Table 2. Summary of studies assessing the prognostic value of p53 in OTSCC providing unadjusted or adjusted estimates of HR and their 95% CIs for one or more endpoints, the HRs contrasting positive to negative expression.
| (Authors, year) Country | Stage or tumour size (primary treatment) | Primary antibody | Cutoff point in percentage | No. of cases | No. of positive cases (%) | Endpoint | Unadjusted analysis | Adjusted analysis | Compliance to REMARK guidelines |
|---|---|---|---|---|---|---|---|---|---|
| (Hogmo et al, 1998) Sweden | I (S) | p53, polyclonal (1 : 700; Novocastra, Newcastle upon Tyne, UK) | Distinct brown staining, confined to the nuclei, at least in 1% of the cells | 54 | 24 (48) | Local recurrence | NA | HR 1.05 (95% CI 0.29–3.81) P=0.936 | Checklist no. 5 was not fulfilled |
| Regional recurrence | P=0.03 | HR 0.28 (95% CI 0.07–1.08), P=0.065 | |||||||
| (Bova et al, 1999) Australia | T1–T4 (S only in 96 patients; and S with adjuvant RT in 52 patients) | p53, DO-7 (1 : 50; Dako, Carpinteria, CA) | 10 | 143 | 89 (62.2) | DFS | HR 1.18 (95% CI 0.60–2.32), P=0.64 | NA | Checklist no. 5 was not fulfilled |
| OS | HR 1.46 (95% CI 0.69–3.06), P=0.32 | NA | |||||||
| (Mineta et al, 2002) Japan | I–IV (S) | p53, DO-7 (1 : 1000; Dako, Copenhagen, Denmark) | 50 | 109 | 56 (52.8) | RFS | NA | HR 1.31 (95% CI 0.77–2.23), P=0.328 | Checklist no. 5 and 6 were not fulfilled |
| (Goto et al, 2005) Japan | I–IV (S) | p53, DO-7 (1 : 100; Dako, Glostrup, Denmark) | 10 | 123 | 62 (50.4) | DFS | HRa 1.02 (95% CI 0.59–1.75) | NA | Checklist no. 5 was not fulfilled |
| DSS | HRa 0.91 (95% CI 0.37–2.24) | NA | |||||||
| OS | HRa 1.27 (95% CI 0.59–2.71) | NA | |||||||
| (Trivedi et al, 2011) India | T1–T4 (S followed by RT in 26 cases, CT in 1 case, RT with CT in 5 cases) | p53, DO-7 (1 : 50; Dako, Glostrup, Denmark) | 10 | 43 | 21 (49) | RFS | HR 3.66 (95% CI 1.42–9.39), P=0.007 | NA | Checklist no. 5 and 6 were not fulfilled |
| OS | HR 4.25 (95% CI 1.39–12.98), P=0.001 | HR 3.69 (95% CI 1.01–13.43), P=0.048 | |||||||
| (Adduri et al, 2014) India | T1–T3 (S) | p53, DO-1 (1 μg ml−1, EMD Millipore Calbiochem, Darmstadt, Germany) | 20 | 79 | 49 (62) | DSS | HR 3.35 (95% CI 1.83–6.14), P=0.0003 | NA | Checklist no. 5 and 6 were not fulfilled |
Abbreviations: CI=confidence interval; CT=chemotherapy; DFS=disease-free survival; DSS=disease-specific survival; HR=hazard ratio; NA=not available; OS=overall survival; RFS=relapse-free survival; RT=radiotherapy; S=surgery.
a
HR in Goto et al study has been calculated by contrasting negative p53 vs positive p53, and we have converted it (as 1 divided by the reported HR and 1 divided by the reported CI) to be similar to all other studies in which HR was calculated by contrasting positive p53 vs negative p53.