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"phase 3" cancer

Jacopo Giuliani, Andrea Bonetti
INTRODUCTION: The introduction of active new agents, such as small molecules and checkpoint inhibitors, for the treatment of metastatic renal-cell cancer (mRCC) is associated with a relevant increase in costs, and it is therefore important to strike a balance between the costs of treatment and the added value represented by the improvement of the clinical parameters of interest such as progression-free survival (PFS) and overall survival (OS). METHODS: This analysis was conducted to assess the pharmacologic costs of second-line treatments for mRCC and was restricted to pivotal phase 3 randomized controlled trials (RCTs) used as second-line therapy...
February 22, 2018: Clinical Genitourinary Cancer
Ross D Cranston, Michelle S Cespedes, Pawel Paczuski, Ming Yang, Robert W Coombs, Joan Dragavon, Alfred Saah, Catherine Godfrey, Jennifer Y Webster-Cyriaque, Elizabeth Y Chiao, Barbara Bastow, Timothy Wilkin
BACKGROUND: The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women aged 9 to 26 years to prevent HPV associated anogenital high-grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in human immunodeficiency virus (HIV)-infected men who have sex with men, and women of qHPV to prevent persistent anal HPV infection. Baseline data are presented here. METHODS: Human immunodeficiency virus-infected men who have sex with men, and women 27 years or older without previous anogenital or oral cancer were enrolled...
April 2018: Sexually Transmitted Diseases
G Lendínez-Cano, I Osman García, C B Congregado Ruiz, J M Conde Sánchez, R A Medina López
OBJECTIVES: To analyse the learning curve for the management of tyrosine kinase inhibitors as the first line of treatment for patients with metastatic renal cancer. MATERIAL AND METHODS: We evaluated 32 consecutive patients treated in our department for metastatic renal cancer with tyrosine kinase inhibitors (pazopanib or sunitinib) as first-line treatment between September 2012 and November 2015. We retrospectively analysed this sample. We measured the time to the withdrawal of the first-line treatment, the time to progression and overall survival using Kaplan-Meier curves...
March 7, 2018: Actas Urologicas Españolas
Toyoaki Hida, Reiko Kaji, Miyako Satouchi, Norihiko Ikeda, Atsushi Horiike, Hiroshi Nokihara, Takashi Seto, Tomohisa Kawakami, Shintaro Nakagawa, Toshio Kubo
INTRODUCTION: Atezolizumab, an anti-programmed death-ligand 1 (PD-L1) agent, is effective and well tolerated in patients with pretreated advanced non-small-cell lung cancer (NSCLC). We assessed its efficacy and safety in Japanese patients through subgroup analyses of the phase 3 OAK study (NCT02008227). PATIENTS AND METHODS: Key eligibility criteria of this randomized, controlled, open-label, international study include locally advanced/metastatic NSCLC, ≥ 1 prior platinum-based chemotherapy, age ≥ 18 years, measurable disease (Response Evaluation Criteria in Solid Tumors v1...
February 1, 2018: Clinical Lung Cancer
Jens Overgaard, Camilla Molich Hoff, Hanne Sand Hansen, Lena Specht, Marie Overgaard, Pernille Lassen, Elo Andersen, Jørgen Johansen, Lisbeth Juhler Andersen, Jan Folkvard Evensen, Jan Alsner, Cai Grau
PURPOSE: To evaluate if correction of low hemoglobin (Hb) levels by means of darbepoetin alfa improves the outcomes of radiotherapy in patients with squamous cell carcinoma of the head and neck (HNSCC). PATIENTS AND METHODS: Patients eligible for primary radiotherapy and who had Hb values below 14.0 g/dl were randomized to receive accelerated fractionated radiotherapy with or without darbepoetin alfa. Patients also received the hypoxic radiosensitizer nimorazole...
