Latest Cancer News

FDA Expands Indication for Revlimid® as a Maintenance Treatment for Patients with Multiple Myeloma Following Autologous Stem Cell Transplant

The U.S. Food and Drug Administration (FDA) expanded the existing indication for Revlimid® (lenalidomide) to include use for patients with multiple myeloma as maintenance therapy following autologous stem cell transplant (ASCT). The expanded indication makes Revlimid® the first and only treatment to receive FDA approval for maintenance use following auto-HSCT.1

Autologous stem cell transplant after induction therapy is part of the continuum of care for transplant-eligible multiple myeloma patients because it has been demonstrated to improve patient outcomes.2 Despite improvement with ASCT most patients will still ultimately see their disease recur or progress after treatment.  Maintenance therapy, which has been shown to increase progression-free survival following autologous stem cell transplant in clinical trials can now be considered a standard of care for these patients.

The recent FDA approval was based on two large studies including more than 1,000 patients comparing Revlimid® maintenance therapy given until disease progression or unacceptable toxicity after ASCT versus no maintenance. One study demonstrated an average survival without myeloma progression of 5.7 years versus 1.9 years for no maintenance, a difference of 3.8 years.  The second study showed an improvement of 3.9 years versus 2 years for no maintenance, a difference of 1.9 years.  Although not designed to evaluate overall survival, the first trial showed an average survival of 9.3 years for Revlimid® versus 7 years for no maintenance.

While Revlimid offers benefit as maintenance therapy for multiple myeloma, it does come with risks, namely the increased risk of second primary cancers.   Patients should understand and discuss these risks with their treating physician before deciding on treatment.3

References:

  1. http://www.businesswire.com/news/home/20170222006533/en/
  2. Cavo M, Palumbo A, Zweegman S, et al. Upfront autologous stem cell transplantation (ASCT) versus novel agent-based therapy for multiple myeloma (MM): A randomized phase 3 study of the European Myeloma Network (EMN02/HO95 MM trial). Abstract #8000. Presented at the 2016 American Society of Clinical Oncology Annual Meeting, Chicago, IL, June 3, 2016.
  3. Badros AZ. Lenalidomide in Myeloma — A High-Maintenance Friend, New England Journal of Medicine. 2012; 366:1836-1838.

Copyright © 2017 CancerConnect. All Rights Reserved.


SWOG Launches National Immunotherapy Clinical Trial for Rare Cancers

People with rare cancers now have the option of joining a national clinical trial testing leading-edge immunotherapies for a wide variety of tumor types. It’s the first federally funded immunotherapy trial devoted to rare cancers. Despite their name, rare cancers make up more than 20 percent of cancers diagnosed worldwide.

The trial is called DART, which stands for Dual Anti-CTLA-4 & Anti-PD-1 blockade in Rare Tumors. It is managed by SWOG, the cancer clinical trials group that is part of the National Cancer Institute’s (NCI) National Clinical Trials Network (NCTN). The trial is sponsored by the NCI and being conducted under the NCI collaborative agreements with Bristol-Myers Squibb for ipilimumab and nivolumab.

The trial draws on the design and takes advantage of the scale of another landmark trial offered through the NCTN – the NCI-Molecular Analysis for Therapy Choice, or NCIMATCH, a precision medicine trial open at more than 1,000 clinical sites. Co-designed by the ECOG-ACRIN Cancer Research Group and the NCI, and led by ECOG-ACRIN, NCI-MATCH is the most sweeping precision medicine trial in the U.S. NCI-MATCH uses a customized tumor gene testing method to match patients with any solid tumor, along with lymphoma and myeloma, to multiple targeted treatments. Currently, there are 24 treatments offered, with plans to add about 10 more. Since NCI-MATCH was launched in August 2015, more than 2,500 patients have completed tumor gene testing out of the 6,000 patients intended to be screened. As of December 1, 2016, nearly 300 patients have entered treatment arms.

According to the definition used for the DART trial, rare cancers are those diseases with less than a 6 in 100,000 incidence per year. These include dozens of types, including cancers in nerves, glands, bones, and skin. But only certain patients will be eligible to enroll in DART. To join, patients must be registered to NCI-MATCH. If they don’t have a treatment option under NCI-MATCH, or if they didn’t respond to treatment on that trial, and their rare cancer is eligible, they can enroll.

