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https://www.readbyqxmd.com/read/28427160/biomarker-analysis-of-the-phase-3-torch-trial-for-first-line-erlotinib-versus-chemotherapy-in-advanced-non-small-cell-lung-cancer-patients
#1
Lucia Kim, Mauro Saieg, Massimo Di Maio, Ciro Gallo, Charles Butts, Fortunato Ciardiello, Ronald Feld, Dengxiao Cheng, Vittorio Gebbia, Marco Angelo Burgio, Yasmin Alam, Simona Signoriello, Antonio Rossi, Natasha Leighl, Paolo Maione, Alessandro Morabito, Geoffrey Liu, Ming-Sound Tsao, Francesco Perrone, Cesare Gridelli
BACKGROUND: The TORCH phase III trial compared the efficacy of first-line erlotinib followed by chemotherapy at progression (experimental arm) with the reverse sequence (standard arm) in unselected advanced non-small cell lung cancer (NSCLC) patients. Here we report biomarker analyses. METHODS: EGFR and KRAS mutation, expression of EGFR family members and of cMET and PTEN and EGFR and ABCG2 germline polymorphisms were tested on tumor tissue or blood samples to either confirm previously proposed predictive role or describe it in an explorative setting...
February 25, 2017: Oncotarget
https://www.readbyqxmd.com/read/28425345/surrogate-marker-analysis-in-cancer-clinical-trials-through-time-to-event-mediation-techniques
#2
Sjouke Vandenberghe, Luc Duchateau, Leen Slaets, Jan Bogaerts, Stijn Vansteelandt
The meta-analytic approach is the gold standard for validation of surrogate markers, but has the drawback of requiring data from several trials. We refine modern mediation analysis techniques for time-to-event endpoints and apply them to investigate whether pathological complete response can be used as a surrogate marker for disease-free survival in the EORTC 10994/BIG 1-00 randomised phase 3 trial in which locally advanced breast cancer patients were randomised to either taxane or anthracycline based neoadjuvant chemotherapy...
January 1, 2017: Statistical Methods in Medical Research
https://www.readbyqxmd.com/read/28404157/nab-paclitaxel-versus-solvent-based-paclitaxel-in-patients-with-previously-treated-advanced-gastric-cancer-absolute-an-open-label-randomised-non-inferiority-phase-3-trial
#3
Kohei Shitara, Atsuo Takashima, Kazumasa Fujitani, Keisuke Koeda, Hiroki Hara, Norisuke Nakayama, Shuichi Hironaka, Kazuhiro Nishikawa, Yoichi Makari, Kenji Amagai, Shinya Ueda, Kazuhiro Yoshida, Hideki Shimodaira, Tomohiro Nishina, Masahiro Tsuda, Yukinori Kurokawa, Takao Tamura, Yasutsuna Sasaki, Satoshi Morita, Wasaburo Koizumi
BACKGROUND: Weekly administration of solvent-based paclitaxel is one of the standard second-line chemotherapy regimens for advanced gastric cancer. Nanoparticle albumin-bound paclitaxel (nab-paclitaxel) was developed to improve the solubility of paclitaxel and does not need premedication to avoid infusion-related reactions associated with solvent-based paclitaxel. Additionally, higher doses of nab-paclitaxel can be administered over a shorter infusion time and at higher drug concentrations compared with solvent-based paclitaxel...
April 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28404155/survival-outcomes-following-laparoscopic-versus-open-d3-dissection-for-stage-ii-or-iii-colon-cancer-jcog0404-a-phase-3-randomised-controlled-trial
#4
Seigo Kitano, Masafumi Inomata, Junki Mizusawa, Hiroshi Katayama, Masahiko Watanabe, Seiichiro Yamamoto, Masaaki Ito, Shuji Saito, Shoichi Fujii, Fumio Konishi, Yoshihisa Saida, Hirotoshi Hasegawa, Tomonori Akagi, Kenichi Sugihara, Takashi Yamaguchi, Tadahiko Masaki, Yosuke Fukunaga, Kohei Murata, Masazumi Okajima, Yoshihiro Moriya, Yasuhiro Shimada
BACKGROUND: Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. METHODS: We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20-75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0-2, and metastasis stage M0; and tumour size of 8 cm or smaller were included...
