Latest Cancer News

Cervical Cancer Survivors Frequently Suffer From Long-Term Side Effects of Treatment

According to a new study around half of women who have been treated for locally advanced cervical cancer suffer from symptoms of insomnia, fatigue or hot flushes.1

Cervical cancer affects more than 500,000 women around the world each year with an average age at diagnosis of 50.  Each year in the United States, more than 12,000 women are diagnosed with cervical cancer and more than 4,000 die of the disease.2   With advances in treatment women are living longer raising questions about long term side effects of treatment.  Side effects can have a substantial impact on patients’ quality of life and they need to be better identified and managed.

The study current study evaluated 1,176 women with locally advanced cervical cancer, treated around the world between 2008 and 2015. All received standard treatment with combined chemotherapy radiotherapy. Patients were followed for an average of 27 months after treatment and assessed for symptoms by their doctors and themselves.

Overall the study found that 64% of women were experiencing fatigue, 43% were experiencing insomnia, and 50% were experiencing hot flashes mainly in the mild to moderate range. Severe symptoms were reported in 2% to 4%. Younger women were more likely to experience these symptoms.

There are increasing management options for these symptoms and in order to ensure the best care patients should understand the presence of these and other symptoms before beginning treatment and monitor carefully throughout treatment and beyond.

References:

  1. The research is part of a larger study on MRI guided brachytherapy in locally advanced cervical cancer called EMBRACE (https://www.embracestudy.dk/).
  2. According to the International Agency for Research on Cancer (IARC), there were 527,624 new cases of cervical cancer in 2012 and 265,672 deaths worldwide. For Europe, the figures are 58,373 and 24,404.

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Alternative Medicine Used Alone Appears to Reduce Survival Rates in Cancer Patients

Patients who choose to receive alternative therapy as treatment for curable cancers instead of conventional cancer treatment have a higher risk of death, according to researchers from the Cancer Outcomes, Public Policy and Effectiveness Research Center at Yale School of Medicine and Yale Cancer Center. The findings were reported online by the Journal of the National Cancer Institute.

There is increasing interest by patients and families in pursuing alternative medicine as opposed to conventional cancer treatment. This trend has created a difficult situation for patients and providers. Although it is widely believed that conventional cancer treatment will provide the greatest chance at cure, there is limited research evaluating the effectiveness of alternative medicine for cancer.

While many cancer patients use alternative therapy in addition to conventional cancer treatments, little is known about patients who use alternative therapy as their only approach to treating their cancer.

To investigate alternative medicine use and its impact on survival compared to conventional cancer treatment, the researchers studied 840 patients with breast, prostate, lung, and colorectal cancer in the National Cancer Database, which represents approximately 70% of newly diagnosed cancers nationwide. Researchers compared 280 patients who chose alternative medicine to 560 patients who had received conventional cancer treatment.

The researchers studied patients diagnosed from 2004 to 2013. They found that alternative medicine when used instead of chemotherapy, surgery, and/or radiation, led to a greater risk of death. The researchers concluded that patients who chose treatment with alternative medicine were more likely to die and urged for greater scrutiny of the use of alternative medicine for the initial treatment of cancer.

Learn More About Complimentary & Alternative Medicine

Join The Discussion and Share Your Experience

“We now have evidence to suggest that using alternative medicine in place of proven cancer therapies results in worse survival,” said lead author Skyler Johnson, M.D. “It is our hope that this information can be used by patients and physicians when discussing the impact of cancer treatment decisions on survival.”   Patients should always discuss the use of alternative medicine with their doctor and ensure their physician is aware of what they are taking.

Reference:  https://news.yale.edu/2017/08/10/using-only-alternative-medicine-cancer-linked-lower-survival-rate

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Head and Neck Cancer-What You Need to Know

Head and neck cancer includes a number of different malignant cancers that develop in or around the throat, larynx (voice box), nose, sinuses and mouth.

Globally, head and neck cancer is the seventh most common type of cancer with an estimated 400,000-600,000 diagnoses every year. Head and neck cancers account for about 3 percent of all cancers in the United States. Men are diagnosed with head and neck cancers nearly twice as often as women. These cancers are more likely to be diagnosed in people over age 50.

