Breaking Research News from sources other than Breastcancer.org
Comments
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As of May 2019 TDM-1 is now used for residual disease after neoadjuvant treatment in early stage HER2+ BC.
I did also see a study that TDM-1 (Kadcyla) and Perjeta cuts Risk Reccurance in half compared to Herceptin/Perjeta. I'm not sure if that's for very small/low risk BS where they just give H/P without Chemo.
I am wondering if there isn't any eventual plan to replace TCHP and AC+THP with Kadcyla (instead of Herceptin)
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I am not aware of any standard protocols for giving H&P without a cytotoxin (chemo). (There may be instances in which physicans moderate or minimize the chemo for particularly frail or intolerant patients. There may have been clinical trials on this.)
Regarding "replace TCHP and AC+THP with Kadcyla," I personally think this would have many advantages; however, a recent clinical trial found that Kadcyla did not provide better outcomes than TCHP, nor was it deemed meaningfully less expensive, so they plan to make patients keep on getting TCHP. This assessment makes a huge error in appreciating patient experience, in my opinion. While "everyone is different" my experience of TCHP was on a different planet vs Kadcyla. Kadcyla was much easier for me to tolerate. Plus there is the issue of hair loss vs. not - which has implications beyond mere vanity. The trial was reported on this board. It would probably show up by searching for Kadcyla for early stage BC or something similar.
I thought AC was only given for TNBC now, but maybe that is not the case.
Thanks.
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BlueGirl: I'm still catching up from an overwhelming schedule. I know it is very frustrating. Sorry you are dealing with that. I am very disappointed that your/our legislative representatives are so unresponsive. The interview you mentioned sounds just heartbreaking. We all keep plodding along.
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" am not aware of any standard protocols for giving H&P without a cytotoxin (chemo). (There may be instances in which physicans moderate or minimize the chemo for particularly frail or intolerant patients. There may have been clinical trials on this.)"
I read a post here or maybe on a Facebook group I belong too where the person mentioned her IDC was so small the MO felt she didn't need Chemo, just a year of Herceprin. But honestly I can't recall if this was recent or an older post.
"thought AC was only given for TNBC now, but maybe that is not the case."
I went to 3 MOs (ended up going with the first one). 2 of the 3 told me TCHP. The 3rd gave me the option of TCHP or AC+THP. She said the results were the same but, TCHP had more toxicity. I was planning on doing Cold Capping which doesn't work well with AC+T. Plus the money of doing weekly taxol with Cold Capping would have been too expensive.😁
I'm happy to hear Kadcyla treated you better than TCHP that seems to be the majority sentiment on the Kadcyla thread. I didn't have any awful time with TCHP, tolerated it well but, I'm worried about 14 Cycles of Kadcyla since it's got Chemo in there. I'm hoping for a pCR when I get my surgery so I can avoid Kadcyla but, I'll do it if I have to, no question
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morrigan_2575: Good luck! Hope all goes well and you have no repeats!
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Lumpie - thank you so much for posting the results from the FAST-Forward trial aka “Hypofractionated Breast Radiotherapy for 1 Week Noninferior to 3 Weeks“. I just emailed my radiation oncologist about it (I’m still going through chemo but plan to start radiation in late July/August). This couldn’t come at a better time for so many given the costs (both real and time-related) and possible COVID-19 exposure from repeated visits to the clinic for radiation.
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sunandsea: Glad that is helpful. If widely adopted, that treatment option would be huge news for lots of people. Less travel, less time off work, and away from family and other obligations. Less reconstruction - or less going without reconstruction. Many forgo the less invasive option of lumpectomy because of challenges with accessing radiation therapy. We can hope that this may make the entire array of options more accessible to the people who need them. Good luck with your treatment!