DART patients will be treated with two immunotherapy drugs – ipilimumab plus nivolumab – a combination treatment that helps the immune system fight cancer. The U.S. Food and Drug Administration approved the combination to treat melanoma, and it is currently being tested on a variety of lung cancers. Bristol-Myers Squibb sells the drugs under the brand names Opdivo (nivolumab) and Yervoy (ipilimumab).

Investigators leading the DART trial want to determine if this combination, given in sixweek cycles, can significantly shrink tumors based on computerized tomography (CT) scans taken upon enrollment, then at regular intervals over the course of treatment. The DART team also wants to evaluate any side effects in patients, and estimate how long patients live and the length of time before their cancer progresses. In addition, a basic science team will use tumor tissue samples to study how immune cells and genes respond to the drug combination, and see if there are any biomarkers that predict treatment response among patients. Trial leaders plan to enroll 300 patients.

Dr. Razelle Kurzrock and Dr. Francis J. Giles are the DART senior study chairs, providing guidance on the trial design and protocol. Kurzrock is senior deputy center director at the University of California San Diego Moores Cancer Center and chair of the early therapeutics and rare cancers committee at SWOG, under whose auspices DART was developed. Giles is chief of the Division of Hematology/Oncology at Northwestern University Feinberg School of Medicine, deputy director of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, and SWOG principal investigator at Northwestern.

Dr. Sandip Patel is DART principal investigator.

“NCI-MATCH’s goal was to include rare cancer patients as part of the trial, and with DART, we hope to increase the impact by offering them this dual immunotherapy,” said Patel, assistant professor of medicine and assistant director of the Clinical Trials Office at UC San Diego Moores Cancer Center. “This trial is an extraordinary team effort between multiple cancer centers connected by SWOG.” Dr. Young Kwang Chae, is principal investigator for the translational medicine component of DART and leads the study with Patel.

“DART could have strong science benefits by allowing us to explore the genomic landscape of rare tumors and their response to combination immunotherapy,” said Chae, assistant professor in the Division of Hematology/Oncology in the Feinberg School of Medicine at Northwestern and co-director of the division’s Developmental Therapeutics Program.

The DART team includes Dr. Donna Hansel, a pathologist and professor at UC San Diego; SWOG biostatisticians Megan Othus, Ph.D., and Melissa Plets, M.S., both of Fred Hutchinson Cancer Research Center; Dr. Christopher Ryan, SWOG executive officer for early therapeutics and rare cancers and professor at the Knight Cancer Institute at Oregon Health & Science University; SWOG protocol coordinator Cara Laubach; and Jeffrey Chuang, Ph.D., and Dr. Karolina Palucka from The Jackson Laboratory, a SWOG basic science partner. DART partners also include ECOG-ACRIN and the NCI’s Cancer Therapy Evaluation Program. DART is funded by the NCI, with support from BristolMyers Squibb, which is providing the study drugs.

“We are hopeful that with the help of the rare disease community, and patients throughout the U.S., this pivotal trial will advance more treatments for people with rare cancers,” said Marcia Horn, SWOG’s patient advocate for early therapeutics and rare cancers and president and CEO of the International Cancer Advocacy Network. SWOG is part of the National Cancer Institute’s National Clinical Trials Network and the NCI Community Oncology Research Program,

SWOG has nearly 12,000 members in 46 states and six foreign countries who design and conduct cancer clinical trials to improve the lives of people with cancer. Founded in 1956, SWOG’s 1,300 trials have led to the approval of 14 cancer drugs, changed more than 100 standards of cancer care, and saved more than 2 million years of human life.

Copyright © 2017 CancerConnect. All Rights Reserved.


Kyprolis® Significantly Improves Overall Survival Compared To Velcade® In Relapsed Or Refractory Multiple Myeloma

The ENDEAVOR trial results were updated at the 16th International Myeloma Workshop in New Delhi.  The trial demonstrated that Kyprolis (Carfilzomib) not only significantly extended progression-free survival compared to Velcade (Bortezomib), but also overall improved overall survival, making it a clinically meaningful advance in the treatment of relapsed or refractory multiple myeloma.  Patients with relapsed or refractory multiple myeloma treated with Kyprolis® and dexamethasone lived 7.6 months longer than those treated with Velcade® and dexamethasone.1

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory, or resistant have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis.

Kyprolis belongs to a class of drugs known as proteasome inhibitors. They work by preventing the breakdown of protein in cancer cells, triggering their death.  Normal cellular processes include the breakdown of proteins that are no longer being used. It is important for cells to get rid of the used proteins to function normally. Proteasomes, structures found in healthy cells, play an important role in the breakdown and recycling of these used proteins.

