Purpose
The aim of the current study was to evaluate the effect of N-acetylcysteine (NAC) on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients.
...Method
A prospective randomized controlled open label study was conducted on 75 breast cancer patients receiving adjuvant paclitaxel 80 mg/m
2
weekly for 12 weeks. Eligible patients were randomized to either the low dose group; 1200 mg daily NAC, the high dose group; 1200 mg NAC twice daily or the control group; received paclitaxel only. The primary endpoint was the incidence of different grades of PIPN using National Cancer Institute’s common toxicity criteria for adverse event (NCI-CTCAE) while secondary endpoints were the severity of PIPN using modified total neuropathy score (mTNS), quality of life (QOL) using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTX) subscale, serum nerve growth factor (NGF), and serum malondialdehyde (MDA).
Results
At the end of the 12-week period, the incidence of grade (2, 3) peripheral neuropathy was significantly lower in the high dose group (28.6%) compared to the low dose group (61.9%) and the control group (100%),
p
value < 0.001. A significant improvement in the mTNS and QOL scores was observed after 6 and 12 weeks in the high dose group and the low dose group compared to the control,
p
value < 0.001. Significantly higher levels of serum NGF in the high dose group and lower level of serum MDA in the high dose and the low dose group were observed.
Conclusion
Oral NAC (1200 mg once and twice daily) might reduce the incidence and severity of PIPN and improve the patients’ QOL.
Trial registry
Clinical Trial.gov registration number: NCT03492047.
Background:
Stage III non-small cell lung cancer (NSCLC) being highly heterogeneous requires multimodal therapeutic strategies for optimal management. We present findings on treatment patterns and ...their associated survival outcomes in patients with stage III NSCLC from the Egypt subset of the KINDLE global real-world study conducted across countries from Asia, Middle East, Africa, and Latin America.
Method:
Retrospective data from the Egypt subset (21 centers) of adult patients diagnosed with stage III NSCLC between January 2013 and December 2017 were analyzed. Descriptive and inferential statistics summarized treatment modalities, progression-free survival (PFS), and overall survival (OS).
Results:
Of 421 patients enrolled (median age: 59.0 years), 77.9% were males, 53.5% had stage IIIA disease, 60.8% had adenocarcinoma, 78.4% had an unresectable disease, and 81.5% had Eastern Cooperative Oncology Group performance status ⩽1. Overall, chemotherapy alone (40.4%) was predominantly used in the initial line, whereas definite radiotherapy was used in only 5.0% of patients. In resectable patients, chemotherapy plus surgery (33.8%), surgery alone (20.6%), or other surgery (20.6%) were the top three modalities used in initial line of treatment. Chemotherapy alone was most preferred (48.8%) in unresectable patients, followed by sequential chemoradiotherapy (CRT) (17.6%) and concurrent CRT (9.3%). The overall median PFS was 10.3 months 95% confidence interval (CI), 9.43–12.02, whereas the median OS was 18.5 months (95% CI, 16.46–21.88). Overall, female gender, adenocarcinoma histology, and radical therapy as surgery or CRT predicted significantly longer OS (all p < 0.05).
Conclusion:
KINDLE-Egypt cohort revealed wide heterogeneities in the treatment patterns of stage III NSCLC. Although deemed resectable, few patients did not undergo surgery, probably due to high smoking rates leading to poor lung function. Lower survival outcomes than other published real-world studies highlight the need for timely approval and availability of novel targeted and immunotherapies to enhance patient outcomes.
Trial registration:
NCT03725475
Nintedanib targets VEGF receptors 1-3, PDGF receptors α and β, FGF receptors 1-3, and Src and Abl kinases, which are all implicated in malignant pleural mesothelioma pathogenesis. Here, we report the ...final results of the phase 3 part of the LUME-Meso trial, which aimed to investigate the efficacy and safety of pemetrexed plus cisplatin combined with nintedanib or placebo in unresectable malignant pleural mesothelioma.
This double-blind, randomised, placebo-controlled phase 3 trial was done at 120 academic medical centres and community clinics in 27 countries across the world. Chemotherapy-naive adults (aged ≥18 years) with unresectable epithelioid malignant pleural mesothelioma and ECOG performance status 0-1 were randomly assigned 1:1 via an independently verified random number-generating system to receive up to six 21-day cycles of pemetrexed (500 mg/m
) plus cisplatin (75 mg/m
) on day 1, then nintedanib (200 mg twice daily) or matched placebo on days 2-21. Patients without disease progression after six cycles received nintedanib or placebo maintenance on days 1-21 of each cycle. The primary endpoint was progression-free survival (investigator-assessed according to mRECIST) in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of their assigned study drug. This study is registered with ClinicalTrials.gov, number NCT01907100.