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Off Target: Investigating the Abscopal Effect as a Treatment for Cancer
The abscopal effect occurs when radiation treatment—or another type of local therapy—not only shrinks the targeted tumor but also leads to the shrinkage of untreated tumors elsewhere in the body. Although the precise biological mechanisms responsible for the abscopal effect are still being investigated, the immune system is thought to play an important role.
https://doi.org/10.1186/s13014-016-0693-8. CC BY 4.0.
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Lumpie,
This is fascinating stuff. I've read about it before, but this is a great article. Thanks for posting!
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Pyrotinib or lapatinib plus capecitabine for HER2+ metastatic breast cancer (PHOEBE): A randomized phase III trial.
Lillie Shockney's takeaways:
Take-Home Message
- Patients with HER2+ metastatic breast cancer previously treated with trastuzumab and taxanes and/or anthracyclines were randomized to receive pyrotinib or lapatinib, and both arms received concomitant capecitabine. The median progression-free survival (PFS) was 12.5 months in the pyrotinib arm versus 6.8 months in the lapatinib arm (HR, 0.39; P < .0001). Common grade 3+ adverse events included diarrhea and hand–foot syndrome.
- Pyrotinib plus capecitabine was associated with significantly improved PFS compared with lapatinib and capecitabine in patients with pretreated HER2+ metastatic breast cancer.
Citation: J Clin Oncol 38: 2020 (suppl; abstr 1003)
DOI: 10.1200/JCO.2020.38.15_suppl.10030 -
Thanks BevJen, I thought so too. I was just this week looking at radiation as a Tx option so it really caught my attention. Sure would be great if they could pin down a way to get that immune response to it work reliably!
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Heat excites the Immune system and pushes cancer cells into being recognized by causing them to give off heat shock protein....
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Lumpie,
Thanks for your posts. I just had a chance to read the one about using radiation. That is very interesting and promising. I wish they could get studies\trials going on some of these findings. It just seems like some of the more promising things happening are still in the labs.
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Simone, I agree there seems to be a lot 'on the cusp' with promise, which is frustrating. Still other things are pretty well validated but hard to make $$ from so they never receive the gold standard of a double blind clinical trial. So they hover at the edge of breaking through to more widespread use but remain "untested".
Hyperthermia/ aka Heat is a very good immune activator, & is safe to healthy cells in a temp range that hurts cancer. And sometimes it can be self administered. If your lump is right by the surface of your skin, a hot hot water bottle will heat it up. External heat can penetrate into tissue, that's how Vets do it for dogs.
In clinical settings, ultrasounds can bring heat as well or probes or heating the whole body externally or heating the blood and recirculating it, or medically inducing a fever. Whatever the method, if the cancer cells hit 108+ for an hour, they die or get very damaged, giving off heat shock protein, and due to HSP they become recognizable by the immune system. Normal cells are good to about 112. So there is a range of temp safe to us but not cancer.
I did this to the point of magenta boob and armpit (mildly burned but not painful) throughout chemo. It took me about four months to fully go back to normal after chemo but healed perfectly. I think it helped me and it was easy to do while watching TV or chilling.
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Santabarbarian, Simone80 and others: It can seem discouraging that there is so much promise from bench research but things don't move to the clinical trial phase. As many of you know, Metavivor funds research on metastatic breast cancer. Someone from the organization said within the last week, there are promising proposals, just not enough funding for all of them. Other organizations fund promising research, too. Unfortunately, I am not able to fund much beyond lunch! But I try to do my part with small donations here and there and fundraising and advocacy work where I can. I don't have to tell readers here how important research is. I think if we all do a little, we can accomplish a lot.
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Important new research from England on DCIS:
Study Gives New Data on Long Term Risks of DCIS
(If that link doesn't work, please speak up and I'll provide another.)
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"Still other things are pretty well validated but hard to make $$ from so they never receive the gold standard of a double blind clinical trial. So they hover at the edge of breaking through to more widespread use but remain "untested"."
