Chemo Protocol Options - Wife PR-, ER-, HER2+, High Grade IDC

yeuker

Hi Everyone,

I've posted in the 'just diagnosed' forum before but I'm new to this one so will introduce myself. My wife (37 year old) has breast cancer, PR-, ER-, HER2+, IDC, 2-3cm, High Grade. She has had a lumpectomy last Wednesday (Jan 13, 2016) and it went well. Surgeon removed 3 lymph nodes.

We are waiting on:

- Results of surgery (pathology, nodes)

- Bone Scan (Feb 2)

- CT Scan - Chest, Abdomen, Pelvis - Some time between now and Feb 8

- Muga scan of heart pre chemo for baseline and to assess health

- Chemo starts Feb 19

We currently have 2 chemo options to discuss with our oncologist. We have been told that neither is a clear winner in terms of treatment but we will have the choice as each has different side effects and potential complications. Our two options can be found here and are as follows:

http://www.bccancer.bc.ca/health-professionals/professional-resources/chemotherapy-protocols/breast

• BRAJDCARBT
• BRAJFECDT

Any advice for us on her specific type of cancer as well as +/- of those protocols would be greatly appreciated. We like many others are very new to this and appreciate the knowledge and support of this community. Does anyone have good knowledge of those protocols or advice they could offer? Is this the right forum?

Thanks,

Cory

BarredOwl

Hi Cory:

Without considering exact doses, those look like what might be more generally called:

(a) "TCH" (a regimen of docetaxel (taxotere, T) and carboplatin (C) and trastuzumab (herceptin, H))

(b) "FEC plus trastuzumab and docetaxel" (a regimen of fluorouracil, epirubicin, and cyclophosphamide, followed by trastuzumab plus docetaxel)

Is that your understanding?

BarredOwl

ElaineTherese

^{Hi Cory!}

^{In the US, HER2+ cancer is usually treated with either 4 - 6 doses of biweekly TCHP(Perjeta) or 4 doses of biweekly Adriamycin/Cytoxan + 12 weekly doses of Taxol/Herceptin/(with 4 doses of Perjeta, every three weeks). Apparently, Perjeta isn't commonly used in Canada yet, and your wife is being offered an older regimen than AC, namely FEC.}

^{TCH involves hair loss and a very small chance of permanent hair loss. For some ladies, TCH can cause gastrointestinal distress. It can affect your taste and can cause fatigue.}

^{Taxol is Taxotere's supposedly gentler cousin, but it gave me mild diarrhea. It also causes fatigue and joint pain.}

^{Either way, your wife will get targeted therapy (Herceptin) For me, Herceptin didn't have much in the way of side effects. But, in some ladies, it can reduce heart function. That's why your wife's heart will be closely monitored during treatment.}

^{I can't tell you much about FEC; hopefully, someone will chime in with some insights about that regimen.}

ruthgoode

Hi there

I don't have much to add to the discussion of regimen, but I would like to bring to your attention a recent clinical trial (the MANTICORE study) that found that certain heart meds (ACE inhibitors and Beta blockers) prescribed for women taking Herceptin seem to help to avoid heart damage. https://uofa.ualberta.ca/news-and-events/newsartic...

It might be worth considering in your wife's case. I had a similar diagnosis - although smaller tumor - was treated with TCH in 2013 and found myself with reduced cardiac function as a result. Although 55 yrs old, I run (and still run) a couple of miles daily, but I am pissed that this study came out after it could have been helpful to me. This may be worth discussing with your oncologist/cardiologist. Although your wife is 35 yrs or so, and younger than I, my understanding is that Herceptin can damange heart function even in younger women. Hope this is helpful.

Skittlegirl

I just finished 6 rounds of TCHP. I was on a 3-week cycle.

Side effects: Fatigue, diarrhea, nosebleeds, loss of taste, fingernail changes

By the second infusion, you couldn't feel the tumor any more.

Herceptin will continue until next fall so that I will have received it for a year.

