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phase III carcinoma

C Genova, A Alama, S Coco, E Rijavec, M G Dal Bello, I Vanni, F Biello, G Barletta, G Rossi, F Grossi
Vinflunine belongs to the class of vinca alkaloids and acts by disrupting the microtubule dynamics during cell cycle; this agent is currently available for previously treated advanced transitional cell carcinoma in Europe. The aim of this invited review is to evaluate the potential role of vinflunine for the treatment of non-small cell lung cancer (NSCLC). Areas covered: The potential role of vinflunine in NSCLC is discussed on the basis of the available data, including full papers and meeting abstracts. Relevant preclinical studies describing the pharmacological properties of vinflunine are also included...
October 22, 2016: Expert Opinion on Investigational Drugs
Matthew D Hale, Matthew Nankivell, Gordon G Hutchins, Sally P Stenning, Ruth E Langley, Wolfram Mueller, Nicholas P West, Alexander I Wright, Darren Treanor, Lindsay C Hewitt, William H Allum, David Cunningham, Jeremy D Hayden, Heike I Grabsch
BACKGROUND: Neoadjuvant chemotherapy followed by surgery is the standard of care for UK patients with locally advanced resectable oesophageal carcinoma (OeC). However, not all patients benefit from multimodal treatment and there is a clinical need for biomarkers which can identify chemotherapy responders. This study investigated whether the proportion of tumour cells per tumour area (PoT) measured in the pre-treatment biopsy predicts chemotherapy benefit for OeC patients. PATIENTS AND METHODS: PoT was quantified using digitized haematoxylin/eosin stained pre-treatment biopsy slides from 281 OeC patients from the UK MRC OE02 trial (141 treated by surgery alone (S); 140 treated by 5-fluorouracil/cisplatin followed by surgery (CS))...
October 18, 2016: Oncotarget
Jing Zhang, Yuan Zong, Gang-Zhu Xu, Ke Xing
OBJECTIVES: To evaluate the efficacy and safety of erlotinib for the treatment of advanced hepatocellular carcinoma (HCC). METHODS: A systematic literature search was undertaken in June 2015. Phase II/III trials of erlotinib for the treatment of advanced HCC were included. A descriptive analysis was applied. The study was conducted in College of Medicine, Honghui Hospital, Xi'an Jiaotong University, Xi'an, China, between June 2015 and January 2016. RESULTS: Ten trials, comprising 9 phase II and one phase III trial, were included in the systematic review...
November 2016: Saudi Medical Journal
Hiroyuki Daiko, Takeo Fujita, Takashi Kojima
Postoperative chemotherapy was initially conducted with surgical treatment as part of a multimodal treatment strategy for esophageal squamous cell carcinoma. Subsequently, a randomized trial comparing post- versus pre-operative chemotherapy with cisplatin and 5-fluorouracil demonstrated the superior efficacy of neoadjuvant treatment with FP(CF). However, the results of subgroup analysis based on T factor revealed no efficacy for cT3 tumors. To improve the survival rate in patients with cT3 tumors, treatments with neoadjuvant chemotherapy using FP(CF)plus docetaxel and concurrent FP(CF)plus radiation were conducted to assess the feasibility of preoperative adjuvant treatment and surgery after neoadjuvant treatment...
October 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
Yun-Chen Li, Lin Zhao, Jiang-Ping Wu, Chen-Xu Qu, Qing-Kun Song, Rui-Bin Wang
BACKGROUND AIMS: To investigate the clinical benefits of cytokine-induced killer (CIK) cell infusions on hepatocellular carcinoma (HCC) patients, combined with other conventional treatments. METHODS: This was a systematic review and meta-analysis conducted among phase II and III randomized control trials worldwide. Review manager 5.2 version was used to pool the effect size across studies. Sensitivity analyses and risk of bias were estimated among included studies...
October 13, 2016: Cytotherapy
Dae-Won Lee, Myoung-Jin Jang, Kyung-Hun Lee, Eun Ju Cho, Jeong-Hoon Lee, Su Jong Yu, Yoon Jun Kim, Jung-Hwan Yoon, Tae-Yong Kim, Sae-Won Han, Do-Youn Oh, Seock-Ah Im, Tae-You Kim
BACKGROUND: Time to progression (TTP) is suggested as a reliable endpoint compared with the progression-free survival in the clinical trials of hepatocellular carcinoma (HCC). However, the correlation between TTP and overall survival (OS) has never been studied. METHODS: We searched PubMed and Embase data to obtain data source. Eligible studies were randomised controlled phase III trials, which evaluated the efficacy of systemic chemotherapy or molecular targeted therapy in advanced HCC...
