Self-perception versus professional assessment of functional outcome after ablative surgery in patients with oral cancer.

PURPOSE: The extent of functional impairment after ablative surgery in the orofacial region may be directly reflected in a reduction in Quality of Life. This study intended to compare the patients' perception with an objective functional evaluation of the orofacial system in order to bilaterally distinguish direct influence factors. METHODS: A total of 45 patients were included in this study and were asked to complete the European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-30) and the Head and Neck 35 Module (H&N 35). Afterward one independent speech therapist evaluated the patients applying the Frenchay Dysarthria Assessment regarding four main categories: mouth opening, tongue motility, swallowing and intelligibility. Comparisons between groups were performed using Whitney-Mann U-Wilcoxon test and calculating Spearman's rho. RESULTS: Overall the professional assessments by the speech therapists revealed significantly higher scores regarding intelligibility, swallowing and mouth opening when compared to the patients' self-perception. Smaller tumor sizes, no bone resection and local reconstruction techniques led to significantly better functional outcomes, when assessed by speech therapists. Swallowing was perceived significantly better by patients in cases of local reconstruction. CONCLUSIONS: From the professionals' point of view differences were perceived in more items compared to the patients' self-assessments, who widely experienced a more severe functional impairment. Physicians should take this into account when discussing adverse therapy effects with the patients.

Measurement of quality of life in second-line patients with advanced NSCLC without targetable mutations: a review.

Quality of life (QoL) is important to cancer patients and is increasingly included as a trial end point. The methodologies/findings of randomized controlled trials evaluating the efficacy and safety of second-line treatments approved for use in the EU in patients with advanced/metastatic NSCLC, without known targetable mutations, were evaluated. Seven trials were identified; five compared active treatments and two compared active treatment to placebo. Methodologies used and reporting varied. The European Organization for Research and Treatment of Cancer lung cancer questionnaire was the most commonly used assessment method (n = 4). There was no evidence to suggest differences in QoL between active treatments. Consistent and appropriate use of standard QoL instruments in future would increase the reliability of results and their applicability to clinical decision-making.

Lifestyle factors and health-related quality of life in colorectal cancer survivors.

PURPOSE: This study investigates the association between a postdiagnosis lifestyle score and health-related quality of life (HrQol) in long-term colorectal cancer (CRC) survivors. METHODS: A cross-sectional study of 1,389 long-term CRC survivors in Northern Germany was analyzed. On average 7.2 years after CRC diagnosis, HrQol was assessed with the EORTC QLQ-C30, and lifestyle factors, including weight, height, diet, physical activity, and smoking were obtained using self-administered questionnaires. A lifestyle score (BMI <30 kg/m², healthy diet, recreationally active, and not smoking) was applied. Participants were categorized in adhering to at most one, two, three, or all recommended lifestyle factors, categorizing unfavorable behaviors with 0 and favorable with 1 point. Multivariable logistic regression models were used to investigate the association between the lifestyle score and HrQol as a binary variable. RESULTS: Approximately 10 % had at most one, 30 % two, 38 % three, and 23 % all favorable factors. Compared to participants with one or zero factors, the odds ratio (OR) for a low global HrQol (gHrQol) decreased with stronger adherence to the score. The OR (95% CI) for a low gHrQol was 0.50 (0.33-0.76) for participants with all favorable lifestyle factors compared to participants with one or zero. Clinical and socio-demographic factors had little impact on these associations, with exception of living arrangement which showed a statistically significant interaction. Associations were stronger for functioning domains, representing mobility rather than mental health. CONCLUSIONS: Favorable lifestyle behaviors might be associated with HrQol in CRC long-term survivors. More research in prospective studies is needed.

Disseminated tumor cells in the bone marrow negatively influence survival after resection of colorectal liver metastases.

