NJ's Regional Moonshot Summit

Yesterday hundreds of researchers, oncologists, advocates,  insurance and pharmaceutical industry representatives met at Howard University in DC for the Cancer Moonshot Summit.

Here in NJ running concurrently with the DC meeting we held a regional Cancer Moonshot Summit.  As in DC advocates, insurance and pharmaceutical industry representatives, oncologists and others met at the Cancer Support Community Central New Jersey (CSCCNJ) to discuss the initiative. Cancer Support Community is a partner in the Moonshot Initiative lead by VP Joe Biden. The Regional Summit was co-sponsored by Rutgers Cancer Institute of NJ. This regional Summit was an excellent way for individuals to share their ideas and provide input to the  White House Cancer Moonshot Initiative.

The NJ Summit included watching VP Biden's speech from DC and a panel discussion. The panel included D. Toppmeyer, MD Rutgers Cancer Institute of NJ, U. Dugan, MD, PhD Bristol Myers Squibb, E. Levine LCSW, W. Wengel III Aetna, D. Gonzalez, US Dept of Health and Human Services and myself.

Panel participants .
Photo courtesy of @RutgersCancer

We discussed putting patients at the center - how to improve the experience of patients when initially diagnosed, after treatment as well as those treating cancer as a chronic illness as well as how to insure the information patients read online is accurate.  We also discussed the best way for oncologists in a community setting to be on top of the latest treatments and clinical trials. We ended with a short discussion of how to recruit patients to clinical trials and dispel the myths associated with clinical trials.

I was honored to be a part of this initiative. I am usually the one Tweeting from conferences but multitasking at this event was a bit of a challenge. So I share this Tweet with you. 

Regional #CancerMoonshot summit: Dee Sparacio patient advoc. & survivor talks about the patient experience #CanServe pic.twitter.com/ye3D5jLTdN

— RutgersCancerInstNJ (@RutgersCancer) June 29, 2016

I have also submitted ideas to the Cancer Moonshot through the website. Do you have an idea? The site is live until July 1,2016 

As VP Biden said "This is Urgent" and I agree . This initiative gives me hope that we will develop a screening test.

Dee
Every Day is a Blessing!

The Days of ASCO - Connections

In addition to being a medical conference where new research results and discussions take place,  the ASCO Annual Meeting is a great place to make connections with oncologists, researchers and advocates. I was able to rekindle friendships with advocates I met at the 2006 LiveSTRONG Survivors Summit and Stanford MedX 2014 and meet in real life folks I have been following on Twitter.

I stopped to say hello to Sarah from CHN. I volunteer with CHN.

I ran into one of my former RCINJ pharmacists in the Oncology Professionals Hall.

 

I got to spend time with the #gyncsm Health Care Moderators, Drs Markham, Westin and Boulay at the ASCO Tweet-Up 

@corrie_painter and @womenofteal meet in person for the first time at the ASCO Tweet Up

#bcsm friends ( @stales, @DrAttai) and @SheWithLynch

@AliveAndKicknDD, @coffeemommy, @trwoodhull

So pleased I got to meet Lucy Kalanithi.(far right)  She spoke during the ASCO Book Club session about her husband, Dr Paul Kalanithi's book, When Breathe Becomes Air

 

 

 

 

 

 

As I finish this last ASCO post I feel honored to have spent time with these amazing advocates, oncologists , physicians and researchers. I want to thank Conquer Cancer Foundation for supporting my scholarship to attend. 

Dee
Every Day is a Blessing!

The Days of ASCO - Biosimilars

Biologics are products that are made from living things - animals, humans, microorganisms. They are manufactured using bio-technology or other methods. They are usually large molecules, organic, complex mixtures and difficult to identify. Conventional drugs are chemical and their structures can easily be identified. Some examples of biologics are: Cytokines - interferon, Monoclonal antibodies - herceptin and vaccines. Biosimilars are biologics that are approved/ licensed by the FDA because they are highly similar to an already FDA approved drug. The FDA approved drug is called the reference product.

In the morning of Tuesday June 7,  I attended the ASCO session Biosimilars: Hear and Now
Speakers: Lemery, Weise, Esteva
 

Biologics have inherent molecular differences. They are not identical so they are not generics.Biotech/ drug companies with a biosimilar product must apply to the FDA for approval.
The general requirements are given below.

 

 Biosimilarity /interchangeability must be based on data from 

• Analytical studies
• Animal studies ( toxicity assessment) 
• clinical studies ( pharmaokinetics and pharmacodynamics

If a product is given a biosimilar designation in the US than the product must be prescribed by the health care provider and should not be substituted ( by the pharmacist) without the intervention of the health care provider.