Risk Factors

  • Alcohol and Tobacco Use: Alcohol and all tobacco products (cigarettes, cigars, pipes and smokeless tobacco) are the two lifestyle factors that contribute most to the risk of head and neck cancer. At least 75 percent of head and neck cancers are caused by alcohol and tobacco use. Individuals who use both tobacco and alcohol are at a much greater risk for developing these cancers than those who use either tobacco or alcohol alone.
  • Human Papillomavirus (HPV) Infection:
Infection with cancer-causing types of human papillomavirus (HPV), especially HPV-16 or 18, is a risk factor for some types of head and neck cancers. 
  • Ultraviolet (UV) Light Exposure:
UV light exposure, such as exposure to the sun or artificial UV rays like tanning beds, is a major cause of skin cancers including melanoma on the head and neck.
  • Other risk factors include previous radiation exposure; poor oral and dental hygiene; occupational exposure to asbestos, wood dust, paint fumes, and certain chemicals; and a history of “mono” infection caused by the Epstein-Barr virus.

Signs and Symptoms of head and neck cancer include:

  • A lump in the neck
  • A sore in the mouth that doesn’t heal or that increases in size
  • Persistent mouth or throat pain
  • Lumps or white or red patches inside the mouth
  • Difficulty chewing, swallowing, or moving the tongue
  • Throat soreness or the feeling that something is caught in the throat
  • Changes in voice or speech
  • Persistent and recurrent nosebleed

Treatment Advances

Recent advances in understanding the role of Human Papilloma Virus in head and neck cancers and breakthrough advances in treatment with precision medicines that help the immune system recognize and attack cancer.

PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1 enhance the ability of the immune system to fight cancer. Keytruda and Opdivo are both PD-1 inhibitors that work by blocking PD-1 and have demonstrated impressive activity in the treatment of head and neck cancers. Keep current with advances in treatment here.

Community Support

CancerConnect: Connect with others to share and learn. Join the leading community of individuals with head and neck cancers.

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FDA Approves IDHIFA A new Targeted Treatment for Acute Myeloid Leukemia

The U.S. Food and Drug Administration today approved Idhifa (enasidenib) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. The drug is approved for use with a companion diagnostic, the Real Time IDH2 Assay, which is used to detect specific mutations in the IDH2 gene in patients with AML.

“Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”

AML is a rapidly progressing cancer that forms in the bone marrow and results in an increased number of abnormal white blood cells in the bloodstream and bone marrow. The National Cancer Institute at the National Institutes of Health estimates that approximately 21,380 people will be diagnosed with AML this year; approximately 10,590 patients with AML will die of the disease in 2017.

Idhifa is an isocitrate dehydrogenase-2 inhibitor that works by blocking several enzymes that promote cell growth. If the IDH2 mutation is detected in blood or bone marrow samples using the RealTime IDH2 Assay, the patient may be eligible for treatment with Idhifa.

The efficacy of Idhifa was studied in a single-arm trial of 199 patients with relapsed or refractory AML who had IDH2 mutations as detected by the RealTime IDH2 Assay. The trial measured the percentage of patients with no evidence of disease and full recovery of blood counts after treatment (complete remission or CR), as well as patients with no evidence of disease and partial recovery of blood counts after treatment (complete remission with partial hematologic recovery or CRh). With a minimum of six months of treatment, 19 percent of patients experienced CR for a median 8.2 months, and 4 percent of patients experienced CRh for a median 9.6 months. Of the 157 patients who required transfusions of blood or platelets due to AML at the start of the study, 34 percent no longer required transfusions after treatment with Idhifa.

Common side effects of Idhifa include nausea, vomiting, diarrhea, increased levels of bilirubin (substance found in bile) and decreased appetite. Women who are pregnant or breastfeeding should not take Idhifa because it may cause harm to a developing fetus or a newborn baby.

The prescribing information for Idhifa includes a boxed warning that an adverse reaction known as differentiation syndrome can occur and can be fatal if not treated. Sign and symptoms of differentiation syndrome may include fever, difficulty breathing (dyspnea), acute respiratory distress, inflammation in the lungs (radiographic pulmonary infiltrates), fluid around the lungs or heart (pleural or pericardial effusions), rapid weight gain, swelling (peripheral edema) or liver (hepatic), kidney (renal) or multi-organ dysfunction. At first suspicion of symptoms, doctors should treat patients with corticosteroids and monitor patients closely until symptoms go away.

