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 |