Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

AIM: A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. METHODS: Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. RESULTS: Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbach's alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). CONCLUSION: The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials.

Toxicity and quality of life outcomes in ovarian cancer patients participating in randomized controlled trials.

MAIN PURPOSE: The objective of this study was to determine the relationship between clinician-graded symptoms based on the common toxicity criteria (CTC) and patient-reported quality of life (QoL). We hypothesized that toxicity symptoms that are objective or observable would have a higher correlation with QoL than subjective data. MATERIAL AND METHODS: A retrospective analyses of data from three closed randomized chemotherapy trials was performed. A total of 2,110 patients with ovarian cancer (stage IIB-IV) who had complete toxicity and QoL data at cycles 3 and 6 were included. Toxicities were graded according to the National Cancer Institute Common Toxicity Criteria. Quality of life was assessed every other cycle by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). MAIN RESULTS: Correlations between CTC grading and the QLQ-C30 functioning scales were weak (<0.30); correlation coefficients between CTC ratings and the QLQ-C30 symptom scales including nausea, vomiting, constipation, pain, and dyspnea ranged from 0.32 to 0.49 except for constipation (0.55). On a symptom level exact agreement between clinician and patient reporting ranged from 54.2% (pain) to 80.8% (emesis/vomiting). When symptom grading differed, patients reported greater severity for pain, constipation, and dyspnea, whereas clinicians graded emesis/vomiting and nausea as more severe than the grading by patients. CONCLUSION: Patient experience is not routinely captured by CTC toxicity scales. Therefore, clinicians should not entirely rely on the CTC grading but consider patient-reported outcomes as well.

Prospective assessment of quality of life in long-term ovarian cancer survivors.

The objective of our study was to compare prospectively the QoL in long-term ovarian cancer survivors with short-term survivors and to explore discriminating variables between short-term and long-term survival. Thirty-three patients were included, 22 died within 5 years post diagnosis and 11 survived beyond 10 years. QoL data were collected pre-treatment (baseline), 1-year post diagnoses and for long-term survivors 10 years post-treatment using the EORTC QLQ-C30. At baseline, there was no difference in terms of FIGO stage, residual tumor and adjuvant chemotherapy. Significantly, more short-term survivors (96%) had intra operative ascites as compared to long-term survivors (55%) (p = 0.01). Before treatment, short-term survivors had clinically significantly lower QoL scores on the physical functioning (mean 75.45) and role functioning scale (mean 68.94) compared to long-term survivors (mean 68.94 and 84.85, respectively). They also reported higher levels of symptoms. One year post-diagnosis, QoL scores were comparable in most domains. Long-term survivors had a significantly better global QoL but more insomnia. Emotional functioning and global QoL/health status improved significantly from baseline to 1-year post-diagnosis and remained relatively stable at the 10-year follow-up. The presence of intra operative ascites and a supporting social network were identified as significant variables that discriminated between short-term and long-term survival. Compared to a reference sample, long-term survivors showed similar QoL scores but more dyspnoea. Although ovarian cancer patients do not belong to the most prevalent survivor populations, we found that long-term survivors have QoL scores similar to females without a history of cancer.

Randomized study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group comparing quality of life in patients with ovarian cancer treated with cisplatin/paclitaxel versus carboplatin/paclitaxel.

PURPOSE: The objective of this study was to compare the quality of life (QoL) of ovarian cancer patients treated with paclitaxel/carboplatin (TC) versus paclitaxel/cisplatin (PT) and to determine the impact of treatment toxicity on the various QoL domains. PATIENTS AND METHODS: In this phase III trial, 798 patients with ovarian cancer stages IIB-IV were randomly assigned to receive TC or PT. The primary end point was progression-free survival; secondary end points included toxicity, QoL, and response to treatment. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 before treatment, within 3 days before the second and the fourth chemotherapy cycle, and 3 weeks after completion of chemotherapy. RESULTS: Previously reported data showed that patients undergoing TC or PT did not differ in progression-free survival and overall survival. However, the TC arm was superior, indicating a better overall QoL compared with the PT arm. Controlling for toxicity and age, a significant treatment by assessment time interaction was found for four QoL functioning scales and three symptoms scales. Patients in the TC arm showed better means scores after treatment on overall QoL (P = .012), physical functioning (P = .012), role functioning (P = .005), and cognitive functioning (P = .024), compared with the PT arm. Concerning symptom experience, patients undergoing TC showed less nausea and vomiting (P < .001), less appetite loss (P < .001), and less fatigue (P = .033) after completion of treatment compared with patients undergoing PT. CONCLUSION: The TC regimen achieved better QoL outcomes compared with the PT regimen. Thus, clinicians may consider replacing cisplatin with carboplatin when treating ovarian cancer patients with chemotherapy.

