scholarly journals Postoperative chemotherapy with single-agent fluoropyrimidines after resection of colorectal cancer liver metastases: a meta-analysis of randomised trials

ESMO Open ◽  
2018 ◽  
Vol 3 (4) ◽  
pp. e000343 ◽  
Author(s):  
Davide Mauri ◽  
George Zarkavelis ◽  
Panagiotis Filis ◽  
Lampriani Tsali ◽  
Georgia Zafeiri ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Survival Benefit ◽  
Meta Analysis ◽  
Single Agent ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Postoperative Chemotherapy ◽  
Colorectal Cancer Liver Metastases

Surgical resection is the only option of cure for patients with metastatic colorectal cancer. Risk of recurrence after metastasectomy is around 75%. Use of adjuvant chemotherapy after metastasectomy is controversial.AimTo address whether adjuvant systemic therapy after colorectal cancer metastasectomy offers any survival benefit compared with surgery alone.MethodsSystematic review of literature and meta-analysis of all available randomised evidence. Relative hazards (RHs) were summarised across trials and heterogeneity was assessed with the Q and I2 statistics.ResultsFive trials were eligible. Three trials, all using single-agent fluoropyrimidine chemotherapy, presented data valuable for analyses. 482 patients were included in the meta-analysis: 238 randomly assigned to receive postoperative chemotherapy and 244 to metastasectomy only. We found no overall survival (OS) benefit with the use of postoperative single-agent fluoropyrimidines compared with surgery alone, even if a trend for benefit was observed (relative hazard (RH)=0.781, 95% CI 0.593 to 1.030, p=0.080). Significant disease-free survival benefit with the use of postoperative chemotherapy was observed (RH=0.645, 95% CI 0.509 to 0.818, p=0.001). No quality of life (QL) data were available. All trials showed accrual delay, two stopped and one recruiting after 10 years. Long follow-up needs were evidenced since OS curves split only after 3.5 years.ConclusionsNo OS benefit was documented from the use of postoperative monochemotherapy. Metastasectomy alone continues to be the standard of care. Combination chemotherapy regimens should be evaluated along with QL assessment in future trials appropriately designed for long-term accrual and follow-up.

New Cases of Acute Promyelocytic Leukemia Treatment by Arsenic Trioxide Alone and Their Long Term Follow up

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 506-506 ◽  
Author(s):  
Ardeshir Ghavamzadeh ◽  
Kamran Alimoghaddam ◽  
Shahrbano Rostami ◽  
Seyed Hamidolah Ghaffari ◽  
Mohamad Jahani ◽  
...  
Keyword(s):  
Complete Remission ◽  
Arsenic Trioxide ◽  
Conflicts Of Interest ◽  
Promising Result ◽  
Single Agent ◽  
Disease Free Survival ◽  
Long Term Follow Up ◽  
Wbc Count

Abstract Abstract 506 Long term follow-up of APL patients treated by ATRA and chemotherapy is available and shows promising results of DFS and OS. Although several studies show acceptable efficacy of Arsenic Trioxide in new cases of APL, its long term result needs better clarification. Materials and methods: one hundred ninety seven, new cases of APL treated by Arsenic trioxide (0.15 mg/kg daily i.v infusion till complete remission). After achieving to CR patients received 4 more courses of Arsenic trioxide as consolidation. Then patients followed by CBC and RT-PCR on peripheral blood for detection of MRD every three months or till relapse or death. Results: Morphologic complete remission rate was 85.8% and most common cause of remission failure was early death due to hemorrhage of APL differentiation syndrome.(14.7%) Most important prognostic factor for early mortality is high WBC count at presentation. Disease free survival was 90%+/−2%, 72.7%+/−3% and 66.7%+/−4% for 2, 3 and 5 years respectively. Relapse for patients who remained in CR after 5 years was very uncommon. Overall survival for patients after diagnosis by intention to treat analysis was 80.2%+/−3%, 75.9%+/−3% and 64.4%+/− 4% for 2, 3 and 5 years. Also OS and DFS were the same between patients with high and low WBC count. Conclusion: Long term follow up of newly diagnosed cases of APL, treated with single agent Arsenic Trioxide shows promising result. Arsenic trioxide potentially eliminates the adverse effect of prognostic factors of APL treatment such as high WBC count. We suggest that it is time to integrate Arsenic trioxide in treatment of new cases of APL. Disclosures: No relevant conflicts of interest to declare.

