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Lu S.,Shanghai JiaoTong University | Cheng Y.,Jilin Provincial Cancer Hospital | Zhou C.-C.,Tongji University | Wang J.,Peking University | And 6 more authors.
Clinical Lung Cancer | Year: 2016

Background: Pemetrexed plus platinum has become a standard of care in first-line treatment for patients with advanced nonsquamous non-small-cell lung cancer. However, elderly lung cancer patients are generally understudied and undertreated in clinical practice in East Asia because of safety concerns. This analysis aimed to provide a picture of the clinical benefit of pemetrexed/platinum in the first-line setting for elderly (age ≥ 65 years) East Asian patients. Patients and Methods: Individual patient data from 3 randomized controlled phase 3 trials that enrolled East Asian patients were analyzed in this meta-analysis. Results: In elderly East Asian patients (63 in the pemetrexed/platinum group and 42 in the control group), pemetrexed/platinum treatment achieved more benefits compared to other platinum-based doublets, including better overall response rate (32.8% vs. 7.5%), favorable progression-free survival (not statistically significant in adjusted hazard ratio), and significantly longer (3.15 vs. 1.54 months) survival without drug-related grade 3/4 toxicity. Overall survival was numerically prolonged (16.33 vs. 13.77 months; not statistically significant). These benefit trends were similar to those in all-age East Asian patients. In elderly East Asians, pemetrexed/platinum treatment was also associated with a lower incidence rate of drug-related grade 3/4 adverse events. The adverse event profile was similar to that in all-age East Asians. There were no unexpected adverse events. Conclusion: Pemetrexed/platinum had good efficacy and also resulted in better overall response and tolerability than other platinum-based doublets as first-line treatment in nonsquamous non-small cell lung cancer in elderly East Asians, which was consistent with data observed in all-age East Asians. © 2016 The Authors.

Zhou Q.,Guangdong General Hospital and Guangdong Academy of Medical science | Cheng Y.,Jilin Provincial Cancer Hospital | Yang J.-J.,Guangdong General Hospital and Guangdong Academy of Medical science | Zhao M.-F.,Shenyang University | And 13 more authors.
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO | Year: 2014

BACKGROUND: CTONG0806 assessed the efficacy of pemetrexed versus gefitinib as second-line treatment in advanced nonsquamous nonsmall-cell lung cancer (NSCLC) harboring wild-type epidermal growth factor receptor (EGFR).PATIENTS AND METHODS: Patients with locally advanced or metastatic nonsquamous NSCLC harboring wild-type EGFR, detected by direct sequencing, and previously treated with platinum-based chemotherapy were randomized to receive gefitinib (250 mg/day) orally or pemetrexed (500 mg/m(2)) i.v. on day 1 of a 21-day cycle until disease progression or unacceptable toxicity. The primary end point was progression-free survival (PFS). The Independent Review Committee (IRC) evaluated all pictorial data.RESULTS: From February 2009 to August 2012, 161 patients were enrolled, and 157 were assessable (81 in the gefitinib arm, 76 in the pemetrexed arm). Baseline characteristics were balanced between the two arms. The median PFSs were 4.8 versus 1.6 months in the pemetrexed and gefitinib arms, respectively [hazard ratio (HR) 0.54, 95% confidence interval (CI) 0.40-0.75, P < 0.001] as confirmed by IRC evaluation (5.6versus 1.7 months, HR 0.53, 95% CI 0.38-0.75, P < 0.001). The median overall survival (OS) showed a trend of superiority in the pemetrexed arm (12.4 versus 9.6 months, HR 0.72, 95% CI 0.49-1.04, P = 0.077). Quality-of-life assessment showed no marked difference between the arms. No unexpected adverse events were found. Of 108 patients with sufficient DNA samples, EGFR mutation status was re-tested by Scorpion amplification refractory mutation system (ARMS); 32 (29.6%) tested positive (19 in the pemetrexed arm, 13 in the gefitinib arm; median PFS: 8.1 versus 7.0 months, HR 0.94, 95% CI 0.43-2.08, P = 0.877).CONCLUSIONS: CTONG0806 is the first trial to show significant improvement in PFS and an improved OS trend with pemetrexed compared with gefitinib as second-line setting treatment of EGFR wild-type advanced nonsquamous NSCLC. ARMS is superior to direct sequencing in excluding false-negative patients.CLINICALTRIALSGOV IDENTIFIER: NCT00891579. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Wang J.,Jilin University | Liu S.,Jilin University | Li H.,Jilin Provincial Cancer Hospital | Sun J.,Jilin University | And 5 more authors.
International Urology and Nephrology | Year: 2015

This article reviews the available rodent models of peritoneal dialysis (PD) that have been developed over the past 20 years and the complications associated with their use. Although there are several methods used in different studies, the focus of this article is not to review or provide detailed summaries of these methods. Rather, this article reviews the most common methods of establishing a dialysis model in rodents, the assays used to observe function of the peritoneum in dialysis, and how these models are adapted to study peritonitis and peritoneal fibrosis. We compared the advantages and disadvantages of different methods, which should be helpful in studies of PD and may provide valuable data for further clinical studies. © 2014, Springer Science+Business Media Dordrecht.

