[Translation and validation in French of a multidimensional scale to evaluate the degree of satisfaction during childbirth]. / Traduction et validation en langue française d'une échelle multidimensionnelle évaluant le degré de satisfaction, lors de l'accouchement.

BACKGROUND: Validation of the French version of the questionnaire: Women's Views of Birth Labour Satisfaction Questionnaire, version 4 (WOMBLSQ4). This self-administered questionnaire measures patient satisfaction with care dispensed during childbirth. METHODS: The WOMBLSQ4 comprises 30 items divided into ten dimensions. Items were translated from English into French and then underwent a linguistic adaptation. The results have been submitted to a descriptive analysis and psychometric tests used for questionnaires, i.e., the Cronbach alpha coefficient and Spearman correlation coefficient. The test-retest reliability has been assessed by a calculation of the intraclass correlation and by Bland-Altman plots. RESULTS: The study was presented to 116 primiparous patients between March and September 2004. One hundred and two (88%) patients agreed to participate in the study and received the French translation of WOMBLSQ4, as well as the Short-Form 12 Health Survey and the Edinburgh Postnatal Depression Scale, 2 months after childbirth. Ninety-two patients (90%) returned the questionnaires. The Cronbach alpha coefficient for the WOMBLSQ4 is 0.85. The results of the test-retest are between 0.54 and 0.83 for the intraclass correlation depending on the scale dimension, and show a homogeneity of the mean differences between the two measures according to the Bland-Altman plot. The average score of satisfaction is 65.2 (+/-12) with a minimum of 35.5 and a maximum of 86.4 according to the dimensions. CONCLUSION: On the technical level, the French version of the WOMBLSQ4 fully meets the criteria for the measurement of quality of care in obstetrics. The internal validity and reproducibility of the WOMBLSQ4 in French are satisfactory. However, in order to obtain results that can be fully interpreted in a French-speaking population, a transcultural adaptation should be considered for certain elements of the questionnaire.

Is cerebral autoregulation impaired in Parkinson's disease? A transcranial Doppler study.

Orthostatic hypotension (OH) is one of the many autonomic disturbances observed in Parkinson's disease (PD). It has been debated whether an additional impairment of cerebral autoregulation (CA) in PD patients may exacerbate the consequences of OH upon brain perfusion. We assessed CA in PD patients and the potential influence of dopaminergic agents. CA was determined by means of transcranial Doppler (TCD) monitoring of the middle cerebral artery (MCA) at rest and during a thigh cuff release test inducing a systemic blood pressure (BP) drop. Fourteen patients were investigated when taking their usual dopaminergic medication and after drug discontinuation for 12 h. A control group was composed of 11 age-matched subjects (CS). In comparison with PD patients, CS presented a significantly higher increase of the mean cerebral blood flow velocities in the MCA after the BP drop. Mean velocities were increased above the initial values in all CS, whereas a flattened curve was observed in PD patients. No significant differences could be further observed between the PD patients regarding the BP, the cerebrovascular resistance, the heart rate and the pulsatility index. These results provide evidence of an impaired cerebral autoregulation in PD patients which appears independent of dopaminergic treatment.

Randomized clinical trial of mechanical bowel preparation versus no preparation before elective left-sided colorectal surgery.

BACKGROUND: Mechanical bowel preparation (MBP) is performed routinely before colorectal surgery to reduce the risk of postoperative infectious complications. The aim of this randomized clinical trial was to compare the outcome of patients who underwent elective left-sided colorectal surgery with or without MBP. METHODS: Patients scheduled for elective left-sided colorectal resection with primary anastomosis were randomized to preoperative MBP (3 litres of polyethylene glycol) (group 1) or surgery without MBP (group 2). Postoperative abdominal infectious complications and extra-abdominal morbidity were recorded prospectively. RESULTS: One hundred and fifty-three patients were included in the study, 78 in group 1 and 75 in group 2. Demographic, clinical and treatment characteristics did not differ significantly between the two groups. The overall rate of abdominal infectious complications (anastomotic leak, intra-abdominal abscess, peritonitis and wound infection) was 22 per cent in group 1 and 8 per cent in group 2 (P = 0.028). Anastomotic leak occurred in five patients (6 per cent) in group 1 and one (1 per cent) in group 2 (P = 0.210) [corrected] Extra-abdominal morbidity rates were 24 and 11 per cent respectively (P = 0.034). Hospital stay was longer for patients who had MBP (mean(s.d.) 14.9(13.1) versus 9.9(3.8) days; P = 0.024). CONCLUSION: Elective left-sided colorectal surgery without MBP is safe and is associated with reduced postoperative morbidity.

