Systematic review and individual patient data based meta-analysis of palonosetron trials for chemotherapy induced nausea and vomiting.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e21688-e21688
Author(s):  
Yuki Okada ◽  
Koji Oba ◽  
Naoto Furukawa ◽  
Yoshito Komatsu ◽  
Yoshimasa Kosaka ◽  
...  
Keyword(s):  
Systematic Review ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Characteristics ◽  
Complete Response ◽  
Fixed Effect Model ◽  
Significant Loss ◽  
Patient Data ◽  
Nausea And Vomiting ◽  
Complete Control

e21688 Background: Several clinical trials have evaluated the need for corticosteroid-containing antiemetic regimens on the days after the first 24 hours to control delayed chemotherapy-induced nausea and vomiting (CINV) during moderate emetogenic chemotherapy (MEC) or anthracycline and/or cyclophosphamide (AC)-containing chemotherapy. Methods:We conducted systematic review using research databases and trial registries for any randomized controlled trials reporting CINV outcomes for a single 1-day-dexamethasone (D1 group) containing antiemetic regimen in chemotherapy-naive adult patients scheduled to receive a MEC or AC-containing chemotherapy, compared with additional dexamethasone on days 2 and 3 (D3 group). We also gathered the individual patient data (IPD) from each study investigator. The primary endpoint was complete response (CR: no vomiting and no rescue antiemetics) in the 5-day study period. Secondary efficacy end points were CR rates in 0–24 h and CR rates in 24–120 h; complete control in the overall, acute, delayed periods. An IPD meta-analysis was conducted to quantify the pooled risk differences between D1 group and D3 group and its interaction with patient characteristics using a fixed effect model. Results: Of 887 articles screened, 5 eligible studies were identified comprising 1194 patients, all enrolled in the meta-analysis. Overall, D1 group was not significantly inferior to D3 group in CR rate as well as CC rate [pooled risk difference in CR rate -1.5%, 95% confidence interval (CI) -7.1–4.0%; in delayed CR rate -2.4%, 95% CI -7.7–2.9%]. There was no significant interaction between dexamethasone regimen and patient characteristics (sex, age category ( < 60 or 60 years), and alcohol consumption). Conclusions: These results strongly suggest that the dexamethasone-sparing regimen is not associated with a significant loss in overall antiemetic control in an adult patient undergoing MEC or AC-containing chemotherapy, irrespective of patient baseline characteristics. These data contribute to simplify antiemetic regimens and spare many patients from the potential side-effects of multiple-day corticosteroids.

Determining the preferred dose of the serotonin antagonist (5-HT3) palonosetron: Results of an individual patient data meta-analysis (MA) of 1,947 patients in all randomized double blinded (RDB) trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20512-e20512
Author(s):  
M. Lesser ◽  
R. Gralla ◽  
B. Napolitano ◽  
H. Raftopoulos ◽  
M. Kline ◽  
...  
Keyword(s):  
Individual Patient Data ◽  
Meta Analysis ◽  
Single Agent ◽  
Complete Response ◽  
Similar Efficacy ◽  
Patient Data ◽  
Significant Heterogeneity ◽  
Complete Control ◽  
Acute Emesis ◽  
Double Blinded

e20512 Background: Progress in antiemetic therapy has had a major impact on the administration of cancer chemotherapy (chemo). 5-HT3 agents are among the most used drugs in oncology and are considered the primary agents in guideline-recommended combination antiemetic regimens. Randomized trials have demonstrated advantages for palonosetron (palo) when compared with other 5-HT3 drugs in single agent trials (Ann Oncol 2003, Ann Oncol 2004) and recently in a combination trial with dexamethasone (Yoshizawa, ESMO 2008). With different doses of palo in use, we undertook this MA to determine if efficacy differs for palo doses of 0.75 mg or 0.25 mg. This has an impact on clinical dosing and on guideline recommendations as to whether there should be a preferred palo dose and a preferred 5-HT3 antiemetic. Methods: After a literature search and colleague inquiry, we identified 8 RDB trials; 4 in highly emetic (HEC) and 4 in moderately emetic (MEC) chemo that included treatment arms with 0.25 mg and 0.75 mg of palo; 6 IV and 2 PO trials. Primary endpoint: Complete Response (CR - no vomiting, no rescue) over days 1–5 after chemo. Secondary endpoints: Complete Control (CC - no vomiting, days 1–5); Acute emesis (day 1); Delayed emesis (days 2 - 5); by chemo (HEC / MEC); by other prognostic factors; by side-effects. Logistic regression, stratifying for protocol and including a treatment x protocol interaction term, was first used to test for heterogeneity (Het) of odds ratios (OR). In the absence of significant Het, the protocols were “pooled” in a protocol-stratified analysis. OR>1 favors palo 0.75 mg. Results: Individual patient data were obtained for the 1947 subjects. Half were randomized to palo 0.25. No significant heterogeneity was found for CR or CC. For CR, the pooled OR = 1.00 (95% CI: 0.83–1.20); for CC, OR = 0.99 (95% CI: 0.83–1.89). Similar ORs for CR and CC were found for HEC and MEC, with no Het. Conclusions: We conclude that trials using 0.25 mg or 0.75 mg palonosetron doses yield similar efficacy for CR and CC so that reports with either dose can be used clinically or in guideline considerations. Findings are true for HEC and MEC regimens as well. [Table: see text]

