Phase II trial results--herceptin + oral & IV vinorelbine for her2+Stage IV 1st line

[Lani]

ABSTRACT: A prospective multicenter phase II study of oral and i.v. vinorelbine plus trastuzumab as first-line therapy in HER2-overexpressing metastatic breast cancer
[Annals of Oncology]

Background: To evaluate the efficacy and safety of oral and i.v. vinorelbine plus trastuzumab as first-line regimen in a patient-convenient application for human epidermal growth factor receptor 2 (HER2)-overexpressing patients with metastatic breast cancer.

Patients and methods: Forty-two women were enrolled in a multicenter study. The patients received i.v. vinorelbine at a dose of 25 mg/m2 on day 1 followed by oral vinorelbine at a dose of 60 mg/m2 on days 8 and 15 in a 3-week cycle. Standard dose trastuzumab was given at 3-week intervals.

Results: Complete response was observed in 7 patients (18.9%) and partial response in 19 patients (51.4%), for an overall response rate of 70.3% [95% confidence interval (CI) 53.0-84.1]. The disease control rate reached 91.9% (95% CI 78.1-98.3). The median time to progression was 9.3 months, while median overall survival reached 35.6 months. Hematological and non-hematological toxic effects were acceptable with grade 3-4 leukopenia of 14% and neutropenia of 38%; cardiac toxicity did not reach the level of clinical relevance.

Conclusion: The combination of i.v. and oral vinorelbine plus trastuzumab demonstrates high activity and good tolerability in first-line treatment of HER2-overexpressing metastatic breast cancer. In addition, it offers convenience for the patients with only one i.v. treatment every 3 weeks.

while median overall survival reached 35.6 months

Please, could somebody say something about that data? It's understood that it is a median. But it means that 50% lived less then 3 years. But it was just a 1st line. Here of this site all people demonstrate better results and doing fine?

[Lani]

No I think you missed the point that these were Stage IV patients ie, those with distant metastases. Yes there are some on this board who have survived many years after becoming Stage IV--certainly not all

And for every person who participates in these discussions on her2suport there are scores who do not and are not as up-to-date on the latest being offered, what constitutes the "standard of care"(in countries who are trying to save healthcare dollars) as well as options to discuss with their oncologists.

I lurked a lot and have read, compared the stats, learned the signatures, remembered and noticed, that since 2003 all fighters were alive not less than 5.5 years, except 5 angels.

[pibikay]

Thank you Lani
It is interesting and I hope it will be available in India soon

PBK,
Vinorelbine=Navelbine is not a new drug.

[Lani]

Unregistered? You must have spent a lot of time gathering that information and I would be interested for you to tabulate it and post it. I used to be able to easily find how many participants there were on this site, but no longer find it with ease. I also have trouble finding the personal histories portion of those who have registered ie, what stage they were, how treated etc I would to find in the past with more ease. However...

There are more than 2 million breast cancer survivors in the US alone out of a US population of 307 million, approximately half of them women (of course many of those are not in the years one normally gets bc ie, 0-20 year olds or commonly gets bc 20-40 year olds--and BRCA triple negative bc tends to be more common in the younger age groups than the ooder.

Since 20-25% of breast cancer is her2+, one could roughly estimate that 400,000 to 500,000 of those 2 million bc survivors are her2+ and a small minority of those are Stage IV. Even then, the number of registered members who post on this website probably make up 1-2 per cent of that ie, only one or two out of every one hundred her2+ breast cancer patients or their friends/families/caregivers posts here and many just lurk. And that is not the half or one-hundredth of it even.

There are 6.8 billion people worldwide--not all are female, nor all in the age groups that get bc, but let's suppose 2.7 billion are. Since the site is international, that would mean that only one or two out of every thousand or so bc patients posts on this site. How does one know when someone stops posting if they just got on with their life/ had other family members whose troubles took over much of their time vs. died of breast cancer vs died of other causes? or many other reasons

A much less time-consuming and more accurate/representative way to have a feel for what the statistics are for her2+ breast cancer, whether Stage I-III or Stage IV, is to look to the scientific literature. California itself has a fully funded agency to gather cancer statistics and it is far from being alone.

I had to Google to get the figures for the US population and World population. There are wonderful resources on the web and on this site for more accurate statistics. Her2 testing is not being performed worldwide, so we may never know how many her2+ breast cancer survivors there really are worldwide, but it can be inferred.

In the best of all possible worlds, all would be tested (and treated) and all have internet access, literacy, the ability to type in foreign languages and a feeling of responsibility to share their experiences with others to be added into the statistics (which would also enable them to be helped by the comradery, information and hope this site provides)