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In order to evaluate the effect on prolonging survival of alternating chemotherapy and radiotherapy schedules in patients with limited disease small cell lung cancer, 89 patients were included in a multi-institutional pilot study between January 1986 and May 1989. Treatment consisted of induction chemotherapy using the combination of doxorubicin, etoposide and ifosfamide (AVI) for four consecutive courses, followed by two cycles of the VI chemotherapy alternating with three hyperfractionated radiotherapy courses and then followed by two additional courses of AVI. Objective response to the four cycles of AVI combination was observed in 65 patients (75%). Thirteen out of 30 patients (44%) who were in partial response (PR) after induction chemotherapy were converted into complete response (CR) after the three alternating courses of chemotherapy and radiotherapy. The principal side effect related to combined modality treatment was acute radiation pneumonitis (21.5% cases) reversible except one which resulted in toxic death, and a second with chronic lung fibrosis with permanent WHO Grade 2 dyspnea (14%). Local relapse was observed in 47% of the patients who were considered in CR at the end of the treatment program and cerebral metastases were the first site of detectable relapse in 25% cases. The 3-year actuarial disease-free survival of the 89 patients is 5%, and the median actuarial survival is 14 months. This study shows that the promising survival rates seen in our previously published interim analysis were not maintained. Reasons for this might include the choice of a non cisplatinum containing induction chemotherapy, the late introduction of thoracic irradiation and/or to the use of non-restrictive criteria for selecting patients.

76 patients with high risk neuroblastoma were treated with one (41 patients) or two consecutive courses (35 patients) of megatherapy. Autologous bone marrow transplantation was scheduled after each megatherapy. Univariate analysis confirmed two prognostic factors in this heterogeneous study population: no bone lesions before megatherapy and age at diagnosis of less than 2 years with 5-year progression-free survival rates of 51% (P0.0007) and 53% (P0.025), respectively. Both factors were shown to be of independent prognostic significance using the Cox proportional hazard model. Identification of prognostic factors should help to define the interest and limits of megatherapy. We consider that elective megatherapy followed by innovative treatments appears justified in patients with persisting bone disease. In contrast, megatherapy has to be re-evaluated for patients showing a more favourable response pattern and/or young age, ideally in a randomised, prospective trial.

In order to better evaluate the role of bone marrow purging procedures in the treatment of stage IV neuroblastoma, two similar groups of patients, prospectively treated during the same period at Léon Bérard Center, Lyon, France, and at Giannina Gaslini Institute, Genova, Italy, were reviewed. 18 children were treated in Lyon with a protocol including induction chemotherapy, surgery and a single course of high-dose chemotherapy followed by purged autologous bone marrow rescue. 21 patients were treated in Genoa with a very similar protocol which did not include purging procedures. Progression-free survival at 6 years was 12% (95% confidence interval 0-24%), without any difference between the two series of patients. The only prognostic factor for long-term survival was the persistence (or not) of bone lesions and the presence of metastatic disease (bone or bone marrow) at graft. The small numbers in the two groups and the very poor outcome make it difficult to conclude on the efficacy of purging.

The environmental contamination of the antineoplastic drugs circuit, due to the centralization of preparation and the increased number of the patients treated, brought about a new occupational hazard: the chronic exposure to low doses of antineoplastic drugs. The rationalization of the hospital budgets imposes a meticulous assessment of the devices available for the preparation, in order to justify their interest, even their cost. A prospective comparative study with parallel arms was led inside the Pharmacy of the Institut de Cancerologie de la Loire in order to evaluate the Spike Swan®, a transfer device. The aim was to assess the Spike Swan® effectiveness. The antineoplastic drugs environmental contamination within the isolators is considered as a potential starting point for a larger dissemination of cytotoxic products. Therefore, the primary endpoint was the surface contamination level with 5-fluorouracil and the comparator was the standard preparation technique using needles and aeration needles. This study did not show significant effectiveness for the Spike Swan ® in reducing surface contamination. Nevertheless, this device could be used to prepare large volumes and to secure occasional handlers, because it is easy to handle.

This paper considers an oncology ambulatory care unit (ACU) in a cancer center. Recently, the ACU we consider in this paper is facing increasing demand for oncologic care and increasingly sophisticated care technologies. The ACU is often over-capacitated leading to high overtime and long patient waiting times. This paper proposes a method for optimizing patients' assignment in order to best smooth the bed utilization, also called bedload, while taking into account constraints such as the care protocols. A simulation model is then proposed to assess the effectiveness of the proposed patient assignment policy. Numerical experiments based data collected from the field show the capability of the proposed method to smooth the bedload.