Between April 14, 2016, and Jan 5, 2018, 541 patients were screened and 458 were randomly assigned to either the nintedanib group (n=229) or the placebo group (n=229). Median treatment duration was 5·3 months (IQR 2·8-7·3) in the nintedanib group and 5·1 months (2·7-7·8) in the placebo group. After 250 events, progression-free survival was not different between the nintedanib group (median 6·8 months 95% CI 6·1-7·0) and the placebo group (7·0 months 6·7-7·2; HR 1·01 95% CI 0·79-1·30, p=0·91). The most frequently reported grade 3 or worse adverse event in both treatment groups was neutropenia (73 32% in the nintedanib group vs 54 24% in the placebo group). Serious adverse events were reported in 99 (44%) patients in the nintedanib group and 89 (39%) patients in the placebo group. The only serious adverse event occurring in at least 5% of patients in either group was pulmonary embolism (13 6% vs seven 3%).
The primary progression-free survival endpoint of the phase 3 part of LUME-Meso was not met and phase 2 findings were not confirmed. No unexpected safety findings were reported.
Boehringer Ingelheim.
Abstract
Background:Globally, triple-negative breast cancer (TNBC) is responsible for approximately 15% of all invasive Breast cancer and has been typically associated with poor prognosis. Some ...retrospective studies have suggested a relatively higher incidence of TNBC in the Middle East and North African Arab countries. Nevertheless, there is complete lack of prospective data, on TNBC in the region, including clinico-pathologic characteristics, treatment patterns and disease outcomes. The TRIPOLI study aims to bridge this information gap.Methods:TRIPOLI is an ongoing prospective multinational, disease registry, designed to recruit 700 newly diagnosed TNBC patients, from 15 institutions within 9 Arab countries: Egypt, Jordon, Morocco, Kingdom of Saudi Arabia, Lebanon, Oman, Kuwait, Qatar and Iraq. This interim analysis includes the patients’ characteristics and treatment approaches of the first 449 cases included in the study from December 2017 to September 2019.Results:All the 449 TNBC patients were females, with a median age of 49 years (range 23.8 - 93.6 years). Premenopausal status was reported in 54.7%, while a positive family history of BC was stated in 25.2% of these cases. 0.2% of patients were below normal (BMI<18.5), 17.2% had normal weight (18.5≤BMI<25), and 30.5% were overweight (25≤BMI<30). Obesity (BMI ≥ 30) was present in 52% of these patients, while a parity of ≥3 children was present in 254 patients (59.8%) Sixty-six patients (14.7%) had tumours smaller than 2cm. 159 patients (35.4%) had node negative disease. The majority of patients had invasive duct carcinoma (87.1%) with 5 patients (1.1%) grade I, 181 (40.3%) grade II and 234 (52.1%) grade III tumours (29 (6.5%) had unknown histological grade). Thirty-four patients (7.6%) presented with stage I disease, 203 patients (45.2%) with stage II, 161 patients (35.9%) with stage III and 50 patients (11.1%) presented with stage IV disease.Out of the 387 patients with non-metastatic disease who started treatment, 217 patients (56.1%) had upfront surgery and 170 patients (43.9%) started with neoadjuvant chemotherapy. Compared to patients > 40 years, patients ≤ 40 years were less likely to be obese (39.4% versus 60.6%; p=0.002), more likely to have grade III tumours (62.3% versus 53.5%; p=0.116), more likely to have T3 or T4 tumours (41.4% versus 32.7%; p=0.038).Conclusion:In this interim analysis, Arab women with TNBC had high parity (≥ 3) and high BMI, compared to existing literature based on western population. High tumor grade, younger age and advanced stages at presentation are in line with similar world-wide reports. Younger women in the Arab region (≤40 years) presented with poor prognostic features, which will be further elucidated in subsequent reports.
Citation Format: Hamdy A. Azim, Alaa Kandil, Heba El Zawahry, Hikmat Abdel-Razeq, Hesham Elghazaly, Suad Al Kharusi, Manal M. Abdelwahab, Salah Fayaz, Ahmed Saadeddin, Huda A. Alabdulkarim, Rasha Aboelhassan, Hassan Errihani, Tahseen Al Rubai, Salha Bujassoum Al Bader, Nashwa Mohamed Abdel Aziz, Nagi El Saghir, Giulia Attinà, Ahmed Yosry, Mohamed El Leithy, Loay Kassem, Marwan Ghosn. Triple negative breast cancer prospective registry in middle East and Africa (TRIPOLI) study: Interim analysis of the patients’ characteristics abstract. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-65.
