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https://www.readbyqxmd.com/read/28537531/clinical-features-of-nivolumab-induced-thyroiditis-a-case-series-study
#1
Ichiro Yamauchi, Yoriko Sakane, Yorihide Fukuda, Toshihito Fujii, Daisuke Taura, Masakazu Hirata, Keisho Hirota, Yohei Ueda, Yugo Kanai, Yui Yamashita, Eri Kondo, Masakatsu Sone, Akihiro Yasoda, Nobuya Inagaki
BACKGROUND: The programmed cell death-1 (PD-1) pathway is a novel therapeutic target in immune checkpoint therapy for cancer. It consists of the PD-1 receptor and its two ligands, programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2). Nivolumab is an anti-PD-1 monoclonal antibody approved for malignant melanoma, advanced non-small cell lung cancer, and advanced renal cell carcinoma in Japan. Thyrotoxicosis and hypothyroidism have both been reported in international phase 3 studies and national postmarketing surveillance of nivolumab in Japan...
May 24, 2017: Thyroid: Official Journal of the American Thyroid Association
https://www.readbyqxmd.com/read/28526538/trastuzumab-emtansine-versus-treatment-of-physician-s-choice-in-patients-with-previously-treated-her2-positive-metastatic-breast-cancer-th3resa-final-overall-survival-results-from-a-randomised-open-label-phase-3-trial
#2
Ian E Krop, Sung-Bae Kim, Antonio Gonzalez Martin, Patricia M LoRusso, Jean-Marc Ferrero, Tanja Badovinac-Crnjevic, Silke Hoersch, Melanie Smitt, Hans Wildiers
BACKGROUND: In the randomised, parallel assignment, open-label, phase 3 TH3RESA study, progression-free survival was significantly longer with trastuzumab emtansine versus treatment of physician's choice in previously treated patients with HER2-positive advanced breast cancer. We report results from the final overall survival analysis of the TH3RESA trial. METHODS: Eligible patients for the TH3RESA trial were men and women (aged ≥18 years) with centrally confirmed HER2-positive advanced breast cancer previously treated with both trastuzumab and lapatinib (advanced setting) and a taxane (any setting) and with progression on two or more HER2-directed regimens in the advanced setting...
May 16, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28526536/trastuzumab-emtansine-versus-capecitabine-plus-lapatinib-in-patients-with-previously-treated-her2-positive-advanced-breast-cancer-emilia-a-descriptive-analysis-of-final-overall-survival-results-from-a-randomised-open-label-phase-3-trial
#3
Véronique Diéras, David Miles, Sunil Verma, Mark Pegram, Manfred Welslau, José Baselga, Ian E Krop, Kim Blackwell, Silke Hoersch, Jin Xu, Marjorie Green, Luca Gianni
BACKGROUND: The antibody-drug conjugate trastuzumab emtansine is indicated for the treatment of patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Approval of this drug was based on progression-free survival and interim overall survival data from the phase 3 EMILIA study. In this report, we present a descriptive analysis of the final overall survival data from that trial. METHODS: EMILIA was a randomised, international, open-label, phase 3 study of men and women aged 18 years or older with HER2-positive unresectable, locally advanced or metastatic breast cancer previously treated with trastuzumab and a taxane...
May 16, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28512684/therapeutic-applications-of-classic-hallucinogens
#4
Michael P Bogenschutz, Stephen Ross
This chapter reviews what is known about the therapeutic uses of the serotonergic or classic hallucinogens, i.e., psychoactive drugs such as LSD and psilocybin that exert their effects primarily through agonist activity at serotonin 2A (5HT2A) receptors. Following a review of the history of human use and scientific study of these drugs, the data from clinical research are summarized, including extensive work on the use of classic hallucinogens in the treatment of alcoholism and other addictions, studies of the use of LSD and psilocybin to relieve distress concerning death, particularly in patients with advanced or terminal cancer, and more limited data concerning the use of classic hallucinogens to treat mood and anxiety disorders...