External factors such as eating habits and physical activity have an important impact on breast cancer risk. This paper reviews the literature on the relationship between breast cancer and lifestyle. It aims to produce recommendations regarding physical activity and dietary intake for clinical practice. Although strong clinical evidence of the impact of lifestyle modifications is still lacking, practising healthy eating should be encouraged for the prevention of cancer, its occurrence or relapse. Physical activity is recommended to avoid excessive weight gain. For example, the beneficial effects on the risk of breast cancer could be achieved by walking half an hour per day. Three to five hours per week of moderate physical exercise therefore should be recommended for optimising the reduction of the risk of cancer. For most women, moderate to intense activity, such as heavy housework, brisk walking, or dancing, could provide an effective level of activity to keep reduce the risk of breast cancer.

Early diagnosis is the most efficient way to decrease mortality rate, side effects and sequelae due to cancer. The first step consists in anticipating diagnosis by simultenaously taking into consideration non specific clinical symptoms and risk of cancer estimated by the combination of individual risk factors. Screening is a different way to anticipate diagnosis of cancer. Screening is a systematic investigation performed without clinical symptoms. Organised cancer screening programs allow quality control, evaluation and efficiency measure of the screening policy. Opportunist screenings as developed in some countries or for particular tumours are decided by practitioners and patients following practice recommendations. Side effects of these approaches have to be kept in mind: overdiagnosis and socio-economic inequalities must be controlled for both opportunistic and organised screenings.

The real need for extensive staging at the time of diagnosis is discussed in regard to small cell lung carcinoma. We performed a decisional retrospective analysis on a series of 182 patients, based on three staging steps: the first step included physical examination and routine biologic tests. The second step consisted of liver ultrasonography and needle aspiration of any clinically detectable tumor mass, and the third step included bone marrow examination, radionuclide bone scan, thoracic, abdominal, and brain CT scan. A stepwise multivariate logistic regression performed on 11 variables considered in the first step shows that a four-parameter model can predict the spread of the disease (limited or extensive): weight loss, performance status, and elevated LDH or alkaline phosphatase levels. Limited disease can be predicted in two ways: (1) elevated LDH with normal alkaline phosphatases, no weight loss, and good performance status, or (2) normal LDH and alkaline phosphatases. In this series, 28 percent of patients can be predicted as having extensive disease and can be treated with chemotherapy alone without chest irradiation. After the second step, the probability of disease being extensive is only 25 percent, and only 84 (46.15 percent) patients would need to undergo the third step of staging procedures (brain CT scan, bone marrow aspiration and biopsy, radionuclide bone scan) with this method. We conclude that a multistep approach represents a simple staging method and offers the advantage of harmlessness and lower costs for patients not to be evaluated in prospective clinical trials.

Pharmacokinetically guided administration of melphalan was investigated during a pilot study in patients with advanced ovarian adenocarcinoma. The schedule involved a fixed dose on day 1 (7.9 mg) followed by a second dose on day 2, calculated on the basis of pharmacokinetic data to achieve a target area under the concentration-time curve (AUC). 20 courses of intravenous melphalan were administered to 7 patients. AUC, standardised to 1 mg/m2, ranged between 4.3 and 8.9 (mg/l) min. In 12 fully evaluable courses, less than 15% deviation from the target AUC was found, showing that AUC monitoring was possible by means of the test dose. Pharmacodynamic effects showed a positive correlation with melphalan AUC. Myelosuppression appeared at 47 (mg/l) min and grade 3 or 4 haematological toxicities were observed in 4 cycles, associated with AUC values ranging between 86 and 112 (mg/l) min. Relative leucocyte decreases were well correlated with AUC values.

Among the patients showing evidence of cerebral metastases without previously known cancer history, lung cancer has been found 37 times as the primary tumor in our institution. There were 34 men and three women and all but two were heavy smokers. Only one presented at diagnosis with thoracic symptoms but the chest radiograph was abnormal in 34. The histologic type of the primary tumor was obtained in 32 cases as a result of thoracic investigations and in five cases from metastatic tumor tissue. The primary tumor appeared to be non-small cell lung carcinoma in 26 cases and small cell lung carcinoma in 11 cases. These results show that patients treated with surgery (20 cases) have a better survival (median 10 months versus 4.5) than the others, and among surgically treated patients only those treated with bifocal resection (eight patients) are long-term survivors. Also, in four of six patients, objective regression of the neurologic symptoms was seen after radiation therapy alone. Central nervous system relapse was seen in 12 patients, but in none of the patients treated with postoperative radiation therapy. Conventional chemotherapy (11 patients) induced objective responses only in the small cell type and proved to be too toxic when used simultaneously with radiation therapy in inoperable patients.