Sentinel Lymph Node Procedure in Colon Cancer: A Systematic Review and Meta-Analysis of Individual Patient Data

2020 ◽  
Author(s):  
Marjolein Ankersmit ◽  
Martijn W. Heymans ◽  
Otto Hoekstra ◽  
Stijn L. Vlek ◽  
Linda J. Schoonmade ◽  
...  
Keyword(s):  
Systematic Review ◽  
Colon Cancer ◽  
Lymph Node ◽  
Sentinel Lymph Node ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data ◽  
Sentinel Lymph Node Procedure

scholarly journals Genome-wide copy number variations as molecular diagnostic tool for cutaneous intermediate melanocytic lesions: a systematic review and individual patient data meta-analysis

2021 ◽  
Author(s):  
Chiel F. Ebbelaar ◽  
Anne M. L. Jansen ◽  
Lourens T. Bloem ◽  
Willeke A. M. Blokx
Keyword(s):  
Systematic Review ◽  
Sensitivity And Specificity ◽  
Copy Number ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Copy Number Variations ◽  
Patient Data ◽  
Melanocytic Lesions ◽  
Genome Wide ◽  
Malignant Lesions

AbstractCutaneous intermediate melanocytic neoplasms with ambiguous histopathological features are diagnostically challenging. Ancillary cytogenetic techniques to detect genome-wide copy number variations (CNVs) might provide a valuable tool to allow accurate classification as benign (nevus) or malignant (melanoma). However, the CNV cut-off value to distinguish intermediate lesions from melanoma is not well defined. We performed a systematic review and individual patient data meta-analysis to evaluate the use of CNVs to classify intermediate melanocytic lesions. A total of 31 studies and 431 individual lesions were included. The CNV number in intermediate lesions (median 1, interquartile range [IQR] 0–2) was significantly higher (p<0.001) compared to that in benign lesions (median 0, IQR 0–1) and lower (p<0.001) compared to that in malignant lesions (median 6, IQR 4–11). The CNV number displayed excellent ability to differentiate between intermediate and malignant lesions (0.90, 95% CI 0.86–0.94, p<0.001). Two CNV cut-off points demonstrated a sensitivity and specificity higher than 80%. A cut-off of ≥3 CNVs corresponded to 85% sensitivity and 84% specificity, and a cut-off of ≥4 CNVs corresponded to 81% sensitivity and 91% specificity, respectively. This individual patient data meta-analysis provides a comprehensive overview of CNVs in cutaneous intermediate melanocytic lesions, based on the largest pooled cohort of ambiguous melanocytic neoplasms to date. Our meta-analysis suggests that a cut-off of ≥3 CNVs might represent the optimal trade-off between sensitivity and specificity in clinical practice to differentiate intermediate lesions from melanoma.

Comparison of surgical and endovascular treatments for fusiform intracranial aneurysms: systematic review and individual patient data meta-analysis

2020 ◽  
Author(s):  
João Paulo Mota Telles ◽  
Davi Jorge Fontoura Solla ◽  
Vitor Nagai Yamaki ◽  
Nicollas Nunes Rabelo ◽  
Saul Almeida da Silva ◽  
...  
Keyword(s):  
Systematic Review ◽  
Intracranial Aneurysms ◽  
Individual Patient Data ◽  
Meta Analysis ◽  
Patient Data
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