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Old 04-25-2017, 08:56 AM   #1
Lani
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Lightbulb the future? MD Anderson trialon ~nonsurgical trtment of T1-2N0-1 her2+(&tn) br.cancer

Pathologic complete response to neoadjuvant therapy in certain breast cancer patients predicts low risk for local metastases


MD Anderson study identifies patients who may avoid nodal surgery after chemotherapy

MD Anderson News Release 04/19/2017

Select breast cancer patients who achieved pathologic complete response (pCR) after chemotherapy may be able to avoid follow-up breast and lymph node, or axillary, surgery, according to new findings from researchers at The University of Texas MD Anderson Cancer Center. The study, published today in JAMA Surgery, identifies the exceptional responders who are at lowest risk for local metastases and thereby are candidates for less invasive treatment options.

Worldwide, triple negative (TN) and HER-2 positive breast cancers account for about 370,000 women diagnosed annually, explains Henry Kuerer, M.D., Ph.D., professor of Breast Surgical Oncology and the study’s principal investigator. In as many as 60 percent of these patients, neoadjuvant chemotherapy (NCT), given as the primary treatment, can result in pCR, or absence of residual disease, in both the breast and axillary lymph nodes.

“This high rate of pCR naturally raises the question of whether breast surgery is required for all patients, particularly those who will receive adjuvant radiation,” said Kuerer. “An important secondary question in these exceptional responders is whether we can also omit axillary surgery to remove lymph nodes.”

In order to determine those patients for whom surgery may be avoided, it is necessary to accurately identify those with a pCR following NCT. However, standard breast imaging techniques were not capable of accurately predicting residual disease.

Recently Kuerer completed a clinical feasibility trial investigating the utility of image-guided biopsies to predict breast pCR. The preliminary results of that study, originally presented at the 2016 San Antonio Breast Cancer Symposium, revealed the technique to have 100 percent accuracy and 100 percent predictive value for determining residual disease following NCT.

“By doing the same image-guided, percutaneous needle biopsies after NCT that we do at time of diagnosis, our preliminary research revealed we can accurately predict which women will have a complete response,” said Kuerer. “With that knowledge, there’s an obligation to test whether no surgery, or ‘ultimate breast conserving therapy,’ is safe.”

The current study sought to determine if patients achieving a pCR following NCT also may avoid axillary surgery for nodal metastases in addition to breast surgery. The prospective single-institution cohort study enrolled 527 women with T1-T2/N0-N1 stage triple negative (264) or HER-2 positive (263) breast cancer treated at MD Anderson between January 2010 and December 2014.

All participants received NCT followed by standard breast and nodal surgery. Clinical staging was determined prior to NCT by core biopsy or fine-needle aspiration, followed by clinical examination, mammography and ultrasound of the breast and axilla. Breast pCR was defined as no residual disease at the time of surgery. Axillary pCR was defined as no evidence of metastatic carcinoma.

Overall, 36.6 percent of patients achieved a breast pCR, with a slightly higher rate among TN (37.5 percent) than HER-2 positive (35.7 percent) patients. Of patients presenting with N1 disease, 77 (32.5 percent) achieved a breast pCR compared to 116 of those with N0 stage disease (40 percent).

All 116 N0 stage patients with a breast pCR also achieved axillary pCR. Similarly, 89.6 percent of patients with N1 disease and a breast pCR were also free of nodal metastases. Overall, there were no significant differences between patients with TN and HER-2 positive breast cancers.

“In our study, patients achieving a breast pCR were more than seven times less likely to have residual nodal disease, with even more pronounced differences among patients presenting with N0 stage disease,” said Audree Tadros, M.D., fellow in Breast Surgical Oncology and the study’s lead author. “Based upon these findings, we anticipate women with initial node-negative disease may avoid breast and axillary surgery if they achieve a pCR after NCT and move on to standard radiotherapy.”

To investigate the efficacy and safety of this approach, MD Anderson’s Institutional Review Board has approved a Phase II clinical trial, which is now open at MD Anderson and will soon open within the MD Anderson Cancer Network®. The study is enrolling women with Stage I and II HER2-positive and TN breast cancer. Study participants who achieve image-guided, biopsy-proved pCR after NCT will undergo whole-breast radiation, without surgery. In those with initial, ultrasound-proven node-negative disease, axillary surgery will also be avoided. The trial will be the first using image-guided biopsies in this setting and not include surgery.

“There is an urgency to test whether surgery is needed. In conversations with my patients, many express concerns about overtreatment. They want the most personalized care with as minimal treatment as possible,” said Kuerer. “If some women are able to avoid unnecessary surgery, it would be groundbreaking for patients – both physically and psychologically.”

Additional authors on the all-MD Anderson study include: Dalliah M. Black, M.D., Anthony Lucci Jr., M.D., Abigail S. Caudle, M.D., Sara M. DeSnyder, M.D., Mediget Teshomem, M.D., Makesha Miggins, M.D., Rosa F. Hwang, M.D., and Kelly K. Hunt, M.D., all of Breast Surgical Oncology; Wei T. Yang, M.D, Gaiane M. Rauch, M.D., Ph.D., Beatriz E. Adrada, M.D., and Tanya Moseley, M.D., all of Diagnostic Radiology; Savitri Krishnamurthy, M.D., Pathology; Benjamin D. Smith, M.D., Radiation Oncology; and Vicente Valero, M.D., and Carlos H. Barcenas, M.D., Breast Medical Oncology.

The study was financially supported by the PH and Fay Etta Robinson Distinguished Professorship in Cancer Research and a Cancer Center Support Grant from the National Institutes of Health (CA16672).
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Old 04-26-2017, 08:27 PM   #2
SoCalGal
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Re: the future? MD Anderson trialon ~nonsurgical trtment of T1-2N0-1 her2+(&tn) br.ca

Makes perfect sense, doesn't it?
__________________
1996 cancer WTF?! 1.3 cm lumpectomy Er/Pr neg. Her2+ (20nodes NEGATIVE) did CMF + rads. NED.
2002 recurrence. Bilateral mastectomy w/TFL autologous recon. Then ACx2. Skin lymphatic rash. Taxotere w/Herceptin x4. Herceptin/Xeloda. Finally stops spreading.
2003 - Back to surgery, remove skin mets, and will have surgery one week later when pathology can confirm margins.
‘03 latisimus dorsi flap to remove skin mets. CLEAN MARGINS. Continue single agent Herceptin thru 4/04. NED.
‘04 '05 & 06 tiny recurrences - scar line. surgery to cut out. NED each time.
1/2006 Rads again, to scar line. NED.

3/07 Heartbreaking news - mets! lungs.sternum. Try Tykerb/Xeloda. Tykerb/Carbo/Gemzar. Switch Oncs.
12/07 Herceptin.Tykerb. Markers go stable.
2/8/08 gamma knife 13mm stupid brain met.
3/08 Herceptin/tykerb/avastin/zometa.
3/09 brain NED. Lungs STABLE.
4/09 attack sternum (10 daysPHOTONS.5 days ELECTRONS)
9/09 MARKERS normal!
3/10 PET/CT=manubrium intensely metabolically active but stable. NEDhead.
Wash out 5/10 for tdm1 but 6/10 CT STABLE, PET improving. Markers normal. Brain NED. Resume just Herceptin plus ZOMETA
Dec 2010 Brain NED, lungs/sternum stable. markers normal.
MAR 2011 stop Herceptin/allergy! Go back on Tykerb and switch to Xgeva.
May-Aug 2011 Tykerb Herceptin Xgeva.
Sept 2011 Tykerb, Herceptin, Zometa, Avastin.
April 2012 sketchy drug trial in NYC. 6 weeks later I’m NED!
OCT 2012 PET/CT shows a bunch of freakin’ progression. Back to LA and Herceptin.avastin.zometa.
12/20/12 add in PERJETA!
March 2013 – 5 YEARS POST continue HAPZ
APRIL 2013 - 6 yrs stage 4. "FAILED" PETscan on 4/2/13
May 2013: rePetted - improvement in lungs, left adrenal stable, right 6th rib inactive, (must be PERJETA avastin) sternum and L1 fruckin'worsen. Drop zometa. ADD Xgeva. Doc says get rads consultant for L1 and possible biopsy of L1. I say, no thanks, doc. Lets see what xgeva brings to the table first. It's summer.
June-August 2013HAPX Herceptin Avastin Perjeta xgeva.
Sept - now - on chemo hold for calming tummy we hope. Markers stable for 2 months.
Nov 2013 - Herceptin-Perjeta-Avastin-Xgeva (collageneous colitis, which explains tummy probs, added Entocort)
December '13 BRAIN MRI ned in da head.
Jan 2014: CONTINUING on HAPX…
FEB 2014 PetCT clinical “impression”: 1. newbie nodule - SUV 1.5 right apical nodule, mildly hypermetabolic “suggestive” of worsening neoplastic lesion. 2. moderate worsening of the sternum – SUV 5.6 from 3.8
3. increasing sclerosis & decreasing activity of L1 met “suggests” mild healing. (SUV 9.4 v 12.1 in May ‘13)
4. scattered lung nodules, up to 5mm in size = stable, no increased activity
5. other small scattered sclerotic lesions, one in right iliac and one in thoracic vertebral body similar in appearance to L1 without PET activity and not clearly pathologic
APRIL 2014 - 6 YRS POST GAMMA ZAP, 7 YRS MBC & 18 YEARS FROM ORIGINAL DX!
October 2014: hold avastin, continue HPX
Feb 2015 Cancer you lost. NEDHEAD 7 years post gamma zap miracle, 8 years ST4, +19 yrs original diagnosis.
Continue HPX. Adding back Avastin
Nov 2015 pet/ct is mixed result. L1 SUV is worse. Continue Herceptin/avastin/xgeva. Might revisit Perjeta for L1. Meantime going for rads consult for L1
December 2015 - brain stable. Continue Herceptin, Perjeta, Avastin and xgeva.
Jan 2016: 5 days, 20 grays, Rads to L1 and continue on HAPX. I’m trying to "save" TDM1 for next line. Hope the rads work to quiet L1. Sciatic pain extraordinaire :((
Markers drop post rads.
2/24/16 HAP plus X - markers are down
SCIATIC PAIN DEAL BREAKER.
3/23/16 Laminectomy w/coflex implant L4/5. NO MORE SCIATIC PAIN!!! Healing.
APRIL 2016 - 9 YRS MBC
July 2016 - continue HAP plus Xgeva.
DEC 2016 - PETCT: mets to sternum, lungs, L1 still about the same in size and PET activity. Markers not bad. Not making changes if I don't need to. Herceptin/Perjeta/Avastin/Xgeva
APRIL 2017 10 YEARS MBC
December 2017 - Progression - gonna switch it up
FEB 2018 - Kadcyla 3 cycles ---->progression :(
MAY30th - bronchoscopy, w/foundation1 - her2 enriched
Aug 27, 2018 - start clinical trial ZW25
JAN 2019 - ZW25 seems to be keeping me stable
APRIL 2019 - ONE DOZEN YEARS LIVING METASTATIC
MAY 2019 - progression back on herceptin add xeloda
JUNE 2019 - "6 mos average survival" LMD & CNS new single brain met - one zap during 5 days true beam SBRT to cord met
10/30/19 - stable brain and cord. progression lungs and bones. washing out. applying for ds8201a w nivolumab. hope they take me.
12/27/19 - begin ds8401a w nivolumab. after 2nd cycle nodes melt away. after 3rd cycle chest scan shows Improvement, brain MRI shows improvement, resolved areas & nothing new. switch to plain ENHERTU. after 4th cycle, PETscan shows mostly resolved or improved results. Markers near normal. I'm stunned but grateful.
10/26/20 - June 2021 Tucatinib/xeloda/herceptin - stable ish.
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