Gwinnett County mourns death of tax commissioner to breast cancer

GWINNETT COUNTY, Ga. (CBS46) — The Gwinnett County Tax Commissioner’s Office is mourning the passing of Tax Commissioner Tiffany P. Porter, Esquire.

A mother of four, 43-year-old Porter is survived by her children Tori, 15, Zoe, 17, Nia, 20, and Brandon, 23. She faced multiple bouts of breast cancer, but ultimately succumbed to the illness.

Porter acted as Tax Commissioner for 16 months. During this time she was responsible for implementing multiple service advancements for the department. Under her guidance, Gwinnett citizens benefited from the ability to set appointments at any office, skipping wait times, while her 160-member staff enjoyed her fun-loving and intelligent leadership style.

Porter’s career was one marked by firsts. She was the first in her family to receive a college degree, law degree, and to pass the bar exam. She was the first African American judge at the Duluth Municipal Court before ultimately becoming the first African American Tax Commissioner in Gwinnett’s history.

Her successes even crossed over into television, where she spent four years as a regular guest legal analyst on Court TV programming. Porter also founded two private-practice law firms during her career.

“Ms. Porter overcame many obstacles to achieve the ambitious goals she set for herself,” Chief Deputy Denise Mitchell said. “I will always remember her as a strong, resilient, brilliant spirit, and all the joy she brought to us. We will miss her.”

Mitchell will act as Tax Commissioner following Porter’s passing, completing the remainder of her term through December 31, 2024.

The Tax Commissioner’s Office is scheduled to be closed on the day of Porter’s service, the date of which has yet to be determined. Stay with CBS46 for updates as they become available.

Soluble B7H3 level in breast cancer and its relationship with clinicopathological variables and T cell infiltration


Aim of the study:

Although early diagnosis of breast cancer (BC) is often associated with a good prognosis, there is currently no biomarker with high sensitivity serving this purpose. B7H3, a recently identified member of the B7 family, appears to inhibit antitumor immunity. We investigated the soluble B7H3 (sB7H3) level in BC and its relationship with clinicopathological variables and stromal tumor-infiltrating lymphocytes (sTILs).


Material and methods:

The study, which was designed as a cross-sectional trial between January 2020 and September 2021, included 93 BC patients, 20 patients with benign breast disease (BBD) and 14 healthy volunteers as the control group. Serum sB7H3 levels were measured using the ELISA (enzyme-linked immunosorbent assay) method and sTILs were measured by immunohistochemistry using Tru-cut biopsy materials.


Results:

sB7H3 levels in BC patients were significantly higher than those in patients with BBD and healthy volunteers. Receiver operating characteristic curve analysis results showed that sB7H3 level may be a potential biomarker for distinguishing patients with BC from those with BBD (AUC: 0.807; sensitivity: 0.786; specificity: 0.706) and from healthy volunteers (AUC: 0.731; sensitivity: 0.700; specificity: 0.692).


Conclusions:

To the best of our knowledge, the present study is the first to investigate the relationship between sB7H3 and disease parameters in BC. We found that sB7H3 may be a clinically practical and meaningful biomarker in differentiating BC from BBD. In order to evaluate the relationship of B7H3 with clinical variables in BC, and especially with sTILs, tissue-based studies with higher numbers of patients are needed.


Keywords:

B7 ligand family; immune checkpoint; stromal tumor-infiltrating lymphocytes.

Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by the Food and Drug Administration (FDA) was based on positive results from the DESTINY-Breast03 Phase III trial that showed Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) (hazard ratio [HR] 0.28; 95% confidence interval [CI]: 0.22-0.37; p<0.0001) in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The approval was granted under the FDA’s Real-Time Oncology Review (RTOR) programme and converts the accelerated approval of Enhertu in later line HER2-positive metastatic breast cancer to standard approval, broadening Enhertu’s breast cancer indication in the US to earlier lines of use in patients with HER2-positive metastatic breast cancer.

Erika Hamilton, MD, Director of the Breast Cancer and Gynecological Cancer Research Program for Sarah Cannon Research Institute, Nashville, Tennessee, US, said: “Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2-positive metastatic breast cancer. Today’s approval is an important milestone for the clinical community as we will now be able to offer Enhertu to these patients earlier in their treatment.”

Catherine Ormerod, Executive Vice President, Strategy and Mission, Living Beyond Breast Cancer, said: “This is an important day for the breast cancer community. With this approval, Enhertu now provides a new treatment option for patients with HER2-positive metastatic breast cancer which can be used earlier in treatment to potentially delay progression of disease.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Enhertu is already established in the later-line treatment of patients with HER2-positive metastatic breast cancer, and we are thrilled that with this approval, patients in the US will now be able to access the transformative potential of Enhertu earlier in their treatment. We look forward to bringing this important, potentially paradigm-shifting medicine to even more patients across the globe in an earlier setting as quickly as possible.”

