TYKERB (lapatinib ditosylate) - Updated Information on Efficacy (Health Canada)

HER-2 Breast Cancer http://goo.gl/LwBZB (Photo credit: TipsTimes)

TYKERB (lapatinib ditosylate) - Updated Information on Efficacy - For Health Professionals - Recalls & alerts - Healthy Canadians Website: 

Note that this was previously highlighted in June of 2012 at ASCO in Chicago:

"In his discussion, Gunter von Minckwitz, MD, PhD, of the German Breast Group and the University of Frankfurt, Germany, said there is increasing evidence that lapatinib is not as active as trastuzumab in a number of breast cancer therapy settings, perhaps because of the rapid development of secondary resistance and because dual blockade appears to be the most promising approach for the future."

It often takes time, but Health Canada has now made notice of updated prescribing information.

Excerpt from Health Canada update via GlaxoSmithKline Inc:

"Subject: Updated Information on Efficacy - TYKERB® (lapatinib ditosylate)-based regimens are less effective than HERCEPTIN®(trastuzumab)-based regimens in certain settings:

Based on the results of preplanned interim analyses of two studies, GlaxoSmithKline would like to advise you of the following:

• In patients with HER2+ metastatic breast cancer who have not received prior trastuzumab, comparative data have shown that lapatinib-based regimens are less effective than trastuzumab based treatment regimens.

• Prescribers are reminded that TYKERB^® should not be prescribed in combination with capecitabine unless patients have progressed on prior trastuzumab therapy in the metastatic setting.

• GlaxoSmithKline has updated the TYKERB^® Product Monograph to include a statement that lapatinib-based regimens are less effective than trastuzumab-based regimens in certain settings.

CEREBEL(EGF111438) (N=540) is a randomised Phase III study comparing the effect of  lapatinib in combination with capecitabine relative to trastuzumab in combination with capecitabine on the incidence of CNS as site of first relapse in women with HER2 positive metastatic breast cancer. Patients were stratified based on prior trastuzumab treatment (yes versus no) and number of prior treatments for metastatic disease (0 versus ≥1 line). The study was stopped early due to results of a pre-planned interim analysis (N=475). There was superior efficacy with the trastuzumab plus capecitabine combination in terms of progression-free survival (PFS) and overall survival (OS) compared to the lapatinib plus capecitabine combination. Median PFS was 6.60 months in the lapatinib-containing arm compared with 8.05 months in the trastuzumab-containing arm (HR=1.30; 95%CI 1.04 to 1.64).  The median OS was 22.7 months in the lapatinib-containing arm compared with 27.3 months in the trastuzumab-containing arm (HR=1.34 (95%CI 0.95 to 1.90).

COMPLETE is a randomised Phase III study (EGF108919) (N=636) comparing the activity of lapatinib plus taxane followed by lapatinib alone versus trastuzumab plus taxane followed by trastuzumab alone as first line therapy for women with HER2 positive metastatic breast cancer. The study was stopped early due to superior efficacy of the trastuzumab plus taxane combination in terms of progression-free survival.  Results from a pre-planned interim analysis showed that  the PFS in the lapatinib-containing arm was lower than in the trastuzumab-containing arm (median PFS was 8.8 months in the lapatinib-containing arm compared with 11.4 months in the trastuzumab-containing arm; HR=1.33; 95% CI 1.06 to 1.67, p=0.01).  The hazard ratio for OS was 1.1 (95% CI 0.75 to 1.61; p=0.62), based on 18% (n=115) deaths."

The revised Product Monograph for TYKERB^® may be accessed on the Health Canada Website or on the Canadian Website of GlaxoSmithKline.

*Click here for link to full Health Canada release information.

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Ty Ulmer: Making the Biggest Save of His Life

The Hockey Writers' Shawn Reznik with an inspirational story of Ty Ulmer, who picked up hockey after battling osteosarcoma.

Excerpt:

Wise Beyond His Years

“I look at life much differently than I used to,” stated Ulmer.  ”Going through something like cancer treatment will do that to a person.  I live my day-to-day life like everyone else should…day by day.  Take every day with a grain of salt and what happens, happens.”

