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Fulltext Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting

Pivot X, Manikhas AG, Shamrai V, Dzagnidze G, Soo Hoo HF, Kaewkangsadan V, et al.

BMC Cancer, 2023 Jan 31;23(1):112.
PMID: 36721174 DOI: 10.1186/s12885-023-10574-2

BACKGROUND: The TROIKA trial established that HD201 and trastuzumab were equivalent in terms of primary endpoints (total pathological complete response) following neoadjuvant treatment. The objective of the present analysis was to compare survival outcomes and final safety.
METHODS: In the TROIKA trial, patients with ERBB2-positive early breast cancer were randomized and treated with either HD201 or the referent trastuzumab. Eligible patients received 8 cycles of either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in combination with 8 cycles of chemotherapy (4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2) in the neoadjuvant setting. The patients then underwent surgery followed by 10 cycles of adjuvant HD201 or referent trastuzumab according to their initial randomization to complete one year of trastuzumab-directed therapy. Event-free and overall survival rates were calculated using Kaplan-Meier analysis. The hazard ratio for event-free survival was estimated by Cox proportional hazards regression.
RESULTS: The final analysis was performed after all patients completed the study at a median follow-up of 37.7 months (Q1-Q3, 37.3-38.1 months). A total of 502 randomized patients received either HD201 or the referent trastuzumab, and 474 (94.2%) were eligible for inclusion in the per-protocol set. In this population, the 3-year event-free survival rates were 85.6% (95% CI: 80.28-89.52) and 84.9% (95% CI: 79.54-88.88) in the HD201 and referent trastuzumab groups, respectively (log rank p = 0.938) (HR 1.02, 95% CI: 0.63-1.63; p = 0.945). The 3-year overall survival rates were comparable between the HD201 (95.6%; 95% CI: 91.90-97.59) and referent trastuzumab treatment groups (96.0%, 95% CI: 92.45-97.90) (log rank p = 0.606). During the posttreatment follow-up period, adverse events were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the reference trastuzumab groups, respectively. Serious adverse events were rare and none of which were related to the study treatment.
CONCLUSIONS: This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03013504.

Matched MeSH terms: Cyclophosphamide/therapeutic use
Fulltext Advances and Opportunities in Passive Wake-Up Radios with Wireless Energy Harvesting for the Internet of Things Applications

Bello H, Xiaoping Z, Nordin R, Xin J

Sensors (Basel), 2019 Jul 12;19(14).
PMID: 31336834 DOI: 10.3390/s19143078

Wake-up radio is a promising approach to mitigate the problem of idle listening, which incurs additional power consumption for the Internet of Things (IoT) wireless transmission. Radio frequency (RF) energy harvesting technique allows the wake-up radio to remain in a deep sleep and only become active after receiving an external RF signal to 'wake-up' the radio, thus eliminating necessary hardware and signal processing to perform idle listening, resulting in higher energy efficiency. This review paper focuses on cross-layer; physical and media access control (PHY and MAC) approaches on passive wake-up radio based on the previous works from the literature. First, an explanation of the circuit design and system architecture of the passive wake-up radios is presented. Afterward, the previous works on RF energy harvesting techniques and the existing passive wake-up radio hardware architectures available in the literature are surveyed and classified. An evaluation of the various MAC protocols utilized for the novel passive wake-up radio technologies is presented. Finally, the paper highlights the potential research opportunities and practical challenges related to the practical implementation of wake-up technology for future IoT applications.

Matched MeSH terms: Cyclophosphamide
Combination cancer chemotherapy--a clinical trial on outpatients

Ti TK, Yong NK

Med J Malaysia, 1974 Mar;28(3):165-70.
PMID: 4278036
Matched MeSH terms: Cyclophosphamide/administration & dosage; Cyclophosphamide/adverse effects; Cyclophosphamide/therapeutic use
Penggunaan Jaringan Neural Tiruan bagi menentukan Kekeruhan air berdasarkan Pencaman Corak Spektrum Pantulan (The use of Artificial Neural Network for Determination of Water Turbidity based on Pattern Recognition of the Reflectance Spectrum)

Mohd. Azwani Shah Mat Lazim, Musa Ahmad, Zuriati Zakaria, Mohd. Nasir Taib

Sains Malaysiana, 2005;34.

