Summary Background Surgical resection is regarded as the only curative option for resectable oesophageal cancer, but pulmonary complications occurring in more than half of patients after open ...oesophagectomy are a great concern. We assessed whether minimally invasive oesophagectomy reduces morbidity compared with open oesophagectomy. Methods We did a multicentre, open-label, randomised controlled trial at five study centres in three countries between June 1, 2009, and March 31, 2011. Patients aged 18–75 years with resectable cancer of the oesophagus or gastro-oesophageal junction were randomly assigned via a computer-generated randomisation sequence to receive either open transthoracic or minimally invasive transthoracic oesophagectomy. Randomisation was stratified by centre. Patients, and investigators undertaking interventions, assessing outcomes, and analysing data, were not masked to group assignment. The primary outcome was pulmonary infection within the first 2 weeks after surgery and during the whole stay in hospital. Analysis was by intention to treat. This trial is registered with the Netherlands Trial Register, NTR TC 2452. Findings We randomly assigned 56 patients to the open oesophagectomy group and 59 to the minimally invasive oesophagectomy group. 16 (29%) patients in the open oesophagectomy group had pulmonary infection in the first 2 weeks compared with five (9%) in the minimally invasive group (relative risk RR 0·30, 95% CI 0·12–0·76; p=0·005). 19 (34%) patients in the open oesophagectomy group had pulmonary infection in-hospital compared with seven (12%) in the minimally invasive group (0·35, 0·16–0·78; p=0·005). For in-hospital mortality, one patient in the open oesophagectomy group died from anastomotic leakage and two in the minimally invasive group from aspiration and mediastinitis after anastomotic leakage. Interpretation These findings provide evidence for the short-term benefits of minimally invasive oesophagectomy for patients with resectable oesophageal cancer. Funding Digestive Surgery Foundation of the Unit of Digestive Surgery of the VU University Medical Centre.
Background
The randomized EORTC 10981-22023 AMAROS trial investigates whether breast cancer patients with a tumor-positive sentinel node biopsy (SNB) are best treated with an axillary lymph node ...dissection (ALND) or axillary radiotherapy (ART). The aim of the current substudy was to evaluate the identification rate and the nodal involvement.
Methods
The first 2,000 patients participating in the AMAROS trial were evaluated. Associations between the identification rate and technical, patient-, and tumor-related factors were evaluated. The outcome of the SNB procedure and potential further nodal involvement was assessed.
Results
In 65 patients, the sentinel node could not be identified. As a result, the sentinel node identification rate was 97% (1,888 of 1,953). Variables affecting the success rate were age, pathological tumor size, histology, year of accrual, and method of detection. The SNB results of 65% of the patients (
n
= 1,220) were negative and the patients underwent no further axillary treatment. The SNB results were positive in 34% of the patients (
n
= 647), including macrometastases (
n
= 409, 63%), micrometastases (
n
= 161, 25%), and isolated tumor cells (
n
= 77, 12%). Further nodal involvement in patients with macrometastases, micrometastases, and isolated tumor cells undergoing an ALND was 41, 18, and 18%, respectively.
Conclusions
With a 97% detection rate in this prospective international multicenter study, the SNB procedure is highly effective, especially when the combined method is used. Further nodal involvement in patients with micrometastases and isolated tumor cells in the sentinel node was similar—both were 18%.
The European Organisation for Research and Treatment of Cancer 10981-22023 AMAROS trial evaluated axillary lymph node dissection (ALND) versus axillary radiotherapy (ART) in patients with cT1-2, ...node-negative breast cancer and a positive sentinel node (SN) biopsy. At 5 years, both modalities showed excellent and comparable axillary control, with significantly less morbidity after ART. We now report the preplanned 10-year analysis of the axillary recurrence rate (ARR), overall survival (OS), and disease-free survival (DFS), and an updated 5-year analysis of morbidity and quality of life.
In this open-label multicenter phase III noninferiority trial, 4,806 patients underwent SN biopsy; 1,425 were node-positive and randomly assigned to either ALND (n = 744) or ART (n = 681).