So you’re probably wondering how Ty is doing up to this point in his life.  Well…so far so good!

“Everything has been going smoothly.  My recent set of post-treatment scans were all clear.  No sign of recurrence in the disease.  I am now, currently, 4 years cancer free,” the upbeat 17-year old said.

The reason he is still cancer free is because he never stopped pressing on against the uphill battle.

“I didn’t give up because I wasn’t just fighting for myself.  I was fighting for my family and friends.  I was fighting for all the kids who had also battled cancer alongside me, and for those who lost their battle, as well.  I’ll never give up on anything that will not give up on me.”

We all look up to superstars, celebrities, musicians, athletes, the whole gamut.  Ty’s role models and support group are the ones who have been by his side through the cancer, the amputation, the chemo, the good news, the bad news, and just about everything else he’s experienced.

“My Dad for having been in the Air Force for 21 years, numerous deployments, missing countless things like birthdays, holidays and milestones in our family, and yet still keeping a positive attitude and making me feel loved.  I am amazed by his courage and I am honored to call him my father.

My Mom for understanding the choices I’ve made, supporting me in those choices, putting up with me, and always being there for me after it all.  For staying strong when my Dad was deployed, and keeping me in good spirits.  I am amazed by her strength and I am very thankful that she is my mother.

My Brother for being the role model he has been throughout my life, always being someone to look up to, for moving back home when he heard I was diagnosed, and helping me with going through all that I have. Always being able to cheer me up if I was feeling depressed.

I couldn’t be happier with the family I have, as they are my true role models.”

There are many people in similar situations as Ty Ulmer, who never get the opportunity he’s been given.  He’s able to play the game that has brought him so much joy.  He’s been given a second chance – of which he never takes for granted.  He’s been supported by friends and family members unconditionally.  He’s experienced things in 17 years of life that people wish they never experience at all.  And still, he remains a humble kid from Meridian, Idaho.

“I decided to play [hockey] because I have a passion for the sport that not everyone has.  I’d enjoy nothing more than to play in goal on any team – beer league or higher.  You don’t have to pay me to play, I just love the game.  I want to play because it’s something that not everyone can do, and I want to show that even the difficult things in life are worth the fight,” Ulmer stressed.

In terms of sport, his goal is quite simple: “to be able to play hockey, and teach others to play hockey (be it kids, teens, adults, or disabled).”

His message to the kid’s in the same position as he once was: “As cliché as it might sound, just don’t give up and keep your head up.  You are lucky enough to have your life, where as not everyone else is.  Life is a gift that you have been given, a gift that isn’t returnable, it is yours to keep, so live it as best as you can, and keep your spirits up.”

The kid has been through it all.  He’s visited the depths of hell and came out clean on the other side.  Cancer carved away at his body like a freshly cut pair of skates against a perfect sheet of ice.  Each slice left an indelible mark on his character, fortitude, and and will power.  Be that as it may, there is only one key point to take out of this piece.

Ty concluded, “Anything, no matter how hard it might be, is possible.  It might take a while to get there, and it might not be the easiest thing in the world, but in the end, it is worth it.”

*Read the full inspirational story at The Hockey Writers. 

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LUNGevity Foundation Hosts Third Annual Hope Summit During May, Lung Cancer Hope Month

Cancer survivors park 2 (Photo credit: Loco Steve)

(WASHINGTON, January 31, 2013) — "LUNGevity Foundation, the nation’s largest lung cancer-focused nonprofit, is inviting lung cancer survivors from across the nation to register for the 2013 LUNGevity Hope Summit taking place May 3-5, 2013 in Arlington, VA. The two day conference, taking place during Lung Cancer Hope Month, is designed for lung cancer survivors of all ages and stages of disease, currently in or out of treatment. 

The summit provides an opportunity for participants to celebrate lung cancer survivorship, and gives survivors the opportunity to learn, collaborate, advocate and use their voices and stories to make a difference in the fight against lung cancer. 

The topics to be addressed at this year’s Hope Summit will include inspirational speakers, medical expert forums, advocacy forums, lung cancer survivor-specific sessions, and opportunities for lung cancer survivors to share and connect with other survivors. There will be sessions specifically for survivors in active treatment and others for those out of treatment to address their specific needs.

