Should we remove a left kidney with a tumor if pulmonary lymph nodes are enlarged? (pulmonary kidney tumor renal nephrectomy)
I also assumed it was very rare, but this study is intriguing, with a 6%
spontaneous remission of metastases after treating kidney cancer, in a
group of about a hundred patients..
Placebo-associated remissions in a multicentre, randomized, double-blind
trial of interferon gamma-1b for the treatment of metastatic renal cell
carcinoma. The Canadian Urologic Oncology Group.
Elhilali MM, Gleave M, Fradet Y, Davis I, Venner P, Saad F, Klotz L, Moore
R, Ernst S, Paton V.
Department of Urology at the Royal Victoria Hospital (MUHC), Canada.
OBJECTIVE: To determine the validity of using an historical maximum
spontaneous regression rate (reportedly 0-1.1% in those with lung metastases
after nephrectomy) in clinical trials of treatments for patients with
metastatic renal cell carcinoma (RCC), as the eligibility criteria for most
studies will select patients with better performance status (and thus
excluding those who are unlikely to respond) and more modern staging methods
would potentially reduce the number of false-positives. PATIENTS AND
METHODS: A multicentre randomized,placebo-controlled, double-blind trial was
recently completed in which 197 patients with metastatic RCC from 17 study
centres across Canada were randomized to receive placebo or recombinant
interferon gamma-1b (60 microg/m2) subcutaneously once every 7 days until
disease progression. All tumour responses were validated by an independent
response committee unaware of the treatment. RESULTS: The median (95%
confidence interval) overall response rate (complete, CR, and partial, PR)
for those on interferon-gamma was 4 (1.4-11.5)% and for those on placebo was
6 (2. 5-13.2)% (P = 0.75). In the six patients who were receiving placebo
the CR and PR (three each) was considered to represent spontaneous
remission. Of these six patients (aged 44-64 years) five had undergone
nephrectomy, one a tumour embolization, four had clear cell carcinoma and
one an adenocarcinoma, and all had regression of lung and/or lymph node
metastases. CONCLUSION: The lack of efficacy of interferon-gamma in this
trial underlines the importance of continued research to identify
alternative therapeutic agents or combinations of agents in phase II
studies. However, the threshold response rate for initiating phase III
trials should be increased to 18% in the phase II trials, i.e. three times
the response rate on placebo.
Peter Moran
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