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F Chauvin

Publications and source records attributed to F Chauvin.

At least 19 recordsLinked to original sources
PubMed2004

Conformity to clinical practice guidelines, multidisciplinary management and outcome of treatment for soft tissue sarcomas.

BACKGROUND: The primary management of adult soft tissue sarcomas (STS) is characterized by heterogeneity across centers. Several studies suggest that it is improved when coordinated by specialized sarcoma centers. PATIENTS AND METHODS: This study, comparing STS patients of the Rhône-Alpes region treated within and outside the cancer network, retrospectively assesses the conformity of medical practice with 'evidence-based medicine' (EBM) reported under the clinical practice guidelines (CPGs) of the French Federation of Cancer Centers. Institutional records of 100 new STS patients seen between 1999 and 2001 in the regional comprehensive cancer center and Lyon University hospital were analyzed retrospectively (50/300 new files randomly selected in each institution). Medical decisions were checked for conformity with CPGs. RESULTS: Median age was 58 years (range 18-88) and median tumor size was 9 cm (range 1-26). The most common primary sites were extremities, viscera or trunk. The most frequent histology was leiomyosarcoma (21%) or liposarcoma (12%). Only 7% of cases were reviewed by formal multidisciplinary committee before biopsy (with 42% pre-surgery biopsies only). The first surgical resection was R0, R1 and R2 in 26, 29 and 45% of cases, respectively. Conformity to CPGs was rated 52, 81, 94 and 95% for initial surgery, radiation therapy, chemotherapy and follow-up, respectively. At multivariate analysis, pre-surgery multidisciplinary discussion, management in reference center and management within cancer network independently predicted conformity to CPGs. CONCLUSIONS: Conformity with EBM was similar to previous reports. Elaboration of treatment strategy within a formal multidisciplinary staff and treatment within a cancer network are both important prognostic factors for optimal clinical care.

Adolescent↗
PubMed2004

[Preliminary results of the assessment of intensity modulated radiotherapy (IMRT) for prostatic and head and neck tumors (STIC 2001)].

INTRODUCTION: Between May 2002 and May 2004, eight French comprehensive cancer centres did a prospective nonrandomized study including 200 patients, 100 with cancer of the prostate and 100 with head and neck cancers. Half of each patient group was treated by IMRT and the others by RTC 3D. This clinical study was associated with an economic study and a physics study. We report here the first results. PATIENTS AND METHODS: For the clinical study, the analysis of the data of the first 88 patients irradiated for a prostatic cancer shows that 39 received RTC and 49 IMRT with a mean dose of 78 Gy at the ICRU point at 2 Gy per fraction. For H&N tumours, the preliminary analysis was done on the 87 first patients with a mean follow-up of 11.5 months (2 to 25 months) and a median of 8.4 months for the IMRT groups and 13.2 months for the RTC group. The economic study was done on the first 157 patients included during the first 18 months: 71 treated by RTC (35 for H&N and 36 for prostate) and 86 treated by IMRT (38 for H&N and 48 for prostate). The assessment of the direct costs was realized by a micro-costing technique. The physical study compared dose distributions for both techniques and has created quality control recommendations. RESULTS: Clinical studies of the acute reactions do not show any difference between groups, but we want to point out the short follow-up and the relatively high dose delivered to cancers of the prostate. The physics study demonstrates that IMRT is technically feasible in good clinical conditions with high quality assurance, a good reproducibility and precision. Dosimetric data show that IMRT could certainly spare organs at risk more than RTC for H&N tumours. The direct costs of "routine" treatments for H&N tumours were 4922 euros for IMRT versus 1899 euros for RTC and for the prostatic cancers 4911 euros for IMRT versus 2357 for RTC.

Adolescent↗
PubMed2003

Baseline and early lymphopenia predict for the risk of febrile neutropenia after chemotherapy.