Artificial neural network (ANN) was used in this study to determine water turbidity by using back propagation algorithm. Three wavelengths which represent reflectance intensity for eight standard samples were used as training input. The finding from the study shows that the trained network with number of epochs of 250,000 and learning rate of 0.001 gave the lowest sum of squared error (SSE) of 0.04. ANN was able to predict the turbidity of water based on the pattern recognition of the reflectance spectrum. The architecture of optimized ANN used in this study was 3:25:1. The average prediction error was 0.02.
[Jaringan neural tiruan (ANN) dengan lagoritma perambatan balik (BP) telah digunakan dalam kajian ini untuk menentukan kekeruhan air. Tiga panjang gelombang yang mewakili serapan bagi lapan sampel telah dipilih sebagai imput latihan. Hasil kajian menunjukkan bagi jaringan terlatih dengan bilangan ulangan latihan 250,000 dan kadar pembelajaran 0.001 telah memberikan nilai SSE yang terendah iaitu 0.04. Dalam kajian ini jaringan ANN didapati boleh menentu dan meramalkan nilai kekeruhan sample air berdasarkan corak serapan pantulan. Arkitektur yang sesuai bagi kajian ini adalah 3:25:1. Purata ralat ramalan adalah 0.02].

Matched MeSH terms: Cyclophosphamide
Minimal change glomerular disease in Malaysian adults and use of alternate day steroid therapy

Wang F, Looi LM, Chua CT

Q. J. Med., 1982;51(203):312-28.
PMID: 7146313

One hundred and forty-eight patients over the age of 12 years seen from July 1972 through December 1980 were accepted for this review of minimal change glomerular disease (MCGD). The diagnosis was based on a typical clinical presentation, and renal biopsy findings. MCGD forms 43.5 per cent of our patients with idiopathic nephrotic syndrome. The patients were predominantly young adults (82 per cent) and the onset of nephrotic syndrome (NS) occurred below the age of 30 years. Most patients had severe oedema and hypoalbuminaemia. Few patients recovered spontaneously. One hundred and thirty patients were given long-term alternate-day steroid (LASt) therapy. Four had cyclophosphamide alone, 21 patients had cyclophosphamide after a trial of LASt. Eighty-four patients (62.7 per cent) were initial responders: 17 of these after cyclophosphamide, 26 (19.4 per cent) were initial non-responders: five cyclophosphamide, 19 were late responders. Nine patients were partial responders, six were non-responders and one went into renal failure. Forty-one patients defaulted, emigrated or were seen only locally at the time of study. Ninety-nine patients were followed for three to 102 months (mean 23 . 3 months). Thirty-seven patients were followed for 36 to 102 months. Relapses were infrequent but occurred as late as 60 months.

Matched MeSH terms: Cyclophosphamide/administration & dosage; Cyclophosphamide/therapeutic use
Five-year review of nephrotic syndrome in Singapore children

Chuan PL, Leng SC, Sinniah R

J Singapore Paediatr Soc, 1975 Oct;17(2):113-23.
PMID: 1207079
Matched MeSH terms: Cyclophosphamide/adverse effects; Cyclophosphamide/therapeutic use
Infectious complications in lupus nephritis treatment: a systematic review and meta-analysis

