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Table 6 REMARK profile for Schirripa et al. (2014) [26]

From: Structured reporting to improve transparency of analyses in prognostic marker studies

Part a: Patients, treatment, and variables
 Patients: tissue samples from patients with metastatic colorectal cancer (mCRC) from 2009 to 2012 were analyzed at the Pathology Department of the University Hospital of Pisa
  ? Patients with available KRAS, BRAF, and NRAS mutational status included
  ? Patients excluded
  786 Patients included for analysis
 Treatment and follow-up: follow-up not mentioned
  Markers M1 = NRAS mutation (y/n), M2 = KRAS mutation (y/n), M3 = BRAF mutation (y/n), M4 = all wt (no NRAS, KRAS or BRAF mutation) (y/n)a
  Outcomes (events) OS (?), PFS (?)
  Further variables v1 = sex, v2 = age at diagnosis, v3 = ECOG PS (0/1–2), v4 = primary tumor site (nominal), v5 = mucinous histology (y/n), v6 = tumoral penetration (pT) (1–2/3–4), v7 = nodal involvement (pN) (0/1–2), v8 = time to metastasis (mts) (binary), v9 = number of mts (1/> 1), v10 = resected primary (y/n), v11 = liver only mts (y/n), v12 = liver mts (y/n), v13 = lung mts (y/n), v14 = nodes mts (y/n), v15 = peritoneal mts (y/n), v16 = bone mts (y/n), v17 = metastasis site (v11–v16) classified into 6 categories; see Table 2
Part b: Statistical analysis of survival outcomes
 Aim n Outcome (events) Variables considered Results/remarks
  IDA: homogeneity 786
various n due to missing
M1–M4, v1–v9, v11–v17 p-values, Tables 1 and 2
  A1: univariable 786 OS (?) M1- M4 Kaplan-Meier-estimate, Log-rank-test (p-value) Fig. 1
  A2: univariable 321 (47 (M1) + 274 (M4), see Table 1) OS (?) M1, M4 Kaplan-Meier estimate, HR, CI, p-value, Fig. 2
  A3: univariable Varies OS (?) M1–M4, v3–v5, v8, v10, v11 HR, CI, p-value, Table 3b
  A4: multivariable M1 vs M4, M2 vs M4, and M3 vs M4 Varies but unknown OS (?) Adjusted for v3–v5, v8, v10, v11 HR, CI, p-value, Table 4
  Additional: NRAS patients treated with anti-EGFR monoclonal antibodies 8 Median OS and PFS   See page 87
  1. Statistical software packages used: no information given
  2. OS overall survival (time from diagnosis of metastatic disease to death of al causes), PFS progression-free survival (time from the beginning of treatment to disease progression or death of any cause)
  3. aTested for NRAS mutation only in patients with wtKRAS and wtBRAF
  4. bOnly significant analyses are shown in Table 3. What about others, e.g., v7: non-significant? No statement