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Prognostic value of pre-treatment lymphocyte count and T cell levels in localized bronchogenic carcinoma.

In the patient with clinically localized bronchogenic carcinoma, the pre-treatment peripheral blood lymphocyte count and the thymus-dependent lymphocyte (T cell) level correlated with the prognosis of the tumor histology was either squamous cell, oat cell, or undifferentiated carcinoma. Patients whose pre-treatment lymphocyte count was less than 1,000/ml or whose T cell level was less than 750/ml either died or developed distant metastases by nine months after treatment of their localized tumor. By contrast, 55% of patients whose pre-treatment T cell level was greater than 750/ml were alive and without evidence of metastases nine months after treatment (P less than 0.02). Analysis of survival of these patients by the life-table method through the first post-treatment year further demonstrates the prognostic value of a low pre-treatment lymphocyte count or T cell level. The pre-treatment lymphocyte count and T cell level in patients with adenocarcinoma did not correlate with prognosis.

Adult↗

Right and left colon carcinoma: a retrospective comparative study.

We studied 347 patients with primary colorectal carcinoma treated by surgery during 1973-1983: 64 (18.2%) with right colon carcinoma, 158 (45.7%) with left colon carcinoma, 14 (4.2%) with transverse colon carcinoma, and 110 (31.9%) with rectal carcinoma. We compared the right-sided carcinoma (RSC) and left-sided carcinoma (LSC) groups. Obstruction was found in 17.2% of RSC compared with 20.3% LSC patients (P greater than 0.05). Advanced disease (Dukes stages C and D) was found in 34.4% on the right and 47.8% on the left side (P = 0.01). Crude 5-year survival rate, by life table method, was 71% on the right and 66% on the left side (P greater than 0.05); this difference became significant (P = 0.03) when Dukes stage B patients were compared. We conclude that patients with RSC are not diagnosed, as is commonly believed, at advanced stages of the disease. We found that the 5-year survival rate of RSC patients was the same or, occasionally, better than that of LSC patients.

Actuarial Analysis↗

Patency rate of endoscopic middle meatus antrostomy.

A series of 145 patients with chronic sinusitis were treated with functional endoscopic sinus surgery. Patency of the middle meatus was evaluated by actuarial life-table methods. After 24 months' follow-up, the overall patency rate of endoscopic middle meatotomy was 94.08%. Questionnaire data indicated that 91.8% of these patients were improved or asymptomatic. This preliminary study indicates that the patency rate of middle meatal antrostomy appears to be greater than that of inferior meatal antrostomy when compared to literature controls, and that a high percentage of these patients are improved by this surgery.

Actuarial Analysis↗

Surgical management of endometriosis with the carbon dioxide laser.

This study was designed to evaluate the efficacy of reconstructive microsurgery with the carbon dioxide laser for the treatment of infertile women suffering from endometriosis. One hundred and eight women evaluated for infertility and endometriosis underwent reconstructive microsurgery with the carbon dioxide laser. All cases were classified in accordance with the American Fertility Society's classification. Postoperatively, conception rates for the mild-to-moderate and the severe-to-extensive groups were estimated by life table methods for analysis. Estimates of the cumulative pregnancy rate were 55% for the mild-to-moderate group and 88% for the severe-to-extensive group. The abortion rate was 17% and the ectopic pregnancy rate was 3%.

Actuarial Analysis↗

Predictability of disease progression in amyotrophic lateral sclerosis.

The aim of this study was to determine the predictors of disease progression in a group of 832 patients with the diagnosis of definite or probable amyotrophic lateral sclerosis (ALS). Disease progression was defined as the time to 20-point change in Appel ALS (AALS) score. The effects of individual prognostic factors on disease progression were assessed with the Kaplan-Meier life-table method. In addition, the prognostic value of each factor was estimated using both univariate and multivariate Cox proportional hazard analyses. The median time to a 20-point change in AALS score in our patient population was 9 months. Age, site of symptom onset, time between first symptom and first examination, total AALS score at first examination, and AALS preslope (rate of disease progression between first symptom and first examination) were significant and independent covariates of disease progression in our population. Identification of predictors of disease progression will facilitate better design of therapeutic trials, permitting the use of disease progression as a primary endpoint and improving baseline stratification of patient populations.

