A prospective international observational prevalence study on prone positioning of ARDS patients: the APRONET (ARDS Prone Position Network) study.

INTRODUCTION: While prone positioning (PP) has been shown to improve patient survival in moderate to severe acute respiratory distress syndrome (ARDS) patients, the rate of application of PP in clinical practice still appears low. AIM: This study aimed to determine the prevalence of use of PP in ARDS patients (primary endpoint), the physiological effects of PP, and the reasons for not using it (secondary endpoints). METHODS: The APRONET study was a prospective international 1-day prevalence study performed four times in April, July, and October 2016 and January 2017. On each study day, investigators in each ICU had to screen every patient. For patients with ARDS, use of PP, gas exchange, ventilator settings and plateau pressure (Pplat) were recorded before and at the end of the PP session. Complications of PP and reasons for not using PP were also documented. Values are presented as median (1st-3rd quartiles). RESULTS: Over the study period, 6723 patients were screened in 141 ICUs from 20 countries (77% of the ICUs were European), of whom 735 had ARDS and were analyzed. Overall 101 ARDS patients had at least one session of PP (13.7%), with no differences among the 4 study days. The rate of PP use was 5.9% (11/187), 10.3% (41/399) and 32.9% (49/149) in mild, moderate and severe ARDS, respectively (P = 0.0001). The duration of the first PP session was 18 (16-23) hours. Measured with the patient in the supine position before and at the end of the first PP session, PaO2/FIO2 increased from 101 (76-136) to 171 (118-220) mmHg (P = 0.0001) driving pressure decreased from 14 [11-17] to 13 [10-16] cmH2O (P = 0.001), and Pplat decreased from 26 [23-29] to 25 [23-28] cmH2O (P = 0.04). The most prevalent reason for not using PP (64.3%) was that hypoxemia was not considered sufficiently severe. Complications were reported in 12 patients (11.9%) in whom PP was used (pressure sores in five, hypoxemia in two, endotracheal tube-related in two ocular in two, and a transient increase in intracranial pressure in one). CONCLUSIONS: In conclusion, this prospective international prevalence study found that PP was used in 32.9% of patients with severe ARDS, and was associated with low complication rates, significant increase in oxygenation and a significant decrease in driving pressure.

[Infections on catheters in hemodialysis: Temporal fluctuations of the infectious risk]. / Infections sur cathéters d'hémodialyse : variations du risque en fonction de la durée de cathétérisme.

BACKGROUND: International guidelines recommend to limit the long-term use of central-veinous catheters in patients undergoing hemodialysis, because they expose the patient to a higher infectious risk than the fistulas. However, for some patients with comorbidity, switching to a permanent vascular access is not possible. In such case, the catheter is used for a longer period. It seems therefore important to study the influence of a prolonged duration of catheterization on infectious complications. The temporal fluctuation profile of the infectious risk is poorly studied in the literature and the results published may be contradictory. METHODS: This multicentric prospective study included 1053 incident tunneled catheters. Multivariate logistic regression was used to identify significant risk factors of infection. An infection-free survival analysis was performed afterwards to estimate the variation of the instantaneous infectious risk during catheterization. RESULTS: The major risks factors of infections on tunneled catheters were: previous Staphylococcus aureus infection (aOR=1.95 [1.16-3.27]; P=0.012), diabetes (aOR=1.67 [1.16-2.41]; P=0.006), and long duration of catheterization (0-3months vs.≥24months: aOR=2.42 [1.34-4.36]; P=0.003). The survival analysis showed a higher risk of infections of tunneled catheters during the first months after placement. Risk declines over time. CONCLUSIONS: The fluctuation profile of the infectious risk show that preventive precautions should target the first months of catheterization.

Ventilator-associated pneumonia in ARDS patients: the impact of prone positioning. A secondary analysis of the PROSEVA trial.