Comparison of accuracy between the Partin tables of 1997 and 2001 to predict final pathological stage in clinically localized prostate cancer.

PURPOSE: We validated externally the predictive accuracy of the 2001 Partin tables and compared the 1997 and 2001 versions. MATERIALS AND METHODS: We used ROC derived AUC to test the predictive accuracy of organ confinement (OC), extraprostatic extension (ECE), seminal vesicle invasion (SVI) and lymph node involvement (LNI) of 1997 and 2001 Partin tables derived probabilities. These probabilities were defined by the pretreatment clinical stage, serum prostate specific antigen and biopsy Gleason grade of 2,139 patients treated with radical prostatectomy for clinically localized prostate cancer. RESULTS: OC, ECE, SVI and LNI were noted in 63.5%, 23.1%, 10.5% and 2.9% of cases, respectively. AUC of the 2001 tables was 0.787, 0.766, 0.775 and 0.790, for OC, ECE, SVI and LNI, respectively. These values were virtually the same as the respective 1997 Partin table AUC values, namely 0.784, 0.728, 0.791 and 0.799. CONCLUSIONS: This external validation of the 2001 Partin tables confirms good predictive accuracy of the updated tables. However, predictive accuracy in this external validation data set of 2,139 European men is virtually the same as that of the original 1997 tables. Therefore, a transition from the 1997 tables to the updated 2001 version does not appear warranted unless superior accuracy is demonstrated in other external cohorts.

Characterisation of biomolecular profiles in primary high-grade prostate cancer treated by radical prostatectomy.

PURPOSE: The aim of this study was to compare the biomolecular profile of high-grade (HG) with low-grade (LG) prostate cancers matched by preoperative serum prostate-specific antigen (PSA) levels. METHODS: From 2,560 patients undergoing radical prostatectomy for localised disease, 24 men with HG cancer (Gleason score > or =9) were eligible. Their clinical data were compared with those of 24 LG tumours (Gleason score < or =6), matched by PSA values. The expression of Ki-67, p53, Bcl-2, chromogranin A, alpha-catenin, and PSA were analysed and compared between both groups. RESULTS: The expression of Ki-67 (P=0.031), p53 (P=0.008), Bcl-2 (P=0.002), and chromogranin A (P=0.042) were expressed significantly higher, and alpha-catenin (P=0.020) and PSA (P<0.001) significantly lower in HG tumours. Cancer volumes of HG and LG differed significantly (10.6 cm3 vs 5.3 cm3; P=0.006). Overall, cancer volume correlated with increased expression of p53 (r=0.52; P<0.001) and chromogranin A (r=0.46; P<0.001), and with decreased expression of PSA (r=0.41; P<0.004). CONCLUSIONS: According to our data, tumour grade is clearly associated with a change in the biomolecular profile, even between patients with similar serum PSA levels. As the prognosis of HG prostate cancer is poor, these tumours should be analysed by immunohistochemical staining to identify specific tumour features for an appropriate selection of adjuvant therapy.

Zonal location of prostate cancer: significance for disease-free survival after radical prostatectomy?

OBJECTIVES: To analyze the zonal location of prostate cancer as a possible predictive feature of progression-free survival after radical prostatectomy. METHODS: Prostate cancers were divided into three groups according to the percentage of cancer volume (70% or more, 31% to 69%, and 30% or less) located in the transition zone (TZ). In a total of 307 patients, 5-year progression-free probabilities were estimated for different clinical and pathologic tumor characteristics using the Kaplan-Meier method. With emphasis on the percentage of cancer volume located in the TZ, univariate and multivariate analyses were performed to calculate their prognostic significance in predicting progression-free probability. RESULTS: Prostate cancer with 70% or more, 31% to 69%, and 30% or less of the cancer volume in the TZ was found in 17.3%, 6.8%, and 75.9% of the patients, respectively. Patients with tumors with 70% or more of the cancer volume in the TZ had a significantly (log-rank P = 0.0402) greater rate of biochemical cure than those with 30% or less (82.1% versus 66.2%). The increasing percentage of cancer volume located in the TZ was significantly (P = 0.0258) associated with a greater progression-free probability in univariate analysis, but did not retain independent significance (P = 0.5748) in multivariate analysis. Instead, pathologic stage (P <0.0001), lymph node involvement (P = 0.0189), and Gleason score on prostatectomy specimen (P = 0.0023) were independent prognosticators. CONCLUSIONS: The location of prostate cancer in the TZ was associated with a greater overall biochemical cure rate after radical prostatectomy. However, it was not an independent prognosticator on multivariate analysis. Therefore, the knowledge about zonal location of prostate cancer offers no advantage over the well-established prognostic factors in predicting disease recurrence.

