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Xeloda After Neoadjuvant Chemotherapy and Surgery

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123Donna View Drop Down
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    Posted: Jun 10 2017 at 2:42pm
Xeloda improves survival for some breast cancer patients who do not achieve a pathological complete response to chemotherapy 

A drug called Xeloda can extend the lives of some women whose breast cancer is not wiped out by standard treatment, a new clinical trial finds.

Oncologists said the results are "practice-changing."

"This drug is already approved, and we've been using it for a long time in cancer treatment," said Dr. Stephen Malamud, an oncologist at Mount Sinai in New York City.

Xeloda (capecitabine) is a pill, so it's easy to take and is "much less toxic" than standard chemotherapy, noted Malamud, who was not involved in the new research.

"Most importantly," he said, "it extended overall survival in this study."

In 1998, Xeloda was approved in the U.S. for advanced breast cancer that had spread to distant sites in the body. The new trial, done in Japan and South Korea, tested the drug for a different group of patients.

It focused on 910 women whose breast tumors were not completely eliminated by standard chemotherapy and surgery. In addition, they all had cancer that lacked a protein called HER2 — which meant they could not benefit from breast cancer drugs that target HER2, such as Herceptin.

Those women have a fairly high risk of seeing their cancer progress, according to the researchers on the trial, led by Dr. Masakazu Toi, of Kyoto University in Japan.

In the study, Xeloda improved those odds. It cut patients' risk of relapse or death by 30 percent over five years.

At that point, 74 percent were still alive and recurrence-free, versus just under 68 percent of women who'd received placebo pills in addition to standard treatment.

"It's not a panacea, by any means," Malamud said. "But it's a nice 'back door' treatment to improve women's outcomes."

Dr. Elizabeth Comen is a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City. She said doctors have already begun using Xeloda for women like those in the trial, based on preliminary reports. (The trial was actually stopped early, in 2015, when it became clear that Xeloda had benefits.)

"This is a landmark trial," Comen said. "It really is, in my opinion, practice-changing."

The women in the study all had breast tumors that had not yet spread to distant sites in the body. But many had cancer in nearby lymph nodes.

They'd all received standard chemotherapy before surgery, but still had "residual" cancer left behind.

Toi's team randomly assigned the patients to one of two groups. Most women in both groups received radiation, and those with hormone-sensitive breast cancer started on hormonal medications.

Only one group received Xeloda, while women in the other group were given placebo pills. The treatment was given in six or eight three-week "cycles," with two weeks on the drug, one week off.

Five years later, 89 percent of Xeloda patients were still alive, compared with just under 84 percent of placebo patients.

The difference was larger among women who had "triple-negative" breast cancer; that means their cancer not only lacked HER2, but was not hormone-sensitive, either — which limits their treatment options.

Among those women, 79 percent of Xeloda patients were alive after five years, compared with 70 percent of placebo patients.

The main side effect -- affecting almost three-quarters of patients -- was hand-foot syndrome. That's a reddening and swelling of the palms and soles of the feet. It's similar, Malamud said, to a "bad sunburn," and it goes away once the drug is stopped.

As for access to the drug, both Malamud and Comen said they would be surprised if an insurer wouldn't pay.

The trial was funded by the Advanced Clinical Research Organization and Japan Breast Cancer Research Group.

The results were published in June in the New England Journal of Medicine.

http://www.chicagotribune.com/lifestyles/health/sc-xeloda-breast-cancer-drug-health-0614-20170601-story.html

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Tulips View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Tulips Quote  Post ReplyReply Direct Link To This Post Posted: Jun 13 2017 at 3:26pm
Thanks for posting this, Donna.  It's good to see the final article in the New England Journal of Medicine this month (it was worth the $20 for me to buy the article!).  Among just the TNBC patients in the trial:
*. Disease free survival was 70% at 5 years for those on capecitabine/Xeloda vs. 56% for the control group (TNBC patients were a mix of Stage 1 - Stage 3B)
*  Overall survival was 79% at 5 years for those on capecitabine/Xeloda vs 70% for the control group.

It was also encouraging to me to see that the steepest part of the curves was at the beginning.  It looks like more than half of the recurrences that happened over the 5 year period occurred in the first 15 months, and then drastically diminished/flattened out after that.  So yes, most of us are told 5 years is a fairly magical timeframe when the risk of recurrence is fairly minuscule after that period; but we can all start breathing quite a bit easier much sooner than that.