BACKGROUND: Despite all efforts in extending the resectability rates of colorectal liver metastases, thus improving the prognosis of the patients, tumor recurrence occurs in many patients. Occult dissemination of tumor cells might reflect a minimal residual disease that is not eliminated by primary surgery. Because the prognostic effect of disseminated tumor cells (DTC) is still uncertain in this clinical setting, we analyzed these cells in the peripheral blood and bone marrow of patients undergoing hepatic resection of colorectal liver metastases. METHODS: In 108 patients with colorectal liver metastases, the presence of DTC in the peripheral blood and bone marrow was detected with CK20 RT-PCR. Clinical data were prospectively collected, and multiple variables were analyzed regarding their influence on overall survival. RESULTS: DTC in the peripheral blood were detected in 40% of the patients. In 25% of the patients, DTC were detected in the bone marrow. The median follow-up was 34 months. Fifty-nine of 108 patients died from tumor relapse. Multivariate analysis determined detection of DTC in the bone marrow to be an independent prognostic factors for overall survival (P = 0.038). CONCLUSIONS: This large series of patients with hepatic resection of colorectal liver metastases demonstrated that detection of CK20-positive DTC via RT-PCR in the bone marrow compartment negatively influences overall survival. The evidence of DTC in the bone marrow might serve as an additional individual marker to select patients for adjuvant treatment after liver metastases resection.

Clinical outcomes and health-related quality of life after thoracoscopic talc pleurodesis.

OBJECTIVES: Thoracoscopic pleurodesis is a safe and effective method of palliative care for patients suffering from malignant pleural effusion. Health-related quality of life (QOL) is an important factor in palliative therapy; however, we are not aware of any studies that have examined the QOL of patients following thoracoscopic pleurodesis. METHODS: A total of 123 patients underwent thoracoscopic pleurodesis between January 2006 and February 2009. A total of 45 patients agreed to take part at the QOL assessment and were enrolled in our prospective study. In addition to clinical outcome, the patients' QOL data were assessed prior to thoracoscopic pleurodesis and for 12 months after surgery using the European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire. We compared the patients' QOL scores at each time point with their preoperative scores and analyzed these data relative to the scores of a healthy age-matched population. RESULTS: Due to the advanced clinical status of the patients in our study, the overall median survival time was 7.5 months versus 10.2 months for patients' QOL data. Following discharge from the hospital, most functional scales (with exception of emotional function, p=0.035) did not significantly differ from preoperative scores. Throughout the study period, patients experienced statistically and clinically significant improvements in functional scales. Global health values increased after surgery throughout the entire study period. There was a clear decline in dyspnea upon discharge, followed by a continuous remote increase throughout the subsequent months. QOL of the study population remained lower than that of the healthy cohort. CONCLUSIONS: Our data are consistent with clinical findings that pleurodesis decreases respiratory symptoms, but does not alleviate impairments in the patient's general condition.

Quality of life in oral cancer patients--effects of mandible resection and socio-cultural aspects.

INTRODUCTION: The aim of this study was to assess the postoperative quality of life in oral cancer patients depending on different mandible resection types and to collect information about their socio-cultural situation. MATERIAL AND METHODS: In this cross-sectional study, patients with primary oral cancer treated with different types of mandibular resection in the Clinic of Oral and Maxillofacial Surgery at the University of Kiel between 1997 and 2007 were included. Quality of life was assessed by means of the EORTC QLQ-C30 and H&N 35 questionnaires. Furthermore, a questionnaire about the socio-cultural background of the patients was applied. To be included, at least one year had to be passed after tumour resection. RESULTS: 111 of 235 questionnaires were returned (47%). Significant differences in quality of life were found between patients with soft tissue resections and bone resections. There were significant worse values for continuity resections compared to only partial resections. Sixty-seven patients (60.4%) had a graduation of an elementary school as the highest school graduation, four patients (3%) had no school graduation. CONCLUSIONS: The postoperative quality of life in our patients was significantly influenced by the extent of bone resection. This should be considered for surgical planning. The socio-cultural data showed a rather low education level for the majority of the patients.

Sexual impairment and its effects on quality of life in patients with rectal cancer.

BACKGROUND: The effects of rectal surgery on patients' postoperative quality of life (QOL) and sexual function has been little studied to date. The present study aims to address this issue. METHODS: 519 patients who had undergone surgery for rectal cancer from January 1997 to January 2003 were included in the study. The EORTC-QLQ-C-30 questionnaire and an additional, tumor-specific module were administered prospectively multiple times over a 2-year period: before surgery, on discharge from the hospital, and at 3, 6, 12, and 24 months after surgery. Comparisons were made between men and women, different age groups, and different surgical procedures: abdominoperineal resection (APR) versus anterior resection (AR). RESULTS: There were significant differences between men and women on scales of function and symptoms. Women had worse scores for physical function and overall quality of life and higher values for fatigue. Sexual life was impaired in both men and women, but the impairment was significantly more severe in men, and men felt more distressed by it than women did. Physical function and overall quality of life were better in patients aged 69 and younger, while patients aged 70 and older suffered from fatigue. Younger patients had a more severe impairment of sexuality, which, over the time period of the study, led to severe emotional symptoms. Sexuality was more severely impaired in patients who had undergone APR than in those who had undergone AR. CONCLUSION: These findings show that the quality of life is changed by surgery for rectal cancer and is influenced by the patient's sex and age, as well as by the particular surgical approach used.

