EORTC Quality Of Life Questionnaire Research Articles

The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients

The EORTC Quality of Life (QL) Group has developed a questionnaire, the EORTC QLQ-PR25, for evaluating QL in prostate cancer. The aim of this study is to assess the psychometric properties of the EORTC QLQPR25 when applied to a sample of Spanish patients. One hundred and thirty-seven prostate cancer patients with localised disease who started radiotherapy with radical intention combined with or without hormonotherapy prospectively completed the EORTC QLQ-C30 and EORTC QLQ-PR25 questionnaires three times: on the first and last day of radiotherapy and in the follow-up period. Psychometric evaluation of the questionnaires' structure, reliability and validity was conducted. Multitrait scaling analysis showed that many of the item-scale correlation coefficients met the standards of convergent and discriminant validity. Exceptions appeared mainly in the scales for bowel symptoms and for hormonal- treatment-related symptoms. Cronbach's coefficients of the scales were good (0.72-0.86) for the urinary symptoms and sexual function scales but they were lower (<0.70) for the bowel and hormonal treatment scales. Most scales of the EORTC QLQ-PR25 had low to moderate intercorrelations. Correlations between the scales of the QLQ-C30 and the module were generally low. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in QL appeared throughout the measurements. These were in line with the treatment process. The EORTC QLQ-PR25 was a reliable and valid instrument when applied to a sample of Spanish prostate cancer patients. These results are in line with those of the EORTC validation study.

The Basic Documentation for Psycho-Oncology (PO-Bado) – an Expert Rating Scale for the Psychosocial Experience of Cancer Patients

Background: The integration of psycho-oncology into the medical care of cancer patients requires a transparent, reliable, and valid assessment of psychosocial stress. The Basic Documentation for Psycho-Oncology (PO-Bado), including a short version and a breast cancerspecific version, is such an instrument. The purpose of this article is to present the current stage of development of the 3 versions. Patients and Methods: All versions of the PO-Bado were developed and psychometrically evaluated based on the empirical analysis of multiple oncological samples. External criteria for the validation and determination of cut-off scores were the Hospital Anxiety and Depression Scale, the Questionnaire on Stress in Cancer Patients, and the EORTC Quality of Life Questionnaire. Inter-rater reliability was examined by different psycho-oncologists who independently rated PO-Bado interviews. Results: Three versions of the PO-Bado are presented: the standard version (PO-Bado, 17 items), the short form (PO-Bado SF, 7 items), and the breast cancerspecific version (PO-Bado BC, 21 items). A manual and interview guideline are provided for all versions. By now, the standard version has been implemented throughout Germany and includes data of 6,365 patients. Conclusion: A consistent nationwide implementation of the PO-Bado for the assessment of psychosocial stress in cancer patients would contribute to the improvement of medical care.

S184 – Communication Experiences and QOL after Laryngeal Cancer

Objectives 1) To investigate the sensitivity to change of the Swedish Self-Evaluation of Communication Experiences after Laryngeal Cancer questionnaire (S-SECEL), addressing communication dysfunction in patients treated for laryngeal cancer. 2) To evaluate longitudinal score changes in relation to established and validated quality of life instruments. Methods 100 patients with Tis-T4 laryngeal cancer were included prior to treatment onset. Patients answered 4 questionnaires at 6 occasions during 1 year; the S-SECEL, the EORTC Quality of Life Questionnaire, the EORTC Head and Neck cancer module, and Hospital Anxiety and Depression (HAD) scale. In addition, performance status was assessed. Differences within groups were tested with the Wilcoxon paired signed ranks test and between-group analyses were carried out using the Mann-Whitney U test. Magnitude of group differences was analyzed by means of effect sizes. Results S-SECEL was well accepted with a response rate of 76%. Communication dysfunction increased at 1 month, followed by a continuous decrease throughout the year. Changes were statistically significant at most measurement (p &lt; 0.001), demonstrating the sensitivity of the S-SECEL to changes in communication over time. The S-SECEL was more sensitive than EORTC regarding communication dysfunction. Conclusions The questionnaire was responsive to change and showed convergent results when compared to established HRQL questionnaires. As a routine screening instrument, the S-SECEL could be a valuable tool for identifying patients at risk for psychosocial problems, to help plan rehabilitation and in-depth counselling. It is therefore recommended for clinical use in evaluation of communication dysfunction for all patients with laryngeal cancer, irrespective of treatment.