BACKGROUND: The goal of this study was to assess the impact of prone positioning on the incidence of ventilator-associated pneumonia (VAP) and the role of VAP in mortality in a recent multicenter trial performed on patients with severe ARDS. METHODS: An ancillary study of a prospective multicenter randomized controlled trial on early prone positioning in patients with severe ARDS. In suspected cases of VAP the diagnosis was based on positive quantitative cultures of bronchoalveolar lavage fluid or tracheal aspirate at the 10(4) and 10(7) CFU/ml thresholds, respectively. The VAP cases were then subject to central, independent adjudication. The cumulative probabilities of VAP were estimated in each position group using the Aalen-Johansen estimator and compared using Gray's test. A univariate and a multivariate Cox model was performed to assess the impact of VAP, used as a time-dependent covariate for mortality hazard during the ICU stay. RESULTS: In the supine and prone position groups, the incidence rate for VAP was 1.18 (0.86-1.60) and 1.54 (1.15-2.02) per 100 days of invasive mechanical ventilation (p = 0.10), respectively. The cumulative probability of VAP at 90 days was estimated at 46.5 % (27-66) in the prone group and at 33.5 % (23-44) in the supine group. The difference between the two cumulative probability curves was not statistically significant (p = 0.11). In the univariate Cox model, VAP was associated with an increase in the mortality rate during the ICU stay [HR 1.65 (1.05-2.61), p = 0.03]. HR increased to 2.2 (1.39-3.52) (p < 0.001) after adjustment for position group, age, SOFA score, McCabe score, and immunodeficiency. CONCLUSIONS: In severe ARDS patients prone positioning did not reduce the incidence of VAP and VAP was associated with higher mortality.

An attempt to validate the modification of the American-European consensus definition of acute lung injury/acute respiratory distress syndrome by the Berlin definition in a university hospital.

PURPOSE: The Berlin definition for acute respiratory distress syndrome (ARDS) is a new proposal for changing the American-European consensus definition but has not been assessed prospectively as yet. In the present study, we aimed to determine (1) the prevalence and incidence of ARDS with both definitions, and (2) the initial characteristics of patients with ARDS and 28-day mortality with the Berlin definition. METHODS: We performed a 6-month prospective observational study in the ten adult ICUs affiliated to the Public University Hospital in Lyon, France, from March to September 2012. Patients under invasive or noninvasive mechanical ventilation, with PaO2/FiO2 <300 mmHg regardless of the positive end-expiratory pressure (PEEP) level, and acute onset of new or increased bilateral infiltrates or opacities on chest X-ray were screened from ICU admission up to discharge. Patients with cardiogenic pulmonary edema were excluded. Patients were further classified into specific categories by using the American-European Consensus Conference and the Berlin definition criteria. The complete data set was measured at the time of inclusion. Patient outcome was measured at day 28 after inclusion. RESULTS: During the study period 3,504 patients were admitted and 278 fulfilled the American-European Consensus Conference criteria. Among them, 18 (6.5 %) did not comply with the Berlin criterion PEEP ≥ 5 cmH2O and 20 (7.2 %) had PaO2/FiO2 ratio ≤200 while on noninvasive ventilation. By using the Berlin definition in the remaining 240 patients (n = 42 mild, n = 123 moderate, n = 75 severe), the overall prevalence was 6.85 % and it was 1.20, 3.51, and 2.14 % for mild, moderate, and severe ARDS, respectively (P > 0.05 between the three groups). The incidence of ARDS amounted to 32 per 100,000 population per year, with values for mild, moderate, and severe ARDS of 5.6, 16.3, and 10 per 100,000 population per year, respectively (P < 0.05 between the three groups). The 28-day mortality was 35.0 %. It amounted to 30.9 % in mild, 27.9 % in moderate, and 49.3 % in severe categories (P < 0.01 between mild or moderate and severe, P = 0.70 between mild and moderate). In the Cox proportional hazard regression analysis ARDS stage was not significantly associated with patient death at day 28. CONCLUSIONS: The present study did not validate the Berlin definition of ARDS. Neither the stratification by severity nor the PaO2/FiO2 at study entry was independently associated with mortality.

Detecting related cases of bloodstream infections using time-interval distribution modelling.

