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- W4384156969 abstract "The IMmotion010 trial, by Sumanta K Pal and colleagues,1Pal SK Uzzo R Karam JA et al.Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial.Lancet. 2022; 400: 1103-1116Summary Full Text Full Text PDF PubMed Google Scholar showed that adjuvant atezolizumab is not superior to placebo in patients with kidney cancer who are at high risk of progression after surgery. Although the trial did not meet its primary endpoint, we applaud the authors for publishing the results of this phase 3 study2Bex A Uzzo R Karam JA et al.LBA66—IMmotion010: efficacy and safety from the phase III study of atezolizumab (atezo) vs placebo (pbo) as adjuvant therapy in patients with renal cell carcinoma (RCC) at increased risk of recurrence after resection.Ann Oncol. 2022; 33: S808-S869Google Scholar immediately after its presentation at the European Society of Medical Oncology congress. In the past, the lack of significant results has been associated with a delay in publishing full results of clinical trials.3Krzyzanowska MK Pintilie M Tannock IF Factors associated with failure to publish large randomized trials presented at an oncology meeting.JAMA. 2003; 290: 495-501Crossref PubMed Scopus (272) Google Scholar However, the publication of well designed negative trials has a tremendous impact in generating new scientific hypotheses and observations and, thus, should be encouraged.4Unger JM Barlow WE Ramsey SD LeBlanc M Blanke CD Hershman DL The scientific impact of positive and negative phase 3 cancer clinical trials.JAMA Oncol. 2016; 2: 875-881Crossref PubMed Scopus (36) Google Scholar Eligible patients for IMmotion010 required pathologically confirmed kidney cancer with either clear cell histology or sarcomatoid differentiation (regardless of the primary epithelial subtype). Among patients’ baseline characteristics, 7% in the atezolizumab-treated group and 8% in the observation group had non-clear cell kidney cancer (with sarcomatoid differentiation), including papillary, chromophobe, and other subtypes.1Pal SK Uzzo R Karam JA et al.Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trial.Lancet. 2022; 400: 1103-1116Summary Full Text Full Text PDF PubMed Google Scholar Inclusion of rare histologies in these large, randomised studies is extremely valuable, as doing a trial specifically for these rare tumours is fraught with difficulties. Since the biology of these rare tumours differs from the biology of clear cell histology, rare tumours should be considered as a separate exploratory statistical cohort.5Agrawal S Haas NB Bagheri M et al.Eligibility and radiologic assessment for adjuvant clinical trials in kidney cancer.JAMA Oncol. 2020; 6: 133-141Crossref PubMed Scopus (5) Google Scholar Although the numbers are small, reporting the survival outcomes for patients by rare histology, with or without therapy, would substantially contribute to our understanding of the natural history of these rare, high-risk tumours in the adjuvant setting. We declare no competing interests. Adjuvant atezolizumab versus placebo for patients with renal cell carcinoma at increased risk of recurrence following resection (IMmotion010): a multicentre, randomised, double-blind, phase 3 trialAtezolizumab as adjuvant therapy after resection for patients with renal cell carcinoma with increased risk of recurrence showed no evidence of improved clinical outcomes versus placebo. These study results do not support adjuvant atezolizumab for treatment of renal cell carcinoma. Full-Text PDF The value of IMmotion010 for rare kidney cancer histologies – Authors' replyWe appreciate the thoughtful insights from Giovanni M Iannantuono and colleagues on our Article1 and concur with the importance of addressing patients with renal cell carcinoma (RCC) bearing non-clear cell histology in prospective trials. The histological and molecular heterogeneity of non-clear cell RCC is underscored by the continued expansion of WHO's classification of renal tumours, which continues to evolve from traditionally defined entities based on tumour morphology and immunohistochemistry to a hybrid system that recognises the importance of genotype variations in biological behaviour. Full-Text PDF" @default.
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- W4384156969 title "The value of IMmotion010 for rare kidney cancer histologies" @default.
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