Novartis drug Afinitor(R) extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors Published: May 21, 2015 1:16 a.m. ET (Thomson Reuters ONE via COMTEX) -- Novartis International AG / Novartis drug Afinitor(R) extended progression-free survival in Phase III trial in advanced gastrointestinal or lung neuroendocrine tumors . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement. - Study in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin met primary endpoint Basel, May 21, 2015 - Novartis announced today that the Phase III study of Afinitor(R) (everolimus) tablets plus best supportive care in patients with advanced nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin met its primary endpoint: significant extension of progression-free survival (PFS) compared to placebo plus best supportive care. The RADIANT-4 study is part of one of the largest clinical trial programs in NET. NET are a rare type of cancer that originate in neuroendocrine cells found throughout the body, and are most often found in the GI tract, lungs or pancreas. NET can be functional or nonfunctional: functional NET produce symptoms caused by the secretion of hormones and other substances; nonfunctional NET do not secrete hormones, and may only produce symptoms caused by the tumor's growth, such as intestinal blockage, pain and bleeding. At time of diagnosis, up to 44% of patients with GI NET and 28% of patients with lung NET have advanced disease, meaning the cancer has spread to other parts of the body and is more difficult to treat. There are limited treatment options for patients with advanced GI or lung NET."We look forward to presenting the findings from the RADIANT-4 trial of everolimus, which has the potential to become an important treatment option for patients with advanced nonfunctional GI or lung NET," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "The results will serve as the basis of planned worldwide regulatory filings for everolimus in these two types of NET, bringing us closer to our goal of offering Afinitor for these patients." Full results from the RADIANT-4 study will be submitted to a major medical meeting. Worldwide regulatory filings are planned for 2015.
About RADIANT-4 RADIANT-4 is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. The trial examined the efficacy and safety of everolimus plus best supportive care versus placebo plus best supportive care in 302 patients with well differentiated advanced NET of GI or lung origin, and no history or active symptoms of carcinoid syndrome, who had documented disease progression within the previous 6 months. Patients were randomized 2:1 to receive either daily everolimus 10 mg or daily placebo orally. The primary endpoint of RADIANT-4 was PFS. Secondary endpoints included safety, objective response rate and overall survival.
About Afinitor(R) (everolimus) tablets Afinitor(R) (everolimus) is approved in more than 95 countries, including the United States and throughout the European Union, for locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin. It is also approved in 119 countries including the United States and European Union for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy. Afinitor is approved in the European Union for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor (NSAI). In the United States, Afinitor is approved for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2 negative (advanced HR+/HER2-) breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. Everolimus is also available from Novartis for use in certain non-oncology patient populations under the brand names Afinitor(R) or Votubia(R), Certican(R) and Zortress(R) and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents. Indications vary by country and not all indications are available in every country. The safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.
Important Safety Information about Afinitor(R) (everolimus) tablets Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including sepsis), and kidney failure, which can lead to death. Patients taking concomitant angiotensin-converting enzyme (ACE) inhibitors may be at an increased risk for angioedema. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men may be affected by treatment with Afinitor/Votubia. The most common adverse drug reactions (incidence >=10 percent) are mouth ulcers, skin rash, feeling tired or weak, diarrhea, absence of menstrual periods, infections (including upper respiratory tract infection, sore throat and runny nose, sinusitis, and pneumonia), nausea, decreased appetite, low level of red blood cells, high levels of cholesterol, abnormal taste, acne, irregular menstrual periods, inflammation of lung tissue, high level of blood sugar, weight loss, itching, swelling of extremities or other parts of the body, nose bleeds, and headache. The most common Grade 3-4 adverse drug reactions (incidence >=2 percent) are mouth ulcers, absence of menstrual periods, low level of red blood cells, infections (including pneumonia), high level of blood sugar, feeling tired or weak, low white blood cells, inflammation of lung tissue, diarrhea, and spontaneous bleeding or bruising. Cases of hepatitis B reactivation, blood clots in the lung or legs, and pneumocystis jirovecii pneumonia (PJP) have been reported. Abnormalities were observed in hematology and clinical chemistry laboratory tests.
