Cooperative trial CWS-91 for localized soft tissue sarcoma in children, adolescents, and young adults.

PURPOSE: To improve risk-adapted therapy for localized childhood soft tissue sarcoma within an international multicenter setting. PATIENTS AND METHODS: Four hundred forty-one patients younger than 21 years with localized rhabdomyosarcoma and rhabdomyosarcoma-like tumors (ie, extraosseous tumors of the Ewing family, synovial sarcoma, and undifferentiated sarcoma) were eligible. Therapy was stratified according to postsurgical stage, histology, and tumor site. In unresectable tumors, treatment was further adapted depending on response to induction chemotherapy, TN classification, tumor size and second-look surgery. A novel five-drug combination of etoposide, vincristine, dactinomycin, ifosfamide, and doxorubicin (EVAIA) was evaluated for high-risk patients, but cumulative chemotherapy dosage and treatment duration were reduced for the remaining individuals as compared with that of the previous trial CWS-86. Hyperfractionated accelerated radiotherapy (HART) was recommended at doses of either 32 or 48 Gy. RESULTS: At a median follow-up of 8 years, 5-year event-free survival (EFS) and overall (OS) survival for the entire cohort was 63% +/- 4% and 73% +/- 4%, respectively (all survival rates in this abstract are calculated and displayed with +/-95% CI). EFS/OS rates by histology were 60% +/- 5%/72% +/- 5% in rhabdomyosarcoma, 62% +/- 10%/69% +/- 10% for Ewing tumors of soft tissues, 84% +/- 12%/90% +/- 10% for synovial sarcoma, and 67% +/- 38%/83% +/- 30% for undifferentiated sarcoma, respectively. Response to one cycle of the five-drug combination EVAIA was similar to that of the four-drug combination VAIA used in CWS-86. Two hundred twelve patients with rhabdomyosarcoma underwent radiation (EFS, 66% +/- 6%); 53 of those patients had a favorable risk profile and received 32 Gy of HART (EFS, 73% +/- 12%). TN classification, tumor site, tumor size, histology, and age were prognostic in univariate analysis. CONCLUSION: Improved risk stratification enabled decreased therapy intensity for selected patients without compromising survival. Intensified chemotherapy with EVAIA did not improve outcome of localized high-risk rhabdomyosarcoma.

Waiting for radiotherapy a national call for ethical discourse on waiting lists in radiotherapy: findings from a preliminary survey.

BACKGROUND AND PURPOSE: Growing incidence of cancer and the demographic changes of the society can cause severe shortage in radiotherapy services. This can lead to the use of waiting lists, which can serve as an indicator model for shortage of medical service. To investigate whether and how waiting lists are used in Germany, a survey was undertaken among German radio-oncologists. Their opinion concerning the use of waiting lists and their attitude toward the involved ethical problems were the central topics of this study. MATERIAL AND METHODS: A questionnaire was developed which consisted of 18 items: four items covered general aspects, four were about the management of waiting lists, seven concerned problems of waiting lists, and three were about the future aspects. From all items, at least ten touched ethical aspects such as patient information or the doctor-patient relationship. 19 consecutive radio-oncologists answered the questionnaire via telephone. The main interest of this study was to generate further hypotheses for future research. RESULTS: From all doctors (n = 19), most did not use waiting lists (n = 12) in their practice, whereas the remaining did use them (n = 7). Limited resources were seen as the central underlying problem (n = 16). Two guiding principles were most often quoted for managing waiting lists: patients with complaints such as pain before those without (n = 18) and curative before palliative radiotherapy (n = 15). Concerning the information given to patients about the use of waiting lists, some doctors voted for detailed information (n = 7), which covers negative side effects of waiting lists such as tumor progression during waiting time, others voted against (n = 11). There was a profound disagreement on the question of whether curative and palliative radiotherapy should be differently treated in the context of waiting lists. 70% of the group, who used waiting lists, could give a moral justification for waiting lists, whereas only 28% of the group, who did not use them, could offer a justification. CONCLUSION: The survey showed that doctors were most concerned about the ethical aspects of waiting lists. Open questions are: (1) What is the best principle for a fair distribution of limited radiotherapy places? (2) How should patients be informed about waiting lists? (3) What moral justifications can be given for waiting lists? These issues must therefore become topics of future research and national dialogue, because the answers to these questions are necessary for the clinical use of waiting lists in radiotherapy.

Ethical aspects of patient information in radiation oncology. An introduction and a review of the literature.

BACKGROUND: While legal aspects of patient information in radiotherapy are often discussed in clinical literature, ethical aspects are mainly a topic of debate only in bioethical literature. Nevertheless, patient information about radiation oncology has many ethical implications which must be considered in order to provide an optimal patient care. Therefore, this publication describes these ethical aspects from a clinical perspective. METHODS: The basis of this project was a Medline search (1990-2002) using the key words "radiotherapy" and "patient information" for the first part, and "radiotherapy" and "ethics" for the second part. RESULTS: The clinical papers (n = 55) demonstrate a serious attempt to improve patient information in clinical practice. Most articles deal with various discussion aids like booklets, audiotapes and others, or deal with the patients' information needs and preference. Under ethical aspects (n = 26 papers), palliative radiotherapy confronts the physician with many unsolved problems concerning telling the truth and the patient's misunderstandings which are often observed. The most important ethical principles of patient information are truth, autonomy, informed consent, and hope. For each of these, a definition is provided, as well as a detailed discussion of various typical situations in radiation oncology such as adjuvant therapy or palliative treatment. CONCLUSION: Considerations regarding the ethical aspects of patient information can provide an impulse to clinical improvement. Therefore, research in this field should be intensified in the future, especially in the area of palliative radiotherapy.

Patient information in radiooncology results of a patient survey.

BACKGROUND: As a result of increased interest and public demand, providing patients with adequate information about radiooncology has become more and more difficult for the doctor. Insufficient patient information can not only cause anxiety for the patient, but can also lead to legal action against the physician. In order to gain a deeper insight into our clinical practice of providing patient information, we developed a special questionnaire. We describe our first experiences in using this questionnaire at our institute. PATIENTS AND METHODS: We examined the amount of information and level of satisfaction, as well as the agreement of assessment between patient and physician after the provision of standard patient information before and at the end of radiotherapy. 51 consecutive patients were interviewed with a newly designed questionnaire. The first questioning with 13 items was carried out before radiotherapy and the second with ten items was done at the end of treatment. Sum scores for information and satisfaction were defined and agreement was measured by the weighted kappa coefficient. RESULTS: Global level of information and satisfaction was good, and a significant increase in information level and a significant decline in satisfaction were seen between questionnaire 1 and 2. Agreement between patient and physician was fair, for example intent of treatment resulted in a kappa coefficient of 0.34, and poor for the doctor's role with a kappa coefficient of -0.002. Only 52% of the patients who received palliative radiotherapy rated correctly the non-curative intent of treatment, whereas 86% of the patients who received curative radiotherapy made a correct statement. Before radiotherapy, emotional state was often both negatively and positively assessed by the patients. CONCLUSION: Our short questionnaire is simple and easy to understand. It provides insights into patient information with respect to assessment of the information, satisfaction level, and agreement between doctor and patient. Therefore, it is suitable for use in the clinical routine. We found a high information and satisfaction score, but limited agreement between physician and patient. In the future, the questionnaire can be used as an aid to evaluate patient information in everyday practice and to train the communication skills of the physician. Further evaluation of the questionnaire is needed and, in particular, the aspect of patient information with palliative radiotherapy has to be improved.