five year follow-up results of FinHer(Finnish trial with only 9 weeks of herceptin)

[Lani]

J Clin Oncol. 2009 Nov 2. [Epub ahead of print]
Fluorouracil, Epirubicin, and Cyclophosphamide With Either Docetaxel or Vinorelbine, With or Without Trastuzumab, As Adjuvant Treatments of Breast Cancer: Final Results of the FinHer Trial.
Joensuu H, Bono P, Kataja V, Alanko T, Kokko R, Asola R, Utriainen T, Turpeenniemi-Hujanen T, Jyrkkiö S, Möykkynen K, Helle L, Ingalsuo S, Pajunen M, Huusko M, Salminen T, Auvinen P, Leinonen H, Leinonen M, Isola J, Kellokumpu-Lehtinen PL.

Departments of Oncology and Cardiology, Helsinki University Central Hospital, Helsinki; Laboratory of Cancer Biology, Institute of Medical Technology, University of Tampere; Tampere University Hospital, Tampere; Kuopio University Hospital, Kuopio; Kanta-Häme Central Hospital, Hämeenlinna; Satakunta Central Hospital, Pori; Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu; Department of Oncology, Turku University Central Hospital; 4Pharma Ltd, Turku; South Karelia Central Hospital, Lappeenranta; Kymenlaakso Central Hospital, Kotka; Vaasa Central Hospital, Vaasa; Jyväskylä Central Hospital, Jyväskylä; and Kajaani Central Hospital, Kajaani, Finland.
PURPOSE: Docetaxel has not been compared with vinorelbine as adjuvant treatment of early breast cancer. Efficacy and long-term safety of a short course of adjuvant trastuzumab administered concomitantly with chemotherapy for human epidermal growth factor receptor 2 (HER2) -positive cancer are unknown. PATIENTS AND METHODS: One thousand ten women with axillary node-positive or high-risk node-negative breast cancer were randomly assigned to receive three cycles of docetaxel or vinorelbine, followed in both groups by three cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC). Women with HER2-positive cancer (n = 232) were further assigned to either receive or not receive trastuzumab for 9 weeks with docetaxel or vinorelbine. The median follow-up time was 62 months after random assignment. RESULTS: Women assigned to docetaxel had better distant disease-free survival (DDFS) than those assigned to vinorelbine (hazard ratio [HR] = 0.66; 95% CI, 0.49 to 0.91; P = .010). In the subgroup of HER2-positive disease, patients treated with trastuzumab tended to have better DDFS than those treated with chemotherapy only (HR = 0.65; 95% CI, 0.38 to 1.12; P = .12; with adjustment for presence of axillary nodal metastases, HR = 0.57; P = .047). In exploratory analyses, docetaxel, trastuzumab, and FEC improved DDFS compared with docetaxel plus FEC (HR = 0.32; P = .029) and vinorelbine, trastuzumab, and FEC (HR = 0.31; P = .020). The median left ventricular ejection fraction of trastuzumab-treated patients remained unaltered during the 5-year follow-up; only one woman treated with trastuzumab was diagnosed with a heart failure. CONCLUSION: Adjuvant treatment with docetaxel improves DDFS compared with vinorelbine. A brief course of trastuzumab administered concomitantly with docetaxel is safe and effective and warrants further evaluation.

PMID: 19884557

[Jyber]

Thanks so much, Lani! I had to cut my herceptin short because I did sustain significant drops in my ejection fraction, so I am particularly interested in studies of shorter-term herceptin treatment.

Does anyone feel up to translating the above into laywoman terms?

[Lani]

This study is very hard to compare with the treatments given in the US in the herceptin adjuvant trials (and even with the HERA trials where dozens of different chemo combinations --or even more--were given before herceptin was given)), as it uses an unusual combination of chemos given before, not during , and then after the herceptin...but the bottomline is they got a similar decrease in recurrence(35-43% better disease free survival depending on whether or not they had lymph node metastasis)by receiving herceptin as well as chemo as the other trials with only 9 weeks of herceptin instead of a year, without the cardiac complications (except in one case) and that er+s and er-s got equal benefit.

There!

[Jyber]

Thanks again, Lani! What a resource you are!

[Becky]

I read it much the same except they got similar results if combined with Taxotere/FEC but not when combined with Navelbine/FEC although adding Herceptin to either chemo was better than not adding it.

The taxane/Herceptin synergy keeps popping up but then the earlier Taxol trials (well before Herceptin) showed that it alone reduces recurrence rates for those with Her2+ disease regardless of hormone status.

I think in the end, we will see that those of us who took one year or more of Herceptin in the adjuvant setting "took too much" and in the future they may find that 3 or 6 months is just as efficient and sufficient.

Keep it coming Lani. I am waiting for the final Hera Trial Results to be published (that compares one yr of Herceptin versus 2 yrs of Herceptin).