Hope Summit attendees from previous years describe the value of the summit in very personal terms:

”Being in a room with 50 or so cancer survivors is an awe-inspiring event. Being in a room with 50 or so LUNG cancer survivors is as life-changing as the disease itself. Thank you all for an amazing weekend. “ - Alan

“The LUNGevity Hope Summit gave me the powerful sense of community that I often see in other groups, such as breast cancer or HIV/AIDS survivors, which I had not experienced since my lung cancer diagnosis.  Your inspirational speakers, medical experts, advocacy training, and lung cancer survivor-specific workshops will be key in empowering us as cancer survivors to connect with other survivors and share our stories” - Jose

LUNGevity designated May as Lung Cancer Hope Month to celebrate the hope for better treatments and cures for lung cancer, as well as improving lung cancer survival rates and ensuring a higher quality-of-life for lung cancer patients and their loved ones. To register for the event and to learn more, go to: www.lungevity.org/HOPESUMMIT. 

LUNGevity is offering a limited number of travel grants, based on need and availability. Deadline for grant applications is March 30. LUNGevity Foundation is also offering Community Partnerships to select organizations.  Please contact Katie Brown, LUNGevity Director of Support and Advocacy, at kbrown@lungevity.org with any questions related to the Hope Summit or Community Partnerships.

About LUNGevity Foundation

The mission of LUNGevity Foundation is to have a meaningful impact on improving lung cancer survival rates, ensure a higher quality-of-life for lung cancer patients and provide a community for those impacted by lung cancer. It does so by supporting critical research into the early detection and successful treatment of lung cancer, as well as by providing information, resources and a support community to patients and caregivers.

LUNGevity seeks to inspire the nation to commit to ending lung cancer.

About Lung Cancer

• 1 in 14 Americans is diagnosed with lung cancer in their lifetime
• Lung cancer is the leading cause of cancer death, regardless of gender or ethnicity
• Lung cancer kills almost twice as many women as breast cancer and more than three times as many men as prostate cancer
• About 55% of all new lung cancer diagnoses are among people who have never smoked or are former smokers
• Only 16% of all people diagnosed with lung cancer will survive 5 years or more, BUT if it’s caught before it spreads, the chance for 5-year survival improves dramatically"

Related articles

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• Dogs Are Able to Sniff Out Lung Cancer
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• Beaumont Opens Comprehensive Lung Cancer Center

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Cancer patients will ‘manage disease’ with new DNA-based treatments | Health | Life | National Post

Cancer patients will ‘manage disease’ with new DNA-based treatments | Health | Life | National Post: 

Excerpt: (click on above link for full article)

"Cancer will become a manageable disease rather than a death sentence thanks to a revolutionary treatment which will be available within five years, British specialists predict.

All patients will soon have their tumour’s DNA, its genetic code, sequenced, enabling doctors to ensure they give exactly the right drugs to keep the disease at bay.

Doctors hope it will be an important step towards transforming cancer into a chronic rather than fatal disease."

***

"Genetic profiling of tumours is already used to some extent, but current methods only look for a few genes. Women with advanced breast cancer are tested to see if their tumours have a particular variant of the HER2 gene, which causes a fifth of cases. Those with it are given Herceptin, but the same drug would do no good for those without the gene variant.

Advanced melanoma patients with a particular gene mutation are prescribed Vemurafenib, a pill that has been shown to increase survival, on average, from 9.6 to 13.2 months, and help patients feel much more energetic.

But average survival times hide massive variations. One patient at the Royal Marsden in Chelsea, where the institute is based, has survived 10 years so far with advanced breast cancer on Herceptin.

Prof Ashworth said that such cases were the exception.

But he added: “We would hope that they will become the norm. By actively profiling patients who respond well, and sequencing their genomes, we can find the genes that are responsible for that.”

***

"Why treating cancer may one day be similar to HIV therapy

It’s an idea that is elegant for its simplicity: Rather than killing cancer with chemo- or radiation therapies, which can also poison healthy tissue, why not conduct the attack with the weapons of the body’s own immune system? Although the idea has been around for decades, the technique, known as immuno­therapy, has long been a frontier of cancer care that’s just out of reach."

