Prognosticators vs limits

[AlaskaAngel]

I'd like to get a better understanding of the logic (if there is any) for barring those with early stage bc who are outside of the time limits set for being eligible to benefit from Herceptin. The scientific assessment of risk at the time of the clinical trial set 1 cm or larger plus factors such as high-grade and HER2 positive as being dangerous enough to need the strongest chemotherapy (Adriamycin) plus radiation, plus if HR+, hormonal treatment as well. At the same time, the scientific assessment of risk in terms of being eligible for the clinical trial as being 2 cm. Can anyone explain the scientific basis for this difference?

[Becky]

I do think it was because for the trial, they wanted patients who would more likely recur so they could measure a difference and 2cm (regardless of node status) is Stage 2 and not Stage 1 (where likelyhood of recurrence on its own) is more reduced. Especially since both the Hera and USA trials used chemotherapy as a mandatory requirement (thereby not testing the Herceptin alone).


Best regards,

Becky

[AlaskaAngel]

Thanks for trying to explain this. Part of it still doesn't make sense to me. I can understand that they wanted to only give Herceptin to those with higher recurrence rates so that the outcome would sell better and more people who were at the most risk would be helped. But 1 cm is still the threshold for chemotherapy under the newest criteria, so on what basis are they now adding Herceptin to chemotherapy for those newly diagnosed who are between 1 and 2 cm? What did the trial prove that showed a difference in outcome for those between 1 and 2 cm compared to just chemotherapy? Since it is more cardiotoxic to have Adriamycin and Herceptin than just Herceptin, are they doing any better than with just chemotherapy? How are they justifying it if they couldn't justify it for the 1 to 2 cm group previously? And if they are getting chemo and Herceptin, how do they know whether those patients would do just as good or better with just Herceptin?

Confused,

A.A.

[Unregistered]

AA, I agree that if the risk for a 1cm invasive her2 bc is big enough for chemotherapy consideration, then certainly Herceptin should be considered as well to improve DFS. Further, I too find it discouraging that 1cm tumors, node positive tumors less than 1cm and perhaps even tumors less than 1 cm with bad prognostic predictors such as high tumor grade with negative hormonal status have not been included in any of the many adjuvant Herceptin trials. It appears this small group has been neglected for study, yet they are at risk for relapse. And as you know, Herceptin may be one of the few medications that could prevent these individuals from relapsing.

Obviously, Herceptin trials are warranted for the small, node negative invasive bcs. Hopefully, there will be such trials that include an arm for Herceptin only, Herceptin plus chemotherapy and chemtherapy alone. However, I haven't heard of such trials in development. But I can say that I have written the NCI about such trials and will post their response on this board.

[Unregistered]

above post by RobinP

[AlaskaAngel]

Yes, exactly.

I am still concerned about the problem not just in regard to Herceptin coverage, but in terms of authorization for insurance purposes.

If there is no basis established by clinical trial for those newly diagnosed who are between 1 and 2 cm or even smaller, then why are they authorized by ASCO to get Herceptin whereas those "too far out from treatment" are not?

Especially considering that there is such concern expressed about potential cardiac damage?