Fifty patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) who had relapsed after a complete remission induced by an Adriamycin-containing chemotherapy regimen participated in this prospective pilot study. The patients ranged in age from 16 to 60 years (median 42 years). All patients received dexamethasone, high-dose cytarabine, and cisplatin (DHAP) for two courses at 3- to 4-week intervals. Patients achieving a partial or complete response were scheduled to receive involved-field radiotherapy and high-dose carmustine, etoposide, cytarabine, and cyclophosphamide (BEAC), followed by autologous bone marrow transplantation (ABMT). Among 48 evaluable patients (ie, 1 was lost to follow-up and 1 had no measurable disease) 7 patients obtained a complete response (CR) and another 21 patients achieved partial response (PR), whereas the remaining 20 patients failed. One responder died of treatment-related toxicity, and six others declined ABMT. The patient with no measurable disease did not progress on DHAP and was submitted to ABMT. Twenty-two patients underwent ABMT [20 with BEAC and 2 with cyclophosphamide plus total body irradiation (TBI)] of whom 2 (9%) died of toxicity and 10 relapsed. One patient was a suicide at 28 months post-ABMT in CCR and 9 are alive disease-free 24 months to 32 months (median 30 months) post- ABMT. The actuarial 2-year event-free survival for patients undergoing transplantation is 40%. This prospective multicenter trial documents the ability of DHAP followed by ABMT to produce durable complete remission in a significant proportion of patients with relapsed aggressive NHL. Forty-four percent of all patients with relapsed lymphoma who entered the study actually underwent ABMT and 20% of the total group are projected to be long-term disease-free survivors.

Patients with cancer frequently suffer a deteriorated quality of life and this is an important factor in the therapeutic decision. The correlation between quality of life and malnutrition seems obvious and bidirectional. The aim of our study was to describe the global quality of life and its various dimensions in patients with cancer, as a function of the nutritional status. A transversal observational study was performed in wards in hospitals in Clermont Ferrand and Saint Etienne on 907 patients. The EORTC questionnaire, QLQ-C30, was used to assess the quality of life. The mean global quality of life score was 48.8 for patients who had a weight loss of more than 10% since the beginning of their illness, compared with 62.8 for the other patients (p < 0.001). A significant association with weight was observed for the main dimensions of the quality of life: physical, functional, cognitive, social, fatigue, nausea, pain, loss of appetite, constipation and diarrhoea. This strong relation between quality of life and weight loss shows the importance of dietary management in patients with cancer.

From January 1986 through December 1988, 227 patients were included in a multi-institutional pilot study for small cell lung cancer (SCLC). Out of the 211 patients who fully completed the staging procedures, 77 (35%) appeared to have SCLC limited to the thorax. All patients received combination therapy consisting of AVI (Adriamycin, VP-16 and Ifosfamide), except during radiotherapy when the Adriamycin was omitted, plus twice daily fractionated 18 MV radiotherapy. Treatment protocol consisted of 4 initial courses of AVI, followed by 3 courses of radiotherapy alternating with modified chemotherapy (VP-16 and Ifosfamide), completed by 2 courses of initial chemotherapy (AVI). Radiotherapy consisted of 1.5 Gy/fraction, 2 fractions/day, 5 days/week in the first course, and 1.8 Gy/fraction, 2 fractions/day, 5 days/week, in the second and third courses, for a total tumor dose of 51 Gy, felt to be equivalent to 60 Gy at normal fractionation. CT treatment planning was employed to design a treatment consisting of multiport radiotherapy, using AP-PA and laterals or obliques beams. During the first course, the homolateral hemithorax received 9 Gy total dose on days 1, 3, 5. During the third course, 360° arctherapy was generally used to boost the reduced tumor volume to a 51 Gy. Besides chest X ray and CT scan, staging and restaging procedures included fiberoptic bronchoscopy. Response rate after irradiation is 61%, with 46% complete responders and 51% local control. The median survival is 14 months, and disease-free survival 42% at 1 year. Complications consisted of cardiac toxicity in 2 patients, 1 death of acute pulmonary toxicity, and 4 instances of moderate chronic radiation pneumonitis. Thus, high doses of radiation can be delivered combined with chemotherapy using this protocol, with an acceptable toxicity and encouraging results in response rate and local control. A longer follow-up is needed to evaluate the impact of these results on survival.