Ken Keller, Global Head, Oncology Business and President and CEO, Daiichi Sankyo, Inc, said: “Today’s FDA approval, which converts the accelerated approval of Enhertu to regular approval, highlights the importance of the FDA’s accelerated pathway that allows for earlier approval of medicines to treat serious medical conditions such as breast cancer. Data from DESTINY-Breast03 not only confirmed the results of DESTINY-Breast01, but also demonstrated the superiority of Enhertu in prolonging progression-free survival compared to T-DM1 in an earlier setting of HER2-positive metastatic breast cancer.”

The DESTINY-Breast03 Phase III trial results were recently published online in The New England Journal of Medicine.1 In the trial, the safety profile of Enhertu was consistent with previous clinical trials, with no new safety concerns identified and no Grade 4 or 5 treatment-related interstitial lung disease events.

Based on the DESTINY-Breast03 data, fam-trastuzumab deruxtecan-nxki (Enhertu) recently was added to the NCCN Clinical Practical Guidelines in Oncology (NCCN Guidelines®) as the Category 1 preferred regimen as second-line therapy for recurrent unresectable (local or regional) or Stage IV HER2-positive disease.2

The US regulatory submission was reviewed under Project Orbis, which provides a framework for concurrent submission and review of oncology medicines among participating international partners. Five national health authorities collaborated with the FDA on this review, including the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency (ANVISA), Health Canada, Israel’s Ministry of Health Pharmaceutical Administration and Switzerland’s Swissmedic.

This approval follows the recent Priority Review and Breakthrough Therapy Designation of Enhertu in the US in this earlier setting.

Regulatory applications for Enhertu are currently under review in Europe, Japan and several other countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen based on the results from the DESTINY-Breast03 trial.

Notes

Financial considerations
Following this approval for Enhertu in the US, an amount of $100m is due from AstraZeneca to Daiichi Sankyo as a 2nd-line milestone payment in HER2-positive metastatic breast cancer. In AstraZeneca, the milestones paid will be capitalised as an addition to the upfront payment made in 2019 and subsequent capitalised milestones and amortised through the profit and loss.

Sales of Enhertu in the US are recognised by Daiichi Sankyo. AstraZeneca reports its share of gross profit margin from Enhertu sales in the US as collaboration revenue in the Company’s financial statements. For further details on the financial arrangements, please consult the collaboration agreement from March 2019.

HER2-positive breast cancer
Breast cancer is the most common cancer and is one of the leading causes of cancer-related deaths worldwide and in the US.3,4 More than two million patients with breast cancer were diagnosed in 2020, with nearly 685,000 deaths globally.3 More than 290,000 new cases are expected in the US in 2022, with more than 43,000 deaths.5 Approximately one in five cases of breast cancer are considered HER2-positive.6

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumours including breast, gastric, lung and colorectal cancers.7 HER2 protein overexpression may occur as a result of HER2 gene amplification and is often associated with aggressive disease and poor prognosis in breast cancer.8

Despite initial treatment with trastuzumab and a taxane, patients with HER2-positive metastatic breast cancer will often experience disease progression.9 More treatment options are needed to further delay progression and extend survival.9-11

DESTINY-Breast03
DESTINY-Breast03 is a global, head-to-head, randomised, open-label, registrational Phase III trial evaluating the efficacy and safety of Enhertu (5.4mg/kg) versus T-DM1 in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab and a taxane.

The primary efficacy endpoint of DESTINY-Breast03 is progression-free survival (PFS) based on blinded independent central review. Secondary efficacy endpoints include overall survival, objective response rate (ORR), duration of response, PFS based on investigator assessment and safety.

DESTINY-Breast03 enrolled approximately 500 patients at multiple sites in Asia, Europe, North America, Oceania and South America. For more information about the trial, visit ClinicalTrials.gov.

Enhertu
Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

Enhertu (5.4mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy, based on results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is also approved in approximately 40 countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens based on the results from the DESTINY-Breast01 trial.

Enhertu (6.4mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

Enhertu development programme
A comprehensive development programme is underway globally, evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers, including breast, gastric, lung and colorectal cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.

Regulatory applications for Enhertu are currently under review in Europe, Japan and several other countries for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2 based regimen based on the results from the DESTINY-Breast03 trial.

Enhertu was granted Breakthrough Therapy Designation in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy, based on the results of the DESTINY-Breast04 trial. Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy.

Enhertu is also currently under review in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy, based on the DESTINY-Lung01 trial, and in Europe for the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior anti-HER2-based regimen based on the DESTINY-Gastric01 and DESTINY-Gastric02 trials.

Daiichi Sankyo collaboration
Daiichi Sankyo Company, Limited (TSE:4568) [referred to as Daiichi Sankyo] and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu (a HER2-directed ADC) in March 2019, and datopotamab deruxtecan (DS-1062; a TROP2-directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation oral selective oestrogen receptor degrader (SERD) and potential new medicine camizestrant.

PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in HER2-negative early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease.

Building on the first approval of Enhertu, a HER2-directed ADC, in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings.

To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, evaluating the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

Contacts
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Novartis’ Kisqali Adds Years to Breast Cancer Patients’ Lives

Courtesy of Cristina Arias/Getty Images

On Monday morning, Novartisannounced positive news for patients with metastatic breast cancer. New data showed Kisqali (ribociclib), in combination with the chemotherapy drug fulvestrant, added nearly 16 months of survival benefit to the lives of patients compared to fulvestrant alone. 

