Biomedical subjects

S Lipsitz

Publications and source records attributed to S Lipsitz.

At least 19 recordsLinked to original sources

PubMed2001

Meta-analysis of binary data: which within study variance estimate to use?

We applied a mixed effects model to investigate between- and within-study variation in improvement rates of 180 schizophrenia outcome studies. The between-study variation was explained by the fixed study characteristics and an additional random study effect. Both rate difference and logit models were used. For a binary proportion outcome p(i) with sample size n(i) in the ith study, (circumflexp(i)(1-circumflexp(i))n)(-1) is the usual estimate of the within-study variance sigma(i)(2) in the logit model, where circumflexpi) is the sample mean of the binary outcome for subjects in study i. This estimate can be highly correlated with logit(circumflexp(i)). We used (macronp(i)(1-macronp)n(i))(-1) as an alternative estimate of sigma(i)(2), where macronp is the weighted mean of circumflexp(i)'s. We estimated regression coefficients (beta) of the fixed effects and the variance (tau(2)) of the random study effect using a quasi-likelihood estimating equations approach. Using the schizophrenia meta-analysis data, we demonstrated how the choice of the estimate of sigma(2)(i) affects the resulting estimates of beta and tau(2). We also conducted a simulation study to evaluate the performance of the two estimates of sigma(2)(i) in different conditions, where the conditions vary by number of studies and study size. Using the schizophrenia meta-analysis data, the estimates of beta and tau(2) were quite different when different estimates of sigma(2)(i) were used in the logit model. The simulation study showed that the estimates of beta and tau(2) were less biased, and the 95 per cent CI coverage was closer to 95 per cent when the estimate of sigma(2)(i) was (macronp(1-macronp)n(i))(-1) rather than (circumflexp(i)(1-circumflexp)n(i))(-1). Finally, we showed that a simple regression analysis is not appropriate unless tau(2) is much larger than sigma(2)(i), or a robust variance is used.

Computer Simulation↗

PubMed2001

Depletion of protein kinase Cepsilon in normal and scleroderma lung fibroblasts has opposite effects on tenascin expression.

OBJECTIVE: To determine whether the extracellular matrix protein tenascin-C (TN-C) is overexpressed in lung fibroblasts from systemic sclerosis (SSc) patients, the molecular mechanisms regulating TN-C secretion in SSc and normal lung fibroblasts, and how these processes might contribute to lung fibrosis in SSc patients. METHODS: TN-C secretion by SSc and normal fibroblasts was compared in vivo (in bronchoalveolar lavage [BAL] fluid) and in vitro (in culture medium). The ability of thrombin to induce TN-C was confirmed at both the protein and the messenger RNA (mRNA) level. The role of protein kinase Cepsilon (PKCepsilon) in the expression of TN-C was evaluated by determining the effects of thrombin on PKCepsilon levels and by directly manipulating PKCepsilon levels via the use of antisense oligonucleotides. RESULTS: BAL fluid from SSc patients contained high levels of TN-C, whereas that from normal subjects contained little or no TN-C. In vitro, SSc lung fibroblasts expressed much higher amounts of TN-C than did normal lung fibroblasts. Consistent with the idea that thrombin is a physiologic inducer of TN-C, thrombin stimulated TN-C mRNA and protein expression in both SSc and normal lung fibroblasts by a mechanism that required proteolytic cleavage of the thrombin receptor. Surprisingly, thrombin treatment and antisense oligonucleotide-mediated depletion of PKCepsilon indicated that TN-C expression is regulated via opposite signaling mechanisms in SSc and normal cells. In SSc lung fibroblasts, thrombin decreased PKCepsilon levels, and the decreased PKCepsilon induced TN-C secretion; in normal fibroblasts, thrombin increased PKCepsilon levels, and the increased PKCepsilon induced TN-C secretion. Normal and SSc lung fibroblasts also differed in the subcellular localization of PKCepsilon, both before and after thrombin treatment. CONCLUSION: These studies are the first to demonstrate that thrombin is a potent simulator of TN-C in lung fibroblasts and that PKCepsilon is a critical regulator of TN-C protein levels in these cells. Furthermore, our results indicate that both the regulation of PKCepsilon levels by thrombin and the regulation of TN-C levels by PKCepsilon are defective in SSc lung fibroblasts.