The ENDEAVOR study is the first of two head-to-head studies for Kyprolis versus Velcade, an established proteasome inhibitor, currently approved to treat multiple myeloma. The randomized ENDEAVOR (RandomizEd, OpeN Label, Phase 3 Study of Carfilzomib Plus DExamethAsone Vs Bortezomib Plus DexamethasOne in Patients With Relapsed Multiple Myeloma) trial of 929 patients evaluated Kyprolis in combination with low-dose dexamethasone, versus Velcade with low-dose dexamethasone in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens. This study was conducted at 235 sites worldwide.2

Reference:

  1. https://www.amgen.com/media/news-releases/2017/03/amgen-presents-overall-survival-data-from-kyprolis-carfilzomib-phase-3-endeavor-trial-at-16th-international-myeloma-workshop/. Accessed March 13, 2017.
  2. Reference: Amgen press release. FDA Approves New Kyprolis® (Carfilzomib) Combination Therapy For The Treatment Of Patients With Relapsed Or Refractory Multiple Myeloma. Available at: http://www.amgen.com/media/news-releases/2016/01/fda-approves-new-kyprolis-carfilzomib-combination-therapy-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma/. Accessed January 22, 2016.

Copyright © 2017 CancerConnect. All Rights Reserved.


Dealing with Distress

Why it’s important to acknowledge distress during cancer care and what to do about it

By Teresa L. Deshields and Clorinda Walley

The moment a patient is diagnosed with cancer, one symptom is likely to surface: distress.

Sadness, fear, helplessness, anger, social concerns, depression, anxiety, panic – just about everyone that has cancer suffers distress at some point. Distress affects the way you think, feel, or act, and may make it harder to cope with having cancer, its other symptoms, or its treatment.

Distress is not only a by-product of the cancer experience but a side effect that can worsen your health. Research shows that people who are distressed are less likely to take their medicines or complete their follow-up visits. As a result, patients end up with extra visits to the doctor’s office and emergency room.  Distressed patients can also have trouble making treatment decisions and be less likely to exercise or quit smoking.  Distress can interfere with sleep and affect how well you can focus or relate to people. If you’re a parent, you might have trouble taking care of your kids.

Distress Triggers

Distress can occur at any time, although some junctures are more likely than others.  Common periods of distress occur upon diagnosis, during a transition in care such as being discharged from a hospital or finishing a treatment plan, or when learning that your health has worsened. Ideally, providers should screen for distress during every health care visit, but certain times in the care continuum are especially important.

Screening for distress is usually a quick process, and when paired with getting help, can yield major benefits. Without standard screening, on the other hand, fewer than half of distressed patients get the help they need.

It is with a deep understanding of the relationship between cancer and distress that the National Comprehensive Cancer Network® (NCCN®) and NCCN Foundation®, in collaboration with the national non-profit health care foundation Good Days, have unveiled the NCCN Guidelines for Patients®: Distress, the latest in the NCCN library of patient education materials. The guide is designed to help patients understand the sources of distress and prepare them to talk about what they’re experiencing with providers. The NCCN patient guides [available free at NCCN.org/patients] are easy-to-understand resources based on the same clinical practice guidelines used by health care professionals nationwide.

The Distress Thermometer and Problem List

The newly-released NCCN Guidelines for Patients®: Distress includes a proven process that providers use to gauge a patient’s distress level and the need for intervention: The Distress Thermometer and Problem List. Working off a scale of 0 to 10, the Distress Thermometer measures distress, and the Problem List helps identify the source, whether physical, emotional, or practical.  A patient who reports a distress level of 4 or higher should be referred for specialized care based on the cause of distress. For instance, a cancer team can help address pain, nausea or other physical issues, but might refer patients to experts in other fields with specialized knowledge and skills, such as chaplains for spiritual concerns, social workers for practical issues such as child care and financial challenges, and psychologists or psychiatrists for emotional or coping difficulties.

Assessing distress is a key part of cancer care. It helps focus the patient’s team on managing your overall care and well being. For these reasons and more, it is important to understand and equip yourself with tools to alleviate distress by taking a comprehensive approach to dealing with it, both personally and with your cancer care team.

###

Teresa L. Deshields, PhD, ABPP, is vice-chair of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Panel for Distress Management and manager of the Counselling Service at the Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine.