A risk model for febrile neutropenia (FN) after conventional cytotoxic chemotherapy, based on early (day 5) lymphopenia and the dose of chemotherapy, has been described. A risk index based on parameters available at day 1 would be easier in daily practice. The objectives of this work were (1) to investigate a risk model for FN using only day 1 blood cell count and (2) to compare the day 1 and day 5 risk models. Three series of patients were used for the delineation and/or validation of these two risk models: (1) the exhaustive cohort of 950 patients treated in the Department of Medicine of the CLB in 1996 (CLB-1996 series), (2) the Elypse 1 series, a prospective series of 321 patients treated in community hospitals and regional cancer centres, and (3) a previously reported Elypse 0 series of 329 patients. Day 1 blood cell count was available in all three series, while day 5 blood cell count was available only in the Elypse 0 and 1 series. In the CLB-1996 series, 92 (9.7%) patients experienced FN; only chemotherapy dose and day 1 lymphopenia < or =700 microl(-1) had an independent prognostic value for FN in multivariate analysis. In patients with both risk factors ('high-risk group'), the incidence of FN was 44, 50 and 61% in the CLB-1996. Elypse 1 and 0 series, respectively, indicating that the 'day 1' risk model enables one to identify patients at high-risk for FN. Besides, the observed incidence of FN in the high-risk group of the 'day 5' model (i.e. patients with day 5 lymphopenia < or =700 microl(-1) and receiving high-risk CT) was 45 and 69% in the Elypse 0 and 1 series, respectively. In the Elypse 1 and 0 series, 15 and 12% of all patients who experienced FN were in the high-risk group of the 'day 1' risk model as compared to 25 and 62% for the high-risk group of the 'day 5' risk model. Both day 1 and day 5 lymphopenia are associated with an increased risk of FN in patients treated with chemotherapy. The 'day 1' model identifies a small population of patients at high risk for FN, but has a lower sensitivity than the day 5 model.

Adolescent↗
PubMed2002

A controlled "before-after" study: impact of a clinical guidelines programme and regional cancer network organization on medical practice.

A regional cancer network has been set up in the Rhône-Alpes region in France. The aim of the project is to improve the quality of care and to rationalize prescriptions in the network. In this network, we assessed the impact of the implementation of a clinical practice guidelines project by assessing the conformity of practice with the guidelines and comparing this with the conformity in an external matched control group from another French region without a regional cancer network. Four hospitals (private and public) accepted to assess the impact of the clinical practice guidelines on the management of breast and colon cancer in the experimental group and three hospitals (private and public) in the control group. In 1994 and 1996, women with non-metastatic breast cancer (282 and 346 patients in the experimental group, 194 and 172 patients in the control group, respectively) and all new patients with colon cancer (95 and 94 patients in the experimental group, and 89 and 118 patients in the control group, respectively) were selected. A controlled "before-after" study, using institutional medical records of patients with breast and colon cancer. The medical decisions concerning the patients were analyzed to assess their compliance with the clinical practice guidelines. When medical decisions were judged to be non-compliant, we verified if they were based on scientific evidence in a published article, if they were not, the medical decision was classified as having "no convincing supporting scientific evidence". The compliance rates were significantly higher in 1996 than in 1994 in the experimental group; 36% (126 out of 346) vs 12% (34 out of 282) and 46% (56 out of 123) vs 14% (14 out of 103) (P<0.001) for breast and colon cancer, respectively. Whereas, in the control group the compliance rates were the same for the two periods; 7% (12 out of 173) vs 6% (12 out of 194) (P=0.46) and 39% (49 out of 126) vs 32% (31 out of 96), P=0.19. In the experimental group, in 1994, 101 of the 282 medical decisions (36%) and 27 of the 103 (26%) for breast and colon cancer, respectively, were classified as having "no convincing supporting scientific evidence" compare with 72 out of 346 in 1996 (21%) for breast cancer, and 21 of the 123 (17%) for colon cancer P<0.05. Whereas in the control group these results were 106 out of 194 in 1994 (55%) and 90 out of 172 in 1996 (52%), P=0.65 for breast cancer and 28 out of 96 in 1994 (29%) and 30 out of 126 in 1996 (24%), P=0.36 for colon cancer. The development and implementation strategy of the clinical practice guidelines programme for cancer management results in significant changes in medical practice in our cancer network. These results would suggest that introducing guidelines with specific implementation strategy might also increase the compliance rate with the guideline and "evidence-based medicine".