Isn't that the worst part?! 😕
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Liver Metastases–Directed Therapy in the Management of Oligometastatic Breast Cancer
- This study was designed to evaluate the outcome and toxicity of liver metastasis–directed therapy in the management of oligometastatic breast cancer. The rate of liver progression-free survival (LPFS) was 52.4% at 1 year and 38.8% at 2 years. The number of metastases predicted LPFS while PFS correlated with the use of systemic therapy prior to metastasis-directed therapy.
- Combination liver-directed therapy and systemic therapy resulted in durable disease control in patients with breast cancer and liver metastases.
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Surgical Intervention for Isolated Breast Cancer Liver Metastasis
- The authors of this study evaluated 148 women with isolated breast cancer liver metastases, comparing outcomes between the 95 patients who underwent intervention (hepatectomy or radiofrequency ablation) and the 53 who did not. After a median follow-up of 36 months, there was no significant difference in progression-free survival between the treatment groups in the overall population. Subgroup analyses suggested a benefit with surgical intervention among patients who received systemic therapy and did not have preoperative progression.
- Hepatic surgery should be considered as a treatment option for select patients with isolated breast cancer liver metastases.
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this is a better link to the British study on DCIS long term risk of invasive bc posted above by Hopeful82014 https://www.bmj.com/content/369/bmj.m1570
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New Clue to Anti-PD-L1 Activity in Breast Cancer?
— Survival benefit with durvalumab in patients with PDL1 copy number alteration
A novel biomarker identified a large subgroup of metastatic breast cancer patients who benefited from an immune checkpoint inhibitor....
Almost a fourth of patients with no identified actionable mutations had copy number alteration (CNA) in the PD-L1 gene. Patients without PD-L1 CNA had a median progression-free survival (PFS) of 9 months when treated with the PD-L1 inhibitor durvalumab (Imfinzi), whereas median PFS had yet to be reached in patients whose tumors had copy number gain (three or four copies) or amplification (more than four).
Data for the CNA analysis came from the SAFIR02 Breast Immuno trial...
https://cslide.ctimeetingtech.com/breast2020/attendee/confcal/session/calendar/2020-05-24
https://clinicaltrials.gov/ct2/show/NCT02299999
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First-Line Pembrolizumab Plus Chemotherapy Improved PFS in PD-L1–Positive mTNBC
Combining pembrolizumab with chemotherapy resulted in significant improvements in progression-free survival compared with chemotherapy alone among women with previously untreated PD-L1–positive metastatic triple-negative breast cancer (TNBC), according to results from the KEYNOTE-355 trial.
Cortes J, Cescon DW, Rugo HS, et al. KEYNOTE-355: Randomized, double-blind, phase III study of pembrolizumab + chemotherapy versus placebo + chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 1000.
ASCO conference reporting here:
{Seems like there are lots of PD-L1 studies in the news right now!}
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HCQ Linked to Harm in Cancer Patients
— Combination with azithromycin associated with three-fold risk of mortality, registry study shows
Use of hydroxychloroquine in cancer patients who are also diagnosed with COVID-19 provided no benefits, and may have worsened outcomes, researchers suggested.
Treatment with the combination of hydroxychloroquine and azithromycin to treat COVID-19 in cancer patients was associated with a 2.89-fold greater risk of 30-day mortality than use of neither drug, reported Jeremy Warner, MD, of Vanderbilt University in Nashville, in a late-breaker abstract at the virtual American Society of Clinical Oncology (ASCO) annual meeting.
ASCO conference coverage here:
https://www.medpagetoday.com/meetingcoverage/asco
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Patient Age, Use of Checkpoint Inhibitors in Cancer Linked to COVID-19 Severity
A study by researchers from the Memorial Sloan Kettering Cancer Center estimated that 40% of the 423 patients with cancer who were symptomatic for SARS-CoV-2 were hospitalized for COVID-19.1 Looking at these patients, the researchers identified several characteristics that conferred risk.