March 6, 2018: Radiotherapy and Oncology: Journal of the European Society for Therapeutic Radiology and Oncology
Takeshi Kotake, Masakazu Toi
There have been numerous clinical trials of CDK4/6 inhibitors performed on various carcinomas including breast cancer. One such inhibitor tested and which has ongoing clinical trials for breast cancer is abemaciclib. Abemaciclib is a molecular-targeted agent that targets basic cell cycle regulatory mechanisms. Areas covered: This review discusses the available clinical data and ongoing clinical trials of abemaciclib in breast cancer. Expert opinion: Abemaciclib has demonstrated a clear anti-tumour effect and manageable toxicity against HR-positive, HER2-negative breast cancer in many clinical trials and is expected to be an important standard therapy...
March 9, 2018: Expert Opinion on Pharmacotherapy
Dana E Rathkopf, Tomasz M Beer, Yohann Loriot, Celestia S Higano, Andrew J Armstrong, Cora N Sternberg, Johann S de Bono, Bertrand Tombal, Teresa Parli, Suman Bhattacharya, De Phung, Andrew Krivoshik, Howard I Scher, Michael J Morris
Importance: Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. Objective: To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS...
March 8, 2018: JAMA Oncology
Su-E Kuo, Hui-San Lai, Jen-Ming Hsu, Yao-Chang Yu, Dong-Zhe Zheng, Ting-Wei Hou
BACKGROUND AND OBJECTIVE: Traditional nutrition evaluations not only require the use of numerous tables and lists to provide sufficient recommendations for patients' diets but are also very time-consuming due to cross-referencing and calculations. METHODS: To personalize patient assessments, this study implemented a Clinical Nutritional Information System (CNIS) to help hospital dietitians perform their daily work more effectively in terms of time management and paper work...
March 2018: Computer Methods and Programs in Biomedicine
Hagop M Kantarjian, Yun Su, Elias J Jabbour, Helen Bhattacharyya, Eric Yan, Joseph C Cappelleri, David I Marks
BACKGROUND: Inotuzumab ozogamicin (InO), an anti-CD22 antibody-calicheamicin conjugate, demonstrated superior clinical activity versus standard-of-care (SOC) chemotherapies for relapsed/refractory B-cell acute lymphoblastic leukemia in the phase 3 randomized controlled INO-VATE trial. The authors assessed patient-reported outcomes (PROs) from that study. METHODS: Patients were randomized to receive either InO (1.8 mg/m2 per cycle for ≤6 cycles) or SOC (fludarabine/cytarabine [ara-C]/granulocyte colony-stimulating factor, or ara-C plus mitoxantrone, or high-dose ara-C for ≤4 cycles) and completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire and the EuroQoL 5 Dimensions Questionnaires at baseline, on day 1 of each cycle, and at the end of treatment...
March 6, 2018: Cancer
Emil Ter Veer, L Bengt van Rijssen, Marc G Besselink, Rosa M A Mali, Jordan D Berlin, Stefan Boeck, Franck Bonnetain, Ian Chau, Thierry Conroy, Eric Van Cutsem, Gael Deplanque, Helmut Friess, Bengt Glimelius, David Goldstein, Richard Herrmann, Roberto Labianca, Jean-Luc Van Laethem, Teresa Macarulla, Jonathan H M van der Meer, John P Neoptolemos, Takuji Okusaka, Eileen M O'Reilly, Uwe Pelzer, Philip A Philip, Marcel J van der Poel, Michele Reni, Werner Scheithauer, Jens T Siveke, Chris Verslype, Olivier R Busch, Johanna W Wilmink, Martijn G H van Oijen, Hanneke W M van Laarhoven
Variations in the reporting of potentially confounding variables in studies investigating systemic treatments for unresectable pancreatic cancer pose challenges in drawing accurate comparisons between findings. In this Review, we establish the first international consensus on mandatory baseline and prognostic characteristics in future trials for the treatment of unresectable pancreatic cancer. We did a systematic literature search to find phase 3 trials investigating first-line systemic treatment for locally advanced or metastatic pancreatic cancer to identify baseline characteristics and prognostic variables...