An algorithm was designed to highlight related bloodstream infections using data from a nosocomial infection surveillance system to help local public health authorities direct specific measures towards clusters of cases. The approach was based on a two-step procedure. The first was a test to identify pathogens with an abnormal number of close cases. The second modelled, for the identified pathogens, the distribution of time intervals between successive cases as a mixture of two theoretical distributions in order to determine a threshold below which a specific investigation is required. The algorithm was applied to bloodstream infection surveillance data collected during a 10-year period (1996-2005) in an 878-bed teaching hospital (24 wards) in Lyon, France. The first step identified seven pathogens among the 18 being studied. The modelling succeeded in setting time thresholds to spot clusters of cases requiring further investigation with defined sensitivity and specificity. Setting the sensitivity level at 95%, the threshold values ranged from 24 days (Acinetobacter baumannii) to 294 days (Enterobacter cloacae); the specificity was higher than 70% (up to 97.5% for A. baumannii) except for E. cloacae (52.1%). Setting the specificity level at 95% resulted in a decrease in sensitivity except for A. baumannii (it reached nearly 100%); it fell below 50% for three pathogens: around 40% for Streptococcus pneumoniae and Enterococcus faecalis and 25% for Enterobacter cloacae. The threshold values then ranged from 8 days (S. pneumoniae) to 67 days (Streptococcus pyogenes). The approach proved promising though further refinements are needed before routine use.

[Changing medical practices and nosocomial infection rates in French maternity units from 1997 to 2000]. / Surveillance des infections nosocomiales dans les maternités du sud-est de la France entre 1997 et 2000.

OBJECTIVES: In this study we describe the changes in medical practices and nosocomial infection rates in obstetrics observed through a surveillance network in the South East of France. MATERIAL AND METHOD: The maternity units which belong to this network participated in voluntary surveillance using the network's methodology. The criteria for the diagnosis of nosocomial infections were in accordance with the methods described by the Centers for Disease Control and Prevention. RESULTS: 101240 pregnancies including 18503 caesareans (18.3%) were included in the network from 1997 to 2000. During the study period, nosocomial infection rates following caesarean section and vaginal delivery decreased respectively from 7.8% to 4.3% (p < 0.001) and from 2.2% to 0.9% (p < 0.001). This evolution was compared with the evolution of collected risk factors. CONCLUSION: In spite of the methodology limits, general value of surveillance and infection control programs in maternity units has been confirmed by the results of this surveillance network. During the study period, both obstetrics-related risk factors for nosocomial infection and observed hospital-acquired infection rates were dramatically reduced, what prove an improvement of quality of care in maternity units.

[Surveillance of infections in chronic hemodialysis patients]. / Surveillance des infections chez les hémodialysés chroniques en centre.

OBJECTIVE: To confirm rates of infections from a previous survey in chronic hemodialysis patients; to get information about incidents and manipulations of vascular access-site, number and reasons of hospitalisation; to asses a relationship between the frequency of vascular access-site infections (VASI) and quality of care during the procedures of vascular access-site use. DESIGN: Prospective, multicenter survey performed from February 2000 to January 2001, including all patients underwent chronic hemodialysis in 5 participating centers. Standardized definitions used and different clinical and biological risk factors recorded. RESULTS: 429 patients for a total of 4273 dialysis months (DM) were enrolled. 245 infections in 164 infected patients were reported. The overall rate was 5.73 infections per 100 DM (18 VASI, 25 bacteraemia, 84 respiratory, 29 urinary tract, 1 endocarditis and 88 other infections). 50% of infections were microbiologically documented. 19 of 21 antibiotics resistant microorganisms were meticillin resistant Staphylococcus aureus. Compared to the incidence rate of fistula (0.05 per 1000 days of follow-up) or prosthesis related VASI (0.11), the incidence rate of catheter related VASI (0.65) was significantly higher. Poor hygiene and duration of catheter use were the significant risk factors for VASI showed by logistic analysis regression. VASI and bacteraemia occurred more frequently after incident or manipulation of the vascular access-site. The decrease of VASI between the 2 periods of survey was significantly higher in centers having reduced the catheter use and implemented written protocols. CONCLUSIONS: This second period of surveillance has confirmed the frequency of infections rate in chronic hemodialysis patients and particularly bacteraemia and VASI. This study has allowed to establish risk factors for infections and showed that VASI in hemodialysis are related to factors in part preventable.

