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result(s) for
"Metastasectomy"
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Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet study): study protocol for a randomized controlled trial
by
Fagerland, Morten Wang
,
Andersen, Marit Helen
,
Kristiansen, Ronny
in
Abdomen
,
Abdominal surgery
,
Ablation (Surgery)
2015
Background
Laparoscopic liver resection is used in specialized centers all over the world. However, laparoscopic liver resection has never been compared with open liver resection in a prospective, randomized trial.
Methods/Design
The Oslo-CoMet Study is a randomized trial into laparoscopic versus open liver resection for the surgical management of hepatic colorectal metastases. The primary outcome is 30-day perioperative morbidity. Secondary outcomes include 5-year survival (overall, disease-free and recurrence-free), resection margins, recurrence pattern, postoperative pain, health-related quality of life, and evaluation of the inflammatory response. A cost-utility analysis of replacing open surgery with laparoscopic surgery will also be performed. The study includes all resections for colorectal liver metastases, except formal hemihepatectomies, resections where reconstruction of vessels/bile ducts is necessary and resections that need to be combined with ablation. All patients will participate in an enhanced recovery after surgery program. A biobank of liver and tumor tissue will be established and molecular analysis will be performed.
Discussion
After 35 months of recruitment, 200 patients have been included in the trial. Molecular and immunology data are being analyzed. Results for primary and secondary outcome measures will be presented following the conclusion of the study (late 2015). The Oslo-CoMet Study will provide the first level 1 evidence on the benefits of laparoscopic liver resection for colorectal liver metastases.
Trial registration
The trial was registered in ClinicalTrals.gov (
NCT01516710
) on 19 January 2012.
Journal Article
Pulmonary Metastasectomy versus Continued Active Monitoring in Colorectal Cancer (PulMiCC): a multicentre randomised clinical trial
2019
Background
Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised controlled trial (RCT).
Methods
Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung metastases to a multicentre, two-arm RCT comparing active monitoring with or without metastasectomy. Other local or systemic treatments were decided by the local team. Randomisation was remote and stratified by site with minimisation for age, sex, primary cancer stage, interval since primary resection, prior liver involvement, the number of metastases, and carcinoembryonic antigen level. The central Trial Management Group were blind to patient allocation until completion of the analysis. Analysis was on intention to treat with a margin for non-inferiority of 10%.
Results
Between December 2010 and December 2016, 65 participants were randomised. Characteristics were well-matched in the two arms and similar to those in reported studies: age 35 to 86 years (interquartile range (IQR) 60 to 74); primary resection IQR 16 to 35 months previously; stage at resection T1, 2 or 3 in 3, 8 and 46; N1 or N2 in 31 and 26; unknown in 8. Lung metastases 1 to 5 (median 2); 16/65 had previous liver metastases; carcinoembryonic antigen normal in 55/65. There were no other interventions in the first 6 months, no crossovers from control to treatment, and no treatment-related deaths or major adverse events. The Hazard ratio for death within 5 years, comparing metastasectomy with control, was 0.82 (95%CI 0.43, 1.56).
Conclusions
Because of poor and worsening recruitment, the study was stopped. The small number of participants in the trial (
N
= 65) precludes a conclusive answer to the research question given the large overlap in the confidence intervals in the proportions still alive at all time points. A widely held belief is that the 5-year absolute survival benefit with metastasectomy is about 35%: 40% after metastasectomy compared to < 5% in controls. The estimated survival in this study was 38% (23–62%) for metastasectomy patients and 29% (16–52%) in the well-matched controls. That is the new and important finding of this RCT.
Trial registration
ClinicalTrials.gov, ID:
NCT01106261
. Registered on 19 April 2010
Journal Article
Pulmonary metastasectomy: outcomes and issues according to the type of surgical resection
by
Nakagiri, Tomoyuki
,
Kuno, Hidenori
,
Ishida, Daisuke
in
Cardiac Surgery
,
Cardiology
,
Cellular biology
2015
According to a recent report by the Committee for Scientific Affairs of the Japanese Association for Thoracic Surgery, pulmonary metastasectomy accounted for as many as 10.2 % of all entry cases of general thoracic surgery, and its use is increasing year by year. Accordingly, many studies have examined the surgical procedures used during pulmonary metastasectomy for metastases from primary tumors affecting various organs as well as the outcomes of and indications for such procedures, but some problems remain. In this article, the following questions related to the surgical approach and the type of resection used during pulmonary metastasectomy are reviewed: (1) Wedge resection—what is a safe margin for preventing local recurrence? (2) What is the clinical significance of node sampling/dissection during pulmonary metastasectomy? and (3) When is segmentectomy necessary? In addition, we discuss: (4) open thoracotomy vs. video-assisted thoracoscopic surgery (VATS), (5) repeated metastasectomy for pulmonary metastases, (6) the surgical approach for bilateral pulmonary metastasectomy, (7) pneumonectomy, and (8) pulmonary metastasectomy combined with resection of the neighboring organs.