Blotting, Northern↗

PubMed2001

Testing for bias in weighted estimating equations.

It is very common in regression analysis to encounter incompletely observed covariate information. A recent approach to analyse such data is weighted estimating equations (Robins, J. M., Rotnitzky, A. and Zhao, L. P. (1994), JASA, 89, 846-866, and Zhao, L. P., Lipsitz, S. R. and Lew, D. (1996), Biometrics, 52, 1165-1182). With weighted estimating equations, the contribution to the estimating equation from a complete observation is weighted by the inverse of the probability of being observed. We propose a test statistic to assess if the weighted estimating equations produce biased estimates. Our test statistic is similar to the test statistic proposed by DuMouchel and Duncan (1983) for weighted least squares estimates for sample survey data. The method is illustrated using data from a randomized clinical trial on chemotherapy for multiple myeloma.

Journal Article↗

PubMed2000

Racial, age, and rural/urban disparity in cervical cancer incidence.

PURPOSE: High mortality rates of cervical cancer among black women have been observed for several decades in the Southeast. The purpose of this study is to assess the factors associated with this geographic and racial enigma, and to see if incidence is consistent with mortality.METHODS: Using the Savannah River Regional Health Information System (SRRHIS), a 5-year cancer registry from 1991-1995, incidence rates were calculated and compared to rates from Surveillance, Epidemiology, and End Results (SEER). The rates per 100,000/year were analyzed by race, rural/nonrural, and age (<45 and >/=45).Rates are similar between SRRHIS and SEER except in the case of black women over the age of 45. These women in rural SRRHIS have 1.66 times the incidence rate compared to those in nonrural SRRHIS and 1.97 times the rate of rural SEER.RESULTS:Table 1CONCLUSIONS: The results of the study suggest that the incidence of cervical cancer in the region is consistent with the mortality rates. The age-group with the highest rates are black women over 45 in rural areas, suggesting the need to target this group to reduce the racial disparity in cervical cancer.

Journal Article↗

PubMed2000

Possible relationship between birth weight and cancer incidence among young adults.

PURPOSE: Fetal and early life events have been associated with diseases that develop later in life. Low birth weight and the adult onset of hypertension, coronary heart disease, cerebrovascular disease, and non-insulin dependent diabetes have been identified. As well, associations with breast, ovarian, and prostate cancer to high birth weight have been found. An assessment of birth weight and cancer incidence was conducted in a cohort of black and white residents under the age of 46 years.METHODS: Cases were obtained from the Savannah River Region Health Information System cancer registry incident cases (1991-1995) and were limited to South Carolinians born in 1950 and later. Controls were obtained from birth certificate records by choosing the next two records after a cancer case record that matched on year of birth, race, and sex. Results were obtained for 117 cancer cases and 238 controls.RESULTS: After examining the birth distribution, the births were split into two groups based on mean birth weight among controls (3215 grams). Conditional logistic regression (CLR) showed that individuals with higher birth weights (> = 3215 g) were 1.65 (95% CI = 1.03-2.64) times more likely to be cancer cases than those with lower birth weights. When weights were categorized into 500 g increments, a CLR Score statistic showed there was a significant trend (p = 0.0006) of increasing proportion of cancer cases with increasing birth weight. Eight out of the eight cases of lymphoma had birth weights greater than 3579 g.CONCLUSIONS: The results of this preliminary study suggest that cancer incidence among the young may be associated with higher birth weights. One possible reason for this finding, which requires further investigation, might be that larger infants are exposed to higher levels of hormones and/or growth factor than smaller infants in utero that might increase the risk of certain cancers later in life. This may be suggestive of possible environmental factors affecting early growth. These findings support the need for additional study of this association.

Journal Article↗

PubMed2000

The impact of birth weight on the racial disparity of end-stage renal disease.

