Dataset Information

Pulmonary metastasectomy in colorectal cancer: a prospective study of demography and clinical characteristics of 543 patients in the Spanish colorectal metastasectomy registry (GECMP-CCR).

ABSTRACT:

Objectives

To capture an accurate contemporary description of the practice of pulmonary metastasectomy for colorectal carcinoma in one national healthcare system.

Design

A national registry set up in Spain by Grupo Español de Cirugía Metástasis Pulmonares de Carcinoma Colo-Rectal (GECMP-CCR).

Setting

32 Spanish thoracic units.

Participants

All patients with one or more histologically proven lung metastasis removed by surgery between March 2008 and February 2010.

Interventions

Pulmonary metastasectomy for one or more pulmonary nodules proven to be metastatic colorectal carcinoma.

Primary and secondary outcome measures

The age and sex of the patients having this surgery were recorded with the number of metastases removed, the interval between the primary colorectal cancer operation and the pulmonary metastasectomy, and the carcinoembryonic antigen level. Also recorded were the practices with respect to mediastinal lymphadenopathy and coexisting liver metastases.

Results

Data were available on 543 patients from 32 units (6-43/unit). They were aged 32-88 (mean 65) years, and 65% were men. In 55% of patients, there was a solitary metastasis. The median interval between the primary cancer resection and metastasectomy was 28 months and the serum carcinoembryonic antigen was low/normal in the majority. Liver metastatic disease was present in 29% of patients at some point prior to pulmonary metastasectomy. Mediastinal lymphadenectomy varied from 9% to 100% of patients.

Conclusions

The data represent a prospective comprehensive national data collection on pulmonary metastasectomy. The practice is more conservative than the impression gained when members of the European Society of Thoracic Surgeons were surveyed in 2006/2007 but is more inclusive than would be recommended on the basis of recent outcome analyses. Further analyses on the morbidity associated with this surgery and the correlation between imaging studies and pathological findings are being published separately by GECMP-CCR.

SUBMITTER: Embun R

PROVIDER: S-EPMC3664355 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pulmonary metastasectomy in colorectal cancer: a prospective study of demography and clinical characteristics of 543 patients in the Spanish colorectal metastasectomy registry (GECMP-CCR).

Embún R R Fiorentino F F Treasure T T Rivas J J JJ Molins L L

BMJ open 20130528 5

<h4>Objectives</h4>To capture an accurate contemporary description of the practice of pulmonary metastasectomy for colorectal carcinoma in one national healthcare system.<h4>Design</h4>A national registry set up in Spain by Grupo Español de Cirugía Metástasis Pulmonares de Carcinoma Colo-Rectal (GECMP-CCR).<h4>Setting</h4>32 Spanish thoracic units.<h4>Participants</h4>All patients with one or more histologically proven lung metastasis removed by surgery between March 2008 and February 2010.<h4>I ...[more]

PMID: 23793698

Similar Datasets

Project description:BackgroundColorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients.MethodsDesigna prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention.Statistical analysisIn relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models.DiscussionThe identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions.Trial registrationClinicalTrials.gov Identifier: NCT02488161 . Registration date: June 16, 2015.

Project description: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.

Project description:Objective: The surgical resection of pulmonary metastases is associated with a survival benefit in selected patients. The use of laser devices for pulmonary metastasectomy (PM) is believed to facilitate the complete resection of metastases while preserving a maximum of healthy parenchyma. This is a prospective study to evaluate surgical outcome including the changes of lung function after laser-assisted surgery (LAS). Methods: A total of 77 operations in 61 patients in which PM was carried out in a curative intent were analyzed. A 1.320 nm diode-pumped Nd: YAG-Laser was used for resection of the metastases. Surgical and clinical data were collected using a standardized form and postoperative lung function changes 3 and 6 months after surgery were assessed using whole body plethysmography and diffusion capacity for carbon monoxide (DLCO). Size and distance of metastases to the pleural surface were measured radiologically. Results: A median of two metastases were resected per operation (range 1-13). The median duration of postoperative air leak was 1 day (range 0-11). LAS associated postoperative minor and major complications were observed in 4 (5%) cases and 1 (1%) case, respectively; there were no mortalities. The analysis of perioperative lung function showed that mean VC 3 months after surgery was reduced by 11 %, FEV1 by 11% and median DLCO by 11% (all p < 0.0001). There was almost no recovery of lung function between 3 and 6 months in the whole cohort. Patients with two or less metastases showed a recovery of lung function after 3 months regarding DLCO (p = 0.003). Decline of DLCO in the whole cohort correlated with the number of resected metastases at 3 months (r = 0.45, p = 0.006) and at 6 months (r = 0.42, p = 0.02) as well as depth of metastases in the parenchyma at 6 months (r = 0.48, p = 0.001). Conclusions: LAS is a safe and effective method for PM even for higher numbers of metastases, with short duration of postoperative air leak and little morbidity. Number and depth, but not size of metastases affect lung function changes after resection.

Dataset Information

Pulmonary metastasectomy in colorectal cancer: a prospective study of demography and clinical characteristics of 543 patients in the Spanish colorectal metastasectomy registry (GECMP-CCR).

Objectives

Design

Setting

Participants

Interventions

Primary and secondary outcome measures

Results

Conclusions

Publications

Pulmonary metastasectomy in colorectal cancer: a prospective study of demography and clinical characteristics of 543 patients in the Spanish colorectal metastasectomy registry (GECMP-CCR).

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure