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Abraxane Superior To Taxol

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123Donna View Drop Down
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    Posted: Dec 16 2014 at 8:32am
Study shows superior activity for nab-paclitaxel vs paclitxel in early breast cancer

The German Breast Group (GBG) said nab-paclitaxel (ABRAXANE®) demonstrated significant benefit for patients with early high risk 
breast cancer when compared to conventional solvent-based paclitaxel. The findings are from the GeparSepto clinical trial sponsored by GBG and conducted together with the German AGO-B study group involving over 1200 patients, which is the largest randomized Phase III study ever completed with nab-paclitaxel and the first one completed in high risk early breast cancer. The results were presented by the coordinating investigator Michael Untch, M.D., Berlin at the 2014 San Antonio Breast Cancer Symposium.

The study found a statistically significant and clinically meaningful 9% absolute improvement from 29% to 38% (p=<0.001) in the pCR (pathological complete response) rate, when neoadjuvant (preoperative) chemotherapy was started with nab-paclitaxel instead of conventional solvent-based paclitaxel followed by epirubicin/cyclophosphamide given all before surgery. Pathological complete response after neoadjuvant treatment for breast cancer is a surrogate marker for long-term efficacy.

"The phase III study provided a head-to-head comparison of weekly nab-paclitaxel with weekly conventional paclitaxel followed by epirubicin/cyclophosphamide in both arms before surgery. Our findings clearly demonstrate nab-paclitaxel is superior to paclitaxel in achieving pCRs in early high risk breast cancer," Prof. Dr. Michael Untch.

"We observed the superior effect of nab-paclitaxel in patients with triple-negative disease (no presence of estrogen,progesterone and HER2 receptor), where the pCR almost doubled with nab-paclitaxel. This is a very important finding, as we know that pCR is most prognostic for outcome in this specific high risk subtype, which comprises about 15% of all breast cancers." highlighted Prof. Dr. Sibylle Loibl, Co-Chair of GBG.

Nab-Paclitaxel encapsulates paclitaxel in near-nano-sized albumin, protein shells. This leverages the natural transport properties of albumin, which allow for higher dose intensity and more drug at the tumor site, compared to solvent based paclitaxel while maintaining tolerability.

http://www.medicalnewstoday.com/releases/286842.php?tw

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 mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2014 at 8:43am
I always knew it.
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote LRM216 Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2014 at 1:52pm
Hello, my friends!  Today I found a few minutes to read and possibly post, lol! 
I'm not surprised by the study posted as my onc felt this way almost 6 years ago when I had my chemo.  I desperately wanted the Abraxane, for two reasons, one being that it didn't have side-effects as awful as taxol or taxotere, and the other reason was not having to be afraid of a deathly bad reaction to it, as with Taxol. 
Alas, my lovely Blue Cross/Blue Shield would not cover the cost of the drug, UNLESS I had a bad reaction to Taxol and lived through it (insurance companies are so understanding and compassionate!) as the drug, at least back then was also much more expensive than even the taxol or taxotere.
 
Anyhoo..... I want to wish everyone a wonderful, love-filled and serene Christmas or Hanukkah and pray the New Year treats each of us and ours kindly.
 
Linda
Linda - diagnosed at age 62
Diag 2/23/09 IDC 1.2 cent. IDC right breast,Stage 1, Grade 3,0/1 nodes - Triple Neg
4 DD AC every two weeks, 1 Dd Taxol, then 3 Taxotere every three weeks - rads x 33
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Post Options Post Options   Thanks (0) Thanks(0)   Quote mainsailset Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2014 at 3:25pm
So good to see you here again dear friend!
dx 7/08 TN 14x6.5x5.5 cm tumor

3 Lymph nodes involved, Taxol/Sunitab+AC, 5/09 dbl masectomy, path 2mm tumor removed, lymphs all clear, RAD 32 finished 9/11/09. 9/28 CT clear 10/18/10 CT clear
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Dec 16 2014 at 11:06pm
Hi Linda!  So good to see you again and that you are doing well.  You are so right, decisions are made based on cost, not what's necessarily best for the patient.  Sigh.
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 LRM216 Quote  Post ReplyReply Direct Link To This Post Posted: Dec 17 2014 at 3:24pm

Thank you Mainy and Donna!  I have been the proverbial "fly on the wall" for the past year - reading, but not posting too much - just due to lack of time.  By the time I get home from work, walk my dog, run a few errands - it's time to go to bed and hit the repeat button again for the next day to begin  (and I thank God everyday for that ability to hit that button!)!  Healthwise - all continues to be well - and long may it reign for all of us!  

