“In December 2016, the FDA informed Advanced Accelerator Applications that its new drug application for Lutathera (177Lutetium DOTA-octreotate) as a treatment for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) would need to be resubmitted.
“The application was based on the phase III NETTER-1 trial, which randomized patients with advanced, progressive, somatostatin receptor-positive midgut NETS to receive either Lutathera (116 patients) plus best supportive care, including octreotide long-acting repeatable (LAR), or octreotide LAR alone (113 patients).”
“A phase I trial found that the HER2 inhibitor ONT-380 had a lower incidence of certain adverse events associated with this class of agent and notable anti-tumor activity in heavily pretreated patients with HER2-positive metastatic breast cancer (MBC).
” ‘Though existing targeted therapies are improving outcomes in patients with HER2-positive MBC, disease resistance does eventually develop in most patients,’ wrote study authors led by Stacy Moulder, MD, of the MD Anderson Cancer Center in Houston. Also, some agents preclude combination with other regimens due to off-target effects such as skin rash and diarrhea.”
“The addition of hormonal therapy to radiation treatment following surgery significantly improved survival in patients with recurrent prostate cancer, according to the results of a study published in The New England Journal of Medicine.
“In the multicenter trial—which initially enrolled 760 men with biochemical recurrence after radical prostatectomy—patients were randomly assigned to treatment with bicalutamide or placebo for 2 years, along with 6.5 weeks of radiation therapy.”
“Results from a large clinical study showed that testing pediatric brain tumors for genetic abnormalities is feasible and could play a role in guiding patients’ treatment.
“The study, published in Neuro-Oncology, showed that more than half of the samples taken from pediatric brain tumors and analyzed using genomic profiling had genetic irregularities that could influence how the disease was diagnosed or treated with approved drugs or agents being evaluated in clinical trials.”
In spring of 2014, Peter Fortenbaugh noticed what appeared to be a tick that had bitten his lower calf. “It turned out not to be a tick, but it didn’t really go away,” he says.
The spot began to grow and bulge, and in October, Peter showed it to his primary care doctor, who referred him to a dermatologist to remove it. At the time, Peter recalls, it did not occur to him that the growth could be serious.
“I was actually very concerned about skin cancer because I spent a lot of time out in the sun sailing,” Peter says. “I put on a tremendous amount of sunscreen and protection, but never on my legs…I never connected the dots.”
However, a biopsy of the growth came back positive for melanoma. Peter, who lives in Palo Alto, California, with his wife and three children, immediately reached out to several doctors in the San Francisco Bay Area, and all had the same advice: “Take it out, take a biopsy.” Continue reading…
“A prospective study is investigating whether breast cancer surgery can be eliminated in patients who respond well to neoadjuvant systemic therapy.
“The phase II single-center trial, conducted out of The University of Texas MD Anderson Cancer Center (NCT02945579), aims to determine how often breast cancer recurs in patients who previously received chemotherapy and follow-up radiation therapy, but not surgery, and have no evidence of disease. Forty patients with early-stage, triple-negative or HER2-positive breast cancer care underwent image-guided biopsy after completing chemotherapy and before beginning radiation therapy to see if surgery is necessary.”
“Clovis Oncology, Inc. (NASDAQ: CLVS) and Strata Oncology, Inc. today announced an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment.
“Rucaparib is an oral inhibitor of poly ADP-ribose polymerase (PARP), approved in the U.S. in 2016 as Rubraca™(rucaparib) as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer, who have been treated with two or more chemotherapies, and selected for therapy by an FDA-approved companion diagnostic. Emerging data suggest PARP inhibition may also provide activity in the treatment of metastatic prostate cancers harboring deleterious mutations in BRCA1/2 and ATM or other human genes associated with DNA damage repair. These mutations may be germline (inherited) or somatic (acquired).”
“Exercise does not appear to have any effect on the development of lymphedema in breast cancer patients, according to findings presented here at the Cancer Survivorship Symposium (CSS) Advancing Care and Research.
“Rates of lymphedema were almost the same for women randomly allocated to receive education only and for women allocated to receive education plus personalized exercise instruction from a physical therapist.
“At 18 months, there was no difference in the incidence of lymphedema. The lymphedema free rate was 58% in the education-only arm vs 55% in education-plus-exercise group.”
“One in four men presenting with elevated prostate-specific antigen (PSA) may be able to safely avoid prostate biopsy if they have triage testing with multi-parametric magnetic resonance imaging (MP-MRI) first, researchers said.
“The use of MP-MRI might also improve the detection of clinically significant cancer compared with transrectal ultrasound-guided prostate biopsy (TRUS-biopsy) and reduce over-diagnosis of clinically insignificant prostate cancer, the multicenter, paired-cohort, confirmatory PROMIS (PROstate MR Imaging Study) showed.”