5. Definitions and results of survival and/or relapse analysis in antigen‐specific antibody studies.
| Study | Analysed | Definition | Results |
| Baumann 2011 | yes | progression‐free survival/overall survival | median progression‐free survival: low dose 70 days (95% CI 63 to 91), high dose 68 days (95% CI 58 to 77) median overall survival: low dose 137 days (95% CI 99 to 218), high dose 185 days (95% CI 134 to 472) |
| Berek 2001 | yes | time to relapse | median time to relapse: placebo 11.3, robust HAMA 16.4, robust Ab2 18.9 months |
| Berek 2004 | yes | time to relapse | all patients: time to relapse: oregovomab 13.3 vs placebo 10.3 months (P = 0.71) (HR 0.881, 95% CI 0.578 to 1.349) successful front‐line therapy patients: time to relapse: oregovomab 24 vs placebo 10.8 months (P = 0.71) (HR 0.543, 95% CI 0.287 to 1.025) |
| Berek 2009 | yes | time to relapse (randomisation to relapse) | median time to relapse: oregovomab 10.3 months (95% CI 9.7 to 13.0 months) vs placebo 12.9 months (95% CI 10.1 to 17.4 months) (P = .29) |
| Braly 2009 | yes | progression‐free survival | median progression‐free survival: simultaneous administration 17.9 months vs delayed administration 16.1 months |
| Buzzonetti 2014 | no | ||
| Ehlen 2005 | yes | time to progression/survival (first dose to death) | time to progression: median 8.4 weeks (range 2 to 61 weeks); survival 37 weeks (range 11 to 110) |
| Gordon 2004 | yes | time to progression/survival (first dose to death) | time to progression: median 11 weeks (T‐cell responders vs non‐responders; P < 0.0001; HR 0.150, 95% CI 0.006 to 0.168); survival: median 70.4 weeks (T‐cell responders vs non‐responders; P < 0.002; HR 0.157, 95% CI 0.009 to 0.347) |
| Heiss 2010 | yes | puncture‐free survival (first dose to therapeutic puncture or death)/overall survival (first dose to death) | Median puncture‐free survival: paclitaxel + catumaxomab 52 days (95% CI 38 to 62) vs catumaxomab 11 days (95% CI 9 to 20) Median overall survival: paclitaxel + catumaxomab 110 days (95% CI 70 to 164) vs catumaxomab 81 days (95% CI 68 to 134) |
| Ma 2002 | no | ||
| Method 2002 | no | ||
| Möbus 2003 | yes | survival (first dose to death)/overall survival (diagnosis to death) | survival: median 16.8 months (95% CI 10.3 to 22.6) (Ab3 responders vs non‐responders 18.2 vs 13.1, P = 0.0896; HAMA responders vs non‐responders 22.6 months vs 7.6 months, P = 0.0016); overall survival: median 34.4 months |
| Nicholson 2004 | no | ||
| Noujaim 2001 | yes | survival (first dose to death) | median survival and 3‐year survival: Ab3 responders vs non‐responders 22.9 vs 13.5 months, P = 0.0089, 38% vs 8%; T‐cell responders vs non‐responders (n = 16) > 84 vs 13.2 months, P = 0.0202, 75% vs 0% |
| Pfisterer 2006 | no | ||
| Reinartz 2004 | yes | survival (first dose to death) | median survival: 19.4 months, Ab3 responders vs non‐responders: 23.4 vs 4.9 months, P < 0.0001 |
| Sabbatini 2006 | yes | time to progression | time to progression: 4 months (95% CI 3 to 5 months) |
| Sabbatini 2013 | yes | recurrence‐free survival (randomisation to recurrence)/overall survival (randomisation to death) | median recurrence‐free survival: abagovomab 403 days (95% CI 323 to 414) vs placebo 402 days (95% CI 323 to 487) 2‐year overall survival rate: abagovomab 80% (SE 1.71) vs placebo 80% (SE 2.43) |
| Schultes 1998 | yes | overall survival (diagnosis to death) | median overall survival: robust Ab3 responders vs non‐robust responders 49 vs 38 months, P = 0.0029; Ab2 robust vs non‐robust responders 30.0 vs 44.0 months, P = 0.0475 |
| Ströhlein 2009 | yes | overall survival | not described separately for ovarian cancer patients |
| van Zanten‐Przybysz 2002 | yes | survival (first dose to death) | median survival: 22.0 months |
| Wagner 1993 | yes | not described | survival: robust Ab2 vs non‐robust Ab2 responders: NS |
Ab2: anti‐idiotype antibody. Ab3: anti‐anti‐idiotype antibody. CI: confidence interval. HAMA: human‐anti‐mouse antibody. HR: hazard ratio. SE: standard error.