Biosimilarity is determined using the totality of the evidence. Analytical comparisons are the foundation for determining that the products are highly similar . There is no need to to re-establish safety /effectiveness of the biosimilar product.

Dr Weise provided an overview of biosimilar use in the European Union. The EU has been using a similar process to approve biosimilars for the past 10 years. The example discussed during the session was Filgrastim, biosimilar to Neupogen.

But there are challenges to biosimilars in the US. There is the need to regulate, monitor and track the safety in patients. Will the biosimilar be covered by insurance?  Will providers be willing to prescribe the biosimilar with the limited efficacy and safety data compared to the original biologic.

Dr Esteva raised another question in his presentation. Will patients accept the biosimilar drugs? As patients in the US play a greater role in their care the safety data and efficacy data of the biosimilars must be communicated with patients effectively.   Currently in the US Zarxio, a biosimilar to Neupogen,  has FDA approval. In development by Pfizer and Amgen are biosimilars to Trastuzumab ( Herceptin) .

One benefit of the use of biosimilars is a lower cost( ~30% lower) .

As I listened to this session I kept wondering what I would do if in the future I was offered a biosimilar. As someone who has had issues after being prescribed generic medications I would definitely ask my doctor to see the  clinical studies used in the approval process.

Dee
Every Day is a Blessing!

Additional sources of information: 

FDA http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm

Oncolink-http://www.oncolink.org/treatment/article.cfm?c=16&id=335

 

The Days of ASCO- Liquid Biopsies

While planning which sessions I would attend I ran across a joint AACR and ASCO session : The Next Frontier of Genomics and Clinical Trials.

One speaker was talking about big data and clinical trials. Accumulating large numbers of patient data - disease information / genetics/  treatment and response in one place will allow researchers to recognize patterns and best practices and that is a good thing.

But the session I couldn't wait to hear was Potential of Liquid Biopsies in Precision Medicine presentation by Dr Luis Diaz. I had often wondered if there was enough circulating tumor DNA (ctDNA) in the blood to measure accurately. And I wondered if you could find ctDNA from ovarian cancer tumors and maybe be able to detect ovarian cancer or a recurrence quicker.

What is a liquid biopsy? When a cancer cell dies it can shed DNA into the blood. This cell-free or circulating tumor DNA can be removed from the plasma and the genetic makeup can be studied. These DNA mutated fragments can be compared to normal alleles.

Why do a liquid biopsy? It is less invasive than a tissue biopsy. It may cost less. It may be used to follow response to treatment or signal a recurrence quicker and it can track genetic changes in the cancer. 

So on Saturday afternoon, I sat in a large standing room only session to listen to Dr Diaz. During his talk Dr Diaz mentioned a pancreatic cancer study where  ctDNA spiked along with the tumor marker CA19-9 showing that liquid biopsy could be used to track a recurrence. Another study (not sure of which cancer ) showed that a rising ctDNA signaled a recurrence which was confirmed by a CT scan.  I was tweeting from the meeting and wanted to be sure I heard correctly when Dr Diaz mentioned that liquid biopsy could only be used for somatic mutations, so I tweeted.

Do I understand that Diaz said liquid biopsy only used for somatic mutations? Not Germline ? #gyncsm #ASCO16

— Dee Sparacio (@womenofteal) June 4, 2016

And got these responses 

@womenofteal liquid biopsy & tumor testing are typically optimized to find somatic mutations...germline mut. would be an unintended finding

— Erica Bednar (@EMBOSU) June 4, 2016

@womenofteal Yes! Cell free DNA or circulating tumor cells are typically used for somatic while DNA from blood cells is used for germline.

— Bjarne Bartlett (@BjarneBartlett) June 4, 2016

There were also other presentations/ posters on the use of liquid biopsy.

During a Tumor Biology presentation, Dr. P. Mack shared results of a study of blood samples from over 5,000 patients with 50 different tumor types (39% lung, 14% breast , 10% colon cancers) . Some of the samples were compared to patient tumor samples. The ctDNA test found mutations in 83% of the samples. And overall 87% of the ctDNA results matched the tumor samples. You may read more about this study here.

Another abstract by Dr Tie showed that the detection of ctDNA in patients with stage II colon cancer who had undergone surgery provided direct evidence of residual disease.

Circulating cell-free DNA : The future of personalized medicine in ovarian cancer management was presented as a poster. The poster reported on a study of ctDNA in the blood of 14 women with ovarian cancer. The tumor tissue of the women underwent next-generation sequencing. The researchers found that ctDNA detected more mutations than what was found in the solid tumors. (poster abstract.).


