Table 3. Summary of studies assessing the prognostic value of Ki-67 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 |
|---|---|---|---|---|---|---|---|---|---|
| (Bova et al, 1999) Australia | I–IV (S in 96 patients, S+RT in 52 patients) | Ki-67, clone 7B11 (1 : 50; Zymed Laboratories, San Francisco, CA) | 50 | 148 | NA | DFS | HR 1.17 (95% CI 0.61–2.27), P=0.63 | NA | Checklist no. 5 was not fulfilled |
| OS | HR 1.24 (95% CI 0.62–2.47), P=0.54 | NA | |||||||
| (Mineta et al, 2002) Japan | I–IV (Radical treatment) | MIB-1, monoclonal (1 : 50; Immunotech, Marseille, France) | 10 | 109 | 52 (48) | RFS | NA | HRa 0.82 (95% CI 0.47–1.44) | Checklist no. 1 was not fulfilled |
| (Sakata et al, 2008) Japan | I–IV (LDR brachytherapy alone in all patients+neck dissection for 9 who had N+) | MIB-1, monoclonal (Dako, Copenhagen, Denmark) | 38 | 68 | NA | Local RFS | P=0.59 | HR 0.59 (95%CI 0.0514–6.74), P=0.7 | Checklist no. 5 was not fulfilled |
| (Wang et al, 2009) China/USA | I–IV (S) | Ki-67, (1 : 200; Abcam) | NA | 42 | NA | OS | HR 0.55 (95%CI 0.03–8.76), P=0.67 | NA | Checklist no. 5 was not fulfilled |
| (Bello et al, 2011) Finland/Israel | I–IV (S in 68 patients, S+RT in 49 patients, S+CRT in 10 patients+S+CT in 1 patient) | Ki-67 polyclonal (1 : 50, Dako A/S, Denmark) | 40.4 | 77 | 18 (23.3) | DSS | HR 0.89 (95% CI 0.31–2.58) | NA | Checklist no. 5 was not fulfilled |
| (Bockelman et al, 2011) Finland | T1–T2 (S in 40 patients, S+RT in 33 patients) | Ki-67, monoclonal (1 : 100, Dako, Cytomation, Denmark) | 30 | 73 | 53 (80.3) | OS | HRb 1.31 (95% CI 0.58–2.98) | NA | Checklist no. 5 was not fulfilled |
| (Hwa et al, 2015) South Korea | T1–T2 (S in 17 patients, S+RT in 8 patients) | Ki-67, monoclonal (1 : 1000; Dako, Carpinteria, CA, USA) | 50 | 25 | 8 (32) | DSS | HR 0.51 (95% CI 0.05–5.05), P=0.57 | NA | Checklist no. 5 was not fulfilled |
Abbreviations: CI=confidence interval; CT=chemotherapy; DFS=disease-free survival; DSS=disease-specific survival; HR=hazard ratio; LDR=low-dose-rate; NA=not available; OS=overall survival; RFS=relapse-free survival; RT=radiotherapy; S=surgery.
a
HR in Mineta et al study has been calculated by contrasting low Ki-67 vs high Ki-67, 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 high Ki-67 vs low Ki-67.
b
HR of 1.31 (95% CI 0.58–2.98) was kindly calculated by the author for this meta-analysis.