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Topic: Genome web “paywall” to access important BC articles?

Forum: Clinical Trials, Research News, Podcasts, and Study Results —

Share your research articles, interpretations and experiences here. Let us know how these studies affect you and your decisions.

Posted on: Jan 12, 2017 07:06PM

ChiSandy wrote:

Anyone else here infuriated by Genome Web’s policy of requiring a costly premium-content subscription in order to read latest important articles about breast cancer research & treatments? I subscribe to their e-mail newsletter(s)—several per day—and when the occasional article about latest developments in genetics and how it affects breast cancer appears in one of those newsletters, I click on the link…and more often than not, am confronted by a big blue box obscuring the article, informing me that I need a premium-content subscription for which I can buy a “free trial” for just $95 for a couple of months. (How is that a “free trial,” unless the regular price is even higher)?

Dunno about you, but I resent the hell out of being told that in order to timely read about things that might affect my treatment and the course of my bc, I must pay a ransom. Told the Mods. about this and they’re looking into it.

Diagnosed at 64 on routine annual mammo, no lump. OncotypeDX 16. I cried because I had no shoes...but then again, I won’t get blisters.... Dx 9/9/2015, IDC, Right, 1cm, Stage IA, Grade 2, 0/4 nodes, ER+/PR+, HER2- (IHC) Surgery 9/23/2015 Lumpectomy: Right Radiation Therapy 11/2/2015 3DCRT: Breast Hormonal Therapy 12/31/2015 Femara (letrozole)
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Jan 12, 2017 07:18PM JuniperCat wrote:

Yes, I've found this to be pretty vexing. A couple of times I've requested an abstract but have received no response. Irksome

Dx 2015 stage 1A IDC 1.5cm ER+ PR- HER2-
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Jan 12, 2017 07:20PM JuniperCat wrote:

For instance, this looks compelling: "German Report Sees No Benefit From Genomic Breast Cancer Tests for Chemo Decisions," however, access to it depends upon a subscription

Dx 2015 stage 1A IDC 1.5cm ER+ PR- HER2-
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Jan 12, 2017 10:18PM ChiSandy wrote:

Yup, that’s the very article—and paywall to read it--that was the last straw. (Apparently, the article is b.s., simply bean-counting rather than real-world reasoning).

Diagnosed at 64 on routine annual mammo, no lump. OncotypeDX 16. I cried because I had no shoes...but then again, I won’t get blisters.... Dx 9/9/2015, IDC, Right, 1cm, Stage IA, Grade 2, 0/4 nodes, ER+/PR+, HER2- (IHC) Surgery 9/23/2015 Lumpectomy: Right Radiation Therapy 11/2/2015 3DCRT: Breast Hormonal Therapy 12/31/2015 Femara (letrozole)
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Jan 12, 2017 10:35PM Jojo0529 wrote:

Also, it looks like oncotype was not considered. Mamaprint and others were reviewed, but not oncotype

ONCO 17 ....ki-67 25% miotic 1. Dx 7/30/2015, IDC, Right, 2cm, Stage IIA, Grade 2, 0/2 nodes, ER+/PR+, HER2- Surgery 8/20/2015 Lymph node removal: Sentinel; Mastectomy: Left, Right; Prophylactic mastectomy: Left Chemotherapy 9/3/2015 Cytoxan (cyclophosphamide), Taxotere (docetaxel) Hormonal Therapy 12/1/2015 Arimidex (anastrozole) Surgery 1/11/2016 Prophylactic ovary removal; Reconstruction (left): Silicone implant, Tissue expander placement; Reconstruction (right): Silicone implant, Tissue expander placement
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Jan 13, 2017 11:10AM - edited Jan 13, 2017 11:45AM by BarredOwl

The GenomeWeb article probably relates to the publication of an assessment and recommendation in connection with a decision regarding health cost reimbursement for biomarker tests in Germany. The assessment was prepared by Germany's Institute for Quality and Efficiency in Healthcare ("IQWiG"). The recommendation will be considered by a decision-making body.

Per Agendia, the group that prepared the IQWiG the assessment "decided not to recommend the reimbursement of [certain] gene expression-based tests for breast cancer recurrence". However, it appears that their recommendation was slated to be considered by a decision-making body, the Federal Joint Committee ("G-BA"):

"It is expected that the G-BA will publish their decision on the reimbursement of genomic assays after due and balanced consideration of all relevant aspects of the IQWiG report, written statements and an oral hearing, later this month."