Clorinda Walley is Executive Director of Good Days, a national, independent 501(c)(3) non-profit charitable organization that provides financial assistance to patients so that they do not have to choose between access to medicine they need and affording everyday living.

CancerConnect

Copyright © 2017 CancerConnect. All Rights Reserved.


Kisqali® Receives FDA Approval as First Line Treatment for HR+/HER2- Metastatic Breast Cancer

The US Food and Drug Administration (FDA) has approved the investigational drug Kisqali® (ribociclib, LEE011) for first line treatment of hormone receptor + HER 2- metastatic breast cancer because when combined with Femera (letrozole) the combination benefits all such women and leads to improved survival without cancer recurrence.

The interim results from a large clinical trial were previously presented at the 2016 European Society for Medical Oncology (ESMO) meeting and published in the New England Journal of Medicine demonstrating that the addition of Kisqali®to Femara improved survival without cancer progression by 44%.

Advanced or metastatic breast cancer refers to cancer that originated in the breast, but has spread to several and/or distant sites in the body. The goals of treatment for metastatic breast cancer are to improve duration of survival while maintaining quality of life.

The majority of breast cancers are referred to as HR+, meaning their cancer is stimulated to grow from exposure to the female hormones estrogen and/or progesterone. These patients are treated with endocrine therapy (sometimes referred to as hormone, or anti-estrogen therapy), which reduces the cancer cells’ exposure to estrogen through varying mechanisms. Endocrine therapy has proven extremely effective in reducing HR-positive cancer growth and spread for extended periods of time.

About Kisqali

Kisqali is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide too quickly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably.

Study Details

The MONALEESA-2 clinical trial directly compared Kisqali plus Femara to Femara alone as initial treatment of 668 postmenopausal women with HR+, human epidermal growth factor receptor 2 negative advanced breast cancer.

Among patients with measurable disease the overall response rate was 52.7% with Kisqali and Femara compared to only 37.1% with Femara alone. After a median follow-up of 15.3 months, Kisqali was also associated with a significant improvement in time to cancer progression.

Breast cancer experts at the meeting believe that CDK4/6 inhibition with Kisqali and other cyclin-dependent kinase inhibitors will be a game changer in the treatment of advanced breast cancer. The key question is whether doctors should use them in all patients or whether some biomarker could be identified to use them more selectively. Doctors do not know whether 100% of patients will benefit, or less.

Reference: Hortobagyi B, Stemmer S, Burris H, et al. First-line Kisqali + letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2–), advanced breast cancer (ABC). Proceedings from the annual meeting of the 2016 European Society for Medical Oncology (ESOM). Abstract LBA1_PR.  Presented October 8, 2016.

Copyright © 2017 CancerConnect. All Rights Reserved.


Regional Chemotherapy Technique for Extremity Sarcoma Salvages Patients’ Limbs from Amputation

Patients with a type of advanced malignant cancer of the arms or legs have typically faced amputation of the afflicted limb as the only treatment option.  However, a technique that limits the application of chemotherapy to the cancerous region can preserve limbs in a high percentage of these patients, researchers from five cancer centers in the United States and Australia report in a study published online as an “article in press” on the Journal of the American College of Surgeons website in advance of print publication.

The researchers used the treatment technique, known as regional chemotherapy with isolated limb perfusion (ILI), in 77 patients with treatment-resistant, locally advanced soft tissue sarcomas (STS), and were able to salvage limbs in 77.9 percent of the cases.  “Isolated limb infusion is a safe and effective technique of treatment of patients with locally advanced soft tissue sarcoma who otherwise might require amputation,” said lead study author John E. Mullinax, MD, from Moffitt Cancer Center, Tampa, Fla.

The study, conducted over a 22-year period from 1994-2016, is the largest one to date of limb preservation using ILI for sarcoma.  “Advocates for ILI in these patients would argue that, with similar long-term survival data and meaningful overall response rates, patients would much prefer a treatment that preserves the affected extremity to one that does not,” Dr. Mullinax said.  ILI has historically been used primarily for melanoma of the extremities and the use of this technique in sarcoma is a more novel approach.  Sarcoma is a rare type of cancer in the extremities with several different subtypes; the study patients who underwent ILI had 17 different subtypes of sarcoma.