Effect of PET-CT on disease recurrence and its management in patients with potentially resectable colorectal cancer liver metastases: The long-term results of a randomized control trial.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 562-562
Author(s):  
Pablo Emilio Serrano Aybar ◽  
Chu-Shu Gu ◽  
Mohamed Husien ◽  
Diederick Jalink ◽  
Guillaume Martel ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Surgical Management ◽  
Disease Recurrence ◽  
Long Term Results ◽  
Colorectal Cancer Liver Metastases ◽  
Pet Ct ◽  
Risks Factors

562 Background: The PETCAM randomized trial evaluated the effect of preoperative PET-CT (vs. no PET-CT) on surgical management in patients with colorectal cancer liver metastases. In this study, 8% of patients had a change in surgical management, including a higher proportion of major liver resections in the PET-CT arm. The current study compares the intervention groups for 5-year disease free (DFS) and overall survival (OS), and evaluated their long-term clinical course, i.e. sites of recurrence and management of disease recurrence. Methods: Recruitment to the trial occurred between 2005-2010, with last follow-up in 2013. Data on recurrence, management of recurrence and mortality from 2013-2017 was collected from patient’s charts. Recurrences according to site and management were described. Cox proportional Hazard Models were used to calculate the risk for recurrence and death. OS was calculated with Kaplan-Meir method and compared with log-rank test. Results: At 5 years, 157 of 404 (39%) patients were still alive and 19 patients were lost to follow-up. Median follow-up is 4.2 years. There were no differences in DFS (HR: 1.12, 95%CI: 0.88-1.42) or OS (HR: 0.97, 95%CI: 0.74-1.28) between groups. The median DFS for the 372 patients who had surgery was 17 months, 95%CI: 14.7-19.4. Risks factors for recurrence were: extrahepatic disease, liver tumour size, and nodal stage. The median OS for all patients was 50 months, 95%CI: 43.5-64.3. Risks factors for death also included age and prior use of chemotherapy. During the follow-up period, 287/404, 71% patients recurred (mostly liver and lung); 137 (48%) were treated solely with chemotherapy and 35% were treated with surgery with curative intent. Of these, the majority recurred (109/116, 94%). The median OS following first recurrence was 27.5 months, 95%CI: 23-30. Conclusions: PET-CT did not improve DFS or OS. Survival following liver resection is similar to previous reports, however most patients experience disease recurrence. A substantial proportion of patients who recur undergo surgery, however it is likely that they will recur again.

Long-term supportive treatment with fermented mistletoe (viscum album L.) extract in primary nonmetastatic colorectal cancer: Best time to start with for optimal effectiveness

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15099-e15099
Author(s):  
H. Matthes ◽  
W. E. Friedel ◽  
P. R. Bock
Keyword(s):  
Colorectal Cancer ◽  
Disease Free Survival ◽  
Viscum Album ◽  
Control Group ◽  
Eligibility Criteria ◽  
Mistletoe Extract ◽  
Beneficial Effects ◽  
Anonymized Data

e15099 Background: Safety and efficacy of fermented mistletoe extract (Iscador, ISC) in supportive care of post-surgical patients with primary colorectal cancer as compared to a parallel control group without ISC. Question: Is supportive ISC most effective when started before, during, or after radio- and/or chemotherapy? Methods: In a comparative, multicenter, non-interventional cohort study with parallel groups ISC was applied additionally to conventional adjuvant chemo- and/or radiotherapy (conv-th). The control group was treated with conv-th only. Unselected, standardized, anonymized data from medical records (1993–2002) meeting the eligibility criteria were followed until last visit or death. The pre-specified endpoints were the incidence of adverse drug reactions (ADR) caused by conv-th, and disease-free survival (DFS) in relation to start of ISC therapy before, during or after conv-th. All endpoints were adjusted to confounders. Results: 804 eligible patients (429 ISC and 375 control) from 26 centers were evaluated. ISC started mostly during conv-th (72.9%), and sometimes before (9.0%) or after (18.1%) conv-th. ISC dose was escalated from 0.01mg to 20mg as s.c. injection, 2–3 times weekly. The median follow-up time was 58 (ISC) vs. 51 months and median ISC duration was 52 months. The adjusted relative ADR risk was significantly lower in the ISC groups as compared to control: odds ratio, OR (95% CI) = 0.46 (0.28–0.77), p=0.003. The best results were found in patients where ISC started in parallel to conv-th. Analysis of DFS in the ISC subgroups is presently ongoing. ISC was well tolerated in all subgroups. Conclusions: The results show reliable safety and clinically relevant beneficial effects of ISC treatment, at best if applied in parallel to conv-th. [Table: see text]