Per intention-to-treat analysis, 10-year ARR cumulative incidence was 0.93% (95% CI, 0.18 to 1.68; seven events) after ALND and 1.82% (95% CI, 0.74 to 2.94; 11 events) after ART (hazard ratio HR, 1.71; 95% CI, 0.67 to 4.39). There were no differences in OS (HR, 1.17; 95% CI, 0.89 to 1.52) or DFS (HR, 1.19; 95% CI, 0.97 to 1.46). ALND was associated with a higher lymphedema rate in updated 5-year analyses (24.5%
11.9%;
< .001). Quality-of-life scales did not differ by treatment through 5 years. Exploratory analysis showed a 10-year cumulative incidence of second primary cancers of 12.1% (95% CI, 9.6 to 14.9) after ART and 8.3% (95% CI, 6.3 to 10.7) after ALND.
This 10-year analysis confirms a low ARR after both ART and ALND with no difference in OS, DFS, and locoregional control. Considering less arm morbidity, ART is preferred over ALND for patients with SN-positive cT1-2 breast cancer.
Background
Multidisciplinary cancer team meetings are intended to optimize the diagnosis of a patient with a malignancy. The aim of this study was to assess the number of correct diagnoses formulated ...by the multidisciplinary team (MDT) and whether MDT decisions were implemented.
Methods
In a prospective study, data of consecutive patients discussed at gastrointestinal oncology MDT meetings were studied, and MDT diagnoses were validated with pathology or follow-up. Factors of influence on the correct diagnosis were identified by use of a Poisson regression model. Electronic patient records were used to assess whether MDT decisions were implemented, and reasons to deviate from these decisions were hand-searched within these records.
Results
In 74 MDT meetings, 551 patients were discussed a total of 691 times. The MDTs formulated a correct diagnosis for 515/551 patients (93.4 %), and for 120/551 (21.8 %) patients the MDT changed the referral diagnosis. Of the MDT diagnoses, 451/515 (87.6 %) were validated with pathology. Patients presented to the MDT by their treating physician were 20 % more likely to receive a correct diagnosis relative risk (RR) 1.2, 95 % confidence interval (CI) 1.1–1.5, while the number of patients discussed or the duration of the meeting had no influence on this (RR 1.0, 95 % CI 0.99–1.0; RR 1.0, 95 % CI 0.9–1.1; resp.). MDT decisions were implemented in 94.4 % of cases. Deviations of MDT decisions occurred when a patient’s wishes or physical condition were not taken into account.
Conclusions
MDTs rectify 20 % of the referral diagnoses. The presence of the treating physician is the most important factor to ensure a correct diagnosis and adherence to the treatment plan.
Vacuum-assisted closure therapy is a relatively new concept described in the literature that increases wound-healing capacity. The authors aimed to investigate the effect of vacuum-assisted closure ...therapy on wound healing, granulation tissue formation, bacterial clearance, pain, time involvement of the staff, and total costs in all types of wounds in comparison with modern wound dressings.
Sixty-five patients with a chronic or acute wound were randomized to initial treatment with vacuum-assisted closure or modern dressings. The authors' primary endpoint was a granulated wound or a wound ready for skin grafting or healing by secondary intention.
The time to the primary endpoint with vacuum-assisted closure therapy was not significantly shorter, except for patients with cardiovascular disease and/or diabetics. Vacuum-assisted closure therapy did not result in significantly faster granulation or wound surface reduction or better bacterial clearance, but patient comfort was an important advantage. Time involvement and costs of nursing staff were significantly lower for the vacuum-assisted closure therapy, but overall costs were similar for both groups.
With vacuum-assisted closure therapy, wound healing is at least as fast as with modern wound dressings. Especially cardiovascular and diabetic patients benefit from this therapy. The total costs of vacuum-assisted closure are comparable to those of modern wound dressings, but the advantage is its comfort for patients and nursing staff.