Breastfeeding and risk of breast cancer: a metaanalysis of published studies.

Evidence in favour of an association of breastfeeding with a breast cancer risk reduction remains limited and inconsistent. To evaluate the relation between breastfeeding and breast cancer, a meta-analysis based on a review of the literature was carried out, using as variables ever/never breastfeeding and duration of breastfeeding. Menopausal status at the time of diagnosis of breast cancer was considered to be a potential effect modifier. Only case-control studies could be included in the final analysis. A slight but significant decreased risk of breast cancer was observed in ever breastfeeding, compared with never breastfeeding parous women, using both the fixed and random-effect models. This decrease was more pronounced in non-menopausal women at the time of diagnosis of breast cancer and in long-term breastfeeding women. Hence, breastfeeding appeared to be a protective factor but was of small magnitude compared with other known risk factors for breast cancer. Whether this result should imply a modification in the attitude of both health care providers and women towards breastfeeding, which represents one of the few identified protective factors which is under the control of the mother, and is thus (theoretically) modifiable, remains questionable.

Initial versus delayed acute renal failure in the intensive care unit. A multicenter prospective epidemiological study. Rhône-Alpes Area Study Group on Acute Renal Failure.

We performed a prospective study in the 28 multidisciplinary intensive care units (ICUs) in the Rhône-Alpes area in France to investigate the role of initial versus delayed occurrence of acute renal failure (ARF) in patient outcome. ARF was defined as a serum creatinine concentration > 300 micromol/L, urine output < 500 ml/24 h (or < 180 ml/8 h), or hemodialysis requirement. Over the 1-yr study period, 1,086 patients presented with ARF on ICU admission or during the first 2 d of ICU stay (Group A; 736 patients), from Day 3 to Day 6 (Group B; 202 patients), or from Day 7 (Group C; 148 patients). The overall hospital mortality rate was 66% (61% in Group A, 71% in Group B, and 81% in Group C; p < 0.0001). Logistic regression analysis of a random sample of 510 patients showed that SAPS II score on ICU admission, number of ARF episodes, previous health status, absence of oliguria, absence of hemodialysis, and absence of ischemic acute tubular necrosis were predictive of patient survival. This model was tested and validated on the basis of the remaining patients. Thus, in this population, late ARF was not a predictive factor for patient outcome.

Effects of proton beam irradiation on uveal melanomas: a comparative study of Ki-67 expression in irradiated versus non-irradiated melanomas.

AIMS: To assess the cellular proliferation using the monoclonal antibody Ki-67, in paraffin embedded uveal melanomas irradiated by proton beam, as well as in non-irradiated uveal melanomas. METHODS: 30 enucleated eyes were included for histopathological study and Ki-67 immunostaining. Patients were enucleated between 1991 and 1996 for uveal melanoma, 14 after proton beam irradiation and 16 without treatment (control group). The mean follow up period was 2.5 years after diagnosis and 1 year after enucleation. RESULTS: A significant relation was found between Ki-67 score and mitotic index (r = 0.56, p = 0.001), histological largest tumour diameter (r = 0.38, p = 0. 03), fibrosis (r = -0.35, p = 0.05), absence of tumoral pigmentation (p = 0.05), and presence of vascular thrombosis (p = 0.03). The Ki-67 score was significantly higher in the non-irradiated group (p = 0.01) and in the group of patients whose cause of enucleation was tumoral evolution (p = 0.005) compared with the group of patients enucleated after neovascular glaucoma. The Ki-67 score was very high in a case of orbital recurrence of uveal melanoma and metastatic death. 70% of metastasised tumours showed a Ki-67 score higher than the median value. CONCLUSION: Ki-67 labelling is a reliable method of estimating the proliferative activity in uveal melanomas after proton beam irradiation. The Ki-67 score is significantly correlated with prognostic variables (mitotic index and histological largest tumour diameter), and with radiation effects after proton beam irradiation.