 
Please know that you are all always in my heart and thoughts.

 

 
Linda - diagnosed at age 62
Diag 2/23/09 IDC 1.2 cent. IDC right breast,Stage 1, Grade 3,0/1 nodes - Triple Neg
4 DD AC every two weeks, 1 Dd Taxol, then 3 Taxotere every three weeks - rads x 33
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Aug 02 2019 at 4:56pm
Abraxane (NAB-Paclitaxel) Examined Against Solvent-Based Paclitaxel (Taxol) in Breast Cancer

Patients who took nanoparticle albumin-bound (NAB)-paclitaxel had significantly better invasive disease-free survival (iDFS) compared with those who took solvent-based (sb)-paclitaxel as neoadjuvant therapy for primary breast cancer.

Previously, NAB-paclitaxel was found to be more effective than sb-paclitaxel in metastatic breast cancer, and earlier results showed an improved pathologic complete response rate (pCR) in the early breast cancer setting.

 “Although in general individual patients with a pCR (pathologic complete rate) also have an improved disease-free survival and overall survival, on a study level a pCR increase does not always translate into a significantly better long-term outcome,” wrote study authors led by Michael Untch, MD, PhD, of Helios Klinikum Berlin-Buck in Germany. They reported the longer term iDFS outcome from the GeparSepto trial, first published online in May in the Journal of Clinical Oncology.

The study included a total of 1,206 patients, randomized to receive either 12-times weekly NAB-paclitaxel (606 patients) or sb-paclitaxel (600 patients) in the neoadjuvant setting. Patients then received epirubicin plus cyclophosphamide, and those with HER2-positive disease also received trastuzumab and pertuzumab concurrently with chemotherapy. They were followed for a median of 49.6 months.

During the follow-up period, there were a total of 243 iDFS events, including 143 in the sb-paclitaxel group and 100 in the NAB-paclitaxel patients. The iDFS rate at four years was 84.0% with NAB-paclitaxel, compared with 76.3% with sb-paclitaxel, for a hazard ratio of 0.66 (95% CI, 0.51–0.86; P = 0.002). However, there was no significant difference with regard to overall survival, at 89.7% and 87.2%, respectively, for an HR of 0.82 (95% CI, 0.59–1.16; P = 0.260). Results were similar across subgroups.

Patients who achieved a pCR were less likely to experience an iDFS event, at 8.9% compared with 25.6% for those who did not achieve a pCR.

A total of 355 patients (29.4%) reported grade 2–4 peripheral sensory neuropathy (PSN); 6.6% had grade 3–4 neuropathy during treatment. The median time to resolve grade 2–4 PSN to grade 1 was shorter in patients who received a NAB-paclitaxel dose of 125 mg/m2 compared to those who received 150 mg/m2; there was no difference between sb-paclitaxel and the 125 mg/m2 NAB-paclitaxel dose.

“The long-term results support the use of NAB-paclitaxel 125 mg/m2 instead of sb-paclitaxel in patients with early BC,” the authors concluded.

In an editorial, Masey Ross, MD, MS, and Charles E. Geyer Jr., MD, of Virginia Commonwealth University School of Medicine in Richmond, noted the “strikingly consistent” results across triple-negative and HR-positive/HER2-negative subgroups. They wrote, though, that other trials have yet to demonstrate improvements in event-free survival or other outcomes with NAB-paclitaxel.

Nonetheless, the robust and clinically meaningful improvements in iDFS demonstrated with the dose and schedule employed in the GeparSepto trial, may still justify consideration of substitution of nab-paclitaxel for s-paclitaxel in neoadjuvant therapy for patients with higher-risk HER2-negative breast cancers,” they wrote.

https://www.cancernetwork.com/breast-cancer/nab-paclitaxel-examined-against-solvent-based-paclitaxel-breast-cancer

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 Kellyless Quote  Post ReplyReply Direct Link To This Post Posted: Aug 02 2019 at 11:43pm
@Monarch, look at this! She's got a possible drug interaction with the taxol, which she's scheduled to start in a month or so. The pharmacist brought it up in a clinic visit with the doctor and suggested the change to Abraxane. Thanks for posting Donna! 