Phase II Study of Single-Agent Arsenic Trioxide for the Front-Line Therapy of Acute Promyelocytic Leukemia

2011 ◽  
Vol 29 (20) ◽  
pp. 2753-2757 ◽  
Author(s):  
Ardeshir Ghavamzadeh ◽  
Kamran Alimoghaddam ◽  
Shahrbano Rostami ◽  
Seyed Hamidolah Ghaffari ◽  
Mohamad Jahani ◽  
...  
Keyword(s):  
Arsenic Trioxide ◽  
Acute Promyelocytic Leukemia ◽  
Residual Disease ◽  
Single Agent ◽  
Disease Free Survival ◽  
Promyelocytic Leukemia ◽  
Newly Diagnosed ◽  
Long Term Follow Up

Purpose The long-term follow-up results of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid and chemotherapy show high cure rates. Several studies have shown high efficacy of single-agent arsenic trioxide in newly diagnosed APL. However, long-term follow-up results are needed. Patients and Methods One hundred ninety-seven patients with newly diagnosed APL were treated with arsenic trioxide 0.15 mg/kg daily intravenous infusion until complete remission (CR). After achieving CR, the patients received one to four more courses of therapy with arsenic trioxide as consolidation and were observed with reverse-transcriptase polymerase chain reaction studies from peripheral blood (to detect of minimal residual disease) every 3 months or until relapse or death. Results The morphologic CR rate was 85.8%. The most common cause of remission failure was early death owing to APL differentiation syndrome (13.2%). The most important prognostic factor for early mortality was a high WBC count at presentation. The 5-year disease-free survival (DFS) rate was 66.7% ± 4% (SE). Relapse after 5 years in CR was rare. The 5-year overall survival (OS) rate by intention-to-treat analysis was 64.4% ± 4%. In patients who achieved CR, OS and DFS were identical. Conclusion The long-term follow-up of newly diagnosed patients with APL treated with single-agent arsenic trioxide shows high rates of DFS and OS.

scholarly journals O20: PREOPERATIVE INTRAVENOUS IRON THERAPY AND SURVIVAL AFTER COLORECTAL CANCER SURGERY: LONG TERM RESULTS FROM THE INTRAVENOUS IRON IN COLORECTAL CANCER-ASSOCIATED ANAEMIA (IVICA) TRIAL

2021 ◽  
Vol 108 (Supplement_1) ◽  
Author(s):  
EA Dickson ◽  
BD Keeler ◽  
O Ng ◽  
A Kumar ◽  
MJ Brookes ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Disease Free Survival ◽  
Intravenous Iron ◽  
Cancer Surgery ◽  
Colorectal Cancer Surgery ◽  
Free Survival ◽  
Disease Free

