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Biomedical subjects

D M Stablein

Publications and source records attributed to D M Stablein.

At least 19 recordsLinked to original sources
PubMed1992

Renal transplantation in children. A report of the North American Pediatric Renal Transplant Cooperative Study.

BACKGROUND: Previous studies of renal transplantation in children have focused on the survival of grafts and patients. Little information is available about the cause of renal disease, the sources of donated organs, or children's growth after transplantation. The North American Pediatric Renal Transplant Cooperative Study was organized to identify the diseases that require transplantation and to analyze factors that affect the success of transplantation in children. METHODS: We collected data from 73 pediatric transplantation centers from 1987 through 1990. These data included information about demographic characteristics of patients, graft function, and therapy one month after transplantation and every six months thereafter for each patient 17 years of age or younger. RESULTS: Altogether, 1550 children received 1667 renal allografts during this period; 31 percent of the children were five years of age or younger. Forty-three percent of the transplanted kidneys came from a living related donor, and 57 percent from a cadaver. The two most common causes of renal disease leading to transplantation were congenital malformations of the kidneys and urinary tract (42 percent of the patients) and focal segmental glomerulosclerosis (12 percent). One year after transplantation, the rate of graft survival in recipients of a kidney from a living related donor was 89 percent; it was 80 percent after three years. For recipients of cadaver kidneys, the comparable rates were 74 percent and 62 percent, respectively (P less than 0.001). The best growth was observed in patients who were no more than five years old at the time of transplantation. During follow-up, 79 patients died, and cancer developed in 12 patients. CONCLUSIONS: The most common causes of end-stage renal disease in children and adolescents are congenital malformations of the kidneys and urinary tract and focal segmental glomerulosclerosis. The rates of graft survival at one and three years are better in children and adolescents who receive a kidney from a living related donor than in those who receive a kidney from a cadaver.

Adolescent↗
PubMed1992

Comparison of azathioprine, methotrexate, and the combination of both in the treatment of rheumatoid arthritis. A controlled clinical trial.

OBJECTIVE: To compare the relative safety and efficacy of azathioprine (AZA), methotrexate (MTX), and the combination of both in the treatment of active rheumatoid arthritis (RA). METHODS: Two hundred twelve patients with active RA were entered into a 24-week prospective, controlled, double-blind, multicenter trial and were randomly assigned to 1 of 3 treatment groups. RESULTS: One hundred fifty-eight patients finished 24 weeks of the study. There were no remissions seen but response rates were greater than 30% for all outcome measures. Combination therapy was not statistically superior to MTX therapy alone, but both combination therapy and MTX alone were superior to AZA alone when patients were analyzed by intent-to-treat and with withdrawals treated as therapy failures. If only patients who continued taking the therapy were analyzed, the mean improvement was greater for AZA therapy than for MTX, while the combination remained the most active. Adverse effects on the gastrointestinal tract and elevations of liver enzyme levels were the most frequent causes for discontinuations. CONCLUSION: Both combination therapy and MTX alone were superior to therapy with AZA alone for active RA but were not statistically different in their effect on outcome assessment.

Adult↗
PubMed1992

Prognosis and other clinical correlates of pathologic review in stage I and II testicular carcinoma: a report from the Testicular Cancer Intergroup Study.

PURPOSE: The Testicular Cancer Intergroup Study (TCIS) was undertaken to evaluate the pathologic findings in early-stage testicular cancer as determined by central pathology review, to compare these findings with the interpretation by the contributing pathologists, and to make correlations with various clinical parameters and outcomes. PATIENTS AND METHODS: The prospective study of non-seminomatous germ cell testicular cancer staged surgically involved 459 eligible patients with stage I (node-negative) or stage II (node-positive) disease. Pathologic materials from both the orchiectomy and lymphadenectomy specimens were submitted to a central laboratory for evaluation. RESULTS: Central and local pathologists differed significantly in their identification of certain cellular histologies (primarily yolk sac tumors [YST]) and recognition of invasion into vascular structures. In contrast to our prior findings with local pathologic assessment, venous/lymphatic invasion as determined by central review predicted relapse in both stages. In pathologic stage I disease, the relapse rate was 19.4% (12 of 62 cases) for those with invasion versus 6.0% (10 of 168 cases) for those without invasion. In pathologic stage II disease, the respective relapse rates were 63.5% (40 of 63 cases) and 24.0% (six of 25 cases). Vascular invasion was jointly predictive with nodal stage for risk of relapse. The percentage of embryonal carcinoma (EC) in the primary tumor was predictive of nodal stage and relapse in a univariate, but not a multivariate, analysis. In a large substudy, immunohistochemical staining identified a correlation between stain intensity in YST and serum alpha-fetoprotein (AFP) levels. In a similar fashion human chorionic gonadotropin (HCG) staining reactivity occurred exclusively in patients with syncytiotrophoblasts and correlated with serum levels of beta-HCG. CONCLUSIONS: A number of tumor histology correlates with clinical parameters have been identified or confirmed. Careful pathologic scrutiny of the primary testicular tumor, especially for vascular invasion, provides important prognostic information.