Thong KM, Chan TM

Lupus, 2019 Mar;28(3):334-346.
PMID: 30744523 DOI: 10.1177/0961203319829817

OBJECTIVES: Infection is an important concern in lupus nephritis treatment, but few studies have focused on this complication. Available data suggest marked variation in occurrence and outcome. This meta-analysis and review aims to provide an overview of infective complications, focusing on the risk factors and outcomes.
METHODS: Original articles on lupus nephritis Class III/IV/V published in the period January 1980 to December 2016 were identified from the Pubmed/Medline electronic database. Meta-analysis of randomized controlled trials was performed to investigate total and serious infections at different phases of treatment and their associated factors. A descriptive review that included all studies was also performed, providing details on the types of infection, infection-related mortality, and potential impact of different eras on infection rates.
RESULTS: A total of 56 studies (32 randomized controlled trials) were included. The incidence rates of overall and serious infections were higher during the induction than maintenance phase of therapy, with serious infections occurring at 8.2-50 and 3.5 per 100 patient-years, respectively. Recent data, predominantly from Asia, suggested lower rates of overall infections with induction regimens that included tacrolimus compared with mycophenolate (risk ratio 0.50, 95% confidence interval 0.33-0.76, p = 0.001). Mycophenolate as induction treatment was associated with lower overall infection risks than cyclophosphamide in non-Asians (risk ratio 0.60, 95% confidence interval 0.48-0.75, p

Matched MeSH terms: Cyclophosphamide/administration & dosage; Cyclophosphamide/adverse effects
Fulltext Protective effect of virgin coconut oil on cyclophosphamide-induced histological changes in lymphoid tissues

Mu’izuddin M. Senin, Imad M. Al-Ani, Mohamed Imad A.M. Mahmud, Naznin Muhammad, Hanif M. Kasmuri

International Medical Journal Malaysia, 2018;17(3):65-74.
MyJurnal

Introduction: Virgin coconut oil (VCO) is known for its health and therapeutic benefits. However, the immunomodulatory effects of VCO have not been extensively investigated. Objective: The present study was devoted to examining the effects of VCO on cyclophosphamide (CY)-induced toxicity of lymphoid tissues. Methods: Thirty healthy male Wistar rats were sorted into 5 groups of 6 animals. The first control (NC) group was given distilled water via gavage at 5 ml/kg once daily. The second (CY) group received CY orally at 10 mg/kg/day for 4 weeks. Rats in the other three groups (CV5, CV10, and CV15) were given 10 mg/kg/day CY for 4 weeks, 5 m/kg/day, 10 ml/kg/day and 15 ml/kg/day VCO for 6 weeks, respectively. Rats were sacrificed at the end of 6th week; blood sample from the animals was collected for full blood count and biochemical analysis. The thymus and spleen of each animal was processed for histological examination. Results: The thymus and spleen showed marked reduction in lymphoid cellularity following daily administration of CY. The thymus also showed a marked reduction in the size of the medulla, and the white pulp areas of spleen had reduction in the follicle number and size. Supplementation with 10 ml/kg and 15 ml/kg VCO showed evidence of restoration of both the thymus and splenic lymphoid architecture. The total white cell counts, absolute lymphocyte counts and plasma globulin levels of the VCO groups were significantly increased compared to CY group. Conclusion: VCO displayed potential protective effects on CYinduced histological changes in lymphoid tissues.

Matched MeSH terms: Cyclophosphamide
Fulltext Investigating the potential of Nigella Sativa and Thymoquinone in salvaging the Embryo from effects of Toxic Paternal Exposure to Cyclophosphamide

Suzanah Abdul Rahman, Nadia Hanis Abdul Samat, Nur Amalina Ahmad, ‘Afif Raihan Abdullah, Syazana Mohamad Zahri, Saheera Kamarzaman

International Medical Journal Malaysia, 2017;16(1):99-106.
MyJurnal

Exposure to cyclophosphamide (CPA) for cancer treatment results in over-production of reactive oxygen species and oxidative stress thus affecting the DNA in male germ cell inducing sperm defects. Our goal is to assess the potential effects of Nigella sativa extract (NSE) and thymoquinone (TQ) on sperm and embryo quality following fertlization of sperm produced from germ cells which have been exposed to the damaging alkylating effects of CPA.

