{"title":"The clinical value of penicillin G outweighs its usage restriction due to a too-much concern for hyperkalemia.","authors":"Hideharu Hagiya, Haruto Yamada, Shiho Kajita, Yoshitaka Iwamoto, Naofumi Hara","doi":"10.1080/1120009X.2021.1994689","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1994689","url":null,"abstract":"The promotion of antimicrobial stewardship, which applies to activities related to sustainable development goals, should be a top priority in this era of antimicrobial resistance (AMR) [1]. Narrow-spectrum antimicrobials can reduce the risk of developing antimicrobial resistant organisms by preserving the use of broad-spectrum antimicrobials. Among the various antimicrobial agents, penicillin is mainly active against gram-positive bacteria and has no superfluous covering spectrum, being one of the narrowest antimicrobial agents in clinical use [2]. Since its discovery, manufacturing, and clinical use in 1940s, penicillin, also referred to as the “magic bullet,” has saved uncountable lives [3]. Of the several forms, penicillin G (PCG, known as potassium benzylpenicillin) is available in Japan. With increased clinical use, penicillin resistance has occurred in many pathogenic organisms as a consequence of molecular changes in penicillin-binding proteins, production of b-lactamases, and overexpression of porin proteins and/or efflux pumps [4]. However, penicillin is still recommended as a first-line therapeutic option for a wide variety of infectious diseases, including streptococcal infections (Streptococcus pneumoniae pneumonia and meningitis, viridans-streptococcal infective endocarditis, and necrotizing fasciitis due to beta-hemolytic streptococcus), spirochetal infections (syphilis, leptospirosis, and Lyme disease), actinomycosis, and Clostridium perfringens infection [5]. Despite its clinical effectiveness and advantage in antimicrobial stewardship, PCG imposes a risk of hyperkalemia due to its potassium (Kþ) salt preparation form. Notably, one vial of PCG comprises 1 million units (MU), which contains 1.53 mEq of Kþ. Furthermore, the maximum dosage of PCG is 24MU (4MU [that is, 6.12 mEq of Kþ] every 4 h), which results in a dose of approximately 36.7 mEq of Kþ per day. Detailed pharmacokinetics of serum or urine Kþ levels related to PCG administration are not available in the literature; however, there have been reports of sudden death involving patients undergoing PCG therapy [6]. Thus, appropriate serum Kþ level monitoring is required, especially in patients with renal dysfunction (creatinine clearance 50ml/min), those with prolonged PCG treatment, those with any underlying cardiac diseases that possibly cause arrhythmia, and those prescribed other drugs that may cause Kþ elevation, such as angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, cyclosporine, tacrolimus, spironolactone, and so on. In general, medical institutes establish standards for intravenous Kþ supplementation from medical safety perspectives. Here is an example of potassium-containing intravenous formulations; (i) Formulations containing Kþ above 40 mEq/L should not be administered in general wards, (ii) The dosing speed should be less than 10 mEq/hr of Kþ, and (iii) The total daily dose of Kþ should not exceed 100 mEq. Table 1 summarizes the Kþ co","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"277-278"},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39831142","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Risk of hypertension with anti-VEGF monoclonal antibodies in cancer patients: a systematic review and meta-analysis of 105 phase II/III randomized controlled trials.","authors":"Gang Yin, Ling Zhao","doi":"10.1080/1120009X.2021.1947022","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1947022","url":null,"abstract":"<p><p>We performed a meta-analysis to fully investigate the hypertension of anti-VEGF mAbs in cancer patients. Databases were searched for randomized controlled trials (RCTs) treated with anti-VEGF mAbs till January 2021. The relevant RCTs in cancer patients treated with anti-VEGF mAbs were retrieved and the systematic evaluation