Idhifa was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition. Idhifa also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Reference: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm569421.htm

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Acalabrutinib granted Breakthrough Therapy Designation for the Treatment of Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for acalabrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Acalabrutinib is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor being evaluated for the treatment of multiple B-cell cancers.

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which demonstrate substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.

About mantle cell lymphoma

Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.  MCL accounts for approximately 3% to 6% of new NHL cases in Western countries each year.  The median age at diagnosis is 68 years, with a 3:1 male predominance.1,2,3

About Acalabrutinib

Acalabrutinib is an inhibitor of Bruton tyrosine kinase. Acalabrutinib was granted Orphan Drug Designation by the FDA for the treatment of patients with MCL. The drug works by permanently binding BTK, which is part of a chain of proteins that relays growth signals from the surface of B cells to genes in the cell nucleus enabling cancer cells to survive and grow. Drugs that block BTK stop the flow of these growth signals and the B cells die. Unlike Imbruvica™ (ibrutinib), the first BTK approved data reported from a clinical study suggests that acalabrutinib may more selectively block the BTK pathway and avoid some known side effects.4

References

  1. Leukemia & Lymphoma Society. Mantle Cell Lymphoma Facts. https://www.lls.org/sites/default/files/file_assets/mantlecelllymphoma.pdf Accessed June 2017
  2. Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal of Clinical Oncology 34, no. 11 (April 2016) 1256-1269.
  1. Hoster E, Klapper W et al. Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network. Journal of Clinical Oncology 2014;32:1338-1346.
  2. http://news.cancerconnect.com/acp-196-brutons-tyrosine-kinase-inhibitor-safe-and-effective-for-chronic-lymphocytic-leukemia-2/

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Roadmap to Personalized Therapies for Sarcoma and other Aggressive Cancers

Sarcoma is a rare and deadly form of cancer occurring in the bones and connective tissue that affects individuals of all ages. Its aggressiveness, rarity and diversity continue to hinder efforts to identify effective therapies for people with this malignancy. Patient-derived orthotopic xenografts (PDOX) are unique models where a patient’s individual tumor is grown in mice. Such xenografts have long shown great promise in modeling how sarcoma and other cancers can respond to and resist therapies, but their feasibility for use in individual patients in clinical settings remains unknown.

A new UCLA study is the first to identify patient and tumor characteristics that predict the successful creation of models and which types of sarcomas are most likely to grow as xenografts. The research, which is the first and largest PDOX study in sarcoma, gives physician-scientists a much-needed roadmap for personalizing therapies for the disease without placing patients at risk for treatment-related complications or ineffective therapy.

There are up to 50 types of soft-tissue sarcomas, making each type rare. Consequently, it is challenging for scientists to design clinical trials to identify effective systemic treatments, such as chemotherapy or targeted therapy.

Recent research has shown that patient-derived orthotopic xenografts faithfully reproduce the biological behavior of the human tumor, including treatment response and resistance that accurately mirrors that of the individual patient. Given the overall promise of PDOX, the UCLA team set out to assess the feasibility of generating individual patient PDOX models in a clinical setting and to determine potential factors that facilitate or prevent the successful development of xenografts from people with sarcomas.

In the yearlong study, the UCLA team collected tumor samples from 107 people with soft-tissue sarcomas. Tumor fragments were then surgically implanted into the mice in the anatomic site corresponding to the original tumor location in the patient. The researchers assessed the ability of the models to successfully “establish,” meaning that after implantation of the human tumor fragments in the mouse model, a new tumor grew. The tumor fragments could also be subsequently transferred and grown in additional mice for further testing, Eilber said.

Eilber and colleagues discovered that only the aggressive, or high-grade, tumors established but not the less aggressive, or low-grade, sarcomas. Of the high-grade tumors that did establish, the highest rates (62 percent) were from people whose tumors had not previously been treated with chemotherapy or radiation. Tumors from people who had undergone pre-operative radiation therapy for their sarcoma saw no successful establishment of PDOX models, and establishment was also lower when patients had received pre-operative chemotherapy (32 percent) compared with those who had untreated tumors.

PDOX establishment rates were as high as 86 percent in some subtypes of untreated aggressive sarcomas and the median time to establishment was 53 days.