Breast Neoplasms↗
PubMed2001

Identification of patients at risk for early death after conventional chemotherapy in solid tumours and lymphomas.

1-5% of cancer patients treated with cytotoxic chemotherapy die within a month after the administration of chemotherapy. Risk factors for these early deaths (ED) are not well known. The purpose of this study was to establish a risk model for ED after chemotherapy applicable to all tumour types. The model was delineated in a series of 1051 cancer patients receiving a first course of chemotherapy in the Department of Medicine of the Centre Léon Bérard (CLB) in 1996 (CLB-1996 cohort), and then validated in a series of patients treated in the same department in 1997 (CLB-1997), in a prospective cohort of patients with aggressive non-Hodgkin's lymphoma (NHL) (CLB-NHL), and in a prospective cohort of patients with metastatic breast cancer (MBC series) receiving first-line chemotherapy. In the CLB-1996 series, 43 patients (4.1%) experienced early. In univariate analysis, age > 60, PS > 1, lymphocyte (ly) count 1 (hazard ratio 3.9 (95% Cl 2.0-7.5)) and d1-ly count <or= 700 microl(-1) (3.1 (95% Cl 1.6-5.8)) were identified as independent risk factors for ED. The calculated probability of ED was 20% (95% Cl 10-31) in patients with both risk factors, 6% (95% Cl 4-9) for patients with only 1 risk factor, and 1.7% (95% Cl 0.9-3) for patients with none of these 2 risk factors. In the CLB-97, CLB-NHL and MBC validation series, the observed incidences of early death in patients with both risk factors were 19%, 25% and 40% respectively and did not differ significantly from those calculated in the model. In conclusion, poor performance status and lymphopenia identify a subgroup of patients at high risk for early death after chemotherapy.

Adolescent↗
PubMed2001

Intensification of adjuvant chemotherapy: 5-year results of a randomized trial comparing conventional doxorubicin and cyclophosphamide with high-dose mitoxantrone and cyclophosphamide with filgrastim in operable breast cancer with 10 or more involved axillary nodes.

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/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks (arm A) or four courses of intensified mitoxantrone 23 mg/m(2) plus cyclophosphamide 600 mg/m(2), 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/m(2) 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.

Adult↗
PubMed2001

High-dose chemotherapy for ovarian carcinoma: long-term results from the Solid Tumour Registry of the European Group for Blood and Marrow Transplantation (EBMT).

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.

Adolescent↗
PubMed2000

Multivariable analysis of prognostic factors for toxicity and survival for patients enrolled in phase I clinical trials.

BACKGROUND: Patients with advanced solid tumors may be included in phase I clinical trials. In such studies, the benefit expected is generally lower than the likelihood of toxicity and may even be non-existent if the patient's life expectancy is too short. This study was performed to identify prognostic variables for toxicity and survival in patients who participate in phase I clinical trials. PATIENTS AND METHODS: One hundred fifty-four patients treated on a phase I clinical trial in our institute were evaluated retrospectively. Univariable and multivariable analyses of patients' characteristics were undertaken to determine their effects on the probability of grade 3 and 4 toxicity and on survival. RESULTS: Grade 3 or 4 toxicity was experienced by 56 patients (36%): dosage level at entry (P < 0.001) and age over 65 years (P = 0.03) were independently associated with the risk of toxicity. Median overall survival was 5 months. The multivariable analysis identified performance status 2 or 3 (P < 0.001) and lactate dehydrogenase levels greater than 600 UI (P < 0.001) as independent adverse prognostic variables for overall survival. Using these two parameters, we determined a prognostic index which allowed us to discriminate three risk groups of patients with an observed median survival of 8.5, 4.5 and 1.5 months, respectively. CONCLUSIONS: Subgroups with different survival expectancy can be identified among patients who are eligible for phase I clinical trials. If confirmed, the proposed prognostic model may be useful for therapeutic decision making in palliative oncology.