Abstract Background Intravenous iron is now the standard treatment to correct preoperative anaemia. However, iron may promote tumour growth and progression which could influence cancer recurrence and survival. We explore the long term postoperative outcomes of patients receiving oral (OI) or intravenous iron (IVI) as part of a randomised controlled trial. Method The multicentre IVICA trial randomised anaemic colorectal cancer patients in a 1:1 fashion to receive either OI or IVI prior to their elective operation. Follow up analysis of all patients was performed and Kaplan-Meier survival estimates and Cox proportional hazard models were used to compare groups. A pooled analysis comparing patients who did/did not achieve preoperative resolution of anaemia was also undertaken. Result, Data were available for 106 of the 116 IVICA patients (OI n=55, IVI n=51). Median follow up was 61 months (IQR 38-68, [range 1-80]). Overall survival estimates at 3 and 5 years were 82%(95% CI 76-90) and 72%(58-83) respectively for OI and 75%(61-86) and 59%(45-72) for IVI, P=0.106. No significant difference in 5-year overall survival (HR 1.73, 95% CI 0.90-3.34 P=0.102) or disease-free survival (HR 1.50, 95% CI 0.83-2.73 P=0.182) was observed between groups. Those non-anaemic at operation demonstrated improved 5 year overall survival (HR 3.26 [1.01-10.58], P=0.05). Non-significant trends in improved disease-free survival (HR 2.29 [0.91-5.81], p=0.08) were observed for the non-anaemic group Conclusion Preoperative correction of anaemia confers a postoperative survival advantage following elective colorectal cancer surgery. Due to its superior efficacy intravenous iron is recommended as the treatment of choice for this anaemia. Take-home message Preoperative correction of anaemia, achieved most effectively with intravenous iron, may offer improved long term postoperative survival after colorectal cancer surgery.

Impact of single and dual neoadjuvant HER2-directed therapy on clinical outcomes among patients with HER2-positive breast cancer (BC).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 647-647 ◽  
Author(s):  
Kerry Lynn Reynolds ◽  
Ashmeet Bhatia ◽  
XingXing Cheng ◽  
Barbara Lynn Smith ◽  
Michelle Connolly Specht ◽  
...  
Keyword(s):  
Meta Analysis ◽  
Single Agent ◽  
Disease Free Survival ◽  
Predictive Biomarkers ◽  
Standard Of Care ◽  
Complete Response ◽  
Breast Conserving Surgery ◽  
Her2 Positive ◽  
Improve Patient Selection ◽  
The Impact

647 Background: While the addition of trastuzumab to neoadjuvant chemotherapy (CTX) is well established for HER2+ BC, the use of dual agent HER2 blockade in the preoperative setting is not considered standard of care. We conducted a comprehensive systematic review and meta-analysis to evaluate the impact of neoadjuvant dual and single agent HER2 blockade on breast conserving surgery (BCS), pathological complete response (pCR) for estrogen receptor (ER)+ and ER- tumors, and impact of pCR on disease-free survival (DFS) and overall survival (OS) for HER2+ BC. Methods: Based on QUORUM guidelines, MEDLINE and Cochrane Controlled Clinical Trials Register databases were queried to identify eligible trials. Inclusion criteria were prospective, neoadjuvant trials that had at least one arm with HER2 directed therapy, and reported pCR. Pooled relative risk ratios (RRs) and 95% confidence intervals (CIs) were estimated for endpoints using the random effects model. Results: We identified 34 trials (N = 4064). High pCR rates (> 40%) were seen with anthracycline-based CTX and trastuzumab, as well as taxane based CTX alone with dual HER2 blockade. The addition of trastuzumab to CTX did not improve BCS rate (RR 1.40, CI: 0.89-2.22, p=.15), but significantly increased rates of pCR (RR 1.91, CI: 1.38-2.64, p=.0001). Similarly, dual HER2 blockade compared to trastuzumab alone did not improve BCS rate (RR 1.03, CI: 0.77-1.38, p=.84), but significantly increased rates of pCR overall (RR 1.38, CI: 1.24-1.53, p<0.00001), in both ER+ (RR 1.72, CI: 1.14-2.61, p=.01) and ER- subsets (RR 1.91, CI: 1.38-2.64, p=.0001). Higher pCR was associated with improved DFS (RR 2.29, CI: 1.27-4.12, p=.006) and OS (RR 4.61, CI: 1.46-14.56, p=.009). Conclusions: Neither the addition of trastuzumab to CTX, nor the dual-HER2 blockade compared to trastuzumab, improves rates of BCS, but both significantly improve rates of pCR, which is associated with improved DFS and OS. A subgroup of HER2+ BC patients can achieve pCR with dual HER2 blockade without dependence on anthracycline-based therapy. Predictive biomarkers are needed to improve patient selection and personalize the optimal regimen for HER2+ BC.

Mechanical thrombectomy in pediatric stroke: systematic review, individual patient data meta-analysis, and case series

2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Neurological Outcomes

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.

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