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Phase 3 oncology

Mark R Gilbert, Stephanie L Pugh, Ken Aldape, A Gregory Sorensen, Tom Mikkelsen, Marta Penas-Prado, Felix Bokstein, Young Kwok, R Jeffrey Lee, Minesh Mehta
Angiogenesis, a hallmark of glioblastoma, can potentially be targeted by inhibiting the VEGF pathway using bevacizumab, a humanized monoclonal antibody against VEGF-A. This study was designed to determine the efficacy and safety of these regimens in the cooperative group setting. Eligibility included age ≥18, recurrent or progressive GBM after standard chemoradiation. Treatment was intravenous bevacizumab 10 mg/kg and either irinotecan (CPT) 125 mg/m(2) every 2 weeks or temozolomide (TMZ) 75-100 mg/m(2) day 1-21 of 28 day cycle...
October 21, 2016: Journal of Neuro-oncology
Satoshi Nagayama, Suguru Hasegawa, Koya Hida, Kenji Kawada, Etsuro Hatano, Kojiro Nakamura, Satoru Seo, Kojiro Taura, Kentaro Yasuchika, Takashi Matsuo, Masazumi Zaima, Akiyoshi Kanazawa, Hiroaki Terajima, Masaharu Tada, Yukihito Adachi, Ryuta Nishitai, Dai Manaka, Tsunehiro Yoshimura, Koji Doi, Takahiro Horimatsu, Akira Mitsuyoshi, Kenichi Yoshimura, Miyuki Niimi, Shigemi Matsumoto, Yoshiharu Sakai, Shinji Uemoto
BACKGROUND: Although liver resection combined with preoperative chemotherapy is expected to improve outcomes of patients with resectable colorectal liver metastasis (CRLM), there is as yet insufficient clinical evidence supporting the efficacy of preoperative systemic chemotherapy. The aim of this phase II study was to assess the feasibility and efficacy of preoperative FOLFOX systemic chemotherapy for patients with initially resectable CRLM. METHODS: A prospective multi-institutional phase II study was conducted to evaluate the feasibility and efficacy of preoperative chemotherapy for resectable CRLM (ClinicalTrials...
October 17, 2016: International Journal of Clinical Oncology
Jaroslaw T Hepel, Kara Lynne Leonard, Howard Safran, Thomas Ng, Angela Taber, Humera Khurshid, Ariel Birnbaum, David E Wazer, Thomas DiPetrillo
PURPOSE: Stereotactic body radiation therapy (SBRT) boost to primary and nodal disease after chemoradiation has potential to improve outcomes for advanced non-small cell lung cancer (NSCLC). A dose escalation study was initiated to evaluate the maximum tolerated dose (MTD). METHODS AND MATERIALS: Eligible patients received chemoradiation to a dose of 50.4 Gy in 28 fractions and had primary and nodal volumes appropriate for SBRT boost (<120 cc and <60 cc, respectively)...
August 31, 2016: International Journal of Radiation Oncology, Biology, Physics
Jan Franko, Qian Shi, Jeffrey P Meyers, Timothy S Maughan, Richard A Adams, Matthew T Seymour, Leonard Saltz, Cornelis J A Punt, Miriam Koopman, Christophe Tournigand, Niall C Tebbutt, Eduardo Diaz-Rubio, John Souglakos, Alfredo Falcone, Benoist Chibaudel, Volker Heinemann, Joseph Moen, Aimery De Gramont, Daniel J Sargent, Axel Grothey
BACKGROUND: Patients with peritoneal metastatic colorectal cancer have reduced overall survival compared with patients with metastatic colorectal cancer without peritoneal involvement. Here we further investigated the effect of the number and location of metastases in patients receiving first-line systemic chemotherapy. METHODS: We analysed individual patient data for previously untreated patients enrolled in 14 phase 3 randomised trials done between 1997 and 2008...
