[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.

Inhibition by diphosphonates of bone resorption induced by the Walker tumor of the rat.

An animal model is described to test the effect of diphosphonates, which are powerful antiosteolytic agents, against bone tumors. This model consists of injecting Walker tumor cells into one iliac artery of a series of rats while the contralateral artery is clamped during the injection, and waiting 7 days to obtain a significant destruction of the femur and tibia of the rats. In most of the animals, after this delay, extensive lesions are observed macroscopically by X-ray and histologically. The parenteral administration of three diphosphonates, dichloromethylene diphosphonate, ethanehydroxydiphosphonate , and aminopropanediphosphonate , at 16 and 160 mumol/kg/day, protects the bones by decreasing the extent of osteolysis. This protective effect is seen both in the tumor-injected leg and in the contralateral leg and is significant when compared to nontreated animals. The most active of the drugs was dichloromethylene-diphosphonate; ethanehydroxydiphosphonate and aminopropanediphosphonate were less active, especially when given at the higher dosage. All diphosphonates produce a marked decrease of the number of osteoclasts; ethanehydroxydiphosphonate at the higher dosage, induced a large increase of nonmineralized bone. These results are discussed in light of recent clinical work, showing that this animal model is a useful tool to test the effect of new drugs against osteolysis of cancer.

Inhibition by two diphosphonates of bone lysis in tumor-conditioned media.

In order to test the effect of diphosphonates in inhibiting bone lysis induced by human tumors, neonatal mouse calvaria are cultured in sterile conditions in different media. Osteolysis is estimated by the amount of 45Ca released from bone to medium, the mice being given injections of 45Ca on their day of birth. An increased bone lysis is observed when calvaria are incubated in the same medium conditioned from cultured tumor fragments. This effect is significantly decreased when the mice have been treated with either ethanehydroxydiphosphonate or dichloromethylenediphosphonate. These experiments represent a first step in estimating the potential effects of different drugs on malignant osteolysis.

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.

Renal toxicity after allogeneic bone marrow transplantation: the combined effects of total-body irradiation and graft-versus-host disease.

PURPOSE: To evaluate retrospectively the cumulative risk probability and factors correlated with renal dysfunction after allogeneic bone marrow transplantation (BMT). PATIENTS AND METHODS: From October 1984 to July 1994, 84 patients with malignant hematopoietic diseases received allogeneic BMT after conditioning with high-dose chemotherapy and total-body irradiation (TBI). Seventy-nine patients with normal renal function before conditioning are included in this study. Conditioning included high-dose cyclophosphamide without (n = 46) or with (n = 33) other agents (daunorubicin, busulfan, cytarabine, and thiotepa) followed by TBI. The TBI dose prescribed to the center of the abdomen was 10 Gy for 24 patients, 12 Gy for 32, and 13.5 Gy for 23. In vitro T-cell depletion was undertaken in 48 cases. The post-BMT nephrotoxicity of aminoglycosides, vancomycin, amphotericin, and cyclosporine was assessed. Time to renal dysfunction was defined as the time to a persistent increase of serum creatinine (SCr) level greater than 110 mumol/L. The potential influence of sex, age, diagnosis, chimerism, and graft-versus-host disease (GvHD) on renal dysfunction was also assessed. RESULTS: The 18-month probability of renal dysfunction-free survival (RDFS) for the whole group was 77%. Only TBI dose and presence of GvHD were significantly correlated with renal dysfunction by multivariate analysis. The 18-month probabilities of RDFS were 95%, 74%, and 55% for the patients conditioned with 10, 12, and 13.5 Gy, respectively. The 18-month RDFS probabilities were 88% and 61% for patients without and with GvHD, respectively. Combining both variables, we have defined two risk categories: low-risk (ie, 10 Gy TBI with/without GvHD and 12 Gy TBI without GvHD) and high-risk (ie, 12 Gy TBI with GvHD and 13.5 Gy TBI with/without GvHD). The predicted 18-month RDFS rates were 93% and 52% for the low- and high-risk groups, respectively. CONCLUSION: Renal dysfunction after allogeneic BMT is strongly related to the delivered TBI dose (and dose per fraction) and to the presence of GvHD. Renal shielding should be recommended if a TBI dose greater than 12 Gy (fractionated twice daily over 3 days) is to be prescribed. Furthermore, in those cases with a high risk of developing GvHD (eg, unrelated allogeneic BMT, absence of T-cell depletion), these data suggest that kidney doses greater than 10 Gy should be avoided.

