Confused about being taken off Herceptin

[ChristineF]

Help

This is my first post, but I have read some great information previously on the message boards. I didn't have a question till now and I thought this is the best place to ask this.

My onc has taken me off Herceptin because a lump has appeared in my lymph node on my neck. I've been on it since Jan'05 when I was diagnosed. I'm only 36 so being taken off it has really upset me because I was hoping to be on it for many, many years since it such a wonderful treatment. She said since it doesn't seem to be working there is no sense of being on it. Yet I've read on the message boards that one woman was being put back on it after a treatment of Abraxane and other round of a chemo combo. Another woman was still on it during a new round of chemo after mets had appeared. I don't understand why I'm being taken off of it and she said she'll never put me back on. I'm very confused. Is the protocol different in Canada? I hope someone can help me with my problem.

Christine

[Joe]

This post has been copied from the Newcomers Board at the writers request.

(also because I wanted to put it on the top of the list)

Regards
Joe

[Cathya]

Christine;

I don't believe the protocol is very different in Canada (I live in Ontario) but herceptin and its use is still very new and different onc's have different opinions. However, this is YOUR life we are talking about here and there is recent research which recommends the continuation of herceptin along with adjuvent theraphy following progression during its use. I believe it was likely posted by Lani. I'll look around and post it later when I find it. You are now in a situation where you must very carefully consider your treatments. If your current onc will not consider treatments you consider important I would switch doctors. I would also consider asking for Zometa as a prophylactic to prevent bone mets. I would also register for a clinical trial of Tykerb (lapitinib). With a tumor on your neck I would want to protect against brain mets and lapitinib is small enough to cross the blood/brain barrier. It is taken in pill form so even if you have to travel to the US once a month...it might well be worth your while. Be strong, stand up for yourself with the medical establishment and we are all here to help in any way as you fight this beast. Cathy

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[Cathya]

Christine;



Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp. 2866-2868
© 2005 American Society of Clinical Oncology (http://www.jco.org/misc/terms.shtml)
DOI: 10.1200/JCO.2005.05.177
(http://www.jco.org/cgi/content/full/23/12/2866#relation_type_10)
CORRESPONDENCE

Continuation of Trastuzumab Beyond Disease Progression

Filippo Montemurro, Roberto Faggiuolo, Stefania Redana



Istituto per la Ricerca e la Cura del Cancro, Candiolo, Torino, Italy

Michela Donadio

Ospedale S. Giovanni Battista, Torino, Italy

Monica Minischetti

Ospedale Cottolengo, Torino, Italy

Antonio Durando

Ospedale S. Anna, Clinica Universitaria, Torino, Italy

Guido Vietti-Ramus

Ospedale Giovanni Bosco, Torino, Italy

Roberta Buosi

Ospedale Maggiore della CaritÃ*, Novara, Italy

Massimo Aglietta

Istituto per la Ricerca e la Cura del Cancro, Candiolo, Torino, Italy

To the Editor:

A few retrospective analyses show that, in patients with HER-2 positive advanced breast cancer progressing on trastuzumab-containing therapy, continuing trastuzumab alone or combined with other cytostatic drugs is feasible and safe.1 (http://www.jco.org/cgi/content/full/23/12/2866#R1)-3 (http://www.jco.org/cgi/content/full/23/12/2866#R3) Moreover, despite the main issue addressed (safety of trastuzumab for long periods), some of these articles report encouraging tumor response and survival data.2 (http://www.jco.org/cgi/content/full/23/12/2866#R2),3 (http://www.jco.org/cgi/content/full/23/12/2866#R3) Preclinical observations indicating that trastuzumab might be beneficial, even in the presence of disease progression, by slowing down tumor growth, lend support to the "continuation" hypothesis. As a consequence, despite the absence of results from randomized trials, many physicians throughout the world consider continuing trastuzumab beyond disease progression a reasonable approach in the current clinical practice. However, because of severe selection biases, retrospective analyses need to be considered with extreme caution. For example, patients with rapidly progressing disease after an initial trastuzumab-based treatment are not likely to have been included in these analyses. On the other hand, patients whose disease progresses at a rate at which additional treatment is possible may fare equally well with chemotherapy or endocrine therapy without trastuzumab. We published a phase II multi-institutional trial in 42 patients with HER2-positive (Dako HercepTest 2+ or 3+; Dako, Carpinteria, CA) advanced breast cancer who received six cycles of docetaxel (75 mg/m2 every 3 weeks) and weekly trastuzumab.4 (http://www.jco.org/cgi/content/full/23/12/2866#R4) Patients responding or showing disease stabilization received weekly trastuzumab until disease progression or unacceptable toxicity. The postprogression treatment was left to the discretion of the treating physician. We recently updated the follow-up information for all the patients registered in our study (median follow-up, 28 months; range, 17 to 53 months) and analyzed postprogression treatments and clinical outcome. During the protocol, three patients stopped treatment because of toxicity, and one patient, who had achieved a partial remission (PR), refused to continue the treatment after the fourth cycle. At the time of the current analysis, of the remaining patients enrolled on the trial, three are still alive and without signs of tumor progression, 35 have progressed, and 23 have died of disease progression. Of the 35 progressing patients, six continued trastuzumab with or without chemotherapy; six with rapidly progressing disease received supportive care alone or with palliative radiation therapy; and 23 received chemotherapy (up to three regimens) and/or endocrine therapy, without trastuzumab. In these 23 patients, one achieved a complete remission, and three, a PR to the first postprogression therapy, for an overall response rate of 17%. The clinical benefit rate to the first postprogression therapy (percentage of patients achieving complete remission, PR, or disease stabilization for http://www.jco.org/math/ge.gif 6 months) was 50%, but tumor responses or stabilizations were also seen during further lines of treatment. The median overall survival was 29.3 months (range, 11 to 53+ months) from the date of the first on-protocol administration of trastuzumab, and 19.0 months (range, 3 to 33.7+ months) from the date of the initiation of postprogression treatment. Median survival from the date of on-protocol progression was 1.9 months for the six patients who experienced rapidly progressing disease, and 20 months for the six patients who continued trastuzumab beyond disease progression. Our findings in patients not continuing trastuzumab beyond disease progression but who could be treated with chemotherapy or hormone therapy, are in the range of what has been reported in retrospective analyses of patients receiving trastuzumab beyond disease progression.

