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Immuno-oncology combinations： raising the tail of the survival curve

Cancer Biology & Medicine 2016年第2期13卷 171-193页

作者： Samuel J. Harris Jessica Brown Juanita Lopez Timothy A. Yap drug Development Unit Royal Marsden Hospital and The Institute of Cancer Research London SM2 5PT UK Lung Unit Royal Marsden Hospital and The Institute of Cancer Research London SM2 5PT UK

There have been exponential gains in immuno-oncology in recent times through the development of immune checkpoint inhibitors. Already approved by the U.S. Food and drug Administration for advanced melanoma and non-small cell lung cancer,immune checkpoint inhibitors also appears to have significant antitumor activity in multiple other tumor types. An exciting component of immunotherapy is the durability of antitumor responses observed, with some patients achieving disease control for many years. Nevertheless, not all patients benefit, and efforts should thus now focus on improving the efficacy of immunotherapy through the use of combination approaches and predictive biomarkers of response and resistance. There are multiple potential rational combinations using an immunotherapy backbone, including existing treatments such as radiotherapy, chemotherapy or molecularly targeted agents, as well as other immunotherapeutics. The aim of such antitumor strategies will be to raise the tail on the survival curve by increasing the number of long term survivors, while managing any additive or synergistic toxicities that may arise with immunotherapy combinations. Rational trial designs based on a clear understanding of tumor biology and drug pharmacology remain paramount. This article reviews the biology underpinning immuno-oncology, discusses existing and novel immunotherapeutic combinations currently in development, the challenges of predictive biomarkers of response and resistance and the impact of immuno-oncology on early phase clinical trial design.

关键词： combination drug therapy oncology clinical trials PD-1 PD-L1 CTLA4 biomarkers immunotherapy

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Curcumin synergistically augments bcr/abl phosphorothioate antisense oligonucleotides to inhibit growth of chronic myelogenous leukemia cells

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Acta Pharmacologica Sinica 2007年第1期28卷 105-110页

作者： Kun-zhong ZHANG~2 Jian-hua XU~(2,4) Xiu-wang HUANG~2 Li-xian WU~2 Yu SU~2 Yuan-zhong CHEN~32 Institute of Clinical Pharmacology,School of Pharmacy,Fujian Medical University,Fujian 350004,China 3 Fujian Institute of Hematology Fujian 350004,China Institute of Clinical Pharmacology School of Pharmacy Fujian Medical University Fujian China Fujian Institute ofHematology Fujian China

Aim:To investigate the growth inhibition effect of the combination of bcr/ablphosphorothioate antisense oligonucleotides（PS-ASODN）and curcumin（cur）,and the possible mechanisms of cur on the chronic myelogenous leukemia cell ***:The K562 cell line was used as a P210bcr/abl-positive cell model invitro and was exposed to different concentrations of PS-ASODN（0-20 μmol/L）,cur（0-20 μmol/L）,or a combination of *** inhibition and apoptosis ofK562 cells were assessed by MTT assay and AO/EB fluorescent staining,*** expression levels of P210bcr/abl,NF-κ3 and heat shock protein 90（Hsp90）were assessed by Western ***:Exposure to cur（5-20 μmol/L）and PS-ASODN（5-20 μmol/L）resulted in a synergistic inhibitory effect on cell *** inhibition was associated with the inhibition of the proliferation and in-duction of *** blot analysis showed that the drugs synergisti-cally downregulated the level ofP210bcr/abland NF-κ*** downregulated Hsp90,whereas no synergism was observed when cur was combined with ***:PS-ASODN and cur exhibited a synergistic inhibitory effect on thecell growth of *** synergistic growth inhibition was mediated throughdifferent mechanisms that involved the inhibition of P210bcr/abl.

