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RISS 인기검색어
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- 저자 : Mauro Orlando (검색결과 9 건)
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이대호,Vichien Srimuninnimit,Rebecca Cheng,Xin Wang,Mauro Orlando 대한암학회 2015 Cancer Research and Treatment Vol.47 No.4
Advances in oncology research have led to identification of tumor-specific biomarkers, someof which are important predictive indicators and ideal targets for novel therapeutics. Onesuch biomarker in non-small cell lung cancer (NSCLC) is the epidermal growth factor receptor(EGFR). Patients with NSCLC who harbor an activating EGFR mutation show a morefavorable response to treatment with an EGFR inhibitor, such as gefitinib, erlotinib, or afatinib,than to chemotherapy. The prevalence of EGFR mutations in East Asian patients ishigher than that in other populations, and in some clinical settings, patients have beentreated with EGFR inhibitors based on clinicopathologic characteristics with no informationon EGFR status. However, based on results from a series of studies in which East Asianpatients with advanced non-squamous NSCLC were treated with EGFR inhibitors alone orin combination with standard chemotherapy, this may not be the best practice becauseEGFRmutation status was found to be a key predictor of outcome. Data from these studieshighlight the necessity of EGFR testing in determining the most suitable treatment forpatients with advanced or metastatic NSCLC.
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이대호,이정신,Jie Wang,Te-Chun Hsia,김종석,Mauro Orlando 대한암학회 2015 Cancer Research and Treatment Vol.47 No.4
Purpose This subgroup analysis of a phase II trial was conducted to assess possible ethnicity-basedtrends in efficacy and safety in East Asian (EA) and non-EA populations with nonsquamousnon-small cell lung cancer (NSCLC). Materials and MethodsNever-smoker patients (n=240) with locally advanced or metastatic nonsquamous NSCLCincluded 133 EA patients randomized to pemetrexed supplemented with dexamethasone,folic acid, and vitamin B12 plus erlotinib (pemetrexed-erlotinib) (n=41), erlotinib (n=49), orpemetrexed (n=43), and 107 non-EA patients randomized to pemetrexed-erlotinib (n=37),erlotinib (n=33), or pemetrexed (n=37). The primary endpoint, progression-free survival(PFS), was analyzed using a multivariate Cox model. ResultsConsistent with the results of the overall study, a statistically significant difference in PFSamong the three arms was noted in the EA population favoring pemetrexed-erlotinib (overallp=0.003) as compared with either single-agent arm (hazard ratio [HR], 0.48; 95%confidence interval [CI], 0.29 to 0.79; p=0.004 vs. erlotinib; HR, 0.40; 95% CI, 0.23 to 0.70;p=0.001 vs. pemetrexed). The EA patients treated with pemetrexed-erlotinib achieved alonger median PFS (7.4 months) compared with erlotinib (4.5 months) and pemetrexed(4.0 months). The PFS results also numerically favored pemetrexed-erlotinib in the non-EApopulation (overall p=0.210) (HR, 0.62; 95% CI, 0.37 to 1.05; p=0.078 vs. erlotinib; HR,0.75; 95% CI, 0.42 to 1.32; p=0.320 vs. pemetrexed) (median PFS: pemetrexed-erlotinib,6.7 months; erlotinib, 3.0 months; pemetrexed, 4.4 months). ConclusionThe PFS results from this subset analysis in both EA and non-EA populations are consistentwith the results in the overall population. The PFS advantage for pemetrexed-erlotinib issignificant compared with the single agents in EA patients.
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Gemcitabine Plus Cisplatin for Advanced Biliary Tract Cancer: A Systematic Review
박준오,오도연,Chiun Hsu,Jen-Shi Chen,Li-Tzong Chen,Mauro Orlando,김종석,임호영 대한암학회 2015 Cancer Research and Treatment Vol.47 No.3
Evidence suggests that combined gemcitabine-cisplatin chemotherapy extends survival in patients with advanced biliary tract cancer (BTC). We conducted a systematic review in order to collate this evidence and assess whether gemcitabine-cisplatin efficacy is influenced by primary tumor site, disease stage, or geographic region, and whether associated toxicities are related to regimen. MEDLINE (1946-search date), EMBASE (1966-search date), ClinicalTrials. gov (2008-search date), and abstracts from major oncology conferences (2009- search date) were searched (5 Dec 2013) using terms for BTC, gemcitabine, and cisplatin. All study types reporting efficacy (survival, response rates) or safety (toxicities) outcomes of gemcitabine-cisplatin in BTC were eligible for inclusion; efficacy data were extracted from prospective studies only. Evidence retrieved from one meta-analysis (abstract), four randomized controlled trials, 12 nonrandomized prospective studies, and three retrospective studies supported the efficacy and safety of gemcitabine-cisplatin for BTC. Median overall survival ranged from 4.6 to 11.7 months, and response rate ranged from 17.1% to 36.6%. Toxicities were generally acceptable and manageable. Heterogeneity in study designs and data collected prevented formal meta-analysis, however exploratory assessments suggested that efficacy did not vary with primary tumor site (gallbladder vs. others), disease stage (metastatic vs. locally advanced), or geographic origin (Asia vs. other). Incidence of grade 3/4 toxicities was not related to gemcitabine dose or cisplatin frequency. Despite individual variation in study designs, the evidence presented suggests that gemcitabine-cisplatin is effective in patients from a diverse range of countries and with heterogeneous disease characteristics. No substantial differences in toxicity were observed among the different dosing schedules of gemcitabine and cisplatin.