PURPOSE: Blacks have a high rate of end-stage renal disease (ESRD) and low birthweight (LBW) than whites. LBW has been associated with ESRD. The purpose of this study was to assess impact of LBW on the racial difference in ESRD.METHODS: Patients born in SC after 1950 and diagnosed with ESRD between 1991-1996 were identified from the ESRD registry. Birth weight was compared for 858 black and 372 white patients and 2460 controls matched for age, sex, and race. LBW was defined as birthweight <2500 g.RESULTS: Among patients with ESRD, mean birthweight was lower in blacks than whites (3179 vs 3367 g, p < 0.001). LBW was more common in blacks than whites with ESRD (13.9 vs 7.5%, p = 0.02). The risk ratio for LBW among ESRD patients was 1.4 (95% C.I. 1.1 to 1.8) for blacks and 1.5 (95% C.I. 0.9 to 2.5) for whites. The population attributable risk (PAR) for ESRD due to LBW was greater for blacks than whites (33.6 vs 4.2 per 100,000).CONCLUSIONS: Birthweights were lower and LBW was more common among blacks than whites with ESRD. Moreover, LBW contributed more to the PAR of ESRD in blacks than whites. Thus, LBW may contribute to the greater risk for ESRD in African Americans than Caucasians. This preliminary study indicates that further research on the link between LBW and ESRD could be instructive in understanding the racial health disparities.

Journal Article↗

PubMed2000

Treatment of squamous cell esophageal cancer with topotecan: an Eastern Cooperative Oncology Group Study (E2293).

Seventeen patients with enhanced measurable squamous cell carcinoma of the esophagus were treated with topotecan 1.5 mg/m2 daily for 5 days repeated every 21 days. Toxicity was severe, with 1 death from myelotoxicity and 10 patients with life-threatening myelotoxicity. Severe gastrointestinal toxicity consisting of vomiting was also seen in three patients. No response was seen in any of the patients in the study. Topotecan given in this manner has no activity in squamous cell carcinoma of the esophagus.

Antineoplastic Agents↗

PubMed2000

Analysis of dichotomous outcome data for community intervention studies.

Community intervention trials are becoming increasingly popular as a tool for evaluating the effectiveness of health education and intervention strategies. Typically, units such as households, schools, towns, counties, are randomized to receive either intervention or control, then outcomes are measured on individuals within each of the units of randomization. It is well recognized that the design and analysis of such studies must account for the clustering of subjects within the units of randomization. Furthermore, there are usually both subject level and cluster level covariates that must be considered in the modelling process. While suitable methods are available for continuous outcomes, data analysis is more complicated when dichotomous outcomes are measured on each subject. This paper will compare and contrast several of the available methods that can be applied in such settings, including random effects models, generalized estimating equations and methods based on the calculation of 'design effects', as implemented in the computer package SUDAAN. For completeness, the paper will also compare these methods of analysis with more simplistic approaches based on the summary statistics. All the methods will be applied to a case study based on an adolescent anti-smoking intervention in Australia. The paper concludes with some general discussion and recommendations for routine design and analysis.

Adolescent↗

PubMed1999

Phase II trial of trimetrexate for patients with advanced gastric carcinoma: an Eastern Cooperative Oncology Group study (E1287).

BACKGROUND: A Phase II study was conducted to evaluate the response, duration of response, and duration of survival of patients with measurable gastric carcinoma treated with trimetrexate (TMTX) who had not had prior chemotherapy. METHODS: Thirty-three patients with unresectable or metastatic gastric adenocarcinoma who had not received previous chemotherapy were treated with intravenous TMTX 12 mg/m(2) daily for 5 days. The dosage of TMTX was reduced to 8 mg/m(2) daily for 5 days for those who had received prior radiotherapy. The cycle was repeated every 3 weeks until disease progression or unacceptable toxicity occurred. RESULTS: Thirty-three patients could be analyzed with follow-up data. There was one Grade 5 (lethal) toxicity and four Grade 4 toxicities. Hematologic toxicity was the most common. The overall response rate was 21%, the overall median progression free survival was 2.7 months, and the overall median survival was 5.9 months for the entire cohort. No patients were alive at last follow-up. CONCLUSIONS: Though TMTX as a single agent has activity in gastric carcinoma with manageable toxicity, it cannot be recommended for routine use as a single agent due to the brief duration of response and median survival.

Adenocarcinoma↗

PubMed1999

A phase II study of 5-fluorouracil, leucovorin, and interferon-alpha in the treatment of patients with metastatic or recurrent gastric carcinoma: an Eastern Cooperative Oncology Group study (E5292).