More than 12,390 cases of soft-tissue sarcoma will be diagnosed in the United States this year, and nearly 5,000 Americans are expected to die from the disease. The use of traditional treatments such as chemotherapy in soft-tissue sarcoma cases continues to result in low response rates and poor survival outcomes, and there is an urgent unmet need for more personalized strategies for the disease.

The study demonstrates that patient-derived orthotopic xenografts are feasible for use in the clinical setting and can provide oncologists with a roadmap to accurately identify which patients will and will not benefit from a specific therapy. This research has the potential to change the way that people with sarcoma and other cancers are treated.

Reference: Published online August 2, 2017 in JCO Precision Oncology..

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FDA Approves Vyxeos for Adults with Poor Prognosis AML

The U.S. Food and Drug Administration granted regular approval to a liposome-encapsulated combination of daunorubicin and cytarabine for the treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.

This is the first FDA-approved treatment specifically for patients with t-AML or AML-MRC.

Approval was based on data from Study CLTR0310-301 (NCT01696084), a randomized (1:1), multicenter, open-label, active-controlled trial comparing Vyxeos to a standard combination of daunorubicin and cytarabine (7+3) in 309 patients 60-75 years of age with newly-diagnosed t-AML or AML-MRC. Vyxeos demonstrated an estimated median overall survival of 9.6 months compared with 5.9 months for the 7+3 control (hazard ratio 0.69; 95% CI: 0.52, 0.90; p=0.005).

The most common adverse reactions occurring in greater than 25% of patients treated with Vyxeos were hemorrhage events, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, dyspnea, headache, cough, decreased appetite, arrhythmia, pneumonia, bacteremia, chills, sleep disorders and vomiting.

Each Vyxeos vial contains 44 mg daunorubicin and 100 mg cytarabine encapsulated together in liposomes. The volume of reconstituted Vyxeos required for each dose is calculated based on the daunorubicin dose (mg/m2) using body surface area. Since Vyxeos is a fixed-dose combination, and dosing based on the daunorubicin component, the corresponding cytarabine dose is included and does not need to be calculated.

For the first induction cycle, the recommended dose of Vyxeos is (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome via intravenous infusion over 90 minutes on days 1, 3, and 5. If needed, the same dose is administered on days 1 and 3 of second induction. The recommended dose for each cycle of consolidation therapy is (daunorubicin 29 mg/m2 and cytarabine 65 mg/m2) liposome via intravenous infusion over 90 minutes on days 1 and 3.

References:

1.https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209401s000lbl.pdf

2.http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf

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Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers

Today investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore whether targeted therapies can be effective for children and adolescents with solid tumors that harbor specific genetic mutations and have progressed during or after standard therapy. Pediatric MATCH will incorporate more than eight different study drugs, each targeting a predefined set of genetic mutations, to match patients with therapies aimed at the molecular abnormalities in their tumors.

The study was developed and will be led jointly by NCI, part of the National Institutes of Health, and COG, part of the NCI-sponsored National Clinical Trials Network.

Pediatric MATCH is a phase 2 trial with sub-studies (arms) for each targeted drug being investigated. It will open with approximately six treatment arms, expanding to eight or more. A similar trial for adults, NCI-MATCH, began enrolling adult patients in August 2015 and is also matching patients to treatments based on the genetic mutations in their tumors. Pediatric MATCH is a separate trial for children and adolescents ages 1 to 21 who have solid tumors — including non-Hodgkin lymphomas, brain tumors, and histiocytoses — that no longer respond to standard treatment or have recurred after treatment.

“Pediatric MATCH is a very special trial,” said Douglas R. Lowy, M.D., NCI acting director. “There aren’t any other cancer trials of this scale exploring targeted treatments for children whose cancers have specific genetic abnormalities. Precision medicine trials like Pediatric MATCH have the potential to accelerate progress in identifying more effective treatments for children with cancer.”

The trial has two enrollment steps. Each patient will initially enroll for a screening study, in which a sample of his or her relapsed tumor will undergo DNA and RNA sequencing to detect genetic abnormalities that could be targeted by one or more of the drugs being studied. Archived tumor samples can be used if they were obtained after the tumor progressed following initial treatment. If there is a genetic abnormality identified in the tumor and a drug in Pediatric MATCH that targets that abnormality, the patient can then enroll in the corresponding treatment arm if he or she meets the eligibility criteria.