October 13, 2016: British Journal of Cancer
R L Ferris, J L Geiger, S Trivedi, N C Schmitt, D E Heron, J T Johnson, S Kim, U Duvvuri, D A Clump, J E Bauman, J P Ohr, W E Gooding, A Argiris
BACKGROUND: Treatment intensification for resected, high-risk, head and neck squamous cell carcinoma (HNSCC) is an area of active investigation with novel adjuvant regimens under study. In this trial, the epidermal growth-factor receptor (EGFR) pathway was targeted using the IgG2 monoclonal antibody panitumumab in combination with cisplatin chemoradiotherapy (CRT) in high-risk, resected HNSCC. PATIENTS AND METHODS: Eligible patients included resected pathologic stage III or IVA squamous cell carcinoma of the oral cavity, larynx, hypopharynx, or human-papillomavirus (HPV)-negative oropharynx, without gross residual tumor, featuring high-risk factors (margins <1 mm, extracapsular extension, perineural or angiolymphatic invasion, or ≥2 positive lymph nodes)...
October 11, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
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
David Propper, Keith Jones, D Alan Anthoney, Wasat Mansoor, Daniel Ford, Martin Eatock, Roshan Agarwal, Michiyasu Inatani, Tomohisa Saito, Masaichi Abe, T R Jeffry Evans
BACKGROUND: TP300, a recently developed synthetic camptothecin analogue, is a highly selective topoisomerase I inhibitor. A phase I study showed good safety and tolerability. As camptothecins have proven active in oesophago-gastric adenocarcinomas, in this phase II study we assessed the efficacy and safety of TP300 in patients with gastric or gastro-oesophageal junction (GOJ) adenocarcinomas. METHODS: Eligible patients had metastatic or locally advanced gastric or Siewert Types II or III GOJ inoperable adenocarcinoma...
October 10, 2016: BMC Cancer
Jörg Trojan, Oliver Waidmann
Sorafenib is still the only systemic drug approved for the treatment of advanced hepatocellular carcinoma (HCC). In recent years, several investigational agents mainly targeting angiogenesis failed in late-phase clinical development due to either toxicity or lack of benefit. Recently, data of the RESORCE trial, a placebo-controlled Phase III study that evaluated the efficacy and safety of regorafenib in patients with HCC and documented disease progression after systemic first-line treatment with sorafenib, were presented at the ESMO World Congress on Gastrointestinal Cancer, 2016...
2016: J Hepatocell Carcinoma
Douglas Adkins, Jessica Ley, Loren Michel, Tanya M Wildes, Wade Thorstad, Hiram A Gay, Mackenzie Daly, Jason Rich, Randal Paniello, Ravindra Uppaluri, Ryan Jackson, Kathryn Trinkaus, Brian Nussenbaum
OBJECTIVES: We previously reported the efficacy of nab-paclitaxel added to cisplatin, 5-FU, and cetuximab (APF-C) followed by concurrent high dose bolus cisplatin and radiation therapy (CRT) in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). In this phase II trial, we determined the efficacy of APF (without cetuximab) followed by CRT in similar patients. MATERIALS AND METHODS: Eligible patients had stage III-IV oropharynx (OP), larynx, or hypopharynx SCC and adequate organ function and performance status...
October 2016: Oral Oncology
M Yamasaki, T Yasuda, M Yano, M Hirao, K Kobayashi, K Fujitani, S Tamura, Y Kimura, H Miyata, M Motoori, O Shiraishi, T Makino, T Satoh, M Mori, Y Doki
BACKGROUND: This phase II trial evaluated the efficacy of cisplatin and fluorouracil (CF)-based combination neoadjuvant chemotherapy on the outcome of patients with resectable locally advanced esophageal squamous cell carcinoma (ESCC). We compared the recurrence-free survival (RFS) associated with CF plus Adriamycin (ACF) with that associated with CF plus docetaxel (DCF) to select an alternative regimen in a new phase III trial investigating the optimal neoadjuvant treatment for patients with ESCC...