Novartis posted follow-up data from its Phase III Monaleesa-3 study that showed Kisqali and fulvestrant provided the additional lease on life as a first-line treatment for postmenopausal women diagnosed with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Novartis said Kisqali is the only CDK4/6 inhibitor-fulvestrant combination to demonstrate an overall survival benefit in this first-line setting.

The data is expected to be presented at the 2022 European Society of Medical Oncology (ESMO) Breast Cancer Congress. The final overall survival analysis demonstrated a statistically significant OS benefit. Also, the data showed the combination therapy offered a relative reduction in the risk of death by 28% compared to fulvestrant alone in the full population.

Jeff Legos, executive vice president and global head of oncology and hematology at Novartis, hailed the overall survival results from Monaleesa-3. Legos described the results as “remarkable.”

“The unique profile of Kisqali continues to be reinforced, with results from Monaleesa-3 pushing the boundaries of how using a Kisqali-combination treatment regimen can extend lives of postmenopausal women living with HR+/HER2- advanced breast cancer without compromising quality of life,” Legos said in a statement.

Novartis said Kisqali remains the only CDK4/6 inhibitor that has shown the longest median overall survival reported, and with consistent overall survival benefit across three Phase III trials. These results are regardless of combination partner, line of therapy, menopausal status, or site and number of metastases, the company said.

Kisqali was first approved by the FDA in March 2017 as a first-line treatment for postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

The updated analysis from Monaleesa-3 showed the combination of Kisqali plus fulvestrant provided patients with 67.6 months median overall survival, compared to 51.8 months for those patients who were treated with fulvestrant alone. Also, patients treated with the combination experienced more than one-and-a-half years of additional delay to subsequent use of chemotherapy, 49.2 months compared to 29 months, respectively, the company said.

The extended follow-up data showed that the estimated survival rate at five years was 56.5% for women who received the Kisqali fulvestrant combination as a first-line treatment compared to 42.1% for women who received fulvestrant alone. Also, Novartis said 16.5% of patients in the Kisqali plus fulvestrant arm were still ongoing on therapy at this longer follow-up compared to 8.6% of those in the fulvestrant only arm. No new adverse events were observed in the study, the company said.

News blog, May 3: Shepparton gains from state budget; Three-time breast cancer survivor to complete Ultraman


Eid al-Fitr Albanian Mosque 2022 Rituals: The men take off their shoes before entering the Mosque.
Photo by
Youssef Saudie

Check back on the news blog throughout the day for all the latest headlines in the region.

Hello and good day,

Caitlyn Grant here. Tuesday is upon us, and you know what that means ‒ it’s hump-day eve.

Today we’re looking at a relatively sunny day with a top of 21 degrees! Good day!

UPDATE, 5.30 pm: Goodbye

Have a lovely evening and get ready for hump day!

UPDATE, 5 pm: Celebrations take place for Eid al-Fitr

As the sun rose on Monday morning, Muslims in the Goulburn Valley woke up to Eid al-Fitr, the ‘Festival of Breaking the Fast’.

It is a two-day celebration marking the end of Ramadan, where people have been fasting from dawn to dusk throughout April.

Nicola Ceccato took to the GV Turkish Mosque to observe all the community celebrations, taking some lovely pictures of families connecting.

Youssef Saudie finished his four-part series on Ramadan with a trip to Shepparton’s Albanian Mosque.

“As hundreds of Muslims in their best clothes exited the mosque, people hugged, shared platters of food and made tea – with some women wearing painted henna tattoos.“

UPDATE, 4 pm: Big fish


They say monsters don’t exist, but look at this big ol’ fish and tell me otherwise.

Cooper Leeder reeled in what some may say is the catch of a lifetime, right in our own backyard ‒ the Murray River.

Bringing it in with only a small hook and 12-pound line, the 110cm Murray cod was a shock to all (and to me reading the article, realising if this fish wore heels we’d be the same height).

Read more on the big boy here, featuring a particularly solid line every fisherman can relate to.

“If the fish had made it off the hook, Mr Leeder admitted the 110cm probably would have been closer to 200cm.”

UPDATE, 2 pm: Budget continues

In a big win for independent member for Shepparton Suzanna Sheed, $25 million has been allocated to construct a 10-bed early parenting centre in Shepparton.

The centre will support families with children up to four years of age to enhance their relationships and achieve their parenting goals.

Ms Sheed has led the charge for the centre.


Budget: In a big win for independent member for Shepparton Suzanna Sheed, pushing for the change, $25 million has been allocated to construct a 10-bed early parenting centre in Shepparton.
Photo by
Rodney Braithwaite

UPDATE, 1.55 pm: Shepparton gains from state budget

Our chief correspondent Darren Linton has the low down on all things state budget, here’s a quick recap. Keep your eyes peeled for more to come.

· On top of the $196 million ‒ which includes a complete rebuild and expansion of the mental health unit at GV Health ‒ the Victorian budget has also delivered on more frequent and faster rail services for Shepparton.

