11 december 2015: lees ook dit artikel: 

https://kanker-actueel.nl/NL/chemo-voor-borstkanker-met-type-luminal-a-hormoongevoelig-met-er-en-pr-pos-en-her2-neg-is-zinloos-en-geeft-geen-enkel-verschil-in-10-jaars-overleving-in-vergelijking-met-geen-chemo-biij-vrouwen-in-leeftijd-voor-de-overgang.html 

en dit artikel: 

https://kanker-actueel.nl/NL/resaic-een-vorm-van-arteriele-chemo-embolisatie-bij-borstkanker-geeft-uitstekende-resultaten-zonder-bijwerkingen-fase-i-studie-met-22-patienten-bevestigt-goede-resultaten.html

30 januari 2011. Bron: J Clin Oncol. 2010;29:251-253, 264-271

Vinorelbine naast Herceptin (Trastuzumab) bij borstkankerpatienten met Her2-Neu positieve expressie, lijkt de beste chemo om te gebruiken wegens de lagere en minder ernstige bijwerkingen t.o.v. Taxotere (Docetaxel). Het effect op levensduur, recidiefkansen en ziektevrije tijd blijkt nagenoeg hetzelfde. Dit zijn de bevindigen van de HERNATA trial, een gerandomiseerde fase III studie, uitgevoerd in Noorwegen, Zweden en Denemarken.

Hier de resultaten uit de studie zoals gemeld door Medscape.

Phase III Randomized Study Comparing Docetaxel Plus Trastuzumab With Vinorelbine Plus Trastuzumab As First-Line Therapy of Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The HERNATA Study.

Study Findings

The study, which was supported by Roche and Sanofi-Aventis, enrolled patients with HER2-positive metastatic or locally advanced breast cancer who had not received previous chemotherapy or HER2-targeted therapy for the treatment of their advanced disease.

A total of 284 patients were randomized to treatment with either docetaxel 100 mg/m2 once every 3 weeks (n =1 43) or vinorelbine (30 mg/m2 or 35 mg/m2, according to institutional predefined preference) on days 1 and 8 of a 21-day cycle (n = 141). Trastuzumab was administered to all patients once every 3 weeks.

Treatment was continued until progression, intolerable toxicity, or patient withdrawal.

The primary study end point was time to progression, which was not statistically significantly different: the median for docetaxel was 12.4 months and for vinorelbine was 15.3 months (hazard ratio , 0.94; 95% confidence interval , 0.71 to 1.25; = .67).

This efficacy outcome favoring vinorelbine was surprising, explain the study authors.

"At the time of conception of the study, it was believed that the vinorelbine plus trastuzumab combination was inferior to docetaxel plus trastuzumab in terms of efficacy," they write.

There was no difference in most of the secondary end points, including overall survival. Median overall survival was 35.7 months for docetaxel and 38.8 months for vinorelbine (HR, 1.01; 95% CI, 0.71 to 1.42; = .98).

The one exception to this — time to treatment failure — cast docetaxel in a negative light. Median time to treatment was significantly shorter for docetaxel than for vinorelbine (5.6 vs 7.7 months; HR, 0.50; 95% CI, 0.38 to 0.64; < .0001).

Toxicity is where the 2 agents were most different, say both the authors and the editorialists. More patients in the docetaxel group than in the vinorelbine group discontinued therapy because of toxicity (20.1% vs 6.5%; < .001).

With docetaxel, compared with vinorelbine, there were also significantly more treatment-related grade 3 to 4 febrile neutropenia (36.0% vs 10.1%), leucopenia (40.3% vs 21.0%), infection (25.1% vs 13.0%), fever (4.3% vs 0.0%), neuropathy (30.9% vs 3.6%), nail changes (7.9% vs 0.7%), and edema (6.5% vs 0.0%).

Dr. Andersson reports receiving honoraria from Roche and Sanofi-Aventis, the 2 companies that sponsored the study. Some of the study coauthors reported financial ties to these companies and others. Dr. Lin reports receiving research funding from Genentech, GlaxoSmithKline, Boehringer Ingelheim, and Infinity Pharmaceuticals. Dr. Winer reports receiving research funding from Genentech.

J Clin Oncol. 2010;29:251-253, 264-271. Abstract, Abstract

J Clin Oncol. 2011 Jan 20;29(3):264-71. Epub 2010 Dec 13.

Phase III Randomized Study Comparing Docetaxel Plus Trastuzumab With Vinorelbine Plus Trastuzumab As First-Line Therapy of Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The HERNATA Study.

Andersson M, Lidbrink E, Bjerre K, Wist E, Enevoldsen K, Jensen AB, Karlsson P, Tange UB, Sørensen PG, Møller S, Bergh J, Langkjer ST.

Department of Oncology 5073, Rigshospitalet, 9 Blegdamsvej, 2100 Copenhagen, Denmark; michael.andersson@rh.regionh.dk.

Abstract

PURPOSE To evaluate docetaxel or vinorelbine, both with trastuzumab, as first-line therapy of human epidermal growth factor receptor 2-positive advanced breast cancer.

PATIENTS AND METHODS Patients naive to chemotherapy for advanced disease were randomly assigned to docetaxel 100 mg/m(2) day 1 or vinorelbine 30 to 35 mg/m(2) on days 1 and 8, both combined with trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance dose) on day 1 every 3 weeks. The primary end point was time to progression (TTP).

Results A total of 143 patients were randomly allocated to docetaxel, and 141 patients were assigned to vinorelbine. The median TTP for docetaxel and vinorelbine respectively was 12.4 months versus 15.3 months (hazard ratio = 0.94; 95% CI, 0.71 to 1.25; P = .67), median overall survival was 35.7 months versus 38.8 months (HR = 1.01; 95% CI, 0.71 to 1.42; P = .98), and the 1-year survival rate was 88% in both arms. Median time to treatment failure for study chemotherapy was 5.6 months versus 7.7 months (HR = 0.50; 95% CI, 0.38 to 0.64; P < .0001). The investigator-assessed overall response rate among 241 patients with measurable disease were 59.3% in both arms. More patients in the docetaxel arm discontinued therapy due to toxicity (P < .001). Significantly more treatment-related grade 3 to 4 febrile neutropenia (36.0% v 10.1%), leucopenia (40.3% v 21.0%), infection 25.1% v 13.0%), fever (4.3% v 0%), neuropathy (30.9% v 3.6%), nail changes (7.9% v 0.7%), and edema (6.5% v 0%) were reported with docetaxel.

CONCLUSION The study failed to demonstrate superiority of any drug in terms of efficacy, but the vinorelbine combination had significantly fewer adverse effects and should be considered as an alternative first-line option.

PMID: 21149659 [PubMed - in process]


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