神经内分泌肿瘤罕见，在全部恶性肿瘤中的比例不足1%，多发生于胃、肠、胰腺。在这类肿瘤中最常见的是类癌，其发生率大约为2.5/100000，占全部胃肠胰神经内分泌肿瘤的50%，根据起源的部位不同，可将类癌分为前肠（肺、支气管及直到空肠的上部胃肠道）、中肠（回肠和阑尾）和后肠（直肠）。此类肿瘤可发生于整个神经内分泌系统，但最常见的累及部位是胰腺。根据肿瘤分泌的物质是否引起典型的临床症状可以将神经内分泌肿瘤分为两大类，有功能性和无功能性。
临床表现
1．类癌综合征 突发性或持续性头面部、躯干部皮肤潮红，可因酒精、剧烈活动、精神压力或进食含3-对羟基苯胺的食物如巧克力、香蕉等诱发；轻度或中度的腹泻，腹泻并不一定和皮肤潮红同时存在，可能与肠蠕动增加有关，可伴有腹痛；类癌相关心脏疾病，如肺动脉狭窄、三尖瓣关闭不全等；其他症状如皮肤毛细血管扩张症、糙皮病等，偶见皮炎、痴呆和腹泻三联征。
2．胃泌素瘤 常表现为Zollinger-Ellison综合征，腹痛腹泻常见，呈间歇性腹泻，常为脂肪痢，也可有反复发作的消化性溃疡。
3．胰岛素瘤 其临床症状与肿瘤细胞分泌过量的胰岛素相关，特征性表现是神经性低血糖症，常见于清晨或运动后，其他还有视物模糊，精神异常等表现。
4．胰高血糖素瘤 常伴有过量的胰高血糖素分泌，典型表现是坏死性游走性红斑伴有贫血以及血小板减少，大约半数患者可有中度糖尿病表现，还可能有痛性红舌、口唇干裂、静脉血栓、肠梗阻及便秘等表现。
5．VIP瘤 典型症状是Verner-Morrison综合征，即胰性霍乱综合征，表现为水样腹泻、低钾血症、胃酸缺乏症和代谢性酸中毒。无功能性的神经内分泌肿瘤常缺乏典型的临床表现，就诊时往往已经出现肝转移。
童罹神經內分泌腫瘤 腸胃鏡檢揪凶 華人健康網作者： 華人健康網 記者駱慧雯／台北報導 | 華人健康網 – 2014年11月5日 1名12歲男童持續出現腹瀉及腹痛症狀，以為是腸躁症或腸胃炎，就醫後症狀不見改善，經內視鏡檢查，才發現12指腸長出多顆腫瘤且轉移至肝臟，確診為腸胃道神經內分泌腫瘤，與因胰臟神經內分泌瘤逝世的蘋果教父史提夫賈伯斯（Steve Jobs）病症類似。而這名男童也是台灣目前發現最年輕的神經內分泌腫瘤個案。
特殊癌症！神經內分泌腫瘤年增400例 神經內分泌腫瘤（neuroendocrine tumor，簡稱NET）為罕見的腸胃道或內分泌器官疾病，好發部位包括腸胃道及胰臟，其次為肺部，臨床症狀為持續性腹瀉、復發性難治的消化道潰瘍、臉潮紅及間歇性的低血糖現象，例如心悸、盜汗、饑餓感或頭昏等。而根據國家衛生研究院於2013年統計國內癌登資料發現，台灣神經內分泌腫瘤的發生率為十萬分之1.51，整體疾病發生率在過去12年間增加5倍，預估每年約新增400位神經內分泌腫瘤確診患者。台大醫院肝膽腸胃科醫師鄭祖耀表示，在過去，神經內分泌腫瘤症狀不易被發現，通常經5至7年才會診斷，且有超過5成的患者發現時已經出現腫瘤轉移，平均存活期僅剩33個月。
內視鏡揪癌蹤 8成患者趁早發現 不過，台灣消化系內視鏡醫學會理事長、台大醫院內視鏡科主任王秀伯表示，根據2014年消化系內視鏡醫學會神經內分泌腫瘤工作小組登錄資料顯示，高達5成神經內分泌腫瘤患者，是在健康檢查時進行內視鏡檢查確診罹患此病；而從自己的臨床經驗統計，也發現透過有效的內視鏡相關檢查，可讓8成神經內分泌腫瘤患者在腫瘤未轉移前就發現。王秀伯醫師強調，對照台大醫院、台北榮總、長庚醫院和成大醫院聯合發表的數據發現，腸胃內視鏡初診斷胰臟神經內分泌腫瘤大小，已經從14年前的8.9公分縮小至2.18公分，有利於早期發現和治療。鄭祖耀醫師表示，一旦確診為神經內分泌腫瘤，主要的治療原則是手術切除乾淨，但若無法完全切除或是發生轉移的神經內分泌腫瘤，則需視情況，採行劑量長效型體抑素類似物、標靶治療或化學治療，緩解症狀。每年11月10日是全球神經內分泌腫瘤日，希望病友勇於站出來接受治療，與疾病奮戰。
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