April 2017: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28401821/-70-gene-signature-as-an-aid-to-treatment-decisions-in-early-stage-breast-cancer
#5
J J M van der Hoeven
OBJECTIVE: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online)...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28397190/surrogate-end-points-for-overall-survival-in-metastatic-locally-advanced-or-unresectable-pancreatic-cancer-a-systematic-review-and-meta-analysis-of-24-randomized-controlled-trials
#6
Eleftherios A Makris, Regina MacBarb, Danielle J Harvey, George A Poultsides
BACKGROUND: Overall survival (OS) has traditionally been the primary end point in studies evaluating the clinical benefit of first-line chemotherapy in metastatic, locally advanced, or unresectable pancreatic cancer (MLAUPC). Given the prolonged follow-up assessment required to obtain OS and its potential to be confounded by second-line treatments, this study sought to determine whether progression-free survival (PFS), response rate (RR), or disease control rate (DCR) can serve as a reliable surrogate for OS...
April 10, 2017: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/28394498/degarelix-versus-goserelin-plus-bicalutamide-in-the-short-term-relief-of-lower-urinary-tract-symptoms-in-prostate-cancer-patients-results-of-a-pooled-analysis
#7
Malcolm Mason, Pierre Richaud, Zsolt Bosnyak, Anders Malmberg, Anders Neijber
OBJECTIVE: In patients with prostate cancer (PCa), prostate enlargement may give rise to lower urinary tract symptoms (LUTS); many patients suffer from moderate-to-severe symptoms. We compare the efficacy of degarelix and goserelin plus bicalutamide in improving LUTS in PCa patients. METHODS: Data were pooled from three Phase 3, randomized clinical trials of once-monthly treatment for 12 weeks with degarelix (240/80 mg; n = 289) or goserelin (3.6 mg) plus bicalutamide (50 mg; n = 174) for initial flare protection...
May 2017: Lower Urinary Tract Symptoms
https://www.readbyqxmd.com/read/28391579/trial-level-analysis-of-progression-free-survival-and-response-rate-as-end-points-of-trials-of-first-line-chemotherapy-in-advanced-ovarian-cancer
#8
REVIEW
Giuseppe Colloca, Antonella Venturino
Progression-free survival (PFS) has been reported as surrogate end point of overall survival (OS) in trials of advanced ovarian cancer (AOC). However, there is not a trial-level evaluation of surrogacy. The aim of this study is to perform an analysis of randomized trials enrolling patients with AOC receiving a first-line systemic chemotherapy, in order to evaluate the results of PFS, the other intermediate end points and their relationship with OS. A literature search of phase 3 randomized trials was performed by a predefined protocol...
May 2017: Medical Oncology
https://www.readbyqxmd.com/read/28389707/the-race-of-10-synthetic-rnai-based-drugs-to-the-pharmaceutical-market
#9
REVIEW
Ricardo Titze-de-Almeida, Catherine David, Simoneide Souza Titze-de-Almeida
Ten years after Fire and Melo's Nobel Prize for discovery of gene silencing by double-stranded RNA, a remarkable progress was achieved in RNA interference (RNAi). Changes in the chemical structure of synthetic oligonucleotides make them more stable and specific, and new delivery strategies became progressively available. The attention of pharmaceutical industry rapidly turned to RNAi, as an opportunity to explore new drug targets. This review addresses nine small-interfering RNAs (siRNAs) and one unique microRNA (miRNA) inhibitor, which entered the phase 2-3 clinical trials...
April 7, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28373007/avelumab-for-metastatic-or-locally-advanced-previously-treated-solid-tumours-javelin-solid-tumor-a-phase-1a-multicohort-dose-escalation-trial
#10
Christopher R Heery, Geraldine O'Sullivan-Coyne, Ravi A Madan, Lisa Cordes, Arun Rajan, Myrna Rauckhorst, Elizabeth Lamping, Israel Oyelakin, Jennifer L Marté, Lauren M Lepone, Renee N Donahue, Italia Grenga, Jean-Marie Cuillerot, Berend Neuteboom, Anja von Heydebreck, Kevin Chin, Jeffrey Schlom, James L Gulley
BACKGROUND: Avelumab (MSB0010718C) is a human IgG1 monoclonal antibody that binds to PD-L1, inhibiting its binding to PD-1, which inactivates T cells. We aimed to establish the safety and pharmacokinetics of avelumab in patients with solid tumours while assessing biological correlatives for future development. METHODS: This open-label, single-centre, phase 1a, dose-escalation trial (part of the JAVELIN Solid Tumor trial) assessed four doses of avelumab (1 mg/kg, 3 mg/kg, 10 mg/kg, and 20 mg/kg), with dose-level cohort expansions to provide additional safety, pharmacokinetics, and target occupancy data...