BACKGROUND: Chemotherapy has a limited impact on adenocarcinoma of the stomach. Although biochemical modulation of 5-fluorouracil (5-FU) by leucovorin (LV) and interferon-alpha (IFN-alpha) has improved the outcomes of patients with metastatic colorectal carcinoma compared with 5-FU alone, this approach has not been extensively evaluated in the treatment of advanced gastric carcinoma. METHODS: Twenty-seven patients with bidimensionally measurable, metastatic gastric carcinoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 received the combination of IFN-alpha (5 million U/m2 administered subcutaneously daily on Days 1-7), LV (500 mg/m2 administered intravenously over 30 minutes immediately after IFN-alpha on Days 2-6), and 5-FU (370 mg/m2 given as an intravenous bolus 60 minutes after LV on Days 2-6), with treatment repeated every 4 weeks. Oral cryotherapy was administered routinely before each dose of 5-FU to reduce the incidence of severe stomatitis. RESULTS: The median age of the patients was 58 years (range, 20-76), and 22 patients had residual, unresectable primary lesions. The median number of cycles received was 3 (range, 1-11). Of 24 patients who received at least 2 cycles of treatment, 15 (62.5%) did not require dose reduction for toxicity during the initial 2 cycles. The predominant toxicities were gastrointestinal: diarrhea and stomatitis of Grade 3-4 occurred in 28.6% and 35.7% of patients, respectively. Other severe (Grade 3-4) toxicities were granulocytopenia (which occurred in 21.4% of patients) and fatigue (in 10.7%). Fever and flu-like symptoms were common but usually mild. Of 24 patients who were evaluable for response, 3 had partial responses (PR) of 16, 23, and 33 weeks' duration, respectively, for a response rate of 12.5% (95% confidence interval = 2.7-32.4%). Two additional patients had reductions in tumor size sufficient for PR, but scans to document the minimum required response duration of 4 weeks were not obtained before progressive disease occurred. The median progression-free and overall survivals were 2.5 and 7.8 months, respectively. CONCLUSIONS: Although this regimen can be administered safely with appropriate supportive care to patients with good performance status, it has limited therapeutic activity in patients with advanced gastric carcinoma.

Adult↗

PubMed1999

A phase II trial of homoharringtonine and caracemide in the treatment of patients with advanced large bowel cancer.

Twenty-four previously untreated, ambulatory patients with advanced colorectal carcinoma were treated with either caracemide (11 patients) or homoharringtonine (13 patients). No objective responses were observed in any of the treatment cohorts. Caracemide was well tolerated with the exception of one death due to sepsis. On the homoharringtonine arm one patient died of pulmonary sepsis, one patient experienced grade 4 leukopenia requiring more than 4 weeks of recovery, and an additional patient developed grade 4 renal failure. These severe and unexpected complications caused early termination of accrual to the homoharringtonine arm of the study. These agents have no activity in the treatment of advanced colorectal carcinoma.

Adult↗

PubMed1998

Using a hypothetical case to measure differences in treatment aggressiveness among physicians in Canada, Germany and the United States.

Variations in physician practice style, within and between countries, account for much of the differences in the utilization of scarce health care resources. Practice style differences are particularly important at the end of life, when a substantial amount of resources are consumed. We use a hypothetical case of a severely ill elderly patient to identify factors associated with aggressive treatment and to test whether physicians in the US practice differently from their counterparts in other countries. Data come from a random sample of practicing physicians in three industrialized countries, the United States, Canada and Germany (N = 1369). Although the case stated that the chance of survival of the patient was low, 73% of all physicians selected the aggressive treatment. Physicians from the United States were the most aggressive (86%), followed by Germany (68%) and Canada (61%). Practicing in the United States was the strongest predictor of aggressiveness in the multiple linear logistic regression; German and Canadian physicians were one fourth as likely to use aggressive treatment. Specialty training, older age and being a resident all increased the likelihood of selecting the more aggressive treatment. The fear of being sued for malpractice and income did not have an effect on treatment decisions.

Adult↗

PubMed1998

Phase II trial of preoperative radiation therapy and chemotherapy for patients with localized, resectable adenocarcinoma of the pancreas: an Eastern Cooperative Oncology Group Study.