[Treatment of soft tissue sarcomas of the extremities and the trunk by conservative surgery and postoperative irradiation. Apropos of a series of 96 patients]. / Traitement des sarcomes des parties molles des extrémités et du tronc par chirurgie conservatrice et irradiation postopératoire. A propos d'une série de 96 patients.

AIM OF STUDY: Retrospective study of a series of 96 patients presenting with soft tissues sarcoma. Homogeneous treatment between 1980-1992 with conservative surgery and post operative irradiation. PATIENTS AND METHODS: Median age of the 96 patients was 58 years. Tumor site was: upper limb 20, lower limb 46, trunk 30. In 35 cases largest diameter of the tumor was 5 cm or less (T1). All patients were M0. The most frequent pathological sub type was: malignant histiocytofibroma 28, liposarcoma 28. A gross complete surgery was performed in 89 cases. Radiotherapy was performed with cobalt or x 18 MV photons. The dose delivered was 50 Gy with a boost of 10 Gy. No adjuvant chemotherapy was given. RESULTS: Mean follow up was 68 months. Local relapse was seen in 19 patients, six were salvaged by surgery, a limb amputation rates were necessary in 4 cases. The 5 and 10 year-overall survival was 70% and 64%. There was no severe radiation toxicity requiring surgery. A good function of the limb was preserved in all cases. CONCLUSION: These results are in agreement with those of the literature and justify a conservative approach for these soft tissues sarcomas.

[Radiotherapy of cancer of the anal canal. 15 years experience at the Lyon civil hospices and brief review of the literature]. / La radiothérapie du cancer du canal anal. Quinze ans d'expérience aux Hospices Civils de Lyon et brève revue de la littérature.

AIM: Retrospective analysis of a series of 287 anal canal carcinomas seen during a 15-year period in the Department of Radiotherapy Oncology of Hospices Civils de Lyon. MATERIAL AND METHOD: Between 1980 and 1995, 287 patients were managed in the radiotherapy department of Hospices Civils de Lyon. In 25 cases, the patients were referred for recurrence. Post or preoperative irradiation was performed in 12 and 23 cases. Palliative treatment was given to 15 cases and simple follow-up in 7 cases. Radiotherapy was given to 205 patients. In 71 cases irradiation alone and in 134 concomitant radiochemotherapy was given. RESULTS: The 5-year overall survival of the group treated by radiotherapy (205 patients) was 71.5% and the 10 year-overall survival was 60.8%. The specific survival at 5 and 10 years was 81.9% and 74.7% respectively. At 5 years the overall survival was 78% for the group treated by concomitant radiochemotherapy and 60% for the group treated by irradiation alone. CONCLUSION: Radiotherapy is the standard treatment for anal canal carcinoma. Radiochemotherapy seems to improve results in advanced cases. The best irradiation of technique has yet to be defined.

The role of radiotherapy in the conservative treatment of rectal carcinoma--the Lyon experience.

The purpose of this study was to present the Lyon experience using radiotherapy alone or with surgery, with intent to cure rectal cancer and to avoid rectal amputation. Two groups of patients were treated between 1980 and 1996: Group I with radiotherapy alone with contact x-ray for T1 N0 (101 patients) or with a combination of external beam radiation therapy (EBRT), contact x-ray and 192 iridium implant in inoperable T2-3 N0-1 patients (43 patients); Group II with preoperative EBRT either as a pilot study (158 patients) or in a randomized trial (210 patients). With contact x-ray alone it was possible to control T1 N0 in 90% of cases, and with the combined approach 70% of the inoperable patients were controlled. In Group II, anterior resection was performed in 60% to 70% of the patients. Local recurrence was seen in 11% of cases. Surgery is the basic treatment used for rectal cancer but radiotherapy is playing an increasing role in the conservative treatment of this cancer.

Usefulness of the prognostic inflammatory and nutritional index (PINI) in hospitalized elderly patients.