· $250 million to deliver 12 new VLocity trains that will support more services on the Shepparton corridor and improve reliability for Warrnambool line passengers.

· The new trains will be manufactured in Victoria, supporting local employment and supply chain jobs – and improving passenger experience on the regional network.

· $5.8 million to continue joint land management of the Barmah National Park in partnership with the Yorta Yorta

· $9.2 million to continue the therapeutic court program, including the Shepparton Drug Court programs.

· An investment of $20 million will expand the Assessment and Referral Court (ARC), including at the Ballarat, Geelong and Shepparton Magistrates’ Courts.

There is also money for improvements to the Numurkah Rd and Graham Street intersection in Shepparton.

We’ll have more in tomorrow’s paper and online this arvo.


Shepparton gains: The Victorian budget has delivered on more frequent and faster rail services for Shepparton.

UPDATE, 12.30 pm: ‘Ultra’ challenge for Shepparton breast cancer survivor


Bittersweet: Mother’s Day Classic Shepparton ambassador Kylie Jones has survived breast cancer three times. She’s competing in the Ultraman on Mother’s Day weekend this year.
Photo by
Anna McGuinness

Three-time breast cancer survivor and Mother’s Day Classic Shepparton ambassador, Kylie Jones said she is feeling bittersweet about missing the annual event this year – instead she’ll be attempting her biggest ever endurance event, the Ultraman.

In 2018, a month after being declared cancer-free, Kylie was diagnosed with stage one breast cancer again.

“About 55 people are diagnosed with breast cancer every day and nine Australians die every day from it – those statistics are still fairly startling,” she said.

Read more on Kylie’s incredible story and strength here.

UPDATE, 8.45 am: Headlines to start the day

A re-elected Coalition Government will commit $25 million towards the upgrade and expansion of the Shepparton Sports Stadium to make it a modern sports and events centre in time for the 2026 Commonwealth Games.

In great news for us penny pinchers, the Victorian Government will give households a one-off $250 payment in the 2022-23 budget to help with rising cost-of-living expenses.

It is hoped a 12-week Shepparton research project will unearth answers on the effects of cannabis oils in cannabis users. Lachlan Durling reports here.

Not sure if you noticed last month, but apparently it was a wet one ‒ much wetter than usual, some may say. We had more than twice the average April rainfall for the past 26 years! Wild.


Rainy April: Last month was much wetter than usual for April in Shepparton.
Photo by
Megan Fisher

In national news, a nurse has told a Victorian coroner Yorta Yorta woman Veronica Nelson should have been immediately taken to hospital rather than a cell at a Melbourne women’s prison but a doctor refused.

A note from our editor

The daily News blog has been a way for our team to keep you updated hour-by-hour in the middle of a global pandemic.

While the continuing serious nature of the COVID-19 outbreak across the globe is not to be downplayed, the conversation has shifted from what do we do ‘now’ to what do we do ‘next’.

The need for analysis, in-depth coverage and exclusive content outweighs the ‘breaking’ nature of the news cycle, and with that comes the commitment of more resources to the daily blog.

It means that from Wednesday, May 4, this content will return to its place behind our paywall. For full digital access, subscribe to our ‘welcome’ bundle; it’s just $2 per week for 12 weeks Join | Shepparton News (sheppnews.com.au/join)

We’ve loved having you along for the ride as we explored a new way to deliver content to you directly – and we hope you will stay with us for the next step on the journey.

Tyler Maher, Shepparton News editor

‘Boobless Wonders’ sisterhood knits together a national community of breast cancer survivors

On the last Sunday of each month, 89-year-old Pat Anderson of Escondido gets together with the six other local senior women who make up her highly specialized knitting circle. But don’t let these ladies’ shared passion for knitting fool you into thinking they’re leisurely hobbyists.

Anderson is the founder of the Sisterhood of the Boobless Wonders, a group of breast cancer survivors who over the past five years have knitted and given away nearly 2,500 pairs of Busters, which are breast-shaped pillowlike bra inserts for women who have lost breasts to mastectomy surgery.

Anderson started the Busters project in 2017 as what she calls her last and largest knitting project in her 50-year career as a dedicated fiber designer. The widowed Minnesota native lost her breasts to cancer at the age of 74. During her recovery, she received a pair of silicone prosthetic forms to wear inside her bra but — like many women — she found the silicone forms were too heavy and they didn’t fit properly.

Pat Anderson, 89, far right, leads the Sisterhood of the Boobless Wonders, a group of seven senior lady knitters who are all breast cancer survivors.

(Lisa Hornak/For The San Diego Union-Tribune)

She tried putting rolled-up socks and bath scrubbers in her bra instead, and then gave up and wore nothing, but her clothes didn’t fit properly, so she decided to create her own knitted wardrobe accessories with acrylic and nylon yarn. The resulting pattern, which she has patented, has triangular knitted panels on top and a flat panel in the back with a hole in the middle that can be used to fill the Buster with enough polyfiber filling to fit any breast cup size.