Age-related impairment of quality of life after lung resection for non-small cell lung cancer.

BACKGROUND: Health-related quality of life (QOL) after resection of non-small cell lung cancer (NSCLC) is of primary interest to clinicians, secondary to clinical outcome. However, few studies have explored QOL following lung resection and, to our knowledge, no studies have specifically examined the QOL of elderly patients. METHODS: A total of 131 patients with NSCLC underwent surgical resection (lobectomy or bilobectomy) between January 1998 and December 2004 and were enrolled in our prospective study. The patients' QOL and clinical data were assessed prior to resection and for up to 24 months after surgery using the EORTC QLQ C-30 questionnaire and the lung-specific questionnaire, QLQ-LC13. Quality of life was then calculated and the QOL of patients younger than 70 years was compared with that of patients aged 70 years or older. RESULTS: The overall 5-year survival rate was 47%, and the rate of complications did not differ significantly between the groups. Overall, most QOL indicators, including physical function (p<0.001), pain (p=0.025), and dyspnea (p<0.001) were significantly impaired after surgery and remained so for up to 24 months. Elderly patients survived for an average of 39 months, while younger patients survived for an average of 49 months (p=0.18). The QOL of younger patients returned to preoperative levels significantly faster than did the QOL of elderly patients. CONCLUSIONS: Elderly patients who underwent lung resection for NSCLC failed to make a complete recovery. They showed a decreased tendency to achieve the preoperative level of QOL compared to younger patients.

Use and misuse of the consolidated standards of reporting trials (CONSORT) guidelines to assess research findings: comment on Coyne, Stefanek, and Palmer (2007).

The basic principles underlying randomized clinical trials have been known for more than 50 years. The Consolidated Standards of Reporting Trials (CONSORT) guidelines, published in 1996 and based on those principles, are a valuable guide to what needs to be reported from any trial within word-limit constraints, but they do not provide guidelines to the decisions that have to be made to generate a trial with credible results. Using these guidelines as do J. C. Coyne, M. Stefanek, and S. C. Palmer (2007) is a misinterpretation of their purpose. Furthermore, Coyne et al. misrepresented the methods and findings of studies of the effects of psychosocial intervention on cancer survival. These errors are systematically reviewed. The results of these questionable analyses led Coyne et al. to recommend stopping research in an area that may be highly productive. Recent developments in the field are summarized. It is a mistaken and dangerous conclusion to declare this or other areas of scientific research off limits.

The extent of lung parenchyma resection significantly impacts long-term quality of life in patients with non-small cell lung cancer.

BACKGROUND: Secondary to clinical outcome, health-related quality of life (QOL) after resection of non-small cell lung cancer (NSCLC) is of particular interest. However, few studies have explored QOL following lung resection. METHODS: Between January 1998 and December 2004, a total of 159 patients with NSCLC underwent surgical resection and were enrolled in this prospective study. QOL and clinical data were assessed prior to resection and for up to 24 months after surgery by applying the European Organization for Research and Treatment of Cancer core questionnaire and the lung-specific questionnaire, the European Organization for Research and Treatment of Cancer lung-specific module. QOL was calculated, and QOL following bilobectomy/lobectomy was compared with QOL after pneumonectomy. RESULTS: Overall, the 5-year survival rate was 42%. Mean survival of the pneumonectomy group was slightly lower than that of the bilobectomy/lobectomy group, although the difference was not statistically significant (p = 0.058). The rate of complications was not significantly different between the two groups. After a postoperative drop, most QOL indicators remained near baseline for up to 24 months, with the exception of physical function (p < 0.001), pain (p = 0.034), and dyspnoea (p < 0.001), which remained significantly impaired. QOL was significantly better (difference > 10 points) after bilobectomy/lobectomy than after pneumonectomy. However, differences were statistically significant only with regards to physical function (at 3 months), social function (at 3 and 6 months), role function (at 3, 6, and 12 months), global health (at 3 and 6 months), and pain (at 6 months). CONCLUSIONS: Patients who underwent lung resection for NSCLC failed to make a complete recovery after 24 months. Patients who underwent pneumonectomy had significantly worse QOL values and a decreased tendency to recover, compared with patients who underwent bilobectomy/lobectomy. Therefore, major lung resection has a much more serious impact on the QOL of affected patients than does major visceral surgery.