A number of companies (including Guardant Health which was used in the Mack study) have introduced liquid biopsy equipment.

I look forward to the application of ct DNA in future ovarian cancer research/ treatment.

Dee
Every Day is a Blessing!

The Days of ASCO: Other Gyn Cancers

This post will cover research I heard that related to endometrial and cervical cancers.

Divide and Conquer

Goodfellow- Mismatch repair mechanisms (MMR) are frequent in endometrial cancers.

Goodfellow endometrial cancer and MMR #gyncsm #asco16 pic.twitter.com/ZeJfjnJxWJ

— Dee Sparacio (@womenofteal) June 4, 2016

Goodfellow PTEN common in endometrial cancer -PTEN associated w/lower anti PD1 efficacy #gyncsm #ASCO2016

— Dee Sparacio (@womenofteal) June 4, 2016

The use of immune checkpoint blockade holds promise for endometrial cancers with MMR.

Surviving the Cure

McCormack - This presentation was on the late effects of radiotherapy (RT)  for gyn cancers.

McCormack You have urological complications - that continue for "decades" after radiotherapy #gyncsm #ASCO16 pic.twitter.com/AaBNyRIQzs

— Dee Sparacio (@womenofteal) June 4, 2016

 A Mayo Clinic study showed 17% of women had lower limb lymphedema after RT.
Radiotherapy can also impacted sexual function.

McCormack need to discuss impact of radiation therapy on sexual function #gyncsm #ASCO16 pic.twitter.com/TDcnKIgrip

— Dee Sparacio (@womenofteal) June 4, 2016

Oral Abstract 
Frenel  Discussed the use of pembrolizumab ( anti-PD1) in 24  women with advanced cervical cancer in a phase 1 trial - KEYNOTE trial (5515) . Pembrolizumab was well tolerated and had promising anti-tumor activity.

Soliman Discussed everolumis, letrozole, and metformin in recurrent/advanced endometrial cancer. (5506)  the study showed that 67% of the women treated with the combined therapy showed a clinical benefit. There was no difference in clinical benefit for those with the KRAS mutation. Side effects included anemia , diarrhea and fatigue.

Poster Session
5518 Clinically applicable molecular-based classification for endometrial cancers.
MMR,  immunohistochemistry (IHC), mutation status of the POLE exonuclease domain, and p53 IHC were  evaluated on a cohort of 456 endometrial  hysterectomy specimens. POLE had the best prognosis while the P53 had the worst prognosis. The "molecular classification tool can be used from time of first diagnosis and will: provide consistent categorization of tumors, improve risk stratification, identify women who may have Lynch syndrome, stratify clinical trials, and we believe ultimately improve outcomes for women with EC."

5520 Phase II study of anastrozole in recurrent estrogen (ER) / progesterone (PR) positive endometrial cancer: The PARAGON trial—ANZGOG 0903 
Women in this study showed improved quality of life ( emotional and physical function) when taking anatrozole.
The SGO shared these videos of research presented at #ASCO16 on endometrial and cervical cancers. Speaker is Dr Shannon Westin, MD Anderson and #gyncsm health care moderator. 

endometrial cancer



cervical cancer



Next post will be on liquid biopsies. 

Dee
Every Day is a Blessing!

The Days of ASCO 16: Ovarian Cancer Research

This post will concentrate on information I learned during the gynecologic cancer sessions which focused on ovarian cancer. A future blog post will discuss research presented on other gynecologic cancers.

Intraperitoneal Chemotherapy for Ovarian Cancer: Trials and Tribulations
Presenters: Drs. Walker, Gourley, Mackay 
A discussion of GOG252 ( phase III trial) that compared IP and IV chemotherapy. All arms received Bevacizumab.

• Arm 1: intravenous carboplatin AUC (area under the curve) 6/intravenous weekly paclitaxel at 80 mg/m²

• Arm 2: intraperitoneal carboplatin AUC 6/intravenous weekly paclitaxel at 80 mg/m²
• Arm 3: intravenous paclitaxel at 135 mg/m² on day 1/intraperitoneal cisplatin at 75 mg/m² on day 2/intraperitoneal paclitaxel at 60 mg/m² on day 8. (Control)

This ASCO POST article  on this session also discusses the trial.