October 12, 2016: Lancet Oncology
Rishi G Vaswani, Victor S Gehling, Les A Dakin, Andrew Cook, Christopher G Nasveschuk, Martin Duplessis, Priyadarshini Iyer, Srividya Balasubramanian, Feng Zhao, Andrew C Good, Robert Campbell, Christina Lee, Nico Cantone, Richard T Cummings, Emmanuel Normant, Steven F Bellon, Brian K Albrecht, Jean-Christophe P Harmange, Patrick Trojer, James E Audia, Ying Zhang, Neil Justin, Shuyang Chen, Jon Wilson, Steve Gamblin
Polycomb repressive complex 2 (PRC2) has been shown to play a major role in transcriptional silencing in part by installing methylation marks on lysine 27 of histone 3. Dysregulation of PRC2 function correlates with certain malignancies and poor prognosis. EZH2 is the catalytic engine of the PRC2 complex and thus represents a key candidate oncology target for pharmacological intervention. Here we report the optimization of our indole based EZH2 inhibitor series that led to the identification of CPI-1205, a highly potent (biochemical IC50 = 0...
October 14, 2016: Journal of Medicinal Chemistry
Li Jiang, Aisha Lofters, Rahim Moineddin, Kathleen Decker, Patti Groome, Cynthia Kendell, Monika Krzyzanowska, Dongdong Li, Mary L McBride, Nicole Mittmann, Geoff Porter, Donna Turner, Robin Urquhart, Marcy Winget, Yang Zhang, Eva Grunfeld
OBJECTIVE: To describe primary care physician (PCP) use and continuity of PCP care across the breast cancer care continuum. DESIGN: Population-based, retrospective cohort study using provincial cancer registries linked to health administrative databases. SETTING: British Columbia, Manitoba, and Ontario. PARTICIPANTS: All women with incident invasive breast cancer from 2007 to 2012 in Manitoba and Ontario and from 2007 to 2011 in British Columbia...
October 2016: Canadian Family Physician Médecin de Famille Canadien
Caroline Brard, Gwénaël Le Teuff, Marie-Cécile Le Deley, Lisa V Hampson
BACKGROUND: Bayesian statistics are an appealing alternative to the traditional frequentist approach to designing, analysing, and reporting of clinical trials, especially in rare diseases. Time-to-event endpoints are widely used in many medical fields. There are additional complexities to designing Bayesian survival trials which arise from the need to specify a model for the survival distribution. The objective of this article was to critically review the use and reporting of Bayesian methods in survival trials...
October 10, 2016: Clinical Trials: Journal of the Society for Clinical Trials
Minh Tam Truong, Qiang Zhang, David I Rosenthal, Marcie List, Rita Axelrod, Eric Sherman, Randal Weber, Phuc Felix Nguyen-Tân, Adel El-Naggar, André Konski, James Galvin, David Schwartz, Andy Trotti, Craig Silverman, Anurag Singh, Karen Godette, James A Bonner, Christopher U Jones, Adam S Garden, George Shenouda, Chance Matthiesen, Quynh-Thu Le, Deborah Bruner
PURPOSE: To analyze the quality of life (QOL) and performance status (PS) (secondary outcome) in patients with stage III to IV head and neck cancer (HNC) enrolled on a prospective randomized phase 3 trial comparing radiation-cisplatin without cetuximab (CIS) or with cetuximab (CET/CIS). The QOL hypothesis proposed a between-arm difference in Functional Assessment of Cancer Therapy-Head and Neck (FACT-HN) total score of ≥10% of the instrument range from baseline to 1 year. METHODS AND MATERIALS: Patients who gave consent to the QOL/PS study completed the FACT-HN, Performance Status Scale for HNC (PSS-HN), and EuroQol (EQ-5D) at baseline through to 5 years...
August 12, 2016: International Journal of Radiation Oncology, Biology, Physics
Canhua Xiao, Qiang Zhang, Phuc Felix Nguyen-Tân, Marcie List, Randal S Weber, K Kian Ang, David Rosenthal, Edith J Filion, Harold Kim, Craig Silverman, Adam Raben, Thomas Galloway, Andre Fortin, Elizabeth Gore, Eric Winquist, Christopher U Jones, William Robinson, David Raben, Quynh-Thu Le, Deborah Bruner
PURPOSE/OBJECTIVE(S): To analyze quality of life (QOL) and performance status (PS) for head and neck cancer (HNC) patients treated on NRG Oncology RTOG 0129 by treatment (secondary outcome) and p16 status, and to examine the association between QOL/PS and survival. METHODS AND MATERIALS: Eligible patients were randomized into either an accelerated-fractionation arm or a standard-fractionation arm, and completed the Performance Status Scale for the Head and Neck (PSS-HN), the Head and Neck Radiotherapy Questionnaire (HNRQ), and the Spitzer Quality of Life Index (SQLI) at 8 time points from before treatment to 5 years after treatment...