Is measurement of D-dimer useful in the diagnosis of cerebral venous thrombosis?

BACKGROUND: The diagnosis of cerebral venous thrombosis (CVT) is a challenge because its clinical presentation is variable, brain CT may be normal, and MRI is not always available. Furthermore, early treatment may be effective. As D-dimer (DD) measurement is a sensitive test for the exclusion of venous thromboembolism, the authors studied whether this test could be useful in the diagnosis of CVT. METHODS: A prospective study of 54 consecutive patients with headaches suggestive of CVT was conducted between October 2000 and September 2002. DD levels were tested for all patients in the emergency room before brain CT or MRI was performed. RESULTS: Twelve (22%) of the 54 patients had CVT, and 10 (83%) of these 12 patients had DD level of >500 ng/mL (sensitivity of 83% and negative predictive value of 95%). Two patients with confirmed CVT and DD of <500 ng/mL had a history of chronic headache of >30 days' duration. In the 42 patients without confirmed CVT, only 4 patients had DD level of >500 ng/mL (specificity of 90% and positive predictive value of 71%). CONCLUSIONS: DD test is useful in the diagnosis of acute CVT. A value below 500 ng/mL makes acute thrombosis unlikely.

Neoadjuvant radiochemotherapy for locally advanced gastric cancer: a phase I-II study.

BACKGROUND: To study in a phase I-II trial the maximum tolerated dose, the toxicity, and the tolerance of adding radiotherapy to systemic chemotherapy administered preoperatively in patients with locoregionally advanced gastric adenocarcinoma. PATIENTS AND METHODS: Patients with adenocarcinoma of the stomach (T(3)(-)(4)N(any) or T(any)N+), performance status

Long-term follow-up after first acute episode of sigmoid diverticulitis: is surgery mandatory?: a prospective study of 118 patients.

PURPOSE: This study was designed to evaluate the long-term natural history of sigmoid diverticulitis in patients treated nonoperatively after a first acute episode and to assess the role of elective colectomy. METHODS: Between 1986 and 1991, 144 patients were admitted for acute diverticulitis diagnosed by abdominal computed tomography and had a successful nonoperative treatment. Remote complications (persisting or recurring diverticulitis) were also diagnosed by computed tomography. Patients had a poor outcome if they had one of these complications. Diverticulitis was graded mild or severe on computed tomography according to Ambrosetti's criteria. We determined statistically whether young age (< or =50 years old) and severe diverticulitis were risk factors for a poor outcome. RESULTS: One hundred eighteen patients with a contributive computed tomographic scan at admission were followed up. Median age was 63 (range, 23-93) years, with a median follow-up of 9.5 (range, 0.2-13.8) years. Eighty patients had no complications, and 38 had remote complications. The incidence of remote complications was the highest (54 percent at 5 years) for young patients with severe diverticulitis on computed tomography and the lowest (19 percent at 5 years) for older patients with mild disease. Young age and severe diverticulitis taken separately were both statistically significant factors of poor outcome (P = 0.007 and P = 0.003, respectively), although age was no longer significant after stratification for disease severity on computed tomography (P = 0.07). Twenty-four patients died. The cause of death was unrelated to diverticulitis in 21 cases and unknown in the remaining 3. CONCLUSIONS: We propose that after a first acute episode of diverticulitis treated nonoperatively, elective colectomy should be offered to young patients (< or =50 years old) with severe diverticulitis on computed tomography.

Patent foramen ovale, a possible cause of symptomatic migraine: a study of 74 patients with acute ischemic stroke.