The rationale for amputation of soft tissue sarcoma of the arm or leg has been to prevent the cancer from spreading to, or metastasizing to, other parts of the body.  Dr. Mullinax noted that one concern with the use of ILI in these cancers is that it does not address distant metastatic disease. “The reality is that those patients who develop metastatic disease after amputation or ILI likely may already have distant microscopic disease at the time of the procedure, but the radiographic staging studies are not sensitive enough to detect it,” Dr. Mullinax said.  “In this sense, the treatment of the extremity disease is not to the determinant of long-term survival.”

In the study population, 19 patients had 21 procedures for upper-extremity disease and 58 patients had 63 infusions for lower-extremity disease.  The results varied significantly for the two groups. The overall three-month response rate to ILI was 58 percent, but it was only 37 percent for those with upper-extremity disease vs. 66 percent for lower-extremity disease.  Likewise, those who had upper-extremity sarcomas had a lower median overall survival than their lower-extremity counterparts, 27.9 months vs. 56.6 months.  For the entire study population, the median overall survival was 44.3 months.

Entering the study, all the patients had sarcomas that could only be removed with an amputation, but afterward 30 percent had a complete response to ILI, many of these because patients were able to have a surgical procedure to remove the tumors without amputation.  For those who eventually needed an amputation, the median time to do so was 4.5 months following ILI.

The ILI technique involves circulating the chemotherapy agents melphalan and actinomycin D in the blood vessels of the affected area of the arm or leg, and the use of a tourniquet to block the chemotherapy drugs from circulating through the rest of the body, thus creating a closed circuit.  The drugs circulate in the target area for 30 minutes, and then are flushed out before the tourniquet is removed and full circulation is restored.  ILI for soft tissue sarcoma of the extremities can be repeated, whereas another procedure to administer chemotherapy to the arms or legs, hyperthermic isolated limb perfusion, requires an incision to openly cannulate the vessels and generally cannot be repeated, Dr. Mullinax explained.

The ILI technique requires a team to help perform the procedure such as an interventional radiology team to place the catheter in the artery before the procedure, a perfusionist to oversee the circuit and an operating room staff familiar with chemotherapy precautions, Dr. Mullinax said.

“Most patients would prefer to have more time with their leg rather than face an amputation,” Dr. Mullinax said.  “It’s known that for patients with soft-tissue sarcoma, the life-limiting disease is not in the extremity but it’s actually in the metastatic disease.  An inoperable sarcoma of the thigh does not affect survival to the degree that metastatic disease in the lung does.”

Dr. Mullinax said one limitation of the study was that it did not randomize patients between ILI and amputation, so a head-to-head comparison of response to treatment and survival cannot be performed with this dataset.  The study also did not evaluate quality of life or patient-related factors for those who had limb salvage vs. those who had amputation.

Reference: Isolated Limb Infusion as a Limb Salvage Strategy for Locally Advanced Extremity Sarcoma.  Journal of the American College of Surgeons.

Copyright © 2017 CancerConnect. All Rights Reserved.


COMBI-v BRAF/MEK Inhibitor Combination Trial Continues to Impress in Melanoma

For advanced melanoma patients with BRAF mutations, two pathway inhibitors are much better than one, according to a study presented at the European Society for Medical Oncology.  The latest data confirm an estimated 45% of patients who received Tafinlar (dabrafenib) + Mekinist (trametinib) combination therapy are alive versus 31% of patients on BRAF monotherapy with with Zelboraf (vemurafenib).1

Of the more than one million new diagnoses of skin cancer each year, roughly 68,000 involve melanoma. More than 8,000 people die of melanoma each year in the United States. Melanoma is dangerous because it is more likely than other types of skin cancer to spread (metastasize) to other parts of the body.

Certain gene mutations affect cancer behavior, and a large and growing number of targeted therapies have been proven effective against cancers that contain these mutations. Many advanced melanomas, for example, contain mutations in the BRAF gene and can be treated with drugs known as BRAF or MEK inhibitors. The BRAF gene is known to play a part in cell growth, and mutations in BRAF are common in several types of cancer.

Approximately half of all melanomas carry a specific BRAF mutation known as V600E. This mutation produces an abnormal version of the BRAF protein that stimulates cancer growth. Some melanomas carry another BRAF mutation known as V600K.

Researches postulated that a combination of a BRAF inhibitor and a MEK inhibitor might mitigate the emergence of disease resistance that occurs with BRAF inhibition alone.  Tafinlar and Mekinist target different kinases within the kinase family.  When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more than either drug alone. The combination of Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide.