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강진형,안명주,김동완,조은경,김주항,신상원,Xin Wang,김종숙,Mauro Orlando,박근칠 대한암학회 2016 Cancer Research and Treatment Vol.48 No.2
Purpose We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexedcisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status. Materials and Methods Patients, who were ! 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment- emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials. gov, NCT01017874. Results Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ! 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFRmutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients. Conclusion Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.
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James Chin-Hsin Yang,안명주,Kazuhiko Nakagawa,Tomohide Tamura,Helen Barraclough,Sotaro Enatsu,Rebecca Cheng,Mauro Orlando 대한암학회 2015 Cancer Research and Treatment Vol.47 No.3
Purpose A recent phase III study (PARAMOUNT) demonstrated that pemetrexed continuation maintenance therapy is a new treatment paradigm for advanced nonsquamous non-small cell lung cancer (NSCLC). The majority of patients enrolled in PARAMOUNT were Caucasian (94%). We reviewed efficacy and safety data from two clinical trials, which enrolled East Asian (EA) patients, to supplement data from PARAMOUNT on pemetrexed continuation maintenance therapy in patients with nonsquamous NSCLC. Materials and Methods Study S110 was a phase II, multicenter, randomized, controlled, open-label trial in never-smoker, chemonaïve, EA patients (n=31) with locally advanced or metastatic nonsquamous NSCLC (n=27). Study JMII was a multicenter, open-label, single-arm, postmarketing, clinical trial in Japanese patients (n=109) with advanced nonsquamous NSCLC. PARAMOUNT was a multicenter, randomized, double-blind, placebo-controlled trial in patients with advanced nonsquamous NSCLC. Results In EA patients with nonsquamous NSCLC, the median progression-free survival (PFS) for pemetrexed continuation maintenance therapy was 4.04 months (95% confidence interval [CI], 3.22 to 5.29 months) in study S110 and 3.9 months (95% CI, 3.2 to 5.2 months) in study JMII. The median PFS for pemetrexed continuation maintenance therapy in PARAMOUNT was 4.1 months (95% CI, 3.2 to 4.6 months). Pemetrexed continuation maintenance therapy in EA patients in studies S110 and JMII did not lead to any unexpected safety events, and was consistent with PARAMOUNT’s safety profile. Conclusion The efficacy and safety data in the EA trials were similar to those in PARAMOUNT despite differences in patient populations and study designs. These data represent consistent evidence for pemetrexed continuation maintenance therapy in EA patients with advanced nonsquamous NSCLC.
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박근칠,조은경,Maximino Bello,안명주,Sumitra Thongprasert,송은기,Victoria Soldatenkova,Henrik Depenbrock,Tarun Puri,Mauro Orlando 대한암학회 2017 Cancer Research and Treatment Vol.49 No.4
Purpose The phase 3 randomized SQUIRE study revealed significantly longer overall survival (OS) and progression-free survival (PFS) for necitumumab plus gemcitabine and cisplatin (neci+GC) than for gemcitabine and cisplatin alone (GC) in 1,093 patients with previously untreated advanced squamous non-small cell lung cancer (NSCLC). This post hoc subgroup analysis assessed the efficacy and safety of neci+GC among East Asian (EA) patients enrolled in the study. Materials and Methods All patients received up to six 3-week cycles of gemcitabine (days 1 and 8, 1,250 mg/m) and cisplatin (day 1, 75 mg/m). Patients in the neci+GC arm also received necitumumab (days 1 and 8, 800 mg) until disease progression or unacceptable toxicity. Hazard ratios (HRs) and 95% confidence intervals (CIs) were estimated from stratified Cox proportional hazards models. Results In EA patients, there were improvements for neci+GC (n=43) versus GC (n=41) in OS (HR, 0.805; 95% CI, 0.484 to 1.341) and PFS (HR, 0.720; 95% CI, 0.439 to 1.180), consistent with the results for non-EA patients observed in the present study. The overall safety data were consistent between EA and non-EA patients. A numerically higher proportion of patients experienced serious adverse events (AEs), grade 3 AEs, and AEs with an outcome of death for neci+GC versus GC in EA patients and EA patients versus non-EA patients for neci+GC. Conclusion Although limited by the small sample size and post hoc nature of the analysis, these findings are consistent with those of the overall study and suggest that neci+GC offers a survival advantage and favorable benefit/risk for EA patients with advanced squamous NSCLC.
