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Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: a single institute experience.

ABSTRACT: Nimotuzumab is a humanized anti-EGFR IgG1 monoclonal antibody and demonstrates a better safety profile than other anti-EGFR antibodies due to its intermediate affinity. Since it was approved in China for the treatment of nasopharyngeal cancer (NPC), it has been widely used in NPC and in many clinical trials for other cancer types. However, the optimal dose and administration frequency of nimotuzumab that should be used and which kind of cancer patients will be more benefited from nimotuzumab is still unknown. In this retrospective study, 205 advanced cancer patients with colorectal cancer, esophageal cancer, head and neck cancer, gastric cancer, non-small cell lung cancer, or other cancers from mainland China, treated with nimotuzumab in combination with chemotherapy, were enrolled. Over 60% of these patients received nimotuzumab > 6 doses and ? 400 mg/week as maintenance therapy. It was well tolerated in real-life patients. This report demonstrates that age, sex and previous treatment might be potential predictive factors for survival, and patients received nimotuzumab > 6 doses and > 200 mg/week might benefit more from nimotuzumab therapy. Using these factors for stratification analysis may form a predictive differential clinical strategy for nimotuzumab to maximize the benefit in patients with different epithelial tumors.

SUBMITTER: Xu S

PROVIDER: S-EPMC5078104 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: a single institute experience.

Xu Shuping S Ramos-Suzarte Mayra M Bai Xianhong X Xu Binghe B

Oncotarget 20160501 22

Nimotuzumab is a humanized anti-EGFR IgG1 monoclonal antibody and demonstrates a better safety profile than other anti-EGFR antibodies due to its intermediate affinity. Since it was approved in China for the treatment of nasopharyngeal cancer (NPC), it has been widely used in NPC and in many clinical trials for other cancer types. However, the optimal dose and administration frequency of nimotuzumab that should be used and which kind of cancer patients will be more benefited from nimotuzumab is ...[more]

PMID: 27050148

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Project description:ObjectivesImmunotherapy plus chemotherapy has recently been applied in the neoadjuvant treatment for locally advanced gastric cancer (LAGC), while its superiority over neoadjuvant chemotherapy (NACT) alone remains to be explored. This study explored the safety and efficacy of NACT plus tislelizumab in patients with LAGC.MethodsThe data on patients with LAGC who received NACT combined with radical gastrectomy and NACT plus tislelizumab followed by radical gastrectomy was retrospectively collected. Clinicopathological characteristics of the two groups were compared.ResultsA total of 119 and 50 patients with gastric cancer treated with NACT and NACT plus tislelizumab, respectively, were enrolled. No significant difference was found between the baseline data of the two groups. The operative time (210.5 ± 70.4 min vs. 237.6 ± 68.4 min, P=0.732), intraoperative blood loss (157.8 ± 75.9 ml vs. 149.1 ± 92.5 ml, P=0.609), and number of dissected lymph nodes (24.7 ± 9.3 vs. 28.1 ± 10.3, P=0.195) was not statistically different between the two groups. In comparison to the NACT plus tislelizumab group, the R0 resection rate (100% vs. 89.9%, P=0.019) and pathologic complete response rate (26.0% vs. 3.4%, P<0.001) were significantly lower in the NACT group. The postoperative complication rates were 24.4% and 26.0% in the NACT and NACT plus tislelizumab groups with no significant difference (P=0.823). In subgroup analysis, tumor regression grade (TRG) (TRG 3: 72.3% vs. 23.5%, P<0.001) and ypN stage (stages 2-3: 46.8% vs. 5.9%, P=0.003) in the NACT group were significantly higher compared with the NACT plus tislelizumab group in esophagogastric junction carcinoma.ConclusionCompared with the S-1 and oxaliplatin (SOX) or 5-fluorouracil, folinic acid, and oxaliplatin (FOLFOX) NACT regimen, NACT plus tislelizumab significantly improved the efficacy and R0 resection rate of LAGC without increasing the incidence of perioperative complications, particularly in esophagogastric junction carcinoma.

Project description:Background and objectiveSintilimab has superior efficacy and safety in patients with advanced or metastatic squamous non-small cell lung cancer (NSCLC), but its cost-effectiveness in China is unclear. This study is to evaluate the cost-effectiveness of sintilimab plus chemotherapy vs. pembrolizumab plus chemotherapy for locally advanced or metastatic squamous NSCLC in China.MethodsFrom the perspective of the Chinese health system, the partitioned survival model with three health states was established in a 3-week cycle and a lifetime time horizon. The two-stage method was used to estimate the overall survival hazard ratios to avoid the bias by crossover design in ORIENT-12 and KEYNOTE-407 studies. The anchored matching adjusted indirect comparison method (MAIC) was used for indirect comparison based on the individual patient data from ORIENT-12 and the publicly published KEYNOTE-407 study due to the lack of head-to-head clinical trials. Only direct medical costs were included, and utilities were derived from the published literature in the base case analysis. Sensitivity analysis was also performed to verify the robustness of the model results. In addition, the scenario analysis where the utilities were derived from the Quality of Life Questionnaire-Core 30 (QLQ-C30) scale in the ORIENT-12 by mapping to the EuroQol-5-dimension 5-level (EQ-5D-5L) was carried out to explore the uncertainty of the results.ResultsCompared with pembrolizumab + chemotherapy, sintilimab + chemotherapy incurred a lower lifetime cost ($12,321 vs. 36,371) and yielded fewer quality-adjusted life-years (QALYs) (0.9902 vs. 1.0085), which resulted in an incremental cost-effectiveness ratio (ICER) of $1,314,208/QALY. A sintilimab strategy is a cost-effectiveness option under the WTP of 1-3 times the GDP per capita in China ($11,250/QALY~$33,749/QALY). The utility value of the post-progression, the unit cost of albumin paclitaxel, and the utility value of the progression-free state were the main drivers in the deterministic sensitivity analysis (DSA). According to the probabilistic sensitivity analysis (PSA), sintilimab + chemotherapy was 100% cost-effective when the WTP was 1-3 times China's per capita GDP. The results of the scenario analysis showed that sintilimab + chemotherapy obtained more QALYs (1.2319 vs. 1.1815) and lower costs ($12,321 vs. 36,371), which implied that sintilimab + chemotherapy may dominate the pembrolizumab + chemotherapy.ConclusionCompared with pembrolizumab + chemotherapy, sintilimab + chemotherapy is more cost-effective for first-line treatment in Chinese patients with locally advanced or metastatic squamous NSCLC.

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Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: a single institute experience.

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Treatment outcome of nimotuzumab plus chemotherapy in advanced cancer patients: a single institute experience.

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