Recent studies reported an increased prevalence of patent foramen ovale (PFO) in patients with migraine with aura (MA+). To investigate the possible relationship between MA+ and paradoxical embolism, we studied the prevalence of both conditions. Investigation of PFO was undertaken in 74 consecutive patients presenting with an acute stroke of undetermined origin. The patients were questioned about MA+ or migraine without aura (MA-) according to the criteria of the International Headache Society. Follow-up was performed to investigate the evolution of MA+ and MA- according to different treatments of stroke. PFO was found in 44 of 74 patients, 16 of whom had MA+ (36%), compared to 4 (13%) MA+ patients without PFO (p = 0.03). Of 25 patients in whom the PFO was considered to play a causal role in the stroke, 13 (52%) had MA+, whereas only 3 (16%) of 19 patients in whom PFO was considered unrelated had MA+ (p = 0.014). Thirty-nine of the patients with MA+ and MA- were studied over a mean follow-up of 13 months. Seven of 15 patients with MA+ and PFO, treated either with surgical closure or anticoagulants, noticed complete disappearance of MA+ attacks. The prevalence of MA+ is high among stroke patients with PFO. In patients with a high presumption of paradoxical embolism, the proportion of MA+ is increased, and this suggests a possible role of this association in the occurrence of the cerebrovascular event. Forty-seven percent of patients with PFO and MA+ reported complete suppression of their aura attacks after surgical closure or anticoagulant treatment. This finding suggests that at least in some patients, MA+ attacks may be due to paradoxical embolism.

Gamma-irradiation markedly inhibits the hydrated collagen gel contradiction by arterial smooth muscle cells.

BACKGROUND: Vessel wall responses to percutaneous transluminal coronary angioplasty include neointimal proliferation and arterial remodeling. The contraction of a collagen gel is a good in vitro model of wound repair and vascular remodeling. Because irradiation is an important new therapeutic modality capable of preventing restenosis, the purpose of this study was to evaluate the effect of irradiation on the contraction of a collagen gel by smooth muscle cells (SMCs), on SMCs viability, and on DNA synthesis. METHODS: We studied the effect of different doses of gamma-irradiation (0 [control], 6, 12, and 18 Gy) on the contraction of a collagen gel seeded with SMCs (calf carotid arteries) during a period of 15 days. RESULTS: Maximal gel diameter reduction (from 35 to 6.8 mm, +/-0.5 mm in control) was markedly inhibited in the 6-, 12-, and 18-Gy groups (35 to 13.7 mm, +/-0.8 mm; 35 to 15.5 mm, +/-0.9 mm; and 35 to 16.1 mm, +/-0.9 mm, respectively; P<0.0001). The irradiated gels showed a dose-dependent reduction in the SMC proliferation rate (P<0.0001) and an increase in the number of nonviable SMCs (P<0.002) 15 days after irradiation. CONCLUSIONS: Gamma-irradiation produces a significant dose-dependent inhibition of the contraction of collagen gels seeded with arterial SMCs. This effect is related to a significant decrease in SMC viability and a decrease in SMC proliferation rate. These findings shed light on mechanisms whereby irradiation may positively affect arterial remodeling after percutaneous transluminal coronary angioplasties.

Randomised controlled trial of three day versus 10 day intravenous antibiotics in acute pyelonephritis: effect on renal scarring.

BACKGROUND: Acute pyelonephritis often leaves children with permanent renal scarring. AIMS: To compare the prevalence of scarring following initial treatment with antibiotics administered intravenously for 10 or three days. METHODS: In a prospective two centre trial, 220 patients aged 3 months to 16 years with positive urine culture and acute renal lesions on initial DMSA scintigraphy, were randomly assigned to receive intravenous ceftriaxone (50 mg/kg once daily) for 10 or three days, followed by oral cefixime (4 mg/kg twice daily) to complete a 15 day course. After three months, scintigraphy was repeated in order to diagnose renal scars. RESULTS: Renal scarring developed in 33% of the 110 children in the 10 day intravenous group and 36% of the 110 children in the three day group. Children older than 1 year had more renal scarring than infants (42% (54/129) and 24% (22/91), respectively). After adjustment for age, sex, duration of fever before treatment, degree of inflammation, presence of vesicoureteric reflux, and the patients' recruitment centres, there was no significant difference between the two treatments on renal scarring. During follow up, 15 children had recurrence of urinary infection with no significant difference between the two treatment groups. CONCLUSION: In children with acute pyelonephritis, initial intravenous treatment for 10 days, compared with three days, does not significantly reduce the development of renal scarring.

Unlabelled iododeoxyuridine increases the cytotoxicity and incorporation of [1251]-iododeoxyuridine in two human glioblastoma cell lines.