IQWiG Press Release and Related Layperson Reports:

Here is an IQWiG press release discussing the IQWiG findings which focus on MammaPrint:

https://www.iqwig.de/en/press/press-releases/press-releases/biomarker-tests-in-breast-cancer-decision-on-chemotherapy-remains-difficult.7700.html

Here are two free articles regarding the IQWiG report and recommendation:

ScienceDaily, Dec. 29, 2016: "Biomarker tests in breast cancer: Decision on chemotherapy remains difficult - Preliminary MINDACT results allow evaluation of the disadvantages of omitting chemotherapy; little specific information on advantages"

https://www.sciencedaily.com/releases/2016/12/161229113441.htm

EurekAlert, Dec. 29, 2016: "Biomarker tests in breast cancer: Decision on chemotherapy remains difficult- Preliminary MINDACT results allow evaluation of the disadvantages of omitting chemotherapy; little specific information on advantages"

https://www.eurekalert.org/pub_releases/2016-12/ifqa-bti122916.php


Extract of the Final Report:

The complete report is a German-language document. An English-language "Extract of the Final Report" can be found here:

"[D14-01] Biomarker-based tests for the decision for or against adjuvant systemic chemotherapy in primary breast cancer"

https://www.iqwig.de/download/D14-01_Biomarkers-in-breast-cancer_Extract-of-final-report.pdf

This is the overall conclusion (bold font added by me):

"6 Conclusion

There is currently no hint of a benefit or harm of a biomarker-based strategy to support the decision for or against adjuvant chemotherapy in primary breast cancer. The data from 6 of the 8 studies included could not be used for the present benefit assessment due to the high proportion of patients not considered in the analyses. Thus only data from 2 RCTs could be used.

The study by Martin 2014 (10-year follow-up period) investigated the interaction between biomarkers and the type of chemotherapy regimen administered and did not show a benefit of the EndoPredict test for the choice between 2 chemotherapies.

The still ongoing MINDACT study is investigating the use of chemotherapy versus no chemotherapy in patients for whom the clinical-pathological assessment and the biomarker test result led to different recommendations (discordant results). The 5-year interim results do not indicate a benefit of a biomarker-based treatment decision by means of the MammaPrint test."

I cannot find any information regarding a final decision from G-BA.


Agendia Response:

Here are two related Press Releases from Agendia:

http://www.agendia.com/agendia-responds-to-iqwig-assessment-for-reimbursement-of-gene-expression-based-breast-cancer-recurrence-tests/

http://www.agendia.com/response-to-iqwig-assessment/


Layperson Impression:

Although the literature search and review included several biomarker tests in current clinical use to inform decisions about chemotherapy in hormone receptor-positive, HER2-negative disease with up to 3 positive nodes, it appears that only two studies were considered of sufficient quality for evaluation, one relating to EndoPredict and one relating to MammaPrint (i.e., MINDACT). The document does include some discussion of Oncotype studies, including Paik (2006), one of the clinical validation studies of OncotypeDX that is featured in the second section of the node-negative Oncotype report. It also refers to the ongoing TAILORx and WGS PlanB studies. While there are some interesting observations regarding the MINDACT results, others seem ludicrous***. My view is that the study has a relatively rigid approach and posture.

Regardless of what the final decision may be, I would suggest patients look to our local consensus guidelines, clinical trial publications, and obtain case-specific expert professional medical advice from their medical oncologist regarding the potential value of such tests in their particular case.

BarredOwl

*** "Data on patient preferences with regard to adjuvant chemotherapy in breast cancer have indicated that, even in the event of only a small proportion of avoidable recurrences, patients are prepared to accept the side effects of chemotherapy. If one looks at the hazard ratio and risk difference of the group difference for recurrences determined in the study, it is doubtful whether patients identified by the biomarker would opt against chemotherapy."

Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).
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Jan 13, 2017 11:19AM - edited Mar 26, 2017 03:05PM by BarredOwl

For those wishing to consult the actual MINDACT publication re MammaPrint, the recent publication can be accessed here:

Cardoso (2016): http://www.nejm.org/doi/full/10.1056/NEJMoa1602253

(The complete article, including all Supplementary Materials, is available for purchase.)

Please note that the Preview Content visible on the New England Journal of Medicine (NEJM) website is not the complete publication, and it is not a comprehensive description of the study, the published results, or the limitations of certain findings.

Hudis editorial (2016): http://www.nejm.org/doi/pdf/10.1056/NEJMe1607947

(The complete article is available for purchase)

Hunter perspective (2016) (Free): http://www.nejm.org/doi/pdf/10.1056/NEJMp1608282

You can purchase a one-day pass to the NEJM, download and save complete pdf copies of the Cardoso paper and the Hudis editorial (plus any other articles of interest to you). Be sure to access and save down pdf copies of the Supplementary Appendix to Cardoso and a copy of the MINDACT Protocol. The Supplementary Appendix contains a large amount of additional data and information and is essential material.