Background: In routine practice, the evaluation of the nutritional status of patients with cancer is not always performed although there is frequent modification as disease progresses. The validated screening and evaluation tools currently available are time-consuming and costly. In this study we analysed factors that could be used to identify patients likely to need nutritional surveillance or intervention. Patients and methods: A cross-sectional survey was carried out for 2 weeks in June 2006 on 477 patients with cancer. Results: 30.2% of the patients had lost more than 10% of their body weight since the start of the illness. After adjustment, the factors significantly associated with weight loss were: depressive state (OR = 3.49; P = 0.002), digestive or ENT tumours (OR = 3.20; P =< 0.001), chemotherapy (OR = 2.66; P = 0.011), male gender (OR = 2.30; P = 0.001) and professional status (OR = 2.08; P = 0.02). Using a logistic model, we calculated the risk of weight loss as a function of the presence of the identified predictive factors. Conclusion: We report a simple screening tool, which will not replace the available evaluation methods but will enable targeting of the patients most likely, after a specific evaluation, to benefit from nutritional intervention. This remains to be validated in further prospective studies.

In France, teenagers with cancer are managed mainly in paediatric units, given that there are only few teenage cancer units. This situation leads to the following question: are teenagers with cancer provided with tailored patient education? The object of this study was to identify education programmes specifically designed for teenagers in French paediatric oncology units. This study was conducted first by questionnaires, second by interviews with health care providers in units where information programs had been implemented. Nine information programmes or projects were identified: 2 booklets, one log book, one Web chat, one video, one DVD, one educative muppet, one peer based education group project, one nursing education session project and one qualitative study project. Only 5 from these programmes or project were specifically designed for teenagers. Four approaches can be identified: conception of education materials, individual patient education, group patient education, informal patient education.

The notion of therapeutic education was only recently introduced in cancer. Although the term is commonly used, no standard definition exists for the concept and principles of therapeutic education and its efficacy remains to be assessed. Therapeutic education is complementary to the healthcare approach and aims to get the patients more involved in their disease and the treatment decision-making process. This discipline, placed at the interface of human and social sciences, was first developed for the management of chronic diseases (diabetes, asthma). It derives from the principle that involving patients in their own care and management can help them better adjust to life with a chronic disease. The lengthening survival time of cancer patients, which contributes to making cancer a chronic disease, as well as changes in the patient-caregiver relationship contribute to the development of therapeutic education in cancer. Pilot studies, conducted principally in the United States, evaluating the side effects of chemotherapy and the management of pain, have demonstrated that such educational programs could improve patient quality of life and decrease the side effects of treatments. The success of these programs depends on several parameters: taking into account patient's opinion in the elaboration and preparation of the programs; involving skilled multidisciplinary teams engaged in iterative educational actions; having recourse to methodological tools to evaluate the impact of implemented programs. Consistent with the World Health Organization guidelines, research should be conducted in France in order to elaborate and implement cancer-specific education programs and evaluate their potential benefit. Patient education programs on pain, fatigue, nutrition and treatment compliance are currently being developed at Saint-Etienne Regional Resource Centre for cancer information, prevention and education, within the framework of the Canceropole Lyon Auvergne Rhône-Alpes.

Understanding medical practices or the whys and wherefores of care decision-making is among the major objectives of medical, economic and sociological research in the current political environment. Although variations of medical practice have long been known to exist, causes and deciding factors remain obscure. This is one of the reasons why medical auditing became widely used in the past years. Using methods similar to those of clinical research, we will explore existing medical practices and their implications, with the aim to propose possible improvements. Elaborating clinical practice guidelines and promoting cancer network activities might prove promising and have a significant impact on clinical practice. This article provides a state-of-the-art overview of the subject, notably in the domain of oncology where substantial advances are being made.

To assess the physicians' use of clinical practice guidelines (CPG) for gastrointestinal oncology.Quantitative study with semistructured individual interviews of 17 physicians treating patients with gastrointestinal cancer in the Rhone district of France.The interviews identified 7 major themes: issues associated with development of the CPG; their usefulness in the physician-patient relationship; their ease of application; relevance of the specific topic; the procedures used for their development; the methods for disseminating them; and monitoring of their impact.The physicians were relatively favorable to the CPG but stressed the need for greater transparency about related issues and effects, economic and legal, in particular, for dissemination through multiple and novel communication tools, and for assessment of their impact.