Italychick

I did TCH. I'm not sure, but carboplatin I think can cross the blood brain barrier and her2 cancers are known for metastasizing to the brain, so that's why I did TCH and no cold capping to save my hair. I have two rounds of Herceptin left (one year almost done!), and I have had little to no side effects from Herceptin. I have kept up with a fairly rigorous exercise routine, bike riding about 100 miles plus a week, so that may have helped me. Today is my one year anniversary from surgery, and all is going well. I did not do Perjeta, but that may have been because my her2 level was 2.4, so I was in the lower end for her2 positive cancer. I didn't know about Perjeta, so I never asked my oncologist about it.

Best of luck whatever you and your wife decide

Moderators

Dear ruthgoode, Welcome to the community and thanks for sharing your story. We hope to see you around the boards. The Mods

yeuker

Wow, great advice everyone. I am substantially more prepared after reading the above and researching for the weekend. My questions/answers for all of you:

- BarredOwl: I don't know. I needed to make calls to get the protocol names/links prior to our meeting with Oncologist. We have had no discussions at all with anyone on any of these protocols.

- Is Perjita only used in NeoAdjuvent Setting?

- Ruth: Thanks for the heads up on the heart meds during treatment.

- Italychick: What did you mean when you said 'no cold capping to save my hair' and also 'her2 level was only 2.4 which puts me in the lower end for her2+ cancer'.

Questions for MO:

- Is Perjita only used in NeoAdjuvent Setting? I'm pretty sure the MO told us the 'dual drug therapy with Perjita' isn't yet legal/availble in Canada. Is my memory correct or was this only in the neo-adjuvent setting?

- Certain heart meds (ACE inhibitors and Beta blockers) prescribed for women taking Herceptin seem to help to avoid heart damage. Will Allison receive these drugs?

yeuker

One more thing. From what I can read, Perjeta is a real treatment option for Allison. I also see that it is only approved for advanced/late stage metastatic breast cancer in Canada. If you were us, is this something you would advocate for?

Edit: Here is a link from a couple close to us who lobbied for Perjeta for Stage 2 HER2+ breast cancer and were not able to get the costs covered by Health Canada:

http://www.ctvnews.ca/health/life-saving-treatment...

Cory

ElaineTherese

Hi Cory!

In the U.S., Perjeta is recommended for HER2+ cancers that are at least two centimeters in size and it is approved for neoadjuvant use. Still, this is the U.S., and some doctors manage to get insurance to cover Perjeta for adjuvant therapy, so I've seen some ladies get it after their surgery. Perjeta's somewhat new, but the studies that are out there suggest that it is very effective against HER2+ cancer. I was glad to do neoadjuvant chemo and have Perjeta as part of the regimen.

Re: cold capping -- what Italychick seems to be saying is that she decided not to cold cap and save her hair because she feared that it would prevent the chemo from circulating effectively in her brain. (Correct me if I'm wrong, Italychick.)

BarredOwl

Hi Cory:

Re the protocols:

BRAJDCARBTBRAJFECDT

There are very small differences between the abbreviations used for your local protocols (confusing nomenclature), and it would be easy to pull up the wrong one.

kayb referred to the second protocol as "FECDT", which actually corresponds to the last five letters of the second protocol (BRAJFECDT), which makes sense:

"FEC plus docetaxel and trastuzumab" (a regimen of fluorouracil (F), epirubicin (E), and cyclophosphamide (C), followed by docetaxel (D) plus trastuzumab (T))

To be certain, it is best practice to confirm all of the information you receive with the MO, including that these particular protocols are properly referred to as "TCH" and "FECDT", respectively.

Italychick please correct me if I am wrong. In another thread Italychick stated that her HER2 status was "equivocal," or fell below the current threshold for clear HER2-positivity (a slightly gray area). She is not sure whether pertuzumab is offered in "equivocal" cases like hers, either then or now. As she was HER2 equivocal, what was offered to Italychick may differ from what is offered to those who are clearly HER2-positive.