Atrial natriuretic factor in patients with congenital heart disease: correlation with hemodynamic variables.

To investigate the alpha-atrial natriuretic factor in congenital cardiac malformations, three groups of children, aged 7 months to 16 years, with different hemodynamic situations were studied during routine cardiac catheterization. Twenty-one (group I) had tetralogy of Fallot, 24 (group II) had a left to right shunt with pulmonary hypertension and 12 (control group) had a minor cardiac lesion. Alpha-atrial natriuretic factor levels were determined by a radioimmunoassay on blood samples from the inferior vena cava, right atrium, pulmonary artery, left atrium and aorta. To evaluate the effect of an acute volume load, measurements of hormone and pressures were repeated after right ventriculography. Alpha-atrial natriuretic factor levels varied over a wide range in all groups and in all chambers investigated. Nevertheless, children with pulmonary hypertension had significantly higher levels of the hormone (p less than 0.01) and were well separated from the control group, but less well from those with tetralogy of Fallot. A 50% increase of alpha-atrial natriuretic factor from the inferior vena cava to the right atrium occurred in patients with shunt lesions with pulmonary hypertension and in patients with tetralogy of Fallot (p less than 0.001) and a further 30% increase from the right atrium to the pulmonary artery (p less than 0.05). After right ventriculography, a 100% to 200% increase of alpha-atrial natriuretic factor was observed in the total sample (p less than 0.001). A positive correlation was observed between right atrial mean pressure and right atrial alpha-atrial natriuretic factor (r = 0.63) and between pulmonary artery mean pressure and pulmonary artery alpha-atrial natriuretic factor (r = 0.61).(ABSTRACT TRUNCATED AT 250 WORDS)

Response of HIV RNA to didanosine as a predictive marker of survival.

OBJECTIVE: To evaluate whether early changes in viraemia in response to didanosine (ddI) predict death and occurrence of new AIDS-defining events. METHODS: Forty-three patients were followed during ddI treatment with sequential determinations of serum viraemia, mutations associated with drug resistance, CD4 counts and clinical evaluation. Patients were stratified into two groups of equal size, responders and nonresponders, using the median of individual changes in viraemia 1 month after initiation of ddI therapy. RESULTS: After 1 month of ddI, mean viraemia decreased by 0.35 log RNA copies/ml of serum (P < 0.001) in the population. A significant difference in survival (median, 14 and 35 months in nonresponders and responders, respectively; log rank, P = 0.004) and in the delay to the occurrence of new AIDS-defining events (median, 8 and 33 months in nonresponders and responders, respectively; log rank, P = 0.018) was observed. After stratification for presence of AIDS before starting ddI, viraemia response at 1 month remained predictive of both overall and AIDS-defining event-free survival (log rank, P = 0.0006 and P = 0.01). After a similar stratification for initial CD4, viraemia response still predicted overall survival (log rank, P = 0.009), but its predictive value for AIDS-defining event-free survival did not reach statistical significance (P = 0.12). High initial levels of HIV RNA, presence of mutation 215 or previous duration of zidovudine therapy were not predictive of survival. CONCLUSIONS: In patients treated with ddI, changes in viraemia at 1 month predict survival independently of initial AIDS diagnosis and initial CD4 counts.

A prospective study on socioeconomic aspects of fracture of the proximal femur.