Link to full article at National Post.

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Study Divides Breast Cancer Into Four Distinct Types - NYTimes.com

More Breast Cancer Treatments Hinted in Study - NYTimes.com: "In findings that are fundamentally reshaping the scientific understanding of breast cancer, researchers have identified four genetically distinct types of the cancer. And within those types, they found hallmark genetic changes that are driving many cancers.

These discoveries, published online on Sunday in the journal Nature, are expected to lead to new treatments with drugs already approved for cancers in other parts of the body and new ideas for more precise treatments aimed at genetic aberrations that now have no known treatment.

The study is the first comprehensive genetic analysis of breast cancer, which kills more than 35,000 women a year in the United States. The new paper, and several smaller recent studies, are electrifying the field.

“This is the road map for how we might cure breast cancer in the future,” said Dr. Matthew Ellis of Washington University, a researcher for the study."

Related articles

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Timing of Commencing HRT Influences Breast Cancer Risk

Via Medscape:

January 31, 2011 — Breast cancer risk associated with combination hormone replacement therapy (HRT) is greater if the therapy is started soon after menopause, according to the results of the observational Million Women Study conducted in the United Kingdom...

...Among current users of estrogen–progestin formulations, the relative risks for breast cancer were greater if use began less than 5 years after menopause (relative risk [RR], 2.04; 95% confidence interval [CI], 1.95 to 2.14) than if it began 5 years or more after menopause (RR, 1.53; 95% CI, 1.38 to 1.70)...

...Overall, for women who used combination HRT, compared with control subjects, there was a 39% increase in the relative risk of developing breast cancer in the Million Women Study and a 26% increase in the WHI trial, which the editorialists call "consistent" findings...

"The question of the effect of estrogen-only formulation use on breast cancer risk in postmenopausal women, even with longer-term hormone use, still stands unanswered," write the editorialists.

J Natl Cancer Inst. Published online January 28, 2011. Full text, Editorial

The other question that remains unanswered is what are the impact of other formulations of estrogen and progesteron supplementation for HRT.

For instance:
- Estrace & Prometrium
- "bioidentical" hormones (compounded)

Interestingly, here is an article that was published Feb '10 (epublished about 6 months ago) in the Gynecological Endocrinology Journal. This article looks at women who were administered natural estrogen plus progesterone with or without DHEA or testosterone. It is obviously not a long-term study looking at breast cancer incidence outcomes, but leaves one thinking "what if" and what would be the outcome should this be readily explored. Ethics may come into the equation, however, given the other mainstream evidence that has been published.


Link: http://bit.ly/bKbwGc

"Mental symptoms experienced upon presentation improved in 90% of the patients. Sixty percent of the patients, who had gained weight during menopause, lost an average of 14.8 lbs [SD 11.98 lbs]. Complications described with traditional HRT did not develop in this group of patients."

Read more...

San Antonio Breast Cancer Update 2010 - Video Highlights

From OncologyEducation.ca (requires registration - Free)
http://www.oncologyeducation.ca/node/1639

4 Parts:

Part 1 - Hormone Receptor Positive
Part 2 - Adjuvant Bisphosphonates
Part 3 - Adjuvant Chemotherapy
Part 4 - Targeted Therapy
(Dr. Sunil Verma)

Read more...

Fulvestrant Dose Approved by US FDA

On September 10, 2010, the US Food and Drug Administration (FDA) approved the use of fulvestrant (Faslodex®, AstraZeneca) injection at a dose of 500 mg intramuscularly per month for hormone receptor–positive metastatic breast cancer in postmenopausal women with disease progression following anti-estrogen therapy. The previously approved dosing regimen was 250 mg monthly.


(J Clin Oncol. 2010;28(30):4594-4600).

Read more...

Eribulin (Halaven) approved by US FDA

Sea sponge - Halichondria okadai

- new treatment option for late-stage breast cancer


- Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.

US FDA News Release Nov. 15, 2010

Read more...