March 2018: Lancet Oncology
Kensei Yamaguchi, Kazumasa Fujitani, Fumio Nagashima, Yasushi Omuro, Nozomu Machida, Tomohiro Nishina, Toshiko Koue, Mika Tsujimoto, Kaijiro Maeda, Taroh Satoh
BACKGROUND: Ramucirumab, a monoclonal antibody vascular endothelial growth factor receptor-2 antagonist, given as monotherapy improved survival in a global phase 3 study (REGARD) of patients with gastric cancer. However, REGARD did not include Japanese patients. This study evaluated the efficacy and safety of ramucirumab monotherapy in Japanese patients with advanced gastric cancer. METHODS: This multicenter, open-label, nonrandomized phase 2 study (Clinicaltrials...
March 5, 2018: Gastric Cancer
Sibylle Loibl, Joyce O'Shaughnessy, Michael Untch, William M Sikov, Hope S Rugo, Mark D McKee, Jens Huober, Mehra Golshan, Gunter von Minckwitz, David Maag, Danielle Sullivan, Norman Wolmark, Kristi McIntyre, Jose J Ponce Lorenzo, Otto Metzger Filho, Priya Rastogi, W Fraser Symmans, Xuan Liu, Charles E Geyer
BACKGROUND: Although several randomised trials in patients with triple-negative breast cancer have shown that the addition of carboplatin, with or without poly(ADP-ribose) polymerase (PARP) inhibitors, to neoadjuvant chemotherapy increases the likelihood of achieving a pathological complete response, the use of these therapies in this setting has remained controversial. The BrighTNess trial was designed to assess the addition of the PARP inhibitor veliparib plus carboplatin or carboplatin alone to standard neoadjuvant chemotherapy in triple-negative breast cancer...
February 28, 2018: Lancet Oncology
Richard M Stone, Paul W Manley, Richard A Larson, Renaud Capdeville
Midostaurin was a prototype kinase inhibitor, originally developed as a protein kinase C inhibitor and subsequently as an angiogenesis inhibitor, based on its inhibition of vascular endothelial growth factor receptor. Despite promising preclinical data, early clinical trials in multiple diseases showed only modest efficacy. In 1996, the relatively frequent occurrence of fms-like tyrosine kinase 3 ( FLT3 ) activating mutations in acute myeloid leukemia (AML) was first recognized. Several years later, midostaurin was discovered to be a potent inhibitor of the FLT3 tyrosine kinase and to have activity against mutant forms of KIT proto-oncogene receptor tyrosine kinase, which drive advanced systemic mastocytosis (SM)...
February 27, 2018: Blood Advances
Valérie Fonteyne, Camille Sarrazyn, Martijn Swimberghe, Gert De Meerleer, Elke Rammant, Barbara Vanderstraeten, Frank Vanpachtenbeke, Nicolaas Lumen, Karel Decaestecker, Roos Colman, Geert Villeirs, Piet Ost
PURPOSE: Hypofractionated radiation therapy (HFRT) for localized prostate cancer is safe and effective. The question that remains is which hypofractionation schedule to implement. We compared 2 different HFRT regimens in the present study. METHODS AND MATERIALS: From June 2013 to July 2016, 160 patients with prostate cancer were randomly assigned (1:1), within this single-center phase III trial, to 56 Gy (16 fractions of 3.5 Gy; arm A) or 67 Gy (25 fractions of 2...
March 15, 2018: International Journal of Radiation Oncology, Biology, Physics
Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmen Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone
BACKGROUND: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. METHODS: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer...
February 23, 2018: Lancet Oncology
Katsuyuki Kiura, Fumio Imamura, Hiroshi Kagamu, Shingo Matsumoto, Toyoaki Hida, Kazuhiko Nakagawa, Miyako Satouchi, Isamu Okamoto, Mitsuhiro Takenoyama, Yasuhito Fujisaka, Takayasu Kurata, Masayuki Ito, Kota Tokushige, Ben Hatano, Makoto Nishio
Background: In the global, Phase 3, ASCEND-5 study, ceritinib improved progression-free survival (PFS) vs chemotherapy in patients with anaplastic lymphoma kinase (ALK)-rearranged non-small cell lung cancer (NSCLC) who had previously progressed on crizotinib and platinum-based chemotherapy. Here, we report efficacy and safety in a subset of Japanese patients from the ASCEND-5 study. Methods: Patients with advanced ALK-rearranged NSCLC received oral ceritinib 750 mg/day or chemotherapy (intravenous pemetrexed 500 mg/m2 or docetaxel 75 mg/m2 [investigator's choice], every 21 days)...