A prospective survey of hip fracture incidence and outcome was conducted to evaluate their socioeconomic impact. Over the course of 1 year, 404 hip fractures were recorded in 339 women and 65 men following minor or moderate trauma. The subjects' ages were 82.8 +/- 10.0 years (mean +/- SD): 84.1 +/- 9.2 in female and 76.4 +/- 13.7 in male subjects. The overall annual incidence was 104.4/100,000; the incidence in women was 167.1 versus 35.3 in men, with a crude female-to-male ratio of 4.7. However, when adjusted for age, this ratio was 2.7. When adjusted to the 1985 U.S.A. population, the incidence rates were 68.6 overall, 108.8 female, and 26.3 male, and were, respectively, 119.1, 188.8, and 46.1 when adjusted to the 1992 Swiss population. As compared with 105 age-matched non-hip-fracture fallers studied in the same emergency ward, fracture subjects lived more often in nursing homes and took cardiovascular drugs (p < 0.001). The mean length of stay in the orthopedic ward was 16.3 +/- 12.0 days (median 14; range 2-193 days), for a total of 6566 bed-days representing 19.8% of available bed-days. The mean length of stay in rehabilitation hospitals was 63.6 +/- 52.6 days (median 50; range 2-349 days), for a total of 17,099 bed-days, representing 5.2% of available bed-days. For patients who where independent before fracture, the greater length of stay was associated with advanced age and consumption of cardiovascular drugs. The total cost of hospital stay amounted to approximately $44,000 per patient. Mortality was 3.2% in the orthopedic ward and 10.8% in rehabilitation hospitals, for an overall in-hospital mortality rate of 10.4%. Overall, the 1-year mortality was 23.8% (21.5% for women and 35.4% for men), and it was significantly higher than in the general population (p < 0.001). Prognostic factors for mortality were age, sex, consumption of cardiovascular drugs, and previous living circumstances. One year after fracture, 62.6% of the fracture patients had returned to their previous living circumstances, but 17.9% needed a more care-intensive environment. The likelihood of returning to autonomous living circumstances 1 year after fracture was higher in younger subjects, in females, in those living with a partner, and in those in overall better health before the fracture. This prospective survey highlights the high socioeconomic impact and burden of osteoporotic fractures of the proximal femur.

Predictive value of codon 215 reverse transcriptase mutation on the efficacy of didanosine in HIV-infected, zidovudine-experienced patients.

We investigated whether or not mutations at codon 215 in the HIV reverse-transcriptase-encoding gene predicted a lower efficacy of didanosine therapy, as defined by survival of patients and change in CD4 cell counts in 121 HIV-infected, zidovudine-experienced patients. A trend for shorter survival, although not reaching significance, was observed for patients with HIV strains with the reverse transcriptase codon 215 mutation (P = 0.07), but this trend disappeared after adjustment for initial CD4 cell counts. During the first 3 months on didanosine therapy, the increase in CD4 cell counts was greater in patients who were wild type at codon 215 than in those with the mutation at codon 215 (P = 0.03). These data suggest that there was a better initial CD4 response to didanosine therapy in patients with HIV without the mutation at codon 215, but that this response did not translate into increased survival.

ABEP as primary chemotherapy for Hodgkin's disease.

20 untreated Hodgkin's disease patients and 1 patient relapsing after radiotherapy (17 stage IIB-IV and 4 stage I-IIA) were given doxorubicin, bleomycin, etoposide and prednisone on a 21-day cycle. The response rate was 95% and 16 patients (76%) achieved complete remission. 4 patients have relapsed 2, 5, 22 and 50 months after treatment. Survival was 100% at a median follow-up of 35 months. However, due to dyspnoea on exertion in 2 patients, bleomycin will be abandoned, and the occurrence of two second malignancies questions the role of etoposide as a leukaemogenic agent.

Rapidly alternating combination of cisplatin-based chemotherapy and hyperfractionated accelerated radiotherapy in split course for stage IIIA and stage IIIB non-small cell lung cancer: results of a phase I-II study by the GOTHA group. Group d'Oncologie Thoracique des Régions Alpines.

The prognosis of stage III non-small cell lung cancer (NSCLC) can be improved by a combination of radiotherapy (RT) and chemotherapy (CT). In this study, the GOTHA group evaluated the feasibility, tolerance, tumour response, pattern of failure and effect on survival of a combination alternating accelerated hyperfractionated (AH) RT and CT in patients with tumour stage III NSCLC. 65 patients received 3 cycles of cisplatin 60 mg/m2 and mitomycin C 8 mg/m2 on day 1, and vindesin 3 mg/m2 on days 1 and 8 in weeks 1-2, 5-6 and 9-10, alternating with AHRT, 2 daily 1.5 Gy fractions, 5 days/week, in weeks 2-3 (30 Gy) and weeks 6-7 (33 Gy). The dose actually delivered was > 98% for RT, and 85-100% for CT. Mean duration before last CT cycle was 9.5 weeks. Toxic effects were leucopenia, nausea and vomiting, mucositis, diarrhoea, alopecia and peripheral neuropathy. 1 patient died of bronchial haemorrhage at the end of RT. 1 of 5 patients, who underwent secondary pulmonary resections, died of acute respiratory distress syndrome. Evaluation of tumour response was hampered by lung condensations in radiation fields. Some long-term survivors had an initial tumour response assessed as partial response or no change. First failures were more frequent outside (34) than within (21) radiation fields. The median survival was 15.7 months and the 5 year survival rate was 15% (95% CI = 6-26%). 1 patient died of bladder cancer and another of myocardial infarction. Alternating CT and AHRT, as used in this study, were well tolerated and allowed full dose delivery within less than 12 weeks. Initial response was not predictive of survival. The survival curve is encouraging and the 5 year survival is superior to the 5% generally observed with conventionally fractionated radiotherapy.