March 31, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28364270/safe-trial-an-ongoing-randomized-clinical-study-to-assess-the-role-of-cardiotoxicity-prevention-in-breast-cancer-patients-treated-with-anthracyclines-with-or-without-trastuzumab
#11
REVIEW
Icro Meattini, Giuseppe Curigliano, Francesca Terziani, Carlotta Becherini, Mario Airoldi, Giacomo Allegrini, Domenico Amoroso, Sandro Barni, Carmelo Bengala, Valentina Guarneri, Paolo Marchetti, Francesca Martella, Pierluigi Piovano, Agnese Vannini, Isacco Desideri, Roberto Tarquini, Giorgio Galanti, Giuseppe Barletta, Lorenzo Livi
Over the years, thanks to the addition of new generation systemic agents, as well as the use of more advanced and precise radiotherapy techniques, it was able to obtain a high curability rate for breast cancer. Anthracyclines play a key role in the treatment of breast disease, with a well-known benefit on disease-free survival of patients with positive nodal status. Trastuzumab have shown a significant outcome advantage after 1-year administration in case of HER2-positive disease. Unfortunately, significant increase in cardiotoxicity has been observed after anthracyclines and trastuzumab therapies...
May 2017: Medical Oncology
https://www.readbyqxmd.com/read/28364229/invention-and-early-history-of-morpholinos-from-pipe-dream-to-practical-products
#12
James E Summerton
Beginning with my concept in 1969 to treat disease at the nucleic acid level using antisense nucleic acids, antisense has evolved to the current Morpholino oligos. Morpholinos have been the dominant gene knockdown system in developmental biology. Lack of delivery technologies has limited their use in adult animals (including humans), though alteration in muscles in Duchenne muscular dystrophy (DMD) allows delivery into adult muscle. Morpholinos are currently in Phase 3 clinical trials for DMD and a Morpholino oligo for skipping dystrophin exon 51 has been approved by the US FDA...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28350787/quality-adjusted-survival-with-combination-nal-iri-5-fu-lv-vs-5-fu-lv-alone-in-metastatic-pancreatic-cancer-patients-previously-treated-with-gemcitabine-based-therapy-a-q-twist-analysis
#13
Uwe Pelzer, Jean-Frédéric Blanc, Davide Melisi, Antonio Cubillo, Daniel D Von Hoff, Andrea Wang-Gillam, Li-Tzong Chen, Jens T Siveke, Yin Wan, Caitlyn T Solem, Marc F Botteman, Yoojung Yang, Floris A de Jong, Richard A Hubner
BACKGROUND: In the NAPOLI-1 Phase 3 trial, nal-IRI+5-fluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST). METHODS: Overall survival was partitioned into time with grade ⩾3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade ⩾3 toxicity (TWiST)...
March 28, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28346484/a-neighborhood-wide-association-study-nwas-example-of-prostate-cancer-aggressiveness
#14
Shannon M Lynch, Nandita Mitra, Michelle Ross, Craig Newcomb, Karl Dailey, Tara Jackson, Charnita M Zeigler-Johnson, Harold Riethman, Charles C Branas, Timothy R Rebbeck
PURPOSE: Cancer results from complex interactions of multiple variables at the biologic, individual, and social levels. Compared to other levels, social effects that occur geospatially in neighborhoods are not as well-studied, and empiric methods to assess these effects are limited. We propose a novel Neighborhood-Wide Association Study(NWAS), analogous to genome-wide association studies(GWAS), that utilizes high-dimensional computing approaches from biology to comprehensively and empirically identify neighborhood factors associated with disease...
2017: PloS One
https://www.readbyqxmd.com/read/28344102/effect-of-visceral-disease-site-on-outcomes-in-patients-with-metastatic-castration-resistant-prostate-cancer-treated-with-enzalutamide-in-the-prevail-trial
#15
Joshi J Alumkal, Simon Chowdhury, Yohann Loriot, Cora N Sternberg, Johann S de Bono, Bertrand Tombal, Joan Carles, Thomas W Flaig, Tanya B Dorff, De Phung, David Forer, Sarah B Noonberg, Hank Mansbach, Tomasz M Beer, Celestia S Higano
BACKGROUND: The Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer Who Have Failed Androgen Deprivation Therapy (PREVAIL) trial was unique as it included patients with visceral disease. This analysis was designed to describe outcomes for the subgroup of men from PREVAIL with specific sites of visceral disease to help clinicians understand how these patients responded to enzalutamide prior to chemotherapy...
