Table 4 Controlled Clinical Studies on VAE Treatment in Breast and Gynaecological Cancer: Tumour Behaviour or Pleurodesis
| Site | Stage | Intervention (evaluable patients) | Outcome | P-value | 95% CI | Author, year, reference |
|---|---|---|---|---|---|---|
| R EMISSION | ||||||
| Randomized controlled trials | ||||||
| Breast, ovary, lung | T1–4, N0–3, M0–1 | ChemotherapyI, Helixor A (115) | Remission rate: no difference | Piao 2004 [56] | ||
| ChemotherapyI, Lentinan (109) | ||||||
| Ovary, others | Inoperable | Radiation, cisplatin, holoxan, Helixor (23) |
10% complete remission 48% partial remission 5% progress | Lange 1985 [63] | ||
| Radiation, cisplatin, holoxan (21) |
17% complete remission 48% partial remission 4% progress | |||||
| Pleural effusionII | Advanced | Helixor (11) |
82% complete remission 9% partial remission | <0.05 III | Kim 1999 [60] | |
| Doxycycline, meperidine, lidocaine (15) |
40% complete remission 27% partial remission | |||||
| D ISEASE-FREE INTERVAL, TIME TO EVENT, RECURRENCE (H AZARD RATIO ) | ||||||
| Randomized controlled trials | ||||||
| Breast | T1a-3, N0, M0 | Iscador (38) |
Time to local recurrences: 0.44 lymphatic metastases: 0.27 distant metastases: 0.50 all events (incl.death) 0.65 |
0.18 0.0048 0.061 0.012 |
0.14–1.44 0.11–0.67 0.24–1.03 0.47–0.91 | Grossarth 2006a [52, 53] |
| None (38) | ||||||
| Non-randomized controlled trials | ||||||
| Breast | T1–3, N0, M0 | Iscador (84) |
Time to local recurrences: 0.42 lymphatic metastases: 0.22 distant metastases: 0.36 all event (incl.death) 0.66 |
0.21–0.83 0.10–0.47 0.21–0.62 0.55–0.79 | Grossarth 2006b [52, 53] | |
| None (84) | ||||||
| Cervix | IB-IVA | Iscador (102) |
Time to local recurrences: 1.42 lymphatic metastases: None distant metast.:1 in Iscador group all event (incl.death) 0.32 |
0.61 n.a. n.a. <0.0001 |
0.37–5.39 n.a. n.a. 0.22–0.48 | Grossarth 2007f [51] |
| None (102) | ||||||
| Retrolective pharmaco-epidemiological cohort study | ||||||
| Breast | I–III | Conventional therapy, Helixor (167) | Recurrence, metastases, reoperation: no difference | Beuth 2008 [69] | ||
| Conventional therapy (514) | ||||||
| I–III | Conventional therapy, Iscador (710) |
Recurrence: 0.98 Dist. metast. 0.65 |
0.947 0.172 |
0.60–1.62 0.35–1.21 | Bock 2004 [70] | |
| Conventional therapy (732) | ||||||
| I–IV | Conventional therapy, Eurixor (219) | Time to relapse: 0.28 | 0.012 | 0.10–0.76 | Schumacher 2003 [71, 72] | |
| Conventional therapy (470) | ||||||