Effect of low-dose chest irradiation before chemotherapy on the rate of local failure in small-cell lung cancer.

PURPOSE: To evaluate the rate of tumor recurrence within the irradiated volume after initial low-dose irradiation of limited-stage small-cell lung cancer (SCLC), to assess the tolerance of a sequential combination of low-dose chest irradiation followed by chemotherapy, and to confirm the responsiveness of limited-stage SCLC to low-dose irradiation. METHODS AND MATERIALS: In this pilot study, 26 patients with limited-stage SCLC were treated by first-line 20-Gy thoracic irradiation followed 3 weeks later by chemotherapy (cisplatin, doxorubicin, and etoposide for six cycles). RESULTS: We present our final results with a median follow-up of surviving patients of 7 years. The response rate to this low-dose irradiation was 83%, with an overall response rate to radiochemotherapy of 96% and a median survival of 21 months. No unexpected early or late toxicity was observed. The rate of initial isolated local failure was 8%, which compares favorably with other published series using higher doses of radiochemotherapy. CONCLUSION: An initial chest irradiation of 20 Gy before chemotherapy could be sufficient to reduce the risk of local failure during the time of survival of patients with limited-stage SCLC. Potential advantages of this treatment may be the prevention of resistance mechanisms to radiotherapy induced by preliminary chemotherapy and a reduced radiation-induced toxicity.

Impact of clinical and therapeutic factors on major late complications after radiotherapy with or without concomitant chemotherapy for anal carcinoma.

PURPOSE: To investigate factors potentially influencing major late morbidity after sphincter-conserving treatment for anal carcinoma. METHODS AND MATERIALS: Grade 3-4 complications were retrospectively analyzed in 144 evaluable patients (pts), 55 pts after split-course radiotherapy (RT), and 89 after concomitant chemo-RT. First sequence RT delivered a median dose of 39.6 Gy using megavoltage photon beams. Boost treatment used either 192Ir implantation or external beam RT (median dose 20 Gy). Chemotherapy started on day 1 and in 83% of pts consisted of Mitomycin-C (10 mg/m2) and a 5-day infusion of 5-fluorourcil (600-800 mg/m2/day). Uni- and multivariate analyses tested the association of following factors with complication rate: age, gender, stage, anatomic tumor extent, type of biopsy, external RT technique (dose, fraction size, field arrangement), boost type (brachytherapy vs. external), brachytherapy dose and dose rate, overall treatment time, and addition of chemotherapy. RESULTS: Five-year actuarial complication rate was 16%. Two variables were significantly associated with complication rate: anatomic tumor extent (canal or margin vs. both +/- rectum; 10 vs. 31% complications, p = 0.0004) and first sequence prescribed dose (< 39.6 Gy vs. > or = 39.6 Gy; 7 vs. 23% complications, p = 0.012), confirmed as independent factors by Cox analysis. Grade 4 anal morbidity correlated significantly with prior local excision. All six bone complications were observed in pts treated by chemo-RT using large pelvic fields, five occurring in pts older than 66. CONCLUSION: Pts with tumors involving more than one anatomic subsite or treated with the higher first sequence RT dose are at greater risk of major complications. Prior tumor excision and combined modality therapy in older pts appear to favor major anal and bone complications, respectively.

The risk of second cancer (SC) in patients treated for testicular seminoma.