Iododeoxyuridine (IUdR), labelled with radioiodines emitting Auger, alpha or beta- radiation, has been proposed as a therapeutic tool in the treatment of cancer. However, the low per cent incorporation in tumour cells and limited cytotoxicity are major obstacles for such an application. Using unlabelled IUdR as a modulator, we have studied the in vitro cytotoxicity of [125I]-IUdR in two human glioblastoma cell lines. Surprisingly, an enhanced cytotoxicity of [125I]-IUdR was observed in the presence of 0.3-10 microM concentrations of unlabelled IUdR in U251 glioblastoma cells and to a lesser extent in LN229 cells. The presence of unlabelled IUdR unexpectedly increased the incorporation of [125I]-IUdR in both cell lines. Thymidine competitively blocked the cytotoxic effects of combined unlabelled and [125I]-labelled IUdR in these cells and DNA-incorporation of radiolabelled IUdR.

Elevated serum vitamin B12 levels associated with CRP as a predictive factor of mortality in palliative care cancer patients: a prospective study over five years.

The relationship between vitamin B12 levels and survival was studied in a group of 161 terminally ill cancer patients who were recruited consecutively between 1988 and 1989. Their average age was 74.7 years. The length of survival decreased with the increase in serum vitamin B12 levels (P = 0.0015, Cox model). In multivariate analyses, C-reactive protein (CRP) was the most important prognostic factor in this population, and vitamin B12 provided information independent of CRP in predicting survival. These data indicate that an elevated serum vitamin B12 level is a predictive factor for mortality in patients with cancer, independent of CRP or other factors. Multiplying it by the CRP makes it possible to create a new, easy-to-use prognostic index, which can distinguish different levels of mortality risk at three months.

Phase II trial of up-front accelerated thoracic radiotherapy combined with chemotherapy and optional up-front prophylactic cranial irradiation in limited small-cell lung cancer. Groupe d'Oncologie Thoracique des Régions Alpines.

PURPOSE: To investigate the feasibility and outcome of bifractionated, up-front thoracic radiotherapy (TR) (45 Gy in 30 fractions of 1.5 Gy twice daily over 3 weeks) combined with chemotherapy (CT) (six cycles of cisplatin and etoposide) and optional low-dose, up-front prophylactic cranial irradiation (18 Gy in 10 fractions of 1.8 Gy twice daily over 5 days) in limited small-cell lung cancer. PATIENTS AND METHODS: CT (etoposide 100 mg/m(2) for 3 days and cisplatin 25 mg/m(2) for 3 days) was started on day 8 or 15 after the first TR treatment. In the five subsequent cycles, cisplatin was given as a single 100-mg/m(2) dose on day 1 every 4 weeks. A total of 52 patients were entered (41 men and 11 women); the median age was 55 years (range, 33 to 67 years). World Health Organization performance status was 0 in 34 patients, 1 in 16 patients, and 2 in two patients. Thirty-six patients (69%) received the full planned six cycles of CT. RESULTS: All treated patients were assessable for response. Thirty-one patients (60%) achieved a complete response, and 16 (30%) had a partial response. One-, 3-, and 4-year survival rates were 74% (95% confidence interval [CI], 60% to 84%), 34% (95% CI, 21% to 49%), and 32% (95 CI, 16% to 46%), respectively. The median survival time was 18 months. Event-free survival at 1 year was 45% (95% CI, 32% to 58%) and at 3 years, 30% (95% CI, 18% to 44%). The main radiation-related acute toxicity was esophageal: 38% of the patients experienced grade 3 or 4 acute toxicity. CT was well tolerated. Although grade 3/4 neutropenia was observed in 86% of the patients, only 4% presented with associated fever. Grade 3/4 nausea and vomiting was seen in 35% of patients. CONCLUSION: This trial demonstrates that up-front accelerated TR associated with CT is feasible, has acceptable toxicity, and shows considerable long-term survival potential.

Infusional ECarboF in patients with advanced breast cancer: a very active and well-tolerated out-patient regimen.