About the COMBI-v Study

COMBI-v is a clinical trial that directly compared the combination of Tafinlar plus Mekinist with Zelboraf monotherapy in 704 patients with BRAF V600E/K mutation-positive unresectable or metastatic melanoma. The Independent Data Monitoring Committee stopped the trial early based on results observed wth Tafinlar plus Mekinist as part of a planned interim analysis.

Overall the response rates, duration of response and overall survival were improved with the combination therapy. The estimated three-year survival rate is 45% for patients receiving the combination of Tafinlar plus Mekinist compared with 31% of patients who received Zelboraf monotherapy Additionally, the estimated three-year progression-free survival rate was 24% for the combination arm and 10% for Zelboraf monotherapy.

References:

  1. Robert C, Karaszewska B, Schachter J, et al. COMBI-v: A randomised, open-label, Phase III study comparing the combination of dabrafenib (D) and trametinib (T) with vemurafenib (V) as first-line therapy in patients (pts) with unresectable or metastatic BRAF V600E/K mutation-positive cutaneous melanoma. ESMO 2014. LBA4_PR.
  2. Robert. C, Karaszewska b, Schachter J, et al. Three-year estimate of overall survival in COMBI-v, a randomized phase 3 study evaluating first-line dabrafenib (D) + trametinib (T) in patients (pts) with unresectable or metastatic BRAF V600E/K-mutant cutaneous melanoma. Abstract #LBA40. 2016 European Society of Medical Oncology (ESMO) Annual Meeting, Copenhagen, Denmark.

Copyright © 2017 CancerConnect. All Rights Reserved.


Know Your Treatment Options: Colorectal Cancer Liver Metastases

Nearly 136,000 Americans are expected to be diagnosed with colorectal (CRC) cancer this year,1 and more than 50% will have their cancer spread to their liver.2  Many individuals with CRC involving the liver erroneously conclude that they have no treatment options other than systemic therapy.  There are however several therapeutic options for the treatment of liver metastases, and others being developed in clinical trials.

The type of liver directed therapy used is determined by the size of the cancer, the number of metastases, and the location of the cancers within the liver. Patients need to understand that many advanced treatment options are only be available at cancer centers specializing in the treatment of CRC and patients should consider getting an opinion at one of these centers. For example:

  • Many liver metastases can be effectively treated with surgery, but not all cancer clinics have the expertise to offer surgery as a treatment option. One analyses has demonstrated that surgery for liver metastases that can be resected has produced long-term overall survival of nearly 50% at five years and nearly 30% at 10 years.6
  • Additional clinical trials have demonstrated that the addition of chemotherapy following surgery for liver metastases further improves treatment outcomes.7
  • In some patients with inoperable liver metastases, an initial round of chemotherapy or neoadjuvant radiation therapy can be used to shrink the liver metastases enough so that surgery becomes possible.8
  • Using minimally invasive techniques such as ablation, embolization, or radioembolization allows the delivery of radiation therapy or chemotherapy directly to the liver tumor(s).

SIR-Spheres® Y-90 microspheres have been added as a new treatment option in the latest National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for colon cancer and rectal cancer.  SIR-Spheres Y-90 resin microspheres are a medical device used in an interventional radiology procedure known as selective internal radiation therapy (SIRT), or radioembolization, which targets high doses of radiation directly to liver tumors. The treatment consists of tens of millions of radioactive Y-90 coated resin particles, each no bigger in diameter than a human hair. SIR-Spheres Y-90 are injected into the hepatic artery, which is the main blood supply to the liver via a catheter inserted into the femoral artery through an incision in the groin. The Y-90 resin microspheres become lodged in the smaller blood vessels that surround cancer in the liver, where they deliver a high dose of radiation to the cancer, while sparing healthy liver tissue.3,4,5

Patients with CRC that has spread to the liver need to make sure they are evaluated at a cancer center that offers advanced liver directed treatment options.  They should also consider the role of clinical trials.

Ongoing research is being conducted in clinical trials to find new treatments for CRC. By learning about clinical trials you can identify opportunities that advance the treatment of CRC and possibly benefit your personal prognosis.

Learn more about clinical trials: No more searching – Advanced cancer treatments can be found in clinical trials. Cure Forward can make finding them easier.

