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Xeloda After Neoadjuvant Chemotherapy and Surgery

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    Posted: Sep 01 2022 at 11:30am

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over capecitabine could not be demonstrated, according to Ingrid A. Mayer, MD, MSCI, of Vanderbilt University, Nashville, who presented the findings at the 2021 ASCO Annual Meeting.1

“The available data show that platinum agents are unlikely to be noninferior or superior to capecitabine in improving invasive disease–free survival, regardless of intrinsic subtype,” Dr. Mayer said. “The study definitely reinforces the role of capecitabine in this high-risk group.”

Of note, the 3-year invasive disease–free survival rate was lower than expected, regardless of study treatment: 42% in the platinum arm and 49% in the capecitabine arm. In the CREATE-X trial, which established the value of adjuvant capecitabine for residual disease, the 5-year disease-free survival was 70% with capecitabine and 56% with observation.2


KEY POINTS

  • The randomized noninferiority EA1131 trial aimed to determine whether adjuvant treatment with a platinum may be better than capecitabine in patients with early triple-negative breast cancer and residual disease after neoadjuvant therapy.
  • Preclinical models have suggested these tumors may be sensitive to platinum.
  • The study could not demonstrate noninferiority or superiority of the platinum.
  • The 3-year invasive disease–free survival rates were low with either treatment: 42% with platinum and 49% with capecitabine.
  • Capecitabine remains the adjuvant treatment of choice in this population.

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 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Jul 18 2019 at 11:59am
SABCS 2018: Does Adjuvant Capecitabine Improve Outcomes in Early-Stage Triple-Negative Breast Cancer?



Observation:  This was a small study of only 876 patients.
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 Elisa Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2018 at 1:01pm
Hi Ladies
An update! I stopped X after my fourth round as my body simply cannot tolerate chemo. I now have constant, low grade shaking and tinnitus. And of course exhaustion. The neuropathy has stuck around, but honestly that is the least of my worries. Has anyone else experienced shaking? My doc refuses to test for pareneoplastic syndrome, which is what I think it is.
Big hugs from Denmark
Elisa
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2018 at 7:48am
From SABCS 2018:

Adding Capecitabine to Adjuvant Therapy Does not Improve Overall Survival in Early TNBC--With One Exception
This study was a phase 3 randomized trial in which one group of patients with early stage TNBC received capecitabine as adjuvant therapy after finishing neoadjuvant chemotherapy and surgery, while the other group got only the neoadjuvant treatment and surgery.. The CREATE-X trial showed no benefit either in disease free survival or overall survival for the patients getting the capecitabine. There was one group, however, for which the results were more promising--patients with the non-basal type of TNBC. That group did have statistically significant improvements in both key measures of the success of the treatment.

Effective treatment for early TNBC is critical as this is primary way to prevent the disease from recurring or spreading to other sites. Researchers are always working on ways to improve the initial treatments that patients receive. It’s also important not to subject patients to side effects from drugs or treatments that are not effective. This study will provide a basis for additional trials with the non-basal TNBC group and help refine the current standard of treatment for all women with TNBC.

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 Sallylovestosing Quote  Post ReplyReply Direct Link To This Post Posted: Sep 11 2018 at 9:44pm
Thanks for taking the time to reply Donna, your message means a lot. Even though I have only just posted my little story, I have used this website (and the IBC site) often during the last year and it's been an invaluable resource. So good to hear from so many smart women taking reponsibility for their own health and so good to not feel quite so alone Smile
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Sep 09 2018 at 12:15am
Sally,

I'm so glad you shared your story.  It's been a long road for you and so happy you have found your joy in singing.  IBC is hard to detect and glad you knew something wasn't right.  Sometimes you have to listen to that inner voice telling you something isn't right.  Yes, life will never be the same, but somehow we become stronger facing this horrible disease.  Keep us posted on how you are doing.