The less issues with neuropathy is big as well. 
IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/16 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote sophie Quote  Post ReplyReply Direct Link To This Post Posted: Aug 02 2019 at 11:46pm
Thank you for the post ... I am glad that I switched from taxol after 1 dose due to severe side effect... this is good news!!!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Aug 28 2019 at 10:26pm
Massey oncologists echo findings that suggest a modified drug combination may reduce risk of recurrence for some breast cancer patients

Oncologists at VCU Massey Cancer Center were invited to co-author an editorial published in the Journal of Clinical Oncology providing expert commentary on findings from a large study conducted by German investigators that a modified drug combination may lead to a decreased chance of disease recurrence for women with high risk, HER-2 negative breast cancer.

Masey Ross, M.D., medical director of the Integrative Health Program and breast medical oncologist at Massey, and Charles Geyer, Jr., M.D., associate director for clinical research, Harrigan, Haw, Luck Families Chair in Cancer Research and breast medical oncologist at Massey, shed an optimistic light on the potential for a shift in the treatment protocol for an important subset of patients with early breast cancer.

Neoadjuvant chemotherapy (given before surgery) is the current standard of care for most women with lymph node positive or high risk, lymph node negative breast cancer. The regimen typically includes the use of the solvent-based drug paclitaxel (Taxol), which often contributes to allergic reactions and nerve damage in many patients.

Research reported by the German Breast Group (GBG) in 2016 had demonstrated that the substitution of the albumin-based drug nab-paclitaxel (Abraxane) instead of Taxol prior to surgery improved  chances for a complete pathologic response at the time of surgery in patients with triple negative breast cancer, but not with other disease subtypes. A complete pathologic response refers to the elimination of all invasive cancer in the breast and lymph nodes.

Nab-paclitaxel was initially approved as a treatment for metastatic breast cancer in 2005.

New findings published by the GBG revealed that the groups of patients who received nab-paclitaxel [Abraxane] instead of the standard paclitaxel [Taxol] before surgery experienced improved long-term outcomes, meaning more of them were alive and disease-free following their surgery. This was found to be the case for women with triple negative, hormone receptor positive and HER-2 positive breast cancers.

These findings challenge a prevailing viewpoint in oncology by suggesting that drugs that aren’t effective in increasing the percentage of complete pathologic responses could still result in better long-term outcomes.

“The study is interesting because it makes us rethink whether drugs administered prior to surgery that do not improve chances of having a complete response should be discarded under the assumption that they will not decrease a patient’s risk of recurrence after surgery,” said Ross, who is also an assistant professor of internal medicine at the VCU School of Medicine.

While the GBG findings indicate that nab-paclitaxel was more effective than standard paclitaxel for breast cancer patients across the board, Geyer and Ross believe that these study results could be particularly important for one breast cancer subtype over the other types.

“In our opinion, this information is most applicable in women with hormone receptor positive, HER-2 negative breast cancer,” said Geyer, also a member of the Developmental Therapeutics research program at Massey and a professor of internal medicine at the VCU School of Medicine. “We feel it may not be particularly relevant for patients with HER-2 positive breast cancer because substantial improvements in HER-2 directed therapies co-administered with chemotherapy in this subset have occurred since the German study finished accruing patients.  The improvements seen with nab-paclitaxel came at a cost of increased rates of neuropathy, and alternative approaches available for patients with HER-2 positive breast cancer are associated with less neuropathy.”

Neuropathy, a debilitating form of nerve damage, may prevent HER-2 positive breast cancer patients from being able to tolerate subsequent administration of highly effective drugs such as T-DM1 that are significantly beneficial for women who did not have a complete pathologic response at the time of surgery.

For triple negative breast cancer patients, some oncologists incorporate the use of a chemotherapy agent called carboplatin, which has been shown to improve chances for a complete response when administered before surgery. The study conducted by the GBG did not factor in the use of carboplatin; therefore, it remains unclear how nab-paclitaxel will interact with it for this patient group.

We suggest that physicians who do not incorporate carboplatin into treatment for women with triple negative breast cancer should consider nab-paclitaxel [Abraxane] over standard paclitaxel [Taxol],” Ross said.


https://www.massey.vcu.edu/about/news-center/2019-archive/massey-oncologists-echo-findings-that-suggest-a-modified-drug-combination-may-reduce-risk-of-recurrence-for-some-breast-cancer-patients




Edited by 123Donna - Aug 28 2019 at 10:27pm
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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