scholarly journals Lactobacillus Kefiri LKF01 (Kefibios®) for Prevention of Diarrhoea in Cancer Patients Treated with Chemotherapy: A Prospective Study

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 385
Author(s):  
Michele Ghidini ◽  
Mariaceleste Nicoletti ◽  
Margherita Ratti ◽  
Gianluca Tomasello ◽  
Veronica Lonati ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Prospective Observational Study ◽  
Primary Outcome ◽  
Final Analysis ◽  
Clinical Effectiveness ◽  
High Grade ◽  
Combination Therapies ◽  
Grade 3 ◽  
Lactobacillus Kefiri ◽  
A Prospective Study

Diarrhoea is one of the main side effects that cancer patients face. The literature showsthat the incidence of chemotherapy (CT)-induced diarrhoea (grade 3–4) in treated patients is in the range of 10–20%, particularly after 5-fluorouracil (5-FU) bolus or some combination therapies of irinotecan and fluoropyrimidines. The aim of the present study was to evaluate the clinical effectiveness of Lactobacillus kefiri LKF01 (Kefibios®) in the prevention or treatment of CT-related diarrhoea in the cancer population. We conducted a prospective observational study. Patients enrolled were adults treated for at least four months with 5-FU-based CT. Kefibios® was administered to patients every day. The primary outcome was the evaluation of the incidence of grade 3–4 CT-induced diarrhoea. We included 76 patients in the final analysis. A 6.6% incidence of high-grade diarrhoea was found in the evaluated population (4.7% of patients treated with 5-FU-based therapy and 8.5% of patients treated with capecitabine-based CT). The overall incidence of high-grade diarrhoea observed was higher in the 1st and 2nd cycles (3.9%), with a subsequent sharp reduction from the 3rd cycle (1.3%) and negativisation from the 5th cycle. Lactobacillus kefiri LKF01 (Kefibios®) is safe and effective in preventing severe diarrhoea in cancer patients receiving 5-FU or capecitabine-based treatment.

scholarly journals Survival analysis of afatinib versus erlotinib for individuals with advanced del19 lung adenocarcinoma with asymptomatic brain metastasis after pemetrexed-cisplatin chemotherapy: a retrospective study

2020 ◽  
Vol 48 (8) ◽  
pp. 030006052093709
Author(s):  
Ye Jiang ◽  
Wenli Chen ◽  
Weiguang Yu ◽  
Ning Shi ◽  
Guowei Han ◽  
...  
Keyword(s):  
Brain Metastasis ◽  
Lung Adenocarcinoma ◽  
Primary Outcome ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Free Survival ◽  
Median Progression Free Survival ◽  
Secondary Outcomes ◽  
Grade 3

Objective To evaluate survival following afatinib (AF) and erlotinib (ER) treatment in advanced del19 lung adenocarcinoma (AD19LA) with asymptomatic brain metastasis (ABM) after pemetrexed–cisplatin chemotherapy (PCC). Methods Data were retrospectively analysed from individuals with AD19LA and ABM after PCC who received AF or ER for 2 years or until intolerable adverse events (AEs), withdrawal, or death. The primary outcome was survival; secondary outcomes were AEs. Results The final analysis included 174 AD19LA individuals (AF: n = 86; ER: n = 88) with a median follow-up of 24.2 months (IQR 2.1–28.3). Significant differences in overall survival (16.2 months [95%CI 15.4–17.1] for AF vs 7.2 months [95%CI 6.3–8.1] for ER) (HR 0.50, 95%CI 0.36–0.71, p<0.0001) and median progression-free survival (9.4 months [95%CI 8.5–9.7] for AF vs 5.6 months [4.7–6.2] for ER) (HR 0.66, 95%CI 0.47–0.94, p=0.02) were observed between the groups. Rates of all-grade AEs were 82.5% for AF and 72.7% for ER, and rates of grade ≥3 AEs were 37.2% for AF and 34.0% for ER. Conclusion Compared with ER, AF treatment may be more beneficial in terms of survival in the management of AD19LA after PCC with a tolerable safety profile.

