Results of a phase ii study of pemetrexed as firstline. Pemetrexed in patients with thymic malignancies previously. Alimta pemetrexed for injection is a folate analog metabolic inhibitor. A phase ii study of pemetrexed in patients with recurrent thymoma.
Vitamin b12 and folate reduce toxicity of alimta pemetrexed disodium, ly231514, mta, a novel antifolateantimetabolite. Results of a phase ii study of pemetrexed as firstline chemotherapy in patients with advanced or metastatic breast cancer article in breast cancer research and treatment 1261. Presented by gilberto lopes at 2018 asco annual meeting. Treatment advances in locally advanced and metastatic nonsmall. The drug substance, pemetrexed disodium heptahydrate, has the chemical name lglutamic acid, n422amino4,7dihydro4oxo1hpyrrolo2,3dpyrimidin5ylethylbenzoyl, disodium salt, heptahydrate with a molecular formula of c 20 h 19 n 5 na 2 o. Few prospective trials have been conducted in patients with advance thymic malignancies. Pemetrexed interactions bnf content published by nice.
Although previous trials demonstrated the efficacy and safety of postoperative cisplatinbased adjuvant chemotherapy for. Phase ii study of everolimus in patients with thymoma. Final appraisal determination pemetrexed maintenance treatment following induction therapy with pemetrexed and cisplatin for nonsquamous nonsmallcell lung cancer issue date. A phase ii trial of erlotinib plus bevacizumab in patients with recurrent thymoma or thymic carcinoma. Ive been involved with the thymoma research since the early 1980s, since i was a fellow, and i continue to do this to present day. Preliminary results of phase ii study of capecitabine and gemcitabine capgem in patients with metastatic pretreated thymic epithelial tumors tets.
Pemetrexed delays lung cancer progression medpage today. Asco guidelines for appropriate chemotherapy dosing in obese adults with. Asco s targeted agent and profiling utilization registry tapur study is a nonrandomized clinical trial aiming to describe the performance of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer with a potentially actionable genomic variant. Features the monostable spool valves in conformity with iec 61508 standard 2010 route 2. The objective response rate was 28 percent, including three complete responses 6 percent. Patients and methods this was a singlearm, singlestage, open. Apr 21, 2009 the mainstay of therapy is complete surgical resection. Fellow publications bedano pm, perkins s, burns m, kessler k, nelson r, schneider b, risley l, dropcho s, loehrer pj. Pdf pemetrexed disodium in recurrent locally advanced or.
What pemetrexed 25 mgml concentrate for solution for infusion contains the active substance is pemetrexed. Pdf pemetrexed for the treatment of nonsmall cell lung cancer. Pemetrexed extends survival in advanced lung cancer. Therapeutic landscape in advanced non small cell lung. As a result, a phase ii trial was initiated to evaluate the clinical activity of pemetrexed in previously treated patients with thymoma thy and thymic carcinoma. Antitumor activity of histone deacetylase hdac inhibitors in this disease has been documented, including one patient with thymoma treated with the panhdac inhibitor belinostat. Pemetrexed disodium in recurrent locally advanced or. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment.
Jun 03, 2009 pemetrexed extends survival in patients with advanced nonsquamous nonsmallcell lung cancer, but whether the chemotherapy should be used as maintenance or secondline therapy is a matter of debate. Purpose in keynote189, firstline pembrolizumab plus pemetrexed platinum significantly improved overall survival os and progressionfree survival pfs compared with placebo plus pemetrexed platinum in patients with metastatic nonsquamous non. Although the effect of third space fluid is not fully defined, studies have determined pemetrexed concentrations in patients with mildtomoderate ascitespleural effusions were similar to concentrations in trials of patients without third space fluid accumulation. Obesity asco guidelines for appropriate chemotherapy dosing in. Pemetrexed a multitargeted antifolate with a broad range of clinical activity, but previously untested in thymic malignancies. Given that the cost of raltitrexed is approximately 15% of the cost of pemetrexed alimta, the committee concluded that pemetrexed alimta did not demonstrate good valueformoney.
Locally advanced thymoma and thymic carcinoma require a multimodality treatment approach with a combination of surgery, chemotherapy, and radiation therapy to decrease the chances of recurrence and improve survival. Measles, mumps and rubella vaccine, live is predicted to increase the risk of generalised infection possibly lifethreatening when given with pemetrexed. Riely is an oncologist in new york, new york and is affiliated with one hospital. Data from a phase ii study support the use of pemetrexed in previously treated unresectable advanced thymoma or thymic carcinoma loehrer 2006. Corticosteroids, the oldest agent in the prevention of.
Please note that although condensed summary information is. Similar results were presented at asco 2008 by brade et al 25 and gadgeel et al 26. Our group has previously conducted a study in 16 patients with advanced pretreated tets with octreotide associated with prednisone. Without pemetrexed n 106 age sex enrollment region ecog ps histology smoking status treated brain metastases chemotherapy regimen 0. Pemetrexed disodium in recurrent locally advanced or metastatic. Pemetrexed disodium in recurrent locally advanced or metastatic squamous cell carcinoma of the head and neck article pdf available in british journal of cancer 855. Gbolahan ob1, porter rf2, salter jt3, yiannoutsos c4, burns m2, chiorean eg5, loehrer pj sr6. Downloaded from by journals press access on june 25, 2018 from 162. Patients and methods patients with advanced thymic. Oncologists diagnose and treat cancers of all types. Biology and treatment of thymoma giuseppe giaccone m. Preliminary results of phase ii study of capecitabine and gemcitabine. Pemetrexed maintenance treatment following induction therapy. Review of pemetrexed in combination with cisplatin for the.
