Raadpleeg ook literatuurlijst niet-toxische middelen en behandelingen specifiek bij alvleesklierkanker van arts-bioloog drs. Engelbert Valstar

En zie in gerelateerde artikelen meer publicaties over maretakinjecties.

22 november 2018: Het volledige studierapport van onderstaand beschreven studie:

Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: A randomised clinical trial on overall survival is inmiddels gratis in te zien. 

Hier de grafiek van de overall overleving van alle 220 patiënten. (zie verder studierapprot of ons artikel uit 2013 hieronder).

Large image of Fig. 5.

Fig. 5

Forest plot (multivariate cox regression including interactions) of the treatment effect on 12-month overall survival of 220 patients with advanced or metastatic pancreatic cancer assigned to a therapy with extract of VaL or to no antineoplastic therapy (Control). Abbreviations: ECOG, Eastern Cooperative Oncology Group (performance scale); VaL, Viscum album [L.]. The squares represent the hazard ratio and their sizes are proportional to the sizes of the subgroups. The horizontal lines show the confidence intervals.

Ik heb de referentielijst behorend bij deze studie onderaan dit artikel ook toegevoegd.

maretak injectie

30 augustus 2013: Bron: 2013 Jul 24. pii: S0959-8049(13)00550-9. doi: 10.1016/j.ejca.2013.06.043. [Epub ahead of print].

Viscum Album L. - Maretakinjecties verdubbelen mediane overleving bij inoperabele uitgezaaide alvleesklierkankerpatiënten in vergelijking met beste zorg. Dit blijkt uit een gerandomiseerde fase III studie bij totaal 220 patiënten waarvoor geen adekwate behandeling meer mogelijk is. De studie maakte een vergelijking tussen beste zorg en beste zorg plus Viscum album L. subcutaan - onderhuids gegeven. Ter informatie: intraveneus gegeven lijkt beter te werken dan onderhuids aldus enkele artsen die ik daarover heb gesproken, maar blijkbaar werkt onderhuids gegeven ook te werken. 

De gegevens uit het abstract zijn echter dermate summier dat ik niet zo heel veel meer aan informatie kan geven. Hier de zo goed als letterlijke vertaling van het abstract. Het volledige studierapport: Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: A randomised clinical trial on overall survival  is tegen betaling in te zien. Onderaan originele engelstalige abstract. Hier de letterlijke vertaling met hulp van google translation van dat abstract:

ACHTERGROND:
De ongunstige neveneffecten van het behandelen van laat-stadiumalvleesklierkanker  vragen om niet-toxische en effectievere therapeutische benaderingen. We vergeleken de totale overleving (OS) van de patiënten die een extract van Viscum album [L.] (Val) kregen of geen antineoplastische therapie (red: geen chemo of andere behandeling).

Methode:
Dit is een prospectieve, parallelle, open-label, monocenter, groeps-sequentiële, gerandomiseerde fase III studie. Patiënten met lokaal gevorderde of uitgezaaide kanker van de pancreas - alvleesklier werden gestratificeerd naar een binaire prognose index, samengesteld uit tumorstadium, leeftijd en performance status, en werden gelijkmatig gerandomiseerd ingedeeld naar subcutane injecties van Viscum album L. (VAL) extracten of geen antineoplastische therapie (controlegroep). VaL werd toegepast in een dosis opgevoerde wijze van 0,01 mg tot 10 mg driemaal per week. Patiënten in beide groepen kregen de beste ondersteunende zorg. Het primaire eindpunt was 12 maanden OS, beoordeeld in een groep-sequentiële analyse.

BEVINDINGEN:
We presenteren de eerste tussentijdse analyse, met inbegrip van gegevens van 220 patiënten. Baseline karakteristieken waren evenwichtig verdeeld tussen de studiegroepen. Mediane overleving - OS was 4.8 maanden voor de Viscum album L. (VAL) groep en 2.7 maanden voor de controlegroep. (prognose gecorrigeerde hazard ratio, HR = 0,49, p <0,0001). Binnen de zogeheten 'goede' prognose subgroep, mediane OS was 6,6 maanden versus 3.2 maanden (HR = 0,43, p <0,0001). Binnen de 'slechte' prognose subgroep was dit 3,4 maanden versus 2.0 maanden respectievelijk (HR = 0,55, p = 0,0031). er werden geen aan Viscum album L. (VAL) gerelateerde bijwerkingen waargenomen.

