BACKGROUND: Adjuvant chemotherapy after curative resection for rectal cancer is the standard of care in several American and European guidelines. OBJECTIVE: The aim of this study was to examine the differences in health-related quality of life over time between patients with rectal cancer who were treated with adjuvant chemotherapy or observation. DESIGN: This is a randomized controlled phase III trial. SETTINGS: Health-related quality-of-life assessments were conducted in Dutch patients from 43 institutes. PATIENTS: Patients with stage II or III rectal cancer who underwent preoperative (chemo)radiotherapy followed by curative surgery (the SCRIPT trial) were included. INTERVENTIONS: Patients were randomly assigned to adjuvant capecitabine monotherapy for 8 cycles or observation. Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer C30 and CR38 questionnaires at 1 month after surgery (before the start of chemotherapy), and 3, 6, and 12 months after surgery. MAIN OUTCOME MEASURES: The primary outcome measure was the difference in quality of life at 6 months after surgery, just after completion of adjuvant chemotherapy for patients in the treatment group. Second, the difference in health-related quality of life at 12 months after surgery was examined. A statistically significant difference of 5 points was considered clinically relevant. RESULTS: Health-related quality-of-life results of 226 of 233 patients were available. At T3, overall quality of life (C30 summary score) was worse for patients treated with chemotherapy compared with observation (mean 82.3 versus 86.9, p = 0.006), but the difference was not clinically relevant. Patients treated with adjuvant chemotherapy reported clinically relevant worse physical functioning (mean 78.3 versus 87.0, p < 0.001) and more reports of fatigue and dyspnea (35.7 versus 21.0 and 17.1 versus 6.7, p < 0.001). All differences were resolved at 12 months postsurgery. LIMITATIONS: A selection of relatively fit patients willing to be randomly assigned may limit the generalizability of the results. CONCLUSIONS: Although inferior health-related quality of life was reported just after completion of adjuvant chemotherapy, no persistent deterioration in quality of life was detected. See Video Abstract at http://links.lww.com/DCR/A907.@en

The reliability of self-reported treatment data is unclear. Therefore 350 (58% response) breast cancer patients completed a questionnaire to compare self-reported data with data from medical records. Agreement was good for type of surgery, receiving chemotherapy, endocrine and radiation therapy. Only moderate agreement was seen for sentinel node biopsy, pathological results an axillary lymph node dissection. Objectives: Medical records are considered the gold standard for accurate treatment information. However, treatment data are increasingly obtained from questionnaires. It can be questioned whether self-reported treatment data are reliable, particularly because patients have to process a lot of information during their diagnosis and treatment process. The present study assesses the reliability of self-reported treatment data compared with medical records. Methods: All patients with stage I, II, and III breast cancer (n = 606) in 5 hospitals in the west of the Netherlands were invited to complete a questionnaire 9 to 18 months after surgery. We calculated kappa statistics, proportion correct, sensitivity, specificity, and positive and negative predictive values to assess agreement. Results: Three hundred fifty patients completed the questionnaire (58%). Agreement was good for type of surgery and receiving chemotherapy, endocrine therapy, and radiation therapy, with sensitivity and specificity of 95% or higher and kappa above 0.90. However, only moderate agreement was seen for sentinel node biopsy, including the pathologic results and axillary lymph node dissection (kappa between 0.60 and 0.80). Lack of agreement was more often found for patients who had received endocrine therapy (odds ratio, 1.85; 95% confidence interval, 1.11-3.10) but not influenced by age (odds ratio, 1.00; 95% confidence interval, 0.98-1.02). Conclusion: Accuracy of self-reported data is high for type of surgery, chemotherapy, endocrine therapy, and radiation therapy, but much lower for sentinel node biopsy including the pathologic results and axillary lymph node dissection. This is relevant for clinicians given the time spent explaining these procedures, and for researchers to help decide what information to obtain from patients or medical records.@en