PURPOSE: A prospective, multiinstitutional trial was initiated in 1991 to examine the tolerance to and efficacy of a program of preoperative chemoradiotherapy (CTRT) and surgical resection for patients with localized adenocarcinoma of the pancreas. PATIENTS AND METHODS: Fifty-three patients were assessable for analysis, with a median follow-up of 52 months for survivors. Radiation therapy (RT) totaling 5,040 cGy in 180 cGy fractions with mitomycin 10 mg/m2 day 2 and fluorouracil (5-FU) 1,000 mg/m2/d continuous infusion days 2 through 5 and 29 through 32 were given as preoperative adjuvant therapy. Twelve patients did not proceed to surgery (one death, one toxicity, three local progression, six distant metastases, one intercurrent illness), whereas 41 patients underwent surgery. Of these, 17 patients did not have resection (11, hepatic and/or peritoneal metastases and six local extension that precluded resection). Twenty-four patients had tumor resection (19 Whipple, four total pancreatectomy, one distal pancreatectomy). RESULTS: Treatment toxicity was primarily hematologic, although a comparable number suffered biliary tract complications, either from obstruction or cholangitis as a result of an occluded stent or the primary tumor. There was one postoperative death. Median survival for the entire group and for the 24 patients with resection was 9.7 and 15.7 months. This survival rate reflected the advanced state of most resected cancers (positive peritoneal cytology, three patients; margins within 2 mm, 13 patients; involved lymph nodes, four patients; and need for superior mesenteric vein (SMV) resection, four patients). Tumor progression was most frequent at metastatic sites. CONCLUSION: This preoperative CTRT protocol was feasible and safe in a cooperative group setting. Entry of patients with advanced tumors probably accounted for the suboptimal resectability and survival results.

Adenocarcinoma↗

PubMed1996

Long-term pulmonary toxicity of multiagent chemotherapy including bleomycin and cyclophosphamide in osteosarcoma survivors.

PURPOSE: To assess long-term pulmonary effects of multiagent chemotherapy, we studied serial pulmonary function tests (PFTs) of 35 children with osteosarcoma up to 12 years after diagnosis. PATIENTS AND METHODS: We analyzed 84 sets of PFTs from 35 patients diagnosed with osteosarcoma between 1981 and 1991. They received bleomycin, cyclophosphamide, methotrexate, doxorubicin, cisplatin, and actinomycin D over 9-12 months and we performed PFTs from 3 days to 152 months after diagnosis. Time period I included 36 PFTs (43%) performed between 1 and 5 months from diagnosis, time period II included 20 PFTs (24%) performed between 8 and 12 months from diagnosis, and time period III included 28 PFTs (33%) performed between 12 and 119 months from diagnosis. Total lung capacity (TLC), forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and carbon monoxide diffusing capacity (DLCO) were analyzed. Maximal respiratory pressures and arterial blood gases were measured to assess muscle weakness and gas exchange, respectively. Mean differences in PFTs were compared among the three time periods and between time period pairs. RESULTS: All mean PFT values showed significant differences among time periods. Significant decline in DLCO; (P=.012), TLC (P=.020), and FEV1 (P=.028) between time periods I and II were noted followed by a trend towards recovery between time periods II and III. Time periods I and III were not significantly different from one another. Mean PFTs performed after 2 years of diagnosis were not different from mean PFTs performed from diagnosis at 2 years. CONCLUSION: This dosage regimen of multi-agent chemotherapy for osteosarcoma patients caused a transient, but significant, decline in PFTs within 8-12 months after administration but appears to cause no significant long-term pulmonary function abnormalities.

Adolescent↗

PubMed1996

Phase II trial of prolonged continuous infusion of 5-fluorouracil and interferon-alpha in patients with advanced pancreatic cancer. Eastern Cooperative Oncology Group Protocol 3292.

Evidence suggests that interferon-alpha (IFN-alpha) augments the antineoplastic activity of 5-fluorouracil (5-FU) in human adenocarcinoma cell lines in vitro and may enhance the efficacy of 5-FU in patients with advanced colorectal carcinoma. In addition, 5-FU may be more effective when given as a prolonged, continuous i.v. infusion (PCI). The Eastern Cooperative Oncology Group performed a Phase II trial of PCI 5-FU plus IFN-alpha in patients with advanced pancreatic carcinoma. Twenty-six patients with advanced, surgically incurable adenocarcinoma of the pancreas received PCI 5-FU (250 mg/m2 daily for 28 days) in combination with IFN-alpha (5 x 10(6) IU/m2 s.c. thrice weekly). Treatment cycles were repeated 14 days or longer after completion of the previous cycle. Treatment was interrupted prior to day 28 if intolerable toxicity developed, and the dose of 5-FU was reduced in subsequent cycles. Partial response occurred in two of 24 evaluable patients (8%; 95% confidence interval, 0-19%). The majority of the study group (88%) had liver metastases. Patients whose serum lactate dehydrogenase (LDH) was more than twofold elevated developed 5-FU-related toxicity significantly sooner than patients with smaller elevations in serum LDH (9 vs. 22 days; p = 0.003). A similar trend was observed for patients with a more than twofold elevation in serum glutamic-oxaloacetic transaminase (SGOT; 9 vs. 15 days; p = 0.07). In conclusion, PCI 5-FU plus IFN-alpha has minimal activity in patients with advanced pancreatic carcinoma, and elevated serum LDH and/or SGOT may be useful for predicting greater toxicity from 5-FU-based therapy in patients with liver metastases.