Nephrotoxicity is the major limiting factor during therapy with the radiolabeled somatostatin analog (90)Y-1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA)-d-Phe(1)-Tyr(3)-octreotide (DOTATOC). Pretherapeutic assessment of kidney absorbed dose could help to minimize the risk of renal toxicity. The aim of this study was to evaluate the contribution of patient-specific adjustments to the standard dosimetric models, such as the renal volume and dose rate, for estimating renal absorbed dose during therapy with (90)Y-DOTATOC. In particular, we investigated the correlation between dose estimates and effect on renal function after therapy. METHODS: Eighteen patients with neuroendocrine tumors (9 men and 9 women; median age, 59 y) underwent treatment with (90)Y-DOTATOC (8.1-22.9 GBq) after pretherapeutic biodistribution study with (86)Y-DOTATOC. Kidney uptake and residence times were measured and the absorbed dose (KAD) was computed using either the MIRDOSE3.1 software assuming a standard kidney volume (KAD(StdVol)) or the MIRD Pamphlet 19 values and the actual kidney cortex volume determined by pretherapeutic CT (KAD(CTVol)). For each patient, the biologic effective dose (BED) was calculated according to the linear quadratic model to take into account the effect of dose rate and fractionation. Renal function was evaluated every 6 mo by serum creatinine and creatinine clearance (CLR) during a median follow-up of 35.5 mo (range, 18-65 mo). The individual rate of decline of renal function was expressed as CLR loss per year. RESULTS: KAD(CTVol) ranged between 19.4 and 39.6 Gy (mean, 28.9 +/- 5.34 Gy). BED, obtained from KAD(CTVol), ranged between 27.7 and 59.3 Gy (mean, 40.4 +/- 10.6 Gy). The CLR loss per year ranged from 0% to 56.4%. In 12 of 18 patients, CLR loss per year was 20% received a BED >45 Gy. Patients who were treated with low fractionation were those with the highest rate of renal function impairment. Conclusion: Radiation nephrotoxicity after (90)Y-DOTATOC therapy is dose dependent. Individual renal volume, dose rate, and fractionation play important roles in an accurate dosimetry estimation that enables prediction of risk of renal function impairment.

In an era where health care expenditure control is a necessity, weighing a new treatment's cost against its added benefits is of crucial importance. These medico-economic analyses may be planned for the evaluation of new molecules in their daily use. Different methods may be used. The medico-economic evaluation of a drug can be performed with the use of clinical studies or modelization techniques. "Clinical studies" include the following methods: randomized trials, so-called "experimental", non-randomized studies, and observational studies. This classification follows a downward evolution of both the investigator's intervention power and the level of proof. Finally, modelization is becoming a commonly used tool. Randomized trials are the "gold standard" but the other, more pragmatic study types, providing a lesser degree of proof can complete the evaluation of a new molecule. One must find the best compromise between the study's objectives and the study type.

Comparative economic evaluations of chemotherapy administered in hospital day-care units or in the home are relatively scarce. Furthermore, most existing evaluations do not include methodologic studies. This study seeks to compare the costs of anticancer chemotherapy with hospital at-home care versus a hospital day-care unit in the Rhône-Alpes region of France.This study is based on a randomized controlled crossover trial that included 42 patients, to whom chemotherapy courses were alternatively given in both settings. All cost categories were taken into account according to microcosting methods. A detailed assessment was performed on coordination and health care in both structures (marginal costs and average costs), from the viewpoint of society.The marginal cost for one chemotherapy administration was significantly higher with hospital at-home care than in the hospital day-care unit ($232.5 vs. $157, p.0001). Conversely, the average cost was significantly lower with home care than at the hospital ($252.6 vs. $277.3, p = .0002).The results show that the interest of developing home care in anticancer chemotherapy is questionable regarding costs. In the French healthcare system, where there is a surplus of hospital beds, marginal costs seem to be more relevant indicators in most cases than average costs.

Commonly used methods for identifying the training needs of general practitioners do not enable the real needs felt during interviews with patients during office visits to be detected. In this study, the authors evaluate how physicians' use of a personal-office-visit diary affects the level of specificity of their expressed training needs. In 1999, the authors carried out a controlled intervention trial using a random sample of 1,038 general practitioners from a region of France, randomized to intervention and control groups. The practitioners in the intervention group were asked to identify their training needs using a personal-office-visit diary. The level of specificity for their expressed needs was compared with that of the expressed needs of the practitioners in the control group. The use of the diary was associated with a significantly higher level of specificity in the training needs identified by the general practitioners who participated. Independent of the intervention, practitioners under 40 years of age, those in urban practice, and those who were members of a continuing medical education (CME) association expressed their training needs with higher specificity. The personal-office-visit diary would seem to be a simple, inexpensive, and useful tool for more specifically identifying training needs, which could help establish more appropriate and better-targeted training programs. However, it should be assessed further by those involved in CME for general practitioners.