CONCLUSIE: 
Viscum album L. (VAL) injecties toonden een significante en klinisch relevante verlenging van de mediane overleving -  OS. De onderzoeksresultaten suggereren  dat Viscum album L. (VAL) een niet-toxisch en effectieve tweedelijns therapie kan zijn die een verlenging van de overleving - OS en minder ziekte gerelateerde symptomen kan opleveren voor patiënten met inoperabele, lokaal gevorderde of uitgezaaide alvleesklierkanker.

Het volledige studierapport: Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: A randomised clinical trial on overall survival  is tegen betaling in te zien. 

Hier het originele engelstalige abstract:

Viscum Album L. therapy showed a significant and clinically relevant prolongation of overall survival - OS. The study findings suggest Viscum Album L. - VaL (mistletoe injections) to be a non-toxic and effective second-line therapy that offers a prolongation of overall survival - OS as well as less disease-related symptoms for patients with locally advanced or metastatic pancreatic cancer.

Eur J Cancer. 2013 Jul 24. pii: S0959-8049(13)00550-9. doi: 10.1016/j.ejca.2013.06.043. [Epub ahead of print]

Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: A randomised clinical trial on overall survival.

Source

Clinical Research Dr. Tröger, Freiburg, Germany. Electronic address: troeger@crdt.de.

Abstract

BACKGROUND:

The unfavourable side-effects of late-stage pancreatic cancer treatments call for non-toxic and effective therapeutic approaches. We compared the overall survival (OS) of patients receiving an extract of Viscum album [L.] (VaL) or no antineoplastic therapy.

METHODS:

This is a prospective, parallel, open label, monocentre, group-sequential, randomised phase III study. Patients with locally advanced or metastatic cancer of the pancreas were stratified according to a binary prognosis index, composed of tumour stage, age and performance status; and were evenly randomised to subcutaneous injections of VaL extracts or no antineoplastic therapy (control). VaL was applied in a dose-escalating manner from 0.01mg up to 10mg three times per week. Patients in both groups received best supportive care. The primary end-point was 12-month OS, assessed in a group-sequential analysis.

FINDINGS:

We present the first interim analysis, including data from 220 patients. Baseline characteristics were well balanced between the study arms. Median OS was 4.8 for VaL and 2.7months for control patients (prognosis-adjusted hazard ratio, HR=0.49; p<0.0001). Within the 'good' prognosis subgroup, median OS was 6.6 versus 3.2months (HR=0.43; p<0.0001), within the 'poor' prognosis subgroup, it was 3.4 versus 2.0months respectively (HR=0.55; p=0.0031). No VaL-related adverse events were observed.

CONCLUSION:

VaL therapy showed a significant and clinically relevant prolongation of OS. The study findings suggest VaL to be a non-toxic and effective second-line therapy that offers a prolongation of OS as well as less disease-related symptoms for patients with locally advanced or metastatic pancreatic cancer.

Copyright © 2013 The Authors. Published by Elsevier Ltd.. All rights reserved.