Adolescent↗
PubMed1992

No evidence of acute cardiovascular complications of chemotherapy for testicular cancer: an analysis of the Testicular Cancer Intergroup Study.

PURPOSE: The purpose of this study is to evaluate the risk of acute vascular events in patients receiving cisplatin-based chemotherapy for testicular cancer. PATIENTS AND METHODS: A questionnaire assessing cardiovascular toxicity was distributed to all participants in the Testicular Cancer Intergroup study and details of toxicity from the chemotherapy flow sheets were reviewed. Patients with pathologic stage I testicular cancer were registered on to the study and observed after retroperitoneal lymphadenectomy. Patients with pathologic stage II disease were randomized to receive two postoperative courses of adjuvant cisplatin-based chemotherapy or observation. Any patient who had disease recurrence after observation or adjuvant therapy was given four cycles of cisplatin-based chemotherapy. RESULTS: Review treatment-related toxicity for those patients receiving adjuvant chemotherapy (n = 97) or chemotherapy for recurrent disease (n = 83) showed no cases of acute cardiovascular toxicity. The median follow-up period after study enrollment was 5.1 years; 459 questionnaires were mailed and 270 were returned. The percent return was equal among the observed adjuvant and recurrent groups (59%, 54%, and 64%). There was a significant increase in the incidence of extremity paresthesias in the two groups receiving chemotherapy. Fatal myocardial infarction was reported in two patients in the observation group and one nonfatal infarction was reported in the adjuvant treatment group. No patient in any group reported an incidence of stroke. Three patients in the observation group and one patient in the recurrent group experienced a thromboembolic event. CONCLUSION: Despite sporadic case reports suggesting a causal association between chemotherapy for testicular cancer and acute vascular events, this retrospective analysis provides no evidence of an increased risk for subsequent cardiovascular disease in this patient population.

Acute Disease↗
PubMed1992

Does human lymphocyte antigen matching improve the outcome in pediatric renal transplants?

Adult studies have shown a high renal graft survival if the donor and recipient match for each antigen of the human lymphocyte antigen (HLA)-A, B and DR loci (six-antigen match). The 4 yr of data from the North American Pediatric Renal Transplant Cooperative Study Registry show a statistically beneficial effect of DR matching for cadaver graft outcome. No antigen matching clearly has a worse outcome, 72% at 1 yr versus those with one or more antigen matching at each loci with a 1-yr graft survival of 81% and 2-yr graft survival of 69%. The long-term improved outcome from better antigen matching suggests that cadaver donor allograft organ assignment should address both the need of the center-driven and patient-driven concepts of recipient selection to achieve the best use of this scarce resource and an improved quality of life.

Cadaver↗
PubMed1991

Staging relationships and outcome in early stage testicular cancer: a report from the Testicular Cancer Intergroup Study.

The Testicular Cancer Center Intergroup Study entered surgically staged patients with nonseminomatous tumor and metastases limited to the regional lymph nodes into a previously reported cooperative trial of immediate versus delayed therapy for positive retroperitoneal node disease. Patients with negative nodes (stage I) were placed in an observation registry with specified treatment strategy upon relapse. Of 264 stage I cancer patients 27 (10.2%) had recurrence: 5 of these 27 patients died after recurrence of the testicular malignancies, while 4 other nontumor-related deaths have occurred. Pre-lymphadenectomy staging characteristics observed to predict significantly node positivity are the results of radiological examinations, presence of tumor invasion, vascular invasion and tumor histology. In a multiple logistic regression analysis with these variables, misclassification still occurs in more than a fourth of the patients. Future refinements in diagnosis may allow for better prediction of these patients at risk to have positive lymph nodes and ultimately recurrence. Presently, if assessment of nodal involvement is the objective, noninvasive procedures are not an adequate substitute for surgical staging with modified lymphadenectomy.