The fpc held that limitation from antifolate to pemetrexed disodium during prosecution constitutes an abandonment of subjectmatter. Lorusso d, ferrandina g, pignata s, et al, evaluation of pemetrexed alimta, ly231514 as secondline. Dec 19, 2016 while the claims of lillys ep 1 3 508 b1 specifically require pemetrexed disodium, amtiris comprises pemetrexed diacid. Pemetrexed continuation improves overall survival in nsclc. Aug 28, 2001 this phase ii study determined response rate of patients with locally advanced or metastatic head and neck cancer treated with pemetrexed disodium, a new multitargeted antifolate that inhibits.
Pronunciation of pemetrexed with 2 audio pronunciations, 2 translations and more for pemetrexed. Asco annual meeting proceedings abstr 7079j clin oncol. I am a medical oncologist and director of the indiana university melvin and bren simon cancer center in the united states. Clinical guidelines and practical recommendations for the prevention of cinv are published and regularly updated by several cancer associations such as multinational association of supportive care in cancer mascc, european society for medical oncology esmo, and american society of clinical oncology asco. This study evaluated the activity of everolimus in patients with advancedrecurrent t or tc previously treated with cisplatincontaining chemotherapy. Jul 11, 20 the paramount study was the first large trial to demonstrate that continuation maintenance therapy can increase progressionfree survival in the setting of advanced nonsquamous nsclc. Apr 18, 2011 purpose thymic epithelial tumors are rare malignancies, and there is no standard treatment for patients with advanced disease in whom chemotherapy has failed. Pemetrexed 8 disodium heptahydrate has the chemical name lglutamic acid, n422amino4,7dihydro4. We compared the clinical and molecule pathological characteristics of good and poor responders among a cohort of 1,848 nonsquamous nsclc patients who had received at least two cycles of. A phase ii study of pemetrexed in patients with recurrent.
As an example, in a hoosier oncology group study, 47 previously treated patients received singleagent pemetrexed. Pemetrexed safety and pharmacokinetics in patients with thirdspace fluid article pdf available in clinical cancer research 1610. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Patients received pemetrexed 500 mgm2, carboplatin area under the concentrationtime curve of. Aug 22, 2018 provides accurate and independent information on more than 24,000 prescription drugs, overthecounter medicines and natural products. Dec 14, 2017 purpose no effective salvage treatments are available for patients with advancedrecurrent thymoma t or thymic carcinoma tc who have progressed after platinumbased chemotherapy. A phase ii study of pemetrexed in patients with recurrent thymoma and thymic carcinoma. Pemetrexed, a multitargeted antifolate, has shown activity in previously treated patients. Folic acid 400 mcg daily orally begin 7 days prior to treatment initiation. Loehrer pj, yiannoutsos ct, dropcho s, et al a phase ii trial of pemetrexed in patients with recurrent thymoma or thymic carcinoma. Jun 10, 2011 the 359 patients on pemetrexed did not progress for a median of 4. Pemetrexed potently inhibits ts, dhfr, and garft as well as aicarft but with a lesser potency and exhibits autitumor activity in a broad range of tumors, including nonsmall cell lung carcinoma, malignant mesothelioma, and carcinomas of the breast, colorectum, uterine cervix, head and neck, and bladder. J clin oncol 2006, asco annual meeting proceedings.
Pemetrexed is widely used for the treatment of advanced nonsquamous nonsmallcell lung cancer nsclc. Sixteen thymoma and 11 thymic carcinoma patients were treated and among 23 evaluable patients, there were two crs and two prs in thymoma patients but none in thymic carcinoma patients. Treatment of advanced thymoma and thymic carcinoma springerlink. But even if it would not be considered an abandonment, the fpc denied an infringement. A phase ii trial of pemetrexed in patients with recurrent. A read is counted each time someone views a publication summary such as the title, abstract, and list of authors, clicks on a figure, or views or downloads the fulltext. The 4 ml vial contains either 100 mg of pemetrexed as 120.
Highlights of prescribing information these highlights do not include all the information needed to use alimta safely and effectively. Pdf pemetrexed safety and pharmacokinetics in patients with. Pemetrexed and cisplatin with concurrent radiotherapy. Pemetrexed alimta is recommended as an option for the maintenance treatment of locally advanced or metastatic non.
Results of the phase ii study evaluating the role of pemetrexed in patients with recurrent tets. Each ml of the concentrate for solution for infusion contains 25 mg of pemetrexed as 30. Loehrer pj, yiannoutsos ct, dropcho s, et al, a phase ii trial of pemetrexed in patients with recurrent thymoma or thymic carcinoma, j clin oncol, 2006, 24suppl. S p e c i a l s e r v i ce p i l ot 1 32 series 362562 visit our website at asco. It is also important to note that not many trials have been published in pretreated tets with chemotherapy and the most active regimens, used in this setting, were octreotide and pemetrexed 15. Pemetrexed for the treatment of nonsmall cell lung cancer. Preliminary results of phase ii study of capecitabine and. Jun 03, 2019 alimta pemetrexed for injection, for intravenous use. However, factors that can predict the benefits of pemetrexed therapy have not yet been defined. Apexbio pemetrexedts, dhfr,garft and aicarft inhibitorcas.