Responsiveness of the generic EQ-5D summary measure compared to the disease-specific EORTC QLQ C-30

Introduction: We investigated whether the sensitivity of the generic health-related quality of life (HRQoL) EQ-5D summary measure (or index) to detect changes over time in a clinical setting is comparable with that of a disease-specific HRQoL questionnaire. Methods: Patients with liver metastases (n = 75) filled out the five domains of the EQ-5D self-classifier, the EQ VAS, and the EORTC QLQ C-30 (a disease-specific (cancer) HRQoL questionnaire). The HRQoL instruments were completed before intervention, and 1/2 month and 3 and 6 months after intervention. Three analyses were performed. First, the EQ-5D index (based on self-classification) was compared to the EQ VAS. Second, the EQ-5D domains were compared to corresponding EORTC QLQ C-30 scales. Third, EQ-5D index and EQ VAS were compared with the EORTC QLQ C-30 global health-status scale. Effect size was chosen as the metric of responsiveness. Results: The EQ-5D index was slightly less responsive than the EQ VAS. Overall, the responsiveness of the EQ-5D index and EQ VAS was equal to the EORTC QLQ C-30 global health-status scale. Conclusion: Despite its generic principle and the apparent crudeness of its framework, the responsiveness of the EQ-5D proved to be comparable to that of a disease-specific HRQoL questionnaire in this specific clinical setting.     

Efficacy of fluorine-18-deoxyglucose positron emission tomography in detecting tumor recurrence after local ablative therapy for liver metastases: a prospective study.

PURPOSE: The aims of this prospective study were to investigate the potential role of fluorine-18-deoxyglucose (FDG) positron emission tomography (PET) in determining the efficacy of the local tumor ablative process and to determine the added value of FDG-PET in the detection of tumor recurrence during follow-up. PATIENTS AND METHODS: Twenty-three patients with unresectable colorectal liver metastases were followed up after local ablative therapy consisting of a standard protocol including FDG-PET scanning, computed tomography (CT) scanning, and carcinoembryonic antigen measurements. The mean follow-up period was 16 months (range, 10 to 21 months). RESULTS: Ninety-six lesions was treated, 56 by local ablative treatment. Within 3 weeks after local ablative treatment, 51 lesions became photopenic on FDG-PET, while five lesions (in five patients) showed persistent activity on FDG-PET. In four of five FDG-PET-positive lesions, a local recurrence developed during follow-up; one FDG-PET-positive lesion turned out to be an abscess. None of the FDG-PET-negative lesions developed a local recurrence during a mean follow-up period of 16 months. During follow-up, 11 patients showed recurrence in the liver outside of the treated area. In all cases, previously negative FDG-PET scans became positive. Extrahepatic recurrence was encountered in nine patients during follow-up; FDG-PET showed all nine cases of tumor recurrence. There was one false-positive FDG-PET caused by an intra-abdominal abscess. In all patients, the time point of detection of recurrence by FDG-PET was considerably earlier than the detection by CT. CONCLUSION: FDG-PET seems to have a significant impact in measuring treatment efficacy directly after local ablative therapy. Furthermore, FDG-PET has an added value in patient follow-up because it reveals recurrences earlier than conventional diagnostic modalities.     

Quality of life after surgical treatment of colorectal liver metastases

BACKGROUND: The surgical approach to colorectal liver metastases is becoming increasingly aggressive. The aim of this prospective study was to evaluate the impact of surgery on health-related quality of life (HRQoL) of patients with colorectal liver metastases. METHODS: HRQoL data from 97 patients with colorectal liver metastases were analysed. Sixty patients (group 1) had surgical treatment of the liver metastases. Seventeen patients (group 2) were shown to have inoperable disease at laparotomy. Twenty outpatients with inoperable disease were included as a control group (group 3). Two validated HRQoL instruments, the European Organization for Research and Treatment of Cancer Core questionnaire (QLQ C-30) and the EuroQol-5D, were applied. RESULTS: By 2 weeks after operation patients in group 1 showed a clear overall deterioration in HRQoL, but after 3 months most HRQoL scores had returned to baseline levels. At 2 weeks after surgery there was clear deterioration in almost all HRQoL domains in group 2, and several symptoms were still being reported at 3 months. Patients in group 3 showed hardly any deterioration in HRQoL over the 3 months. CONCLUSION: The fast recovery of HRQoL, generally within 3 months, justifies an aggressive surgical approach to colorectal liver metastases. However, careful preoperative evaluation is crucial to avoid needless laparotomy, considering the ongoing deteriorated HRQoL of group 2.     