Adult↗
PubMed1990

Hyperfractionated radiation and chemotherapy for unresectable localized adenocarcinoma of the pancreas. The Gastrointestinal Tumor Study Group experience.

Eighteen patients with unresectable localized adenocarcinoma of the pancreas were treated by a combination of chemotherapy plus hyperfractionated radiation therapy to the pancreas for 4080 cGy with an additional 960 cGy to the pancreatic tumor and a surrounding margin. One hundred and twenty cGy were given twice daily 4 to 6 hours apart. High-energy photon or electron beams were used with treatment planning based on computed tomographic (CT) scans. Patients were given chemotherapy in the form of 5-fluorouracil (5-FU) at 350 mg/m2 on the first 3 and last 3 days of radiation therapy. On day 53, chemotherapy was given that included 600 mg/m2 IV of 5-FU, 1 gm/m2 of streptozotocin, and 10 mg/m2 IV of mitomycin C. The 5-FU and streptozotocin were repeated on days 60, 81, and 88, and the stretozotocin and mitomycin (SMF) cycles were repeated every 8 weeks until progression. Radiation toxicity was generally tolerable with one of 18 evaluable patients having severe nausea and vomiting and two of 18 patients having severe diarrhea. One patient had total liver failure and died 3 months after initiation of therapy. Six patients had severe hematopoietic toxicity during chemotherapy. Overall, the severe toxicity rate was higher (67%) than in previous studies. Median survival was 35 weeks, the 1-year survival rate was 39%, and the patient who survived the longest died at 68 months. Although this schedule of hyperfractionated radiation and chemotherapy was disappointing, combined experimental radiation approaches plus chemotherapy for localized unresectable adenocarcinoma of the pancreas deserve additional research.

Adenocarcinoma↗
PubMed1989

Survival of patients with stage B2 colon carcinoma. The Gastrointestinal Tumor Study Group experience.

The Gastrointestinal Tumor Study Group, a multispecialty collaborative clinical research program, executed two studies of surgically resected colon carcinoma, including patients with serosal penetration but no positive regional lymph nodes (stage B2). In the first study, 232 patients with stage B2 disease were operated on and survival was unaffected by therapy. In the stage B2 group, survival was 78% at five years, and is estimated to be 64% ten years after surgery. A second study, begun in 1979, compared survival and recurrence data on patients who underwent surgical resection and were treated postoperatively with fluorouracil and hepatic irradiation vs those who were observed. Hematologic toxicity of the regimen and accumulation of data from the first study caused the termination of randomization of patients with stage B2 disease with continued registration to observation only. One hundred twenty-four untreated patients with stage B2 carcinoma had a five-year survival rate of 77%, confirming the relatively high survival of this group of patients who are treated with surgery alone. Our patients' five-year survival of 78% corresponds favorably to the 87% survival rate anticipated in an age-, sex-, and race-matched cohort of Americans not specifically diagnosed as having cancer. Adjuvant trials, in seeking improved survival, should recognize that our review of 356 patients implies a considerably higher-than-anticipated five-year survival for the patient with stage B2 disease who undergoes surgical resection.(ABSTRACT TRUNCATED AT 250 WORDS)

Aged↗
PubMed1989

Timing and characteristics of multiple peritonitis episodes: a report of the National CAPD Registry.

Patterns of recurrent peritonitis episodes were examined in 6,335 new continuous ambulatory peritoneal dialysis (CAPD) patients entered into the National CAPD Registry. Forty-six percent of all peritonitis episodes were initial occurrences, with 8% of the patients reporting four or more episodes. The proportion of gram-positive and gram-negative infections was constant across episodes. In patients with multiple infections, negative organisms were found to have increased risk of recurring as gram-negative infection. A similar observation was made for fungal infections. Of patients with multiple peritonitis episodes, more than 40% of those who transferred to other maintenance renal replacement therapy identified peritonitis as the reason for transfer. A discrete time logistic model was used to estimate peritonitis risk in 4-month follow-up periods. Patients like those on the registry are estimated to have a 22% risk of developing peritonitis during any 4-month period. This risk was increased 4% for patients aged less than 21 years, 7% for nonwhite patients, and 19% in the period following a peritoneal infection.

Adult↗
PubMed1989

The modulation of fluorouracil with leucovorin in metastatic colorectal carcinoma: a prospective randomized phase III trial. Gastrointestinal Tumor Study Group.