Improvement of functional status with physiotherapy is an important goal for patients with postoperative complications and an increased length of hospital stay (LoS) after esophagectomy. Supervised ...physiotherapy with telerehabilitation instead of conventional face-to-face care could be an alternative to treat these patients in their home environment after hospital discharge (T0), but its feasibility has not yet been investigated in detail.
The aim of this study was to investigate the feasibility of a 12-week supervised postoperative physiotherapy intervention with telerehabilitation for patients with esophageal cancer who underwent esophagectomy and had postoperative complications or who had an increased LoS. The secondary objective was to investigate the preliminary effectiveness of telerehabilitation on functional recovery compared with usual care.
A prospective feasibility study with a matched historical comparison group was performed. Feasibility outcomes included willingness and adherence to participate, refusal rate, treatment duration, occurrence of adverse events, and patient satisfaction. Secondary outcome measures were measurements of musculoskeletal and cardiovascular functions and activities according to the domains of the International Classification of Functioning, Disability and Health.
A total of 22 patients with esophageal cancer who underwent esophagectomy and had postoperative complications or an increased LoS were included. The mean age at surgery was 64.55 (SD 6.72) years, and 77% (17/22) of patients were male. Moreover, 15 patients completed the intervention. Patient adherence was 99.8% in the first 6 weeks and dropped to 75.6% in the following 6 weeks, with a mean difference of -24.3% (95% CI 1.3 to 47.2; P=.04). At 3 months post operation, no differences in functional status were found between the intervention group and the matched historical comparison group.
This study showed that a postoperative physiotherapeutic intervention with telerehabilitation is feasible for patients with postoperative complications or an increased LoS after esophageal cancer surgery up to 6 weeks after T0.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, UILJ, UKNU, UL, UM, UPUK
Background
Cancer survivors’ perspectives on a successful return to work (RTW) may not be captured in the common measure of RTW, namely time until RTW.
Objective
The purpose of this study was ...therefore to develop an RTW outcome measure that reflects employed cancer survivors’ perspectives, with items that could be influenced by an employer, i.e. the Successful Return-To-Work questionnaire for Cancer Survivors (I-RTW_CS), and to assess its construct validity and reproducibility.
Methods
First, three focus groups with cancer survivors (
n
= 14) were organized to generate issues that may constitute successful RTW. Second, a two-round Delphi study among 108 cancer survivors was conducted to select the most important issues. Construct validity of the I-RTW_CS was assessed using correlations with a single-item measure of successful RTW and the Quality of Working Life Questionnaire for Cancer Survivors (QWLQ-CS;
n
= 57). Reproducibility (test–retest reliability) was assessed using the intraclass correlation coefficient (ICC;
n
= 50).
Results
Forty-eight issues were generated, of which seven were included: ‘enjoyment in work’; ‘work without affecting health’; ‘confidence of employer without assumptions about work ability’; ‘open communication with employer’; ‘feeling welcome at work’; ‘good work–life balance’; and ‘joint satisfaction with the situation (employer and cancer survivor)’. Correlations with single-item successful RTW and QWLQ-CS were 0.58 and 0.85, respectively. The reproducibility showed an ICC of 0.72.
Conclusions
The I-RTW_CS provides an RTW outcome measure that includes cancer survivors’ perspectives and weights its items on an individual basis, allowing a more meaningful evaluation of cancer survivors’ RTW. This study provides preliminary evidence for its construct validity and reproducibility.
Background
Numerous patients will develop recurrent disease after esophagectomy for esophageal carcinoma (EC). In literature, survival after recurrent EC is poor with 6–8 months. In these studies, ...diagnostic imaging during follow-up (FU) is routinely performed. In the Netherlands, routine imaging is not part of FU and only performed on indication. The aim of this study was to determine survival after diagnosis of recurrent disease in patients after esophagectomy without routine imaging during FU.
Methods
All EC patients who underwent esophagectomy between 1993 and 2010 were included and followed for clinical evidence of recurrent EC. Location, symptoms, diagnosis, and treatment of recurrent disease were registered. Pattern of recurrence was compared between patients who underwent neoadjuvant therapy and patients who underwent surgery alone. Survival after detection of recurrence was determined in all patients and related to the year of surgery.
