Development and validation of a questionnaire to evaluate how a cosmetic product for oily skin is able to improve well-being in women.

BACKGROUND: Skin diseases are known to negatively affect self-image and to have detrimental psychosocial effects. Oily skin is a cosmetic skin problem that women often describe as 'invalidating'. OBJECTIVE: To develop and validate a questionnaire to assess the psychological and psychosocial effects of oily skin condition in women and the outcome of a targeted cosmetic skincare treatment. METHODS: We developed and validated a concise 18-item questionnaire [oily skin self-image questionnaire (OSSIQ)] to assess perception, behavioural, and emotional consequences associated with oily skin condition. The questionnaire was then used to assess the effects of a skincare treatment for oily skin and compare them with sebum level measurements. RESULTS: The 18-item questionnaire clearly distinguished the oily skin group from the control group. Responsiveness, reliability, and construct validity showed satisfactory performance. The questionnaire provided a relevant assessment of the psychological benefits associated with the skincare programme. CONCLUSION: The OSSIQ is a valid tool that can be used to monitor the benefits of cosmetic skincare treatments.

Determinants of patient satisfaction in oncology settings from European and Asian countries: preliminary results based on the EORTC IN-PATSAT32 questionnaire.

The aim of this study was to identify factors associated significantly with hospitalised cancer patients' satisfaction with care. Patients were recruited from four geographical/cultural groups, including five European countries and Taiwan. They rated their level of satisfaction by completing the EORTC IN-PATSAT32 questionnaire at home. Additionally, data were collected on the sociodemographic and clinical characteristics and the quality of life of the patients, as well as on institutional characteristics. Of 762 patients recruited, 647 (85%) returned a completed questionnaire. The number of nurses and doctors per bed, institution size, geo-cultural origin, ward setting, teaching/non-teaching setting, treatment toxicity, global health status, participation in clinical trials and education level were all associated significantly at the multivariate level with satisfaction with doctor and nurse interpersonal skills, information provision, availability, and/or overall satisfaction. A number of patient-, institutional- and culture-related factors are associated with the perceived quality of cancer care. Future studies, with appropriate sampling frames and stratification procedures, are needed to better understand cross-national and cross-cultural differences in cancer patient satisfaction.

[Multisite validation study of questionnaire assessing out-patient satisfaction with care questionnaire in ambulatory chemotherapy or radiotherapy treatment]. / Validation multicentrique d'un questionnaire de satisfaction des soins lors d'un traitement de chimiothérapie ou radiothérapie ambulatoire.

Patient satisfaction is now recognised as an important quality of care outcome which is particularly relevant in oncology. Adapted from the EORTC In-Patsat32, the Out-Patsat35 is a 35-item satisfaction with care questionnaire measuring cancer outpatients' perception of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric properties of this scale. Patients undergoing ambulatory chemotherapy (CT) or radiotherapy (RT) in 7 cancer centres in France were invited to complete at home the Out-Patsat35 as well as EORTC QLQ-C30 for psychometric testing. Of 416 eligible patients recruited, 96% returned the questionnaire. Most patients (71% in CT; 69% in RT) completed this scale within 15 minutes and the mean rate of item omission was only 4.4%. Confirmatory analyses revealed good convergent validity and excellent internal consistency, although some subscales within the Out-Patsat35 were relatively highly correlated. Items and subscales of the Out-Patsat35 and of the QLQ-C30 were not significantly correlated, underlying that the two questionnaires are assessing quite distinct concepts. The subscales of the Out-Patsat35 were not related to age, gender and education, suggesting a cultural evolution in French cancer patients towards a greater homogeneity in their opinion toward care. This study supports the acceptability to patients, and the psychometric properties of the EORTC Out-Patsat35 questionnaire.

An international prospective study of the EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT32).