Adult↗
PubMed2000

Economic impact of harmonizing medical practices: compliance with clinical practice guidelines in the follow-up of breast cancer in a French Comprehensive Cancer Center.

PURPOSE: The introduction of clinical practice guidelines (CPGs) and the increasing desire to harmonize clinical practices draw attention to the economic impact of these trends. In 1994, CPGs were introduced in a French Comprehensive Cancer Center (Centre Régional Léon Bérard, Lyon). We evaluated the application of these CPGs in addition to the consequences of harmonizing clinical practices with respect to the distribution of resources by specifically analyzing the posttherapeutic follow-up of patients with localized breast cancer. METHODS: A before-and-after analysis of the records of patients who received posttherapeutic follow-up for localized breast cancer as of either 1993 or 1995 was performed. Two hundred records were chosen at random, 100 from 1993 and 100 from 1995. Follow-up was continued for as long as possible and CPG compliance was studied for each year of the follow-up periods. RESULTS: Follow-up that was not CPG-compliant required a significantly greater amount of resources. This difference was due to neither consultations nor mammographies, but was due to other examinations that were systematically performed without any warning signs to justify them. Depending on the follow-up year, noncompliant follow-up cost the Social Security from 2.2 to 3.6 times more than compliant follow-up. A noticeable change in medical practices was observed after the introduction of CPGs in 1994. This was confirmed by a sharp decrease in mean Social Security expenditure per patient of more than one third between 1993 and 1995, regardless of the follow-up year considered. CONCLUSION: In the follow-up of patients with localized breast cancer, a large decrease in costs has been observed along with the evolution of medical practices toward CPG compliance. This finding is probably generalizable to other settings, but there is nothing that proves that it is applicable to other treatment strategies.

Aged↗
PubMed2000

[Huriet law: application in a regional cancer centre (Centre Léon-Bérard, Lyon)].

Clinical research is one of the main activities in cancer centres and is submitted in France to a specific law (named "loi Huriet") which includes good clinical practices. We are now conducting a general program of quality evaluation and improvement in the regional cancer centre of Lyon (centre Léon-Bérard). Part of this program is an audit of the application of the Huriet law. Since no instrument exist for measuring this application, we have created a specific one, that attribute notation according to the different aspects of the law. Results show a good level of conformity but sometime non sufficient. There is no difference between the two studied years. Quality changes according to promoters (private or academic) and monitoring. Written procedures and specific training for the different actors are required to improve quality of clinical research with focus on the patient interest.

Cancer Care Facilities↗
PubMed1999

High-dose methotrexate and HELP [Holoxan (ifosfamide), eldesine (vindesine), platinum]--doxorubicin in non-metastatic osteosarcoma of the extremity: a French multicentre pilot study. Fédération Nationale des Centres de Lutte contre le Cancer and Société Française d'Oncologie Pédiatrique.

UNLABELLED: This study evaluates histological response, long-term outcome, and toxicity in an intensive chemotherapy program given before surgery. PATIENTS AND METHODS: Sixty-two patients (39 males, 23 females: median age 14) with biopsy, chest computerised-tomography, technetium bone-scan and magnetic resonance imaging, were enrolled. Primary localisations were femur (44%) and tibia (26%). Induction chemotherapy involved seven courses of high-dose methotrexate and two courses of HELP (ifosfamide, eldesine (vindesine), cisplatin (platinum)-doxorubicin. After surgery, patients received six courses of high-dose methotrexate and two courses of HELP-doxorubicin. RESULTS: Pre- and postoperative toxicities were similar. Fifty-nine patients underwent surgery; histological response was good in thirty-eight patients (64%) and poor in twenty-one (36%). Median follow-up is 57 months (range 30-80), with 77% overall survival and 59% progression-free survival. In a multivariate analysis, age under 10 years is the only prognostic factor that significantly correlates with outcome. CONCLUSIONS: This regimen appears to increase histological necrosis, but associates with severe toxicity. Results for patients with less necrosis at surgery are encouraging. Future trials should determine the minimum effective doses to reduce toxicity. New drugs should be added.