Measurement and interpretation of social distress using the social difficulties inventory (SDI)

Cancer has a significant social impact. There is a requirement to undertake formal assessment of this in research and clinical practice. Aim To establish values of clinically meaningful differences and changes in social distress (SOCD) using the social difficulties inventory (SDI). Methods Newly diagnosed patients treated with curative intent completed the SDI and the EORTC quality of life questionnaire (EORTC QLQ-C30) at baseline, 6, 12 and 24 months. Minimally important differences (MIDs) were estimated using anchor and distribution methods. Results One hundred and eighty-eight patients participated. SOCD was elevated at baseline demonstrating the social burden of cancer on patients following diagnosis. Anchor estimates for MIDs were by age groups 3.37 and in comparison to EORTC QLQ-C30 social functioning scale from 0 to 6.27. Using distribution methods: SEM 2.01–4.92 and SD 1.67–3.57. Conclusion For general guidance, an estimate of 3 (range 0–44) is recommended as a clinically important difference, illustrated by case studies and group comparisons.

Quality of life one year after chemoradiotherapy for localized primary gastric diffuse large B-cell lymphoma

We assessed the quality of life (QOL) at least one year after sequential chemoradiotherapy for the treatment of localized gastric diffuse large B-cell lymphoma (DLBCL). We used the EORTC Quality of Life Questionnaire for Stomach Cancer (EORTC QLQ-STO22). Among the 45 patients available at the one-year follow-up after radiation therapy, 40 patients completed the EORTC QLQ-STO22 questionnaire. Their median age was 54.5 (range, 20-70 years). Social functioning was most adversely affected among the respondents with a score of 59, whereas other functions and the global scales were preserved above a score of 70 by linearly transformed values. Fatigue, the financial impact and specific emotional problems such as "thinking about their illness" (STO-ANX) and "worry about weight loss or future health" (STO-BI) were persistently bothersome for some patients. Other stomach-related symptoms such as dysphagia, pain, or reflux were negligible at 1 year after treatment. Therefore, this organ-preserving combined approach was effective for the maintenance of the QOL and minimization of stomach abnormalities in patients with gastric lymphoma.

Psychosocial intervention as a component of routine breast cancer care—who participates and does it help?

Women who participated in the hospital psychosocial support groups following breast cancer surgery were compared with non-participants. The Hospital Anxiety and Depression Scale and the EORTC quality of life questionnaire were used to measure emotional distress and quality of life at the time of diagnosis and after 12 months. The General Life Orientation Test-Revised was used to measure dispositional optimism. Of 165 women, 87% reported that they had been invited to participate, and 66% participated. The salient predictor for participating in support group was optimism (OR 0.89 CI: 95% 0.83-0.98, p=0.01). No significant difference was found between the prevalence of anxiety and depression caseness at the time of diagnosis, but after 12 months, the prevalence of anxiety caseness was significantly lower among the participants than that among the non-participants (19% vs 34%, p=0.04). In conclusion, psychosocial intervention as a component of routine breast cancer care appears to have a long-term clinical beneficial effect on anxiety. For depression and quality of life, the study is inconclusive. Self-selection may prevent patients at risk of adverse outcome to participate in support groups.

The prognostic effects of performance status and quality of life scores on progression-free survival and overall survival in advanced ovarian cancer

Objective. Performance status (PS) is an important prognostic factor in advanced ovarian cancer. The purpose of this study was to evaluate the prognostic significance of PS and quality of life (QoL) assessment on progression-free survival (PFS) and overall survival (OS) in patients with advanced ovarian cancer. Methods. We studied Canadian patients participating in an intergroup study in ovarian cancer (NCIC-OV10), which randomized patients to receive either standard chemotherapy using cisplatin/cyclophosphamide or cisplatin/paclitaxel chemotherapy. QoL was assessed using the EORTC quality of life questionnaire (QLQ-C30+3). The effects of multiple variables including the relevant clinical variables, PS and QoL scores were analyzed by Cox stepwise regression at baseline and again 3 months after completion of chemotherapy. Results. At baseline and at 3 months after chemotherapy, there were 151 and 93 patients respectively who completed the QLQ-C30+3 questionnaires. Baseline PS, global QoL score and treatment were independent predictors for both PFS and OS. Baseline cognitive functioning score was also an additional independent predictor for OS. At 3 months after completion of chemotherapy global QoL score, PS and grade were significant independent predictors of OS; however, only physical functioning score, emotional functioning score and tumor grade predicted for PFS. Conclusions. Performance status and global quality of life scores at baseline are prognostic factors in advanced ovarian cancer for both PFS and OS. Higher baseline cognitive functioning scores were also associated with improved survival. Global QoL scores at 3 following completion of chemotherapy proved to be of prognostic significance for OS but not PFS.

