Dataset Information

Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

ABSTRACT:

Purpose

Whether patients with smoldering multiple myeloma (SMM) needed to receive early interventional treatment remains controversial. Herein, we conducted a meta-analysis comparing the efficacy and safety of early treatment over deferred treatment for patients with SMM.

Methods

MEDLINE and Cochrane Library were searched to May 2014 for randomized controlled trials (RCTs) that assessed the effect of early treatment over deferred treatment. Primary outcome measure was mortality, and secondary outcome measures were progression, response rate, and adverse events.

Results

Overall, 5 trials including 449 patients were identified. There was a markedly reduced risk of disease progression with early treatment (Odds Ratio [OR]?=?0.13, 95% confidence interval [CI]?=?0.07 to 0.24). There were no significant differences in mortality and response rate (OR?=?0.85, 95% CI?=?0.45 to 1.60, and OR?=?0.63, 95% CI?=?0.32 to 1.23, respectively). More patients in the early treatment arm experienced gastrointestinal toxicities (OR?=?10.02, 95%CI?=?4.32 to 23.23), constipation (OR?=?8.58, 95%CI?=?3.20 to 23.00) and fatigue or asthenia (OR?=?2.72, 95%CI?=?1.30 to 5.67). No significant differences were seen with the development of acute leukemia (OR?=?2.80, 95%CI?=?0.42 to 18.81), hematologic cancer (OR?=?2.07, 95%CI?=?0.43 to 10.01), second primary tumors (OR?=?3.45, 95%CI?=?0.81 to 14.68), nor vertebral compression (OR?=?0.18, 95%CI?=?0.02 to 1.59).

Conclusions

Early treatment delayed disease progression but increased the risk of gastrointestinal toxicities, constipation and fatigue or asthenia. The differences on vertebral compression, acute leukemia, hematological cancer and second primary tumors were not statistically significant. Based on the current evidence, early treatment didn't significantly affect mortality and response rate. However, further much larger trials were needed to provide more evidence.

SUBMITTER: Gao M

PROVIDER: S-EPMC4184905 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

Gao Minjie M Yang Guang G Tompkins Van S VS Gao Lu L Wu Xiaosong X Tao Yi Y Hu Xiaojing X Hou Jun J Han Ying Y Xu Hongwei H Zhan Fenghuang F Shi Jumei J

PloS one 20141003 10

<h4>Purpose</h4>Whether patients with smoldering multiple myeloma (SMM) needed to receive early interventional treatment remains controversial. Herein, we conducted a meta-analysis comparing the efficacy and safety of early treatment over deferred treatment for patients with SMM.<h4>Methods</h4>MEDLINE and Cochrane Library were searched to May 2014 for randomized controlled trials (RCTs) that assessed the effect of early treatment over deferred treatment. Primary outcome measure was mortality, a ...[more]

PMID: 25279718

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Project description:PurposeSmoldering multiple myeloma (SMM) is a rare asymptomatic plasma cell disorder. Even with emerging therapeutic approaches and risk stratification, the optimal time to treat SMM remains controversial. This meta-analysis aimed to compare early treatment with deferred treatment of SMM, especially high-risk SMM.MethodsEarly treatment was defined as treatment immediately after diagnosis. Deferred treatment was initiated after progression. The primary outcome was progression. Secondary outcomes were mortality, response, and safety. PubMed, EMBASE, Medline, Cochrane, and ClinicalTrials.gov databases were searched from January 1990 to March 2019. Randomized controlled trials (RCTs) comparing early treatment with deferred treatment in SMM patients were eligible. Risk ratios (RRs) with 95% confidence interval (CI) were pooled.ResultsEight RCTs covering 885 SMM patients were included. Considering all the different treatment approaches, early treatment significantly decreased progression of SMM (RR=0.53, 95% CI 0.33-0.87, P=0.01). In subgroup analysis, melphalan plus prednisone (RR=0.22, 95% CI 0.08-0.64, P=0.005) and immuno-modulatory drugs (RR=0.43, 95% CI 0.31-0.59, P<0.00001) significantly reduced progression. However, neither mortality nor response rate was significantly affected by early treatment. In terms of high-risk SMM patients, early treatment significantly decreased both progression (RR=0.51, 95% CI 0.37-0.70, P=0.0001) and mortality (RR=0.53, 95% CI 0.29-0.96, P=0.04). Frequently seen adverse events were infection, constipation, asthenia, and second primary malignancy. A remarkably elevated risk of constipation was associated with early treatment using immuno-modulatory agents (RR=4.43, 95% CI 2.14-9.12, P<0.0001). Second primary malignancy was significantly increased with early treatment (RR=4.13, 95% CI 1.07-15.97, P=0.04). No significant difference was identified in infection or asthenia.ConclusionThese findings suggest that early treatment could decrease progression and mortality of high-risk SMM patients with a tolerable safety profile.