A total of 343 patients with previously untreated metastatic measurable colorectal carcinoma were studied to evaluate the impact on toxicity, response, and survival of leucovorin-modulated fluorouracil (5-FU). A maximally tolerated intravenous bolus loading course regimen of 5-FU alone (500 mg/m2 x 5 days every 4 weeks with 25 mg/m2 escalation) was compared with a high-dose leucovorin regimen (600 mg/m2 of 5-FU with 500 mg/m2 of leucovorin weekly for 6 weeks with a 2-week rest) and with a similar low-dose leucovorin regimen (600 mg/m2 of 5-FU with 25 mg/m2 of leucovorin weekly for 6 weeks with a 2-week rest). The dose-limiting toxicity for the two 5-FU and leucovorin regimens was gastrointestinal, specifically diarrhea; severe diarrhea was seen frequently, and treatment-related toxicity was implicated in the demise of 11 of the patients (5%). Significant improvements in response rates were observed with a response rate of 33 of 109 (30.3%) on the high-dose leucovorin regimen (P less than .01 v control); 13 of 107 (12.1%) on the 5-FU control; and 21 of 112 (18.8%) on the low-dose leucovorin regimen. A trend toward longer survival in the 5-FU plus high-dose leucovorin regimen was observed. In this study, leucovorin was shown to significantly enhance the therapeutic effect of 5-FU in metastatic colorectal carcinoma.

Aged↗
PubMed1988

Toxicity comparisons between two chemotherapy regimens as adjuvant or salvage treatment in nonseminomatous testicular cancer.

The Testicular Cancer Intergroup Study was initiated to evaluate the efficacy of adjuvant chemotherapy in Stage II and salvage therapy in Stage I nonseminomatous testicular carcinoma. Chemotherapy regimens of cisplatin, vinblastine, and bleomycin (PVB) or the same drugs plus cyclophosphamide and dactinomycin (VAB) were used at institution or cooperative group preference. A comparison of the toxicities of these two regimens shows that VAB caused significantly more mucosal, dermatologic, and otologic toxicity than PVB, and PVB caused more leucopenia. Both regimens were equally effective in controlling cancer. Either regimen could be used as chemotherapy in testicular cancer, and the decision about which one to use could be based on their differences in toxicity and degree of patient convenience.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1988

Comparing incomplete paired binomial data under non-random mechanisms.

In many paired experiments designed to compare two treatments, various mechanisms can lead to the data being incomplete. Such mechanisms may be of a non-random nature and may depend on the treatment or the outcome. This paper considers several methods for testing the equality of two correlated binomial proportions when the incompleteness is caused by non-random mechanisms. Several simple procedures are justified in certain cases. The tests based on all available data are more efficient compared to those utilizing only portions of the data. McNemar's test based only on the complete paired observations and the likelihood test are the most robust, although no efficient test exists when the mechanisms are not independent.

Craniocerebral Trauma↗
PubMed1988

The clinical significance of unconventional orchiectomy approaches in testicular cancer: a report from the Testicular Cancer Intergroup Study.

Despite the clear indications for an inguinal approach, reports indicate that up to 53 per cent of all testicular tumors are diagnosed or initially treated in a manner inconsistent with the classical radical orchiectomy. Of 462 evaluable patients from the Testicular Cancer Intergroup Study 47 (10.2 per cent) had undergone a nonclassical orchiectomy as the initial surgical management. This group was analyzed separately to determine the prognostic significance of needle aspiration, open biopsy, a scrotal approach and tumor contamination. Within this group of patients, those who received no adjuvant chemotherapy exhibited no increase in local or distant recurrence. While the recurrence rate similarly was not adversely affected by even gross tumor contamination, this subset underwent significantly more aggressive local surgical salvage (p less than 0.01), with scrotectomy procedures found to be of probable therapeutic value. While not to be condoned, we conclude that deviations from the classical orchiectomy, when followed by appropriate surgical management and close observation, can be of little clinical impact.

Antineoplastic Agents↗
PubMed1988

An organized multi-institutional interdisciplinary evaluation of role of radiation therapy alone or combined with chemotherapy in treatment of adenocarcinoma of the gastrointestinal tract.

