Summary Tumours respond differently to immunotherapies compared with chemotherapeutic drugs, raising questions about the assessment of changes in tumour burden—a mainstay of evaluation of cancer ...therapeutics that provides key information about objective response and disease progression. A consensus guideline—iRECIST—was developed by the RECIST working group for the use of modified Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) in cancer immunotherapy trials, to ensure consistent design and data collection, facilitate the ongoing collection of trial data, and ultimate validation of the guideline. This guideline describes a standard approach to solid tumour measurements and definitions for objective change in tumour size for use in trials in which an immunotherapy is used. Additionally, it defines the minimum datapoints required from future trials and those currently in development to facilitate the compilation of a data warehouse to use to later validate iRECIST. An unprecedented number of trials have been done, initiated, or are planned to test new immune modulators for cancer therapy using a variety of modified response criteria. This guideline will allow consistent conduct, interpretation, and analysis of trials of immunotherapies.
Summary Background No consensus exists on the validity of the sentinel-lymph-node procedure for assessment of nodal status in patients with colorectal cancer. We aimed to assess the diagnostic ...performance of this procedure. Methods We searched Embase and PubMed databases for studies published before March 20, 2010. Eligible studies had a prospective design, a sample size of at least 20 patients, and reported the rate of sentinel-lymph-node positivity. Individual patient data were requested for localisation and T-stage stratification. A subset of reports with high methodological quality was selected and analysed. Findings We identified 52 eligible studies, which included 3767 sentinel-lymph-node procedures (2961 78·6% colon and 806 21·4% rectal carcinomas). Most tumours 2339 (62·1%) were stage T3 or T4. 1887 (50·1%) of patients were male, 1880 (49·9%) female. Mean overall weighted-detection rate was 0·94 (95% CI 0·92–0·95), at a pooled sensitivity of 0·76 (0·72–0·80) with limited heterogeneity (χ2 =286·08, degrees of freedom=51; p=0·003). A mean weighted upstaging of 0·15 (95% CI 0·12–0·19) was noted. Individual patient data were available from 19 studies that included 1168 patients. Analysis of these data showed no significant difference in sensitivity between colon (0·86 95% CI 0·83–0·90) and rectal cancer (0·82 0·77–0·88; p=0·23). Also, there was no dependency of sensitivity on T stage for both colon (pT1: 0·79 95% CI 0·73–0·84, pT2: 0·76 0·62–0·90, pT3: 0·73 0·59–0·87, pT4: 0·73 0·53–0·93) and rectal cancer (T1 or T2: 0·81 0·52–0·94 vs T3 or T4: 0·80 0·51–0·93). The subgroup of eight studies with high methodological quality showed a mean detection rate of 0·96 (95% CI 0·90–0·99) for colonic tumours and 0·95 (0·75–0·99) for rectal tumours, and a mean sensitivity of 0·90 (95% CI 0·86–0·93) for colonic tumours and 0·82 (0·60–0·93) for rectal tumours. Interpretation The sentinel-lymph-node procedure shows a low sensitivity, regardless of T stage, localisation, or pathological technique. For every patient diagnosed with colon or rectal cancer without clinical evidence of lymph-node involvement or metastatic disease, this procedure in addition to conventional resection should be considered, since the prognostic information provided by this technique could be clinically significant. Funding Cancer Center Amsterdam Foundation, Amsterdam, Netherlands.
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