Weekly vinorelbine versus docetaxel for metastatic breast cancer after failing anthracycline treatment.

BACKGROUND: Vinorelbine and docetaxel are active in anthracycline-pretreated, metastatic breast cancer. We compared their efficacy. PATIENTS AND METHODS: Patients were randomized to receive weekly vinorelbine (VIN) or weekly docetaxel (DOC), 6 weekly doses per 8-week cycle, with optional crossover (X-DOC vs. X-VIN. The primary end point was time to progression (TTP) on initial treatment. Remission induction, survival, and quality of life were secondary end points. RESULTS: Among 122 poor risk patients, a non-significant trend for better TTP was seen for DOC, both on initial and on crossover treatment. Responses were seen on either treatment, but progression was more common with VIN than with DOC, while more patients had a response with X-DOC than with X-VIN. Survival was identical in those receiving only the initial VIN vs. DOC and in the subgroups receiving crossover treatments. Grade 3-4 toxicity, especially hematological toxicity resulting in treatment delay, was more common with VIN. Non-graded toxicity contributed to abandoning DOC. Quality of life scores reflected worse results in patients crossing treatment arms, in either direction. CONCLUSIONS: DOC showed marginally better activity but did not improve TTP or other endpoints over VIN in this poor risk population.

Impact of psychotherapeutic support for patients with gastrointestinal cancer undergoing surgery: 10-year survival results of a randomized trial.

PURPOSE: The impact of psychotherapeutic support on survival for patients with gastrointestinal cancer undergoing surgery was studied. PATIENTS AND METHODS: A randomized controlled trial was conducted in cooperation with the Departments of General Surgery and Medical Psychology, University Hospital of Hamburg, Germany, from January 1991 to January 1993. Consenting patients (N = 271) with a preliminary diagnosis of cancer of the esophagus, stomach, liver/gallbladder, pancreas, or colon/rectum were stratified by sex and randomly assigned to a control group that received standard care as provided on the surgical wards, or to an experimental group that received formal psychotherapeutic support in addition to routine care during the hospital stay. From June 2003 to December 2003, the 10-year follow-up was conducted. Survival status for all patients was determined from our own records and from three external sources: the Hamburg cancer registry, family doctors, and the general citizen registration offices. RESULTS: Kaplan-Meier survival curves demonstrated better survival for the experimental group than the control group. The unadjusted significance level for group differences was P = .0006 for survival to 10 years. Cox regression models that took TNM staging or the residual tumor classification and tumor site into account also found significant differences at 10 years. Secondary analyses found that differences in favor of the experimental group occurred in patients with stomach, pancreatic, primary liver, or colorectal cancer. CONCLUSION: The results of this study indicate that patients with gastrointestinal cancer, who undergo surgery for stomach, pancreatic, primary liver, or colorectal cancer, benefit from a formal program of psychotherapeutic support during the inpatient hospital stay in terms of long-term survival.

Validation of the German prostate-specific module.

Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.

Quality of life assessment in otorhinolaryngology. History, measures and methods.

The term "quality of life" was first mentioned in 1920 in economic journals and became an issue in the early 1960s in North America. Initially it became accepted in social sciences and later in medicine. The development of generic measures began in the early 1970s and continues today. Disease-specific measures were introduced in the 80th and 90th. During that time methodological studies were implemented and additional emphasis was put on analytic approaches, interpretation of scale scores and cultural including language issues. In ENT study groups began slowly with research in the 1980s and expanded during the 1990s. Today Quality of Life is an accepted part of medical research and covers a broad field of issues. Study groups in ENT work on allergy treatment, oncology and economic aspects of Quality of Life research as well as patient's perception of hearing devices. Future challenges include conceptualization and testing of theoretical models, further refinement of individualized measures for use in routine clinical practice and the inclusion of Quality of Life information in health databases. This article describes the methodological concept, the history of Quality of Life assessment in ENT and gives a detailed overview on current measures.

Gender differences in quality of life of patients with rectal cancer. A five-year prospective study.