Quality of life of breast cancer patients in the course of adjuvant radiotherapy

In cancer patients, there is an ongoing interest in evaluating the impact of therapeutic interventions on health-related quality of life (hrqol). However, only a few longitudinal studies are published being able to measure the influence of therapy for the patients' quality of life. Based on these data, our aim was to evaluate changes of hrqol during the course of adjuvant radiotherapy in breast cancer patients with special focus on subgroup analysis. Sixty-one women undergoing radiotherapy after breast conserving surgery were asked to answer the EORTC Quality of life questionnaire (EORTC-QOL-C30) three times: at the beginning of radiotherapy, in the forth week and 6 weeks after the end of treatment. To identify patients with changes of their qol during the observation time, the function scale "Global health status/Quality of life" was used enabling us to classify three subgroups: (1) unchanged hrqol (NC), (2) increasing hrqol (INC), (3) decreasing of hrqol (DEC). Patients with an increasing hrqol (N = 25) demonstrated a significant increase in the role as well as in the emotional functioning scales. In patients with a decreasing hrqol (N = 15), no changes in any of the function scales were found, while a significant decrease in their cognitive functioning was observed in patients with no change in hrqol (N = 21). Although the interpretation of these data is difficult because only a few data are available to compare our results, it could be demonstrated that emotional support and the ability to maintain a daily routine in additionally irradiated breast cancer patients is important to optimise hrqol. If hrqol decreases during the course of radiotherapy, the function scales of the EORTC-QOL-C30 seem to be insensitive to reflect this decrease.

Late swallowing dysfunction and dysphagia after radiotherapy for pharynx cancer: Frequency, intensity and correlation with dose and volume parameters

Background and purpose Dysphagia and swallowing problems are common in pharynx cancer patients treated with radiotherapy. Dysfunction of the upper aerodigestive tract may lead to reduced quality of life, malnutrition and aspiration pneumonia. The aim of the current study was to describe swallowing function after radiotherapy and examine its correlation with irradiated volume and dose. Patients and methods All recurrence free patients treated for pharynx cancer with radical radiotherapy at our institution, between 1998 and 2002, were invited to participate, 35 (55% of eligible) agreed. Patients were examined with EORTC quality of life questionnaires and functional endoscopic evaluation of swallowing. Organs at risk were delineated on planning CT scans, available for 25 patients. Results Eighty-three percent of patients had some degree of dysphagia. Reduced sensitivity was observed in 94%, residues in 88%, penetration in 59% and aspiration in 18% of patients. Several significant correlations were found between both subjective and objective swallowing problems and DVH parameters of the upper aerodigestive tract. Doses less than 60 Gy to the supraglottic region, the larynx and upper esophageal sphincter resulted in a low risk of aspiration. Discussion Both subjective and objective swallowing problems were frequent and severe after radiotherapy for pharynx cancer. Swallowing dysfunction was correlated with dose and volume parameters of the upper aerodigestive tract.