Pediatric MATCH will use a single sequencing test to screen for many molecular abnormalities at once. The test, which is also being used for the adult NCI-MATCH trial, was developed by the Molecular Characterization Laboratory at the NCI-sponsored Frederick National Laboratory for Cancer Research (FNLCR) in Frederick, Maryland. The latest version of this test looks for alterations in more than 160 genes associated with cancer.

To ensure quality control, biopsy specimens from all patients will be sent to a single location, the COG Biopathology Center at Nationwide Children’s Hospital in Columbus, Ohio, for DNA and RNA processing. The sequencing analysis for Pediatric MATCH will be done at two laboratories that carried out sequencing for adult NCI-MATCH: the FNLCR and MD Anderson Cancer Center.

Cancer mutations that match one of the drugs being studied are expected to be found in only about 10 percent of tumors from children and adolescents with cancer. The trial investigators, therefore, project that they will screen 200 to 300 patients a year, for a total of 1,000 patients screened, to identify patients potentially eligible for each of the sub-studies. Patients with a matched drug will be able to receive treatment as long as their tumors remain stable in size or get smaller. At least 20 patients will be targeted for enrollment in each arm, and additional treatment arms will be added as the trial progresses.

“Pediatric MATCH is a cutting-edge trial in many ways,” said COG chair Peter C. Adamson, M.D., of the Children’s Hospital of Philadelphia. “It will bring molecular analysis, coupled to a portfolio of new targeted agents, to children and adolescents with relapsed cancer across the United States. Importantly, it will also help us learn more about relapsed cancer in pediatric patients, catalyzing research aimed at developing better treatments.”

The drugs being used in Pediatric MATCH are all investigational (experimental) agents in children and contributed by pharmaceutical companies that have partnered with NCI to support this study.

“This trial would not have been possible without the enthusiastic support of the partnering pharmaceutical companies, as evidenced by their willingness to provide targeted agents for this trial,” said NCI study co-chair Nita Seibel, M.D., of NCI’s Division of Cancer Treatment and Diagnosis. “Some of the agents included have not previously been tested in children, so this trial will provide broader access to targeted agents for children and adolescents.”

Although most of the DNA mutations identified in study patients will be present only in cancer cells and not elsewhere in the body, some may have been inherited. For this reason, in Pediatric MATCH “we will also look at whether mutations found in tumors are detected in blood samples and hence were inherited,” said COG study co-chair Will Parsons, M.D., Ph.D., of Baylor College of Medicine in Houston. “This will allow us to provide the treating physician with guidance for the patient’s family regarding the need for formal genetic testing, counseling, and follow-up care.”

Enrollment in Pediatric MATCH will be available at children’s hospitals, university medical centers, and cancer centers across the United States that are part of COG.

About the Children’s Oncology Group (COG): COG, a member of NCI’s National Clinical Trials Network (NCTN), is the world’s largest organization devoted exclusively to childhood and adolescent cancer research. COG unites more than 9,000 experts in childhood cancer at more than 200 leading children’s hospitals, universities, and cancer centers across North America, Australia, New Zealand, and parts of Europe in the fight against childhood cancer. Today, more than 90 percent of the 14,000 children and adolescents diagnosed with cancer each year in the United States are cared for at COG member institutions. COG’s mission is to improve the cure rate and outcome for all children with cancer.

About the National Cancer Institute (NCI): NCI leads the National Cancer Program and the NIH’s efforts to dramatically reduce the prevalence of cancer and improve the lives of cancer patients and their families, through research into prevention and cancer biology, the development of new interventions, and the training and mentoring of new researchers. For more information about cancer, please visit the NCI website or call NCI’s Contact Center (formerly known as the Cancer Information Service) at 1-800-4-CANCER (1-800-422-6237).

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Nipple-Sparing Mastectomy Has Low Rate of Breast Cancer Recurrence

Investigators say most women with breast cancer are eligible for this type of mastectomy, which leaves the natural nipple in place

Women with breast cancer who undergo nipple-sparing mastectomy (NSM) have a low rate of the cancer returning within the first five years, when most recurrences in the breast are diagnosed, findings of a single-center study show.  The new study, published in the Journal of the American College of Surgeons website in advance of print publication, found an overall 5.5 percent recurrence rate among 311 operations at a median (midrange) follow-up of 51 months, with no recurrence involving the retained nipple.