Little is known about patients' satisfaction with care in oncology hospitals across cultural contexts. Within the EORTC, we developed a 32-item satisfaction with care questionnaire to measure patients' appraisal of hospital doctors and nurses, as well as aspects of care organisation and services. This study assessed the psychometric characteristics of the questionnaire, the EORTC IN-PATSAT32, in a large, international sample of patients with cancer. Patients discharged from a surgery or medical oncology ward in nine countries were invited to complete at home the EORTC IN-PATSAT32 as well as other instruments for psychometric testing. Of 762 eligible patients recruited, 15% failed to return the questionnaire. Of the 647 compliant patients, 63% completed the questionnaires within 15 min and 82% required no help in its completion. Multitrait scaling analysis revealed excellent internal consistency and convergent validity, although some scales within the IN-PATSAT32 were relatively highly correlated. Test-retest data on 113 patients showed high reliability for most scales. Scales of the IN-PATSAT32 and of the QLQ-C30 were not significantly correlated, suggesting that the two questionnaires are assessing quite distinct concepts. The scales of the IN-PATSAT32 were able to discriminate clearly between patients with differing care expectations and differing intentions to recommend their hospital to others. This study supports the acceptability to patients, and the psychometric robustness of the EORTC IN-PATSAT32 questionnaire. Further studies are needed to assess the responsiveness of the questionnaire to changes in the structure and process of care over time.

Patient preference for either the EORTC QLQ-C30 or the FACIT Quality Of Life (QOL) measures: a study performed in patients suffering from carcinoma of an unknown primary site (CUP).

The objective of this study was to examine and compare two core measures of Quality Of Life (QOL) used in cancer clinical trials: the European Organisation for Research and Treatment of Cancer QOL Core Questionnaire 30 (EORTC QLQ-30) and the Functional Assessment of Chronic Illness Therapy (FACIT), in order to identify which one patients have the strongest preference for using. 68 patients suffering from Carcinomas of an Unknown Primary site (CUP) were recruited in a multicentric study; all of them completed both questionnaires, administered in a randomised manner. The criteria were the percentage of preferences, and four indicators of acceptability. The results indicated that an equal proportion of patients preferred the QLQ-C30 (19%) and FACIT (19%). 54% of patients felt both questionnaires were acceptable. All the indicators of acceptability favoured the QLQ-C30. Analysis of open-ended questions shed light on the difficulties encountered by the patients. As no significant preference was observed for one of the questionnaires, the QLQ-C30 was chosen on the basis of its significantly better acceptability criteria.

[Quality of life in children: what is a good evaluation tool?]. / Qualité de vie chez l'enfant: qu'est ce qu'un bon outil d'évaluation?

The tools most often used to measure subjective data in health, especially quality of life, are based on psychometry. The object of this article is to provide as simply as possible an explanation to the specific methodological aspects of this field. As an example, the child version of the Children Health Questionnaire (CHQ-CF87) is used to study how to demonstrate the qualities required for a good assessment tool: acceptability in practice, responsiveness, reliability and validity. These qualities must be reassessed when a given tool is translated into another language.

Radiotherapy followed by high dose busulfan and thiotepa: a prospective assessment of high dose chemotherapy in children with diffuse pontine gliomas.

BACKGROUND: The role of high dose chemotherapy (HDC) in patients with pediatric brain tumors currently is ill-defined. The purpose of this pilot study was to assess the feasibility and the benefit of HDC after radiotherapy in a group of children with newly diagnosed diffuse pontine gliomas. METHODS: Patients eligible for study were ages 3-18 years with diffuse intrinsic tumors arising in the pons, who were not treated previously with radiotherapy or chemotherapy. Histologic confirmation was not mandatory, provided clinical findings and magnetic resonance imaging were typical. Patients were given focal radiotherapy followed 2-3 months later by HDC. Busulfan (150 mg/m(2) on Days 8, 7, 6, and 5) and thiotepa (300 mg/m(2) on Days 4, 3, and 2) were administered prior to autologous bone marrow transplantation. Survival was the endpoint, and the statistical procedure was based on sequential subgroup analysis. RESULTS: Thirty-six patients were entered on to the study, 12 of whom underwent stereotactic biopsy or open surgery at the time of diagnosis. One patient eventually was excluded due to inappropriate eligibility criteria. All 35 eligible patients received irradiation. Early progression (9 patients) and parental refusal (2 patients) precluded the use of HDC in 11 patients. Three patients died of HDC-related complications. All 21 patients who survived HDC eventually died of disease progression. The median survival time was 10 months for the study group. The median survival time in the subgroup of patients who received HDC was 10 months (range, 3-26 months). Statistical analysis did not suggest any evidence of survival benefit. CONCLUSIONS: For patients with diffuse pontine gliomas, survival using this aggressive treatment modality does not appear to be any better than that reported for conventional radiotherapy.

The development of the DEGR(R): A scale to assess pain in young children with cancer.