BarredOwl

UPDATE: Cardoso (2016) and all Supplementary Materials, including the Supplementary Appendix, are now available for FREE at the link above.

Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).
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Jan 13, 2017 11:42AM Moderators wrote:

Hi Chisandy and all,

Thanks for your inquiry and input.

We're sorry that you're finding GenomeWeb to be disappointing. To be honest, no one on our staff has heard of this website. It seems to be a small news organization based in New York City. However, since it doesn't give you access to much content, you might consider getting your news from other medical/oncology news sites that will give you complete summaries of research. More on that in a minute.

Our senior editor did some online searching and found what she believes is the report referred to in the GenomeWeb story. First, please know that it is a report, *not* a research study. The report was written by the Institute for Quality and Efficiency in Health Care, a group based in Germany, and came out at the end of December 2016. In summary, the report says that there is insufficient evidence that the MammaPrint test is helping women diagnosed with breast cancer as it claims to do. In essence, the report confirms German recommendations that the Oncotype DX test is the only genomic test for breast cancer that has been validated with prospective research. There is a story in The Nation here: http://www.nationmultimedia.com/news/life/living_health/30302417

The report is the German institute's reaction to preliminary results from the MINDACT study which were presented at the 2016 San Antonio Breast Cancer Symposium. We decided not to cover this presentation because it doesn't really make a strong case for the MammaPrint test and would not change what we have on the site about MammaPrint: http://www.breastcancer.org/symptoms/testing/types/mammaprint

According to our medical experts, most doctors prefer to use the Oncotype DX test because it has the strongest research behind it.

If you'd like to keep up with breast cancer research, we'd recommend the following sites:

All are free to access and all will send you daily briefings if you register, which is also free. In most cases, the news stories on these sites also will give you a link so you can see at least the abstract of the research study being reported on.

Also, we appreciate your suggestions on cross-posting our Research News stories and we will begin to make an effort to post appropriate stories in corresponding forums, so that they may be viewed by the members the stories can help.

Thank you and we hope this helps your quest for information.

Best,

--The Mods

To send a Private Message to the Mods: community.breastcancer.org/mem...
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Jan 13, 2017 11:56AM cp418 wrote:

Looks like this is the article... I take the title and do an online search to find another source. I will not PAY for this information!

https://medicalxpress.com/news/2016-12-biomarker-b...



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Jan 13, 2017 11:58AM BarredOwl wrote:

cp418:

It was covered in ScienceDaily and EurekAlert also, per my links above.

BarredOwl

Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).
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Jan 13, 2017 12:16PM MTwoman wrote:

BarredOwl,

" My view is that the study has a relatively rigid approach and posture." :) Having lived and worked as a Health Researcher in Germany for 6 years, I would suggest that your statement reflects the general tendency of German researchers in general and the authoritarian undertones (overtones) in the language, sadly enough, reflect the approach of many health care providers. :o Am very glad to be back, where I am part of my team.

Dx 12/10/2002, DCIS, Right, 1cm, Stage 0, Grade 2, 0/3 nodes, ER-/PR-, HER2- Surgery 12/20/2002 Lumpectomy: Right; Lymph node removal: Sentinel Surgery 12/23/2003 Reconstruction (right): Nipple reconstruction Surgery Reconstruction (right): Saline implant Surgery Reconstruction (right): Tissue expander placement Surgery Mastectomy: Right
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Jan 13, 2017 01:04PM - edited Jan 13, 2017 04:29PM by BarredOwl

Moderators and others:

Re the remark: "In essence, the report confirms German recommendations that the Oncotype DX test is the only genomic test for breast cancer that has been validated with prospective research."

I'm not sure what exactly you mean by "validated". Nor do I read the German IQWiG report as supporting Oncotype over any other test.

MammaPrint is supported by a large, fully prospective clinical validation trial (MINDACT). Whether the results of the trial (together with prior results) support the use of the MammaPrint test, or reliance upon the results of the test in clinical decision-making, in particular patient subgroups or in particular patients is a separate question.

I have posted several times on the distinction between what consensus guidelines may include versus what payors (governmental or private insurance) may choose to reimburse. These may not be coextensive. The fact that some German entity (which is not the deciding body, by the way) was not in favor of providing reimbursement for a particular test does not weigh very heavy in my mind, particularly if that test is within our local consensus guidelines.