Adult↗

Salvage surgery for chemorefractory ovarian germ cell tumors.

This study was undertaken to determine whether secondary surgical debulking is beneficial for patients with malignant ovarian germ cell tumors (OGCT). Twenty patients with OGCT treated at our institution between 1975 and 1992 were retrospectively identified and analyzed. Survival was analyzed using the life-table methods of Kaplan and Meier and the statistical significance of various perioperative factors was tested by both the log-rank and the Wilcoxon tests. Histologic tumor type included 8 immature teratomas, 6 mixed tumors, 5 endodermal sinus tumors, and 1 dysgerminoma. After primary surgery, all patients received chemotherapy--non-platinum-based in 12 patients, platinum-based in 5, and both types in 3 patients. Treatment failure was classified as progression in 14 patients, persistence in 3, and recurrence in 3. Salvage surgery consisted of exploratory laparotomy and tumor debulking in 18 patients, inguinal lymphadenectomy in 1, and thoracotomy and wedge resection in 1. Sixteen patients subsequently received salvage chemotherapy. At the time of analysis, 11 patients were alive disease-free, 1 was alive with tumor, 6 had died of tumor progression, and 2 had died of treatment-related complications. Survival of patients with immature teratoma who underwent salvage surgery was significantly better than survival of those with other tumor cell types (P = 0.006). In conclusion, although the role of secondary debulking in chemorefractory OGCT remains undetermined, it may have some benefit for a select group of patients, particularly those with immature teratoma.

Adolescent↗

The role of surgery in the treatment of small cell carcinoma of the lung.

The role of surgical treatment of non-small-cell carcinoma of the lung is controversial. Surgical therapy of small cell carcinoma of the lung has been the subject of criticism for two decades - in contrast to our opinion about the important role of initial surgical therapy in limited disease of this type of lung carcinoma. In a review of the results of surgical therapy in 109 patients with undifferentiated small cell carcinoma of the lung in the period from 1962 to 1979 and an attempt to define the role of the curative effect, we report on 109 thoracotomies after negative preoperative mediastinoscopy and exclusion of hematogenous spread of the cancer. The resection rate (94/109) was considerably lower than in differentiated lung carcinoma. Pneumonectomy (40%) and extended pneumonectomy (27%) were more frequently performed for small cell carcinoma than for differentiated tumors; thus, the rate of lobectomy and segmental resection (28/94 = 30%, and 3/94 = 3%, respectively) was low. When we included the postoperative lethality in the calculation rather than using the life-table method, we found in a follow-up study of 99% of the patients who had undergone resection, in absolute numbers, 3-year survival in 21/93 patients (23%). In the different stages I, II, and III, we noted 3-year survival rates of 32%, 25%, and 14%. Correlation to the N and T stages was N0 (10/29) 35%; N1 (6/34) 18%; N2 (5/30), 17%; N1 + 2 (11/64) 17%; T1 (11/28) 39%; T2 (8/35) 23%; T3 (2/30) 7%; and T2 + 3 (9/34) 14%.(ABSTRACT TRUNCATED AT 250 WORDS)

Carcinoma, Small Cell↗

Prospective follow-up of cervical HPV infections: life table analysis of histopathological, cytological and colposcopic data.