May 18, 2017: Current Topics in Behavioral Neurosciences
https://www.readbyqxmd.com/read/28512389/evaluation-of-quality-of-life-at-progression-in-patients-with-soft-tissue-sarcoma
#5
Stacie Hudgens, Anna Forsythe, Ilias Kontoudis, David D'Adamo, Ashley Bird, Hans Gelderblom
Introduction. Soft Tissue Sarcoma (STS) is a rare malignancy of mesodermal tissue, with international incidence estimates between 1.8 and 5 per 100,000 per year. Understanding quality of life (QoL) and the detrimental impact of disease progression is critical for long-term care and survival. Objectives. The primary objective was to explore the relationship between disease progression and health-related quality of life (HRQoL) using data from Eisai's study (E7389-G000-309). Methods. This was a 1 : 1 randomized, open-label, multicenter, Phase 3 study comparing the efficacy and safety of eribulin versus dacarbazine in patients with advanced STS...
2017: Sarcoma
https://www.readbyqxmd.com/read/28508916/direct-oral-anticoagulants-for-the-treatment-of-cancer-associated-venous-thromboembolism-what-do-we-know-so-far
#6
Minna Voigtlaender, Florian Langer
Cancer patients with venous thromboembolism (VTE) are at increased risk for both bleeding and VTE recurrence. Anticoagulation with low-molecular-weight heparin (LMWH) is the standard of care during the initial and long-term treatment phase (i.e. during the first 3 - 6 months of therapy) based on its overall beneficial safety and efficacy profile compared to vitamin K antagonists (VKAs). The direct oral anticoagulants (DOACs) rivaroxaban, apixaban, edoxaban, and dabigatran are approved for the treatment of acute VTE, and the combined six phase-3 trials have included > 1500 patients with active cancer, as defined by variable selection criteria...
May 16, 2017: Hämostaseologie
https://www.readbyqxmd.com/read/28504033/salvage-chemotherapy-and-autologous-stem-cell-transplantation-for-peripheral-t-cell-lymphoma-a-subset-analysis-of-the-canadian-cancer-trials-group-ly-12-randomized-phase-3-study
#7
Tanya Skamene, Michael Crump, Kerry J Savage, Tony Reiman, John Kuruvilla, David Good, David LeBrun, Ralph M Meyer, Laurie H Sehn, Denis Soulières, Julie Stakiw, Nicole Laferriere, Stefano Luminari, Lois E Shepherd, Marina Djurfeldt, Liting Zhu, Bingshu E Chen, Annette E Hay
Peripheral T-cell lymphoma (PTCL) is a rare, heterogeneous malignancy. Of the 619 patients with relapsed and refractory (R/R) aggressive lymphoma enrolled in the Canadian Cancer Trials Group LY.12 phase 3 trial, 59 (9.5%) had PTCL. Among these, 81% had advanced stage disease, 41% had an International Prognostic Score ≥3, and 41% were refractory to primary therapy. Within the PTCL cohort, the overall response rate after two cycles of salvage chemotherapy was 36%; no difference was observed between dexamethasone, cytarabine, cisplatin (10/30, 33%), and gemcitabine, cisplatin, dexamethasone (11/29, 38%) therapy...
May 15, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28501140/alectinib-versus-crizotinib-in-patients-with-alk-positive-non-small-cell-lung-cancer-j-alex-an-open-label-randomised-phase-3-trial
#8
Toyoaki Hida, Hiroshi Nokihara, Masashi Kondo, Young Hak Kim, Koichi Azuma, Takashi Seto, Yuichi Takiguchi, Makoto Nishio, Hiroshige Yoshioka, Fumio Imamura, Katsuyuki Hotta, Satoshi Watanabe, Koichi Goto, Miyako Satouchi, Toshiyuki Kozuki, Takehito Shukuya, Kazuhiko Nakagawa, Tetsuya Mitsudomi, Nobuyuki Yamamoto, Takashi Asakawa, Ryoichi Asabe, Tomohiro Tanaka, Tomohide Tamura
BACKGROUND: Alectinib, a potent, highly selective, CNS-active inhibitor of anaplastic lymphoma kinase (ALK), showed promising efficacy and tolerability in the single-arm phase 1/2 AF-001JP trial in Japanese patients with ALK-positive non-small-cell lung cancer. Given those promising results, we did a phase 3 trial to directly compare the efficacy and safety of alectinib and crizotinib. METHODS: J-ALEX was a randomised, open-label, phase 3 trial that recruited ALK inhibitor-naive Japanese patients with ALK-positive non-small-cell lung cancer, who were chemotherapy-naive or had received one previous chemotherapy regimen, from 41 study sites in Japan...