Introduction: Given increasing numbers of breast cancer survivors, there is an increased focus on quality of life and quality of care. This study aims to investigate whether clinical or patient reported outcomes are most important for perceived quality of care by breast cancer patients. Methods: Overall, 606 patients aged 18 years or older, who underwent breast cancer surgery 9-18 months ago in five hospitals in the Netherlands, were invited to complete an internet-based questionnaire. Patients were asked to judge a random selection of 24 patient profiles and choose which of 2 presented patients had received the best quality of care, using conjoint analysis. The individual relative importance (RI) for each outcome was estimated using Hierarchical Bayes Estimation, and averaged over all patients to assess which outcomes were most important. Results: Complete data were available for 350 patients (58%). Avoiding severe breast symptoms was most important for good quality of care according to patients (RI 23.22 [95% Confidence Interval (95% CI) 22.32-24.12]), followed by a 2 year longer disease free survival (18.30 [17.38-19.22]). However, the importance differed by age: younger patients (<50 years) assigned higher importance to longer disease free survival (21.99 [19.52-24.46]) than older patients (65 + years) (15.03 [13.88-16.18]). Conclusion: Avoiding severe breast symptoms rather than 2 year longer disease free survival is considered most important in our population of breast cancer patients for evaluation of quality of care. These data should thus be included in both information provision prior to treatment choices and post treatment quality of care evaluation.@en

Objectives: The standard treatment for hormone-receptor positive, postmenopausal early breast cancer patients is 5 years of adjuvant endocrine therapy. Previous studies demonstrate that prolonging adjuvant endocrine therapy may improve disease-free survival. However, endocrine therapy is known for its adverse events, which may negatively affect Quality of Life (QoL). The aim of this study is to assess the impact of extended adjuvant endocrine therapy on long-term QoL outcomes. Methods: 471 patients selected from the IDEAL trial were invited to complete a questionnaire 1-1.5 years after starting with extended therapy. The questionnaire consisted of the EORTC QLQ-C30 and QLQ-BR23 questionnaires. Mean QoL outcomes were compared with EORTC reference values for stage I and II breast cancer patients and the general population. Furthermore, QoL outcomes were compared between different treatment regimens. A difference of eight points was considered clinically relevant. Results: IDEAL patients receiving extended adjuvant endocrine therapy have significantly and clinically relevant better global QoL compared with reference values for stage I and II breast cancer patients (79.6 versus 64.6; p<0.01) and the general population (79.6 versus 71.2; p<0.01). Similar results were found for emotional function, pain, appetite loss, diarrhea and financial problems. Between treatment regimens prior to extended adjuvant endocrine therapy, differences were only found on specific QoL domains (e.g.arm symptoms). Conclusion: Breast cancer patients on extended adjuvant endocrine therapy have significantly and clinically relevant better global QoL compared with other stage I-II breast cancer patients and the general population, 6-8.5 years after diagnosis.@en

Context: High-quality cancer care should be accessible for patients and healthcare professionals. Involvement of patients as partners in guideline formation and consensus processes is still rarely found. EURECCA, short for European Registration of Cancer Care, is the platform to improve outcomes of cancer care by reducing variation in the diagnostic and treatment process. EURECCA acknowledges the important role of patients in implementation of consensus information in clinical practice. Objective: The aim of this article is to describe the process of involving patients in the consensus process and in developing the patient summary of the consensus for colon and rectal cancer care. Methods: The Delphi method for achieving consensus was used. Three online voting rounds and one tele-voting round were offered to an expert panel of oncology professionals and patient representatives. At four different stages, patients and/or patient representatives were involved in the process: (1) during the consensus process, (2) lecturing about the role of the patient, (3) development of the patient summary, and (4) testing the patient summary. Results: Representatives were invited to the voting and commenting rounds of this process and given an equal vote. Although patients were not consulted during the planning stages of this process, patient involvement increased following the panel's discussion of the implementation of the consensus among the patient population. After the consensus meeting, the patient summary was written by patient representatives, oncologists and nurses. A selection of proactive patients reviewed the draft patient summary; responses were positive and several patient-reported outcomes were added. Questionnaires to evaluate the use and implementation of the patient summary in daily practice are currently being developed and tested. Patient consultation will be needed in future planning for selection of topics. Discussion: The present study may function as a model for future consensus processes to involve patients at different stages and to implement both patient and healthcare professional versions in daily practice.@en