To determine how quality of life changes over time and to assess gender-related differences in quality of life of rectal cancer patients we conducted a 5-year study. Little is known about how quality of life (QoL) changes over time in patients after surgery for rectal cancer, and whether gender of the patients is associated with a different perception of QoL. The aim of this study was to assess prospectively, changes in quality of life after surgery for rectal cancer, with a focus on gender related differences. Over a 5-year period, the EORTC-QLQ-C-30 and a tumor-specific module were prospectively administered to patients before surgery, at discharge, 3, 6, 12, and 24 months postoperatively. Comparisons were made between female and male patients. A total of 519 patients participated in the study, 264 men and 255 women. The two groups were comparable in terms of surgical procedures, adjuvant treatment, tumor stage, and histology. Most QoL scores dropped significantly below baseline in the early postoperative period. From the third month onward, global health, emotional and physical functioning, improved. Female gender was associated with significantly worse global health and physical functioning and with higher scores on treatment strain and fatigue. Men reported difficulties with sexual enjoyment; furthermore, over time, sexual problems created high levels of strain in men, worse than baseline levels in the early postoperative period. These problems tended to continue over the course of time. The findings in this study confirm that QoL changes after surgery and differs between men and women. Women appear to be affected by impaired physical functioning and global health. Female gender is associated with significantly higher fatigue levels and increased strain values after surgery. Through impaired sexual enjoyment, men are put more under strain than woman.

Significant negative impact of adjuvant chemotherapy on health-related quality of life (HR-QoL) in women with breast cancer treated by conserving surgery and postoperative 3-D radiotherapy. A prospective measurement.

PURPOSE: To prospectively assess health-related quality of life (HR-QoL) in women after conserving surgery for breast cancer during/after postoperative 3-D radiotherapy. PATIENTS AND METHODS: 109 consecutively treated patients were analyzed. HR-QoL was assessed at initiation (t1), end (t2), and 6 weeks after radiotherapy (t3) using the EORTC modules QLQ-C30/BR23. Patients were divided into three therapy groups. Group I comprised 41 patients (radiotherapy and adjuvant chemotherapy), group II 45 patients (radiotherapy and adjuvant hormonal therapy), and group III 23 patients (radiotherapy alone). Reliability was tested. Scale means were calculated. Univariate (ANOVA) and multivariate (MANCOVA) analyses were performed. RESULTS: Reliability testing revealed mean Cronbach's alpha> 0.70 at all measurement points. ANOVA/MANCOVA statistics revealed significantly better HR-QoL for patients in group II versus I. Patients receiving radiotherapy alone (group III) showed the best results in HR-QoL. However, scale mean differences between groups II and III were not significant. CONCLUSION: HR-QoL measurement using EORTC instruments during/after radiotherapy is reliable. Adjuvant chemotherapy significantly lowered HR-QoL versus hormones or radiotherapy alone. Chemotherapy patients did not recover longitudinally (from t1 to t3).

Prospective evaluation of quality of life of patients receiving either abdominoperineal resection or sphincter-preserving procedure for rectal cancer.

BACKGROUND: Study results on quality of life (QoL) between patients receiving an anterior resection (AR) or abdominoperineal resection (APR) for rectal cancer vary greatly. A main reason is grounded in unequal methodology. The aims of this study were to assess differences in perceived QoL over time among patients treated with AR or APR with a recommended study design and methodology. METHODS: In a prospective study, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and a tumor-specific module were administered to patients with rectal cancer before surgery, at discharge, and 3, 6, and 12 months after the operation. Comparisons were made between patients receiving an AR and those receiving an APR. RESULTS: Two hundred forty-nine patients were included; 46 patients received an APR and 203 an AR. QoL data were available for 212 patients, of which 112 were female and 100 male. No differences in the distribution of age, sex, or tumor stage were observed between groups. EORTC function scales showed no significant differences, including body image scales, between patients receiving an AR and those receiving an APR. In symptom scores, AR patients had more difficulty with diarrhea and constipation, whereas patients with APR experienced more impaired sexuality and pain in the anoperineal region. At discharge, patients receiving an AR were more confident about their future. CONCLUSIONS: QoL in patients receiving an AR and those receiving an APR is not different. Although patients with APR experience more impaired sexuality, patients receiving an AR experience decreases in QoL because of impaired bowel function.

Ten-year historic cohort of quality of life and sexuality in patients with rectal cancer.