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박근칠,김주항,조은경,강진형,Jin-Yuan Shih,Annamaria Hayden Zimmermann,Pablo Lee,Ekaterine Alexandris,Tarun Puri,Mauro Orlando 대한암학회 2016 Cancer Research and Treatment Vol.48 No.4
Purpose REVEL demonstrated improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) with docetaxel+ramucirumab versus docetaxel+placebo in 1,253 intent-to-treat (ITT) stage IV non-small cell lung cancer patients with disease progression following platinum-based chemotherapy. Results from the East Asian subgroup analysis are reported. Materials and Methods Subgroup analyses were performed in the East Asian ITT population (n=89). Kaplan-Meier analysis and Cox proportional hazards regression were performed for OS and PFS, and the Cochran-Mantel-Haenszel test was performed for response rate. Results In docetaxel+ramucirumab (n=43) versus docetaxel+placebo (n=46), median OS was 15.44 months versus 10.17 months (hazard ratio [HR], 0.762; 95% confidence interval [CI], 0.444 to 1.307), median PFS was 4.88 months versus 2.79 months (HR, 0.658; 95% CI, 0.408 to 1.060), and ORR was 25.6% (95% CI, 13.5 to 41.2) versus 8.7% (95% CI, 2.4 to 20.8). Due to increased incidence of neutropenia and febrile neutropenia in East Asian patients, starting dose of docetaxel was reduced for newly enrolled East Asian patients (75 to 60 mg/m2, n=24). In docetaxel+ramucirumab versus docetaxel+placebo, incidence of neutropenia was 84.4% versus 72.7% (75 mg/m2) and 54.5% versus 38.5% (60 mg/m2). Incidence of febrile neutropenia was 43.8% versus 12.1% (75 mg/m2) and 0% versus 7.7% (60 mg/m2). Conclusion Results of this subgroup analysis showed a trend favoring ramucirumab+docetaxel for median OS, PFS, and improved ORR in East Asian patients, consistent with ITT population results. Reduction of starting dose of docetaxel in East Asian patients was associated with improved safety.
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Li-Tzong Chen,오도연,류민희,Kun-Huei Yeh,Winnie Yeo,Roberto Carlesi,Rebecca Cheng,김종석,Mauro Orlando,강윤구 대한암학회 2017 Cancer Research and Treatment Vol.49 No.4
Despite advancements in therapy for advanced gastric and gastroesophageal junction cancers, their prognosis remains dismal. Tumor angiogenesis plays a key role in cancer growth and metastasis, and recent studies indicate that pharmacologic blockade of angiogenesis is a promising approach to therapy. In this systematic review, we summarize current literature on the clinical benefit of anti-angiogenic agents in advanced gastric cancer. We conducted a systematic search of PubMed and conference proceedings including the American Society of Clinical Oncology, the European Society for Medical Oncology, and the European Cancer Congress. Included studies aimed to prospectively evaluate the efficacy and safety of anti-angiogenic agents in advanced gastric or gastroesophageal junction cancer. Each trial investigated at least one of the following endpoints: overall survival, progression-free survival/time to progression, and/or objective response rate. Our search yielded 139 publications. Forty-two met the predefined inclusion criteria. Included studies reported outcomes with apatinib, axitinib, bevacizumab, orantinib, pazopanib, ramucirumab, regorafenib, sorafenib, sunitinib, telatinib, and vandetanib. Second-line therapy with ramucirumab and third-line therapy with apatinib are the only anti-angiogenic agents so far shown to significantly improve survival of patients with advanced gastric cancer. Overall, agents that specifically target the vascular endothelial growth factor ligand or receptor have better safety profile compared to multi-target tyrosine kinase inhibitors.
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