Determination of uracil/UH2 ratio as a potential surrogate for DPD status in cancer patients presenting with severe toxicities during fluoropyrimidine treatment

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 2020-2020 ◽  
Author(s):  
C. Mercier ◽  
C. Yang ◽  
J. Ciccolini ◽  
M. Balti ◽  
A. Evrard ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Low Cost ◽  
Fatal Outcome ◽  
Hplc Method ◽  
Severe Toxicity ◽  
Ratio Measurement ◽  
Reliable Marker ◽  
Grade 3 ◽  
A Prospective Study

2020 Background: DPD deficiency is a rare pharmacogenetic syndrome leading to overexposure to fluoropyrimidine drugs, with subsequent exacerbation of toxicity and, possibly, fatal outcome in the most severe cases. Methods: We developed a simple and rapid surrogate method for evaluating the DPD status of cancer patients. This method was retrospectively validated by following 860 patients treated with fluoropyrimidines over a 3-year period at our institute. We applied the Uracil to UH2 ratio measurement as an indirect insight into DPD functionality in a subset of 120 patients (14%), who had presented with severe toxicity (grade 3–5, WHO) after fluoropyrimidine administration. We also searched for the canonical IVS14+1G>A single nucelotide permutation (SNP), which is associated with severe DPD deficiency. Results: More than 70% of the patients with severe toxicity and 80% of those with fatal outcome displayed U/UH2 ratios out of the range previously defined with a separate reference, non-toxic population thus strongly suggesting a correlation. In contrast, IVS14+1G>A SNP was not found to be a reliable marker for predicting toxicities. Conclusions: Taken together, our data indicate U/UH2 ratio appears to be frequently implicated in the occurrence of iatrogenic events with fluoropyrimidine therapy. In addition, our simple and rapid HPLC method may meet the requirements of routine screening, allowing identification of patients who might be at risk of severe toxicity during fluoropyrimidine administration, at relatively low cost. The predictive value of our test is being investigated in a prospective study with pharmacokinetic support. No significant financial relationships to disclose.

Prognosis of early breast cancer patients treated with sentinel node biopsy: A prospective study from the Japanese society for sentinel node navigation surgery.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 1106-1106
Author(s):  
Shigeru Imoto ◽  
Takashi Aikou ◽  
Hiroyuki Takei ◽  
Noriaki Wada ◽  
Tomohiko Aihara ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Prospective Study ◽  
Sentinel Node ◽  
Cancer Patients ◽  
Lymphovascular Invasion ◽  
Breast Cancer Patients ◽  
Isolated Tumor Cells ◽  
Node Biopsy ◽  
Grade 3 ◽  
A Prospective Study

1106 Background: Sentinel node biopsy (SNB) is a new standard of care for clinically node-negative breast cancer patients. Our society conducted a prospective study on SNB for early breast cancer patients from Jul 2004 to Oct 2005 (UMIN000006126). A preliminary result regarding with success rates of multiple mapping methods and the adverse events was presented at the 2007 ASCO. We observed patient’s outcome for 5 years. Methods: Of the 1,411 cases registered, the objects were 1,107 cases excluding cases with bilateral breast cancer, non-invasive breast cancer, past history of other malignancy or failure of SNB and cases treated with primary chemotherapy or endocrine therapy. Adjuvant therapy and breast irradiation were decided by physician’s discretion and patient’s preference. To evaluate the risk of isolated tumor cells or micrometastases in sentinel lymph nodes (SLN), clinicopathological factors were analyzed using the Cox regression model. Results: After a median follow-up of 62 months, there were 85 recurrences and 14 deaths. 5-year Kaplan-Meire estimates for disease-free survival and overall survival (OS) were 92.6% and 97.5% in 848 cases with pN0(sn), 96.2% and 100% in 26 with pN0(i+)(sn), 89.3% and 95.3% in 68 with pN1mi(sn) and 82.8% and 92.0% in 165 with pN1(sn) or greater nodal metastases. No axillary lymph node dissection (ALND) was performed in 809 cases (95.4%), 18 (69.2%), 38 (55.9%), and 24 (14.5%), respectively. Regional node recurrence was found in 8 cases (0.9%), 0 (0%), 2 (2.9%) and 2 (1.2%), respectively. Univariate analysis showed that pN1(sn) or greater nodal metastases, pT2-4, nuclear grade 3, lymphovascular invasion, negative hormone receptor status, SNB followed by ALND, chemotherapy therapy were significant risk factors for OS. However, from multivariate analysis, nuclear grade 3, lymphovascular invasion and SNB followed by ALND were independent unfavorable prognostic factors (hazard ratio: 3.21, 2.61 and 3.93). Conclusions: Although a non-randomized prospective study, isolated tumor cells and micrometastases in SLN did not affect patient’s survival. ALND should be omitted for early breast patients with those metastases.