Generally, the use of pertuzumab (PERJETA) in the ADJUVANT setting was incorporated into the NCCN guidelines for treatment of breast cancer in 2014, per an ASCO Post article,

[EDIT (4/17/2016) to fix link]:

http://www.ascopost.com/issues/may-15-2014/nccn-clinical-practice-guidelines-in-oncology-2014-updates/

The current version of the NCCN guidelines (Version 1.2016) regarding ADJUVANT therapy (i.e., in the case where neoadjuvant therapy is not indicated or not elected) applicable to ductal carcinoma, hormone receptor-negative, HER2-positive, tumor > 1 cm, and regardless of node status, provides for adjuvant chemotherapy with trastuzumab, with the following footnote regarding the addition of pertuzumab in certain subsets:

(bb) "A pertuzumab-containing regimen can be administered to patients with ≥T2 or ≥N1, HER2-positive, early-stage breast cancer."

T2 = Tumor > 20 mm but ≤ 50 mm in greatest dimension

N1 = Micrometastases; or metastases in 1–3 axillary lymph nodes; and/or in internal mammary nodes with metastases detected by sentinel lymph node biopsy but not clinically detected***

Examples of regimens optionally incorporating pertuzumab include:

• AC followed by T + trastuzumab ± pertuzumab

(doxorubicin (aka Adriamycin) and Cyclophosphamide, followed by paclitaxel (T) plus trastuzumab ± pertuzumab, various schedules)

• TCH (docetaxel/carboplatin/trastuzumab) ± pertuzumab

The NCCN guidelines include some uses which are not approved by FDA and are considered "off-label". The FDA-approved label for pertuzumab (version approved May 29, 2015) includes certain uses in the metastatic setting and neoadjuvant setting. It does not appear to include use in the adjuvant setting by my layperson's read. See "Indications and Usage" at page 1, column 1.

http://www.accessdata.fda.gov/drugsatfda_docs/labe...

I have no idea whether you should advocate for pertuzumab or not, what the nature of the evidence of benefit in the adjuvant setting is, or what factors (besides size and node status) would lead an MO to recommend its use in the adjuvant setting in a particular patient. In the article you linked, the pertuzumab was "later recommended by her oncologist in Saskatoon." So, you may wish to explore these questions with the MO. Reimbursement aside, and though such use may be off-label in Canada and in the US in the adjuvant setting, would it be recommended or not in your wife's particular case, or seen as superior to BRAJDCARBT and BRAJFECDT regimens in terms of risk/benefit. If not recommended/superior, the possible access questions may be moot.

As usual, I am a layperson with no medical training, so any information above should be confirmed with your MO, to ensure accurate, current, case-specific expert professional advice.

BarredOwl

(P.S., Note kayb's comments above re FEC versus AC (where A = Doxorubicin (also known as ADRIAMYCIN®), and C = Cyclophosphamide), and practice in the US versus elsewhere.)

[EDIT: It should be noted that the info I provided above specifically addresses what the guidelines say in a narrow set of circumstances which are relevant to Cory's wife, who did not receive neoadjuvant, is ER-, PR-, HER2-positive, ductal tumor > 1cm and node status currently unknown. It is NOT a summary of all adjuvant uses of pertuzumab, and does not exclude its use in patients with different features than those recited. Anyone interested in whether pertuzumab is an option for them should always ask their MO, to ensure accurate, current, case-specific expert professional advice.]

[EDIT 4/17/2016: Updated FDA Label (version approved March 22, 2016):

http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf]

Italychick

yeuker the women above are correct. I did not cold cap, which involves using this contraption with dry ice to prevent the chemo from circulating through your scalp, thus saving hair. After researching that her2 cancers can go to the brain, I decided I wanted to give the chemo every chance to work and I did not use cold capping to save my hair. Hopefully my information makes sense. I am not sure if there is any basis for my belief that cold capping might make Herceptin and chemo less effective, other than my feeling that if I went through chemo, I didn't want to do anything that might sabotage the effectiveness.