We performed a trial using the combination of epirubicin 50 mg/m2/day 1, carboplatinum AUC 5/day 1 and continuous 5-fluorouracil (5-FU) 200 mg/m2/day (every 4 weeks for 6 months) to confirm the efficacy and low toxicity profile of this regimen in breast cancer. In 51 patients with metastatic (n = 33) or locally advanced (n = 18) breast cancer the overall response rate was 86% (95% confidence interval (95% CI): 73%-94%): 94% in locally advanced and 81% metastatic disease. Grade 3-4 toxicity was low: 4% of patients presented with febrile neutropenia, 16% with severe palmar-plantar syndrome, 10% with Port-a-cath thrombosis. This study confirms the high efficacy of infusional 5-FU-based regimens and justifies further research into novel promising oral 5-FU derivatives.

Effect of calcitonin on bone and connective tissue metabolism in hemiplegic patients: a two-year prospective study.

OBJECTIVES: To test the effects of 200 IU/day of a nasal spray of salmon calcitonin in modulating the increased bone tissue metabolism observed in hemiplegic patients. DESIGN: A two-year, prospective, randomized, double-blind, placebo-controlled study. PATIENTS: Thirty-four patients with hemiplegia due to a cerebrovascular accident were included in the study during the first month after onset of hemiplegia after giving their informed consent. All patients followed a suitably planned course of active rehabilitation according to Bobath. They were randomly allocated to either the calcitonin or the placebo group but all of them received a daily oral calcium supplementation of 1000 mg. RESULTS: Biochemical markers of bone formation, serum total alkaline phosphatase, osteocalcin and type I procollagen did not vary during the two years of follow-up. Cross-linked carboxy-terminal telopeptide of type I collagen, a biochemical marker of bone resorption, was elevated initially after stroke and then decreased significantly (p <0.001), stabilizing as of month 12. Urinary calcium/creatinine and total hydroxyproline/creatinine ratios presented with similar profiles. The serum levels of the type III procollagen, a marker of connective tissue metabolism, were also elevated upon entry and decreased thereafter. No significant difference could be found between the calcitonin-treated and the placebo group for any of the biochemical markers at any time point. CONCLUSION: This prospective study demonstrated that biochemical markers of bone and connective tissue metabolism were elevated shortly after the occurrence of stroke and then gradually decreased during the first two years after injury. The daily administration of 200 IU of intranasal calcitonin did not influence the levels of these markers.

Aortic valve repair by cusp extension with the use of fresh autologous pericardium in children with rheumatic aortic insufficiency.

OBJECTIVES: Our goal was to evaluate the midterm results of aortic valve repair by a more sophisticated tailoring of cusp extension-taking into account the dimensions of the native aortic cusps-with the use of fresh autologous pericardium. PATIENTS AND METHODS: Forty-one children who had severe rheumatic aortic insufficiency (mean age 11.5 +/- 2.7 years) underwent aortic valve repair by means of this cusp extension technique over a 5-year period. Twenty-four of them underwent concomitant mitral valve repair for associated rheumatic mitral valve disease. All children were then followed up by transthoracic echocardiography before discharge, at 3 and 6 months after the operation, and at yearly intervals thereafter. RESULTS: Follow-up was complete in all patients and ranged from 3 months to 5 years (median 3 years). No operative and no early postoperative deaths occurred. Only 1 patient died, 9 months after the operation, of septicemia and multiple organ failure. Actuarial survival was 97% at 1 year and has remained unchanged at 3 years. On discharge, the degree of aortic insufficiency was grade 0 for 27 children and grade I for 14. Exacerbation of aortic insufficiency from grade I to grade II was observed in only 1 patient, and none of the children required reoperation for aortic insufficiency during the follow-up period. Mean peak systolic aortic valve gradients at discharge were lower than preoperative values (P =.04), and no significant increase in the peak systolic transvalvular gradient was detected thereafter during the follow-up period. Mean left ventricular dimensions were significantly reduced at discharge when compared with preoperative values (P <.0001). CONCLUSIONS: Functional results of aortic valve repair with cusp extension using fresh pericardium have been satisfactory at medium term, particularly in children with a small aortic anulus at the time of initial repair, because the expansion potential of fresh autologous pericardium is equivalent to that of the growing sinotubular junction and aortic anulus diameters.

The influence of field size and other radiotherapy parameters on acute toxicity in pharyngolaryngeal cancers.