Qin S.,Cancer Center | Bi F.,University of Sichuan | Jin J.,Peking University | Cheng Y.,Jilin Provincial Cancer Hospital | And 8 more authors.
OncoTargets and Therapy | Year: 2015

Background: This registrational trial evaluated the efficacy, safety, and patient-reported outcomes of axitinib versus sorafenib as a second-line treatment in Asian patients with clear-cell metastatic renal cell carcinoma (mRCC). Methods: In this open-label, multicenter study, previously treated Asian patients with clear-cell mRCC were stratified by Eastern Cooperative Oncology Group performance status and prior therapy and randomized in a 2:1 ratio to receive axitinib (5 mg twice daily) or sorafenib (400 mg twice daily). The primary end point was progression-free survival (PFS) assessed by a masked independent review committee. Results: A total of 204 Asian patients received axitinib (n=135) or sorafenib (n=69). Median PFS (95% confidence interval [CI]) was 6.5 (4.7–9.1) months with axitinib versus 4.8 (3.0–6.5) months with sorafenib (hazard ratio, 0.731; 95% CI, 0.506–1.058; one-sided P=0.0531). The objective response rate (95% CI) was 23.7% (16.8%–31.8%) with axitinib versus 10.1% (4.2%–19.8%) with sorafenib. Common, grade ≥3, all-causality adverse events were hypertension (19.3%), weight decrease (5.2%), and proteinuria (5.2%) with axitinib and hypertension (8.7%) and palmar-plantar erythrodysesthesia (7.2%) with sorafenib. In a time-to-deterioration composite end point of death, progression, and worsening of Functional Assessment of Cancer Therapy Kidney Symptom Index score, patients treated with axitinib demonstrated a 17%–24% risk reduction compared with sorafenib-treated patients. Conclusion: Axitinib is clinically active and well tolerated in previously treated Asian patients with mRCC, consistent with the results from the global Phase III trial. These results establish axitinib as a second-line treatment option for Asian patients with mRCC. © 2015, Qin et al.

Gong J.,Peking University | Liu T.,Fudan University | Fan Q.,Zhengzhou University | Bai L.,Chinese Peoples Liberation Army | And 8 more authors.
BMC Cancer | Year: 2016

Background: The ToGA study showed that trastuzumab plus chemotherapy prolonged median survival in patients with human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. Among chemotherapy options, oxaliplatin might be as effective as cisplatin but has shown to be more tolerable. To further improve treatment options for patients with advanced gastric cancer, we initiated a study to evaluate the efficacy and safety of trastuzumab plus oxaliplatin/capecitabine in patients with HER2-positive advanced gastric cancer. Methods: CGOG1001 was an open-label, multicenter, prospective phase II study. Patients with chemotherapy-naive HER2-positive advanced gastric cancer were eligible. Trastuzumab was administered at a loading dose of 8 mg/kg followed by 6 mg/kg infusion every 3 weeks (q3w). Oxaliplatin was administrated as a 130 mg/m2 infusion, q3w, for up to 6 cycles. Capecitabine 1000 mg/m2 was given orally twice daily on days 1-14 followed by a 7-day rest interval. Trastuzumab and capecitabine were continued until disease progression or intolerable toxicity. The primary endpoint was objective response rate. Simon two-stage design (H0 = 40 %, H1 = 60 %, aα = 0.05, β = 0.2) by Response Evaluation Criteria In Solid Tumors 1.0 was applied. Results: Fifty-one patients were enrolled. Confirmed response was recorded in 46 patients. One patient achieved complete response and 33 patients achieved partial response (response rate 34/51 [66.7 %] in the intent-to-treat population). Median follow-up time was 28.6 months, with a median progression-free survival of 9.2 months (95 % confidence interval [CI]: 6.5-11.6) and a median overall survival (OS) of 19.5 months (95 % CI: 15.5-26.0). Patients with a HER2/CEP17 ratio of greater than five achieved improved OS (20.9 vs 19.5 months, p = 0.001). The most common adverse events of grade 3 or above were thrombocytopenia (21.6 %), neutropenia (13.7 %), anemia (5.9 %) and leucopenia (3.9 %). Conclusion: The addition of trastuzumab to oxaliplatin/capecitabine was well tolerated and the results demonstrated encouraging efficacy. Trial registration: ClinicalTrials.gov NCT01364493. © 2016 Gong et al.

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