Reliability and validity of the Functional Assessment of Cancer Therapy-melanoma (FACT-M)

8554 Background: Our group has developed a disease-specific module for the Functional Assessment of Cancer Therapy (FACT) instrument to assess quality of life (QOL) in melanoma patients. The purpose of this study was to assess the reliability and validity of the melanoma subscale (MS) and melanoma surgery subscales (MSS) as well as the total FACT-M, which includes the FACT combined with the MS and MSS. Methods: 273 melanoma patients (stages I-IV) attending an outpatient melanoma clinic completed a battery of questionnaires at baseline assessment. The scores from the MS, MSS, and total FACT-M were compared to patient performance status (ECOG and Karnofsky scales), disease stage, treatment status, and other instruments with related domains including the Profile of Mood States, Marlowe-Crowne Social Desirability Scale, and the EORTC Quality of Life Questionnaire - melanoma module. Patients were assessed 1 week after baseline to assess test-retest reliability, and 163 patients completed assessments at 3 months to evaluate the responsiveness to change in performance status. Results: Internal consistency and test-retest reliability for the MS (Cronbach's a = 0.85, r = 0.81), MSS (a = 0.85, r = 0.82), and the total FACT-M (a = 0.95, r = 0.90) were excellent. Overall, the scales correlated with other measures and correlations were in the hypothesized direction. As predicted, FACT-M, MS, and MSS scores were lower for patients with advanced (stage III/IV) melanoma, patients with poor performance status, and patients who were receiving active treatment. In addition, total FACT-M, MS, and MSS scores were highly sensitive to changes in performance status (p = 0.0012, 0.0004, and 0.0006, respectively). Conclusions: The FACT-M is a reliable and valid QOL assessment tool for patients with melanoma. This disease-specific instrument should be utilized for melanoma QOL assessment in clinical trials. No significant financial relationships to disclose.

Validation of the University of Washington quality of life questionnaires for head and neck cancer patients in India

Quality of life (QOL) is a multidimensional construct capturing the subjective wellbeing of patients in physical, emotional, functional and social domains. Available work on post treatment QOL have only been made in western literature and less in Indian literature. To translate the UW-QOL into both Hindi and Marathi and psychometrically validate the translation in HandN cancer patients in Indian population. A prospective study was done at the Tata Memorial Hospital for patients who were treated for H and N cancers. 147 patients were enrolled from January to April 2005. The study was carried out in two phases. Patients were given translated versions of the UW-QOL and EORTC QOL questionnaires pre-operatively, 15 days post-operatively and then three months post-operatively. Both the Hindi and Marathi translations had strong internal consistency (Cronbach's alpha=0.7971 and 0.7839). UW-QOL composite scores correlated well with the global questions on overall QOL in both the Hindi (r=0.69) and Marathi (r=0.66) translations and also with T-stage. QOL scores were worse three months post-operatively than pre-operatively and for patients undergoing surgery that violated the mucosa. A strong correlations was observed (r>0.50) between all similar domains on the UW-QOL and EORTC HandN35 except the saliva item on the Marathi translation, where r< 0.50, but P-values were significant. The Marathi and Hindi versions of the UW-QOL appear to be valid and reliable instruments for assessing the QOL in Indian population and will be a vital tool for achieving greater insight into the short- and the long term QOL.

Palliative chemotherapy beyond three courses conveys no survival or consistent quality-of-life benefits in advanced non-small-cell lung cancer

This randomised multicentre trial was conducted to establish the optimal duration of palliative chemotherapy in advanced non-small-cell lung cancer (NSCLC). We compared a policy of three vs six courses of new-generation platinum-based combination chemotherapy with regard to effects on quality of life (QoL) and survival. Patients with stage IIIB or IV NSCLC and WHO performance status (PS) 0–2 were randomised to receive three (C3) or six (C6) courses of carboplatin (area under the curve (AUC) 4, Chatelut's formula, equivalent to Calvert's AUC 5) on day 1 and vinorelbine 25 mg m−2 on days 1 and 8 of a 3-week cycle. Key end points were QoL at 18 weeks, measured with EORTC Quality of Life Questionnaire (QLQ)-C30 and QLQ-LC13, and overall survival. Secondary end points were progression-free survival and need of palliative radiotherapy. Two hundred and ninety-seven patients were randomised (C3 150, C6 147). Their median age was 65 years, 30% had PS 2 and 76% stage IV disease. Seventy-eight and 54% of C3 and C6 patients, respectively, completed all scheduled chemotherapy courses. Compliance with QoL questionnaires was 88%. There were no significant group differences in global QoL, pain or fatigue up to 26 weeks. The dyspnoea palliation rate was lower in the C3 arm at 18 and 26 weeks (P<0.05), but this finding was inconsistent across different methods of analysis. Median survival in the C3 group was 28 vs 32 weeks in the C6 group (P=0.75, HR 1.04, 95% CI 0.82–1.31). One- and 2-year survival rates were 25 and 9% vs 25 and 5% in the C3 and C6 arm, respectively. Median progression-free survival was 16 and 21 weeks in the C3 and C6 groups, respectively (P=0.21, HR 0.86, 95% CI 0.68–1.08). In conclusion, palliative chemotherapy with carboplatin and vinorelbine beyond three courses conveys no survival or consistent QoL benefits in advanced NSCLC.