was conducted. One hundred and five RCTs and 65358 patients were included. Our study suggests that anti-VEGF mAbs significantly increased the risks of all-grade (RR, 3.22; 95%CI, 2.83-3.65; p < 0.00001; I<sup>2</sup>=71%) and high-grade (RR, 6.15; 95%CI, 5.58-6.78; p < 0.00001; I<sup>2</sup>=48%) hypertension in cancer patients. Those risks may be dependent on drug type. Icrucumab did not association with an increased risk of hypertension. The RR of hypertension did not vary significantly according to the type of cancer, line of therapy, and treatment duration. The available data suggested that the use of anti-VEGF mAbs were associated with a significantly increased risk of hypertension.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"221-234"},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/1120009X.2021.1947022","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39158594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Xiao-Bin Lin, Xiao-Guang Hu, Yan-Zhe Xia, Xiao-Man Liu, Tao Liang, Xiao Chen, Chang-Jie Cai
{"title":"Voriconazole pharmacokinetics in a critically ill patient during extracorporeal membrane oxygenation.","authors":"Xiao-Bin Lin, Xiao-Guang Hu, Yan-Zhe Xia, Xiao-Man Liu, Tao Liang, Xiao Chen, Chang-Jie Cai","doi":"10.1080/1120009X.2021.2014725","DOIUrl":"https://doi.org/10.1080/1120009X.2021.2014725","url":null,"abstract":"<p><p>The pharmacokinetics (PK) of several drugs including antimicrobials might be highly altered during extracorporeal membrane oxygenation (ECMO) therapy. We present the change of voriconazole (VRC) PK during ECMO in a critically ill patient who received intravenous VRC at a maintenance dose of 200 mg every 12 h for empirical antifungal therapy. Two PK profiles were drawn before and after the initiation of ECMO therapy. Though the trough levels (both <i>C</i><sub>0</sub> and <i>C</i><sub>12</sub>) with ECMO were slightly lower than that without ECMO (12.58 and 12.84 <i>vs.</i> 14.02 μg/mL), the peak levels and the area under the concentration-time curve from 0 h to 6 h (AUC<sub>0-6</sub>) were comparable (16.36 <i>vs.</i> 16.06 μg/mL and 90.78 <i>vs.</i> 91.45 μg·h/mL, respectively), indicating that VRC plasma exposure during ECMO therapy did not greatly decrease in our patient. The circuit factors including the type of membrane should be taken into account to further identify the effects of ECMO on the PK of VRC.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"272-276"},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39812832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Drugs and liver injury: a not to be overlooked binomial in COVID-19.","authors":"M Vitrone, F Mele, E Durante-Mangoni, R Zampino","doi":"10.1080/1120009X.2021.1988203","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1988203","url":null,"abstract":"<p><p>SARS-CoV-2 infection (COVID-19) results predominantly in pulmonary involvement but a direct, virus-induced liver damage may also occur, whose mechanisms are being actively investigated. Accordingly, it appears of utmost importance to monitor liver function and carefully evaluate hepatic safety of the various drugs administered during COVID-19. In this respect, many drugs, biological agents and novel molecules, whose efficacy in COVID-19 is under scrutiny, have also been shown to potentially cause or worsen liver damage. In this article, we review safety data of established as well as promising agents for COVID-19.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"207-220"},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39513691","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ivana Kolarov Bjelobrk, Jelena Radic, Jasna Trifunovic, Jasna Pesic, Vladimir Vidovic, Bojana Vranjkovic, Nemanja Petrovic, Bojana Andrejic Visnjic