Adolescent↗
PubMed1999

Small-cell lung cancer: patients included in clinical trials are not representative of the patient population as a whole.

PURPOSE: To determine the clinical characteristics of the subpopulation of patients not included in clinical trials, their outcome, and the reasons for their ineligibility and non-participation. PATIENTS AND METHODS: We studied 57 patients (out of 178 consecutive patients with SCLC), who were not included in any of the three successive clinical trials completed at our center during the study period. We also compared 37 patients excluded from the largest clinical trial to their 73 included counterparts. RESULTS: Reasons for ineligibility (n = 53) included low Karnofsky index (n = 17), advanced age (n = 12), non-feasible long-term follow-up (n = 12), previous history of cancer (n = 8), contraindication for anthracyclines (n = 5), and other medical reasons (n = 11). Only four eligible patients were not included in the trials. As compared to patients included in the studies, non-included patients had a significantly lower Karnofsky index, were older, presented more frequently with metastatic disease, and had a lower response rate to treatment and a shorter survival. However, exclusion from the trial was not an independent prognostic factor by multivariate analysis. CONCLUSIONS: Selection biases were unlikely in the three trials, based on the high ratio of included/eligible patients. However, the subgroup of patients included in the trials was not representative of the patient population as a whole because of restrictive eligibility criteria. Results from published clinical trials to the overall population should be extrapolated only with caution. We suggest that the proportion and major characteristics of ineligible and non-participating patients be mentioned in any publication of a clinical trial.

Adult↗
PubMed1999

A novel endothelial cell-based gene therapy platform for the in vivo delivery of apolipoprotein E.

A major focus in gene therapy has been the use of recombinant viruses to deliver genes in vivo. Although this approach shows much promise, there are many safety concerns associated with the use of viral materials in the treatment of human diseases. Our alternative cell-based gene therapy approach utilizes endothelial cells (Pro 175) isolated from the murine embryonic yolk sac. These endothelial cells were evaluated for their potential use in gene therapy as a gene delivery platform. As a test model, we used these cells to deliver apolipoprotein E (apoE) in the murine apoE knockout atherosclerosis model. The lack of apoE protein in these animals results in high levels of serum cholesterol and formation of severe aortic plaques and lesions at a young age. After transplantation of the apoE secreting Pro 175 endothelial cells into apoE-deficient mice, serum cholesterol levels were measured at 2 week intervals. During the 3 months after the initiation of these experiments, levels of cholesterol in the animals having received the apoE secreting endothelial cells were statistically lower compared with the levels of age-matched controls having received non-secreting endothelial cells. Concomitant with cholesterol reduction, atherosclerotic aortic plaques were noticeably reduced in the experimental apoE+ animals. These results highlight the potential of these unique endothelial cells as an efficient delivery platform for somatic gene therapy.

Animals↗
PubMed1999

[Cervical cancer screening for high risk women: is it possible? Results of a cervical cancer screening program in three suburban districts of Lyon].

Between november 1993 and october 1996, a cervical screening program was proposed for women 25-65-year-old who tend to have little or no medical supervision, in three suburban districts of Lyon. The data and results of the two last Pap-smears have been collected together with details of gynecological follow-up. Both general practitioners and gynaecologists were actively involved. A total of 3,792 women (12.3% of the target) were registered, with a larger proportion of women over 60 (17.7%). According to the "Consensus of Lille", only 403 women (34.4%) had adequate screening (over 50 y: 25.8%, 35-49 y: 39.4%, 25-35 y: 36.5%) and 2,489 women had inappropriate gynaecological follow-up: no smear for 185 women (4.9%) and inadequate schedule of follow-up visits for 476 others (12.5%). Missing data (date or results of Pap smear) were noted for 1,828 patients (48.2%). The screening procedure for women over 50 years was carried out mainly by general practitioner. Of 3,127 registered smears, 62 positive results were found (2.1%). Of these women, 9 were lost to follow-up and 4 did not have appropriate tests. Others results were: 27 negative further investigations, 9 CIN1, 7 CIN2, 3 CIN3, 1 in situ carcinoma and 2 invasive carcinoma. Despite low participation, this pilot study indicates that a procedure can be established to integrate high risk women in cervical cancer screening programme. Active participation of general practitioners is essential.