The prognostic inflammatory and nutritional index (PINI) is a simple scoring system of overall health which aggregates two blood markers of inflammatory (C-reactive protein and alpha(1)-acid glycoprotein) and of nutritional (albumin and transthyretin) states. This study was undertaken with a view to evaluate, in comparison to currently used predictive approaches, the potential usefulness of PINI to forecast hospital mortality and outcome of patients hospitalized in an acute geriatric unit. 1,066 elderly patients, aged 82.7 +/- 6.6 years and fulfilling inclusion criteria, were enrolled in the study. Logistic regression analysis and calculation of relative risk (RR) were carried out for epidemiological data with a cut-off value of 25 for PINI. Immediate mortality (7.9%) of admissions) was predicted by PINI > or = 25 (RR = 4.34). Only 387 patients (36.3%) could rejoin their residence location (home or family). A sizeable proportion of acute patients (55.8%) failed to recover and/or developed diseased states requiring chronic care management. Incapacity to return home was predicted by PINI > or = 25 (RR = 2.04). Hypoalbuminaemia < or = 30 g/L was not found a predictor of mortality but was associated with total disability (RR = 9.08). The optimal PINI cut-off value to predict mortality was calculated at 8.8 using the ROC analytic approach. We conclude that the PINI formula is helpful to predict both nearest lethality and chronic institutionalization. This scoring system should take a place within the battery of tests used to identify and to follow up acutely ill elderly patients at risk of major complications.

Treatment of anal canal carcinoma with high dose radiation therapy and concomitant fluorouracil-cisplatinum. Long-term results in 95 patients.

PURPOSE: To evaluate the long-term results of the treatment of anal canal carcinoma (ACC) with a combined concomitant radiochemotherapy (CCRT) treatment using fluorouracil (5 FU) and cisplatinum (CDDP) with a high dose of radiation therapy. PATIENTS AND METHODS: Between 1982 and 1993 a series of 95 patients were treated. Staging showed a majority of advanced squamous ACC, i.e. 6 T1, 47 T2, 28 T3, 14 T4, 53 NO, 32 N1, 6 N2 and 4 N3. Irradiation was done with high dose external beam radiation therapy (EBRT) followed by a boost with 192 Iridium implant. During EBRT all patients received one course of 5 FU continuous infusion (1 g/m2/day, days 1-4) and CDDP (25 mg/m2/day, bolus days 1-4). RESULTS: The median follow-up time was 64 months. At 5 and 8 years the overall survival was 84 and 77%, the cancer specific survival was 90 and 86% and the colostomy-free survival was 71 and 67%, respectively. The stage and the response of the tumor after EBRT were of prognostic significance. Patients with pararectal lymph nodes had an overall 5-year survival of 76% (versus 88% for non-N1). Among 78 patients who preserved their anus, the anal sphincter function was excellent or good in 72 (92%). CONCLUSION: According to these results and recent randomized trials, CCRT appears as the standard treatment of ACC. Radical surgery should be reserved for local recurrence or persisting disease after irradiation. High dose irradiation in a small volume with concomitant 5 FU-CDDP appears to give a high rate of long-term local control and survival. Careful evaluation of pararectal nodes is essential for a good staging of the disease.

Intraoperative radiation therapy combined with limited lymph node resection in gastric cancer: an alternative to extended dissection?

PURPOSE: To describe the results of a series of 63 Western patients presenting with gastric adenocarcinoma and treated with surgery and intraoperative radiation therapy (IORT) over a 8-year period and to discuss the role of IORT when combined with limited lymph node dissection. METHODS AND MATERIALS: From 1986 to 1993, 63 patients with gastric adenocarcinoma have been operated in the department of radiation oncology of the Hospices Civils de Lyon. The stage was: I in 17, II in 11, IIIA in 9, IIIB in 20, and IV in 6. The lymph node dissection was considered to be limited in 56 patients and extended in 7. The IORT dose ranged from 12 to 23 Gy (median: 15). Thirty patients also underwent a postoperative external beam irradiation with a standard dose of 44-46 Gy. RESULTS: The postoperative mortality rate was 4.8%. The 5-year overall survival in the entire series was 47% and was 82, 55, 78, 20, and 0% in Stages I, II, IIIA, IIIB, and IV, respectively. Loco-regional relapse occurred in 15 of 63 patients and metastases in 15 of 63. CONCLUSION: In Western patients treated by gastrectomy for adenocarcinoma of the stomach, IORT combined with limited lymph node dissection may provide overall survival similar to that observed after gastrectomy with extended lymph node dissection but with less postoperative mortality.