Objective: To determine if composite measures based on process indicators are consistent with short-term outcome indicators in surgical colorectal cancer care. Design: Longitudinal analysis of consistency between composite measures based on process indicators and outcome indicators for 85 Dutch hospitals. Setting: The Dutch Surgical Colorectal Audit database, the Netherlands. Participants: 4732 elective patients with colon carcinoma and 2239 with rectum carcinoma treated in 85 hospitals were included in the analyses. Main outcome measures: All available process indicators were aggregated into five different composite measures. The association of the different composite measures with risk-adjusted postoperative mortality and morbidity was analysed at the patient and hospital level. Results: At the patient level, only one of the composite measures was negatively associated with morbidity for rectum carcinoma. At the hospital level, a strong negative association was found between composite measures and hospital mortality and morbidity rates for rectum carcinoma (p<0.05), and hospital morbidity rates for colon carcinoma. Conclusions: For individual patients, a high score on the composite measures based on process indicators is not associated with better short-term outcome. However, at the hospital level, a good score on the composite measures based on process indicators was consistent with more favourable risk-adjusted short-term outcome rates.

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Background: Carcinoembryonic antigen (CEA) as a marker in the follow-up after curative resection of colorectal carcinoma (CRC) is often omitted from follow-up despite guideline recommendations. One reason is the assumption that when a normal CEA value exists before curative resection of CRC, it will neither rise during follow-up. This study investigates this relationship. Method: Data were derived from a study initiated to evaluate treatment regimes for rectal carcinoma (Dutch TME trial, n = 1861) from which 954 were eligible for analysis. Recurrent disease occurred in 272 of these patients (29.5%). The pre-operative CEA value was compared to CEA values during follow-up, using threshold values of 2.5 and 5.0 ng/ml. Results: Normal pre-operative CEA values were present in 63% (CEA < 5.0) and 39% (CEA < 2.5) of patients with recurrent disease. Patients with a normal pre-operative CEA and recurrent disease had elevated CEA values during follow-up in 41% (CEA < 5.0), 50% (CEA < 2.5) and in 60% with both threshold values when the last measurement was done within 3 months before recurrent disease was diagnosed. Conclusion: A normal pre-operative CEA is common in patients with rectal carcinoma. CEA does rise due to recurrent disease in at least 50% of patients with normal pre-operative values. Serial post-operative CEA testing cannot be discarded based on a normal pre-operative serum CEA.

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Objective: Follow-up after curative resection of colorectal carcinoma (CRC) has been subjected to debate concerning its effectiveness to reduce cancer mortality. Current national and international guidelines advise CEA measurements every 3 months during 3 years after surgery. The common clinical practice and opinion about follow-up for colorectal carcinoma, was evaluated by means of a survey among Dutch general surgeons. Method: A web-based survey of follow-up after treatment of CRC was sent to all registered Dutch general surgeons. A reply from 246 surgeons treating patients for colorectal carcinoma in 105 out of 118 hospitals was received (response rate 91%). Questions related to actual follow-up protocol, opinion about serum CEA monitoring, liver and/or lung metastasectomy, and motivation to participate in a new trial concerning follow-up. Results: For the majority of surgeons the length of follow-up was influenced by age of the patient (62%) and physical condition (76%) prohibiting hepatic metastasectomy. The generally accepted follow-up protocol consisted of CEA measurements every 3 months in the first year and six-monthly thereafter, and ultrasound examination of the liver every 6 months. Nearly all surgeons (92%) were willing to participate in a new study of follow-up protocol. Conclusion: The adherence to national guidelines for the follow-up of colorectal carcinoma is low. The indistinctness about follow-up after curative treatment of colorectal carcinoma also affects clinical practice. Recent advancements in imaging techniques, liver and lung surgery have changed circumstances, which are not yet anticipated upon in current guidelines. Renewal of follow-up based upon scientific evidence is required.@en