Eager to share her creation with others, Anderson reached out to Sharp Memorial Hospital’s oncology patient navigators to get referrals for women who’d like a pair of Busters. As word spread nationwide about Anderson’s self-funded campaign, she has gradually recruited six other master knitters to the fold: Pat Moller, Jan Rillie, Pat Hamada, Ann Hornby, Bobbie Weiss and K.J. Koljonen.

The recruitment job has been a big challenge. Not only must the all-volunteer team members be professional-level knitters willing to give dozens of hours of their time each month to knit flawless Busters, they must also be breast cancer survivors. That’s the key, Anderson said, to being part of the Sisterhood of the Boobless Wonders, or SBW for short.

“They must be breast cancer survivors in order to be part of a team that is making a really significant difference in other women’s lives,” Anderson said. “When we are working on Busters, our entire mental, physical and emotional energy is focused on the project and we transfer that energy to the project through our hands.”

Anderson said it takes about eight hours to complete a set of Busters, which come in a variety of pretty pastel colors to brighten their wearers’ spirits. Whenever Anderson receives an order via email (spinshuttlestudio@gmail.com), she gets the owner’s size preference and address, gift wraps a set, puts it in a packing envelope and ships it immediately.

In the early years, Anderson covered all the yarn, packaging and shipping costs herself, but many recipients respond with a thank-you note and donation to pay forward the gift of Busters to another breast cancer survivor. Any cash donations left over at the end of the year after product costs are covered have been donated to Sharp Memorial Hospital.

Last year, after “PBS NewsHour” did a national story on the Sisterhood, so many Busters orders and donations poured in that Anderson had $9,600 in donations left over at year-end. She gave $6,100 to Sharp Memorial, $1,000 to KPBS Television and $2,500 to the Bay area chapter of Pink Ribbon Girls, a survivors-run movement that provides hot meals, housekeeping, babysitting, rides to appointments and other services to women undergoing breast cancer treatment.

The PBS report was a boon for Anderson’s knitting team, which was largely idled for much of the pandemic. Last month, Anderson shipped out 31 pairs of Busters. In the same month last year, she shipped just five pairs. Her goal is to get enough orders to keep the team engaged — they have a group goal of 82 pairs a month — so they have plenty of inventory available in all colors and cup sizes and no one has to wait more than a few days for a pair.

Anderson said many of her new clients over the past two years have ordered Busters because the small boutiques around the country that fitted and sold silicone prosthetics went out of business during the pandemic. Anderson said women could still shop online for these products, which can cost up to $300 per prosthetic, but they can’t test it out first. She said some of these silicone devices weren’t returnable and some women have had trouble filing the necessary paperwork to get reimbursed by their insurers.

Besides maintaining a steady stream of orders, Anderson has another goal — to recruit more knitters. She will turn 90 in September and two other knitters are also in their 80s. The youngest knitter is 68. Anderson is now making plans to train the other Busters knitters to share the responsibilities of purchasing materials, handling orders, shipping and charitable giving when she’s gone.

Recently, Anderson learned she was nominated for a community hero award at this summer’s San Diego County Fair. She was touched by the nomination and she’s proud of the work Busters has accomplished over the past five years.

“This is the culmination of all those 50 years that I spent working toward this,” she said. “It feels awfully good to see that this particular project, which is the most important one I’ve ever done, has made such a difference to so many people.”

To order Busters, email Anderson at spinshuttlestudio@gmail.com.

Biomarker Testing Will Fuel Next Wave of Treatment Innovations in Breast Cancer

Significant progress has shifted the treatment paradigm in various spaces within breast cancer, including therapy options for patients with HER2-positive metastatic breast cancer, hormone receptor (HR)–positive, HER2-negative breast cancer, and triple-negative breast cancer (TNBC). However, further advancements in treatment will derive from increased knowledge surrounding biomarkers in breast cancer, according to Christos Vaklavas, MD.

“We are increasingly recognizing that we have to understand the biology [of breast cancer] better. Our approaches have to be tailored to the biology of the cancer. Right now, we are using crude biomarkers, like PD-L1, or even before that, [estrogen receptor (ER) and] HER2,” Vaklavas said in an interview with OncLive® following an Institutional Perspectives in Cancer (IPC) webinar on breast cancer, which he chaired.

In the interview, Vaklavas discussed highlights from the meeting, including an increased emphasis on investigating tumor biology in breast cancer, plus the evolving treatment landscapes in HER2-positive breast cancer, HR-positive, HER2-negative breast cancer, and TNBC. He is the physician leader in breast cancer at the Huntsman Cancer Institute and an associate professor in internal medicine in the Division of Oncology at the University of Utah.

OncLive®: Your presentation focused on HR-positive, HER2-negative breast cancer. What are the pertinent updates in this space?

Vaklavas: The addition of CDK4/6 inhibitors to a backbone of endocrine therapy, whether it is letrozole, anastrozole, or potentially exemestane, has been associated with equal magnitude of benefit in progression-free survival. We have started seeing benefit in overall survival [OS], specifically with ribociclib [Kisqali]. We do not know what the pharmacologic underpinning of this benefit is specifically with ribociclib. Whether this is practice changing, or whether we should start prescribing ribociclib, we do not know yet. [These developments] are giving us confidence that the CDK4/6 inhibitors are associated with benefits in OS, although perhaps not all to the same extent.