July 25, 2016: International Journal of Radiation Oncology, Biology, Physics
Tomokazu Aoki, Yoshiki Arakawa, Tetsuya Ueba, Masashi Oda, Namiko Nishida, Yukinori Akiyama, Tetsuya Tsukahara, Koichi Iwasaki, Nobuhiro Mikuni, Susumu Miyamoto
The objective of this phase I/II study was to examine the efficacy and toxicity profile of temozolomide (TMZ) plus nimustine (ACNU). Patients who had received a standard radiotherapy with one or two previous chemo-regimens were enrolled. In phase I, the maximum-tolerated dose (MTD) by TMZ (150 mg/m(2)/day) (Day 1-5) plus various doses of ACNU (30, 35, 40, 45 mg/m(2)/day) (Day 15) per 4 weeks was defined on a standard 3 + 3 design. In phase II, these therapeutic activity and safety of this regimen were evaluated...
October 11, 2016: Neurologia Medico-chirurgica
Jinhyun Choi, Yong Bae Kim, Kyung Hwan Shin, Sung-Ja Ahn, Hyung-Sik Lee, Won Park, Su Ssan Kim, Jin Hee Kim, Kyu Chan Lee, Dong Won Kim, Hyun Suk Suh, Kyung Ran Park, Hyun Soo Shin, Chang-Ok Suh
PURPOSE: The aim of this study is to present the incidence of radiation pneumonitis (RP) reported within 6 months after treatment for breast cancer with or without internal mammary node irradiation (IMNI). METHODS: In the Korean Radiation Oncology Group (KROG) 08-06 phase III randomized trial, patients who were node-positive after surgery were randomly assigned to receive radiotherapy either with or without IMNI. A total of 747 patients were enrolled, and three-dimensional treatment planning with computed tomography simulation was performed for all patients...
September 2016: Journal of Breast Cancer
Hitoshi Katai, Junki Mizusawa, Hiroshi Katayama, Masakazu Takagi, Takaki Yoshikawa, Takeo Fukagawa, Masanori Terashima, Kazunari Misawa, Shin Teshima, Keisuke Koeda, Souya Nunobe, Norimasa Fukushima, Takashi Yasuda, Yoshito Asao, Yoshiyuki Fujiwara, Mitsuru Sasako
BACKGROUNDS: No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy. METHODS: We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG...
October 7, 2016: Gastric Cancer
Nermine O Basta, Gail C Halliday, Guy Makin, Jillian Birch, Richard Feltbower, Nick Bown, Martin Elliott, Lucas Moreno, Giuseppe Barone, Andrew Dj Pearson, Peter W James, Deborah A Tweddle, Richard Jq McNally
BACKGROUND: Despite therapeutic advances, survival following relapse for neuroblastoma patients remains poor. We investigated clinical and biological factors associated with length of progression-free and overall survival following relapse in UK neuroblastoma patients. METHODS: All cases of relapsed neuroblastoma, diagnosed during 1990-2010, were identified from four Paediatric Oncology principal treatment centres. Kaplan-Meier and Cox regression analyses were used to calculate post-relapse overall survival (PROS), post-relapse progression-free survival (PRPFS) between relapse and further progression, and to investigate influencing factors...
October 4, 2016: British Journal of Cancer
Chaitra S Ujjani, Sin-Ho Jung, Brandelyn Pitcher, Peter Martin, Steven I Park, Kristie A Blum, Sonali M Smith, Myron Czuczman, Matthew S Davids, Ellis Levine, Lionel D Lewis, Scott E Smith, Nancy L Bartlett, John P Leonard, Bruce D Cheson
Chemoimmunotherapy in follicular lymphoma is associated with significant toxicity. Targeted therapies are being investigated as potentially more efficacious and tolerable alternatives for this multiply-relapsing disease. Based on promising activity with rituximab and lenalidomide in previously untreated follicular lymphoma (ORR 90-96%) and ibrutinib in relapsed disease (ORR 30-55%), the Alliance for Clinical Trials in Oncology conducted a phase I trial of rituximab, lenalidomide, and ibrutinib. Previously untreated patients with follicular lymphoma received rituximab 375 mg/m(2) on Day 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycle 4, 6, 8, 10, lenalidomide as per cohort dose on Days 1-21/28 for 18 cycles, and ibrutinib as per cohort dose daily until progression...