scholarly journals Risk of Atrial Fibrillation with Ibrutinib in Patients with B-Cell Malignancies: An Updated Meta-Analysis of Phase III Randomized Controlled Trials

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 1869-1869
Author(s):  
Somedeb Ball ◽  
Wasawat Vutthikraivit ◽  
Avash Das ◽  
Peggy J Edwards ◽  
Lukman Tijani ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
B Cell ◽  
Meta Analysis ◽  
Final Analysis ◽  
Phase Iii ◽  
Controlled Trials ◽  
High Grade ◽  
B Cell Malignancies ◽  
Randomized Controlled ◽  
Grade 3

Abstract Introduction: Ibrutinib is an irreversible inhibitor of Bruton's tyrosine kinase which has become an important part of the therapeutic armamentarium for B-cell malignancies. Ibrutinib has been associated with an increased incidence of atrial and ventricular arrhythmias in studies. We conducted an updated systematic review and meta-analysis of all phase III randomized controlled trials (RCT) to determine the relative risk of atrial fibrillation (AF) associated with ibrutinib use, relative risk of high grade AF (grade 3-5), and to evaluate if the estimation of risk has changed with emergence of new data since prior reports on this adverse event. Methods: We performed a systematic search of PubMed, Embase, Web of Science, Scopus, Clinical Trials.gov, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews with appropriate keywords through 07/10/18, to find all RCTs comparing ibrutinib with other agents or placebo in patients with B-cell malignancies and also reporting AF as a treatment-emergent adverse event. The search strategy, study selection, data extraction, and analysis were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta Analyses (PRISMA) guidelines. We pooled the point estimates using random effects model of the generic inverse-variance method described by Der Simonian and Laird. Statistical analyses were performed using the Stata/SE 15.1 (StataCorp LP, College Station, TX, USA). Results: A total of 6 phase III RCTs randomizing 1811 patients (pt; 935 on ibrutinib arms and 876 in the control arms) were included in the final analysis. Four trials were conducted in pts with CLL, one in pts with Waldenstrom macroglobulinemia and the other one in pts with mantle cell lymphoma. Characteristics of these trials are shown in Table 1. In 4 RCTs ibrutinib was compared with an active agent (i.e., ofatumumab, chlorambucil, temsirolimus, and rituximab) and in the other two trials, it was compared with placebo. Ibrutinib was administered as a 1st-line therapy in the RESONATE-2 trial and both as 1st line and in refractory cases in the iNNOVATE trial. The median duration of treatment across studies with ibrutinib was 17.7 months (range 9.4-38.7 months). The pooled risk ratio (RR) for all grade atrial fibrillation was 4.27 [95% confidence interval (CI): 2.26-8.06, p<0.001, I2=0.0%, figure 1A] in patients on ibrutinib across all B-cell malignancies, as compared to patients in the control arms. The overall incidence of high-grade (grade 3-5) AF was also significantly increased in the ibrutinib arms, as compared to control [pooled RR 4.85, 95% CI: 2.02-11.63, p<0.001, I2=0.0%, figure 1B]. In subgroup analysis of trials (n=4) in pts with CLL only, ibrutinib was again associated with a statistically significant increase in risk of all grade and high-grade AF [pooled RR 4.03, 95% CI: 1.99-8.15, p<0.001, I2=0.0%, figure 2A, and pooled RR 3.83, 95% CI: 1.29-11.42, p=0.016, I2=0.0%, figure 2B, respectively]. No publication bias was observed across all the studies included in final analysis. Conclusion: In agreement with prior reports, this updated meta-analysis confirmed that ibrutinib was associated with a significantly increased risk of all grade AF in pts with B-cell malignancies (RR 4.27). Our analysis shows that the risk of high grade AF (grade3-5) is also significantly increased with ibrutinib (RR 4.85). These pts need to be closely monitored for development of AF to help improve morbidity and mortality. Disclosures Short: Takeda Oncology: Consultancy. Maiti:Celgene Corporation: Other: Research funding to the institution.