Have you checked out the IBC website?

https://www.theibcnetwork.org
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 Sallylovestosing Quote  Post ReplyReply Direct Link To This Post Posted: Sep 08 2018 at 10:15pm
Hi, I have been reading these boards since my diagnosis with TN IBC in November 2017.  I was 53 and otherwise completely healthy.
I spotted the cancer myself ( a mammogram the previous year had shown nothing out of the ordinary) which manifested as a heavier, fuller feeling than usual right breast with a slight pinkish flush on one side. Further close investigation revealed a small patch of orange peel skin under the areola (this was hard to see as I have full breasts and it was hidden when looking in the mirror. A lying down, arm over the head self exam of the breast revealed a largeish (8cm across maybe) patch of firmer tissue, but you wouldn't really call it a lump.
All in all not much to see for the doctor, more just a feeling of not rightness for me.
I went straight to the GP who was fab - although he said he thought it was nothing to worry about and more likely the result of a bump to the breast (My big dog had jumped up on me a week or two prior and planted his massive paws on my boobs!). The GP referred me immediately for a mammogram and ultrasound. Once this was done a few days later, everything started to move like crazy. The day after the U/S I was called back for a biopsy and then the diagnosis of Stage III Grade 3 Triple Neg Inflammatory BC. 
I've been very lucky to receive what I think from all my reading is Gold Standard treatment:
4 X 2 weekly cycles of AC )Doxyrubicin/Cyclophosphate)
12 x 1 weekly cycles Taxol (paclitaxel)
Modified radical mastectomy (Right Side) - I have chosen no reconstruction, although you have to wait a year or two with IBC in any case. I didn't get a PCR but apparently the residual cancer in the breast was only a millimetre or two across. Margins were great.
5 weeks radiation therapy
And now what I refer to as my "bonus round of chemotherapy" - 6 months of Capecitabine (Xeloda) given 2 weeks on, one week off.
I am only on my third day of this drug so will post a little later about how I go with side effects. I am a bit worried about the Hand/Foot syndrome as I had a very bad reaction to my first dose of Taxol and had super sore hands and feet, all the skin peeled off and I couldn't use my finger print to access my phone or security locks for nearly two months!

When the Oncologist first told me about the Capecitabine, my initial reaction was NO! I thought my treatment was over and I could concentrate on getting back to "normal"- I was very disappointed. I had a few weeks to think about it while I was undergoing radiation so I did as much reading as I could and read the results of the big 900 person trial (can't remember the name of it, sorry!) with statistics for improved survival/recurrence rates. Of course I realised that there are few drug therapies available to us TNBCers once our primary treatment cycle is complete, so despite my initial resistance I have of course agreed to try it.

One thing I have done for myself from early on in my treatment, after reading everything I could get my hands on, is to adopt a plant based, wholefood diet and completely stop drinking alcohol. I am convinced this has helped me enormously by giving my body underlying support to deal with the systemic poisoning that is chemotherapy and putting as little extra pressure on my organs as I could. I also believe that the reduction of animal proteins will help prevent a recurrence of the cancer for many reasons, but a big one is the effect of IGF (Insulin Like Growth factor - very high in meat, eggs and dairy products). IGF has been shown to feed tumour growth.

I am really shocked at the complete disregard for the importance of diet from almost every branch of the medical profession - surely this is a no-brainer? Despite the excellence of my care in every other way, none of my doctors wants to engage on the subject of diet. I'm amazed.

I've tried to keep walking every day (not always possible, but mostly I've managed it) and also tried to keep doing yoga - again not always possible, but I try to approach each day as a new start. I have kept working and best of all I've kept singing - this is very important physically as well as mentally! if you need something to help hold you up, join a choir!

Even though we know this is going to be a tough gig when we get our diagnosis, I don't know if any of us really get that what it actually means is that life will never be the same again - a year in, it's starting to dawn on me!




Edited by Sallylovestosing - Sep 08 2018 at 10:18pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote srb32281 Quote  Post ReplyReply Direct Link To This Post Posted: Aug 27 2018 at 10:57am
Hello! I have been reading these boards since December of 2017 when my mom was diagnosed with TNBC.  I, myself, work in a medical oncology office for almost 13 years--so it's safe to say I was blown away and felt like a nuclear war went off in my body when I found out about my mom since I kind of see the backside of things. 