Introduction De plus en plus de chimiotherapies sont administrees par voie orale. Les traitements en cancerologie sont, de ce fait, soumis au meme risque de non-adherence que les autres traitements oraux. Ce travail de these avait pour objectif d’etudier : (i) les facteurs de risques de non-adherence ; (ii) de developper un programme d’education du patient (PEP) permettant d’ameliorer l’adherence des patients. Methode (i) Enquete transversale realisee par questionnaire telephonique aupres d’oncologues prescripteurs de chimiotherapies orales, afin d’evaluer le contenu et l’encadrement de leur pratiques de prescription, (ii) etude prospective de cohorte portant sur des patients souffrant de cancers traites par Capecitabine orale. L’objectif etait d’identifier des profils-types de patients en termes d’adherence, grâce a une approche mixte quantitative (analyse en composante multiple) et sociologique, (iii) etude pilote de faisabilite et d’evaluation d’un PEP visant a ameliorer l’adherence de patientes traitees par hormonotherapie adjuvante du cancer du sein. Resultats (i) Au total, 157 oncologues ont repondu a l’enquete : 23 % declarent ne jamais controler l’adherence de leurs patients et 54 % seulement fournissent du materiel educatif a la premiere prescription ; (ii) trois profils de patients ont ete identifies : les patients actifs avec un niveau educatif eleve sont moins adherents que les deux autres ; (iii) le PEP a demontre une efficacite dans l’amelioration des connaissances des patientes et de la confiance dans le traitement. Discussion Identifier les facteurs de risques de non-adherence au traitement permet de construire des strategies d’amelioration de l’adherence ciblees et efficaces, en faisant levier sur ces facteurs.

Purpose: to determine the outcome of epithelial ovarian cancer in patients registered with the European Group for Blood and Marrow Transplantation (EBMT).Patients and methods: A retrospective analysis was performed on 254 patients with advanced or recurrent disease, median age 46 years (14-63) from 39 centres treated between 1982 and 1996. Only 25% of patients were known to have no or microscopic disease after initial surgery; in approximately 20% the disease status was unknown, the remainder had macroscopic disease.Results: One hundred five patients received high-dose chemotherapy in complete or very good partial remission, twenty-seven in second remission and the remainder in the presence of residual disease. Most received melphalan or carboplatin, or a combination (86%) supported by autologous bone marrow or peripheral blood stem cells. The survival of patients treated in remission was significantly better than in other groups (median 33 vs. 14 months; P = 0.0001). The durability of remission was longer after transplantation in first remission than in second remission (median disease-free survival 18 vs. 9 months; P = 0.005). With a median follow-up of 76 months from diagnosis the median disease-free and overall survival in stage III disease transplanted in remission is 42 and 59 months and for stage IV disease 26 and 40 months.Conclusions: High-dose chemotherapy has a potential benefit for patients in remission. The results support the conduct of randomised studies to determine whether there is a real value from this treatment.

PURPOSE: To determine whether intensifying the dose of adjuvant chemotherapy improves the outcome of women with primary breast cancer and 10 or more involved axillary nodes. PATIENTS AND METHODS: Patients (n = 150) were randomized to receive either four cycles of standard doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 every 3 weeks (arm A) or four courses of intensified mitoxantrone 23 mg/m2 plus cyclophosphamide 600 mg/m2, with filgrastim 5 g/kg/d from days 2 to 15, every 3 weeks (arm B). Disease-free survival (DFS), distant disease-free survival (DDFS), and overall survival (OS) were determined using life-table estimates. RESULTS: There were no significant differences in DFS (P = .44), DDFS (P = .67), or OS (P = .99) between the two groups at 5 years; DDFS was 45% (arm A) versus 50% (arm B), and DFS was 41% versus 49%, respectively. Five-year survival was similar in both arms (61% v 60%, respectively). Failure to note an intergroup difference in outcome was unrelated to relative dose-intensity. Analysis of patients with 15 or more positive nodes revealed a significant difference in 5-year DDFS (19% v 49% in arm B; P = .01). Toxicity was generally mild in both groups, with no toxic death. The incidence of febrile neutropenia was low (0.3% v 3%). Alopecia was less frequent in arm B (P < .001). CONCLUSION: This randomized trial confirms the feasibility of administering mitoxantrone 23 mg/m2 with cyclophosphamide and filgrastim. Although there was no significant difference between conventional and intensified arms at 5 years, according to subgroup analysis, intensified treatment may decrease the risk of relapse in patients with 15 or more positive nodes compared with doxorubicin an cyclophosphamide.