The Gustave Roussy Child Pain Scale (Douleur Enfant Gustave Roussy, DEGR(R)Scale) is a scale for grading prolonged pain in children aged 2-6 years with cancer. The scale comprised six behaviours specific to pain items, five psychomotor inertia items, and four anxiety items, with a total score ranging from 0 to 60. This work was designed to confirm the scale structure and to study its construct validity and convergent validity.Our work was composed of two parts. In the first part of the study, 152 children with progressive cancer were scored by two nurses using the DEGR(R)scale, in a cross-sectional design. And in the second part, 53 of these 152 children were video-recorded. The tapes were assessed both by a panel of four pain specialists using a 0 to 7 Likert scale and by a nurse using DEGR(R)scale.As for the 152 children, the mean of the total scores derived from the DEGR(R)is 20.2 (SD = 6.2). Both the degree of agreement between the nurses (the weighted kappa coefficient) and the internal consistency of the scale (Cronbach alpha coefficient = 0.90) were high, providing evidence of good reliability. Multivariate factor analyses showed a first factor of intensity of pain (51% of the total variance) and a second factor (14% of the total variance) which distinguishes the psychomotor inertia items from the items concerning voluntary expression of pain. Also, the results showed that psychomotor inertia items contribute to both factors and that it is an important sign of prolonged pain. Construct validity was strengthened by the absence of correlation between DEGR(R)scores and variables not related to pain, including fever, neutropenia and anaemia (indicative of poor medical condition) and the absence of parents' visits (indicative of psychological distress).Concerning the 53 video-recorded children, the nurses' DEGR(R)ratings were strongly correlated with the specialists panel scores indicating a fairly good case for convergent validity. Copyright 1999 European Federation of Chapters of the International Association for the Study of Pain.

Treatment of non-metastatic rhabdomyosarcomas in childhood and adolescence. Results of the second study of the International Society of Paediatric Oncology: MMT84.

The second International Society of Paediatric Oncology (SIOP) study for rhabdomyosarcoma (MMT84) had several goals. The two principal aims were: (1) to improve the survival of children with rhabdomyosarcoma; and (2) to reduce the late effects from therapy by restricting the indications for surgery and/or radiotherapy after good response to initial chemotherapy. A further aim was to investigate the role of high-dose chemotherapy in young patients with parameningeal primary tumours. 186 previously untreated eligible patients entered the study. Patients with completely resected primary tumour received three courses of IVA (ifosfamide, vincristine and actinomycin D). Patients with incompletely resected tumour received six to 10 courses of IVA according to stage. Patients achieving complete remission with chemotherapy alone did not usually receive radiotherapy or undergo extensive surgery, but patients remaining in partial remission received local therapy with surgery and/or radiotherapy. Only patients over 5 years of age with parameningeal disease and patients over 12 years with tumours at any site were given systematic irradiation. Complete remission was achieved in 91% (170/186) of all patients. With a median follow-up of 8 years, the 5-year overall survival was 68% (+/- 3% standard error of the mean (SEM) and the 5-year event-free survival 53% (+/- 4% SEM). These results show an improvement over previous SIOP study (RMS75) in which survival was 52% and event-free survival was 47%. Among the 54 patients who exhibited isolated local relapse, 35% (19/54) survived in further remission longer than 2 years after retreatment, including local therapy (surgery +/- radiotherapy). Analysis of the overall burden of therapy received by all surviving children (including primary treatment and treatment for relapse if required) showed that 24% (28/116) were treated by limited surgery followed by three courses of IVA, 29% (34/116) were treated by chemotherapy alone (after initial biopsy) and 13% (15/116) received chemotherapy plus conservative local treatment (limited surgery or radiotherapy for residual disease). Only 34% (39/116) received intensive local therapy defined as radical wide field radiotherapy or radical surgery or both. Compared with the results obtained in the previous SIOP study, treatment in MMT84 was based on response to initial chemotherapy and, despite an overall reduction of the use of local therapy, significantly improved survival for patients with non-metastatic disease. This trial, also for the first time, provides evidence that retreatment after local relapse can achieve long-term second remissions.

CD30(+) anaplastic large-cell lymphoma in children: analysis of 82 patients enrolled in two consecutive studies of the French Society of Pediatric Oncology.