A total of 532 women with established cervical HPV infection have been prospectively followed (without treatment) since 1981 for a mean of 45 (SD 21) months. The patients were examined by colposcopy, PAP smears and/or punch biopsy every 6 months. The life-table method was applied to analyze the clinical course (i.e. regression and progression) of the HPV lesions, stratified by their colposcopic pattern, PAP smear findings and grade of CIN. During the follow-up, 107 (41.8%) of 256 patients with HPV-NCIN lesion in the first punch biopsy, experienced spontaneous regression. The corresponding proportions for HPV-CIN I, HPV-CIN II and HPV-CIN III lesions were 31.1%, 34.2%, and 20.7%, respectively. In the overall comparison between these four groups, the heterogeneity in the probability of regression was statistically significant (p = 0.0005). Clinical progression was also associated significantly with the histological grade of the lesions in the first biopsy. Progression rate was only 5.8% for HPV-NCIN lesions, as compared to 12.3% for HPV-CIN I, 20% for HPV-CIN II, and 55.2% for HPV-CIN III. The probability of progression varied significantly between the four groups (p less than 0.00001). Cumulative proportion of regression was 46% for patients with PAP smear class I, 84% with class II, and 82% for those with class III, cells, i.e. PAP smear was not of value in predicting the regression. However, PAP smears predicted clinical progression (p = 0.006 overall).(ABSTRACT TRUNCATED AT 250 WORDS)

Actuarial Analysis↗

Holmium YAG laser sclerostomy ab externo for refractory glaucoma.

Ab externo thermal sclerostomy was performed with the holmium YAG (thulium, holmium, chromium-doped YAG crystal) laser in 21 eyes of 20 patients with refractory glaucoma. We used either the 5-fluorouracil (5-FU) or mitomycin C (MMC) antimetabolites in all cases. The rate of intraocular pressure (IOP) control defined as IOP < 21 mmHg regardless of whether antiglaucoma medication was applied postoperatively) was estimated by the life-table methods of Kaplan-Meier. The postoperative IOP control rate was 47.1% in the MMC-treated group at 57 months, and 14.3% in the 5-FU-treated group at 52 months. There were statistically significant differences in success rates between the MMC- and 5-FU-treated groups. We observed no clinically significant complications except excess filtration associated with a shallow anterior chamber in one case. This procedure is thought to have several advantages over more conventional filtration surgery; the operation time is shorter, and there is no need for intraocular manipulation, which means conjunctival trauma is minimal. However, the IOP control rate was substantially lower than that achieved via conventional trabeculectomy. Our results suggest that the selection of patients and the use of MMC is an important factor in maintaining successful filtration.

Adolescent↗

Prenatal hydrocephalus: outcome and prognosis.

The clinical records of 108 infants presenting with hydrocephalus at birth and operated on from 1971 to 1981 were reviewed in order to evaluate the functional results. Premature newborns and spina bifida patients were excluded. Communicated hydrocephalus (39 cases) and aqueductal stenosis (32 cases, excluding 6 X-linked hydrocephalus and 4 toxoplasmoses) were the two main types of hydrocephalus in this series. Eighty-four percent of the infants were operated on before the age of 3 months. The mean follow-up time was 7 years (range 1 to 14 years). The survival rate, calculated by the life table method, was 62% at 10 years. The functional results were evaluated according to intellectual performance, academic level, and psychological status. Of the 75 surviving children, 28% have an I.Q. over 80 and 50% an I.Q. under 60. The mean I.Q. is 54 (range 0 to 130). Of the 52 children who have now reached school age, only 29% have reached a normal academic level. The psychological status is normal or borderline in 46% of the patients. The importance of head enlargement at birth, ventricular size, and the age at the time of surgery are not related to late functional results. The results were best when there were no associated malformations, no shunt infection, when hydrocephalus was due to aqueductal stenosis (excluding X-linked hydrocephalus and toxoplasmosis), or when the first developmental quotient measured at 6 months was over 80.

Age Factors↗

Response of brain tumors to chemotherapy, evaluated in a clinically relevant xenograft model.