The exact risk of second cancer (S.C.) following treatment of testicular seminoma is not well determined in most series. At our institution, 122 patients with pure seminoma were treated by orchidectomy followed by radiation therapy from 1951 to 1986. Six were lost to follow-up. For the 116 remaining patients, the overall 5-, 10-, 15- and 20-year survival probability was 95%, 90%, 87%, and 84%, respectively. Eleven patients developed 12 second cancers, with a cumulative risk of 7%, 16%, and 16% at 10, 15, and 20 years, respectively. Overall, the risk of second cancer was increased (O/E = 1.97, p = 0.023). There were 3 controlateral seminoma (O/E = 50, p = 0.001), 2 transitional carcinoma of the bladder (O/E = 6.9, p = 0.035), 2 non-Hodgkin's lymphoma (N.S.), 1 acute myeloblastic leukemia, 1 chronic lymphocytic leukemia, 1 intracranial dysgerminoma, 1 rectal and 1 lung adenocarcinoma. Four tumors developed within the previously irradiated field (O/E = 2.2, N.S.). Excluding second seminoma, the overall risk of second cancer was not significant (O/E = 1.33). Five of the 11 patients with second cancer are currently alive without recurrent cancer. We conclude that patients treated for seminoma have an increased risk of second cancer but the overall prognosis remains excellent. The potential factors responsible for second cancer, including irradiation, are discussed.

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.

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.

An association of cigarette smoking with recurrent subareolar breast abscess.

In a series of 60 patients suffering from recurrent subareolar breast abscess (RSBA) heavy cigarette smoking was found at an unusually high frequency compared to a control group. In contrast with findings reported in the literature no relation was found with parity, oral contraceptive use or nipple retraction. The strong association of cigarette smoking and RSBA with a relative risk of 9.2 (3.6-23.5) for a light smoker and of 26.4 (9.9-70.2) for a heavy smoker counterbalances possible bias introduced by the retrospective analysis and by the hospital control group. The pathogenesis of RSBA is still not established. Cigarette smoking could have either a direct toxic effect on the retroareolar lactiferous ducts or an indirect effect via hormonal stimulation of the breast secretion; both hypotheses could explain the recurrent aspect of the disease.

A randomized trial comparing vaginal and cervical prostaglandin gel for cervical ripening and labor induction.

OBJECTIVE: To compare the effectiveness of intravaginal and intracervical prostaglandin E2 (PGE2) gel for cervical ripening, defined as an increase of 3 or greater in the Bishop score, and for induction of labor. METHODS: Women with Bishop score 4 or less were assigned randomly to receive either 2 mg PGE2 intravaginally (n = 125) or 0.5 mg intracervically (n = 122). If the Bishop score was 4 or less, another dose of PGE2 was given after 6 hours, and up to two additional doses were given 6 hours apart on the second day. An oxytocin infusion was begun when the Bishop score was 5 or greater in absence of spontaneous labor, or if labor had not begun on the third day. RESULTS: Baseline characteristics of the two groups were similar. Survival analysis showed that time from PGE2 application, to obtain an increase of 3 or greater in the Bishop score, to vaginal delivery was significantly shorter with intravaginal PGE2 (logrank test: P = .003 and < .001 after stratification for parity, respectively). Thirty-one percent of women in the intravaginal gel group required oxytocin for labor induction compared with 63% in the intracervical group (P < .001). There were no significant differences in relation to cesarean delivery rate, Apgar scores at 5 minutes, and arterial umbilical cord pH, although the power of our study was limited to detect differences in proportions of adverse outcomes. CONCLUSION: Vaginal PGE2 gel is more effective than intracervical gel for cervical ripening and labor induction.

Factors influencing long-term survival after lung metastasectomy.

BACKGROUND: Disease-free interval, histology of primary tumor, and number and size of metastases resected (at first metastasectomy) were studied after resection of pulmonary metastases. METHODS: Between 1980 and 1993, 276 consecutive patients underwent lung resections for curative removal of metastatic disease. At subsequent relapse, 63 patients had a second-stage metastasectomy, 12 went on to a third phase, and 2 patients had four stages. RESULTS: The primary tumor was sarcoma in 126 cases (46%), teratoma in 88 (32%), carcinoma in 53 (19%), melanoma in 5, and miscellaneous in 4. Actuarial survival was 69% at 2 years (95% confidence interval 62% to 74%), 48% at 5 years (40% to 55%), and 35% at 10 years (23% to 44%). CONCLUSIONS: Survival was not related to disease-free interval. Multivariate analysis showed that nearly all predictive information can be obtained through histologic studies (p < 0.0001); inclusion of the number of metastases resected contributed to a lesser degree (p = 0.032). Short disease-free intervals, numerous lung metastases, or even deposits recurring after a first or second metastasectomy should not preclude patients from operation.