PURPOSE The purpose of this study was to investigate the prognostic value of time to relapse in 188 adult patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) included on the Parma trial at the time of their first relapse. PATIENTS AND METHODS The median follow-up of these patients is 102 months after registration onto the Parma study. Time to relapse was calculated from initial diagnosis, and a cutoff of 12 months was used to separate 77 patients defined as early relapse from 111 patients defined as late relapse. RESULTS Patients with early and late relapses had significantly different overall response rates to salvage therapy with two courses of dexamethasone, high-dose cytarabine, and cisplatin (DHAP; 40% v 69%; P=.00007) and different 8-year survival rates (13% v 29%; P=.00001). Features at relapse with a negative prognostic value in univariate analysis were higher than normal lactic dehydrogenase (LDH) levels, tumor size greater than 5 cm, Ann Arbor stages III to IV, and Karnofsky score less than 80%. Therefore, multivariate analyses were performed. Time to relapse (P=.001) and LDH levels at relapse (P=.003) had independent prognostic value, whereas tumor size did not reach statistical significance in the logistic model that predicted overall response after two courses of DHAP. The study of prognostic factors for overall survival (OS) and progression-free survival (PFS) confirmed the prognostic value of time to relapse (P < .0001 for OS and P=.005 for PFS) independent of response or treatment after two courses of DHAP. CONCLUSION Time to relapse may be used to stratify patients at time of first relapse of intermediate to high-grade non-Hodgkin's lymphoma.

e13594 Background: Given the expanding use of oral chemotherapies, optimal compliance to treatment is critical to achieve the best clinical outcome in terms of efficacy and safety. The aim of the OCTO clinical study was to measure patient compliance, either electronically or by self-assessment, to capecitabine-based treatment. Methods: A cohort of patients with either locally advanced or metastatic, breast or colorectal, cancer were monitored for 6 cycles, and ambulatory treated with monotherapy of capecitabine (Xeloda). Treatment was prescribed at 1250 mg/m² as a combination of 500 and 150 mg pills, taken twice daily for 14 days every 3-week cycle. Tumor response was evaluated after 3 and 6 cycles using the RECIST criteria. Toxicity was evaluated using the NCI CTC scale. Compliance was assessed in all patients by self-completed questionnaires on disease, treatment and ambulatory management of side effects; and in half of the cohort by electronic medication event monitoring systems (MEMS) recording the opening times of the pill bottle. Results: Forty patients were enrolled between November 2008 and September 2011 and treated by capecitabine for an average of 4.75 cycles (range: 1-6). 63% patients completed 6 cycles, 22% and 15% patients discontinued due to respectively disease progression and adverse events. Best tumor response was evaluable in 35 patients: 23% had partial response, 54% stable disease and 23% progressed. Hand-foot syndrome was the most reported toxicity (77% patients), and to a lesser extent diarrhea (45%), nausea (30%) and vomiting (30%). In the MEMS cohort, 20 patients were included. Patient compliance was excellent with very few missing occasions (23/2272 records). Timing of morning doses was less variable (p=0.03) than timing of evening ones. Thirty-eight questionnaires were returned. Autonomy of ambulatory oral treatment was appreciated by 54% patients, while resulting in anxiety in 6%. Only 39% patients were concerned by the potential impact of non-compliance while 45% declined answering the question. Conclusions: Compliance to oral anticancer chemotherapy was found excellent in this population, with few deviations from prescription.

By addressing questionnaires to 24 cancer patients candidate to immunotherapy, we evaluated both the effects and the effectiveness of the medical information provided to the patient on their knowledge of the disease and the treatment. Most patients had correctly understood the information but 69% stated that they had been unable to ask all the questions they wished, and 62% required additional information. Most patients admitted to being emotionally distressed throughout the interview. These results are not significantly different from those obtained in patients candidate to new chemotherapy agents, but show that important improvements in the informed consent procedure are required.