The second takeaway [involves] oral selective ER degraders [SERDs], a new class of drugs coming around. The phase 3 EMERALD trial [NCT03778931] was positive with elacestrant, but we found that a second study, the phase 2 AMEERA-3 trial [NCT04059484] with amcenestrant was negative. This new generation of SERDs may be effective in patients who have ESR1 mutations, whether they arise [at diagnosis] or they arise as a consequence [of treatment], and [the latter] is considerably more frequent. Those mutations [tend] to arise because of therapeutic pressure with first-line therapy.

The third point [relates] to what is coming [down the pipeline]: a series of agents for patients [who] progress on 1, 2 or, even 3 lines of endocrine therapy. There are novel antibody-drug conjugates [that are being studied in] HER2-positive and HER2-low breast cancer. In the next few months with the announcements of those results, [treatment options] will settle.

Mei Wei, MD, of the University of Utah, spoke about early-stage and metastatic HER2-positive breast cancer. What are some of the updates we have seen there?

[New] HER2[-targeted agents] are moving [into the] second-line [setting]. Recently in the New England Journal of Medicine, we saw [updated data the phase 3 DESTINY-Breast03 trial [NCT03529110] with fam-trastuzumab deruxtecan-nxki [Enhertu] vs ado-trastuzumab emtansine [Kadcyla; T-DM1] in patients with HER2-positive breast cancer. [Trastuzumab deruxtecan] has been incorporated in the National Comprehensive Cancer Network guidelines, and, [potentially] soon, the FDA is going to approve trastuzumab deruxtecan as a second-line therapy in the metastatic setting.

Treatment in the third line and thereafter are still in flux right now. We know that tucatinib [Tukysa] probably has a leading edge in [patients] with brain metastases, but there is some emerging evidence that [trastuzumab deruxtecan] may be efficacious in patients with active brain metastases, as well. It has not been specifically looked at, but there are studies that are looking into it right now. [This could be] practice changing.

Right now, a taxane, trastuzumab [Herceptin], and pertuzumab [Perjeta] is the preferred first-line therapy in the metastatic setting. [There have been] no changes in the adjuvant or neoadjuvant setting yet. In the first-line metastatic setting, a taxane, pertuzumab, and trastuzumab have been associated with benefits in OS. However, a lot of studies are ongoing in [the first-line] space to challenge the dogma of a taxane, trastuzumab, and pertuzumab.

In DESTINY-Breast03, the rate of interstitial lung disease (ILD) was lower than it was in the phase 2 DESTINY-Breast01 trial (NCT03248492). What are some of the interventional and management strategies that led to that reduction?

Early recognition [was key]. An algorithm for the management [of ILD] and the aggressive discontinuation of [trastuzumab deruxtecan] with grade 2 or greater ILD brought the rate down to around 10%, which is not significantly different from [the rate in DESTINY-Breast01 of] about 13%. There is still a lot to be learned about ILD and [our management] algorithm. There is still a lot to learn about the natural history. [Does increased exposure to the drug] increase the risk of ILD? Is there something idiosyncratic, something special with those patients that they are developing ILD?

We need to understand it, and I do have patients that have ILD or lymphocytic carcinomatosis of the lung. At least up until recently, we were appalled at the idea of giving those patients HER2[-targeted therapy]. Now, I am a little bit bolder and give those patients HER2[-targeted therapy] with the idea that the disease will go into remission, and [we can] worry about ILD later.

Namita Chittoria, MBBS, of the University of Utah, focused on TNBC. What is important for practicing oncologists to know about advancements in this space?

The biggest advance in recent years is the approval of sacituzumab govitecan-hziy [Trodelvy] as a third-line therapy [for patients with unresectable locally advanced or metastatic TNBC who received 2 or more prior systemic therapies, with at least 1 of prior therapy for metastatic disease]. The data are compelling to use this drug in patients with metastatic breast cancer.

The second biggest advance or practice-changing development was the approval of pembrolizumab [Keytruda] in the adjuvant setting alongside carboplatin plus paclitaxel, followed by epirubicin and cyclophosphamide in patients with stage II or III, early-stage, nonmetastatic, TNBC. There are some developments in terms of the adjuvant setting, such as the phase 3 OlympiA trial [NCT02032823], which evaluated [adjuvant] olaparib [Lynparza] in patients with a germline BRCA1/2 mutation.

Moving to the presentation by Cristina DeCesaris, MD, of the University of Utah, on novel and de-escalation radiotherapeutic regimens in breast cancer, what would you say has emerged in this space?

The techniques are getting better, and they are getting safer. The biggest advance is that there are many clinical trials whose results are going to be practice-changing, because they’re incorporating biologic features of the disease captured with [the Oncotype DX test], primarily to escalate or de-escalate radiation therapy. [The field is] moving away from the one-size-fits-all [treatment approach] and is looking into the biology of the disease and accordingly tailoring [a patient’s] radiotherapeutic approach.