A multivariable analysis showed that patients 65 years or older and those who had been treated with immune checkpoint inhibitors (ICIs) within 90 days of admittance had a higher likelihood for hospitalization and severe disease. ***In contrast, receipt of chemotherapy within 30 days and prior major surgery did not increase the risk of developing the virus.*** {emphasis added}
These data were published online on medRxiv.org. The data were not peer-reviewed, and the results of the study should be considered preliminary.
"Until more extensive studies are available, it is prudent not to alter treatment decisions, but consider SARS-CoV-2 testing for patients initiating or continuing treatment with ICIs irrespective of symptoms."
Robilotti EV, Babady NE, Mead PA, et al. Determinants of severity in cancer patients with COVID-19 illness [preprint published online May 8, 2020]. medRxiv. doi: 10.1101/2020.05.04.20086322
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Thank you for sharing that Lumpie! it Is so good to have some studies/data about risks and cancer. And of course we owe gratitude for that information to our sisters and brothers who went into this unknown first
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Study Challenges the Association Between Surgical Margin Size and Breast Cancer Recurrence
Surgical margin size did not appear to be associated with locoregional recurrence for patients with breast cancer who underwent breast-conserving surgery and *neoadjuvant* chemotherapy, a retrospective, single-institution study found. The results were recently reported in BMC Cancer.
Patients with breast cancer who received neoadjuvant chemotherapy between January 2008 and April 2018 were identified from an institutional database.
Lin J, Lin K, Wang Y, Huang L, Chen SL, and Chen D. Association of surgical margins with local recurrence in patients undergoing breast-conserving surgery after neoadjuvant chemotherapy [published online May 20, 2020]. BMC Cancer. doi: 10.1186/s12885-020-06955-6
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Disconnect Between FDA Approval of Oncology Drugs and Publication of Results of Registration Trials
During 2000 to 2019, no peer-reviewed publication of registration trial results was available for nearly half of oncology drugs granted accelerated approval by the US Food and Drug Administration (FDA) at the time of authorization, according to findings of a retrospective study released as part of the ASCO20 Virtual Scientific Program.1
No systematic investigations have evaluated the timing of oncology drug registration trial publication relative to the approval of these drugs by the FDA.
Although package inserts include data from these studies, "FDA labels can be highly variable in the amount of information that they provide, and they rarely contain the information that is found in published manuscripts, in particular details such as the study protocol [and] inclusion and exclusion criteria,"
In their concluding remarks, the study authors noted that because "trial publications help with adoption of new treatments and mitigation of adverse effects … efforts are needed to ensure trial results are published in a timely manner."
- Khaki AR, Desai A, Schoen MW, et al. Timing of US Food and Drug Administration (FDA) cancer drug approvals relative to publication of clinical trial results. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 2071.
- HemOnc.org. https://www.hemonc.org/wiki/Main_Page. Accessed May 27, 2020.
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From the PALLAS trial: Ibrance for early stage hormone receptor positive breast cancer failed to meet the primary endpoint.
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Machine Learning Algorithm Predicts Financial Burden Due To Cancer Treatment
A machine-learning algorithm was able to predict the rate of financial stress on patients who underwent treatment for their breast cancer, according to a retrospective survey and algorithm-modeling study. These findings were presented during the ASCO 2020 Virtual Scientific Program.
The machine learning algorithm predicted financial burden with a high accuracy (83%), sensitivity (81%), and specificity (82%), and area under the receiver operating curve (0.82)
The study authors concluded that their machine learning model could accurately predict financial difficulties due to treatment of breast cancer. These predictions may aide in the decision-making process and that with careful planning, financial distress may be avoided. As financial toxicity is associated with poorer clinical outcomes, avoiding this stressor would ultimately lead to better quality of care.
Sidey-Gibbons C, Asaad M, Pfob A, Boukovalas S, Lin YL, Offodile. Machine learning algorithms to predict financial toxicity associated with breast cancer treatment. Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl):abstr 2047.
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