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Recombined humanized endostatin (Endostar) intravenous infusion in the treatment of refractory nasopharyngeal carcinoma: Three case reports.

ABSTRACT: RATIONALE:Refractory nasopharyngeal carcinoma is challenging to treat and at present there is no standard treatment or any good choice. PATIENT CONCERNS:Although the three patients in our case reports had already underwent multiple treatments before, they still suffered from disease recurrence of nasopharyngeal carcinoma. DIAGNOSIS:They were diagnosed as refractory nasopharyngeal carcinoma. INTERVENTIONS:A continuous infusion of Endostar, an antiangiogenic agent, combined with chemotherapy and radiation therapy was given to treat the patients. OUTCOMES:Patients showed complete or partial response to the combined therapy as evidenced by regression of tumors and decrease in plasma Epstein-Barr virus (EBV) DNA load. LESSONS:Continuous infusions of Endostar in combination with chemotherapy and/or radiation therapy showed promising efficacy and safety. The combination therapy indicates a new approach to treat refractory nasopharyngeal carcinoma.

SUBMITTER: Chen C

PROVIDER: S-EPMC6709293 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Recombined humanized endostatin (Endostar) intravenous infusion in the treatment of refractory nasopharyngeal carcinoma: Three case reports.

Chen Chen C Liu Song-Ran SR Zhou Shu S Li Xiao-Hui XH Wang Xiao-Hui XH Tao Ya-Lan YL Chang Hui H Zhang Wen-Wen WW Li Wen-Fei WF Zhou Si-Lang SL Xia Yun-Fei YF

Medicine 20190801 32

<h4>Rationale</h4>Refractory nasopharyngeal carcinoma is challenging to treat and at present there is no standard treatment or any good choice.<h4>Patient concerns</h4>Although the three patients in our case reports had already underwent multiple treatments before, they still suffered from disease recurrence of nasopharyngeal carcinoma.<h4>Diagnosis</h4>They were diagnosed as refractory nasopharyngeal carcinoma.<h4>Interventions</h4>A continuous infusion of Endostar, an antiangiogenic agent, com ...[more]

PMID: 31393358

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Project description:BACKGROUND:Both intermittent intravenous (IIV) infusion and continuous intravenous (CIV) infusion of Endostar are widely used for NSCLC in China. We aimed to compare the efficacy and safety of CIV of Endostar versus IIV in combination with first-line chemotherapy for patients with advanced NSCLC. METHODS:RCTs, NRCTs and cohort studies which compared CIV of Endostar with IIV in advanced NSCLC patients and reported efficacy or safety outcomes were eligible. Two reviewers independently screened records, extracted data and assessed risk of bias. Pooled risk ratios (RRs) with 95% confidence intervals were calculated using random effects meta-analysis for short-term efficacy and safety outcomes, and hazard ratios (HRs) for survival outcomes. RESULTS:Finally nine studies involving 597 patients were included, containing two RCTs, three NRCTs and four cohort studies. For short-term efficacy, moderate quality of evidence showed that there were no significant differences between CIV of Endostar and IIV in objective response rate (ORR; RR 1.34, 95% CI 0.91-1.98, P?=?0.14) and disease control rate (DCR; RR 1.11, 95% CI 0.94-1.30, P?=?0.21). Very low quality of evidence indicated that CIV of Endostar significantly improved both overall survival (OS; HR 0.69, 95% CI 0.48-0.99, P?=?0.046) and progression-free survival (PFS; HR 0.71, 95% CI 0.55-0.93, P?=?0.01) compared with IIV. As for safety outcomes, moderate quality of evidence found that CIV of Endostar significantly reduced the risk of myelosuppression (RR 0.55, 95% CI 0.32-0.96, P?=?0.03) and cardiovascular toxicity (RR 0.21, 95% CI 0.06-0.78, P?=?0.02) compared with IIV. CONCLUSIONS:In advanced NSCLC, compared with IIV, CIV of Endostar had similar short-term efficacy, and substantially lower risk of myelosuppression and cardiovascular toxicity. Although very low quality of evidence supported the survival benefit of CIV compared with IIV, large RCTs with long-term follow-up are needed to demonstrate survival benefits. Caution should be given for off-label use of CIV of Endostar.

Project description:Background DFP-10917 is a cytotoxic deoxycytidine analogue that causes DNA fragmentation, G2/M-phase arrest, and apoptosis. This agent has been shown to have antitumor activity against colorectal cancer (CRC) in preclinical studies and to be tolerable in patients. The purpose of our phase II trial was to evaluate the safety, efficacy and pharmacogenomics of DFP-10917 as well as DNA damage studies in patients with advanced CRC refractory to cytotoxic chemotherapy. Methods In this single-arm, Simon two-stage, phase II trial, patients with chemotherapy-refractory advanced CRC received 2.0 mg/m2/day DFP-10917 via 14-day continuous infusion. Enrollment criteria included age ? 18 years, Eastern Cooperative Oncology Group status of 0 or 1, and adequate organ function. The primary endpoint was 3-month progression-free survival, defined as the proportion of patients who did not have progressive disease or death within 3 months of starting therapy. All patients who received any amount of DFP-10917 were included in the safety analysis. DNA damage study was assessed by comet assay. Results Of 28 patients initially enrolled, 26 received DFP-10917. Three patients (12%) were progression free at 3 months. The median progression-free survival was 1.3 months (95% confidence interval, 1.3-1.6 months). There were no complete or partial responses. Most patients (n?=?20, 77%) had progressive disease, and only six (23%) had stable disease at any time. The trial was terminated according to the pre-planned stopping rule. The most frequent (?5%) medication-related grade 3 or higher adverse events were neutropenia (n?=?10, 38%), fatigue (n?=?4, 15%), anemia (n?=?3, 12%), and leukopenia (n?=?3, 12%). DNA strand-breaks were detected after infusion (medians of % tail intensity were 2.89 and 12.64 on day 1 and day 15, respectively, p?<?0.001, sign test). Conclusion Overall, single-agent DFP-10917 did not show meaningful antitumor activity in chemotherapy-refractory advanced CRC. The safety profile of DFP-10917 was tolerable and similar to that observed in earlier clinical studies.

Dataset Information

Recombined humanized endostatin (Endostar) intravenous infusion in the treatment of refractory nasopharyngeal carcinoma: Three case reports.

Publications

Recombined humanized endostatin (Endostar) intravenous infusion in the treatment of refractory nasopharyngeal carcinoma: Three case reports.

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