My mom was stage 2 (IDC 2.8cm mets to lymph node) when she was finally staged.  She under went 4 cycles of Adria/Cytoxan then 12 weeks of taxol/carbo.  She had a unilteral mastectomy with axillary dissection with immediate reconstruction with tissue expander a month ago.  She had a partial response--her breast tumor/skin showed no cancer or residual diease and 2 out of the 6 LN were positive but showed treatment effects.  

She will undergo radiation in a few weeks for 6 weeks more than likely.  Then her doctor (who is also my boss) will put her on xeloda for 6 months.  Which makes me happy since I read about this before her surgery and was kind of hoping he would put her on something since she can't do endocrine therapy.  

She is doing amazing and I hope it will continue when she is placed on xeloda--she is just happy she won't lose her hair again.  Granted she won't start for another couple of months, but it makes me breathe a bit better knowing she will be taking something. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Aug 26 2018 at 12:09pm
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 Elisa Quote  Post ReplyReply Direct Link To This Post Posted: Aug 24 2018 at 4:52am
Hi Ladies. I am now in my third cycle (2 weeks on, 1 off). My first cycle I was on 75% of the full dose, and the second and third 87,5%. This third cycle is really starting to get to me. Generally speaking I have a good amount of fatigue, constant low grade nausea (have pills for that and it’s ok), sporadic tummy issues, shakiness, a very difficult time sleeping (yay Ambien!) and now numbness on the bottoms of my feet and starting numbness in my fingers. And to boot? I am dumber than a box of hair. If I can remember my own name I feel like a winner! Talking to my oncologist today about dosage. It’s all in all still very tolerable, but I’m a hairdresser. So being on my feet and having to do my job well and interact is very difficult. I’ll update as time passes. Hope this helps.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Elisa Quote  Post ReplyReply Direct Link To This Post Posted: Jun 25 2018 at 4:15pm
THANK You Jen! I start next week for 6 months at 75% because i had so many reactions on the other chemos. Fingers crossed!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote JenAus01 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 15 2018 at 4:28am
Hello Michelle7 and Elisa, I've now finished my 5 cycle of Xeloda.  Its been 3 weeks on and 1 week off.  I am so grateful that my medical team have put me on the drug as the results from the Japanese study were very exciting.   I had positive lymph nodes after neoadjuvant treatment and was put on Xeloda 4 weeks after surgery, mastectomy and full reconstruction.   

In answering your question.   I have tolerated it well, I work as a teacher and have been working full time.   The first two cycles I experienced tiredness and in the second week of the cycle trouble sleeping.  The cycles there after, dryness of my hands and feet, with blisters (not terribly painful).  My fifth cycle, I've had diarrhea and my fingers cuticles bleeding, possibly from the dryness.   I have been using an assortment of creams including urea creams, but have found regular cooking olive oil massaged in the best.   Everyone reacts differently, but overall compared to AC and Taxol Chemo, its very tolerable.   Oh and my hair has continued growing!!!  
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Post Options Post Options   Thanks (0) Thanks(0)   Quote michelle7 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 12 2018 at 8:20pm
I am on radiation right now and will be starting oral chemo, Xeloda, in three weeks.  I, too, would like to know your experiences on it.  Does everyone suffer the hand foot issues?  How badly?  Did you lose your hair?  My hair is just starting to grow back after six months of chemo that I have been off for a couple of months.  Thank you for replying.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote michelle7 Quote  Post ReplyReply Direct Link To This Post Posted: Jun 12 2018 at 8:19pm
I am on radiation right now and will be starting oral chemo, Xeloda, in three weeks.  I, too, would like to know your experiences on it.  Does everyone suffer the hand foot issues?  How badly?  Did you lose your hair?  My hair is just starting to grow back after six months of chemo that I have been off for a couple of months.  Thank you for replying.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Elisa Quote  Post ReplyReply Direct Link To This Post Posted: May 23 2018 at 11:24am
Hello Ladies!
It looks like I will be doing oral chemo after surgery due to having to stop T after some nasty side effects. Can any of you tell me of your experiences on oral chemo?
Hugs from Copenhagen,
Elisa
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Nov 14 2017 at 8:10am
Bumping for new members

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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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 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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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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