Comparison Between Local Ablative Therapy and Chemotherapy for Non-Resectable Colorectal Liver Metastases: A Prospective Study

Background There is a growing interest for the use of local ablative techniques in patients with non-resectable colorectal liver metastases. Evidence on the efficacy over systemic chemotherapy is, however, extremely weak. In this prospective study we aim to assess the additional benefits of local tumour ablation. Methods A consecutive series of 201 colorectal cancer patients, without extrahepatic disease, that underwent laparotomy for surgical treatment of liver metastases, were prospectively followed for survival and HRQoL. At laparotomy three groups were identified: patients in whom radical resection of metastases proved feasible, patients in whom resection was not feasible and received local ablative therapy, and patients in whom resection or local ablation was not feasible for technical reasons and who received systemic chemotherapy. Findings Patients in the chemotherapy and in local ablation group were comparable for all prognostic variables tested. For the local ablation group overall survival at 2 and 5 years was 56 and 27%, respectively (median 31 months, n = 45), for the chemotherapy group 51 and 15%, respectively (median 26 months, n = 39) (P = 0.252). After resection these figures were 83 and 51%, respectively (median 61 months, n = 117) (P < 0.001). The median DFS after local ablation was 9 months, HRQoL was restored within 3 months. Patients after local ablation gained far more QALY’s (317) than in the chemotherapy group (165) (P < 0.001). Interpretation Although overall survival did not reached statistical significance, the median DFS of 9 months suggests a beneficial effect of local tumour ablation for non-resectable colorectal liver metastases. Moreover, compared with systemic chemotherapy more QALY’s were gained after local ablative therapy. Paul F.M. Krabbe and Cornelis J.A. Punt equally contributed to this study.     

Biopsychosocial predictors of sexual function and quality of sexual life: a study among patients with colorectal cancer

Objective

A low sexual function (SF) has been reported in patients with colorectal cancer. However, research often focusses on clinical predictors of SF, hereby omitting patients’ subjective evaluation of SF [i.e., the quality of sexual life (QoSL)] and psychosocial predictors of SF and QoSL. In addition, research incorporating a biopsychosocial approach to SF and QoSL is scarce. Therefore, this study aimed to evaluate (I) relatedness between SF and the QoSL, (II) the course of SF and QoSL, and (III) biopsychosocial predictors of SF and QoSL.

Methods

Patients completed questionnaires assessing sociodemographic factors (i.e., age, sex) and personality characteristics (i.e., neuroticism, trait anxiety) before surgery. Questionnaires assessing psychological (i.e., anxious and depressive symptoms, body image, fatigue) and social (i.e., sexual activity, SF, non-sensuality, avoidance of sexual activity, non-communication, relationship function) aspects were measured preoperative and 3, 6, and 12 months after surgery. Clinical characteristics were obtained from the Eindhoven Cancer Registry (ECR). Bivariate correlations evaluated relatedness between SF and QoSL. Linear mixed-effects models examined biopsychosocial predictors of SF and QoSL.

Results

SF and QoSL are related constructs (r=0.206 to 0.642). Compared to preoperative scores, SF did not change over time (P>0.05). Overall, patients’ QoSL decreased postoperatively (P=0.001). A higher age (β=−0.02, P=0.006), fatigue (β=−0.02, P=0.034), not being sexually active (β=−0.081, P<0.001), and having a stoma (β=0.37, P=0.035) contributed to a lower SF. Having rectal cancer (β=−1.64, P=0.003), depressive symptoms (β=−0.09, P=0.001), lower SF (β=1.05, P<0.001), and more relationship maladjustment (β=−0.05, P=0.027) contributed to a lower QoSL (P<0.05). In addition, partners’ SF (β=0.24, P<0.001) and QoSL (β=0.30, P<0.001) were predictive for patients’ SF and QoSL, respectively. A significant interaction between time and gender was reported for both outcomes (P’s=0.002).

Conclusions

SF and QoSL are related but distinctive constructs. The course of SF and QoSL differed. Different biopsychosocial predictors were found for SF and QoSL. The contribution of partner-related variables to patients’ outcomes suggests interdependence between patients and partners. Men and women showed different SF and QoSL trajectories. We recommend that health care professionals, when discussing sexuality, realize that SF and QoSL are no interchangeable terms and should, therefore, be discussed as two separate entities. In addition, it is favored that clinicians focus not only on biological predictors of SF and QoSL, but obtain a broader perspective in which they also pay attention to psychosocial factors that may impair SF and QoSL. More in depth research on interdependence between patients and partners, biopsychosocial predictors of partners’ SF and QoSL, and gender effects is needed.     