In this regard, the relevant ASCO Biomarker Guideline was issued in early 2016, prior to the recent publication of the MINDACT results. NCCN guidelines (Version 2.2106) include the Oncotype test in the appropriate case, but also state that "Other prognostic multigene assays may be considered to help assess risk of recurrence . . . " The MammaPrint (70-gene test) and 2016 AACR abstract re MINDACT are reviewed in the Discussion section of the NCCN guidelines. Thus, by my reading, while NCCN guidelines may currently favor Oncotype, they do not provide for the exclusive use of any single biomarker test, and can be read to "include" MammaPrint in the appropriate case.

Regarding the German view about Oncotype, at least one German consensus guideline supports the use of OncotypeDX (per the press release below):

"German National Cancer Guidelines Distinguish Oncotype DX® as First and Only Multi-gene Breast Cancer Test with 1A Level of Evidence" (MARCH, 2016)

http://www.prnewswire.com/news-releases/german-national-cancer-guidelines-distinguish-oncotype-dx-as-first-and-only-multi-gene-breast-cancer-test-with-1a-level-of-evidence-300232981.html

"The latest update by AGO supports public reimbursement in Germany, one of our key European markets, and furthers international growth as we continue to bring precision medicine to breast cancer patients worldwide," said Jim Vaughn, R.Ph. Chief Commercial Officer, Genomic Health. "Together with a recently established access program by the National Health Service in Englandand existing public reimbursement for the Oncotype DX breast cancer test in Switzerland, Ireland, Greece and Spain, we continue to pioneer the delivery of value-based testing to healthcare systems across Europe."

It is a little ambiguous, but this seems to express the hope that incorporation of the Oncotype test into a German clinical consensus guideline should support a future decision in favor of reimbursement of the Oncotype test in Germany, such reimbursement already being approved in the listed nations. It should be appreciated that the above German guideline change also predates publication of the MINDACT trial results re MammaPrint in August, 2016.

It should be understood that this particular IQWiG Report (published December 5, 2016) did not recommend providing reimbursement for any biomarker test, including OncotypeDX.

As far as OncotypeDX, the IQWiG report is not very complimentary of Paik (2006), one of the clinical validation studies featured in node-negative Oncotype reports. Despite reviewing certain Oncotype-related publications, the report states that they were NOT USED in the present benefit assessment because of certain perceived deficiencies:

"The results of the prospective-retrospective study by Paik 2006 [re OncotypeDX] were based on less than 70% of the patients to be included in the analysis. These results were therefore not used in the present benefit assessment."

"The results of the 5 prognostic studies (Buus 2016, Filipits 2011, Fitzal 2015, Gnant 2014 and Sgroi 2013) were in each case based on less than 70% of the patients to be included in the analysis, so they were not considered in the present benefit assessment."

The main conclusions of the IQWiG report were posted by me earlier in this thread. The conclusions cannot fairly be read as supporting the superiority of Oncotype (or its validation) over MammaPrint or other tests. In fact, the IQWiG appears to take the position that it was MammaPrint (and not Oncotype) that had clinical evidence of sufficient quality to even permit an opinion to be formed.

BarredOwl

Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).
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Jan 13, 2017 01:06PM - edited Jan 13, 2017 01:08PM by BarredOwl

Hi MTWoman:

I think it reflects in part the tendency of public and private payors (in many countries) to apply standards that may tend to lean towards non-payment. It remains to be seen whether the deciding body will adopt the IQWiG recommendation.

BarredOwl

Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).
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Jun 3, 2019 10:40PM - edited Jun 3, 2019 10:52PM by ChiSandy

The dang GenomeWeb paywall is confounding me again--this time asking me for my "organization" and cc data before letting me get $95 90-day trial. I am itching to read this article that came out of this weekend's ASCO conference in Chicago. Anyone have access to this and can post it?:

One Year Post-TAILORx: Attitudes Shift and Questions Linger in Breast Cancer Recurrence Testing

(never mind, I found a link on Twitter. Nothing new--still no reports on continuing endocrine therapy after 5 yrs., which was what I thought a year later, access to the data in the study might address)

Diagnosed at 64 on routine annual mammo, no lump. OncotypeDX 16. I cried because I had no shoes...but then again, I won’t get blisters.... Dx 9/9/2015, IDC, Right, 1cm, Stage IA, Grade 2, 0/4 nodes, ER+/PR+, HER2- (IHC) Surgery 9/23/2015 Lumpectomy: Right Radiation Therapy 11/2/2015 3DCRT: Breast Hormonal Therapy 12/31/2015 Femara (letrozole)

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