Chemotherapy for brain tumors remains unsatisfactory. Despite increasing participation in clinical trials, there is a clear need for pre-clinical models. Heterotransplantation of surgical specimens directly into the anterior chamber of the nude mouse eye has been demonstrated to produce evaluable xenografts. Drug access in this model is considered to mimic the blood-brain barrier. Five clinical specimens in 3 children with primitive neuroectodermal tumor/medulloblastoma were the sources of 293 intraocular xenografts (5 cohorts by source). Each tumor-bearing mouse received 1 of 5 drugs or normal saline, by intraperitoneal injection, weekly for 5 weeks. Response was monitored for up to 22 weeks, using a staging system which estimates the proportion of the anterior chamber filled by tumor. Results were analysed both as response rates (shrinkage in excess of 50%) at the conclusion of the treatment course and as time to tumor progression by the life table method. Comparison of response rates within cohorts by source of xenografts (exact chi-square test for overall and 2-sided Fisher's exact test for paired comparisons) indicated cyclophosphamide to be the most effective single agent. In logrank analyses cyclophosphamide achieved significantly longer delays to progression than all other drugs in one cohort and longer delays than all but diaziquone in 2 other cohorts. The intraocular xenograft model is a clinically relevant system for the study of therapeutic agents in brain tumors. The effectiveness of intensive dosage cyclophosphamide in a model dependent on access across the blood-aqueous barrier is important and consistent with recent clinical data.

Animals↗

[Late results in supraaortic reconstructions (author's transl)].

Since 1965 we have performed 602 reconstructions at the supraaortic branches, mainly at the carotid artery. Follow-up showed equally good long-term results in subclavian reconstructions by transthoracic and extrathoracic approach. The patency was 90% after 6 years. Mortality in carotid endarterectomy was 1.6%. According to the Life Table Method the survival rate was 57.6% after 5 years in stage I, 73.7% in stage II, and 66% in stage IV.

Carotid Arteries↗

[Late results of 336 femorotibial bypasses (author's transl)].

A total of 336 femorotibial reconstructions were performed at the surgical clinic of the University of Erlangen and the Fürth City Hospital between 1966 and 1978. Mortality was 1.5%, and 89.6% of the patients were discharged with functioning reconstructions. The Life Table Method showed a patency of 58.7% after 5 years and 56.7% after 7 years follow-up for the saphenous vein graft.

Adult↗

Portasystemic shunts in primary biliary cirrhosis: survival is the same as in patients with Laennec's cirrhosis and postnecrotic cirrhosis.

There is little information regarding survival of patients with primary biliary cirrhosis (PBC) who undergo portasystemic shunt operations. The few published reports suggest that survival may be better in this group than in patients with other types of cirrhosis who undergo this procedure. Therefore, we reviewed our experience with 17 patients with PBC who underwent portasystemic shunts and compared their survival with 100 patients with Laennec's and postnecrotic cirrhosis, using the life-table method. We find that survival rates are the same in patients with PBC, Laennec's cirrhosis, and postnecrotic cirrhosis following portasystemic anastomosis.

Adult↗

[Acute leukemia in multiple myeloma: case histories, a review of the literature and assessment of the incidence].

The results of a follow-up study of 112 patients with multiple myeloma are presented. Three of these patients developed acute leukaemia during the respective period of clinical observation (maximum: 11 years)--one case of acute myeloblastic leukaemia, myelomonocytic leukaemia and erythroleukaemia, respectively. For estimating the incidence of acute leukaemia in the presence of multiple myeloma an extended life table method was applied. On the basis of our data this method gave a probability of 5.9% for a patient to develop acute leukaemia at any time after the diagnosis of multiple myeloma. In a statistical discussion this result is considered to confirm the assumption of a highly increased AL-risk in patients with multiple myeloma. In a survey of the literature some important data of 100 cases with the association acute leukaemia--multiple myeloma are reported.

Acute Disease↗

[Sequential combination chemotherapy with vinblastine/bleomycin and adriamycin/cis-dichlorodiammineplatinum (II) in non-seminomatous testicular cancer. I. Results of a prospective randomized phase III-study with 71 patients with disseminated disease (stage IV) (author's transl)].