Adenocarcinomas of the gastrointestinal tract have generally been considered to be radioresistant. In 1974-1975, following an early lead from the Mayo Clinic (Rochester, MN), the Gastrointestinal Tumor Study Group initiated a series of clinical trials of radiation therapy and chemotherapy as surgical adjuvant programs for patients with pancreatic and rectal cancer and for the treatment of locally unresectable gastric and pancreatic adenocarcinomas. The first protocols for pancreatic cancer included a controlled trial of radiation therapy and chemotherapy following pancreatoduodenectomy or total pancreatectomy and also a randomized trial of high-dose radiation therapy, with or without chemotherapy, compared to a lower dose of radiation therapy combined with chemotherapy for patients with locally unresectable tumors. In the treatment of locally incurable gastric cancer, radiation therapy plus chemotherapy was compared to chemotherapy alone, while the rectal trial was a randomized comparison of radiation therapy; chemotherapy; the combination of radiation therapy and chemotherapy; and no further treatment following surgical extirpation. In all cases, the agent used during the course of radiation was 5-fluorouracil. Subsequent trials in pancreatic cancer compared radiation combined with either 5-fluorouracil or doxorubicin and included a pilot study of hyperfractionated radiation therapy combined with 5-fluorouracil. Confirmatory trials were undertaken and are still under analysis in gastric cancer and in rectal cancer. A follow-up trial in pancreatic cancer was developed to establish the importance of the radiation therapy component of combined modality therapy in the treatment of patients with locally unresectable disease. A final study examined the potential for radiation therapy of the liver and systemic chemotherapy in the prevention of metastatic adenocarcinoma of the colon.(ABSTRACT TRUNCATED AT 250 WORDS)

Adenocarcinoma↗
PubMed1987

Immediate adjuvant chemotherapy versus observation with treatment at relapse in pathological stage II testicular cancer.

Between 1979 and 1984, 195 evaluable patients were entered in an international multicenter study comparing two regimens for patients with completely resected pathological Stage II testicular cancer (that is, with positive retroperitoneal lymph nodes). All patients had undergone orchiectomy and dissection of the retroperitoneal lymph nodes. They were randomly assigned to be treated with two cycles of immediate adjuvant cisplatin-based chemotherapy or to be observed monthly with treatment at relapse. The median follow-up period was four years. Of the 97 patients assigned to adjuvant chemotherapy, 6 (6 percent) had a recurrence; however, only 1 had received adjuvant chemotherapy before the recurrence. Three died (one of testicular cancer), and 94 of the 97 survived. Of the 98 patients who were observed, 48 (49 percent) had a relapse. However, almost all patients with relapses were effectively treated, and 93 of the 98 are alive and disease-free; 3 have died of testicular cancer. No identifiable factors were strongly associated with the risk of relapse. We conclude that two courses of cisplatin-based adjuvant chemotherapy will almost always prevent relapse in pathological Stage II testicular cancer treated with orchiectomy and retroperitoneal-lymph-node dissection. However, when surgery, follow-up, and chemotherapy are optimal, observation with chemotherapy only for relapse will lead to equivalent cure rates.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1987

The effects of liver directed radiotherapy and chemotherapy on liver function tests and hematological parameters in patients with surgically resected colon cancer: findings from the Gastrointestinal Tumor Study Group.

The effects on liver function tests of liver-directed radiation (RT) and systemic chemotherapy (CT) were examined at 6 months after initiation of treatment on two Gastrointestinal Tumor Study Group protocols. Data from patients on protocol GI 6175 (adjuvant CT or no adjuvant therapy) were used to evaluate the effect of CT alone, and data from patients on protocol GI 6179 (adjuvant CT plus liver directed RT or no adjuvant therapy) were used to evaluate the combined effects of CT and RT. Finally, data from patients on GI 6179 who received less than protocol specified RT doses were used to determine whether minor differences in dose are detectable via liver function tests. In 40 patients receiving CT, the serum level of alkaline phosphatase was not significantly increased (p = 0.14) compared to that of control patients whereas the level of serum glutamate oxoloacetate transaminase was significantly elevated (p = 0.03). In 31 patients receiving both CT and RT, both alkaline phosphatase and SGOT were significantly elevated (both p = 0.03). In addition, in 19 patients who received less than full RT doses, the changes in dose were not detectable from those patients who received full dose (all p greater than 0.10). In summary, CT alone may elevate hepatocellular enzymes, whereas a combination of CT and liver-directed RT is associated with a significant increase in both SGOT and alkaline phosphatase. Small alterations in the dose of volume of RT are not detectable by liver function test variations.

Alkaline Phosphatase↗