing of chemotherapy in the last month of life were also obtained. RESULTS: Among the 130 cancer patients who were enrolled, CLML was administered to a total of 55 patients (42.3 %), of whom 26 patients (50 %) received more than one cytotoxic drug. Oral drug was only given to 9 patients (16.4 %). Interestingly, CLML increased the risk of death in the last month of life (p = 0.02), yet progression of disease constituted the major cause of death in this subgroup (54.6 %). The only variable to have statistical significant correlation with CLML was performance status (p = 0.03). The type of tumor and recent diagnosis of less than 2 months were also correlated to CLML (p = 0.03 and 0.024, respectively). CONCLUSION: The high percentage of patients receiving CLML underlines the difficulty of end-of-life discussions in patients from Middle Eastern societies. This is true in the context of a country with little availability of palliative care resources, where health policies should be more focused on incorporating palliative medicine in all medical strategies.


Subject(s)
Antineoplastic Agents/adverse effects , Neoplasms/drug therapy , Outcome Assessment, Health Care/statistics & numerical data , Palliative Care/standards , Terminal Care/standards , Aged , Aged, 80 and over , Antineoplastic Agents/administration & dosage , Disease Progression , Female , Humans , Lebanon , Male , Middle Aged , Palliative Care/statistics & numerical data , Retrospective Studies , Terminal Care/statistics & numerical data
19.
Qual Life Res ; 25(6): 1597-604, 2016 06.
Article in English | MEDLINE | ID: mdl-26659898

ABSTRACT

INTRODUCTION: Despite worldwide trends toward optimizing full disclosure of information (DOI), the prevailing belief that cancer diagnosis should be concealed from patients, for their own good, has endured for a substantial period of time in Middle Eastern communities. OBJECTIVES: This study would assess the reliability of the Arabic translated version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-INFO 25). The study was also designed to quantify DOI to Lebanese cancer patients and determine patient satisfaction with this DOI. Moreover, we compared the differences in the level of information among groups based on clinical and biographical variables. METHODS: A sample of patients, being treated for a variety of malignancies, was prospectively evaluated. A physician interviewed patients using the Arabic version of the EORTC QLQ-INFO 25, on the day of hospitalization for chemotherapy, before treatment was administered. RESULTS: In total 201 patients were interviewed. The translated version of the EORTC QLQ-INFO 25 showed high reliability when assessed using Cronbach's alpha coefficients for internal consistency with values scoring higher than 0.7 for all scales and the full questionnaire. There was a considerable lack of information provided to the participants with 38.8 % being unaware of their diagnosis and more than half being uninformed about the extent of their disease. Paradoxically, 86.5 % of patients expressed their satisfaction about the amount of information they received and 89.5 % believe the information provided was helpful. Further analysis showed no significant association between gender, marital status, cancer site and stage and the amount of information received. However, age and level of education were associated with DOI such as younger and more educated patients received more information. Older patients were also found to be the most satisfied with the information they received, despite having less access to information. CONCLUSIONS: Although a high proportion of patients were not properly informed about their diagnosis, the overwhelming majority were satisfied with the amount of information they received and believed it was useful, reflecting the complexity of Middle Eastern cultural influences on cancer patients' perspectives.


Subject(s)
Neoplasms/psychology , Patient Satisfaction/statistics & numerical data , Psychometrics/instrumentation , Quality of Life/psychology , Surveys and Questionnaires , Truth Disclosure , Adult , Aged , Female , Humans , Lebanon , Male , Middle Aged , Prospective Studies , Reproducibility of Results , Translating
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