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The United States Food and Drug Administration (FDA) has approved the agent Zejula (niraparib) for the treatment of recurrent ovarian, fallopian tube, and peritoneal cancers. The indication for this approval includes its use for maintenance therapy for these types of cancers that have achieved a partial or complete disappearance following platinum-based chemotherapy. Maintenance therapy is intended to delay the growth of cancer cells following prior therapy.


The National Cancer Institute (NCI) estimates that over 22,000 women will be diagnosed with ovarian, fallopian tube, or peritoneal cancers in 2017, and more than 14,000 will succumb to these diseases. The ovaries are located in the pelvis, and are responsible for storing and releasing female eggs, as well as producing female hormones. The fallopian tubes carry the egg from the ovaries to the uterus, and the peritoneum is a lining of the abdominal wall.


Zejula creates anti-cancer effects by blocking an enzyme called ADP-ribose polymerase (PARP). PARP helps to repair damaged DNA within cells; if it is blocked, it is unable to repair damaged DNA within cancer cells, which can result in their death. Zejula is referred to as a PARP inhibitor.


The trial that prompted FDA approval of Zejula included 553 patients with recurrent ovarian, fallopian tube or peritoneal cancers of epithelial origin (meaning the cancer started in the epithelial cells which line the organs or structures). Patients had received at least 2 prior therapies, and had experienced a partial or complete disappearance of their cancer following their last treatment which included a platinum-based chemotherapy. One group of patients was treated with Zejua, and one group received a placebo (inactive substitute) as maintenance therapy. Patients were also tested for the genetic mutation referred to as BRCA which is a mutation associated with an increased risk of developing ovarian cancer.


• The median duration of time for cancer to progress for patients with the BRCA mutation was 21 months for those treated with Zejula, compared with only 5.5 months for those who received placebo.
• The median duration of time for cancer to progression for patients without the BRCA mutation was 9.3 months for those treated with Zejula, compared with only 3.9 months for those who received placebo.
• Common side effects associated with Zejula were low levels of blood cells, heart palpitations, and gastrointestinal symptoms.


Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence stated that “Zejula offers patients a new treatment option that may help delay the future growth of these cancers, regardless of whether they have a specific genetic mutation.”


Patients with recurrent ovarian, fallopian tube, or peritoneal cancers may wish to speak with their physician regarding their individual risks and benefits of treatment with Zejula.


Reference: United States Food and Drug Administration. FDA News Release. FDA approves maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers. Accessed June 1, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548948.htm.

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The United States Food and Drug Administration (FDA) has approved the agent Bavencio (avelumab) for the treatment of advanced merkel cell carcinoma (MCC) in both adult and pediatric patients. The approval is indicated for patients whose cancer has spread to distant sites in the body, whether or not they have received prior therapy.


Merkel cell carcinoma is a rare type of skin cancer, affecting approximately 1,600 people in the United States each year. If detected early, MCC can be removed surgically. However, 30% of patients develop metastatic MCC, whereby cancer spread from its site of origin to distant and/or several sites in the body. MCC is considered to be an aggressive type of cancer, and until now, no agent has been approved specifically for MCC.


Bavencio targets the PD-1/PD-L1 pathway, a cellular pathway whereby cancer cells are able to manipulate the immune system to not attack them. Bavencio disables a cancer cell’s ability to evade immune cells through the PD-1/PD-L1 pathway, so the immune system can initiate an attack against the cancer.


The trial that prompted the approval of Bavencio included 88 patients with metastatic MCC who had received at least one prior chemotherapy regimen. All patients were treated with Bavencio.


• 33% of patients achieved a partial or complete disappearance of their cancer.
• Of the patients who achieved an anti-cancer response, 86% had responses lasting more than 6 months, and 45% had a response lasting more than one year.
• Common side effects include fatigue, pain in the muscles and bone and gastrointestinal symptoms.


In the FDA press release announcing the approval of Bavencio, Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research and director of the FDA’s Oncology Center of Excellence stated that “While skin cancer is one of the most common cancers, patients with a rare form called Merkel cell cancer have not had an approved treatment option until now,” “The scientific community continues to make advances targeting the body’s immune system mechanisms for the treatment of various types of cancer. These advancements are leading to new therapies—even in rare forms of cancer where treatment options are limited or non-existent.”


Patients diagnosed with advanced MCC may wish to speak with their physician regarding their individual risks and benefits associated with treatment including Bavencio.


Reference: United States Food and Drug Administration (FDA). FDA News Release. FDA approves first treatment for rare form of skin cancer. Accessed June 23, 2017. Available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm548278.htm

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The new chemotherapy combination consisting of docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) is now considered the new standard of care for patients with operable gastric and gastroesophageal junction cancers. This new standard of care is based on results presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO).


Gastric cancer is cancer of the stomach, and gastroesophageal junction (GEJ) cancer is cancer of the junction where the esophagus and stomach connect. Standard treatment for gastric and GEJ cancer that is considered operable includes chemotherapy, surgery and/or radiation therapy. The standard chemotherapy regimen consisted of epirubicin, cisplatin and fluorouracil (ECF).


Patients are often treated with perioperative chemotherapy, meaning that chemotherapy is administered both prior to, and following the surgical removal of the cancer


Researchers recently conducted a clinical trial to directly compare the perioperative chemotherapy regimen consisting of FOT to the historic standard, ECF. The trial consisted of 716 patients with operable gastric or GEJ cancers: one group was treated with perioperative FLOT,, and the second group was treated with perioperative ECF.


• The median duration of overall survival was 50 months for the group of patients treated with FLOT, compared with only 35 months for the group of patients treated with ECF.
• At 3 years, 57% of patients treated with FLOT were still alive, compared with 48% of patients treated with ECF
• Median survival time without progression of cancer was 30 months for those treated with FLOT, compared with 18 months for those treated with ECF.