I had three her2 tests, I can't remember what they were called. The third one counted her2 cells, and then compared them to other receptors, such as a cen something, and two others, and calculated a ratio. I have seen women post her+++ in their signature lines, which I believe indicates a her level over 3. After researching her2 cancer, I went with one of the Herceptin protocols based on the advice of my oncologist, because if there was a chance that Herceptin would help me, then I wanted that chance.

As far as Perjeta in the adjuvant setting, I have a lot of confusion around that drug, because there were women in my March 2015 chemo forum with stage 1 lumps that were estrogen positive that received Perjeta in addition to Herceptin after their lump was removed. I am not sure how they got it approved or what the criteria is for approval.

Kathy044

BarredOwl BRAJ is an in house prefix used for breast adjuvant drug protocols at the BC Cancer Agency.

Hi Cory being ER+ and HER2- (but node positive) I have little to contribute on your wife's choices but I did thoroughly research what I could find about FEC-D back in 2009 when I was offered chemo. I was 65 almost age 66 at the time which is the upper limit for the use of this combo for adjuvant chemo and I was concerned about heart toxicities.

I found a study that compared the protocal FEC D ( 3x FEC, 3x Docetaxol) with the older 6x FEC protocol, the FEC-D was more effective against the cancer but more importantly to me, FEC-D with only three cycles with Epirubicin had fewer, none serious, heart related events compared to FEC with six cycles. A 3rd generation chemo was the recommended choice at the time with node positive breast cancer so I went with it. The chance to use Trastuzumab would make the choice today different.

Kathy

BarredOwl

It should be noted that the info I provided above specifically addresses what the guidelines say in a narrow set of circumstances which are relevant to Cory's wife, who did not receive neoadjuvant, is ER-, PR-, HER2-positive, ductal tumor > 1cm and node status currently unknown.

It is NOT a summary of all adjuvant uses of pertuzumab, and does not exclude its use in patients with different features than those recited.

BarredOwl

Italychick

barredowl interesting, maybe that's why I didn't get Perjeta either since I have no er or pr receptors either

BarredOwl

Hi Italychick:

Looking at your profile, you were ductal, ER-, PR-, and (borderline) HER2-positive, but it looks like you were also T1 (T1 Tumor ≤ 20 mm in greatest dimension) and node-negative. The circumstances described in the footnote (bb) above where adjuvant pertuzumab (perjeta) is an option would not apply to T1, node-negative by my read:

(bb) "A pertuzumab-containing regimen can be administered to patients with ≥T2 or ≥N1, HER2-positive, early-stage breast cancer."

Anyone interested in whether pertuzumab is an option for them should always ask their MO, to ensure accurate, current, case-specific expert professional advice.

BarredOwl

Italychick

so what indicates Perjeta as an adjuvant treatment? A girl on my forum had same size tumor I did, no nodes, but was er/pr/her2 positive, and 28 years old. Maybe her age

BarredOwl

Hi Italychick:

The guidelines appear to say the same thing for ductal, hormone receptor-positive, HER2-positive, Tumor >1 cm, and node-negative, with the addition of adjuvant endocrine therapy:

"Adjuvant endocrine therapy + adjuvant chemotherapy with trastuzumab"

"(bb) A pertuzumab-containing regimen can be administered to patients with ≥T2 or ≥N1, HER2-positive, early-stage breast cancer."

Again, assuming I am reading it correctly, the guidelines do not include the option of adjuvant pertuzumab (perjeta) where such a person is Tumor >1 cm, but still T1 and node-negative.

However, the guidelines are not mandatory, and in appropriate cases, patients and their doctors may depart from what they provide. I don't know what those reasons may be, but I would also guess that very young age could have been a factor in the decision if she received adjuvant chemotherapy, plus trastuzumab and pertuzumab.

Anyone interested in whether pertuzumab is an option for them should always ask their MO, to ensure accurate, current, case-specific expert professional advice.

BarredOwl