Intraoperative radiotherapy in resected pancreatic cancer: feasibility and results.

BACKGROUND AND PURPOSE: To evaluate the impact of intraoperative radiotherapy (IORT) combined with postoperative external beam irradiation in patients with pancreatic cancer treated with curative surgical resection. MATERIALS AND METHODS: From January 1986 to April 1995 25 patients (11 male and 14 female, median age 61 years) underwent a curative resection with IORT for pancreatic adenocarcinoma. The tumour was located in the head of the pancreatic gland in 22 patients, in the body in two patients and in the tail in one patient. The pathological stage was pT1 in nine patients, pT2 in nine patients, pT3 in seven patients, pN0 in 14 patients and pN1 in 11 patients. All the patients were pM0. A pancreaticoduodenectomy was performed in 22 patients, a distal pancreatectomy was performed in two patients and a total pancreatectomy was performed in one patient. The resection was considered to be complete in 20 patients. One patient had microscopic residual disease and gross residual disease was present in four patients. IORT using electrons with a median energy of 12 MeV was performed in all the patients with doses ranging from 12 to 25 Gy. Postoperative EBRT was delivered to 20 patients (median dose 44 Gy). Concurrent chemotherapy with 5-fluorouracil was given to seven patients. RESULTS: The overall survival was 56% at 1 year, 20% at 2 years and 10% at 5 years. Nine local failures were observed. Twelve patients developed metastases without local recurrence. Twenty patients died from tumour progression and two patients died from early postoperative complications. Three patients are still alive; two patients in complete response at 17 and 94 months and one patient with hepatic metastases at 13 months. CONCLUSION: IORT after complete resection combined with postoperative external beam irradiation is feasible and well tolerated in patients with pancreatic adenocarcinoma.

Adenocarcinoma of the body and tail of the pancreas: is there room for adjuvant radiotherapy?

AIMS AND BACKGROUND: Adenocarcinoma of the body and tail of the pancreas is a rare malignancy with a poor prognosis. Few long-term survivors have been reported in the literature. The role of adjuvant treatment after curative resection has not yet been assessed. This retrospective study aims to describe the patterns of failure and the survival of 10 patients treated with resection and adjuvant radiotherapy. MATERIALS AND METHODS: From 1982 to June 1994, 10 patients with adenocarcinoma of the body and tail of the pancreas received adjuvant radiotherapy in our department. There were 4 females and 6 males, with a median age of 63 years (range, 45-77). The pT distribution was 2 pT1, 4 pT2, 4 pT3 and for pN it was 7 pN0 and 3 pN1. Four patients had stage I, 3 stage II and 3 stage III disease. All the patients underwent a resection: distal pancreatectomy in 7, partial resection of the body in 1, and total pancreatectomy in 2. Gross residual disease was present in 2 cases. Three patients received intraoperative radiotherapy up to a dose of 12-15 Gy. Postoperative radiotherapy was given in 9 patients with a dose ranging from 40 to 50 Gy (median, 45). One patient who received intraoperative radiotherapy had no postoperative radiotherapy. In 4 patients, chemotherapy with 5-fluorouracil was given during the first week of irradiation. RESULTS: Six patients experienced a local-regional relapse and 3 developed metastases. The median survival was 21 months. The 5-year overall survival was 15%. Eight patients died of progressive disease. One patient who presented with stage I disease was alive and free of disease at 24 months from diagnosis and, interestingly, one with stage III disease was alive at 111 months. No severe treatment-related complications were observed. CONCLUSIONS: As in carcinoma of the head of the pancreas, adjuvant radiotherapy should be considered as an adjuvant treatment of resected adenocarcinoma of the body and tail of the pancreas. Further evaluation is necessary to assess the role of intraoperative radiotherapy.