Quality of life as an outcome measure in surgical oncology

BACKGROUND: There is a growing interest in assessing the impact of a disease and the effect of a treatment on a patient's life, expressed as health-related quality of life (HRQoL). HRQoL assessment can provide essential outcome information for cancer surgery. METHODS: The core of this review is derived from a literature search of the Medline database. RESULTS: Three types of HRQoL instrument can be distinguished: generic, disease specific and symptom specific. There are criteria against which HRQoL instruments may be evaluated. The instrument chosen must be reliable, valid and sensitive to change. CONCLUSION: HRQoL measurement may be useful in identifying the optimal surgical procedure. It may also be of help in deciding whether surgery in patients with limited life expectancy should still be considered. No HRQoL instrument fits all the recommended conditions or is suitable in all clinical situations. Using the appropriate instrument is essential to arrive at valid and clinically meaningful outcome measures.     

Value of positron emission tomography with [F-18]fluorodeoxyglucose in patients with colorectal liver metastases: a prospective study.

PURPOSE: To assess prospectively the value of fluor-18-deoxyglucose (FDG) positron emission tomography (PET), in addition to conventional diagnostic methods (CDM), as a staging modality in candidates for resection of colorectal liver metastases. PATIENTS AND METHODS: In 51 patients analyzed for resection of colorectal liver metastases, clinical management decisions were recorded after a complete work-up with CDM. Afterward, FDG-PET scans were performed and any change of clinical management according to FDG-PET results was carefully documented. Discordances between FDG-PET and CDM results were identified and related to the final diagnosis by histopathology, intraoperative findings, and follow-up. RESULTS: In 10 (20%) out of 51 patients, clinical management decisions based on CDM were changed after FDG-PET findings were known. FDG-PET detected unresectable pulmonary (n = 5) and hepatic metastases (n = 1) and ruled out extrahepatic (n = 2) and hepatic disease (n = 2). Due to FDG-PET, eight patients were spared unwarranted liver resection or laparotomy and two other patients were identified as candidates for liver resection. When the results of FDG-PET were regarded as decisive in a retrospective analysis, potential change of management was 29% (15 patients). FDG-PET and CDM showed discordant extrahepatic results in 11 patients (22%) and discordant hepatic results in eight patients (16%). Compared with CDM, FDG-PET resulted in true upstaging (n = 11), true downstaging (n = 5), false upstaging (n = 1), and false downstaging (n = 2). The detection rate of liver metastases on a lesion basis was generally better for computed tomography than for FDG-PET (80% v 65%); this was related to tumor size. CONCLUSION: FDG-PET as a complementary staging method improves the therapeutic management of patients with colorectal liver metastases, especially by detecting unsuspected extrahepatic disease.     

Comparative Quality of Life in Patients Following Transanal Minimally Invasive Surgery and Healthy Control Subjects

Background

Transanal minimally invasive surgery (TAMIS) is considered the successor of transanal endoscopic microsurgery (TEMS). It makes use of more readily available laparoscopic instruments and single-port access platforms with similar perioperative, clinical and oncological outcomes. Little is known about quality of life (QoL) outcomes after the use of TAMIS. The aim of this study was to assess QoL after TAMIS in our patients and compare this with QoL in the healthy Dutch population.

Methods

All patients undergoing TAMIS for selected rectal neoplasms between October 2011 and March 2014 were included in this analysis. Patients were studied for a minimal period of 24 months. QoL outcomes were measured using the Short-Form 36 Health Survey (SF-36) questionnaire; faecal continence was measured using the Faecal Incontinence Severity Index questionnaire. Patient reported outcomes were compared to case-matched healthy Dutch control subjects. We hypothesise that undergoing TAMIS will subsequently result in a decreased quality of life in patients compared to healthy individuals.

Results

Thirty-seven patients (m:f?=?17:20, median 67 years) were included in the current analysis. In four patients (10.8%), postoperative complications occurred. The median follow-up was 36 (range 21–47) months. Postoperative QoL scores are similar comparable to those reported by Dutch healthy controls. Patients reported a statistically significant better QoL score in the ‘bodily pain’ domain when compared to the controls (81.8 vs. 74.1 points) (p?=?0.01). Significant worse QoL scores for the ‘social functioning’ domain were reported by patients after TAMIS (84.4 vs. 100 points) (p?=?0.03).

Conclusion

TAMIS seems to be a safe technique with postoperative QoL scores similar to that of healthy case matched controls in 3-year follow-up. There seems to be no association between faecal incontinence and reported QoL. Negative effects of TAMIS on social functioning of patients should not be underestimated and should be discussed during preoperative counselling.