Translation and validation of the EORTC QLQ-C30 for use among Turkish and Moroccan ethnic minority cancer patients in the Netherlands

The purpose of this study was to validate the core EORTC quality of life questionnaire, the QLQ-C30 (version 3.0), for use among Turkish and Moroccan cancer patients in the Netherlands. The questionnaire was translated into two oral Moroccan languages , and the existing Turkish version was culturally adapted for use in the Netherlands. Ninety Turkish and 79 Moroccan patients completed the questionnaire. Administration of the questionnaire proved feasible, with low levels of missing questionnaires (4%) and missing items (on average, 1.5–2.4%). With one minor exception, the evidence of convergent validity was strong for all multi-item scales. Internal consistency reliability was above 0.70 for all scales except the cognitive functioning scale in the Turkish sample. The questionnaire was able to distinguish clearly between subgroups formed on the basis of performance status and comorbidity, and was moderately responsive to change over time in performance status. These data support the use of the QLQ-C30 among Turkish and Moroccan cancer patients residing in the Netherlands. Additional studies are needed to confirm the psychometrics of the questionnaire when used among these ethnic minority groups residing in other Western European countries.

The relationship between observer-based toxicity scoring and patient assessed symptom severity after treatment for head and neck cancer. A correlative cross sectional study of the DAHANCA toxicity scoring system and the EORTC quality of life questionnaires

Background and purpose Morbidity is an important issue in cancer research. The observer-based toxicity scoring system used by DAHANCA (the Danish head and neck cancer study group) has proved itself sensitive to differences in toxicity in a large randomised study, but like other toxicity scoring systems it has not been formally validated. Conversely, the EORTC quality of life questionnaire (QLQ) has been validated as a tool for collecting information about the consequences of disease and treatment on the well being of cancer patients. The purpose of this study was to examine the relationship between the two methods of side effect recording. Patients and methods One hundred and sixteen recurrence free patients with laryngeal ( n=44), pharyngeal ( n=34) and oral cavity ( n=38) cancer attending follow-up after radiotherapy ( n=83) or surgery ( n=33) completed EORTC C30, the core questionnaire concerning general symptoms and function and EORTC H&N35 the head and neck specific questionnaire. The attending physicians in the follow-up clinic evaluated and recorded DAHANCA toxicity scores on the same patients. Results The DAHANCA toxicity scoring system and the EORTC QLQ correlated with several clinical endpoints. The conceptually similar endpoints of the two methods correlated significantly. The objective endpoints of the DAHANCA scoring system were only correlated with quality of life endpoints to a very low degree. The DAHANCA toxicity scores had a low sensitivity (0.48–0.74) in detecting equivalent subjective complaints from the questionnaires and the observer-based scoring system severely underestimated patient complaints. A specific patient group where the DAHANCA score had a higher tendency to fail could not be detected. Conclusion The DAHANCA toxicity score is an effective instrument in assessing objective treatment induced toxicity in head and neck cancer patients but insensitive and non-specific with regard to patient assessed subjective endpoints. This weakness seems inherent in an observer-based scoring system, and will probably also apply to newer ones like CTCAE 3.0.