A year and a half ago I had to really advocate for my MO to prescribe the capecitabine to me when I learned I had residual TNBC after neoadjuvant chemo/surgery.  He wasn't completely sold on the preliminary results reported at San Antonio in December 2015.  Now it seems this will probably be close to standard practice to offer it with residual.  I'm so glad I did my research and discovered these results;  if I had not, I would be livid and regretful that this information was out there (albeit in preliminary form) and I hadn't had an opportunity to decide if it was right for me.  There are further follow-up studies going on to confirm/repeat these types of findings, but it will be many years before that information is available.  I'll never know if capecitabine specifically helped me (unless of course I recur, in which case I'll know that it did not--or at best delayed things), but it helps me to know that I took every reasonable step available to me.

One thing I find frustrating is that these trials don't allow us access to a scrubbed/no-names version of the data!  I'd really like to cut the data myself, to look at people most similar to me (people with TNBC at my stage, my grade, my age group, who had similar neoadjuvant treatments, with same BRCA status, same LVI status, same RCB level, etc).  I know we can't cut it that precisely (there were only about 300 total patients with TNBC in the study), but still, I'd love to play with the data myself to try to look at as relevant a population for me as possible.  They had unleashed some points slicing the data in certain ways (response of those with lymph node involvement vs no lymph node involvement, for example), but that was for the whole study population (a combination of TNBC and HR+/HER2- patients)....I would have loved to see that info for just the TNBC patients, and other examples.  For the trials to help guide our decision-making, access to this information can be really useful. I  want to advocate for more transparency in trial reports!

Anyway, thanks for this.  Capecitabine may not be the right choice for everyone who faces residual TNBC, but everyone should at least have access to this information to make an informed decision.
Dx April 2015 IDC TN 2.2 cm, Grade 3, Chemo started May 2015: Taxol/Carbo then AC, Lx with SNB Nov 2015, 33 Rad Dec 2015-Feb 2016. 6 months Capecitabine starting March 2016
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SusaninVA View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote SusaninVA Quote  Post ReplyReply Direct Link To This Post Posted: Jun 13 2017 at 4:38pm
Thank You, Donna, I didn't realize this had been published.  I can relate to Tulip's thoughts on having the specific data.  I often wonder how women with my criteria are faring.  Since I had surgery first (was not offered a choice), I did not receive any feedback regarding the efficacy of the chemotherapy.  Thankfully, the tumor was small, but already in two lymph nodes.  All I have is the survival estimate from my oncologist (77%).  Was not offered the Xeloda.  I did mention to my oncologist at a recent checkup that many women are following up with this after radiation, and he was unaware of it.  So he did take a minute and looked at the preliminary data on his laptop.  I wish my surgeon would have offered the option of doing chemo first, but was so scared at the time, I just did what they told me to do.  I think the great mystery of cancer is why some women who are stage I recur and some women who are stage III do not.  It's almost like a random "crapshoot" which never will make sense to any of us.  I have finally gotten to the point I only worry about today and find joy in it.  I will deal with tomorrow when it comes.  My heart aches for those who post on this forum with a recurrence.  So unfair, especially to those who are young.  (I just turned 58 yo, so I have lived a good life; would appreciate more, but am thankful for what I have had.)
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jun 13 2017 at 9:13pm
Tulips,

I'm glad you did your research and that your onc listened to you even with only preliminary results.  Many times we are not given an option.  

From the report:  "The difference was larger among women who had "triple-negative" breast cancer".  I agree with you - I wish they'd report by bc type too, just not overall results where everyone is lumped together.  

I remember when I entered the phase 3 clinical trial - expanded access because the study was going so well they opened it up to everyone, only to find out it did not meet their "end points" and Iniparib was not granted FDA approval.  I told my onc they needed to look at the subset of people that responded to this drug and chemo combination and see what they had in common.   What was different about them vs the entire study sample?  Was it breast cancer type, eg TNBC?  BRCA status?  Tumor genetic mutation(s)?   


DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote rstar Quote  Post ReplyReply Direct Link To This Post Posted: Jul 03 2017 at 3:06pm
Donna, U might fall into this rare group of TNBC that Dr. O'Shaughnessy mentions in this video.



Edited by rstar - Jul 03 2017 at 5:33pm
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123Donna View Drop Down
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jul 03 2017 at 4:52pm
Rstar,

I just watched her video and I think you might be right.  Thanks!

Donna
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote rstar Quote  Post ReplyReply Direct Link To This Post Posted: Jul 03 2017 at 5:37pm
No problem. 
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