Project description:Inconsistent results exist regarding the treatment effectiveness of immediate versus deferred percutaneous coronary intervention (PCI) in patients with acute coronary syndrome (ACS). This meta-analysis aimed to evaluate the efficacy and safety of immediate versus deferred PCI in ACS patients. PubMed, EMBASE, and Cochrane Library electronic databases were systematically searched from their inception up to August 2019. Random-effects models were employed to calculate pooled relative risks (RRs) and weight mean differences (WMDs) with 95% confidence intervals (CIs). A total of 10 randomized controlled trials (RCTs) that recruited 3350 patients were selected for inclusion in the final meta-analysis. Four trials included patients with non-ST elevation ACS (NSTEACS), whereas the remaining six trials included patients with ST elevation myocardial infarction (STEMI). There were no significant differences between immediate versus deferred PCI for the risk of major adverse cardiovascular events (NSTEACS patients: RR, 0.76, 95%CI, 0.33-1.75, P = 0.513; STEMI patients: RR, 1.24, 95%CI, 0.80-1.92, P = 0.335), myocardial infarction (NSTEACS patients: RR, 0.88, 95%CI, 0.27-2.81, P = 0.826; STEMI patients: RR, 0.86, 95%CI, 0.43-1.74, P = 0.678), all-cause mortality (NSTEACS patients: RR, 0.85, 95%CI, 0.38-1.88, P = 0.686; STEMI patients: RR, 1.16, 95%CI, 0.82-1.66, P = 0.407), target vessel revascularisation (NSTEACS patients: RR, 1.26, 95%CI, 0.29-5.43, P = 0.756; STEMI patients: RR, 1.01, 95%CI, 0.51-1.97, P = 0.988), or major bleeding (NSTEACS patients: RR, 0.99, 95%CI, 0.64-1.54, P = 0.972; STEMI patients: RR, 0.90, 95%CI, 0.45-1.77, P = 0.753). Although patients who underwent immediate PCI may experience increased incidences of cardiac death (RR, 1.19, 95%CI, 0.69-2.07, P = 0.525) and no or slow reflow (RR, 1.60, 95%CI, 0.91-2.84, P = 0.105), these increases were not statistically significant. We noted that immediate versus deferred PCI was associated with a reduced incidence of myocardial brush grade 3 (RR, 0.70, 95%CI, 0.56-0.88, P = 0.002); however, no significant differences were observed between immediate and deferred PCI for TIMI III flow (RR, 0.98, 95%CI, 0.93-1.03, P = 0.453), complete ST-segment resolution (RR, 0.93, 95%CI, 0.75-1.17, P = 0.548), and ejection fraction (WMD, -1.05, 95%CI, -2.58 to 0.49, P = 0.182). The findings of this study suggested that deferred PCI did not yield significant benefits for clinical endpoints. Further large-scale RCTs should be conducted to verify the findings of this study.

Project description:BACKGROUND:Carpal tunnel syndrome is a common compressive neuropathy of the median nerve. The efficacy and safety of endoscopic versus open carpal tunnel release remain controversial. QUESTIONS/PURPOSES:The purpose of this study was to determine whether endoscopic compared with open carpal tunnel release provides better symptom relief, validated outcome scores, short- and long-term strength, and/or digital sensibility; entails a differential risk of complications such as nerve injury, scar tenderness, pillar pain, and reoperation; allows an earlier return to work; and takes less operative time. METHODS:The English-language literature was searched using MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Central Register of Controlled Trials. Randomized controlled trials that compared endoscopic and open carpal tunnel release were included in the meta-analysis. Methodologic quality was assessed with the Consolidated Standards Of Reporting Trials (CONSORT) checklist, and a sensitivity analysis was performed. Symptom relief, Boston Carpal Tunnel Questionnaire (BCTQ) scores, strength, digital sensibility, complications, reoperation, interval to return to work, and operative time were analyzed. Twenty-one randomized controlled trials containing 1859 hands were included. RESULTS:Endoscopically treated patients showed similar symptom relief and BCTQ scores; better early recovery of grip strength (mean difference [MD], 3.03 kg [0.08-5.98]; p = 0.04) and pinch strength (MD, 0.77 kg [0.33-1.22]; p < 0.001) but no advantage after 6 months; lower risk of scar tenderness (risk ratio [RR], 0.53 [0.35-0.82]; p = 0.005); higher risk of nerve injury (RR, 2.84 [1.08-7.46]; p = 0.03), most of which were transient neurapraxias. Similar risk of pillar pain and reoperation; an earlier return to work (MD, -8.73 days [-12.82 to -4.65]; p < 0.001); and reduced operative time (MD, -4.81 minutes [-9.23 to -0.39]; p = 0.03). CONCLUSIONS:High-level evidence from randomized controlled trials indicates that endoscopic release allows earlier return to work and improved strength during the early postoperative period. Results at 6 months or later are similar according to current data except that patients undergoing endoscopic release are at greater risk of nerve injury and lower risk of scar tenderness compared with open release. While endoscopic release may appeal to patients who require an early return to work and activities, surgeons should be cognizant of its elevated incidence of transient nerve injury amid its similar overall efficacy to open carpal tunnel release. Additional research is required to define the learning curve of endoscopic release and clarify the influence of surgeon volume on its safety.

Dataset Information

Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

Purpose

Methods

Results

Conclusions

Publications

Early versus deferred treatment for smoldering multiple myeloma: a meta-analysis of randomized, controlled trials.

Similar Datasets

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