Do you have any anecdotal experiences with de-escalated therapy?

Our institution participates in the phase 2 I-SPY trial [NCT01042379]. Up until recently, the dogma was to complete a set of agents in the preoperative setting. I-SPY has pushed the envelope a little further, and with the use of MRI and biopsies, we get what is called a pre–residual cancer burden [RCB]. Pre-RCB [gives] the probability of having achieved complete pathologic response [pCR] based on the MRI and the tumor biopsy.

If the pre-RCB is high, the patient has a high likelihood of having achieved a pCR. Then they do not need to receive epirubicin and cyclophosphamide, the second half of the treatment. Thus far, with all the patients that we have subjected to pre-RCB, their pre-RCB [result] was consistent with [their achieving] a complete response. [In those cases,] we omitted the epirubicin and cyclophosphamide, and the patients underwent surgery.

Is there any ongoing or planned research at Huntsman Cancer Institute that you wanted to highlight?

The FORESEE trial [NCT04450706] that we are doing integrates the development of patient-derived xenografts and patient-derived organoids in patients with HR-negative breast cancer. [The study is examining] newly diagnosed patients with metastatic breast cancer––either TNBC [in the] first line or HR-positive, HER2-negative breast cancer that has exhausted endocrine options. We take a biopsy, and we generate patient-derived organoids. Those organoids are miniature reflections of the patient’s cancer, and we leverage those organoids to conduct medium-throughput drug screens.

We integrate the information we collect from those medium-throughput drug screens, [along] with circulating tumor DNA and tumor tissue DNA testing and compile a report that we share with the patient, with the most likely drugs that the patient will respond [to] as a second-line therapy.

We would like to foresee what the optimal treatment is for patients in the second line in metastatic TNBC or metastatic HR-positive, HER2-negative breast cancer that has exhausted all endocrine options, because right now, the choice of second-line therapy comes down to a little bit of guessing work. We [usually] give patients chemotherapy that the cancer has not seen before, assuming that these chemotherapies will have the best benefit. However, we call it functional precision oncology, because essentially, we move it one step further. We don’t look at the DNA and the RNA right now. We take snapshots of the genomic composition of the cancer. But we leverage those organoids to do medium-throughput drug screens.

What other questions are trying to be answered in clinical research in breast cancer?

Some of the questions have to do with what the future will bring and how all those novel therapies are going to be integrated. The phase 3 KEYNOTE-355 trial [NCT02819518] led to the current standard of care of chemotherapy with pembrolizumab. The key question that I have is whether we need to treat everybody with this intensive regimen vs spreading a few agents, spreading a few cycles, or spreading certain toxicities [over time] in patients who are going to do well either way. We as a scientific community are doing clinical trials to understand [that and] de-escalate therapy. We are not there yet, but hopefully we are going to get there.

How would you summarize all the advances that we have seen in breast cancer recently, where the field is now, and potentially where it is heading?

Now we are [relying more on] MammaPrint, OncotypeDX, next-generation sequencing, PIK3CA [mutation status], mutational burden, and mismatch repair proficiency or deficiency. All those biomarkers are increasingly having therapeutic implications. Advances in understanding the biology of breast cancer bring more biomarkers and more biomarker-driven therapeutic interventions [to patients].

Over 4 crore women have undergone breast screening for cancer detection under Ayushman Bharat: Irani

Minister for Women and Child Development Smriti Irani also raised the issue of bias against women workers in the pharma and healthcare industry

Minister for Women and Child Development Smriti Irani also raised the issue of bias against women workers in the pharma and healthcare industry

As many as 4.07 crore women have undergone breast screening for detection of its cancer, while 3.16 crore others were screened for cervical cancer under the Centre’s Ayushman Bharat Yojana, Union Minister Smriti Irani said here on Sunday.

The Minister for Women and Child Development also said that as many as 45 crore visits by women have been registered in the last two years at the health and wellness centres set up under Ayushman Bharat, the Centre’s health protection scheme, for primary health care.

The sheer number of women beneficiaries under the Ayushman Bharat scheme shows why it is “profitable to enhance the role of women in pharmacology and healthcare”, she said while speaking at the inaugural session of a national conference on “Soaring heights of empowerment in pharma and healthcare industry”.

“Breast screening under Ayushman Bharat— especially remember this is for the poorest of the poor in our country— has been over four crore seven lakh. For screening of the cancer of the cervix, the number of women who get themselves screened under the Ayushman Bharat Yojana is 3.16 crore,” she said.

“Now tell me ladies and gentlemen, do we have that many female specialists only in this one particular sector?” she asked.

“Look at us (women) as consumers, who want to ensure that we have the best of medical practices by women who lead out of sheer competence,” she said.

Ms. Irani also raised the issue of bias against women workers in the pharma and healthcare industry, and said that only 11% of the workforce in the sector comprises women. Five per cent women are in sales and marketing, 12% in manufacturing, and 25% in corporate functions, she said.

“If we, the best and the brightest of minds, do not acknowledge the problem and do not address the elephant in the room, how are we then, irrespective of our gender, going to find the solution?” she asked.