Introduction Aujourd’hui, pres d'une femme sur 10 developpe un cancer du sein au cours de sa vie. Un depistage de ce cancer existe en France : il est actuellement conseille aux femmes de 50 a 74 ans une surveillance par mammographie bilaterale (2 incidences par sein), effectuee tous les deux ans. Les femmes ont deux parcours de sante a leur disposition pour realiser ce depistage. Le premier, le Depistage Individuel (DI) consiste en la prescription directe d’une mammographie par le medecin de famille ou le gynecologue dans le cadre du suivi individuel de la patiente. Ce DI n’est pas encadre et son organisation est laissee au seul medecin. Le deuxieme, le Depistage Organise (DO) est developpe au niveau national. Il prevoit l’invitation par courrier de toutes les femmes de 50 a 74 ans – grâce aux fichiers des organismes d’Assurance Maladie a realiser une mammographie. Cette prise en charge est totalement remboursee par l’assurance maladie, sans avance de frais. Elle assure aussi une qualite renforcee de l’interpretation des cliches par une deuxieme lecture centralisee des mammographies negatives.

Objectives To examine knowledge about HPV vaccination and behaviour towards STD among 14–23-year-old (yo) girls and determine the correlation with HPV vaccination status. Methods From 11/2008 to 04/2009, 316 girls were recruited by general practitioners in a cross-sectional study and filled a self-administered questionnaire. Twenty-eight were interviewed by a sociologist. Results Of the 316 girls, HPV vaccination was reported by 135 (42.7%). Parents were involved in the decision of vaccination for 62.4% of the 14–20 yo. Majority of unvaccinated girls preferred to wait (34.2%), did not feel concerned (27.3%) or intended to get the vaccine soon (25.5%). During the interviews, the 10 vaccinated girls declared having the same opinion as their parents and uncertain girls thought they were not yet concerned. Knowledge of HPV and pap-smear, need of pap-smear despite HPV vaccination was higher in vaccinated girls (13.3% vs 5.5%; 60.6% vs 34.9% in 14–16 yo girls and 60% vs 25.6% in 21–23 yo girls respectively). Overall, 87.2% cited condom for STD prevention and 88% of sexually active girls used it, irrespective of HPV vaccine status. Conditions for stopping condom use were more often reported by vaccinated 14–16 yo girls (24.2% vs 11.1%). Conclusion Knowledge about CC prevention was poor but seemed higher among vaccinated girls. Knowledge and behaviours about STD prevention seemed appropriate, whatever the HPV vaccination status. HPV vaccination should be widely proposed to adolescents and their parents and information on it and on CC prevention should be reinforced.

We did a meta-analysis of all published polychemotherapy vs supportive care clinical trials in patients with non-resectable non small cell lung cancer. 7 studies with more than 700 patients were selected. We used the number of deaths at 3, 6, 9, 12, and 18 months as the endpoints because we were unable to obtain all the individual data. Our analysis showed a reduction in mortality during the first 6 months with polychemotherapy. Although small, this increase in survival, together with an improved quality of life, suggests that polychemotherapy should be recommended for patients with non-resectable non small cell lung cancer.

Sixteen patients who after prior systemic immunotherapy had progressing disease received fotemustine (100 mg/m2) i. v. on days 1, 8, and 15 followed by a 5-week rest period. In responding or stabilized patients, maintenance therapy consisted of 100 mg/m2 fotemustine given once every 3 weeks until progression on toxicity occurred. No objective response was observed. Four patients showed stable disease (median duration: 4 months; range: 3–19). The main toxicities were neutropenia (WHO grade 3 and 4: 27%) and thrombocytopenia (WHO grade 3 and 4: 27%). Fotemustine was administered on an outpatient basis and was generally well tolerated, but in our series of patients it had no antitumour activity in metastatic renal cell carcinoma after failure of immunotherapy.

Human gallstones were studied by visual inspection, computerized tomographic imaging, and chemical analysis to assess physicochemical characteristics that may determine the outcome of in vitro shock-wave fragmentation. Eighty-five stones (mean diameter: 13.2 +/- 5 mm) were each collected from different patients. Fifty-five (65%) calculi were angular and 30 (35%) round or oval-shaped. Three easily obtained measures were derived from each stone's optimal computerized tomographic image including the mean stone density, a measure corresponding to the standard deviation of the mean stone density value which we termed the stone density distribution index and which may reflect the physicochemical heterogeneity of a given gallstone, as well as the density range. After the administration of 2500 shock waves using an electrohydraulic generator, fragmentation was noted in 68 calculi (80%) and was satisfactory in 27 (32%) (where the largest resulting fragment diameters were all less than or equal to 5 mm). Strong determinants of satisfactory fragmentation on multivariate analysis included a stone diameter of less than or equal to 15 mm, the presence of an angular stone shape, and a stone density distribution index of greater than or equal to 60 Hounsfield units. The other parameters did not independently determine satisfactory fragmentation. Prospective clinical trials are needed to assess whether these findings result in a better prediction of the success of extracorporeal biliary lithotripsy and a broadening of its indications.