May 10, 2017: Lancet
https://www.readbyqxmd.com/read/28497756/s-1-versus-placebo-in-patients-with-sorafenib-refractory-advanced-hepatocellular-carcinoma-s-cube-a-randomised-double-blind-multicentre-phase-3-trial
#9
Masatoshi Kudo, Michihisa Moriguchi, Kazushi Numata, Hisashi Hidaka, Hironori Tanaka, Masafumi Ikeda, Seiji Kawazoe, Shinichi Ohkawa, Yozo Sato, Shuichi Kaneko, Junji Furuse, Madoka Takeuchi, Xuemin Fang, Yoshito Date, Masahiro Takeuchi, Takuji Okusaka
BACKGROUND: Unresectable advanced hepatocellular carcinoma is a heterogeneous disease, for which sorafenib is the first targeted agent approved for first-line therapy, and treatment options for patients with sorafenib-refractory advanced hepatocellular carcinoma are limited. We assessed the efficacy and safety of S-1, a chemotherapeutic agent based on fluorouracil, in patients with sorafenib-refractory advanced hepatocellular carcinoma. METHODS: We did a randomised, double-blind, placebo-controlled, phase 3 study done at 57 sites in Japan...
June 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28479233/addition-of-gemcitabine-to-paclitaxel-epirubicin-and-cyclophosphamide-adjuvant-chemotherapy-for-women-with-early-stage-breast-cancer-tango-final-10-year-follow-up-of-an-open-label-randomised-phase-3-trial
#10
Helena M Earl, Louise Hiller, Helen C Howard, Janet A Dunn, Jennie Young, Sarah J Bowden, Michelle McDermaid, Anna K Waterhouse, Gregory Wilson, Rajiv Agrawal, Susan O'Reilly, Angela Bowman, Diana M Ritchie, Andrew Goodman, Tamas Hickish, Karen McAdam, David Cameron, David Dodwell, Daniel W Rea, Carlos Caldas, Elena Provenzano, Jean E Abraham, Peter Canney, John P Crown, M John Kennedy, Robert Coleman, Robert C Leonard, James A Carmichael, Andrew M Wardley, Christopher J Poole
BACKGROUND: The tAnGo trial was designed to investigate the potential role of gemcitabine when added to anthracycline and taxane-containing adjuvant chemotherapy for early breast cancer. When this study was developed, gemcitabine had shown significant activity in metastatic breast cancer, and there was evidence of a favourable interaction with paclitaxel. METHODS: tAnGo was an international, open-label, randomised, phase 3 superiority trial that enrolled women aged 18 years or older with newly diagnosed, early-stage breast cancer who had a definite indication for chemotherapy, any nodal status, any hormone receptor status, Eastern Cooperative Oncology Group performance status of 0-1, and adequate bone marrow, hepatic, and renal function...
May 4, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28474297/niraparib-first-global-approval
#11
Lesley J Scott
Oral niraparib, a highly-selective, potent poly(ADP-ribose) polymerase (PARP)-1 and PARP-2 inhibitor, is approved in the USA for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. It is also under regulatory review in the EU for use in maintenance treatment in patients with platinum-sensitive, recurrent epithelial ovarian cancer who are in response to platinum-based chemotherapy...
June 2017: Drugs
https://www.readbyqxmd.com/read/28473255/inhibition-of-akt-and-other-agc-kinases-a-target-for-clinical-cancer-therapy
#12
REVIEW
Vincent Prêtre, Andreas Wicki
AGC kinases have been identified to contribute to cancer development and progression. Currently, most AGC inhibitors in clinical development are Akt inhibitors such as MK-2206 or GDC-0068, which are known to promote cell growth arrest and to sensitize cancer cells to radiotherapy. Response rates in clinical trials with single agent Akt inhibitors are typically low. The observed adverse events are within the expected limits for compounds inhibiting the PI3K-mTOR axis. Preclinical and early clinical data for combination therapies are accumulating...