Journal Article
Metastasectomy for Distant Metastatic Melanoma: Analysis of Data from the First Multicenter Selective Lymphadenectomy Trial (MSLT-I)
by
Howard, J. Harrison
,
Thompson, John F.
,
Elashoff, Robert
in
Female
,
Follow-Up Studies
,
Humans
2012
Background
For stage IV melanoma, systemic medical therapy (SMT) is used most frequently; surgery is considered an adjunct in selected patients. We retrospectively compared survival after surgery with or without SMT versus SMT alone for melanoma patients developing distant metastases while enrolled in the first Multicenter Selective Lymphadenectomy Trial.
Methods
Patients were randomized to wide excision and sentinel node biopsy, or wide excision and nodal observation. We evaluated recurrence site, therapy (selected by treating clinician), and survival after stage IV diagnosis.
Results
Of 291 patients with complete data for stage IV recurrence, 161 (55 %) underwent surgery with or without SMT. Median survival was 15.8 versus 6.9 months, and 4-year survival was 20.8 versus 7.0 % for patients receiving surgery with or without SMT versus SMT alone (
p
< 0.0001; hazard ratio 0.406). Surgery with or without SMT conferred a survival advantage for patients with M1a (median > 60 months vs. 12.4 months; 4-year survival 69.3 % vs. 0;
p
= 0.0106), M1b (median 17.9 vs. 9.1 months; 4-year survival 24.1 vs. 14.3 %;
p
= 0.1143), and M1c (median 15.0 vs. 6.3 months; 4-year survival 10.5 vs. 4.6 %;
p
= 0.0001) disease. Patients with multiple metastases treated surgically had a survival advantage, and number of operations did not reduce survival in the 67 patients (42 %) who had multiple surgeries for distant melanoma.
Conclusions
Our findings suggest that over half of stage IV patients are candidates for resection and exhibit improved survival over patients receiving SMT alone, regardless of site and number of metastases. We have begun a multicenter randomized phase III trial comparing surgery versus SMT as initial treatment for resectable distant melanoma.
Journal Article
Is survival really better after repeated lung metastasectomy?
2021
Several groups have observed that average survival time after a second lung metastasectomy is longer than after a first metastasectomy. The randomised controlled trial Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) found no survival benefit from lung metastasectomy. In fact, median survival was longer, and four-year overall survival was higher, in the control group than in those randomly assigned to metastasectomy, although not significantly so. The illusion of benefit is because survival without metastasectomy has been assumed to be near zero, as stated in Society of Thoracic Surgeons’ Expert Consensus Document on Pulmonary Metastasectomy 2019. It has been repeatedly found that survival is influenced by the selection of patients who have characteristics associated with better prognosis. The passage of time while monitoring and assessing patients, and observing their rate of progression, provides for immortal time bias. Reselection of the most favourable patients for repeated metastasectomy is the likely reason for any differences in survival between first and repeated metastasectomy operations.
Journal Article
Role of metastasectomy for liver metastasis in stage IV anal cancer
by
Betances, Avril
,
Goldner, Matthew
,
Spitz, Francis R.
in
Adenocarcinoma
,
Anal cancer
,
Anal cancer liver metastases
2021
There is a paucity of data on the role of metastasectomy for metastatic anal cancer on survival outcomes. We aim to define the role of metastasectomy in stage IV anal cancer.
National Cancer Database (NCDB) from 2004 to 2014 was accessed to include patients with metastatic anal cancer, excluding adenocarcinoma, neuroendocrine, and ‘other’ histologies. We compared patients undergoing metastasectomy (n = 165) to those who did not have metastasectomy (n = 2093) by age, sex, cancer grade, and site of metastasis, including metastasis to bone, liver, and lung, using chi-square analysis. The primary outcome was overall survival.