Unlike a standard mastectomy, which removes the whole breast and breast skin including the nipple, NSM removes the breast tissue but leaves intact the breast skin, nipple, and areola (the ring of darker skin around the nipple).  Some physicians have reservations about the oncologic, or cancer-related, safety of nipple preservation because of lack of long-term follow-up, said principal investigator Barbara L. Smith, MD, PhD, FACS, a surgical oncologist and director of the Breast Program at Massachusetts General Hospital, Boston, where the study took place.

“More women are requesting NSM because of the superior cosmetic results, but doctors don’t want to take any chances with breast cancer patients’ safety for the sake of cosmetic improvement,” Dr. Smith said.  “Our study, which has one of the longest reported follow-ups after therapeutic NSM in the United States, provides additional support that it’s safe to leave the nipple intact during mastectomy with only a few exceptions.”

Their recurrence rate, she said, is comparable to reported rates of disease recurrence after standard mastectomy.  Furthermore, the procedure has several advantages over standard mastectomy.

“Often, a woman feels more whole when she keeps her nipple,” Dr. Smith said.  “Not only does the breast look more natural after NSM, a woman who still has fully intact breast skin can often choose to have a single-stage breast reconstruction with an implant, rather than needing a tissue expander (an inflatable breast implant) to stretch the skin over several months.”

More Women Eligible for Nipple Preservation

As the Massachusetts General Breast Program team has gained experience over the past decade since the hospital began performing NSM, its patient selection criteria have expanded, Dr. Smith said.  According to the authors, women with breast cancer are candidates for the NSM procedure unless they have any of the following conditions:  clinical or imaging evidence of cancerous involvement of the nipple and areola, which doctors call the nipple-areola complex; locally advanced breast cancer involving the skin; inflammatory breast cancer; or very large or sagging breasts, which would result in an unacceptable location of the nipple.

Dr. Smith credited their success with NSM to advances in breast cancer treatment, her team’s study of breast anatomy, and their surgical techniques.  Earlier European approaches to NSM typically left some breast tissue under the nipple and then applied radiation to the nipple during the operation, she said.  However, she said her team and most U.S. surgeons thoroughly remove the breast tissue under the “envelope” of breast skin and nipple because they believe that recurrence rates will be lower using this technique.  They then remove and test the breast tissue under the nipple.  If the biopsy result shows cancer, the surgeon later removes the nipple in an outpatient procedure.  Some patients can keep most of the areola, she noted.

Conceivably, however, breast tissue could remain at the nipple-areola complex or skin flaps, which might lead to a cancer recurrence, the study authors wrote.  Therefore, in this study, they reviewed medical records of 297 patients whose breast cancer was treated with NSM from June 2007 through December 2012, to analyze rates and patterns of recurrence.  Fourteen of these patients had cancer in both breasts and underwent NSM on both sides, for a total of 311 surgical procedures.

More than three-fourths of the women had stage 0 or stage 1 breast cancer, and the remainder had stage 2 or 3 cancer, the investigators reported.  They determined that ductal carcinoma in situ, in which cancer cells have not left the milk ducts, was the diagnosis in 23 percent of cases, and the other 77 percent had invasive cancer.  Results of the nipple biopsy found cancer in 20 of 311 breasts (6.4 percent), requiring later removal of the nipple or nipple-areola complex.

Because any mastectomy involves cutting nerves in the breast there is a loss of sensation at the nipple.  In NSM, a small chance exists that the nipple will wither and the tissue will die, a condition called necrosis.  The rate of nipple necrosis in this study was reportedly 1.7 percent.

High Survival Rate

Patient follow-up rates ranged from four to 101 months after NSM, with most patients having follow-up exams with their oncologists or other physicians for three to five years (56 percent) or longer (21 percent).  According to the researchers, the disease-free survival rate—the percentage of patients who were alive and without breast cancer recurrence—was 95.7 percent at three years and 92.3 percent at five years.

Breast cancer recurred in 17 patients at 51 months’ median follow-up.  Among these, 10 patients had only local-regional recurrence, meaning the cancer returned in the breast, chest wall, or underarm lymph nodes; two patients had both local-regional and distant recurrence (return of their cancer elsewhere in the body); and seven had distant recurrences alone.  The rate of local-regional recurrence that this study reported was 3.7 percent.