October 3, 2016: Blood
Flora Stavridi, Konstantine T Kalogeras, Kyriaki Pliarchopoulou, Ralph M Wirtz, Zoi Alexopoulou, Flora Zagouri, Elke Veltrup, Eleni Timotheadou, Helen Gogas, Angelos Koutras, Georgios Lazaridis, Christos Christodoulou, George Pentheroudakis, Apostolos Laskarakis, Petroula Arapantoni-Dadioti, Anna Batistatou, Maria Sotiropoulou, Gerasimos Aravantinos, Pavlos Papakostas, Paris Kosmidis, Dimitrios Pectasides, George Fountzilas
BACKGROUND-AIM: Early breast cancer is a heterogeneous disease, and, therefore, prognostic tools have been developed to evaluate the risk for distant recurrence. In the present study, we sought to develop a risk for recurrence score (RRS) based on mRNA expression of three proliferation markers in high-risk early breast cancer patients and evaluate its ability to predict risk for relapse and death. In addition the Adjuvant! Online score (AOS) was also determined for each patient, providing a 10-year estimate of relapse and mortality risk...
2016: PloS One
Carmine Pinto, Lorenzo Antonuzzo, Luca Porcu, Giuseppe Aprile, Evaristo Maiello, Gianluca Masi, Fausto Petrelli, Mario Scartozzi, Valter Torri, Sandro Barni
BACKGROUND: Whether bevacizumab represents a feasible option for the first-line treatment of unfit and elderly patients with metastatic colorectal cancer (mCRC) remains controversial. The present systematic review and meta-analysis evaluated the efficacy and safety data of bevacizumab combined with first-line fluoropyrimidine monochemotherapy for these complex patients. PATIENTS AND METHODS: A systematic search of the published data was conducted through May 31, 2016...
August 31, 2016: Clinical Colorectal Cancer
Kan Yonemori, Akihiro Hirakawa, Asuka Kawachi, Fumie Kinoshita, Hitomi Ohkuma, Tadaaki Nishikawa, Tamura Kenji, Yasuhiro Fujiwara, Naoko Takebe
Interstitial lung disease is a serious drug related condition that can cause life threatening organ failure. The incidence and risk factors of drug-induced interstitial lung disease (DILD) is unknown in oncology phase I trials. This study analyzed clinical information from 8,906 patients with malignancies who were enrolled in 470 phase I trials sponsored by the Cancer Therapy Evaluation Program, National Cancer Institute, from 1988 to 2014. Logistic and Cox statistical analyses were utilized to determine clinical differences between patients who developed DILD and patients who did not...
September 29, 2016: Cancer Science
Michele Scialpi, Luisa Pierotti, Sabrina Gravante, Alberto Rebonato, Irene Piscioli, Alfredo D'Andrea, Raffaele Schiavone, Barbara Palumbo
BACKGROUND: In oncologic patients, the liver is the most common target for metastases. An accurate detection and characterization of focal liver lesions in patients with known primary extrahepatic malignancy are essential to define management and prognosis. OBJECTIVES: To assess the diagnostic accuracy of the split-bolus multidetector-row computed tomography (MDCT) protocol in the characterization of focal liver lesions in oncologic patients. PATIENTS AND METHODS: We retrospectively analyzed the follow-up split-bolus 64-detector row CT protocol in 36 oncologic patients to characterize focal liver lesions...
April 2016: Iranian Journal of Radiology: a Quarterly Journal Published By the Iranian Radiological Society
Dong Wook Shin, Juhee Cho, So Young Kim, Hyung Kook Yang, BeLong Cho, Dong-Bok Shin, Mi Son Chun, Young Joo Min, Young-Woo Kim, Jong Hyock Park
OBJECTIVE: Phase I oncology trials have raised concerns that patients' 'unrealistic' optimism could compromise the validity of informed consent, and that patients often participate in trials to conform to physicians' or family members' recommendations. We aimed to determine whether patients or families-given the same information of risk-benefit profile-are more likely to participate in Phase I trials than their physicians and whether people in family or physician situations are more likely to recommend trial participation to patients than they would want for themselves as patients...
September 27, 2016: Japanese Journal of Clinical Oncology
B R Prestidge, K Winter, M G Sanda, M Amin, W S Bice, J Michalski, G S Ibbott, J M Crook, C N Catton, H A Gay, V Donavanik, D C Beyer, S J Frank, M A Papagikos, S A Rosenthal, H J J Barthold, M Roach, H M Sandler
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
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