May 1, 2017: Seminars in Cancer Biology
https://www.readbyqxmd.com/read/28472437/romana-3-a-phase-3-safety-extension-study-of-anamorelin-in-advanced-non-small-cell-lung-cancer-nsclc-patients-with-cachexia
#13
D Currow, J S Temel, A Abernethy, J Milanowski, J Friend, K C Fearon
Background: HASH(0x2cc65b0) Patients and methods: HASH(0x3285a48) Results: HASH(0x3750b88) Conclusion: HASH(0x374b9c0) Clinical trial registration numbers: HASH(0x377b998)
May 4, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28467869/tofacitinib-as-induction-and-maintenance-therapy-for-ulcerative-colitis
#14
RANDOMIZED CONTROLLED TRIAL
William J Sandborn, Chinyu Su, Bruce E Sands, Geert R D'Haens, Séverine Vermeire, Stefan Schreiber, Silvio Danese, Brian G Feagan, Walter Reinisch, Wojciech Niezychowski, Gary Friedman, Nervin Lawendy, Dahong Yu, Deborah Woodworth, Arnab Mukherjee, Haiying Zhang, Paul Healey, Julian Panés
BACKGROUND: Tofacitinib, an oral, small-molecule Janus kinase inhibitor, was shown to have potential efficacy as induction therapy for ulcerative colitis in a phase 2 trial. We further evaluated the efficacy of tofacitinib as induction and maintenance therapy. METHODS: We conducted three phase 3, randomized, double-blind, placebo-controlled trials of tofacitinib therapy in adults with ulcerative colitis. In the OCTAVE Induction 1 and 2 trials, 598 and 541 patients, respectively, who had moderately to severely active ulcerative colitis despite previous conventional therapy or therapy with a tumor necrosis factor antagonist were randomly assigned to receive induction therapy with tofacitinib (10 mg twice daily) or placebo for 8 weeks...
May 4, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28464211/osteoporosis-therapy-and-outcomes-for-postmenopausal-patients-with-hormone-receptor-positive-breast-cancer-ncic-ctg-ma-27
#15
Allan Lipton, Judith-Anne W Chapman, Kim Leitzel, Ashwani Garg, Kathleen I Pritchard, James N Ingle, G Thomas Budd, Matthew J Ellis, George W Sledge, Manuela Rabaglio, Lei Han, Catherine R Elliott, Lois E Shepherd, Paul E Goss, Suhail M Ali
BACKGROUND: Breast cancer patients in the MA.27 trial had similar outcomes with steroidal aromatase inhibitor (AI) exemestane and nonsteroidal anastrozole. AIs increase the risk of osteoporosis. This study examined the effects of self-reported osteoporosis and osteoporosis therapy (OPT) on outcomes. METHODS: The MA.27 phase 3 adjuvant trial enrolled 7576 postmenopausal women. The primary outcome was event-free survival (EFS), and the secondary outcome was distant disease-free survival (DDFS)...
May 2, 2017: Cancer
https://www.readbyqxmd.com/read/28463149/duration-of-androgen-deprivation-in-locally-advanced-prostate-cancer-long-term-update-of-nrg-oncology-rtog-9202
#16
Colleen A F Lawton, Xiaolei Lin, Gerald E Hanks, Herbert Lepor, David J Grignon, Harmar D Brereton, Meena Bedi, Seth A Rosenthal, Kenneth L Zeitzer, Varagur M Venkatesan, Eric M Horwitz, Thomas M Pisansky, Harold Kim, Matthew B Parliament, Rachel Rabinovitch, Mack Roach, Young Kwok, James J Dignam, Howard M Sandler
PURPOSE: Trial RTOG 9202 was a phase 3 randomized trial designed to determine the optimal duration of androgen deprivation therapy (ADT) when combined with definitive radiation therapy (RT) in the treatment of locally advanced nonmetastatic adenocarcinoma of the prostate. Long-term follow-up results of this study now available are relevant to the management of this disease. METHODS AND MATERIALS: Men (N=1554) with adenocarcinoma of the prostate (cT2c-T4, N0-Nx) with a prostate-specific antigen (PSA) <150 ng/mL and no evidence of distant metastasis were randomized (June 1992 to April 1995) to short-term ADT (STAD: 4 months of flutamide 250 mg 3 times per day and goserelin 3...
