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All TopicsForum: DCIS plus HER2-positive Microinvasion → Topic: Has treatment for cancer improved and how much?

Topic: Has treatment for cancer improved and how much?

Forum: DCIS plus HER2-positive Microinvasion —

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Posted on: Jan 24, 2018 04:46PM - edited Jan 27, 2018 07:49PM by Pipandor

Pipandor wrote:

I have undergone chemotherapy and immunotherapy and I sure hope they were effective but this article argues that progress has not been as great as the pharmaceuticjals would have us believe. An interesting overview that might interest the breast cancer.org community.

www.sarah-constantin.org/blog/2018/1/14/chemothera...


Dx 1/2016, IDC, Left, 1cm, Stage IA, Grade 3, 0/3 nodes, ER-/PR-, HER2+ (IHC) Surgery 2/5/2016 Lumpectomy: Left Chemotherapy 3/10/2016 Taxol (paclitaxel) Targeted Therapy 3/11/2016 Herceptin (trastuzumab) Radiation Therapy Whole-breast: Breast
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Jan 26, 2018 12:24PM VL22 wrote:

I’m obviously biased, but I think the “progress” made for those of us with TN is shameful

Dx 5/5/2017, IDC, Right, <1cm, Stage IA, Grade 1, 0/2 nodes, ER+/PR+, HER2- Surgery 6/15/2017 Lumpectomy: Right; Lymph node removal: Sentinel Dx 6/23/2017, IDC, Right, 1cm, Stage IB, Grade 3, 1/2 nodes, ER-/PR-, HER2- Chemotherapy 8/10/2017 AC + T (Taxol)
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Jan 26, 2018 12:52PM MelissaDallas wrote:

To make the link active, hit enter at the end of the link after you paste it in.

www.sarah-constantin.org/blog/2018/1/14/chemothera...


LCIS, extensive sclerosing adenosis, TAH/BSO & partial omentectomy for mucinous borderline ovarian tumor.
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Jan 26, 2018 01:03PM marijen wrote:

This is interesting from the article...

Palbociclib is a CDK4 and CDK6 inhibitor for ER-positive and HER2-negative advanced breast cancer. It increases progression-free survival from 10 months to 20 months but does not increase overall survival times (37.5 months with palbociclib + letrozole vs. 33.3 months with letrozole alone.)

Palbociclib aka Ibrance.

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Jan 26, 2018 01:07PM - edited Jan 26, 2018 01:21PM by BarredOwl

This Post was deleted by 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 26, 2018 01:57PM marijen wrote:

Here is more information on Ibrance

https://www.cancer.gov/types/breast/research/palbo...


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Jan 26, 2018 03:35PM - edited Jan 26, 2018 04:33PM by BarredOwl

The blog post linked above is neither comprehensive nor current regarding breast cancer drugs.

The sum total of the information on palbociclib in the blog post is the sentence quoted by marijen:

"Palbociclib is a CDK4 and CDK6 inhibitor for ER-positive and HER2-negative advanced breast cancer. It increases progression-free survival from 10 months to 20 months but does not increase overall survival times (37.5 months with palbociclib + letrozole vs. 33.3 months with letrozole alone.)"

The second citation is to an August 2014 review article that cites to a 2014 meeting abstract reporting results from "PALOMA-1/TRIO-18", a small Phase II trial performed in 165 patients, in which 84 were assigned to palbociclib plus letrozole and 81 to letrozole alone.

What the second citation actually says about overall survival is:

"An interim analysis of overall survival, based on 61 patients, showed a nonsignificant trend in favor of the combination (37.5 months versus 33.3 months, respectively; HR 0.813; P=0.2105), these data were immature, and final analysis is outstanding."

I find it interesting that the blogger failed to mention that this result was: (i) from a Phase II trial; (ii) based on only 61 patients; and (iii) was an interim analysis of overall survival, and that the assessment of overall survival was on-going at the time. Seems important.

These interim results from 61 patients simply do not support the blogger's statement that palbociclib "does not increase overall survival times." While a statistically significant improvement in overall survival was not demonstrated, such a result does NOT establish that the drug "does not increase overall survival times." It doesn't demonstrate an improvement, but it is not adequate to negate a possible overall survival benefit either.

As it happens, final overall survival from the Phase II PALOMA-1/TRIO-18 trial were published here are are not that different from the interim result:

Finn (2017), "Overall survival results from the randomized phase II study of palbociclib (P) in combination with letrozole (L) vs letrozole alone for frontline treatment of ER+/HER2– advanced breast cancer (PALOMA-1; TRIO-18)"

http://ascopubs.org/doi/abs/10.1200/JCO.2017.35.15_suppl.1001

"As of Dec 2016, there were 116 OS events. Median OS was 37.5 mos (95% CI: 31.4, 47.8) with P+L vs 34.5 mos (95% CI: 27.4, 42.6) for L (HR = 0.897 [95% CI: 0.623, 1.294]; P= 0.281)."

"In PALOMA-1, P+L provided a statistically non-significant trend towards an improvement in OS. Survival data from the phase III, PALOMA-2 study is awaited."

That said, Phase II trials in the advanced breast cancer setting typically are not designed to and are not capable of detecting a statistically significant improvement in overall survival, usually because their size limits statistical power. As noted here, the Phase II PALOMA-1/TRIO-18 trial "was not powered to look at overall survival."


As of this date, some results of Phase III trials are now available for palbociclib, including PALOMA-2 (a Phase III trial of palbociclib plus letrozole) here and PALOMA-3 (a Phase III trial of palbociclib plus fulvestrant) here and here, the latter noting that overall survival follow‐up in PALOMA-3 is in progress.

This Feb. 2017 feature notes that:

"While we do not yet have data for overall survival from any of the phase III trials of CDK4/6 inhibitors, the doubling in progression-free survival seen with the addition of CDK4/6 inhibition to endocrine therapy represents a breakthrough in the treatment of patients with metastatic hormone receptor–positive breast cancer."

Other CDK inhibitors are being evaluated, including abemaciclib and ribociclib. Here's an editorial from the scientific literature with a more favorable take on the achievements with respect to this class of drugs:

Griggs (2017), http://ascopubs.org/doi/full/10.1200/JCO.2017.73.9375

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 26, 2018 10:41PM jo6359 wrote:

BarredOwl-Thanks for the clarification. You are the best. You provide information which is well thought out. It is greatly appreciated. Thanks

Dx 1/29/2018, DCIS, Right, Stage 0 Dx 1/29/2018, IDC, Right, 2cm, Stage IIB, Grade 2, 1/18 nodes, ER-/PR-, HER2+ (FISH) Targeted Therapy 2/16/2018 Perjeta (pertuzumab) Targeted Therapy 2/16/2018 Herceptin (trastuzumab) Chemotherapy 2/16/2018 Carboplatin (Paraplatin), Taxotere (docetaxel)

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