“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 group of doctors and other healthcare industry professionals have set out to develop a more efficient tool for assessing the true value of immuno-oncology (I/O) drugs. They note that these drugs often come with high prices that may distract from their advantages over other types of therapy. For example, Kroger Pharmacy is selling the checkpoint inhibitor ipilimumab (Yervoy) for $140 per mg. At the recommended dose of 3 mg/kg for melanoma patients, the total expense can be high. However, ipilimumab is one of the class of I/O drugs that have improved expectations on supportive care costs and survival benefit. The old measures of value may not apply. Therefore, how does one determine whether $140/mg is a fair price for the drug?”
“In a single-arm phase II study, cabozantinib demonstrated clinical activity in patients with advanced carcinoid and pancreatic neuroendocrine tumors (pNETs). Partial responses (PRs) were observed in 15% of each cohort treated with cabozantinib and stable disease was the best response in about two-thirds of patients.
“Median progression-free survival (PFS) exceeded 20 months in the pNET cohort and was >30 months in the carcinoid tumor cohort, said Jennifer A. Chan, MD, at the 2017 Gastrointestinal (GI) Cancers Symposium.”
“Patients with small intestine neuroendocrine tumors often have mesenteric tumor deposits (MTDs) in the abdomen – discrete tumor nodules that are not connected to the primary tumor. The clinical significance of these tumor deposits has not been thoroughly investigated, and they are not included in the American Joint Committee on Cancer (AJCC) staging system for midgut neuroendocrine tumors.
“Chanjuan Shi, M.D., Ph.D., and colleagues examined the prognostic significance of MTDs associated with midgut neuroendocrine tumors in 132 patients. Using pathologic slides from resected tumors and electronic medical records, the researchers reviewed AJCC tumor stage, lymph node and liver metastasis, presence of MTDs and survival data.”
“Being diagnosed with cancer is a stressful, life-changing event that can evoke feelings of fear, worry, sadness, and anger. Depression gives one feelings of hopelessness and helplessness, disinterest in previously enjoyable activities, and a consistently down and sad mood. Depression often interferes with one’s ability to work, sleep, eat, and enjoy life. Patients with cancer are especially at risk for depression because of the physical changes and limitations from symptoms and treatment as well as of the uncertainty their treatment holds on their lives.”
“Five rounds of the usual chemotherapy/radiation protocol kept Alan Gross alive through decades of living with lymphoma. The treatments were grueling, but he was living proof that science was giving us ways to live with cancer. Then the disease came roaring back, and doctors told him that their medicine no longer worked. They told him to get his affairs in order.
“Every day, thousands of Americans get the end-of-life warning that Alan and his wife, Jane Townsend, heard two years ago. The words are so powerful that they can have a concussive effect, making it hard to hear, to speak, to process information. ‘Your ability to think clearly and concentrate isn’t there,’ Jane told me.”
“A new therapy in development for the treatment of midgut neuroendocrine tumors, a rare type of cancer that occurs in the small intestine and colon, shows improved progression-free survival and response rates for patients with advanced disease. Results of the international phase 3 clinical trial of lutetium-177 (177Lu)-Dotatate compared to high-dose octreotide LAR were published in the Jan. 12 issue of the New England Journal of Medicine.
” ‘Patients diagnosed with midgut neuroendocrine tumors often have advanced disease that has spread to other sites. Treatment options are limited. 177Lu-Dotatate is an effective option to delay tumor progression for patients with this disease,’ says Jonathan R. Strosberg, head of the Neuroendocrine Tumor Program at Moffitt Cancer Center. ‘There is also preliminary evidence of survival benefit that requires confirmation on final survival analysis, expected in several years.’ ”
“The FDA has issued a complete response letter (CRL) to Advanced Accelerator Applications informing the company 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 CRL, which follows a discipline review letter (DRL) issued in November, requests new subgroup data, a safety update, and that revisions be made to the previously submitted data. The letter did not request the initiation of additional studies of Lutathera.”
“Who might benefit from a clinical trial for an experimental cancer treatment?
“A common misperception is that such trials are strictly for patients who have reached the end of the road and have no more hope of being helped by standard treatments.
” ‘But it’s not last-ditch,’ said Dina G. Lansey, the assistant director for diversity and inclusion in clinical research at the Johns Hopkins Kimmel Cancer Center. New forms of immunotherapy are being tested in many types of cancer, and not just at late stages.”