According to presenters at the 2017 annual ASCO meeting, perioperative treatment with FLOT chemotherapy should now be considered the standard of care operative gastric and GEJ cancers.


Reference: Al-Batran S-E, Homann N, Schmalenberg H, et al. Perioperative chemotherapy with docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) versus epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/ECX) for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma (FLOT4-AIO): A multicenter, randomized phase 3 trial. Proceedings from the 2017 annual meeting of the American Society of Clinical Oncology (ASCO). Abstract #4004.

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The addition of abiraterone acetate to standard therapy significantly delays cancer progression among patients with newly diagnosed prostate cancer that has spread to distant sites in the body. These results were presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO), as well as published in the New England Journal of Medicine.

Prostate cancer is stimulated to grow from circulating male hormones. An important component to therapy for many patients with prostate cancer is androgen therapy, a treatment that suppresses or counteracts the effects of male hormones in the body. Unfortunately, many patients become resistant to specific types of androgen therapy after they receive treatment for an extended time.

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Among patients diagnosed with stage III colon cancer, those who followed a healthy lifestyle after completing treatment, which included a diet high in fruits, vegetables and whole grains and low in red or processed meats, physical exercise, a healthy body weight, and moderate alcohol intake lived significantly longer than their counterparts who did not live a healthy lifestyle according to these variables. These results were presented at the 2017 annual meeting of the American Society of Clinical Oncology (ASCO).


Although it is well known that a healthy lifestyle including healthy nutrition, physical exercise, and no smoking is associated with improved health outcomes for individuals, its long-term impact on survival and outcome measures among colon cancer patients who have already completed treatment is not yet well known.


To further evaluate the issue of healthy lifestyles among cancer survivors, researchers recently conducted a study including nearly 1,000 patients with stage III colon cancer who underwent surgery followed by chemotherapy. Patients were assessed on their lifestyle for a median of 7 years. The variables assessed were the following: intake of fruits, vegetables, whole grains, red meat and processed meat; physical activity; healthy body weight; and alcohol intake.


• At a median of 7 years follow-up, patients who tended to have a higher intake of fruits, vegetables and whole grains, a low intake of red and processed meats, those who involved physical activity in their lives, and those with a healthy body weight had a 42% reduced risk of death, compared to those who tended to have a lower intake of fruits, vegetables, and whole grains, and a higher intake of red and processed meats, those who did not include much physical activity in their lives, and those outside of a healthy body weight.


• When alcohol intake was taken into consideration in addition to the other stated variables, excessive amounts of alcohol also appeared to increase the risk of death compared to no or moderate alcohol intake levels.
The results from this stud indicate that a healthy lifestyle significantly affects long-term survival among patients treated for stage III colon cancer. Cancer survivors should speak with their healthcare providers regarding their lifestyle habits.


Reference: Van Blarigan E, Fuchs C, Niedzwiecki, et al. American Cancer Society (ACS) Nutrition and Physical Activity Guidelines after colon cancer diagnosis and disease-free (DFS), recurrence-free (RFS), and overall survival (OS) in CALGB 89803 (Alliance). Proceedings from the 2017 annual meeting of the American Clinical Society of Oncology. Abstract 10006. Available at: http://abstracts.asco.org/199/AbstView_199_193741.html

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The addition of the chemotherapy agent, Temodar (temozolomide), to radiation therapy has demonstrated a huge survival benefit compared to treatment with radiation therapy only among patients with newly diagnosed glioma. These results were recently presented at the 2016 annual meeting of the American Society of Clinical Oncology.

Gliomas refer to a class of brain cancers. There are several different types of gliomas, classified according to their degree of aggressiveness; their extent of spread; and certain cancer characteristics.

As treatment for cancer continues to progress, genetics has become an important part individualizing therapy. Patients with a type of glioma known as anaplastic glioma who have specific gene mutations referred to as 1p/19q co-deletions, tend to have improved survival and a greater sensitivity to treatment with chemotherapy.

Researchers recently conducted a clinical trial to evaluate the effectiveness of the addition of the chemotherapy agent, temozolomide to radiation therapy in patients with newly diagnosed anaplastic glioma. The trial, referred to as the CATNON trial included 748 patients with anaplastic glioma that did not have the 1p/19q co-deletions. One group of patients was treated with radiation only, while the other group was treated with radiation followed by temozolomide. The median follow-up of patients was 27 months.

• At both 2 years, and 5 years following initiation of therapy, overall survival was significantly improved among patients treated with the addition of temozolomide, compared to those treated with radiation therapy only.

• Different groups in the study are also being evaluated for differences in outcomes depending upon when temozolomide was initiated (ie, delivered during radiation therapy)

• Molecular markers are also being evaluated in subgroup analyses to further clarify exactly which patients benefit the most from the addition of chemotherapy.
The researchers concluded that the addition of temozolomide after radiation therapy significantly improves long-term survival compared to radiation therapy only among newly diagnosed patients with anaplastic glioma without the 1p/19q co-deletion, and could be considered the new standard of care for treatment of this disease.

Reference: Van Den Bent M, Erridge S, Vogelbaum M, et al. Results of the interim analysis of the EORTC randomized phase III CATNON trial on concurrent and adjuvant temozolomide in anaplastic glioma without 1p/19q co-deletion: An Intergroup trial. Presented at the 2016 annual meeting of the American Society of Clinical Oncology. Late-breaking abstract (LBA) 2000. Available at: http://meetinglibrary.asco.org/content/162108-176. Accessed January 4, 2017.

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