{"title":"The efficacy of lapatinib in patients with metastatic HER2 positive breast cancer who received prior therapy with monoclonal antibodies and antibody-drug conjugate: a single institutional experience.","authors":"Ivana Kolarov Bjelobrk, Jelena Radic, Jasna Trifunovic, Jasna Pesic, Vladimir Vidovic, Bojana Vranjkovic, Nemanja Petrovic, Bojana Andrejic Visnjic","doi":"10.1080/1120009X.2021.2009722","DOIUrl":"https://doi.org/10.1080/1120009X.2021.2009722","url":null,"abstract":"<p><p>The choice of the anti-HER2 agent depends on country-specific availability, the specific, previously administered anti-HER2 therapy and the relapse-free interval, although there is not much published data on the use of lapatinib after progression on pertuzumab and/or T-DM1. The aim of this research is to determine efficacy of lapatinib in this setting. This research included 111 patients with metastatic HER2 positive breast cancer who received lapatinib with capecitabine at The Oncology Institute of Vojvodina. Lapatinib was given to 83 patients after trastuzumab without prior exposure to pertuzumab or T-DM1 while 28 patients received lapatinib after prior exposure to trastuzumab, pertuzumab and/or T-DM1. In order to determine efficacy of lapatinib in both groups, we measured progression free survival (PFS) and overall survival (OS), as well as by subsets: hormonal status (ER-positive and/or PR-positive tumours versus ER-negative and PR-negative tumours), the number of positive axillary lymph nodes (four or more positive axillary lymph nodes versus less than four positive axillary lymph nodes), marker of proliferation (Ki-67 ≥ 30 versus Ki-67 < 30), disease free interval (metastatic recurrence ≤ 1 year after initial diagnosis versus metastatic recurrence > 1 year after initial diagnosis or de novo metastatic disease. Median PFS was 5.6 months (95% CI 4.6-6.6) in the group of patients who received lapatinib after prior exposure to trastuzumab, pertuzumab and/or T-DM 1 and 7.4 months (95% CI 6.1-10.2) in the group of patients who received lapatinib after trastuzumab (HR, 0.79; 95% CI 0.61-0.98; P = 0.09). The patients with negative prognostic factors such as hormone receptor negativity, more than four positive axillary lymph nodes, marker of proliferation Ki 67 ≥ 30 and metastatic recurrence ≤ 1 year after initial diagnosis, had a similar PFS, regardless of receiving lapatinib after prior exposure to trastuzumab, pertuzumab and/or T-DM1 or without prior exposure. Median OS was 10.1 months (95% CI 8.6-NR) in the group that received lapatinib after exposure to trastuzumab, pertuzumab and/or T-DM1 and 16.3 months (95% CI 14.4-20.2) in the group of patients who received lapatinib after trastuzumab (HR, 0.76; 95% CI, 0.59-0.94; P = 0.04). Patients with negative prognostic factors such as hormone receptor negativity, more than four positive axillary lymph nodes and marker of proliferation Ki 67 ≥ 30, had no distinctly worse OS, regardless of receiving lapatinib after prior exposure to trastuzumab, pertuzumab and/or T-DM1 or without prior exposure. Lapatinib with capecitabine is an effective therapeutic option, especially in patients with negative prognostic factors, who have received prior chemotherapy, trastuzumab, pertuzumab, T-DM1 and remains an acceptable option for HER2 positive metastatic breast cancer until the novel drugs are approved in developing countries.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"264-271"},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39676828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Evaluation of association between parameters related to penetration into cerebrospinal fluid and the microbiological efficacy of vancomycin in patients with bacterial meningitis.","authors":"Masayuki Ishikawa, Masashi Uchida, Shingo Yamazaki, Yuki Shiko, Yohei Kawasaki, Takaaki Suzuki, Yasuo Iwadate, Itsuko Ishii","doi":"10.1080/1120009X.2021.2012326","DOIUrl":"https://doi.org/10.1080/1120009X.2021.2012326","url":null,"abstract":"<p><p>Vancomycin (VM) is used as empirical therapy for bacterial meningitis (BM). We investigated the relationship of the microbiological efficacy of VM for BM with VM minimum inhibitory concentration (MIC<sub>VM</sub>), serum VM trough concentration (VM<sub>ser</sub>) and cerebrospinal fluid (CSF) protein (P)/serum albumin (SA) ratio, which may reflect the extent of blood-brain barrier (BBB) disruption. Twelve BM patients were enrolled and VM was microbiologically effective in seven (58.3%). VM<sub>ser</sub>, MIC<sub>VM</sub>, and CSF-P/SA ratio were not associated with the microbiological efficacy of VM. The microbiological efficacy of VM was significantly associated with CSF-P/SA ratio multiplied by VM<sub>ser</sub> relative to the MIC<sub>VM</sub> (η = 0.61, <i>p</i> = 0.04). These results indicate that the parameter combining VM<sub>ser</sub>, MIC<sub>VM</sub>, and the extent of BBB disruption could be associated with the microbiological efficacy of VM in BM patients.