The purpose of this study was (1) to investigate the efficacy of chemotherapy regimens designed by the French Society of Pediatric Oncology for childhood anaplastic large-cell lymphoma (ALCL) and (2) to identify prognostic factors in these children. Eighty-two children with newly diagnosed ALCL were enrolled in two consecutive studies, HM89 and HM91. The diagnosis of ALCL was based on immuno-morphological features and all the cases but 2 were investigated using ALK1 antibody directed to the NPM/ALK protein associated with the 2;5 translocation. Treatment consisted of 2 courses of COPADM (methotrexate, cyclophosphamide, doxorubicin, vincristine, and prednisone) and a maintenance treatment of 5 to 7 months. Seventy-eight patients (95%) achieved a complete remission and 21 relapsed. The probability of survival and event-free survival at 3 years was of 83% (72% to 90%) and 66% (54% to 76%), respectively, with a median follow-up of 49 months. In multivariate analysis, visceral involvement, mediastinal involvement, and lacticodeshydrogenase (LDH) level >/=800 UI/L were shown to be predictive of a higher risk of failure. In conclusion, this type of regimen demonstrated efficacy in childhood ALCL. However, therapeutic results have to be improved for children with adverse prognostic parameters such as visceral or mediastinal involvement or a high LDH level.

[Evaluation of the quality of life in clinical research in cancerology]. / Evaluation de la qualité de vie dans la recherche clinique en cancérologie.

This article clarifies the methodological aspects of quality of life evaluation and its use in cancer research. The quality of life of an individual is a complex, multidimensional, subjective concept, the perception of which is expressed optimally by individual his/herself. The tools most often used to measure the quality of life in clinical research are based on psychometry. They take at least three dimensions into account: physical, psychological and social. They must be valid, reliable and sensitive. These qualities must be verified again when translated into another language. A review of the main tools is provided. The place to be assigned to quality of life evaluation in clinical research is discussed. Routine evaluation is to be excluded because the quality of life is a subjective phenomenon that is tricky to measure and this evaluation increases the temporal and financial costs of the study, without forgetting the intrusive aspect of this action. On the other hand, as long as it contributes substantially to decision-making regarding the choice of curative or palliative treatments, or interventions necessary for the rehabilitation of the patient, it is an assessment criterion that must be included in the study.

Parameningeal rhabdomyosarcoma: results of an international workshop.

PURPOSE: A retrospective analysis was performed on children with nonmetastatic rhabdomyosarcomas (RMS) involving a parameningeal site treated by one of the four major cooperative groups: Intergroup Rhabdomyosarcoma Study (IRS), International Society of Pediatric Oncology (SIOP), German Cooperative Group (CWS), and Italian Cooperative Group (ICS) to analyse survival and prognostic factors. METHODS AND MATERIALS: Between 1979 and 1989, 230 children (median age 6 years) were treated in the IRS III, SIOP 84, CWS 81, and ICS 79 studies. All patients received chemotherapy, and 203 were irradiated. Radiotherapy doses were similar in the four studies, although treatment volumes were not similar. The SIOP patients had smaller volumes treated. In addition, the SIOP patients with a low risk of meningeal involvement and children under 5 years of age were not irradiated if they had a complete response (CR) to chemotherapy. Time to initiation of irradiation was earlier in the IRS and Italian studies. RESULTS: Median follow-up was 62 months (range 22-140). The 5-year survival and 5-year event-free survival were better for the IRS study (74% and 71%) than for the other study groups (55% and 36% for SIOP, 47% and 47% for CWS, and 39% and 39% for ICS). The low-risk (LR) patients in the IRS study had improved survival. However, patients with high risk of meningeal involvement had similar survival in all four studies. The most significant prognostic factor was the size of tumor (> 5 cm). CONCLUSION: The improved results from the IRS group, especially among the LR patients, could be related to the IRS treatment employed, particularly the systematic use of radiation, to the inclusion of patients with smaller tumors, and to the routine use of quality control of radiation.

Metastatic neuroblastoma in children older than one year: prognostic significance of the initial metaiodobenzylguanidine scan and proposal for a scoring system.

