Prognostic factors for survival in patients with advanced renal cell carcinoma treated with recombinant interleukin-2

Palmer, Peter; Vinke, Jan; Philip, Thierry; Négrier, Sylvie; Atzpodien, Jens; Kirchner, Hartmut; Oskam, R.; Franks, C. R.

doi:10.1093/oxfordjournals.annonc.a058239

Cited by 147 publications

(68 citation statements)

References 14 publications

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“…In agreement with previous reports (Palmer et al, 1992;Fossa et al, 1994), the present study shows that clinical response and prolonged survival time are mostly seen in the patients showing good prognostic index. This clearly suggests that immunotherapy is able to control only a subset of mRCC patients -about 40% in this trial.…”

Section: Resultssupporting

confidence: 93%

“…Patients' characteristics are shown in Table 1. The enrolled patients were grouped in three groups according to a prognostic index, taking into account weight loss > 10% within the previous 6 months, ECOG performance status and erythrocyte sedimentation rate (Palmer et al, 1992;Fossa et al, 1994). Ten (48%) patients were classified as good risk and five (24%) as intermediate risk.…”

Section: Methodsmentioning

confidence: 99%

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Effectiveness of very low doses of immunotherapy in advanced renal cell cancer

Buzio

Palma²,

Passalacqua³

et al. 1997

Br J Cancer

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Summary Twenty-one nephrectomized patients with metastatic renal cell cancer were treated with recombinant interleukin 2 (rlL-2) and interferon alpha (rlFNa). rlL-2 was administered s.c. at a dose of 1 x 106 U im-2 every 12 h on days 1 and 2, followed by 0.5 x 106 IU twice daily on days 3-5; rlFNa-2 was given i.m. as 1.8 x 106 IU m-2 on days 3 and 5 of each week for 4 consecutive weeks. The cycle was regularly repeated at 4-month intervals and continued ad libitum in patients showing some response and in patients with progressing disease. Of 20 patients evaluable for treatment response, one (5%) had a complete response and three (15%) showed partial response. Three patients (15%) achieved stable disease and 13 (65%) were evaluated as having progressive disease. The estimated actuarial 44-month survival rate was 44%. Toxicity was limited to WHO grades 1 and 2 only.

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Section: Resultssupporting

confidence: 93%

Section: Methodsmentioning

confidence: 99%

Effectiveness of very low doses of immunotherapy in advanced renal cell cancer

Buzio

Palma²,

Passalacqua³

et al. 1997

Br J Cancer

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“…These include performance status, recent weight loss, disease-free interval, pretreatment ESR, lactate dehydrogenase (LDH), neutrophils, haemoglobin, extrapulmonary and bone metastases, and the number of metastatic sites (Elson et al, 1988;Palmer et al, 1992;Lopez-Hänninen et al, 1996;Gelb, 1997;Culine et al, 1998;Hoffmann et al, 1999;Motzer et al, 1999Motzer et al, , 2002. A recent study of 425 good performance status patients added C-reactive protein (CRP) to this list and presented a model based on neutrophils, CRP, LDH, time from primary diagnosis to metastases, number of metastatic sites and presence of bone metastases (Atzpodien et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

Is treatment with interferon-α effective in all patients with metastatic renal carcinoma? A new approach to the investigation of interactions

Royston

Sauerbrei²,

Ritchie

2004

Br J Cancer

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The first analysis of the MRC RE01 trial in metastatic renal carcinoma identified a 28% reduction in the hazard of death for patients treated with interferon-a compared with medroxyprogesterone acetate (MPA). No subgroup was identified in which treatment with interferon-a was more or less effective than MPA. We used a new approach based on fractional polynomials to investigate the updated data from this trial for the possible interaction of treatment with prognostic factors. In the spirit of hypothesis generation, we considered 10 possible prognostic variables, of which white cell count (WCC) was found to influence the effectiveness of interferon treatment. In patients treated with MPA, there was no prognostic effect of WCC, whereas, in patients treated with interferon, the risk of dying increased significantly with WCC level. We defined subgroups of patients based on WCC levels and estimated a hazard ratio of 0.53 in favour of interferon in patients with WCC o6.5 Â 10 9 , whereas for patients with WCC 410 Â 10 9 the risk appears to be similar between the treatment groups, or even slightly raised in the interferon group. Since our results are derived from flexible statistical models, they may be interpreted as a new hypothesis and require validation in independent data. British Journal of Cancer (2004) Between 1992 and 1997, 350 patients with metastatic renal carcinoma were randomised to enter the MRC RE01 trial comparing interferon-a with medroxyprogesterone acetate (MPA) at 31 centres in the UK. In the first paper based on 335 patients and 236 deaths, a 28% reduction in the risk of death in the interferon-a group was reported (MRCRCC, 1999). The trial was stopped early, because the treatment effect crossed the effectiveness boundary in a triangular sequential design. Owing to the side effects of the interferon-a regimen, it is important to investigate whether the clear overall survival advantage is present in all patients. In the initial report (MRCRCC, 1999), there was no evidence from w 2 tests of heterogeneity that any prognostic factor had an influence on the effectiveness of interferon-a. Thus, no subgroup was identified in which the treatment was more or less effective.Updated data with 322 deaths were analysed by using a new approach to modelling interactions between treatment and continuous covariates (Royston and Sauerbrei, 2003). We systematically investigated whether any of the potential prognostic factors recorded at randomisation exhibits any predictive value, meaning that the effect of treatment depends on such a factor.Details of results on further end points such as progression-free survival may be found in the first paper (MRCRCC, 1999). Here we will consider only the primary end point of the trial, overall survival. In this investigation, we considered age, WHO performance status and other clinical and laboratory features listed in Table 2. With the exception of weight loss, erythrocyte sedimentation rate (ESR) and nuclear grade, this list includes the 'standard' prognostic factors for advan...

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“…The Kaplan -Meier productlimit method was used to estimate the survival distribution and response duration, which were compared between groups using the log-rank test. To adjust for imbalances in potential baseline prognostic factors for mRCC (including: performance status, prior therapy, prior nephrectomy, number of metastatic sites (1, 2, and X3) and time from diagnosis to treatment (424 vs p24 months) (Palmer et al, 1992), and age, a multivariate regression analysis (Cox proportional hazards model) was used to assess survival. All statistical analyses were performed using SAS s version 6.07 or higher (SAS Institute, Cary, NC, USA).…”

Section: Statistical Analysesmentioning

confidence: 99%

“…Therefore, a multivariate analysis was done. After correcting for imbalances in baseline characteristics to be potentially prognostic for mRCC, known at the time these studies were done (performance status, number of metastatic sites, time from diagnosis to treatment (Palmer et al, 1992), and for significant different baseline characteristics between the two treatment cohorts (age, weight, prior therapy)) the s.c. and c.i.v. regimens were found not to be significant different in terms of overall survival (P ¼ 0.08).…”

Section: Efficacymentioning

confidence: 99%