Toxicity, Efficacy, and Pharmacology of Suramin in Adults With Recurrent High-Grade Gliomas

2001 ◽  
Vol 19 (13) ◽  
pp. 3260-3266 ◽  
Author(s):  
Stuart A. Grossman ◽  
Surasak Phuphanich ◽  
Glenn Lesser ◽  
Jack Rozental ◽  
Louise B. Grochow ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Primary Outcome ◽  
High Grade ◽  
Newly Diagnosed ◽  
Time To Progression ◽  
Disease Stabilization ◽  
Newly Diagnosed Glioblastoma ◽  
High Grade Gliomas ◽  
Grade 3 ◽  
To Receive

PURPOSE: To determine the toxicity, efficacy, and pharmacology of suramin in patients with recurrent or progressive recurrent high-grade gliomas. PATIENTS AND METHODS: Fifty adults were to receive suramin. However, if no responses were seen in the first ten patients, the study was to be terminated. A total of 12 patients were enrolled onto this trial. Ten patients had glioblastoma multiforme, and 11 had received prior nitrosoureas. RESULTS: Drug-related toxicities were modest and reversible. Three patients developed grade 3 to 4 neutropenia, constipation, diarrhea, or nausea. No CNS bleeding was observed. Median time to progression was 55 days (range, 17 to 242 days) and median survival was 191 days (range, 42 to 811 days). No partial or complete responses were seen at 12 weeks. However, the clinical outcome of three patients suggests that evidence of suramin activity may be delayed. One patient who “progressed” after 12 weeks of suramin had a subsequent marked reduction in tumor size and has maintained an excellent partial response for over 2 years without other therapy. Two others had disease stabilization and lived for 16 and 27 months. Pharmacokinetics from 11 patients revealed that all reached target suramin concentrations. CONCLUSION: This study demonstrates that suramin is well tolerated by patients with recurrent high-grade gliomas and may have efficacy in this disease. Its pharmacology seems unaffected by anticonvulsants. As a result of this data, suramin and radiation are now being administered concurrently to patients with newly diagnosed glioblastoma multiforme, with survival as the primary outcome.

scholarly journals Incidence and Risk of Hypertension in Cancer Patients Treated With Atezolizumab and Bevacizumab: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 11 ◽  
Author(s):  
Linhan Jiang ◽  
Xiaoxia Tan ◽  
Jun Li ◽  
Yaling Li
Keyword(s):  
Cancer Patients ◽  
Fixed Effects ◽  
Meta Analysis ◽  
Cardiovascular Complications ◽  
High Grade ◽  
Fixed Effects Model ◽  
Total Risk ◽  
Increased Risk ◽  
Significant Difference ◽  
Grade 3

PurposeThis study aims to inform previous clinical assessments to better understand the total risk of hypertension with atezolizumab and bevacizumab (hereafter referred to as “A-B”) in cancer patients, and reduce future incidence of hypertension-related cardiovascular complications.MethodsDatabases, including PubMed, Embase, Cochrane, and Web of Science were searched to identify relevant studies, which were retrieved from inception to March 6, 2021. Studies focused on cancer patients treated with A-B that provided data on hypertension were included. Statistical analyses were conducted to calculate hypertension incidence and relative risk (RR) with a random-effects or fixed-effects model, hinging on heterogeneity status.ResultsTen studies including 2106 patients with renal cell carcinoma (RCC), hepatocellular carcinoma (HCC), ovarian cancer, anal cancer, neuroendocrine tumors (NETs), and cervical cancer were selected for this meta-analysis. For patients treated with A-B, the all-grade and high-grade (grade 3) hypertension incidence were 31.1% (95% CI: 25.5-37.3) and 14.1% (95% CI: 10.9-18.1), respectively. No significant difference was observed in all-grade hypertension incidence between RCC and a non-RCC patients (32.9% [95% CI: 25.3-42.6] v.s. 29.2% [95% CI: 19.7-39.6)]). However, the number of high-grade hypertension incidence in RCC patients (9.4% [95% CI: 4.1-21.3]) was lower than that of non-RCC patients (15.6% [95% CI: 12.8-19.1]). RCC or HCC patients who received the A-B treatment were associated with significantly increased risk of all-grade hypertension with a RR of 7.22 (95% CI: 3.3-15.7; p = 0.6) compared with patients treated with atezolizumab.ConclusionsCancer Patients treated with atezolizumab and bevacizumab have a significantly increased risk of hypertension. Sufficient monitoring is highly recommended to prevent the consequences of treatment-induced hypertension and other cardiovascular complications.