Stated Preferences of Patients with Cancer for Health-related Quality-of-life (HRQOL) Domains During Treatment

It is postulated that patients with different cancer diagnoses, stages of disease and treatments will exhibit different individual preferences for health-related quality-of-life (HRQOL) functional domains and symptoms. A stated-preference (SP) instrument incorporating all functional domains and symptoms of the EORTC Quality of Life Questionnaire (QLQ-C30) was administered to 400 patients with either breast (n = 150); colorectal (n = 150) or non-small cell lung cancer (n = 100) who had previously experienced chemotherapy. The SP survey asked patients to make choices between a series of hypothetical functional/symptom pairs defined by combinations of HRQOL attributes, and depicted by levels of functioning and symptomatology. In the 400 patients, considered as one group, role, cognitive, and social functioning, fatigue, nausea/vomiting, pain, appetite loss, diarrhea and financial difficulties were most important, whereas physical and emotional functioning, dyspnea, constipation and insomnia were less important. The four effects that patients with breast cancer most wished to avoid were nausea and vomiting, pain, and decreases in emotional and role functioning. Patients with colorectal cancer listed diarrhea as the second most important effect to avoid (after nausea/vomiting, but before pain and role functioning), whereas those with non-small cell lung cancer listed dyspnea as the fourth most important effect to avoid. These results provide more precise information regarding patient treatment concerns than that provided by the usual measurement of HRQOL. This information can be used by clinical trial investigators to design more precise interventions to improve HRQOL in the domains of greatest importance to patients and by all health care professionals to improve counseling of patients.

CHOP followed by involved field radiotherapy for localized primary gastric diffuse large B-cell lymphoma: Results of a multi center phase II study and quality of life evaluation

We aimed to define the role of cyclophosphamide, vincristine, doxorubicin, prednisone (CHOP) followed by involved field radiotherapy (IFRT) for treating localized primary gastric diffuse large B-cell lymphoma (DLBCL). Newly diagnosed patients with localized primary gastric DLBCL were to receive four cycles of CHOP followed by IFRT of 40.0 Gy. At 1 year after the completion of treatment, patients filled out the EORTC Quality of Life Questionnaire specified for stomach cancer (QLQ-C30-STO22). Fifty evaluable patients (25 men, 25 women) were included. The median age was 54.5 years (range, 21 – 73 years. The overall response rate to the CHOP was 94% (95% confidence interval [CI], 87 – 100) in the intent-to-treat population. Forty-one of the 50 patients (82%; 95% CI, 71 – 93) achieved complete remission (CR). After the completion of radiotherapy, five patients who were in PR following chemotherapy eventually attained CR. The overall complete response rate was thus 92% (95% confidence interval, 84 – 99). With a median follow-up period of 30 months, the 2-year progression-free and overall survival rate was 92% and 92%, respectively. The gastric function was well preserved with negligible stomach-related symptoms at 1 year after the completion of treatment. This organ-preserving combined treatment is highly effective and well tolerated for the patients with localized gastric DLBCL.

Multidimensional Constructs of the EORTC Quality of Life Questionnaire (QLQ-C30) in Korean Cancer Patients with Heterogeneous Diagnoses

The aim of this study was to evaluate the multidimensional constructs of the EORTC Quality of Life Questionnaire (QLQ-C30) in patients with cancer, employing not only the commonly used multitrait scaling analysis and interscale correlations, but also the factorial and multidimensional scaling (MDS) analyses. A total of 334 Korean cancer patients participated in this cross-sectional study. All patients completed the QLQ-C30. With the multitrait scaling analysis, the cognitive functioning scale did not meet item convergent and divergent validities. With the interscale correlations, the physical and role functioning scales were found to be highly correlated; this was also evident in the factorial analysis. The MDS showed that each item within the social, emotional, global health status/quality of life, and nausea/vomiting scales were clustered close together, but far from those of the other scales. The authors conclude that the four way evaluation of the QLQ-C30 produced results that supported the original hypothesized constructs. However, the physical and role functioning scales were not distinctive, and that of the cognitive functioning was somewhat problematic in the Korean population with cancer.

Surgery for recurrent laryngeal carcinoma after radiotherapy: Partial laryngectomy or total laryngectomy for a better quality of life?

To investigate the quality of life after partial laryngectomy versus total laryngectomy for recurrent laryngeal carcinomas after radiotherapy. A retrospective study performed at least one year after treatment. This study was performed in a university hospital. Twenty-three patients (N = 12 partial laryngectomy, N = 11 total laryngectomy) with recurrent laryngeal cancer after radiotherapy were included in the study. Three different questionnaires, 1) EORTC Quality of Life Questionnaire (QLQ)-C30 Dutch version 3.0, 2) EORTC-H & N 35, and 3) the Voice Handicap Index, were sent to all patients. The only major difference in quality of life of patients after partial laryngectomy versus total laryngectomy was found to be smell and taste related. No other differences were found. We did not find much difference in quality of life after treatment with a partial laryngectomy or a total laryngectomy in patients with recurrent laryngeal cancer after radiotherapy.

