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Pemetrexed for previously treated patients with metastatic gastric cancer: a prospective phase II study.

ABSTRACT: Gastric cancer is one of the leading causes of cancer-related death worldwide. There were debates on the value of the second-line and beyond chemotherapy by the time we designed this trial. So we designed this phase II trial to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.Thirty-four patients with pretreated metastatic gastric cancer were enroled in the study. Patients received pemetrexed 500?mg?m(-2) every 21 days until the presence of progressive disease (PD) or unacceptable toxicity.A total of 34 patients were enroled in the study; 34 were eligible for toxicity and 30 for response. The response rate was 13.3%, 13.3% patients achieved a partial response, 50.0% achieved stable disease and 36.7% had a PD as the best response. The median overall survival time and median progression-free survival time was 6.4 months (95% confidence interval (CI) 5.8-9.5 months) and 2.2 months (95% CI 2.0-5.5 months), respectively. Most haematologic and non-haematologic toxicity were grade 1/2. Grade 3/4 toxicity included fatigue, neutropenia, thrombocytopenia, weight loss, anorexia and transaminase elevation.The monochemotherapy of pemetrexed is active and well tolerated when used in previously treated patients with metastatic gastric cancer.

SUBMITTER: Zhang DS

PROVIDER: S-EPMC4453460 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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Pemetrexed for previously treated patients with metastatic gastric cancer: a prospective phase II study.

Zhang D S DS Jin Y Y Luo H Y HY Wang Z Q ZQ Qiu M Z MZ Wang F H FH Li Y H YH Xu R H RH

British journal of cancer 20141204 2

<h4>Background</h4>Gastric cancer is one of the leading causes of cancer-related death worldwide. There were debates on the value of the second-line and beyond chemotherapy by the time we designed this trial. So we designed this phase II trial to assess the efficacy and safety of pemetrexed in patients with pretreated metastatic gastric cancer.<h4>Methods</h4>Thirty-four patients with pretreated metastatic gastric cancer were enroled in the study. Patients received pemetrexed 500 mg m(-2) every ...[more]

PMID: 25474247

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Project description:BackgroundPatients with advanced sarcomas have a poor prognosis and few treatment options that improve overall survival. We assessed the efficacy and tolerability of pemetrexed and cisplatin combination therapy in patients with refractory bone and soft tissue sarcoma (STS).Patients and methodsPatients were included in this multicenter, phase II study (ClinicalTrials.gov identifier NCT03809637) if they progressed after receiving one or more chemotherapy regimens containing an anthracycline and/or ifosfamide. Pemetrexed was first administered intravenously, followed by cisplatin, over a cycle of 21 days, for a maximum of six cycles. The primary endpoint was a progression-free rate (PFR) at 3 months (3-month PFR).ResultsFrom January 2017 to September 2019, we enrolled 37 patients; of these, 73% had previously undergone three or more rounds of chemotherapy. Five patients (13.5%) exhibited objective responses, including two patients (2/6, 33.3%) with malignant peripheral nerve sheath tumors, one patient (1/4, 25%) with synovial sarcoma, one patient (1/4, 25%) with undifferentiated pleomorphic sarcoma, and one patient (1/4, 25%) with angiosarcoma. The median progression-free survival was 2.6 months, and the 3-month PFR was 45.9% (n = 17). None of the four patients with osteosarcoma exhibited objective responses or were progression free at 3 months. The most frequent treatment-related grade 3-4 toxicities included neutropenia (16.2%), anemia (13.5%), thrombocytopenia (13.5%), and fatigue (8.1%). Among 26 patients (70.3%) available for immunohistochemical assessments, patients in the low-excision repair cross-complementation group 1 (ERCC1) and low-thymidylate synthase expression groups showed a tendency for longer overall survival.ConclusionsCombination therapy with pemetrexed and cisplatin was associated with clinically meaningful and sustained responses among patients with advanced and refractory STS. The combination therapy met its predefined primary study endpoint.

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Pemetrexed for previously treated patients with metastatic gastric cancer: a prospective phase II study.

Publications

Pemetrexed for previously treated patients with metastatic gastric cancer: a prospective phase II study.

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