June 1, 2017: International Journal of Radiation Oncology, Biology, Physics
https://www.readbyqxmd.com/read/28461256/smoking-history-predicts-sensitivity-to-parp-inhibitor-veliparib-in-patients-with-advanced-non-small-cell-lung-cancer
#17
Martin Reck, Normand Blais, Erzsebet Juhasz, Vera Gorbunova, C Michael Jones, Laszlo Urban, Sergey Orlov, Fabrice Barlesi, Ebenezer Kio, Ulrich Keilholz, Qin Qin, Jiang Qian, Caroline Nickner, Juliann Dziubinski, Hao Xiong, Rajendar K Mittapalli, Martin Dunbar, Peter Ansell, Lei He, Mark McKee, Vincent Giranda, Suresh S Ramalingam
INTRODUCTION: Tobacco-related non-small cell lung cancer (NSCLC) is associated with reduced survival and greater genomic instability. Veliparib, a potent PARP inhibitor, augments platinum-induced DNA damage. A phase 2 trial of untreated advanced NSCLC showed a trend for improved outcomes (overall survival [OS], HR 0.80, 95% CI: 0.54-1.18; p=0.27; and progression-free survival [PFS], HR 0.72, 95% CI: 0.45-1.15; p=0.17) when veliparib was added to carboplatin/paclitaxel. Here we report an exploratory analysis by smoking history...
April 28, 2017: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/28453701/an-exploratory-analysis-of-alkaline-phosphatase-lactate-dehydrogenase-and-prostate-specific-antigen-dynamics-in-the-phase-3-alsympca-trial-with-radium-223
#18
O Sartor, R E Coleman, S Nilsson, D Heinrich, S I Helle, J M O'Sullivan, N J Vogelzang, Ø Bruland, S Kobina, S Wilhelm, L Xu, M Shan, M W Kattan, C Parker
Background: Baseline clinical variables are prognostic for overall survival (OS) in patients with castration-resistant prostate cancer (CRPC). Their prognostic and predictive value with agents targeting bone metastases, such as radium-223, is not established. Patients and methods: The radium-223 ALSYMPCA trial enrolled patients with CRPC and symptomatic bone metastases. Prognostic potential of baseline variables was assessed using Cox models. Percentage changes in biomarker levels from baseline were evaluated during the trial period; changes from baseline to week 12 were evaluated for association with OS and surrogacy...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28453697/prediction-of-overall-survival-in-stage-ii-and-iii-colon-cancer-beyond-tnm-system-a-retrospective-pooled-biomarker-study
#19
R Dienstmann, M J Mason, F A Sinicrope, A I Phipps, S Tejpar, A Nesbakken, S A Danielsen, A Sveen, D D Buchanan, M Clendenning, C Rosty, B Bot, S R Alberts, J Milburn Jessup, R A Lothe, M Delorenzi, P A Newcomb, D Sargent, J Guinney
Background: TNM staging alone does not accurately predict outcome in colon cancer (CC) patients who may be eligible for adjuvant chemotherapy. It is unknown to what extent the molecular markers microsatellite instability (MSI) and mutations in BRAF or KRAS improve prognostic estimation in multivariable models that include detailed clinicopathological annotation. Patients and methods: After imputation of missing at random data, a subset of patients accrued in phase 3 trials with adjuvant chemotherapy (n = 3016)-N0147 (NCT00079274) and PETACC3 (NCT00026273)-was aggregated to construct multivariable Cox models for 5-year overall survival that were subsequently validated internally in the remaining clinical trial samples (n = 1499), and also externally in different population cohorts of chemotherapy-treated (n = 949) or -untreated (n = 1080) CC patients, and an additional series without treatment annotation (n = 782)...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28449055/primary-tumor-sidedness-has-an-impact-on-prognosis-and-treatment-outcome-in-metastatic-colorectal-cancer-results-from-two-randomized-first-line-panitumumab-studies
#20
N Boeckx, R Koukakis, K Op de Beeck, C Rolfo, G Van Camp, S Siena, J Tabernero, J-Y Douillard, T André, M Peeters
Background: : Previous studies have reported the prognostic impact of primary tumor sidedness in metastatic colorectal cancer (mCRC) and its influence on cetuximab efficacy. The present retrospective analysis of two panitumumab trials investigated a possible association between tumor sidedness and treatment efficacy in first-line mCRC patients with RAS wild-type (WT) primary tumors. Material and methods: Data from two randomized first-line panitumumab trials were analyzed for treatment outcomes by primary tumor sidedness for RAS WT patients...
April 25, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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