In a time when careful usage of healthcare resources is crucial even in the most developed countries, continuing trastuzumab beyond disease progression in the absence of data from randomized trials is at least debatable. In our opinion, it is significant that the only phase III trial designed by colleagues at The M.D. Anderson Cancer Center to evaluate the worth of continuing trastuzumab beyond disease progression had to be closed because of lack of accrual (G.N. Hortobagyi, personal communication).

Authors' Disclosures of Potential Conflicts of Interest

The following authors or their immediate family members have indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. Other Remuneration: Filippo Montemurro, Roche SPA. For a detailed description of these categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section of Information for Contributors found in the front of every issue.

Acknowledgment

The authors whish to acknowledge Dr Gabriel N. Hortobagyi for reviewing this letter.

REFERENCES
<LI value=1>Mackey J, Gelmon KA, Verma S, et al: Continued use of Herceptin after disease progression in women with HER2-positive (HER2+) metastatic breast cancer (MBC): Results from a retrospective analysis of 105 cases. Proc Am Soc Clin Oncol 21:51a, 2002 (abstr 207) <LI value=2>Fountzilas G, Razis E, Tsavdaridis D, et al: Continuation of trastuzumab beyond disease progression is feasible and safe in patients with metastatic breast cancer: A retrospective analysis of 80 cases by the hellenic cooperative oncology group. Clin Breast Cancer 4:120-125, 2003[Medline] (http://www.jco.org/cgi/external_ref?access_num=12864940&link_type=MED) <LI value=3>Tripathy D, Slamon DJ, Cobleigh M, et al: Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 22:1063-1070, 2004[Abstract/Free Full Text] (http://www.jco.org/cgi/ijlink?linkType=ABST&journalCode=jco&resid=22/6/1063)
Montemurro F, Choa G, Faggiuolo R, et al: A phase II study of three-weekly docetaxel and weekly trastuzumab in HER2-overexpressing advanced breast cancer. Oncology (Karger) 66:38-45, 2004




Related Reply


In Reply: Gabriel N. Hortobagyi JCO 2005 23: 2868-2869 [Full Text] (http://www.jco.org/cgi/content/full/23/12/2868)

[Cathya]

Christine;

I want to bring your post back up to the top for other comments. I think you have an important question.

Best regards,

Cathy

[Lolly]

Hi Christine;

I'm one who has progressed while on Herceptin, and my onc's method has been to add a single agent chemo for 6 months until I'm in remission or considered stable enough to maintain on Herceptin until I need a chemo again. For me, this has been very effective. The chemo's we've used so far have been Navelbine (for 3 recurrences) and Xeloda added to this last round of Navelbine/Herceptin. In fact, I just saw my onc today and we decided to drop the Navelbine as I've responded so well, and maintain on Xeloda/Herceptin for awhile.

If you search the message board using "herceptin progression" you'll find quite a few posts on this subject, but in case you have difficulty doing that here's a link(hopefully) to the search I did:

Message Board "herceptin progression"

http://her2support.org/vbulletin/search.php?searchid=17889

<3 Lolly

PS. Sorry if the link didn't work when I first posted it, I think it's fixed now.

[Sheila]

Christine
I have also progressed on Herceptin but remain on it with Xeloda added like Lolly for stubborn lymph nodes in my neck...the Xeloda is a great combo with herceptin and I have had excellent results in 3 rounds of Xeloda....

[jojo]

I have been on weekly Herceptin from the beginng -- that was 3 summers ago. At first, it was actually off-label, only good for just one year. But I got mets that year later. So, ever since then, I have been on maintenance Herceptin 00 for how long, I don't know, just indefinitely for now.

So, I recurred to a malignant lymph node (officially by biopsy) & also brain mets down the road, I was never taken off the Herceptin. My onc just put me on hormonal therapy first for about 1.5 years -- until they stopped working -- along with the Herceptin. Then I was put on Xeloda & Abraxane, in that order.

Though, my onc does not believe in the mix of chemo's & hormonal therapy at the same time, just because she would not be able to tell which kind of med (chemo vs blocker) would not be effective in a patient's case.

Christine, for some reason you cannot to get to stay on your Herceptin, I would seek a 2nd, even 3rd opinion.

Please keep us posted on your developments. Good luck!