Matched MeSH terms: Cyclophosphamide
Antimutagenic effects of aqueous fraction of Myristica fragrans (Houtt.) leaves on Salmonella typhimurium and Mus musculus

Akinboro A, Bin Mohamed K, Asmawi MZ, Yekeen TA

Acta Biochim. Pol., 2014;61(4):779-85.
PMID: 25520963

Natural plant extracts offer a promising hope in the prevention/treatment of cancer arising from genetic mutations. This study evaluated in vitro and in vivo mutagenic and antimutagenic effects of aqueous fraction of Myristica fragrans (AFMF) leaves on TA100 strain of Salmonella typhimurium and Mus musculus (Male Swiss albino mice), respectively. The antioxidant activity of AFMF against 2,2-diphenyl-1-picrylhydrazyl (DPPH), total phenolic and flavonoid contents were determined, followed by its phytochemical elucidation using the Ultra Performance Liquid Chromatography technique (UPLC). The mutagenicity of AFMF at 4, 20, 50, 100, 200, 500, and 1000 µg/well was <2.0 in S. typhimurium and the induced micronucleated polychromatic and normochromatic erythrocytes at 500, 1000, 2000, and 4000 mg/kg were not significantly different from the negative control (p≥0.05). The mutagenic activity of benzo[a]pyrene and cyclophosphamide was significantly suppressed above 50.0% throughout the tested concentrations. Fifty percent of the free radicals from DPPH were scavenged by AFMF at 0.11 mg/ml. Total phenolic and flavonoid contents of AFMF were 51.0 mg GAE/g and 27 mg QE/g, respectively. Rutin was elucidated by the UPLC technique, and thereby suspected to be the phytochemical responsible for the observed antimutagenic activity. Thus far, AFMF seems to contain a promising chemotherapeutic agent for the prevention of genetic damage that is crucial for cancer development.

Matched MeSH terms: Cyclophosphamide/pharmacology
Fulltext Association of creatinine clearance with neutropenia in breast cancer patients undergoing chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide (FAC)

Montoya JE, Luna HG, Morelos AB, Catedral MM, Lava AL, Amparo JR, et al.

Med J Malaysia, 2013 Apr;68(2):153-6.
PMID: 23629563

Fluorouracil, doxorubicin, cyclophosphamide protocol (FAC) is a commonly used regimen for breast cancer due to its proven efficacy, acceptable toxicity, high affordability. While hepatic insufficiency dosing for doxorubicin and fluorouracil have been set, there is paucity of data in the literature on how to reduce doses in renal insufficiency. We sought to determine whether there is an association with pre-chemotherapy creatinine clearance, and the occurrence of clinically significant grade 3 to 5 neutropenia during the course of FAC chemotherapy.

Matched MeSH terms: Cyclophosphamide*
Infantile fibrosarcoma of the penis in a 2-year-old boy

Taib F, Mohamad N, Mohamed Daud MA, Hassan A, Singh MS, Nasir A

Urology, 2012 Oct;80(4):931-3.
PMID: 22854139 DOI: 10.1016/j.urology.2012.05.021

Fibrosarcoma is rare in the pediatric age group. It generally involves the extremities and the trunk but rarely involves the genital area. We report a case of a large fungating infantile fibrosarcoma of the penis in a 2-year-old Malay boy. Partial recovery of the penile structure was achieved after chemotherapy. The difficulty in managing the social and surgical aspect of this case is discussed in our report. To the best of our knowledge, this is the first case report of infantile fibrosarcoma involving the penis in an Asian region.