BACKGROUND: Accelerated radiotherapy and/or chemo-radiotherapy of the head and neck region decrease the tolerance of acute responding tissues. Tissue tolerance is also field size dependent. PATIENTS AND METHOD: An attempt to retrospectively quantify the risk of acute toxicity (peak scores) with field size was undertaken in 286 patients irradiated for unresected head and neck tumors with or without chemotherapy, and with or without accelerated radiotherapy between 1979 and 1990. A Grade-3 to -4 acute toxicity score (RTOG) and > 5% weight loss were chosen as endpoints. RESULTS: For Grade-3 to -4 toxicity, the risk increased from 0.06 for 5 x 5 cm2 to 0.68 for 17 x 17 cm2 fields and conventional radiotherapy, and from 0.33 for 5 x 5 cm2 to 0.94 for 17 x 17 cm2 and multiple daily fractionation. For > 5% weight loss, the risk ranged from 0.07 for 5 x 5 cm2 to 0.94 for 17 x 17 cm2 fields. CONCLUSIONS: The size of the cervical fields receiving the first 50 Gy was an indicator for severe acute toxicity and weight loss. Taking these data into account may help to improve preventive and treatment measures.

Benefit of prestorage leukocyte depletion of single-donor platelet concentrates.

BACKGROUND AND OBJECTIVES: The presence of contaminating white blood cells (WBCs) in platelet concentrates is associated with transfusion reactions and may adversely alter the quality of platelets during storage. Leukocyte depletion by filtration of platelets has been increasingly used to avoid these complications. However, the best time for filtration and the benefits of filtering single-donor platelet concentrates (thrombapheresis, TH) have yet to be clearly defined. METHODS: In a randomized study of 202 TH collected with an Autopheresis C system, we determined whether prestorage filtration (preSF) of WBCs from TH as compared with poststorage (bedside) filtration (postSF) resulted in a better product. Levels of cytokines and C3a accumulating in the medium during storage, platelet activation state, in vivo platelet recovery, and transfusion reactions were compared in pre- and poststorage products. RESULTS: As compared to preSF, significantly more postSF TH had detectable levels of tumor necrosis factor-alpha (TNF-alpha; 47 vs. 15%; p<0.0001) and interleukin 6 (13 vs. 3%; p = 0.02), lower pH (p<0.0001) and decreased levels of C3a (910 vs. 2,000 pg/ml; p<0. 0001). Furthermore, platelet activation was increased in postSF TH (p = 0.022). PostSF TH tended to plug the bedside filter (27% of postSF TH delivered) from day 3 onward. There was also a significant difference in platelet recovery, postSF TH showing a lower corrected count increment (CCI; p = 0.0055) when taking into account the postSF TH that plugged filters (CCI = 0), but no difference when plugged TH were excluded. A correlation could be established between TNF-alpha levels and poor in vivo recovery (p<0.0001). Febrile nonhemolytic transfusion reactions were low in both groups (4 and 9%). CONCLUSION: These results indicate a benefit of preSF TH as compared with postSF TH based on the following parameters: decrease in cytokine levels, less platelet activation, maintenance of higher pH, and more efficient use of stored platelets (27% of postSF TH were lost because of plugging of filters). These results apply particularly to the Autopheresis C systems with its high initial WBC content.

Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors.

RATIONALE AND OBJECTIVES: The authors attempted to determine the frequency and severity of adverse reactions to gadolinium-based magnetic resonance (MR) contrast agents and to identify strategies for management of patients at increased risk. MATERIALS AND METHODS: American Society of Neuroradiology program directors were surveyed about adverse reactions at their institutions to gadolinium-based contrast agents, the contrast agents responsible, and the management of patients with allergy-like reactions to iodinated or gadolinium-based agents who required MR contrast agent administration. RESULTS: Fifty-three (50.5%) surveys were received from 105 centers. Of 687,255 gadopentetate dimeglumine injections, 314 (0.046%) nonallergic reactions and 107 (0.016%) mild, 28 (0.004%) moderate, and five (0.001%) severe allergy-like reactions occurred. Of 74,275 gadodiamide injections, 11 (0.015%) nonallergic and 12 (0.016%) mild allergy-like reactions occurred. Of 64,005 gadoteridol administrations, 171 (0.267%) nonallergic reactions and 49 (0.077%) mild, 29 (0.047%) moderate, and 11 (0.017%) severe allergy-like reactions occurred. Twenty-six departments took no precautions for patients with previous allergy-like reactions to iodinated contrast material. Nineteen did not premedicate patients who previously had reactions to gadolinium-based agents before repeat administration of MR contrast agents. CONCLUSION: Although MR contrast agents are safe, adverse reactions occur. Many centers have not adopted policies for the OFF

Combined chemoradiotherapy for invasive bladder cancer: a feasibility approach in a non selected population.