Adenocarcinoma↗

PubMed1996

Regression analysis with missing covariate data using estimating equations.

In regression analysis, missing covariate data has been among the most common problems. Frequently, practitioners adopt the so-called complete-case analysis, i.e., performing the analysis on only a complete dataset after excluding records with missing covariates. Performing a complete-case analysis is convenient with existing statistical packages, but it may be inefficient since the observed outcomes and covariates on those records with missing covariates are not used. It can even give misleading statistical inference if missing is not completely at random. This paper introduces a joint estimating equation (JEE) for regression analysis in the presence of missing observations on one covariate, which may be thought of as a method in a general framework for the missing covariate data problem proposed by Robins, Rotnitzky, and Zhao (1994, Journal of the American Statistical Association 89, 846-866). A generalization of JEE to more than one such covariate is discussed. The JEE is generally applicable to estimating regression coefficients from a regression model, including linear and logistic regression. Provided that the missing covariate data is either missing completely at random or missing at random (in addition to mild regularity conditions), estimates of regression coefficients from the JEE are consistent and have an asymptotic normal distribution. Simulation results show that the asymptotic distribution of estimated coefficients performs well in finite samples. Also shown through the simulation study is that the validity of JEE estimates depends on the correct specification of the probability function that characterizes the missing mechanism, suggesting a need for further research on how to robustify the estimation from making this nuisance assumption. Finally, the JEE is illustrated with an application from a case-control study of diet and thyroid cancer.

Biometry↗

PubMed1995

Phase II trial of taxol in patients with adenocarcinoma of the upper gastrointestinal tract (UGIT). The Eastern Cooperative Oncology group (ECOG) results.

Taxol was administered as a 24-hour continuous infusion at 250 mg/m2 in this Phase II trial in patients with adenocarcinomas of the upper gastrointestinal tract (UGIT). Twenty-five patients were entered between July 1991 and June 1992, twenty-three were eligible and were evaluated for toxicity and twenty-two were assessable for response. There was one partial response (4.5%) in a patient with liver metastases, with a duration of 6 months. Toxicity was primarily neutropenia. Taxol as a single agent appears to have little activity in adenocarcinoma of the UGIT.

Adenocarcinoma↗

PubMed1995

Hepatocellular carcinoma. An ECOG randomized phase II study of beta-interferon and menogaril.

This study was undertaken to investigate the response rate, time to treatment failure and survival time of patients with hepatocellular cancer (HCC) treated with beta-interferon or menogaril. Sixty-nine patients with histologically confirmed, advanced, measurable hepatocellular carcinoma were randomized to receive beta-interferon or menogaril. Eligibility criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2, or 3, as well as adequate kidney and liver function and hematologic reserve. The number of patients with lethal, life-threatening, and severe toxicities on beta-interferon were 1, 3, and 12 and on menogaril 2, 5, and 10, respectively. No objective responses were documented among the 61 patients who had HCC, histologically reviewed and confirmed. The time to treatment failure was 6.7 weeks on beta-interferon and 8.6 weeks on menogaril. The median survival time was 11.1 weeks on beta-interferon and 23.1 weeks on menogaril (South African patients 10.1 weeks). The difference is not significant. Poor prognostic factors were jaundice, age, and associated hepatitis. After controlling for other covariates, beta-interferon appears to increase the relative risk of dying by 2.7. This trial reconfirms the importance, previously reported by ECOG of jaundice and age in the prognosis of patients with HCC. It shows that further trials with neither beta-interferon nor menogaril are warranted.

Aged↗