Referentielijst maretakstudie

References

  1. 1Bayraktar, S., Bayraktar, U.D., and Rocha-Lima, C.M. Recent developments in palliative chemotherapy for locally advanced and metastatic pancreas cancer. World J Gastroenterol. 2010; 16: 673–682
  2. 2Cascinu, S., Falconi, M., Valentini, V., and Jelic, S. Pancreatic cancer: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010; 21: v55–v58
  3. 3Conroy, T., Desseigne, F., Ychou, M. et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011; 364: 1817–1825
  4. 4Richter, J. and Saif, M.W. Locally advanced pancreatic adenocarcinoma: where are we and where are we going? Highlights from the “2010 ASCO Gastrointestinal Cancers Symposium”. Orlando, FL, USA. January 22–24, 2010. JOP. 2010 Mar 5; 11: 139–143
  5. 5Jacobs, A.D., Burris, H.A. III, Rivkin, S. et al. A randomized phase III study of rubitecan (ORA) vs. best choice (BC) in 409 patients with refractory pancreatic cancer report from a North-American multi-center study. J Clin Oncol. 2004; 22: 4013
  6. 6Pelzer, U., Schwaner, I., Stieler, J. et al. Best supportive care (BSC) versus oxaliplatin, folinic acid and 5-fluorouracil (OFF) plus BSC in patients for second-line advanced pancreatic cancer: a phase III-study from the German CONKO-study group. Eur J Cancer. 2011; 47: 1676–1681
  7. 7Boeck, S., Bruns, C.J., Sargent, M. et al. Current oncological treatment of patients with pancreatic cancer in germany: results from a national survey on behalf of the Arbeitsgemeinschaft Internistische Onkologie and the Chirurgische Arbeitsgemeinschaft Onkologie of the Germany Cancer Society. Oncology. 2009; 77: 40–48
  8. 8Cragg, G.M. and Newman, D.J. Plants as a source of anti-cancer agents. J Ethnopharmacol. 2005; 100: 72–79
  9. 9Kienle, G.S. and Kiene, H. Review article: influence of Viscum album L (European mistletoe) extracts on quality of life in cancer patients: a systematic review of controlled clinical studies. Integr Cancer Ther. 2010; 9: 142–157
  10. 10Büssing, A. Mistletoe. The genus Viscum. (p. 1–265)Hardwood Academic Publishers, Amsterdam; 2000
  11. 11Büssing, A., Wagner, M., Wagner, B. et al. Induction of mitochondrial Apo2.7 molecules and generation of reactive oxygen-intermediates in cultured lymphocytes by the toxic proteins from Viscum album L. Cancer Lett. 1999; 139: 79–88
  12. 12Kienle, G.S. and Kiene, H. Die Mistel in der onkologie – fakten und konzeptionelle grundlagen. (p. 1–749)Schattauer Verlag, Stuttgart; 2003
  13. 13Thies, A., Dautel, P., Meyer, A., Pfuller, U., and Schumacher, U. Low-dose mistletoe lectin-I reduces melanoma growth and spread in a scid mouse xenograft model. Br J Cancer. 2008; 98: 106–112
  14. 14Rostock, M., Huber, R., Greiner, T. et al. Anticancer activity of a lectin-rich mistletoe extract injected intratumorally into human pancreatic cancer xenografts. Anticancer Res. 2005; 25: 1969–1975
  15. 15Matthes, H., Buchwald, D., Schad, F., and Jeschke, E. Intratumorale applikation von Viscum album L. (Mistelgesamtextrakt; Helixor M) in der therapie des inoperablen pankreaskarzinom. (http://dx.doi.org/10.1055/s-2007-988162)Z Gastroenterol. 2007; 45
  16. 16Mansky, P.J., Blackman, M.R., Grem, J., Swain, S.M., and Monahan, B.P. NCCM/NCI phase I study of mistletoe extract and gemcitabine in patients with advanced solid tumors. J Clin Oncol. 2010; 28: 2559
  17. 17Kienle, G.S., Grugel, R., and Kiene, H. Safety of higher dosages of Viscum album L. in animals and humans – systematic review of immune changes and safety parameters. BMC Complement Altern Med. 2011; 11: 72
  18. 18Rostock, M. and Huber, R. Randomized and double-blind studies – demands and reality as demonstrated by two examples of mistletoe research. Forsch Komplementärmed Klass Naturheilkd. 2004; 11: 18–22