Treatment of Del(5q) Myelodysplastic Syndrome with All-Trans-Retinoic Acid and Tocopherol-α.

All-trans-retinoic acid (ATRA) alone or in combination with cytokines and vitamins has shown erythroid remitting capacities in low-grade myelodysplastic syndromes (MDS). We performed a phase II study on 29 patients with MDS and isolated del(5q) including bands 5q31–5q33 to determine the efficacy and safety of ATRA in combination with tocopherol-α. All patients had low/intermediate-1 risk MDS according to the international prognostic scoring system. Inclusion criteria were isolated del(5q), medullary blast count of <10%, hemoglobin <10g/dl or transfusion dependent anemia, and ECOG performance score <3. Included were 18 women and 11 men. Median age of patients was 64 years. FAB subtypes were 25 refractory anemias, 1 refractory anemia with ring sideroblasts, 3 refractory anemias with excess of blasts. Median MDS duration before ATRA treatmnet was 31.7 months. Median hemoglobin level was 8.4 g/dl at study entry. Patients received 45 mg/m² ATRA day 1 to 90, and 90 mg/m² day 91 to 180. Tocopherol dosage was 600 IU three times daily. 24 patients completed dose level I, 12 patients dose level II. 86% of patients experienced side effects. 13 interrupted study drug treatment due to adverse events: Skin reactions (NCI grade 3), conjunctivitis (grade 3), headache and joint pain (grade 3) were the worst recorded. Other adverse events included hair loss, CNS symptoms, cheilitis, stomatitis, creatinine elevation, hypertriglyceridemia, hypercholesterinemia, nausea and vomiting, and elevation of liver function tests. 3 patients were admitted to hospital for side effects and these were therefore qualified as serious. Response criteria were qualified as recommended by the international working group for MDS. One patient (3%) achieved a major erythroid response resulting in transfusion independence throughout the study. He became transfusion dependent again within one month after study termination. 4 patients (14%) achieved a minor erythroid response with reduction of >50% of transfusion needs. No patient had a cytogenetic response. Responders did not show a reduction in del(5q) as determined in interphase fluorescence in-situ hybridization. There was no significant improvement in quality of life in responding patients as measured by the EORTC quality of life questionnaire. We conclude that the combination of ATRA and tocopherol-α is not recommended for the treatment of del(5q) MDS.

Does the assessment of quality of life (QoL) correlate with clinical response? Results of a prospective study in 374 patients with advanced gynecological malignancies

5146 Background: In palliative care of patients (pts) with advanced gynaecological malignancies every therapeutic intervention should be evaluated by its impact on QoL. Different treatment modalities (e.g. chemotherapy) are indicated to improve symptoms. In general the response of palliative therapy will be assessed by radiological methods (e.g. CT, MRI). The purpose of this prospective study was to investigate whether QoL assessment can be used as an additional instrument to evaluate the clinical response on palliative treatment. Methods: First, we performed a phase I/II trial in 50 pts to calculate the number of required pts to answer the question: “Is there a significant difference in QoL between pts with partial response (PR) and stable disease (SD)?”. Eligibility criteria: Pts with advanced gynaecological malignancies who underwent palliative treatment. Response evaluation by radiological or serological or clinical measurements within the last 4 weeks. QoL was examined using EORTC QoL Questionnaire C30 (QLQ-C30). Results: Overall, 374 pts (median age 59 years) were recruited (11/02–11/03): 62 pts showed complete response (CR), 143 PR, 105 stable disease (SD) and 64 progressive disease (PD), respectively. Breast and ovarian cancer were the most frequent diagnosis. Best results in global health scores and symptom scales were achieved in pts with PR. Especially in fatigue, physical- and role functioning scales the differences between patients with PR and SD were significant. Conclusions: We conclude that for patients with PR and SD the assessment of QoL seems to reflect clinical response of the treatment. The results indicate that QoL assessment is an important additional instrument to asses clinical response in the palliative setting. Supported by ESSEX Pharma. No significant financial relationships to disclose.