Results
A total of 493 of 1,088 patients (45 %) who underwent esophagectomy between 1993 and 2010 developed recurrent disease. Median interval between esophagectomy and recurrence was 10.5 months. Within the first 2 years after surgery, 33 % of patients developed recurrent EC. The majority of patients (51 %) were diagnosed with distant metastases. Locoregional recurrence occurred significantly less often among patients who underwent neoadjuvant therapy (6 vs 16 %,
p
= .017). Median survival after diagnosis of recurrent disease was 3 months. No relation was observed between the year of surgery and survival after recurrent disease (
p
= .931).
Conclusions
Survival after recurrent EC in patients who undergo FU without routine imaging after esophagectomy is approximately 3 months and has not improved over the past 18 years.
Gastrointestinal (GI) cancer is frequently diagnosed in people of working age, and many GI cancer patients experience work-related problems. Although these patients often experience difficulties ...returning to work, supportive work-related interventions are lacking. We have therefore developed a tailored work-related support intervention for GI cancer patients, and we aim to evaluate its cost-effectiveness compared with the usual care provided. If this intervention proves effective, it can be implemented in practice to support GI cancer patients after diagnosis and to help them return to work.
We designed a multicentre randomized controlled trial with a follow-up of twelve months. The study population (N = 310) will include individuals aged 18-63 years diagnosed with a primary GI cancer and employed at the time of diagnosis. The participants will be randomized to the intervention or to usual care. 'Usual care' is defined as psychosocial care in which work-related issues are not discussed. The intervention group will receive tailored work-related support consisting of three face-to-face meetings of approximately 30 min each. Based on the severity of their work-related problems, the intervention group will be divided into groups receiving three types of support (A, B or C). A different supportive healthcare professional will be available for each group: an oncological nurse (A), an oncological occupational physician (B) and a multidisciplinary team (C) that includes an oncological nurse, oncological occupational physician and treating oncologist/physician. The primary outcome measure is return to work (RTW), defined as the time to a partial or full RTW. The secondary outcomes are work ability, work limitations, quality of life, and direct and indirect costs.
The hypothesis is that tailored work-related support for GI cancer patients is more effective than usual care in terms of the RTW. The intervention is innovative in that it combines oncological and occupational care in a clinical setting, early in the cancer treatment process.
METC protocol number NL51444.018.14/Netherlands Trial Register number NTR5022 . Registered 6 March 2015.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Purpose
To perform a process evaluation of a tailored work-related support intervention for patients diagnosed with gastrointestinal cancer.
Methods
The intervention comprised three tailored ...psychosocial work-related support meetings. To outline the process evaluation of this intervention, we used six key components: recruitment, context, reach, dose delivered, dose received and fidelity. Data were collected using questionnaires, checklists and research logbooks and were analysed both quantitatively and qualitatively.
Results
In total, 16 hospitals, 33 nurses and 7 oncological occupational physicians (OOPs) participated. Analysis of the six key components revealed that the inclusion rate of eligible patients was 47%. Thirty-eight intervention patients were included: 35 actually had a first meeting, 32 had a second and 17 had a third. For 31 patients (89%), the first meeting was face to face, as per protocol. However, in only 32% of the cases referred to support type A (oncological nurse) and 13% of the cases referred to support type B (OOP), the first meeting was before the start of the treatment, as per protocol. The average duration of the support type A meetings was around the pre-established 30 min; for the OOPs, the average was 50 min. Protocol was easy to follow according to the healthcare professionals. Overall, the patients considered the intervention useful.
Conclusions
This study has shown that the strategy of tailored work-related support is appreciated by both patients and healthcare professionals and applicable in clinical practice.
Implications for Cancer survivors
The intervention was appreciated by patients; however, whether the timing of the work-related support was adequate (i.e. before treatment was started) requires further research.
Trial registration
NTR5022.
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