Purpose
Soft tissue sarcomas (STS) are a heterogeneous group of rare mesenchymal neoplasms, accounting for < 1% of all newly diagnosed malignancies. These tumors can occur in almost any anatomic site ...though they most frequently occur in the extremities. The objective of the study was to describe the epidemiology, treatment paradigm, and real-world outcomes in the clinical management of metastatic STS (mSTS) in the Middle East and North Africa (MEA) region.
Methods
MOON was an observational, multicenter, retrospective patient chart review study which included 200 patients with mSTS in the final analysis. The primary objective of the study is exploratory, so it is presented using descriptive statistics.
Results
At the time of presentation, 62.0% patients had metastatic disease, 27.5% had received only their primary diagnosis and 10.0% had experienced a local recurrence. The most frequent STS localizations were lower extremities (74%), trunk (28.5%) and upper extremities (10.5%). Primary tumor was staged as T2b in the majority (60%) of patients. Surgical treatment was performed most often for the primary disease, whereas radiation therapy and chemotherapy were predominantly administered with palliative intent. A total of 38 patients received treatment with pazopanib. Thirteen adverse events (AEs) were attributed to pazopanib in eight patients.
Conclusion
Adult patients treated for STS have al most equal gender ratio and mostly are middle aged. The majority of patients have metastatic disease and disease progression, and half of the patients died from the disease during the period of evaluation. This study obtained real-life data on the clinical management of STS in MEA countries which could be shared with the medical community.
Granulocytic Sarcoma (GS) is a rare condition with a wide list of differential diagnosis and debatable guidelines of treatment in different cancer centers. Most of literature recommended systemic ...chemotherapy with or without radiation therapy and small role of surgery. One of the rarest sites for myeloid sarcoma is hard palate, which usually worsen the quality of life of the patient due to difficulty in feeding, drinking and speaking. We are reporting a case of hard palatine fistula caused by granulocytic sarcoma, in which we tried to get local control of disease with 3 dimension conformal radiation therapy 3DCRT and surgery with systemic control with chemotherapy using recommendation of multidisciplinary team and targeting mainly patient quality of life.
To evaluate and compare the effect of tooth preparation designs and different CADCAM. materials on stress distribution and Weibull survival probability of endocrowns. applied to root canal-treated ...lower first permanent molar using the 3D finite element. analysis method.
A root canal-treated lower first permanent molar was prepared for endocrowns with a. butt joint or with a ferrule design by placing, circumferentially, a 1-mm wide shoulder. finish line. The prepared molar was scanned for the two designs and modeled on a 3D. Finite element model. Monolithic zirconia (IPS e.max ZirCAD MT, FCZ), lithium. disilicate (IPS e.max CAD, EX), and nano-ceramic resin composite (Lava Ultimate, LU). CAD-CAM materials were used for each preparation to design the virtual endocrown. A. total of six models were built according to the different tooth preparation designs and. endocrown materials. An occlusal load of 600 N and a transverse load of 20 N in. magnitude that simulates the average occlusal load was directed toward the occlusal. surfaces. von Mises and maximum principle values were evaluated Weibull risk-ofrupture. analysis was used to analyze the survival probability of the restorations and. tooth in the different models.
The highest von Mises were found in the butt joint design for FCZ, EX, and LU (45.3. MPa, 35.2 MPa, and 24.2 MPa, respectively) compared to the ferrule design for the. same materials (42.6 MPa, 31.2 MPa, and 23.6 MPa, respectively). For von Mises. stress distribution in the remaining part of tooth structure (dentin), the highest stresses. were found in LUFerrule which was closely similar to LUButt joint (135.4 MPa and. 134.7 MPa, respectively), followed by EXFerrule and FCZFerrule (132.2 MPa and. 131.7 MPa, respectively), while the lowest stresses were found in EXButt joint and. FCZButt joint (129.0 MPa and 128.4 MPa, respectively). Shear stresses within the. resin cement were the highest in FCZ and EX compared to LU. EX was found to be the. most reliable material with the highest survival probability, while FCZ showed the. lowest survival probability according to the Weibull risk-of-fracture results.
Materials with high elastic modulus transfer more stresses to the endocrown and less. to the remaining tooth structure. Endocrown tooth preparation with ferrule design has. better stress distribution and magnitude compared to the butt joint design.