Adult↗
PubMed1998

The International Prognostic Index correlates to survival in patients with aggressive lymphoma in relapse: analysis of the PARMA trial. Parma Group.

The objectives of the present study were to investigate the prognostic value of the International Prognostic Index (IPI) at relapse in the 215 patients with intermediate- or high-grade non-Hodgkin's lymphoma (NHL) included in the PARMA trial. The IPI at relapse was available in 204 (95%) of these patients. Response rates to 2 courses of DHAP were 77%, 54%, 55%, and 42% in patients with an IPI of 0, 1, 2 and 3, respectively (P <.02), whereas complete response (CR) rates were 33%, 29%, 20%, and 0% in the same groups of patients (P <.03). With a median follow-up period of 79 months, overall survival (OS) at 5 years was 46%, 25%, 25%, and 11% in these four groups (P <.001). One hundred nine patients responding to 2 courses of DHAP were randomized to receive either BEAC (carmustine, etoposide, cytarabine, cyclophosphamide and mesna) followed by autologous bone marrow transplantation (ABMT) or 4 additional courses of DHAP: IPI at relapse was found highly correlated to OS in patients treated in the DHAP arm (5-year OS: 48%, 21%, 33%, and 0% for IPI 0, 1, 2, and 3, respectively; P =.006), but not in the BEAC arm (5-year OS: 51%, 47%, 50%, and 50% for IPI 0, 1, 2, and 3, respectively; P =.90). OS was significantly superior in the BEAC arm as compared with the DHAP arm in patients with an IPI >0 (P <.05), but not in patients with an IPI of 0. In conclusion, these results show that IPI correlates to response and overall survival in patients with aggressive NHL in relapse and enables us to identify patients with a significantly different outcome among those treated with conventional chemotherapy alone.

Adolescent↗
PubMed1998

Iatrogenic risks of endometrial carcinoma after treatment for breast cancer in a large French case-control study. Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC).

Since tamoxifen is widely used in breast cancer treatment and has been proposed for the prevention of breast cancer, its endometrial iatrogenic effects must be carefully examined. We have investigated the association between endometrial cancer and tamoxifen use or other treatments in women treated for breast cancer in a case-control study. Cases of endometrial cancer diagnosed after breast cancer (n = 135) and 467 controls matched for age, year of diagnosis of breast cancer and hospital and survival time with an intact uterus were included. Women who had received tamoxifen were significantly more likely to have endometrial cancer diagnosed than those who had not (crude relative risk = 4.9, p = 0.0001). Univariate and adjusted analyses showed that the risk increased with the length of treatment (p = 0.0001) or the cumulative dose of tamoxifen received (p = 0.0001), irrespective of the daily dose. Women who had undergone pelvic radiotherapy also had a higher risk (crude relative risk = 7.8, p = 0.0001). After adjusting for confounding factors, the risk was higher for tamoxifen users (p = 0.0012), treatment for more than 3 years (all p < 0.03) and pelvic radiotherapy (p = 0.012). Women who had endometrial cancer and had received tamoxifen had more advanced disease and poorer prognosis than those with endometrial cancer who had not received this treatment. Our results suggest a causal role of tamoxifen in endometrial cancer, particularly when used as currently proposed for breast cancer prevention. Pelvic radiotherapy may be an additional iatrogenic factor for women with breast cancer. Endometrial cancers diagnosed in women treated with tamoxifen have poorer prognosis. Women who receive tamoxifen for breast cancer should be offered gynaecological surveillance during and after treatment. A long-term evaluation of the risk-benefit ratio of tamoxifen as a preventive treatment for breast cancer is clearly warranted.

Adenocarcinoma↗