Walker  
Progession Free Survival (PFS) for all arms was similar
IP cisplatin arm had increased blood pressure with Bevacizumab
16% of the IP patients moved into the IV arm which may have influenced results
Neurotoxicity side effect in all arms were equal. All are lower than in GOG 172.
Questions asked regarding the  GOG 252 results:
    Did the dose dense paclitaxel in control make the control arm better than the control arms in the  other studies? 
    Did the addition of Bevacizumab negate the previous positive IP results? 
    Did the surveillance with CT every 6 months decrease PFS results?

Gourley
Other studies ( GOG 104,114,172) showed longer PFS using IP compared to  IV 
The subgroup of BRCA1/2 patients could benefit from IP

 Mackay
"There are still unresolved issues" regarding the use of IP chem
No evidence for combining IP/IV with Bevacizumab
No data so therefore no role of HIPEC ( hyperthermic interperitoneal chemotherapy) to treat ovarian cancer outside of clinical trial. 
Need to understand the microenvironment and biology of  OC
Would use of IP chemotherapy benefit subgroups of patients based on histologic or molecular profiles or platinum sensitivity? 

Divide and Conquer: Epithelial OC Beyond BRCA
Kristeleit, Kohn , Goodfellow 

This session discussed genes and pathways that influence the development of ovarian cancer. In addition to germline BRCA 1/2  mutations you can also find somatic BRCA 1/2 mutations, BRCA1 methylation, EMSY amplification, TP53, mutation, tumour suppressors RB1, NF1, RAD51B and PTEN ( which can lead to chemo resistance) and overexpression of MDR1.

Some clinical trials are also looking at Wee1 inhibition ( phase II), Hypoxia, combining parp inhibitors and immunotherapy, and PD1, PDL1 immunotherapy. 

Symptom Management for Patients with Gynecologic Cancers 
Le, McCormack , Mayer  
Menopause
Dr Le spoke about the impact of menopause symptoms ( hot flashes, genitourinary ) after surgery. She recommended asking patients about what menopausal symptoms they were experiencing, assess the risk of hormone therapy and refer to  gynecologist/PCP for hormonal or non-hormonal treatment. 

Survivorship Care Plans
Dr Mayer presented background information about the quality of life issues of women diagnosed with ovarian cancer. This slide shows the informational needs of ovarian cancer survivors ( Papadakos, 2012). Younger women had greater needs than older women. 

She concluded that women with gynecologic cancers can experience a number of long terms and late side effects, they have unmet needs especially fear of recurrence ,  patient reported outcomes can help identify the issues and survivorship care plans can help address those needs. 

Oral Abstracts- Ovarian Cancer

5501- Overall survival (OS) in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC) receiving olaparib maintenance monotherapy
Patients receiving maintenance olaparib after responding to platinum therapy had an overall survival advantage. Patients with a BRCA mutation and platinum sensitive relapsed serous ovarian cancer showed a significant progression free survival benefit. Germline and somatic BRCA mutation gave the same results. 

 

5502 Hormonal maintenance therapy for women with low grade serous carcinoma of the ovary or peritoneum Low grade ovarian cancer is more platinum resistant than high grade ovarian cancer. Women with stage II-IV low grade ovarian cancer who received hormonal maintenance chemotherapy following primary treatment had a statistically significant improvement in progression free survival compared with women who were under surveillance . 

 

LBA5503 OV21/PETROC: A randomized Gynecologic Cancer Intergroup (GCIG) phase II study of intraperitoneal (IP) versus intravenous (IV) chemotherapy following neoadjuvant chemotherapy and optimal debulking surgery in epithelial ovarian cancer (EOC).  After 3-4 courses of IV platinum chemotherapy followed by optimal debulking surgery women were optimized to 1) IV carbo/taxol , 2) IP cisplatin / IV taxol or 3) IV taxol/ IP carboplatinum.  The IP carboplatin based regimen, post neoadjuvant chemotherapy and debulking surgery, was tolerated and a lower number of women showed progression at 9 months compared to IV therapy. 

 

5504 Multicenter phase II study of intraperitoneal carboplatin plus intravenous dose-dense paclitaxel in patients with suboptimally debulked epithelial ovarian or primary peritoneal carcinoma Prospective study of stage II-IV OC. Chemotherapy with dose dense Placitaxel / Cisplatin  is safe and effective for suboptimal residual ovarian patients.

 

5505 The MITO8 phase III international multicenter randomized study testing the effect on survival of prolonging platinum-free interval (PFI) in patients with ovarian cancer (OC) recurring between 6 and 12 months after previous platinum-based chemotherapy: A collaboration of MITO, MANGO, AGO, BGOG, ENGOT, and GCIG  This study showed that  prolonging the platinum-free interval by using a non platinum based chemotherapy  does not improve and even worsens efficacy outcomes in patients with partially platinum sensitive recurrent ovarian cancer . 