Bevacizumab Status in Breast Cancer

FDA begins process to remove breast cancer indication from Avastin label Drug not shown to be safe and effective in breast cancer patients


the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

FDA: Bevacizumab (marketed as Avastin) Information http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm193900.htm

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Vitamin D role in preventing aromatase inhibitor-induced arthralgia

Courtesy of MDLinx.com:

Vitamin D threshold to prevent aromatase inhibitor-induced arthralgia: a prospective cohort study

Breast Cancer Research and Treatment, 08/04/2010
Exclusive author commentary
Prieto–Alhambra D et al.

Aromatase inhibitor (AI)–associated arthralgia limits adherence to therapy in breast cancer...After supplementation (daily 800 IU and additional 16,000 IU every 2 weeks), 50% of them still failed to reach adequate concentrations at 3 months. In the whole cohort, there was an increase in joint pain and the increase was significantly attenuated in those that reached concentrations of 25(OH)D of > or =40 ng/ml, with a lower risk of incident arthralgia. A target concentration of 40 ng/ml 25OHD may prevent development of AI arthralgia but higher loading doses are required to attain this level in women with deficiency at baseline.

Daniel Prieto-Alhambra (08/05/2010) comments:
Adherence to aromatase inhibitor(AI) therapy is required to improve survival in women with early breast cancer who can be treated with these drugs. AI-induced arthralgia is highly associated with discontinuation. We have shown for the first time that Vitamin D repletion (with target concentrations > or 40ng/ml) might prevent development of joint pain associated with AI therapy, and thus, may improve adherence. A randomized clinical trial is required now to ensure causality."

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Continuing Education And Certificate Programs

There are some great CEU programs out there. I wanted to highlight just a sampling of these.

Projects In Knowledge have some great individual CEUs, as well as various certificate programs. You can do individual courses or complete them all to obtain the certificate. All are free, but you need to register.

1. The Advanced Certificate Program: Lung Cancer Management
Curriculum I courses present a basic overview of management strategies for optimal personalized care of lung cancer patients. Curriculum II presents more-advanced courses that build on scientific advances and the topics covered in Curriculum I.

2. The Advanced Certificate Program: Breast Cancer Management
Curriculum I courses present a basic overview of management strategies for optimal personalized care of breast cancer patients. Curriculum II presents more advanced courses that build on new scientific developments and the topics covered in Curriculum I.

3. The Certificate Program in Advanced/Metastatic Colorectal Cancer features the very latest information about:
- Colorectal Cancer Diagnosis
- Colorectal Cancer Treatment
- Colorectal Cancer Disease Management

4. The Advanced Certificate Program in Hepatocellular Carcinoma

5. Caring for Oncology Patients: Tips and Tools for Managing Targeted Therapy
"The curriculum offered in this CME/CE program promises to be a timely and continuously updated source of practical information that can be immediately used in treating, monitoring, and managing side effects in cancer patients receiving targeted therapy."


Other CEUs to be had include:
- PainEDU CE Course:
"Interactive case-based learning modules address a range of topics in pain assessment and pain management. Articles and treatment recommendations explore a balanced approach to care with the patients who are prescribed opioids. Update your clinical skills, test your knowledge, and enhance your approach to care!"

- CaPHO's "HOPE" series of CE features topics such as: CINV, Epigenetics, and Molecular Biology of Cancer and Promise of Targeted Therapy.

- Advancing the Safe and Appropriate Use of Oral Chemotherapy Agents: An Interdisciplinary Educational Series for Healthcare Professionals

- http://www.oncologyeducation.ca/ - have to register


Feel free to post other CEUs you find in the comments.

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Long-term Tamoxifen Use Linked To Second Breast Cancer

{Tamoxifen 3D - photo left}

Long-term tamoxifen use linked to second breast cancer:
http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20090825/tamoxifen_risk_090825/20090825?hub=Health
From The Canadian Press, “A new study suggests long-term use of tamoxifen is linked to an increased risk of a second type of breast cancer…another rare subtype of the disease increased by more than 400 per cent.”