74 patients with disseminated non-seminomatous testicular cancer were randomly entered on a prospective sequential combination chemotherapy regimen with mandatory crossover, consisting of either vinblastine/bleomycin or adriamycin/cis-dichlorodiammineplatinum (II) (DDP) as initial therapy. Independent of the randomization the overall remission rate in 71 evaluable patients was 89% including 54% complete remissions. 35% of the patients remained disease-free at 2+ to 28+ months with a median of 12 months. By additional surgical removal of residual pulmonary metastases in two patients the complete remission rate was increased to 40/71 (56%), and the number of patients with no evidence of disease to 27/71 (38%). According to the life-table method the two-years survival rates were 63% for complete responders and 29% for all other patients, which was significantly lower. 53 patients (75%) were alive at 3 to 28 months with a median of 9 months. Additional advanced abdominal disease, initially elevated beta-HCG and LDH and extension of pulmonary disease were of significant negative influence on the prognosis. The evaluation of single chemotherapy courses revealed equal efficacy of both combinations. However, response to adriamycin/DDP occurred in 46% of the courses, when vinblastine/bleomycin had failed, while response to vinblastine/bleomycin occurred only in 21% of the courses when adriamycin/DDP had failed. Thus different patterns of cross-resistance between these alternative regimens may exist.

Bleomycin↗

[The doubling time of circulating CEA as an individual prognostic criterion of recurrence in patients with gastrointestinal cancers].

In a prospective study of 928 patients with gastrointestinal cancer registered for primary resection, the postoperative carcinoembryonic antigen (CEA) time courses were analysed in connection with disease recurrence. Only patients with established diagnosis of disease recurrence and complete follow-up to death entered the evaluation of prognostic criteria of the CEA time course. In this group the CEA time courses of 103/201 patients with recurrent disease exhibited an exponential increase of the serum CEA concentration, i.e. a linear relationship of log CEA and time, which allowed the calculation of the CEA doubling time. All 103 patients developed metastatic spread and generally exhibited CEA doubling times ranging between 10 and 158 days, in patients developing peritoneal carcinosis up to 343 days. The individual CEA doubling times of patients with recurrent disease who received no treatment (n = 71) correlated well with the times of individual survival after the initial CEA increase of the log CEA phase (rs = 0.812; P less than 0.001) thus confirming the results of a previous retrospective study. When the survival time is expressed in multiples of the individual CEA doubling time (IDT), no patient survived longer than 10.8 IDT. The median value of survival was 5.4 IDT. Patients with metastatic spread who underwent various treatments of recurrent disease (n = 32) survived distinctly longer showing survival times up to 32.6 IDT. This could be confirmed by comparing the observed survival after the initial CEA increase of treated and untreated patients (life table method) exhibiting highly significant differences (P less than 0.001).

Carcinoembryonic Antigen↗

Current pattern of in-hospital aneurysmal rebleeds. Analysis of a series treated with individually timed surgery and intravenous nimodipine.

The management of aneurysmal subarachnoid haemorrhage has recently changed considerably. Emergency admission to specialized centres and early surgery have become common practice. In addition, the use of nimodipine has gained widespread acceptance. Little data are available concerning the frequency and temporal profile of reruptures under the current policies. The case histories of 387 patients treated for aneurysmal subarachnoid haemorrhage between January 1984 and March 1992 were reviewed with regard to the incidence of in-hospital reruptures. All patients were managed according to the same protocol including a policy of individually timed early surgery and intravenous nimodipine. A total of 44 first in-hospital rebleeds were observed during the waiting period. Two percent of the patients admitted on the day of haemorrhage had a rebleed on the same day after admission to the hospital. No rebleeds were observed on the day after subarachnoid haemorrhage. Rebleed rates on day 2 and 3 were also low with 0.6 and 0.8% of the population with an unclipped aneurysm. For the following 10 days, the daily rate of rerupture increased. A further peak was observed during the 4th week. Using life-table methods, the cumulative rate of rebleeds was calculated as 23% within 2 weeks and 42% within 4 weeks. Although patients suffering rebleeds differed in several respects from patients without rebleeds, most of the differences could be identified to be a consequence of a selection bias resulting in a longer period of exposure to the risk of rerupture for certain subgroups. Only patients suffering a loss of consciousness after the initial subarachnoid haemorrhage were definitively exposed to a higher daily risk of rerupture.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