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Table 6 Single-Arm Cohort Studies (e.g. Phase II Trials) on VAE Treatment in Breast and Gynaecological Cancer

From: Viscum album L. extracts in breast and gynaecological cancers: a systematic review of clinical and preclinical research

Author, Year TreatmentI SiteII OutcomeIII NIV Quality Criteria FulfilledVI
  Preparation Injection site Dosage Escalating dosage Duration   CR PR NC PD QoL   L M N O P Q
Breast, Ovary, CIN
Mansky 2008 [44, 73] Helixor
(& gemcitabine)
sc Up to 250 mg, daily Yes 9 w Breast, others 0% 10% 47% 43%   27 (+) + + -V (+) (+)
Schink 2006 [45] Helixor
(& surgery)
sc 3/week, varying individually Yes Up to 2 years Breast, colon - - - - IIIa 40 + + (+) (+)V (+) -
Schöffski 2004 [32] Aviscumine iv 10 – 6400 ng/kg, 2/w Yes 3–24 w, median 6 w Ovary, breast, others 0% 0% 30% 70%   37 + (+) + + + +
Mahfouz 1999 [74] Viscum fraxini sc or it 1 × 45 mg/w No 16–136 w Breast 8% 54% 35% 4% 26 (+) (+) + (+) + +
Mahfouz 1998 [75] Abnobaviscum Fr sc 1 × 45 mg/w No 17 w Breast 0% 44% 33% 22% 9 - (-) (+) - - (+)
Finelli 1998 [76] Lektinol sc 2,5 μl/kg, 2/w No Up to 12 w Breast, others - - - - 884 + + + - + +
Portalupi 1995 [77] Iscador M sc 2 × 1 ng MLI/kg bw × w No 16 w CIN I–III 41% 27% 27% 5%   22 + + + + + (+)
Malignant effusion
Bar-Sela 2006 [46] Iscador M ip 10 mg No repeatedly Ascites (ovary, others) Increase of interval between two successive paracenteses from 7 to 12 days, p = 0.001IIIb     IIIc 23 (+) (+) + (+) + +
Werner 1999 [78] Abnobaviscum Fr ipl 1 × 75 mg/w No 3–8 w Pleural effusion (breast, others) 88%     32 + + + - (+) (+)
Stumpf 1994 [79] Helixor A, M or P ipl 100–1000 mg Yes repeatedly Pleural effusion (breast, others) 61% 11% 22%    18 + + + (+) + +
Friedrichson 1995 [80] Helixor A, M ip 100–1000 mg, 2/w Yes repeatedly Ascites (ovary, others) 70%     12 (+) (-) + - (-) +
  1. I sc: subcutaneous, it: intratumoural, ipl: intrapleural, ip: intraperitoneal; iv: intravenous infusion; bw; body weight; w: week
  2. II CIN: cervical intraepithelial neoplasia. Stage: advanced, except in Portalupi 1995, and partly Schink 2006 and Finelly 1998; plural effusion and ascites indicates treatment site
  3. III CR: complete, PR: partial remission, NC: no change, PD: progredient disease, QoL: quality of life, : improved, impaired
  4. IIIa Especially physical functioning, role, fatigue, appetite
  5. IIIb Median values, comparable abdominal circumference and symptom score or drained fluid before or during each paracentesis respectively
  6. IIIcTrend improvement in symptom score, especially abdominal pain, abdominal pressure, and waking up at night due to shortness of breath
  7. IV N: Number of participants
  8. V Concomitant conventional oncological cytoreductive therapies in some of the patients
  9. VI L Well-described patient characteristic and disease (diagnosis, stage, duration), prognostic factors
  10. M Outcome parameter relevant and well described
  11. N Well-described intervention
  12. O Concomitant therapies well described
  13. P Outcome clearly described, temporal relationship between applied therapy and observed outcome precisely described
  14. Q Selection of patients excluded
  15. + = adequately fulfilled, (+) = partly fulfilled, (-) = little fulfilled, - = not fulfilled