  19. 19Guidance for Industry. Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071590.pdf 2007 May.
  20. 20Matthes, H., Friedel, W.E., Bock, P.R., and Zanker, K.S. Molecular mistletoe therapy: friend or foe in established anti-tumor protocols? A multicenter, controlled, retrospective pharmaco-epidemiological study in pancreas cancer. Curr Mol Med. 2010; 10: 430–439
  21. 21Schaefermeyer, G. and Schaefermeyer, H. Treatment of pancreatic cancer with Viscum album (Iscador): a retrospective study of 292 patients 1986–1996. Complement Ther Med. 1998; 6: 172–177
  22. 22Freedman, L.S. Tables of the number of patients required in clinical trials using the logrank test. Stat Med. 1982; 1: 121–129
  23. 23Lan, K.K. and DeMets, D.L. Discrete sequential boundaries for clinical trials. Biometrika. 1983; 70: 659–663
  24. 24Emerson, S.S. and Fleming, T.R. Parameter estimation following group sequential hypothesis testing. Biometrika. 1990; 77: 875–892
  25. 25Hrobjartsson, A. and Gotzsche, P.C. Placebo interventions for all clinical conditions. Cochrane Database Syst Rev. 2010; 20: CD003974
  26. 26Grossarth-Maticek, R. and Ziegler, R. Randomised and non-randomised prospective controlled cohort studies in matched-pair design for the long-term therapy of breast cancer patients with a mistletoe preparation (Iscador): a re-analysis. Eur J Med Res. 2006; 11: 485–495
  27. 27Kienle, G.S., Berrino, F., Büssing, A. et al. Mistletoe in cancer – a systematic review on controlled clinical trials. Eur J Med Res. 2003; 8: 109–119
  28. 28Kienle, G.S. and Kiene, H. Systematic reviews on mistletoe in cancer – what implications for future research can be drawn?. Phytomedicine (Jena). 2007; 14: 11
  29. 29Kleeberg, U.R., Suciu, S., Bröcker, E.B. et al. Final results of the EORTC 18871/DKG 80–1 randomised phase III trial: rIFN-a2b versus rIFN-g versus Iscador M versus observation after surgery in melanoma patients with either high-risk primary (thickness >3 mm) or regional lymph node metastasis. Eur J Cancer. 2004; 40: 390–402
  30. 30Steuer-Vogt, M.K., Bonkowsky, V., Ambrosch, P. et al. The effect of an adjuvant mistletoe treatment programme in resected head and neck cancer patients: a randomised controlled clinical trial. Eur J Cancer. 2001; 37: 23–31
  31. 31Fung, M.C., Takayama, S., Ishiguro, H. et al. Chemotherapy for advanced or metastatic pancreatic cancer: analysis of 43 randomized trials in 3 decades (1974–2002). Gan To Kagaku Ryoho. 2003; 30: 1101–1111
  32. 32Andersen, J.R., Friis-Moller, A., Hancke, S. et al. A controlled trial of combination chemotherapy with 5-FU and BCNU in pancreatic cancer. Scand J Gastroenterol. 1981; 16: 973–975
  33. 33Andren-Sandberg, A., Holmberg, J.T., and Ihse, I. Treatment of unresectable pancreatic carcinoma with 5-fluorouracil, vincristine, and CCNU. Scand J Gastroenterol. 1983; 18: 609–612
  34. 34Ciuleanu, T.E., Pavlovsky, A.V., Bodoky, G. et al. A randomised phase III trial of glufosfamide compared with best supportive care in metastatic pancreatic adenocarcinoma previously treated with gemcitabine. Eur J Cancer. 2009; 45: 1589–1596
  35. 35Gilliam, A.D., Broome, P., Topuzov, E.G. et al. An international multicenter randomized controlled trial of G17DT in patients with pancreatic cancer. Pancreas. 2012; 41: 374–379
  36. 36Glimelius, B., Hoffman, K., Sjoden, P.O. et al. Chemotherapy improves survival and quality of life in advanced pancreatic and biliary cancer. Ann Oncol. 1996; 7: 593–600
  37. 37Huguier, M., Barrier, A., Valinas, R. et al. Randomized trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer. Hepatogastroenterology. 2001; 48: 875–878