Adjuvant Hormonal Therapy for Breast Cancer and Risk of Hormone Receptor–Specific Subtypes of Contralateral Breast Cancer
http://cancerres.aacrjournals.org/cgi/content/abstract/0008-5472.CAN-09-1355v1
From Cancer Res 2009;69(17):6865–70, “Compared with the breast cancer risk women in the general population have, breast cancer survivors have a substantially higher risk of developing a second primary contralateral breast cancer. Adjuvant hormonal therapy reduces this risk, but preliminary data indicate that it may also increase risk of hormone receptor–negative contralateral tumors…Compared with women not treated with hormonal therapy, users of adjuvant tamoxifen for 5 years had a reduced risk of ER+ contralateral breast cancer [odds ratio, 0.4; 95% confidence interval (CI), 0.3–0.7], but a 4.4-fold (95% CI, 1.03–19.0) increased risk of ER- contralateral breast cancer. Tamoxifen use for <5>

From U.S. News (HealthBuzz):
http://health.usnews.com/articles/health/2009/08/26/health-buzz-rare-risk-of-cancer-after-taking-tamoxifen-and-other-health-news.html
“The study's lead author (Dr. Christopher Li ) told HealthDay News he does not think women should be afraid to take the drug, stating that its benefits outweigh its risks. Tamoxifen is customarily given only for five years because there's no evidence that longer-term use has additional benefits.”

Read more...

SSRIs and Tamoxifen: Does the Combination Increase Recurrence?

As recently reported by CTV: {excerpts from the article; data presented at ASCO May 31/09}

ORLANDO, Fla. — Breast cancer survivors risk having their disease come back if
they use certain antidepressants while also taking the cancer prevention drug
tamoxifen, worrisome new research shows...The new study, reported Saturday at a
cancer conference in Florida (ASCO), is the largest to look at the issue. It found that
using these interfering drugs -- including Prozac, Paxil or Zoloft -- can
virtually wipe out the benefit tamoxifen provides...Breast cancer recurred in
about seven per cent of women on tamoxifen alone, and in 14 per cent of women
also taking other drugs that could interfere -- mainly the antidepressants Paxil
and Prozac, and, to a lesser extent, Zoloft...No greater breast cancer risk was
seen in women taking the antidepressants Celexa, Lexapro or Luvox with
tamoxifen, and there are reasons to think that other antidepressants may be safe
as well, Epstein said..."This is a very controversial area," said Dr. Claudine
Isaacs, a breast specialist at Georgetown University's Lombardi Comprehensive
Cancer Center. "Until these data are absolutely clear, I would avoid drugs that
impact on tamoxifen metabolism."

From OncocologySTAT:

"SRIs, however, can also inhibit the 2D6 enzyme that converts tamoxifen to its
main active metabolite, endoxifen, thus possibly decreasing its efficacy."

Massachusetts General Hospital Centre For Women's Health posted an article in June '08 regarding interactions between tamoxifen and antidepressants. I discovered this post when searching for solutions after detecting the interaction via Micromedex/Lexicomp.
{Click here for link to article}.

The following table from the above mentioned article provides some guidance when faced with such a dilemma:

CPY2D6 Inhibitors

Strong Inhibitors (Should be avoided if
possible):
Paroxetine
Fluoxetine
Bupropion
Duloxetine

Moderate Inhibitors:
Sertraline
Citalopram/Escitalopram
Doxepin

Weak Inhibitors (Use not restricted by treatment with
tamoxifen):
Venlafaxine
Desvenlafaxine

If antidepressants are indicated in the treatment of a woman currently
taking tamoxifen, the following treatment recommendations have been made:
*If possible, avoid antidepressants, including fluoxetine and paroxetine, that are
strong inhibitors of the CPY2D6 enzyme (see the list of inhibitors above)
*If the antidepressant is being used solely for the management of hot
flushes, other agents, such as gabapentin, may be used instead
*If it is not possible to avoid these antidepressants, another option for postmenopausal women
only would be to switch from tamoxifen to an aromatase inhibitor, if medically
appropriate

Please post your comments below or email me at: chrisral@cancerboard.ab.ca

* Thanks to Scott Edwards, PharmD for the link to the CTV News article.

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