References:

  1. American Cancer Society. Colorectal Cancer Facts & Figures 2017-2019. Atlanta: American Cancer Society, 2017.
  2. Cho M, Gong J and Fakih M.The state of regional therapy in the management of metastatic colorectal cancer to the liver. Expert Review of Anticancer Therapy, 2016; 16(2): 229–245.
  3. van Hazel GA, Heinemann V, Sharma NK et al. SIRFLOX: Randomized Phase III trial comparing first-line mFOLFOX6 (plus or minus bevacizumab) plus selective internal radiation therapy in patients with metastatic colorectal cancer. Journal of Clinical Oncology. 2016; 34: 1723–1731.
  4. Kennedy AS, Ball D, Cohen SJ et al.Multicenter evaluation of the safety and efficacy of radioembolization in patients with unresectable colorectal liver metastases selected as candidates for 90Y resin microspheres. Journal of Gastrointestinal Oncology. 20156: 134–142.
  5. SIR-Spheres® microspheres (Yttrium-90 Microspheres) Product Information.
    Available at: com/us/clinicians/package-insert/.
  6. Wei A, Greig P, Grant D, et al. Survival After Hepatic Resection for Colorectal Metastases: A 10-Year Experience. Annals of Surgical Oncology. 2006; 13:668-676.
  7. Portier G, Elias D, Bouche O, et al. Multicenter Randomized Trial of Adjuvant Fluorouracil and Folinic Acid Compared With Surgery Alone After Resection of Colorectal Liver Metastases: FFCD ACHBTH AURC 9002 Trial. Journal of Clinical Oncology. 2006; 24: 4976-4982.
  8. Capussotti L, Muratore A, Mulas MM, Massucco P, Aglietta M. Neoadjuvant Chemotherapy and Resection for Initially Irresectable Colorectal Liver Metastases. British Journal of Surgery. 2006;93:1001-1006.

Copyright © 2017 CancerConnect. All Rights Reserved.


Zykadia receives FDA Priority Review for first-line use in patients with ALK+ metastatic NSCLC

The US Food and Drug Administration (FDA) granted Priority Review for the expanded use of Zykadia® (ceritinib) as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA also granted Breakthrough Therapy designation to Zykadia for the first-line treatment of patients with ALK+ metastatic NSCLC with metastases to the brain.

About Zykadia

Zykadia is an oral, selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can fuse with others to form an abnormal “fusion protein” that promotes the development and growth of certain tumors in cancers including non-small cell lung cancer (NSCLC).

The FDA’s decision on Zykadia is based on the primary analysis of ASCEND-4, a global clinical trial which evaluated Zykadia compared to platinum-based chemotherapy in adult patients with Stage IIIB or IV ALK+ NSCLC.

About ASCEND-4

ASCEND-4 was a Phase III randomized, open-label, multicenter, global clinical trial to evaluate the safety and efficacy of Zykadia compared to standard chemotherapy, including maintenance, in adult patients with Stage IIIB or IV ALK+ advanced NSCLC who received no prior therapy for their advanced disease. Patients received Zykadia orally at 750 mg/daily or standard pemetrexed-based platinum doublet chemotherapy per label (pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5-6) for 4 cycles followed by pemetrexed maintenance.

Of 376 patients, 189 (59 with brain metastases) were randomized to Zykadia and 187 (62 with brain metastases) to chemotherapy. Approximately 60% of patients with baseline brain metastases treated with Zykadia did not have prior radiation therapy, the current standard of treatment for baseline brain metastases. Among patients randomized to the chemotherapy arm, 105 (72%) of 145 received an ALK inhibitor as their first treatment after discontinuation of chemotherapy.

In the ASCEND-4 trial patients treated with first-line Zykadia had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for patients treated with standard first-line platinum chemotherapy.

Patients receiving Zykadia without brain metastases experienced a median PFS of 26.3 months compared with 8.3 months among patients treated with chemotherapy1.

In a pre-specified analysis of patients receiving Zykadia with brain metastases at baseline, the median PFS was 10.7 months (95% CI: 8.1, 16.4) in the Zykadia group versus 6.7 months (95% CI: 4.1, 10.6) in the chemotherapy group (HR = 0.70 [95% CI: 0.44, 1.12])[1]. Intracranial overall response rate (ORR) (72.7%, [95% CI: 49.8, 89.3]) is consistent with whole body ORR (72.5% [95% CI: 65.5, 78.7]).

References

[1] Soria JC, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): A randomized, open-label Phase 3 study. The Lancet. 2017.