BACKGROUND: Metaiodobenzylguanidine (mIBG) is a guanethidine analog that has demonstrated a high sensitivity and specificity in detecting bone metastases in about 90% of metastatic neuroblastomas. However, the predictive value of initial mIBG scan in neuroblastoma patients older than 1 year of age regarding response to initial chemotherapy has yet to be ascertained. Therefore, a scoring system for grading the positivity of mIBG scans was devised and applied in a retrospective study in an attempt to determine whether this score had a prognostic value in neuroblastoma patients older than 1 year of age at diagnosis. METHODS: Eighty-six children, older than 1 year of age, with metastatic neuroblastomas were homogeneously treated and had a mIBG scan performed at diagnosis and following the induction regimen to assess bone metastases. Each mIBG scan was assigned a reproducible score and the predictive value of the initial mIBG score was assessed in order to evaluate response to induction regimen. RESULTS: The relative risk of failing to achieve complete remission after four courses of induction therapy was 6.9 times higher in patients who had more than four mIBG spots at diagnosis. A multivariate analysis including the established prognostic factors revealed that the initial mIBG score was the only significant factor (P < 0.001). CONCLUSIONS: The initial mIBG scan is of prognostic significance to predict response to chemotherapy for metastatic neuroblastoma in children older than 1 year of age. A prospective study comparing this initial mIBG score with other recently established prognostic factors is warranted.

[Problems which arise when testing the equivalence of 2 survival distributions]. / Problèmes posés par la recherche de l'équivalence de deux distributions de survie.

Clinicians' interest in equivalence trials has been increasing for many years. In cancer research we are more often concerned with survival or event free survival (EFS). The usual logrank test has to be modified to test whether the true value r of the relative risk is at least equal to a limit value rL. An equivalence trial of post-operative therapy was carried out in children with stage II nephroblastomas without lymph node involvement, and serves as an illustration of some problems, discussed here, which arise in such design: ethical questions when defining the equivalence region, the choice of a one sided or a two sided formulation, the required number of patients or the power of the comparison. A formula is given in order to allow calculation for the required number of patients to ensure a given power when the treatment effects are the same. Other problems are also encountered when analyzing the observed results as the number of events which is evidently low in a de-escalation trial, may be reduced due to a stopping rule. We also discuss about the possibility to use event free survival as a surrogate of overall survival, and about the difficulties encountered when interpreting the results in terms of significance level.

Osteosarcoma recurrences in pediatric patients previously treated with intensive chemotherapy.

PURPOSE AND METHODS: Between January 1981 and June 1993, 137 children and adolescents were each treated at the Institut Gustave Roussy for an initially nonmetastatic osteosarcoma of the extremities. We report the retrospective analysis of 42 cases of recurrence that occurred in this population. RESULTS: The median interval between the diagnosis of the primary osteosarcoma and the first recurrence was 21 months (range, 5 to 60). The site of the first recurrence was limited to the lung in 20 patients, the bone in seven patients, was local in six patients, and was confined to soft tissue in one patient. In eight patients, the first recurrence affected multiple sites. Subsequent recurrences often involved unusual or multiple sites. Management of recurrences included surgery and/or various regimens of second-line chemotherapy, and in one case involved high-dose chemotherapy followed by autologous bone marrow transplantation. Overall survival and event-free survival were, respectively, 36% and 27% at 36 months. At present, 13 patients are alive without evidence of disease. Response of the primary tumor to preoperative chemotherapy, the time between the diagnosis and the first recurrence, and the number of metastatic lesions did not correlate with survival. The survival rate is better in patients with a local or a pulmonary first recurrence. CONCLUSION: The most important prognostic indicator at first recurrence seems to be the possible complete resection of disease. Patients not amenable to surgery and patients with a second or a third recurrence have a poor prognosis. The potential benefit of more aggressive treatments such as high-dose chemotherapy and autologous bone marrow transplantation should be investigated for these patients.

How to establish equivalence when data are censored: a randomized trial of treatments for B non-Hodgkin lymphoma.

Interest in equivalence trials has been increasing for many years, though the methodology which has been developed for such trials is mainly for uncensored data. In cancer research we are more often concerned with survival. In an efficacy trial, the null hypothesis specifies equality of the two survival distributions, but in an equivalence trial, a null hypothesis of inequivalence H0 has to be tested. The usual logrank test has to be modified to test whether the true value r of the ratio of hazard rates in two treatment groups is at least equal to a limit value r0. If prognostic factors have to be taken into account, the Cox model provides tests of Ho, and a useful confidence interval for the adjusted relative derived from the regression parameter for the treatment indicator. An equivalence trial of maintenance therapy was carried out in children with B non-Hodgkin lymphoma, and serves as an illustration.

Metastatic rhabdomyosarcoma and histologically similar tumors in childhood: a retrospective European multi-center analysis.