Patients had equal distribution of metastatic sites between those who underwent metastasectomy versus no metastasectomy: bone (7.64% vs 4.85%, p = 0.22), brain (0.24% vs 0%, p = 1.0), liver (23.22% vs 29.70%, p = 0.07), and lung (11.85% vs 9.09%, p = 0.38). Survival following metastasectomy was increased at one year (71% vs. 61%, p = 0.016), two years (50% vs. 38%, p = 0.014), and five years (30% vs. 19%, p = 0.025). Median overall survival was increased (23 months vs. 16 months; p = 0.015) for patients with metastasectomy. Survival increases were demonstrated only in the group with liver metastasis undergoing metastasectomy. When stratifying for liver metastases only, median overall survival time was further increased (34 months vs. 16 months; p < 0.0001) following metastasectomy.
These results demonstrate a survival benefit for hepatic metastasectomy in stage IV anal cancer. Our findings demonstrate a potential survival benefit in highly select patients with metastatic anal cancer to the liver. These findings support further investigation in a randomized clinical trial to delineate these findings.
•Metastasectomy for anal cancer liver metastases improved overall survival compared to non-metastasectomy.•No difference in survival was seen for metastases involving bone or lung.•Consideration for surgical intervention in stage IV anal cancer may provide survival benefit for select patients.
Journal Article
Surgery for Oligometastatic Pancreatic Cancer: Defining Biologic Resectability
2024
Pancreatic ductal adenocarcinoma (PDAC) is most often metastatic at diagnosis. As systemic therapy continues to improve alongside advanced surgical techniques, the focus has shifted toward defining biologic, rather than technical, resectability. Several centers have reported metastasectomy for oligometastatic PDAC, yet the indications and potential benefits remain unclear. In this review, we attempt to define oligometastatic disease in PDAC and to explore the rationale for metastasectomy. We evaluate the existing evidence for metastasectomy in liver, peritoneum, and lung individually, assessing the safety and oncologic outcomes for each. Furthermore, we explore contemporary biomarkers of biological resectability in oligometastatic PDAC, including radiographic findings, biochemical markers (such as CA 19-9 and CEA), inflammatory markers (including neutrophil-to-lymphocyte ratio, C-reactive protein, and scoring indices), and liquid biopsy techniques. With careful consideration of existing data, we explore the concept of biologic resectability in guiding patient selection for metastasectomy in PDAC.
Journal Article
Survival outcomes and surgical morbidity based on surgical approach to pulmonary metastasectomy in pediatric, adolescent and young adult patients with osteosarcoma
2023
Background Thoracotomy is considered the standard surgical approach for the management of pulmonary metastases in osteosarcoma (OST). Several studies have identified the advantages of a thoracoscopic approach, however, the clinical significance of thoracotomy compared to thoracoscopy is yet to be evaluated in a randomized trial. Aims The primary aim was to determine the survival outcomes in OST patients based on surgical approach for pulmonary metastasectomy (PM) and secondary aim was to assess the post‐operative morbidities of OST PM through various surgical approaches. Materials and Methods We conducted a single institution retrospective study to compare survival outcomes and surgical morbidity according to the surgical approach of the management of pulmonary metastases in patients with OST. Results Sixty‐one patients with OST underwent PM. Twenty‐one patients were metastatic at diagnosis and underwent PM during primary treatment; nine had thoracotomy, six thoracoscopy, and six combined thoracoscopy with thoracotomy (CTT). Forty‐three patients with first pulmonary relapse or progression underwent PM; 18 had thoracotomy, 16 thoracoscopy and nine CTT. There was no difference in survival between surgical approaches. There were significantly more postoperative morbidities associated with thoracotomy for initial PM (pain and postoperative chest tube placement), and for PM at first relapse (pneumothoraces, pain, Foley catheter use and prolonged hospitalizations). Conclusion Our study demonstrates that patients with OST pulmonary metastases have comparable poor outcomes despite varying surgical approaches for PM. There were significantly more postoperative morbidities associated with thoracotomy for PM. Surgical bias and other competing risks could not be assessed given the limitations of a retrospective study and may be addressed in a prospective trial evaluating surgical approach for PM in OST.
Journal Article
Pulmonary metastasectomy in colorectal cancer: the PulMiCC trial
by
Fallowfield, Lesley
,
Treasure, Tom
,
Lees, Belinda
in
Biological and medical sciences
,
Cancer therapies
,
Cardiology. Vascular system
2012
PulMiCC (Pulmonary Metastasectomy in Colorectal Cancer) is a randomised controlled trial funded by Cancer Research UK. Patients with a history of resected colorectal cancer who are found to have pulmonary metastases are first registered for evaluation and, if subsequently eligible for the trial, they are invited to be randomly allocated to ‘active monitoring’ or ‘active monitoring with pulmonary metastasectomy’. The clinical outcomes are overall survival, relapse-free survival, lung function and patient-reported quality of life.
Journal Article