PURPOSE: In various studies, type of surgery, age, and gender had different impact on sexuality and quality of life in patients with rectal cancer. This study was designed to investigate how sexuality and quality of life are affected by age, gender, and type of surgery. METHODS: A total of 516 patients who had undergone surgery for rectal cancer in our department from 1992 to 2002 were included. Within one year after the operation, 117 patients died. Questionnaires were sent to 373 patients 12 to 18 months after surgery. We received quality of life data from 261 patients. Comparisons were made after adjusting age, gender, and type of surgical procedure. RESULTS: For patients receiving abdominoperineal resection sexuality was most impaired. Significant differences were seen in symptom and function scales between males and females. Females reported more distress from the medical treatment insomnia, fatigue, and constipation. Both genders had impaired sexual life; however, males had significantly higher values and felt more distressed by this impairment. Younger females felt more distress through impaired sexuality. In males sexuality was impaired independent of age. Adjuvant therapy had no influence on sexuality but on quality of life one year after surgery. CONCLUSIONS: Assessing quality of life with general and specific instruments is helpful to determine whether patients improved through the treatment. The study showed that gender, age, and type of surgery influence sexuality and that quality of life after surgery for rectal cancer is impacted. Because quality of life is a predictor for complications and survival, availability of such data may help to direct supportive treatment to improve outcome.

Impact of age on quality of life in patients with rectal cancer.

Some studies indicate that age at the time of surgery has a general effect on outcomes. The impact of age on the quality of life (QOL) of patients with rectal cancer, however, has not been investigated. The present study was conducted to address this issue. Over a 5-year period the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C-30 and a tumor-specific module were prospectively administered to patients before surgery, at discharge, and at 3, 6, 12, and 24 months postoperatively. Comparisons were made between age groups. A total of 519 patients participated in the study. QOL data were available for 253 patients. Significant differences were observed only between patients aged 69 years and younger (< or =69 years) (169/253) and those aged 70 years and older (> or =70 years) (85/253). Physical and role functioning was better for patients < or =69 years; patients > or =70 years suffered from increased pain and fatigue. Younger patients had more difficulty with sexual enjoyment, and over time sexual strain was worse for patients aged > or =70 years during the early postoperative period but improved, whereas patients aged < or =69 years had increasing levels of strain over time. The findings in this study confirmed that QOL is dynamic over time and that age has an impact on QOL and sexuality. Patients aged > or =70 years are affected by impaired physical functioning, global health, and fatigue, whereas increased treatment strain during the early postoperative period improves over time. Patients aged < or =69 years experience increased strain because of impaired sexual function.

Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer.

PURPOSE: To report long-term outcomes in terms of health-related quality of life (HRQoL) and survival of a dose-escalating radiotherapy protocol and to validate a new disease-specific HRQoL instrument. PATIENTS AND METHODS: 189 consecutive men with prostate cancer were analyzed; 127 patients had T1-2 (1% T1, 66% T2) and 62 patients (33%) T3 tumors. The pelvic lymphatics were treated to a dose of 50 Gy by external-beam irradiation. The prostate dose was limited to 40 Gy using compensators. The prostate was treated to the total nominal dose of 70 Gy using high-dose-rate (HDR) brachytherapy. The fraction dose was 15 Gy in the McNeal zone (planning target volume [PTV] 1), while 8-9 Gy were applied in the entire prostate (PTV 2). The HRQoL of the 145 long-term survivors was assessed using the EORTC QLQ-C30 and a new prostate-specific instrument (PSM-G 1.0). The reliability of the instruments used and HRQoL scale scores were calculated. Uni-/multivariate analyses of variance were performed. RESULTS: At a mean follow-up of 6.5 years 86.3% of the patients were disease-free, and 78% were biochemically controlled. The mean Cronbach's alpha-values were 0.81 for the QLQ-C30, and 0.74 for the prostate-specific module. Univariate analyses of variance by T-stage, grading, prostata-specific antigen (PSA) status after therapy and adjuvant androgen suppression (AS) revealed that PSA elevation after irradiation and AS were associated with significantly diminished HRQoL. In multivariate analyses AS significantly lowered the HRQoL without survival benefit. CONCLUSION: The described radiotherapy regimen represents a curative and well-tolerated treatment for localized prostate cancer. The HRQoL assessment with both instruments used was reliable. Adjuvant AS and PSA elevation were associated with diminished HRQoL.