  38. 38Koeppler, H., Duru, M., Grundheber, M. et al. Palliative treatment of advanced pancreatic carcinoma in community-based oncology group practices. J Support Oncol. 2004; 2: 159–163
  39. 39Mallinson, C.N., Rake, M.O., Cocking, J.B. et al. Chemotherapy in pancreatic cancer: results of a controlled, prospective, randomised, multicentre trial. Br Med J. 1980; 281: 1589–1591
  40. 40Matsumoto, K., Miyake, Y., Kato, H. et al. Effect of low-dose gemcitabine on unresectable pancreatic cancer in elderly patients. Digestion. 2011; 84: 230–235
  41. 41Negi, S.S., Agarwal, A., and Chaudhary, A. Flutamide in unresectable pancreatic adenocarcinoma: a randomized, double-blind, placebo-controlled trial. Invest New Drugs. 2006; 24: 189–194
  42. 42Palmer, K.R., Kerr, M., Knowles, G. et al. Chemotherapy prolongs survival in inoperable pancreatic carcinoma. Br J Surg. 1994; 81: 882–885
  43. 43Rosenberg, L., Barkun, A.N., Denis, M.H., and Pollak, M. Low dose octreotide and tamoxifen in the treatment of adenocarcinoma of the pancreas. Cancer. 1995; 75: 23–28
  44. 44Shimoda, M., Katoh, M., Kita, J., Sawada, T., and Kubota, K. The Glasgow Prognostic Score is a good predictor of treatment outcome in patients with unresectable pancreatic cancer. Chemotherapy. 2010; 56: 501–506
  45. 45Shinchi, H., Takao, S., Noma, H. et al. Length and quality of survival after external-beam radiotherapy with concurrent continuous 5-fluorouracil infusion for locally unresectable pancreatic cancer. Int J Radiat Oncol Biol Phys. 2002; 53: 146–150
  46. 46Takada, T., Nimura, Y., Katoh, H. et al. Prospective randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C for non-resectable pancreatic and biliary carcinoma: multicenter randomized trial. Hepatogastroenterology. 1998; 45: 2020–2026
  47. 47Taylor, O.M., Benson, E.A., and McMahon, M.J. Clinical trial of tamoxifen in patients with irresectable pancreatic adenocarcinoma. The Yorkshire Gastrointestinal Tumour Group. Br J Surg. 1993; 80: 384–386
  48. 48Tsavaris, N., Tentas, K., Tzivras, M. et al. Combined epirubicin, 5-fluorouracil and folinic acid vs no treatment for patients with advanced pancreatic cancer: a prospective comparative study. J Chemother. 1998; 10: 331–337
  49. 49Wang, P., Meng, Z.Q., Chen, Z. et al. Survival rate of pancreatic cancer in elderly patients. Hepatogastroenterology. 2008; 55: 681–686
  50. 50Weinerman, B.H. and MacCormick, R.E. A phase II survival comparison of patients with adenocarcinoma of the pancreas treated with 5-fluorouracil and calcium leucovorin versus a matched tumor registry control population. Am J Clin Oncol. 1994; 17: 467–469

Plaats een reactie ...

1 Reactie op "Maretakinjecties - Viscum album L. verdubbelt mediane overleving bij uitgezaaide, inoperabele alvleesklierkanker met betere kwaliteit van leven copy 1"

  • Simone :
    Beste Kees,
    Zou je, als specialist op de behandeling van kanker en kankeronderzoek, in begrijpbaar Nederlands kunnen uitleggen wat de volgende tekst uit je artikel betekent:
    Dit is een prospectieve, parallelle, open-label, monocenter, groeps-sequentiële, gerandomiseerde fase III studie. Patiënten met lokaal gevorderde of uitgezaaide kanker van de pancreas - alvleesklier werden gestratificeerd naar een binaire prognose index, samengesteld uit tumorstadium, leeftijd en performance status, en werden gelijkmatig gerandomiseerd ingedeeld naar subcutane injecties van Viscum album L. (VAL) extracten of geen antineoplastische therapie (controlegroep).
    Ik ben namelijk sinds kort erg geïnteresseerd in dit onderwerp en wil er alles van weten!

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