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"157-165"},"PeriodicalIF":1.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39607008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bahar Uncu Ulu, Mehmet Sinan Dal, İpek Yönal Hindilerden, Olga Meltem Akay, Özgür Mehtap, Nurhilal Büyükkurt, Fehmi Hindilerden, Ahmet Kürşad Güneş, Tuğçe Nur Yiğenoğlu, Semih Başcı, Merih Kızıl Çakar, Didar Yanardağ Açık, Serdal Korkmaz, Turgay Ulaş, Gülsüm Özet, Burhan Ferhanoğlu, Meliha Nalçacı, Fevzi Altuntaş
{"title":"Brentuximab vedotin and bendamustine: an effective salvage therapy for relapsed or refractory Hodgkin lymphoma patients.","authors":"Bahar Uncu Ulu, Mehmet Sinan Dal, İpek Yönal Hindilerden, Olga Meltem Akay, Özgür Mehtap, Nurhilal Büyükkurt, Fehmi Hindilerden, Ahmet Kürşad Güneş, Tuğçe Nur Yiğenoğlu, Semih Başcı, Merih Kızıl Çakar, Didar Yanardağ Açık, Serdal Korkmaz, Turgay Ulaş, Gülsüm Özet, Burhan Ferhanoğlu, Meliha Nalçacı, Fevzi Altuntaş","doi":"10.1080/1120009X.2021.1976912","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1976912","url":null,"abstract":"<p><p>The prognosis is poor for relapsed or refractory (R/R) classical Hodgkin Lymphoma (cHL) patients. The brentuximab vedotin (Bv) and bendamustine (B) combination has been used as a preferable salvage regimen in R/R cHL patient trials. We retrospectively evaluated response rates, toxicities, and the survival in R/R cHL patients treated with the BvB combination. In a multi-centre real-life study, 61 R/R HL patients received intravenous doses of 1.8 mg/kg Bv on the first day plus 90 mg/m<sup>2</sup> B on the first and second days of a 21-day cycle as a second-line or beyond-salvage regimen. Patients' median age at BvB initiation was 33 (range: 18-76 years). BvB was given as median third-line treatment for a median of four cycles (range: 2-11). The overall and complete response rates were 82% and 68.9%, respectively. After BvB initiation, the median follow-up was 14 months, and one- and two-year overall survival rates were 85% and 72%, respectively. Grade 3/4 toxicities included neutropenia (24.6%), lymphopenia (40%), thrombocytopenia (13%), anaemia (13%), infusion reactions (8.2%), neuropathy (6.5%), and others. The BvB combination could be given as salvage regimen aiming a bridge to autologous stem cell transplant (ASCT), in patients relapse after ASCT or to transplant-ineligible patients with manageable toxicity profiles.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"190-198"},"PeriodicalIF":1.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39410697","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ti Yin, Jiun-Ji Lai, Wei-Cheng Huang, Shu-Chen Kuo, Tsung-Ta Chiang, Ya-Sung Yang
{"title":"<i>In vitro</i> and <i>in vivo</i> comparison of eravacycline- and tigecycline-based combination therapies for tigecycline-resistant <i>Acinetobacter baumannii</i>.","authors":"Ti Yin, Jiun-Ji Lai, Wei-Cheng Huang, Shu-Chen Kuo, Tsung-Ta Chiang, Ya-Sung Yang","doi":"10.1080/1120009X.2021.2005755","DOIUrl":"https://doi.org/10.1080/1120009X.2021.2005755","url":null,"abstract":"<p><p>Several antimicrobial combination therapies are used to treat multiple drug resistant (MDR) and extensively drug resistant (XDR) <i>Acinetobacter baumannii</i> infections. A novel antibiotic, eravacycline, shows a higher potency than tigecycline. The efficacies of eravacycline-based therapies have not yet been evaluated. We demonstrated the effectiveness of eravacycline- and tigecycline-based combination therapies in XDR and especially tigecycline resistant <i>A. baumannii</i>. Thirteen eligible isolates were selected from 642 