Prognostic significance of visible lesions on transrectal ultrasound in impalpable prostate cancers: implications for staging.

PURPOSE: The current tumor-node metastasis (TNM) staging system classifies impalpable prostate cancers identified by needle biopsy and invisible by imaging as T1c and those visible as T2. Palpable cancers are classified as at least T2. However, most urologists consider impalpable prostate cancers T1c tumors, irrespective of findings on transrectal ultrasound (TRUS). The aim of this article is to provide a differentiated view of the significance of TRUS findings for staging purposes in impalpable prostate cancers. PATIENTS AND METHODS: A consecutive series of 1670 patients with impalpable tumors and palpable T2 cancers after radical prostatectomy were evaluated. Tumor characteristics and 5-year biochemical cure rates of cancers invisible and visible on TRUS were compared, as well as the rates of impalpable but visible and palpable T2 cancers. RESULTS: Impalpable cancers invisible on TRUS presented significantly more favorable pathologic stages and lower cancer volumes than those visible on TRUS (P =.002, P =.010). In the latter, these clinical features were more favorable compared with T2 cancers (P <.001, P <.001). Progression-free probability of impalpable cancers invisible on TRUS was 86.8%; progression-free probability for impalpable cancers visible on TRUS was 85.4% (log-rank test P =.2060). The corresponding rate for T2 tumors was 73.9%, significantly lower when compared to those of visible and impalpable cancers (log-rank test P =.0001). CONCLUSION: Impalpable prostate cancers invisible on TRUS present more favorable cancer features than those that are visible on TRUS. However, these differences are not as pronounced as those between impalpable but visible cancers and palpable T2 tumors. Thus, based on our data, it seems inappropriate to classify impalpable prostate cancers visible on TRUS as T2 cancers.

Insignificant prostate cancer in radical prostatectomy specimen: time trends and preoperative prediction.

OBJECTIVES: We analysed systematically a consecutive series of radical prostatectomy specimens performed between January 1992 and June 2002 with emphasis to time trends, tumour characteristics and preoperative prediction of insignificant prostate cancers (cancer volume < or =0.5 cm(3) and Gleason pattern < or =6). METHODS: In a total of 1254 patients, prostate cancers (PC) were divided by a cancer volume of 0.5 cm(3). The two groups were compared in their clinical and pathological tumour characteristics. Correlation was determined between yearly incidence rates of T1c and insignificant PC. Furthermore, a logistic regression analysis was performed to calculate the ability to predict insignificant PC and a statistical model was established. RESULTS: Overall, 73 (5.8%) of 1254 men presented with insignificant PC. The incidence of insignificant PC showed no significant linear correlation with that of T1c PC (p<0.61). PSA density and percentage of cancer per biopsy set were assessed as independent prognosticators predicting insignificant PC. Using a threshold of 1% of cancer per biopsy set and a PSA density < or =0.10, positive and negative predictive values were 45.0% and 93.3%, respectively. CONCLUSION: In our series, only few men undergoing radical prostatectomy were affected by insignificant PC. Their incidence showed no statistically significant correlation with that of T1c tumours. Furthermore, insignificant PC was predictable by PSA density and percentage of cancer per biopsy set. Mainly elderly patients facing different treatment options for localized PC may benefit from this information.

Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy.

OBJECTIVES: We assessed the incidence of morbidity and bother on quality-of-life (QL) after radical retropubic prostatectomy for prostate cancer. METHODS: At least 12 months after surgery, self-reporting questionnaires were completed and returned by 368 (77.8%) of 473 eligible patients. Surgery related morbidity was evaluated by adhoc constructed questions. QL was assessed by the European Organization for Research and Treatment of Cancer QL core questionnaire (EORTC QLQ-C30). Multivariate and univariate analysis as well as regression analysis were used to assess the bother factors. RESULTS: Postoperative urinary incontinence significant enough for the patient to use some kind of protection was reported by 27.2%. After surgery, 14.2% of preoperative potent men were able to get and maintain an erection sufficient enough for sexual intercourse without any aid. Overall 10.6% of respondents had undergone surgery for anastomotic stricture and 23.6% reported on adjuvant therapy. Furthermore, 43.2% reported on fear of not being cured from cancer. Postoperative urinary incontinence and fear of not being cured were associated with significant lower global QL scores and turned out as independent predictors for global QL. In contrast, postoperative erectile dysfunction, anastomotic stricture and adjuvant therapy were not independent predictors. In addition, 82.1% would vote for surgery again. CONCLUSION: The majority of the patients would opt for surgical treatment again, although morbidity is common after radical prostatectomy and may impair QL. Particularly urinary incontinence and fear of not being cured are independent predictors for global QL after surgery. Therefore, surgical techniques with a low morbidity are requested as well as some kind of psychological support in order to cope with existential fear.