March 3, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28343976/prophylactic-cranial-irradiation-versus-observation-in-patients-with-extensive-disease-small-cell-lung-cancer-a-multicentre-randomised-open-label-phase-3-trial
#16
Toshiaki Takahashi, Takeharu Yamanaka, Takashi Seto, Hideyuki Harada, Hiroshi Nokihara, Hideo Saka, Makoto Nishio, Hiroyasu Kaneda, Koichi Takayama, Osamu Ishimoto, Koji Takeda, Hiroshige Yoshioka, Motoko Tachihara, Hiroshi Sakai, Koichi Goto, Nobuyuki Yamamoto
BACKGROUND: Results from a previous phase 3 study suggested that prophylactic cranial irradiation reduces the incidence of symptomatic brain metastases and prolongs overall survival compared with no prophylactic cranial irradiation in patients with extensive-disease small-cell lung cancer. However, because of the absence of brain imaging before enrolment and variations in chemotherapeutic regimens and irradiation doses, concerns have been raised about these findings. We did a phase 3 trial to reassess the efficacy of prophylactic cranial irradiation in the treatment of extensive-disease small-cell lung cancer...
March 23, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28341108/treatment-rationale-and-design-for-j-axel-a%C3%A2-randomized-phase-3-study-comparing-nab-paclitaxel-with-docetaxel-in-patients-with-previously-treated-advanced-non-small-cell-lung-cancer
#17
Yasuto Yoneshima, Satoshi Morita, Masahiko Ando, Satoru Miura, Hiroshige Yoshioka, Tetsuya Abe, Terufumi Kato, Masashi Kondo, Yukio Hosomi, Katsuyuki Hotta, Nobuyuki Yamamoto, Junji Kishimoto, Yoichi Nakanishi, Isamu Okamoto
BACKGROUND: Nanoparticle albumin-bound (nab) paclitaxel is a promising new therapeutic agent for all histologic types of non-small-cell lung cancer (NSCLC). We recently performed a phase 2 study of weekly nab-paclitaxel in patients with previously treated advanced NSCLC, finding promising activity and acceptable toxicity for this regimen. We have now designed a randomized phase 3 intergroup study (J-AXEL, UMIN000017487) to examine the clinical benefit and safety of nab-paclitaxel compared to docetaxel in patients with previously treated advanced NSCLC...
January 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28339098/quality-of-life-with-cediranib-in-relapsed-ovarian-cancer-the-icon6-phase-3-randomized-clinical-trial
#18
Dan P Stark, Adrian Cook, Julia M Brown, Michael D Brundage, Andrew C Embleton, Richard S Kaplan, Fharat A Raja, Ann Marie W Swart, Galina Velikova, Wendi Qian, Jonathan A Ledermann
BACKGROUND: The ICON6 trial showed that cediranib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, improved clinical outcomes for patients with platinum-sensitive relapsed ovarian cancer when it was used with chemotherapy and was continued as maintenance therapy. This study describes health-related quality of life (QOL) during the first year of treatment. METHODS: Four hundred fifty-six women were randomly allocated to receive standard chemotherapy only, chemotherapy with concurrent cediranib, or chemotherapy with cediranib administered concurrently and continued as maintenance...
March 24, 2017: Cancer
https://www.readbyqxmd.com/read/28333844/the-impact-of-an-international-network-gynecologic-cancer-intergroup-for-clinical-research-on-global-capacity-for-gynecologic-cancer-clinical-trials
#19
Gavin C E Stuart, Henry C Kitchener, Jan B Vermorken, Michael J Quinn, William Small, Eric Pujade-Lauraine, Hansen Chou, Michelle Wong, Monica Bacon
OBJECTIVE: The objective of this study was to demonstrate that the construction of the Gynecologic Cancer InterGroup (GCIG) has increased collaboration and accrual to high-quality phase 3 trials at a global level. MATERIALS AND METHODS: The GCIG is a collaboration of 29 international cooperative clinical trial groups committed to conduct of high-quality phase 3 trials among women with gynecologic cancer. A complete bibliography of the reported phase 3 trials has been developed and is available on the GCIG Web site http://www...
March 23, 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28327055/the-evaluation-of-the-anti-cancer-activity-of-ixazomib-on-caco2-colon-solid-tumor-cells-comparison-with-bortezomib
#20
Selin Engür, Miriş Dikmen
Proteasome inhibition has recently emerged as a clinically effective anticancer therapeutic approach. The first proteasome inhibitor, bortezomib (Velcade, PS-341), and new proteasome inhibitors including ixazomib have become more important in the development of targeted cancer therapies. Under physiological conditions, MLN9708 (ixazomib citrate), the stable citrate ester drug substance, hydrolyzes rapidly to MLN2238 (ixazomib), the biologically active boronic acid. It is a second-generation proteasome inhibitor, similar to the well-known proteasome inhibitor bortezomib, which is currently being investigated in phase 3 trials as a treatment for multiple Myeloma...
March 22, 2017: Acta Clinica Belgica
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