 

5507 Performance characteristics and stage distribution of invasive epithelial ovarian/tubal/peritoneal cancers in UKCTOCS This study was first discussed at ASCO 2015 and this abstract presented a further analysis. Patients were randomized to either the Multi modal (MM) Risk of Ovarian Cancer Algorithm (ROCA) arm or ultrasound (USS)  for screening. Sensitivity of the MM was 86% with 4 operations per invasive cancer detected. Sensitivity of the USS was 63 % with 17 operations per invasive cancer detected.

 

 5508 Baseline quality of life (QOL) as a predictor of stopping chemotherapy early, and of overall survival, in platinum-resistant/refractory ovarian cancer (PRROC): The GCIG symptom benefit study (SBS) This Symptom Benefit study showed that Global Health status, Physical function,  Role Function and Abdominal/ GI symptoms were independent predictors for overall survival were significantly associated with stopping chemotherapy early. The worse symptoms the shorter survival. Assessment could help identify patients who may not benefit from palliative chemotherapy. 

Clinical Sciences Session: Leveraging the Immuno-molecular Landscape of Gynecologic Cancers - OVARIAN CANCER

5510 Kurian This study included over 95,000 women with ovarian cancer were tested using the Myriad 25 gene hereditary panel test . Personal histories were also taken. 

Most of the women had BRCA1/2 mutations.  ATM ( a mutation associated with breast cancer)  was seen for the first time . 

5511 Tanyi Mesothelin is a tumor associated antigen in ovarian cancer. This immunotherapy study was Phase 1 and included 6 women with recurrence ovarian cancer . Each women received an intravenous infusion of autologous T cells transduced to express a chimeric antigen receptor directed against mesothelin (CART-meso). The infusion was found to be safe. 

 

Education Session : Neoadjuvant Chemotherapy : Location , Location Location                    Leary and Chi  

There is a risk of progression while on neoadjuvant chemotherapy (NACT). There may also be a risk of driving chemo resistance on NACT. Previous studies showed improved survival but there was no quality control of the surgical aspect of the trials. How much disease remained after surgery? Ultimately it is the clinicians decision whether or not to use neoadjuvant chemotherapy. 

Here is an SGO video on ovarian cancer research at #ASCO16 on ovarian cancer. Presenter is Dr Shannon Westin, MD Anderson.



Dee 
Every Day is a Blessing! 

The Days of ASCO 2016

I returned yesterday from the ASCO Annual Meeting in Chicago.  Over 30,000 oncologists, researchers, related professionals and advocates attended the meeting. McCormick Place was very busy from June 3 -7 , 2016. And the amount of information on topics from tumor biology to immunotherapy to targeted therapy to care delivery to the value of care was at times overwhelming.

In Chicago Here I Come- ASCO 2016, I wrote about the sessions I had hoped to attend. But it turns out even after planning a schedule in advance I still had to make adjustments. I didn't attend the Patient and Survivor Care, the Cancer Prevention and Epidemiology or the Genomics and Biomarker sessions. But I did add the Developmental Therapeutics and Transitional Research session on Biosimilars and the ASCO Book Club session When Breathe Becomes Air  as wells as a special advocate session on TAPUR to my schedule.

Some more schedule adjustments were made when I learned I would have the privilege of hearing Vice President Biden address the meeting attendees.  It was a great experience  and an ASCO experience I will not forget. Hearing him talk about the Cancer Moonshot program and how important collaboration and big data is to program gave me hope that it will a success.

Over the next week or so I will blog about the sessions I attended in person. I plan to cover:

• Ovarian Cancer Research: IV vs IP chemotherapy, neoadjuvant chemotherapy and immunotherapy/targeted therapy study results
• Endometrial and Cervical Cancer studies
• Liquid Biopsies in Precision Medicine
• Biosimilars in Cancer Treatment
• ASCO's TAPUR Study 

In addition to the research I heard about, there are other benefits of attending the ASCO meeting. I was able to ask questions, share my story and thank the researchers and oncologists who have made finding a cure for cancer their priority. In the Advocate Lounge and at the Research Advocacy Network dinner and the President's reception,  I was able to interact with other research advocates. We talked about how we could be better advocates, how we could work together to make a difference and how we could reach more survivors through social media. Those interactions will have a separate blog post.

I look forward to sharing what I learned with my readers. 

Dee
Every Day is a Blessing