Risk of hypocalcemia in cancer patients treated with cabozantinib: A meta-analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17067-e17067
Author(s):  
Adam Khorasanchi ◽  
Shenhong Wu
Keyword(s):  
Cancer Patients ◽  
Fixed Effects ◽  
Calcium Metabolism ◽  
Kinase Inhibitor ◽  
Meta Analysis ◽  
High Grade ◽  
Fixed Effects Model ◽  
Increased Risk ◽  
Grade 3 ◽  
Tumor Types

e17067 Background: Cabozantinib as a multiple tyrosine kinase inhibitor has been used extensively in cancer treatment and clinical trials, and is associated with the development of hypocalcemia. Its impact on calcium metabolism is not clear. We have performed a meta-analysis to determine the overall risk of hypocalcemia with cabozantinib in cancer patients. Methods: Databases including PubMed and Google Scholar until January 2020 were used to identify relevant studies. Studies of patients assigned to cabozantinib with available data on hypocalcemia were included. Incidence and relative risk (RR) of hypocalcemia were calculated using a random-effects or fixed effects model, depending on the heterogeneity of the included studies. Results: 88 articles were screened with a total of eight studies including 1,460 cancer patients were selected for analysis. For patients receiving cabozantinib, the overall incidences of all-grade and high-grade (grade 3 or 4) hypocalcemia were 15.5% (95% CI: 12.1-42.5%) and 3.5% (95% CI: 1.1-6.8%), respectively. The incidences of all-grade and high-grade hypocalcemia varied significantly with tumor types and cabozantinib dose. Cabozantinib was associated with a significantly increased risk of all-grade and high-grade hypocalcemia with RR of 6.2 (95% CI: 2.6-14.5, p < 0.001) and 10.7 (95% CI: 2.0-56.2, p = 0.005) in comparison with controls including placebo or sunitinib. Conclusions: Cabozantinib was associated with a significantly increased risk of developing all-grade and high-grade hypocalcemia in cancer patients. Further studies are needed to understand the effect of cabozantinib on calcium metabolism and patient outcome.

scholarly journals Impact of Maternal Lateral Tilt On Cardiac Output During Caesarean Section Under Spinal Anaesthesia: A Prospective Observational Study

2022 ◽  
Author(s):  
Chiara Sonnino ◽  
Luciano Frassanito ◽  
Alessandra Piersanti ◽  
Pietro Paolo Giuri ◽  
Bruno Antonio Zanfini ◽  
...  
Keyword(s):  
Cardiac Output ◽  
Stroke Volume ◽  
Prospective Observational Study ◽  
Primary Outcome ◽  
Final Analysis ◽  
Arterial Elastance ◽  
Lateral Tilt ◽  
Non Invasive ◽  
Hemodynamic Variables ◽  
Continuous Hemodynamic Monitoring

Abstract Background: Left uterine displacement (LUD) has been questioned as an effective strategy to prevent aortocaval compression after spinal anesthesia (SA) for cesarean delivery (CD). We tested if LUD has a significant impact on cardiac output (CO) in patients undergoing CD under SA during continuous non-invasive hemodynamic monitoring.Methods: Forty-six patients were included in the final analysis. We considered 4 timepoints of 5 minutes each: T1=baseline with LUD; T2=baseline without LUD; T3=after SA with LUD; T4=after SA without LUD. LUD was then repositioned for CD. Primary outcome was to test if CO decreased from T3 to T4. We also compared CO between T1 and T2 and other hemodynamic variables: mean, systolic and diastolic blood pressure (respectively MAP, SAP and DAP), heart rate (HR), stroke volume (SV), stroke volume variation (SVV), pulse pressure variation (PPV), contractility (dP/dt), dynamic arterial elastance (Eadyn) at the different timepoints. Data on fetal Apgar scores and umbilical arterial and venous pH were collected.Results: CO did not vary from T3 to T4 [CO mean difference -0.02 L/min [95% CI -0.88 to 0.82; p=1]. No significant variation was registered for any variable at any timepoint. Conclusions: LUD did not show a significant impact on CO during continuous hemodynamic monitoring after SA for CD.Trial registration: (retrospectively registered on 03/12/2021) NCT05143684.

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