BACKGROUND: We aimed to evaluate the tolerance and response rate to neo-adjuvant combined chemo-radiotherapy and to determine the possibilities of conservative treatment in patients (pts) with muscle invasive bladder cancer. METHODS: Thirty-nine T1-4, NO-3 pts were enrolled in this study. After 2 cycles of treatment, responders at intermediate assessment were treated by either additional chemotherapy +/- radiotherapy or radical cystectomy. If there was evidence of persistent tumour, radical cystectomy was performed whenever possible. RESULTS: Thirty-five (90%) pts completed the pre-operative treatment, 26/39 (67%) were in remission at intermediate assessment and 8 of them underwent a radical cystectomy. The median follow-up was 87 months, and 15 pts are alive without evidence of tumour and 5 with bladder preservation. The 3 and 5-year survival was 51 and 40%, respectively. Median survival differences between the responding operated or non-operated pts were not statistically different. CONCLUSIONS: Neo-adjuvant chemo-radiotherapy for invasive bladder cancer is effective with acceptable toxicity, and inoperable patients can benefit from such treatment.

Alternating radiotherapy and chemotherapy for inoperable Stage III non-small-cell lung cancer: long-term results of two Phase II GOTHA trials. Groupe d'Oncologie Thoracique Alpine.

PURPOSE/OBJECTIVE: To report on two consecutive Phase II cooperative trials in which we evaluated the combination of alternating hyperfractionated accelerated radiotherapy and cisplatin-based chemotherapy in inoperable Stage III non-small cell lung cancer (NSCLC). PATIENTS & METHODS: Between February 1986 and September 1989, 65 patients were entered in the first trial (GOTHA I), and between December 1989 and October 1992 67 were enrolled in the second trial (GOTHA II). In both protocols, radiotherapy (RT) was administered twice daily, at 6 h intervals, 5 days a week, to a total dose of 63 Gy in 42 fractions of 1.5 Gy. RT was given during weeks 2, 3, 6, and 7, over an elapsed time of 6 weeks. In GOTHA I, three cycles of cisplatin, 60 mg/m2 day 1, mitomycin, 8 mg/m2 day 1, and vindesin 3 mg/m2 day 1 and the first day of the following week, were given during weeks 1, 5, and 9; in GOTHA II, cisplatin 70 mg/m2 day 1 and vinblastin 5 mg/m2 day 1 and the first day of the following week were given during weeks 1, 5, 9, 13, 17, and 21. RESULTS: With a minimum follow-up of 3 years, the 1-, 2-, 5-, and 8-year overall survival probability was 56% (95% CI 47-64%), 27% (20-35%), 12% (7-18%) and 9% (3-16%), respectively, with a median survival of 13.6 months (11.4-16.8). Median follow-up for survivors was 6 years (3.3-9.9). There were no survival differences between Stages IIIA and IIIB (p = 0.84), performance status 0, 1, 2 (p = 0.87), sex (p = 0.45) or between the two treatment protocols. At this time, 14 patients are alive, and 118 have died: 102 from NSCLC, 4 from acute toxicity, 2 from secondary surgery, 4 from other medical causes, and 6 from unknown causes. Correlation between response and long-term survival was poor, since of the 24 patients who survived 3 years or more, only 6 (25%) were classified as having a complete response; the remainder having either a partial response (11, 46%), no change (6, 25 %), or "progressive disease" (1, 4 %). First site of relapse was local in 31% of these cases, distant in 43%, local and distant in 15 %, and unknown in 11%. Main grade 3-4 acute toxicities were nausea-vomiting (17%), mucositis (15%), leukopenia (41%), and thrombocytopenia (11%). Eight patients presented with grade 3-4 symptomatic lung radiation pneumopathy. CONCLUSION: Based on this experience with 132 patients, this combination of alternated RT and chemotherapy (CT) for inoperable Stage III NSCLC is feasible with acceptable toxicity, and long-term results suggest a gain in survival when compared to those obtained with conventional RT alone. However, the still high local and distant failure rates indicate that both local and systemic therapies need to be improved.