关键词： combination drug therapy curcumin abl genes antisense oligonucleotides chronic myelogenous leukemia bcr-abl fusion proteins

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Efficacy of sequential treatment of HCT116 colon cancer monolayers and xenografts with docetaxel,flavopiridol,and 5-fluorouracil

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Acta Pharmacologica Sinica 2006年第10期27卷 1375-1381页

作者： Jun GUO~2 an-wu ZHOU~2 Yu-cai FU~3 Udit N VERMA~2 Debu TRIPATHY~2 Eugene P FRENKEL~(2,5) Carlos R BECERRA~4 ~2Harold C.Simmons Cancer Center,Division of Hematology-Oncology,Department of Medicine,University of Texas Southwestern Medical Centel.Dallas,Texas 75390,USA ~3Laboratory of Cell Senescence,Shantou University Medical College,Shantou 515041,China ~4Sammons Cancer Center,Baylor University Medical Center,TOPA-US Oncology,Dallas,Texas 75246,USA Division of Hematology-Oncology Department of Medicine Harold C. Simmons Cancer Center University of Texas Southwestern Medical Center Dallas USA Laboratory of Cell Senescence Shantou University Medical College Shantou China Sammons Cancer Center Baylor University Medical Center TOPA-US Oncology Dallas USA

Aim:Clinical treatment of solid tumors with docetaxel,flavopiridol,or 5-fluorou-racil(5-FU)often encounters undesirable side effects and drug *** aims to evaluate the potential role of combination therapy with docetaxel,flavopiridol,or 5-FU in modulating chemosensitivity and better understand howthey might be used ***:HCT116 colon cancer cells were treatedwith docetaxel,flavopiridol,and 5-FU in several different administrative sche-dules in vitro,either sequentially or *** survival was measuredby MTT *** activity of caspase-3 was determined by caspase-3 assaysand the soft agar colony assay was used to test the colony formation of HCT116cells in soft *** also established xenograft models to extend in vitro obser-vations to an in vivo ***:The maximum cytotoxicity was found whenhuman colon cancer HCT116 cells were treated with docetaxel for 1 h followed byflavopiridol for 24 h and 5-FU for another 24 *** sequential combinationtherapy not only inhibits tumor cell growth more strongly compared to othercombination therapies but also significantly reduces colony formation in soft agarand augments apoptosis of HCT116 *** of docetaxel followed 1 hlater by flavopiridol,followed 24 h later by 5-FU in xenograft models,also resultedin delayed tumor growth and higher survival ***:These resultshighlight the importance of an administrative schedule when combining docetaxelwith flavopiridol and 5-FU,providing a rationale explanation for its developmentin clinical trials.

关键词： combination drug therapy docetaxel flavopiridol fluorouracil colonic neoplasms

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Azithromycin-containing versus standard triple therapy for Helicobacter pylori eradication:A meta-analysis

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World Journal of Gastroenterology 2009年第48期15卷 6102-6110页

作者： Jie Dong Xiao-Feng Yu Jian Zou Deoartment of Gastroenterology Huadong Hospital Fudan University Shanghai 200040 China

AIM： To evaluate whether adding azithromycin to firstline Helicobacter pylori （H pylorl） eradication improved eradication and reduced side effects. METHODS： Eligible articles were identified by searches of electronic databases. We included all randomized trials that compared azithromycin-containing with standard triple-therapy regimens for first-line treatment of H pylori infection. Statistical analysis was performed with Review Manager 5.0.10. Sub-analyses were also performed. RESULTS： We identified 14 randomized trials （1431 patients）. Pooled Hpylori eradication rates were 72.01% （95% CI： 58.09%-85.93%） and 69.78% （95% CI： 66.47%-73.09%） for patients with or without azithromycin by intention-to-treat analysis, and the odds ratio （OR） was 1.17 （95% CI： 0.64-2.14）. The occurrence of side effects differed significantly and was 15.81% （95% CI： 12.50%-19.12%） and 25.20% （95% CI： 21.44%-28.96%） for treatment with or without azithromycin, respectively, and the summary OR was 0.58 （95% CI： 0.41-0.82）. Furthermore, the azithromycin-containing group had a lower occurrence of diarrhea, nausea and taste disturbance. CONCLUSION： Our review suggests that azithromycincontaining triple-therapy regimens could be equally effective in eradication of Hpylori compared with standard first-line triple-therapy regimens.