Matched MeSH terms: Cyclophosphamide/administration & dosage
Fulltext Outcome of 85 lupus nephritis patients treated with intravenous cyclophosphamide: a single centre 10 year experience

Chan AYK, Hooi LS

Med J Malaysia, 2000 Mar;55(1):14-20.
PMID: 11072485

Retrospective analysis was done on 85 patients (76 female, 9 male) with lupus nephritis who started intravenous cyclophosphamide between 1/1/1989 and 31/12/1998. The initial renal biopsy (World Health Organisation) classification was III (4.7%), IV (89.4%) and V (5.9%). Average serum creatinine at time of biopsy was 0.12 +/- 0.12 mmol/l. Median duration of nephritis before biopsy was 2 months (range 0-133). Median duration of follow-up from time of biopsy to outcome (death or end-stage renal failure) was 3.3 years (range 0.3-11.8). Nineteen patients died. The calculated proportion alive at 5 years was 75% and at 10 years 64%. The calculated proportion alive with renal function was 74% and 54% at 5 and 10 years respectively. Fifty-two patients completed cyclophosphamide therapy at the end of the study. There were ten episodes of herpes zoster, the most common infection seen. No malignancy was reported.

Matched MeSH terms: Cyclophosphamide/therapeutic use*
Fulltext Chemotherapy in nasopharyngeal carcinoma: review of results at University Hospital, Kuala Lumpur

Khanijow VK, Prasad U, Chang CM

Med J Malaysia, 1989 Dec;44(4):329-33.
PMID: 2520043

Nasopharyngeal carcinoma (NPC) is one of the commonest presentation of head and neck cancers in Malaysia, especially in the Chinese. The standard treatment is radical radiotherapy to the post-nasal space and the neck. Chemotherapy is given to patients with primary advanced disease and to patients with recurrence. The study reviews results of chemotherapy given to 33 patients at the University Hospital, Kuala Lumpur, over the last four years.

Matched MeSH terms: Cyclophosphamide/therapeutic use
Fulltext Chemotherapy for ovarian cancer

Adlan A, Sen DK, Sivanesaratnam V

Med J Malaysia, 1981 Sep;36(3):159-65.
PMID: 7329372
Matched MeSH terms: Cyclophosphamide/administration & dosage
Life-threatening complications of Henoch-Schönlein purpura: diffuse alveolar haemorrhage, venous thrombosis and bowel ischaemia

Dhaliwal KK, Lile NA, Tan CL, Lim CH

BMJ Case Rep, 2020 Sep 29;13(9).
PMID: 32994270 DOI: 10.1136/bcr-2020-235905

Henoch-Schönlein purpura (HSP) is a common systemic vasculitis occurring in children. Making a diagnosis of HSP is often straightforward, managing its complications can be difficult. Diffuse alveolar haemorrhage (DAH), bowel ischaemia and venous thrombosis are rare complications of this disorder. We present a case of a 15-year-old teenage girl presenting with typical purpuric rash of HSP, developed DAH, bowel ischaemia and venous thrombosis. She was successfully treated with pulse methylprednisolone, intravenous Ig and intravenous cyclophosphamide.

Matched MeSH terms: Cyclophosphamide/therapeutic use
Fulltext Treatment of small cell lung cancer with cyclophosphamide, adriamycin and vincristine (CAV) combination therapy: experience at University Hospital, Kuala Lumpur, Malaysia

Lee SM

Singapore Med J, 1990 Aug;31(4):317-20.
PMID: 2175049

Seventeen patients with small cell lung cancer (SCLC) were treated with cyclophosphamide, adriamycin and vincristine (CAV) combination chemotherapy. The overall response rate was 76.5% with 47% achieving complete response and 29.5% partial response. In limited and extensive stage disease, complete response was achieved in 67% and 36.5% respectively. Chinese were the predominant ethnic group affected (82%). Six patients presenting with superior vena cava obstruction responded significantly to CAV chemotherapy alone. Median survival for patients with extensive disease was 7.4 months. All patients with limited disease were still alive. Two relapsed patients with limited disease achieved significant response to VP-16/Cisplatin combination chemotherapy.