September 29, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Ying Sun, Wen-Fei Li, Nian-Yong Chen, Ning Zhang, Guo-Qing Hu, Fang-Yun Xie, Yan Sun, Xiao-Zhong Chen, Jin-Gao Li, Xiao-Dong Zhu, Chao-Su Hu, Xiang-Ying Xu, Yuan-Yuan Chen, Wei-Han Hu, Ling Guo, Hao-Yuan Mo, Lei Chen, Yan-Ping Mao, Rui Sun, Ping Ai, Shao-Bo Liang, Guo-Xian Long, Bao-Min Zheng, Xing-Lai Feng, Xiao-Chang Gong, Ling Li, Chun-Ying Shen, Jian-Yu Xu, Ying Guo, Yu-Ming Chen, Fan Zhang, Li Lin, Ling-Long Tang, Meng-Zhong Liu, Jun Ma
BACKGROUND: The value of adding cisplatin, fluorouracil, and docetaxel (TPF) induction chemotherapy to concurrent chemoradiotherapy in locoregionally advanced nasopharyngeal carcinoma is unclear. We aimed to compare TPF induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone in a suitably powered trial. METHODS: We did an open-label, phase 3, multicentre, randomised controlled trial at ten institutions in China. Patients with previously untreated, stage III-IVB (except T3-4N0) nasopharyngeal carcinoma, aged 18-59 years without severe comorbidities were enrolled...
September 26, 2016: Lancet Oncology
I Tinhofer, A Stenzinger, T Eder, R Konschak, F Niehr, V Endris, L Distel, M G Hautmann, R Mandic, C Stromberger, W Weichert, V Budach
BACKGROUND: Based on epidemiological (HPV status, smoking habits) and clinical risk factors (T/N stage), three subgroups of patients suffering from locally advanced oropharyngeal carcinoma with significantly different outcome after concurrent chemoradiation (cCRTX) can be distinguished. Mutational profiling by targeted next-generation sequencing (NGS) might further improve risk stratification. PATIENTS AND METHODS: Patients with stage IV squamous cell carcinoma of the oropharynx and hypopharynx who had been enrolled in a randomized phase III trial (ARO-0401) comparing two regimens of cCRTX and from whom archival tumor specimens were available were included...
September 28, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
M-O Grimm
Immune checkpoint inhibitors are establishing itselves as a new systemic treatment option (in addition to chemotherapy and targeted therapy) for metastatic tumours. (Re)activating the immune system, these antibodies may lead to impressive remissions lasting for a long time in some patients. Regarding urological tumours, the anti-PD-1 antibody Nivolumab (Opdivo(®)) has been approved this year for advanced, previously treated renal cell carcinoma. In the United States, Atezolizumab (Tecentriq(®)) has been approved for metastatic urothelial carcinoma after platinum-based chemotherapy...
September 2016: Aktuelle Urologie
Stefano Colagrande, Andrea L Inghilesi, Sami Aburas, Gian G Taliani, Cosimo Nardi, Fabio Marra
Hepatocellular carcinoma (HCC) is an aggressive malignancy, resulting as the third cause of death by cancer each year. The management of patients with HCC is complex, as both the tumour stage and any underlying liver disease must be considered conjointly. Although surveillance by imaging, clinical and biochemical parameters is routinely performed, a lot of patients suffering from cirrhosis have an advanced stage HCC at the first diagnosis. Advanced stage HCC includes heterogeneous groups of patients with different clinical condition and radiological features and sorafenib is the only approved treatment according to Barcelona Clinic Liver Cancer...
September 14, 2016: World Journal of Gastroenterology: WJG
Y Ito, K Kato, J Hashimoto, T Akimoto, S Katano, Y Saito, H Igaki
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
N Houédé, G Locker, C Lucas, H Soto Parra, U Basso, D Spaeth, R Tambaro, L Basterretxea, F Morelli, C Theodore, L Lusuardi, N Lainez, A Guillot, G Tonini, J Bielle, X Garcia Del Muro
BACKGROUND: Platinum-based systemic chemotherapy is considered the backbone for management of advanced urothelial carcinomas. However there is a lack of real world data on the use of such chemotherapy regimens, on patient profiles and on management after treatment failure. METHODS: Fifty-one randomly selected physicians from 4 European countries registered 218 consecutive patients in progression or relapse following a first platinum-based chemotherapy. Patient characteristics, tumor history and treatment regimens, as well as the considerations of physicians on the management of urothelial carcinoma were recorded...
2016: BMC Cancer
Chee-Kiat Tan
INTRODUCTION: The current curative treatment modalities for hepatocellular carcinoma (HCC) are unfortunately fraught with high rates of HCC recurrence. Hence there is a need to prevent or reduce HCC recurrence after initial curative therapy. Peretinoin is a synthetic oral retinoid showing significant reduction in the incidence of recurrent or new HCC in patients who had received curative HCC therapy. AREAS COVERED: Peretinoin is analysed against the background of molecular pathogenesis of the different causes of HCC...
September 20, 2016: Expert Review of Gastroenterology & Hepatology
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