February 21, 2018: Japanese Journal of Clinical Oncology
Georgia Ritchie, Harry Gasper, Johnathan Man, Sally Lord, Ian Marschner, Michael Friedlander, Chee Khoon Lee
Importance: Checkpoint inhibitors have a unique mechanism of action that differs from chemotherapy or targeted therapies. The validity of objective response rate (ORR) as a surrogate for progression-free survival (PFS) and overall survival (OS) in checkpoint-inhibitor trials is uncertain. Objective: To determine the types of primary end points used in phase 2 checkpoint-inhibitor trials, and to assess the strength of associations for ORR with PFS and OS. Data Sources: Trials listed in electronic databases from 2000 to 2017 (PREMEDLINE, MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials)...
February 22, 2018: JAMA Oncology
Ross D Cranston, Michelle S Cespedes, Pawel Paczuski, Ming Yang, Robert W Coombs, Joan Dragavon, Alfred Saah, Catherine Godfrey, Jennifer Y Webster-Cyriaque, Elizabeth Y Chiao, Barbara Bastow, Timothy Wilkin
BACKGROUND: The quadrivalent human papillomavirus (HPV) vaccine (qHPV; types 6, 11, 16, 18) is indicated for men and women 9-26 years to prevent HPV associated anogenital high grade squamous intraepithelial lesions (HSIL) and cancer. ACTG 5298 was a randomized placebo controlled Phase 3 study in HIV-infected men who have sex with men (MSM), and women of qHPV to prevent persistent anal HPV infection. Baseline data is presented here. METHODS: HIV-infected MSM, and women ≥ 27 years without previous anogenital or oral cancer were enrolled...
October 13, 2017: Sexually Transmitted Diseases
Rolf D Issels, Lars H Lindner, Jaap Verweij, Rüdiger Wessalowski, Peter Reichardt, Peter Wust, Pirus Ghadjar, Peter Hohenberger, Martin Angele, Christoph Salat, Zeljko Vujaskovic, Soeren Daugaard, Olav Mella, Ulrich Mansmann, Hans Roland Dürr, Thomas Knösel, Sultan Abdel-Rahman, Michael Schmidt, Wolfgang Hiddemann, Karl-Walter Jauch, Claus Belka, Alessandro Gronchi
Importance: Patients with soft tissue sarcoma are at risk for local recurrence and distant metastases despite optimal local treatment. Preoperative anthracycline plus ifosfamide chemotherapy improves outcome in common histological subtypes. Objective: To analyze whether the previously reported improvement in local progression-free survival by adding regional hyperthermia to neoadjuvant chemotherapy translates into improved survival. Design, Setting, and Participants: Open-label, phase 3 randomized clinical trial to evaluate the efficacy and toxic effects of neoadjuvant chemotherapy plus regional hyperthermia...
February 15, 2018: JAMA Oncology
Jacques Cadranel, Alexis B Cortot, Hervé Lena, Bertrand Mennecier, Pascal Do, Eric Dansin, Julien Mazieres, Christos Chouaid, Maurice Perol, Fabrice Barlesi, Gilles Robinet, Sylvie Friard, Luc Thiberville, Clarisse Audigier-Valette, Alain Vergnenegre, Virginie Westeel, Khemaies Slimane, Alexandru Buturuga, Denis Moro-Sibilot, Benjamin Besse
Here we report our experience of ceritinib in crizotinib-pretreated patients with anaplastic lymphoma kinase ( ALK ) positive ( ALK + ) non-small cell lung cancer (NSCLC) in a French temporary authorisation for use (TAU) study. The French TAU study included crizotinib-pretreated patients with advanced ALK + or ROS proto-oncogene 1 positive ( ROS1 + ) tumours. Patients received oral ceritinib (750 mg·day -1 as a starting dose) and best tumour response (as evaluated by the investigator) and safety were reported every 3 months...
January 2018: ERJ Open Research
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