This is a retrospective analysis of children with metastatic soft tissue sarcoma (STS) registered in the major European STS studies: the SIOP MMT 75, the German CWS 1981 and 1986 studies, the Italian STS study, and the United Kingdom Children's Cancer Study Group centres in Britain. One hundred forty-six patients out of 164 were evaluable in this analysis. The median age was 7 years (1-18) and the male/female ratio was 1.3:1. The median follow-up was 80 months (7-171). The most common site of the primary tumor was the extremity (28%), which correlated well with the high preponderance (39%) of the alveolar type of RMS (aRMS). There was no dominant combination of metastatic sites and the most common single organ with metastasis was the lung (41%). Since the therapy depended on the country and period in which the patient was treated, we did not analyse the outcome and therapy together. Complete remission was achieved in 50% of the cases. Those with aRMS had a good chance of achieving CR (61%) but the majority of these patients relapsed (78%). The median time needed to relapse was 243 days (53 days to 47 months) for all patients. Analysis of the site of the primary tumor showed that the CR rate was best in the GU non-BP site (62%) and worst in PM cases (35%). The overall survival and DFS rate were 18% and 15%, respectively. The GU non-BP patients had a DFS rate of 50%, while the rate for all other sites varied between 12% and 18%. A total of 24 patients remained in CCR. The majority of them had embryonal type of RMS and metastases in only one anatomic site. Our analysis indicates that the best chance of prolonged survival was in metastatic GU non-BP cases, patients with embryonal type RMS, and those with metastases in only one organ. To try to improve the treatment of metastatic STS, a prospective European cooperative study was started in 1989.

Prognostic factors of alveolar rhabdomyosarcoma in childhood. An International Society of Pediatric Oncology study.

Pretreatment characteristics of 57 patients with alveolar rhabdomyosarcoma (RMS) registered by the International Society of Pediatric Oncology (SIOP) between January 1975 and December 1983 were identified to perform a prognostic factor study. Living status and disease-free survival (DFS) time were assessed for all patients on January 1, 1988. By multi-variate analyses, lymph node involvement (P = 0.0003) and tumor invasiveness (P = 0.007) were identified as the most significant covariates correlated with survival. A model including N stage (P = 0.001) and age (P = 0.03) was selected for predicting DFS rates. Children between 5 and 10 years of age had better DFS rates than those younger than 5 years of age or those older than 10 years of age. The authors suggest a prognostic classification that could allow treatment to be adjusted according to clinical staging.

High survival rate in advanced-stage B-cell lymphomas and leukemias without CNS involvement with a short intensive polychemotherapy: results from the French Pediatric Oncology Society of a randomized trial of 216 children.

From April 1984 to December 1987, the French Pediatric Oncology Society (SFOP) organized a randomized trial for advanced-stage B-cell lymphoma without CNS involvement to study the possibility of reducing the length of treatment to 4 months. After receiving the same three intensive six-drug induction courses based on high-dose fractionated cyclophosphamide, high-dose methotrexate (HD MTX), and cytarabine in continuous infusion, patients were evaluated for remission. Those who achieved complete remission (CR) were randomized between a long arm (five additional courses with two additional drugs; 16 weeks of treatment) and a short arm (two additional courses; 5 weeks). For patients in partial remission (PR), intensification of treatment was indicated. Two hundred sixteen patients were registered: 15 stage II nasopharyngeal and extensive facial tumors, 167 stage III, and 34 stage IV, 20 of the latter having more than 25% blast cells in bone marrow. The primary sites of involvement were abdomen in 172, head and neck in 30, thorax in two, and other sites in 12. One hundred sixty-seven patients are alive in first CR with a minimum follow-up of 18 months; four are lost to follow-up. Eight patients died from initial treatment failure, 14 died from toxicity or deaths unrelated to tumor or treatment, and 27 relapsed. The event-free survival (EFS), with a median follow-up of 38 months, is 78% (SE 3) for all the patients, 73% (SE 11) for the stage II patients, 80% (SE 3) for the stage III patients, and 68% (SE 8) for the stage IV and acute lymphoblastic leukemia (ALL) patients. One hundred sixty-six patients were randomized: 82 in the short arm and 84 in the long arm. EFS is, respectively, 89% and 87%. Statistical analysis confirms equivalence of both treatment arms with regard to EFS. Moreover, morbidity was lower in the short arm. This study confirms the high survival rate obtained in the previous LMB 0281 study without radiotherapy or debulking surgery and demonstrates the effectiveness of short treatment.