The minister lamented the absence of women participants at the conference and pointed out that only a few topics to be discussed during the event revolved around women.

She also used the example of a woman professional from the sector who said that when she asks for an increment, her male counterpart gets it instead on the grounds that he has to run a family.

“The bias is so deep-seated that educated people also practise that culture…Our bias , our prejudices, our fears are so deep-seated that we see women excel right before us and we still treat them with gloved hands,” she said.

She also hailed the contribution of 6.6 million women who have contributed to the protection of the country during the pandemic, especially the female workers who conducted door-to-door surveys to collect samples, among other things.

Fox 5’s Ayesha Khan inspiring others to get tested for breast cancer

April 21st marked a major milestone for our own Ayesha Khan. 

Friday, Khan joined anchor Marina Marraco in the FOX 5 studio for the first time in almost 8 months. She spoke about ringing the bell that marked the end of 16 rounds of chemo to treat stage 3 breast cancer, and the support she’s received throughout her journey.  

Since February, Khan has been taking FOX 5 viewers behind the scenes of her experience through the series, “Cancer: Fight over Fear.”

Cancer: Fight over Fear pt. 1 Fox 5’s Ayesha Khan shares ongoing experience with breast cancer treatment

Khan said the celebration at the Aquilino Cancer Center in Montgomery County, Maryland was one for the books. 

“This is my official reality,” she said. “I can’t believe I made it this far.”

Khan said that while one of the most trying challenges of her experience with breast cancer is over, the treatment isn’t.

She still has to complete six weeks of daily radiation followed by hormone therapy that will last for about 10 years.

Part 2 of “Cancer: Fight over Fear,” aired on Thursday Feb. 17 where Ayesha shared her life post single mastectomy.

“For now, I’m just soaking in the milestones as they come, reminding myself to never disconnect and stay in the present,” Khan said.

Ever since Khan’s story aired, many people including co-workers have been so much more proactive and vigilant about taking charge of their health, she said. 

They are even encouraging their loved ones to do the same.

Fox 5’s Ayesha Khan shares wellness resources and help for mental health during cancer treatment

Khan said she received a lot of messages from women her age, younger and older saying that they are making appointments to get their mammograms done. 

It’s something they admit they had been putting off until they saw her story. 

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Khan said that she continues to receive a tremendous outpouring of love and encouragement from the community and her FOX 5 family.

She’s thankful for all the care packages, get-well-soon cards from viewers, special prayer blankets, and even the food one of her managers dropped off at her family’s home.

Ashfield’s very own ‘calendar girls’ set to raise funds and awareness for breast cancer

Mhairi Taylor (left) ringing the bell after finishing chemo and Lindsay Childerley (right).

The idea was the brainchild of Mhairi Taylor, from Kirkby, and Lindsay Childerley, from Sutton, who have both just undergone chemotherapy for the disease at King’s Mill Hospital.

More than a dozen other local women with breast cancer have pledged to join them in creating the calendar, for which they will be photographed in the nude with props covering certain areas.

The ladies have set up a JustGiving page to raise funds to help bring the calendar idea to life, which has already raised more than £2,000.

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Mhairi said: “Any monies left once we have the calendar produced is being donated to our two chosen charities – Macmillan Cancer Support and The Pink Ribbon Foundation.

“These charities have helped us all in some form throughout our breast cancer journeys. We want to be able to give something back, as well as raising awareness.”

Mhairi said she was “shocked” when she received her breast cancer diagnosis in her 40s, having no history of the disease within her family and no other known risk factors.

“I want to spread the word and let people know it can happen to anyone,” she said.

“Most men aren’t aware that it could happen to them too. They need to check their ‘boobs’ as well.

“It really is a cruel disease that can come out of nowhere.

“Sadly prior to our photoshoot taking place, one of our ladies, Shannon Smedley, who was just 33, lost her battle. She leaves her three children and fiance.

“When we do this calendar, Shannon will never be far from our thoughts and she’ll never be forgotten.”

The calendar’s co-creator Lindsay was 50 when she discovered she had breast cancer following a routine mammogram.

“I just broke down. I couldn’t believe it,” she said.

“In July last year, I went in hospital for my lumpectomy and they removed some fat from my stomach and sides to fill my breast.

“Then when I went back for my results from this, I was told I had two types of cancer with two different grades so had to have chemotherapy.

“I hated having chemo – hated losing my hair my eyebrows my eyelashes.

“I have been told I am now cancer free but I’m still trying to process the fact that I had cancer and I’m struggling to believe it’s really gone.

“I think I will always be scared it will come back and that’s something I have to live with.”

The photoshoot for the calendar is set to take place in July in preparation for an autumn release.

It will feature 12 seasonal photos of all the women, some of whom have had mastectomies and are brave enough to show their scars to the world.

Mhairi added: “We are hoping to launch our 2023 calendar in October this year, seeing as it will be Breast Cancer Awareness Month.

“We are hoping that there might be some local companies that could help with the printing side of things to help us keep costs down so we can give more to the cause.”

To donate and help bring the calendar to life, click here.

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