Matched MeSH terms: Cyclophosphamide/administration & dosage
Successful treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in systemic lupus erythematosus (SLE) with oral cyclophosphamide

Jasmin R, Sockalingam S, Shahrizaila N, Cheah TE, Zain AA, Goh KJ

Lupus, 2012 Sep;21(10):1119-23.
PMID: 22433918 DOI: 10.1177/0961203312440346

Peripheral neuropathy is a known manifestation of systemic lupus erythematosus. However, the association of primary autoimmune inflammatory neuropathies such as chronic inflammatory demyelinating polyneuropathy (CIDP) with SLE is uncommon. We report a 26-year-old man who simultaneously presented with severe CIDP and photosensitive rash, but was unresponsive to intravenous immunoglobulin infusion and continued to progress. He was found to have underlying SLE and improved with combined corticosteroid and immunosuppressive therapy with oral cyclophosphamide. CIDP with underlying SLE may be more resistant to conventional therapy with IVIG, requiring the addition of other immunosuppressive agents.

Matched MeSH terms: Cyclophosphamide/administration & dosage; Cyclophosphamide/therapeutic use*
Randomized controlled trial of pulse intravenous cyclophosphamide versus mycophenolate mofetil in the induction therapy of proliferative lupus nephritis

Ong LM, Hooi LS, Lim TO, Goh BL, Ahmad G, Ghazalli R, et al.

Nephrology (Carlton), 2005 Oct;10(5):504-10.
PMID: 16221103 DOI: 10.1111/j.1440-1797.2005.00444.x

BACKGROUND: The aim of the present study was to evaluate the efficacy of mycophenolate mofetil in the induction therapy of proliferative lupus nephritis.
METHODS: Forty-four patients from eight centres with newly diagnosed lupus nephritis World Health Organization class III or IV were randomly assigned to either mycophenolate mofetil (MMF) 2 g/day for 6 months or intravenous cyclophosphamide (IVC) 0.75-1 g/m(2) monthly for 6 months in addition to corticosteroids.
RESULTS: Remission occurred in 13 out of 25 patients (52%) in the IVC group and 11 out of 19 patients (58%) in the MMF group (P = 0.70). There were 12% in the IVC group and 26% in the MMF group that achieved complete remission (P = 0.22). Improvements in haemoglobin, the erythrocyte sedimentation rate, serum albumin, serum complement, proteinuria, urinary activity, renal function and the Systemic Lupus Erythematosus Disease Activity Index score were similar in both groups. Twenty-four follow-up renal biopsies at the end of therapy showed a significant reduction in the activity score in both groups. The chronicity index increased in both groups but was only significant in the IVC group. Adverse events were similar. Major infections occurred in three patients in each group. There was no difference in gastrointestinal side-effects.
CONCLUSIONS: MMF in combination with corticosteroids is an effective induction therapy for moderately severe proliferative lupus nephritis.

Matched MeSH terms: Cyclophosphamide/administration & dosage*; Cyclophosphamide/adverse effects
Ovarian failure in oral cyclophosphamide treatment for systemic lupus erythematosus

Wang CL, Wang F, Bosco JJ

Lupus, 1995 Feb;4(1):11-4.
PMID: 7767332 DOI: 10.1177/096120339500400103

Ninety-two women with systemic lupus erythematosus treated with oral cyclophosphamide were studied to ascertain the prevalence and the factors associated with ovarian dysfunction. Menstrual disturbance during treatment occurred in 55% of patients: 36% had amenorrhoea and 19% had oligomenorrhoea. Sustained oligomenorrhoea occurred in 12% patients. Permanent amenorrhoea (> 12 months) after cessation of oral cyclophosphamide occurred in 27% of patients. Hormonal studies in these patients were consistent with ovarian failure. Older age at initiation of treatment and high cumulative dose of cyclophosphamide were found to be associated with this outcome. There was a trend towards linear relationship between the age of initiation of cyclophosphamide therapy and frequency of amenorrhoea. A statistically significant association between amenorrhoea and cumulative dose of cyclophosphamide after adjustment for age was found whereas no such association was linked to the duration of treatment. Fourteen of the 23 women who wished to become pregnant after cessation of treatment conceived resulting in 20 live births and two abortions.

Matched MeSH terms: Cyclophosphamide/administration & dosage; Cyclophosphamide/adverse effects*

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