No patient had a recurrence involving the nipple-areola complex, the investigators found.  Furthermore, they reported that no breast cancer developed at the nipple in any of the other 1,871 NSM procedures performed at their hospital between 2007 and 2016 for cancer treatment or as a “prophylactic” mastectomy—an operation performed to try to prevent breast cancer in women. The nipple is an uncommon site for breast cancer to start, even in high-risk patients.

No known study has compared NSM with standard mastectomy by randomly assigning women to one or the other operation, Dr. Smith said.  However, she added, it appears from the low local recurrence rate in this and other reported studies that breast cancer patients who undergo NSM have no increased risk of their cancer returning because they keep their nipple.

“Women planning a mastectomy should ask their surgeon whether they are eligible for a nipple-sparing operation,” she said.

Reference: Oncologic Safety of Nipple Sparing Mastectomy in Women with Breast Cancer, Journal of the American College of Surgeons.  DOI: http://dx.doi.org/10.1016/j.jamcollsurg.2017.06.013

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Balance and Gait is Negatively Impacted By Chemotherapy Treatment

A single chemotherapy treatment can result in a significant negative impact on walking gait and balance, putting patients at an increasing risk for falls, according to a new study involving breast cancer patients conducted by researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James).

Up to 60 percent of patients experience chemotherapy-induced peripheral neuropathy (CIPN), nerve damage that impacts feeling in the hands or feet; however, when and to what extent this damage impacts functional abilities has been largely unknown.

This new study is the first to objectively measure the functional abilities of cancer patients during and after taxane-based chemotherapy. Researchers followed 33 patients with stage I-III breast cancer, assessing functional performance (standing balance and gait) and patient-reported outcomes at five timepoints spanning before treatment began up to three months post-treatment completion.

Researchers observed a 28 percent increase in side-to-side sway (medial-lateral) after just one chemotherapy treatment. That increased to 48 percent with cumulative chemotherapy exposure. Patients also demonstrated a 5 percent reduction in walking speed after three cycles of chemotherapy.

“This is not simply a quality of life concern – CIPN can impact a patient’s ability to receive treatment at all, limiting the potential for a cure. For patients who have great difficulty with neuropathy, we often have to modify their treatment regimen to make it tolerable — sometimes the therapy has to be ceased entirely,” says Maryam Lustberg, MD, MPH, senior author of the study and director of breast cancer survivorship services at the OSUCCC – James. “We need to make these treatments more tolerable to patients so they can get the full benefit of the treatments.”

Lustberg and her colleagues report that taxane exposure is also associated with worsened sensory symptoms and poorer postural control. There was also an association between patients’ balance and self-reported sensory symptoms.

Significant Clinical Problem

CIPN leads to pain, falls and difficulty walking as well as performing activities of daily living. Although symptoms can improve with time, up to 30 percent of patients have persistent symptoms that last at least six months.

Researchers say the study provides initial support for the feasibility and potential utility of implementing objective measures of physical function into the oncology clinic.

“Cancer survivors are at a significant increased risk for falls, and the incidence rate of falling after chemotherapy is a serious concern for survivors’ long-term quality of life,” adds Lustberg. “Our study provides new insights on how taxane-based chemotherapy can impact fundamental aspects of patient function. These new insights can help us develop better strategies to help patients combat these challenges and, in some cases, choose a different therapy to treat the disease but with reduced side effects.”

The OSUCCC – James is expanding this research to assess CIPN in colon cancer patients receiving taxane-based chemotherapy.

Integrating Gait, Balance Testing Into Clinical Practice

Study co-author Ajit Chaudhari, PhD, associate professor of physical therapy, orthopedics, mechanical engineering and biomedical engineering at The Ohio State University Wexner Medical Center says the study was an important first step in achieving better long-term outcomes after cancer and provides a new tool for integrating gait and balance screening into clinical care.

“We have created an easy-to-use clinical tool that has strong potential to quickly help clinicians identify patients — very early on — who are developing a chemotherapy reaction that impacts gait and balance,” says Chaudhari. “It’s no longer good enough for someone to just ‘survive’ cancer because many patients have decades of life ahead of them. It is critical to do everything we can to make the rest of their lives as productive and enjoyable as they want it to be.”

Reference: https://link.springer.com/article/10.1007/s10549-017-4230-8

Media Contact:
Amanda J. Harper
OSUCCC – James Media Relations
614-685-5420
Amanda.Harper2@osumc.edu

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