关键词： Azithromycin He/icobacter pylori combination drug therapy Adverse effects

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Immunotherapy for recurrent hepatocellular carcinoma

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World Journal of Gastroenterology 2023年第15期29卷 2261-2271页

作者： Ahan Bhatt Jennifer Wu Division of Hematology and Oncology Perlmutter Cancer Center of NYU Langone HealthNYU School of MedicineNew YorkNY 10016United States

Hepatocellular carcinoma(HCC)is presented frequently in late stages that are not amenable for curative *** for patients who can undergo resection for curative treatment of HCC,up to 50%*** patients who were not exposed to systemic therapy prior to recurrence,recurrence frequently cannot be subjected to curative therapy or local *** patients have several options of immunotherapy(IO).This includes programmed cell death protein 1(PD-1)and cytotoxic T-lymphocyte associated protein 4 treatment,combination of PD-1 and vascular endothelial growth factor inhibitor or single agent PD-1 therapy when all other options are deemed *** are also investigational therapies in this area that explore either PD-1 and tyrosine kinase inhibitors or a novel agent in addition to PD-1 with vascular endothelial growth factor *** minireview explored IO options for patients with recurrent HCC who were not exposed to systemic therapy at the initial *** also discussed potential IO options for patients with recurrent HCC who were exposed to first-line therapy with curative intent at diagnosis.

关键词： Liver neoplasms Immune checkpoint blockade combination drug therapy PD-1-PD-L1 blockade CTLA-4 inhibitor

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Standard triple therapy for Helicobacter pylori infection in China: A meta-analysis

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World Journal of Gastroenterology 2014年第40期20卷 14973-14985页

作者： Ben Wang Zhi-Fa Lv You-Hua Wang Hui Wang Xiao-Qun Liu Yong Xie Xiao-Jiang Zhou Department of Gastroenterology The First Affiliated Hospital of Nanchang University

AIM: To assess the efficacy and safety of standard triple therapy compared with other pre-existing and new therapies in China.

关键词： Helicobacter pylori Eradication combination drug therapy Amoxicillin Clarithromycin Adverse effects Meta-analysis

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Patient Characteristics, Safety, and Tolerability With Telaprevir Treatment for HCV in the Clinic:a Retrospective, Multicenter Study

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Journal of Clinical and Translational Hepatology 2014年第2期2卷 65-73页

作者： Steven L. Flamm Paul J. Pockros Leif Bengtsson Mark Friedman Northwestern University Feinberg School of Medicine Chicago Illinois USA Scripps Clinic and Scripps Translational Science Institute La Jolla California USA Vertex Pharmaceuticals Incorporated Boston Massachusetts USA

Background and Aims: There is a paucity of information regarding similarities and differences between patients from the phase 3 studies of telaprevir and those receiving telaprevir in clinical practice. Methods: This retrospective chart review evaluated baseline characteristics and follow-up safety and tolerability data for patients with hepatitis C virus (HCV) infection treated with telaprevir and peginterferon alfa and ribavirin (PR) in clinical practice. Results: In total, 338 charts from patients at four academic and three community US treatment centers who received telaprevir and PR and had at least 12 weeks of follow-up data were included;62%were from academic centers and 38% were from community centers. Of the 338 patients, 269 completed 12 weeks of telaprevir and PR;32 discontinued due to adverse events. Mean age was 55 years;patients were predominantly white (79.3%) males (58.9%) with genotype 1a HCV infection (61.8%);35.5%were reported to have cirrhosis at baseline;and 55.3%previously received PR. Hypertension and depres-sion were the most common comorbidities. Patient charac-teristics outside the per-protocol minimum criteria used in the phase 3 studies of telaprevir were, e.g., hemoglobin, 9.2%;albumin, 5.3%;platelets, 11.5%;and neutrophil count, 5.6%. Adverse events occurred in 329/338 (97.3%) patients, with anemia, fatigue, nausea, and rash being the most common. Of 38 hospitalizations, 26 were deemed related to telaprevir and PR. Three patients died due to pneumonia, septic shock, and hepatorenal syndrome (n=1 each). Conclusions: These findings complement those reported from rigorous, randomized controlled studies with telaprevir-based treatment and provide a general assess-ment of similarities and/or differences between patients from the phase 3 studies of telaprevir and those treated with telaprevir in clinical practice.

关键词： Hepatitis C virus combination drug therapy Protease inhibitors Liver diseases

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