A Randomized Phase II Study of Acivicin and 4ʼDeoxydoxorubicin in Patients with Hepatocellular Carcinoma in an Eastern Cooperative Oncology Group Study

Falkson, Geoffrey; Cnaan, Avital; Simson, I. W.; Dayal, Yogeshwar; Falkson, H. C.; Smith, Thomas J.; Haller, Daniel G.

doi:10.1097/00000421-199012000-00012

Cited by 39 publications

(26 citation statements)

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“…The most accurate measure of the value of treatment, in a dis ease with so limited a life expectancy as inoperable hepa tocellular cancer, remains survival time. The median sur vival time of 20 weeks, documented in the current study with vindesine, is similar to the median survival time of 19 weeks in patients treated with 5-fluorouracil and leucovorin [9], 14 weeks with mitoxantrone [6], 15 weeks with doxorubicin, 17 weeks with 5-fluorouracil plus methyl-CCNU plus doxorubicin [7] and 21 weeks with 4'deoxydoxorubicin [5]. That treatment with vindesine was well documented and that subjective improvement occurred in some patients is of little value as this can be best obtained without cytotoxic agents.…”

supporting

confidence: 77%

“…In randomized Eastern Coo perative Oncology Group (ECOG) trials the response rate to doxorubicin was 10% in one trial [3] and in a subse quent trial, 9% in the North American and 22% in the South African patients [4], Although a higher response rate was seen with a combination of doxorubicin, 5-fluorouracil and methyl CCNU this was associated with pro hibitive toxicity. Two of 30 patients randomized to receive 4'deoxydoxorubicin responded to treatment [5]. In a randomized ECOG trial no response was seen with mitoxantrone [6], Analysis of data on 432 South African and North American patients entered into randomized ECOG trials showed that there is no treatment that pre dictably gives a response rate of 20%, in patients with inoperable hepatocellular carcinoma, and differences in the median survival times of patients with this disease are explained by known prognostic factors [7].…”

mentioning

confidence: 99%

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A Phase II Trial of Vindesine in Hepatocellular Cancer

Falkson¹,

Burger²

1995

Oncology

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Sixteen patients with histologically confirmed inoperable hepatocellular carcinoma were treated with vindesine 3 mg/m² i.v. weekly. Anemia, leukopenia and neuritis were documented but no severe or life-threatening toxicity was seen. There were no objective responses among the 14 evaluable patients. Eight had a no change status (median duration of 16 weeks, range 6-33), while the remaining 6 had progressive disease as their best evaluation. The median survival time was 20 weeks. Vindesine does not have a therapeutic effect in patients with advanced hepatocellular carcinoma.

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supporting

confidence: 77%

mentioning

confidence: 99%

A Phase II Trial of Vindesine in Hepatocellular Cancer

Falkson¹,

Burger²

1995

Oncology

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“…28 Regarding the core group, 4 studies compared treatment versus conservative management 29,30,32,33 and 2 compared treatment versus suboptimal therapies (one using systemic chemotherapy with 5-fluorouracil 27 and one using oral tamoxifen 31 ). Four studies included 2 73 IV doxorubicin ϩ VM26 ϩ 5-FU (n ϭ 74 IV 75 IV deoxydoxorubicin (n ϭ 76 Oral tegafur/uracil (28) Excluded ( 82 Oral linolenic acid (31) Excluded (2) Placebo (31) NOTE. Fourteen RCTs were included in the meta-analysis.…”

Section: Meta-analysismentioning

confidence: 99%

Systematic review of randomized trials for unresectable hepatocellular carcinoma: Chemoembolization improves survival

2003

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There is no standard treatment for patients with unresectable hepatocellular carcinoma (HCC). Survival benefits derived from medical interventions are controversial. The aim of this systematic review was to assess the evidence of the impact of medical treatments on survival. Randomized controlled trials (RCTs) that were published as full papers assessing survival for primary treatments of HCC were included. MEDLINE, the Cochrane Library, CANCERLIT, and a manual search from 1978 to May 2002 were used. The primary end point was survival, and the secondary end point was response to treatment. Estimates of effect were calculated according to the random effects model. Sensitivity analysis included methodological quality. We identified 61 randomized trials, but only 14 met the criteria to perform a meta-analysis assessing arterial embolization (7 trials, 545 patients) or tamoxifen T he incidence of hepatocellular carcinoma (HCC) is increasing worldwide. 1 Liver cancer is the fifth most common cancer in the world and the third most common cause of cancer-related death. 2 Cohort studies and cost-efficiency modeling have suggested that surveillance of well-defined cirrhotic patients may decrease tumor-related mortality. However, only 30% of patients benefit from curative therapies such as resection, transplantation, or percutaneous ablation 3 and achieve 5-year survival rates of 50% to 75%. 4 Most patients with HCC are diagnosed at intermediate to advanced stages, and there is no standard treatment for these patients. 3,4 The most reliable method to show survival advantages is to perform large randomized controlled trials (RCTs) that include more than 1,000 patients comparing treatment versus no treatment in a well-defined strata of individuals. 5-10 These investigations are lacking in patients with HCC. On the contrary, several medical interventions have been tested in the setting of small RCTs. However, the reduced size of these studies may cause questions of their statistical power when detecting survival differences, which, as in many areas of health care and oncology, are unlikely to be large. This raises the need for a systematic meta-analysis assessment, with a major role to integrate valid information and provide estimates of treatment effects when RCTs themselves are not of sufficient size. 9,10 Two systematic reviews published years ago 11,12 suggested a potential benefit for at Abbreviations: HCC, hepatocellular carcinoma; RCT, randomized controlled trial; OR, odds ratio; CI, confidence interval.

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“…We consider data from the Eastern Cooperative Oncology Group liver cancer clinical trials (Falkson et al, 1990(Falkson et al, , 1994. We are interested in the logistic regression model for the probability of jaundice as a function of performance status and the biochemical marker gammaglobulin, i.e., …”

Section: Examplementioning

confidence: 99%

“…Unfortunately, values of the covariates of interest may be missing for some subjects, either by accident or study design. For example, consider data from Eastern Cooperative Oncology Group liver cancer clinical trials (Falkson, Cnaan, and Simson, 1990;Falkson et al, 1994). Our primary interest here is to model the probability of jaundice when entering the clinical trial as a function of performance status (a measure of overall health, dichotomized as good or poor) and the biochemical marker gammaglobulin, classified as normal or abnormal.…”

Section: Introductionmentioning

confidence: 99%