[2] US Food and Drug Administration. Priority Review. Available at http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm. Accessed February 2, 2017.

[3] US Food and Drug Administration. Fact Sheet: Breakthrough Therapies. Available at http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed February 6, 2017.

[4] World Health Organization. Estimated number of deaths, both sexes, worldwide in 2012. World Health Organization. http://gco.iarc.fr/today/online-analysis-pie?mode=cancer&mode_population=continents&population=900&sex=0&cancer=11&type=1&statistic=0&prevalence=0&color_palette=default. Accessed on January 19, 2017.

[5] World Health Organization. International Agency for Research on Cancer. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Lung Cancer. Available at http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx?cancer=lung. Accessed February 2, 2017.

[6] Lovly, C., L. Horn, W. Pao. 2016. Molecular Profiling of Lung Cancer. My Cancer Genome. Available at https://www.mycancergenome.org/content/disease/lung-cancer/. Accessed February 7, 2017.

[7] Riess JW, Wakelee, HA. Metastatic Non-Small Cell Lung Cancer Management: Novel Targets and Recent Clinical Advances. Clinical Advances in Hematology & Oncology. 2012; 10: 226-224.

Copyright © 2017 CancerConnect. All Rights Reserved.


New Ovarian Cancer Immunotherapy Study Poses Question: Can Microbiome Influence Treatment Response?

A clinical study with Keytruda (pembrolizumab) in a novel untried combination is the first ovarian cancer clinical trial to incorporate gut flora analysis.  Dr. Emese Zsiros, the study’s Principal Investigator, explains a new, unique clinical trial investigating immunotherapy for patients with advanced ovarian cancer.

A new clinical study underway at Roswell Park Cancer Institute is the first to test the combination of the immunotherapy Keytruda with two other drugs as treatment for recurrent epithelial ovarian cancer, and is also the first ovarian cancer clinical trial to incorporate analysis of patients’ microbiomes — the bacteria present in the human gut and other organs.

This new study, led by Dr. Zsiros Assistant Professor of Oncology in Roswell Park’s Department of Gynecologic Oncology and Center for Immunotherapy is a phase II clinical trial that will enroll approximately 40 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, and will evaluate the impact of the combination of the PD1-targeting antibody Keytruda with intravenous Avastin (bevacizumab) and oral Cytoxan (cyclophosphamide) on antitumor immune responses and on progression-free survival.

Keytruda has been approved by the U.S. Food and Drug Administration for treatment of advanced melanoma, some metastatic non-small cell lung cancers and recurrent squamous cell head/neck carcinoma, but has only been tested in a small number of ovarian cancer patients, as a single drug and showing modest response. The investigators say a strong scientific rationale supports their hypothesis that the combination of Keytruda with two other drugs that have already been approved to treat ovarian cancer — Avastin and low-dose oral cyclophosphamide — may have much broader benefit for patients.

“Our biggest hope is that by trying these three drugs in combination, we can significantly extend the lives of patients with recurrent ovarian cancer. We also hope to minimize the side effects associated with chemotherapy drugs, and to markedly improve the quality of our patients’ lives,” says Dr. Zsiros. “We will be looking at potential biomarkers that will tell us who can most benefit from this therapy combination and to better understand how cancer cells and immune cells communicate with one another so that we can design better medications to kill cancer efficiently.“

As part of this study, the clinical team will analyze blood, tumor, stool, vaginal and skin microbiome samples, looking to identify possible associations between these markers with clinical outcomes and tumor response. The study, which is supported by a grant from Merck & Co. Inc., maker of Keytruda, will be one of the first to analyze these bacteria to determine possible associations with response to immunotherapeutic agents in patients with cancer.

“We’re looking at how to improve our immune defenses to cancer, but we’re looking at it from a variety of angles,” says Dr. Zsiros. “There’s a whole new area of research suggesting that what’s going on in our gut, our gut flora, has a huge influence on your overall health and happiness, and this study will extend that work into some new directions.”

According to the National Cancer Institute, epithelial ovarian cancer is one of the most common gynecologic malignancies and is the fifth most frequent cause of cancer death in women.

To learn more about the clinical research study, call 1-877-ASK-RPCI (1-877-275-7724) or send an e-mail to ASKRPCI@roswellpark.org. Additional details are available at ClinicalTrials.gov.

Copyright © 2017 CancerConnect. All Rights Reserved.


1 2 3 4 5 6 7 8 9 10 ... 19 20   Next »