non-duplicate <i>Acinetobacter</i> blood isolates from four medical centres in 2010-2014. Tigecycline/imipenem and eravacycline/imipenem combinations were simultaneously effective against some isolates <i>in vitro</i> with fractional inhibitory concentration index of 0.5. In contrast, eravacycline- and tigecycline-based combination therapies provided no additional benefits in mouse survival compared to those for monotherapy. In summary, colistin is still the final resort for XDR-<i>A. baumannii</i> treatment according to the sensitivities. Owning to rapid development of resistance in <i>A. baumannii,</i> novel antibiotics are urgently needed.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"166-172"},"PeriodicalIF":1.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39655771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bictegravir/emtricitabine/tenofovir alafenamide combination in the management of kidney transplant patients with HIV receiving immunosuppressants.","authors":"Jennifer Lagoutte-Renosi, Mylène Flammang, Didier Ducloux, Jamal Bamoulid, Pierre-Yves Royer, Quentin Lepiller, Anne-Laure Clairet, Siamak Davani, Patrice Muret","doi":"10.1080/1120009X.2021.1940436","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1940436","url":null,"abstract":"<p><p>We report here a drug-drug interaction with tacrolimus in a HIV-positive patient with renal transplant, after switch from highly active antiretroviral therapy with boosted protease inhibitors to the combination bictegravir/emtricitabine/tenofovir alafenamide. Although the tacrolimus doses were adapted to take account of the pharmacokinetic interactions with protease inhibitors, a tacrolimus overdosage occurred in the patient nonetheless. Through this case report, we highlight the need to consider a sufficient timeframe of withdrawal of protease inhibitors, which induce a prolonged drug-drug interaction with tacrolimus. To conclude, we purport that the combination bictegravir/emtricitabine/tenofovir alafenamide could be an attractive alternative in the context of transplantation provided a discontinuation of boosted protease inhibitors for more than 48 hours before introducing tacrolimus.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"199-202"},"PeriodicalIF":1.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/1120009X.2021.1940436","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39046685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"From clinical trials to clinical practice: the use of everolimus and exemestane in the treatment of hormone receptor-positive metastatic breast cancer: real-world data.","authors":"Hikmat Abdel-Razeq, Baha' Sharaf, Hazem Abdulelah, Nayef Abdel-Razeq, Mourad Salam, Bayan Inserat, Rayan Bater","doi":"10.1080/1120009X.2021.1959787","DOIUrl":"https://doi.org/10.1080/1120009X.2021.1959787","url":null,"abstract":"<p><p>Everolimus combined with exemestane can modulate endocrine resistance. The combination showed significant improvement in progression-free survival (PFS) in phase III clinical trials for hormone receptor positive metastatic breast cancer patients. It also showed serious adverse events. We evaluate the efficacy and prevalence of serious adverse events in a real-world setting. We retrospectively examined 91 breast cancer patients; all were previously treated with chemotherapy and fulvestrant (84% and 59%, respectively). After a 13-month median follow-up, 29% had a partial response, and 32% had stable disease. The PFS was 7.8 months. Due to adverse events, 19% of patients stopped the treatment, while 31% required a dose reduction. Despite enrolling heavier-pretreated patients, our real-world outcome for the efficacy and safety of the exemestane and everolimus match those of the clinical trials. Such results should assure clinicians and lead to wider adoption of this oral, chemotherapy-sparing regimen.</p>","PeriodicalId":191589,"journal":{"name":"Journal of Chemotherapy (Florence, Italy)","volume":" ","pages":"184-189"},"PeriodicalIF":1.8,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39405553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}