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Slight advantages of nimotuzumab versus cetuximab plus concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

ABSTRACT: This study aimed to compare the efficacy of nimotuzumab (Nimo) versus cetuximab (C225) plus concurrent chemoradiotherapy (CCRT) in locally advanced esophageal squamous cell carcinoma (LA-ESCC). A total of 95 patients with LA-ESCC were retrospectively reviewed, including 65 in Nimo and 30 in C225. The results showed that the ORR in Nimo (61.0%; CR 22.0%, 13/59; PR 39.0% 23/59) was slightly higher than that in C225 (43.5%; CR 8.7%, 2/23; PR 34.8%, 8/23) but without significant difference (p = 0.81). The DCR was 79.7% vs. 73.9% in C225, favoring Nimo plus CCRT (p = 0.04). The median PFS in Nimo was significantly longer than that in C225 (19.6 months vs. 13.0 months, p = 0.02). The median OS of the whole cohort, the Nimo group and the C225 group were 21.3, 24.5, and 20.9 months, respectively. The rates of OS at 1-, 3-year in Nimo were 77.7% and 33.5%, compared to 73.3% and 20.0% in C225 (HR = 1.17, p = 0.23). Grade 3 or worse hematological toxicity and non-hematological toxicity (radiation esophagitis) in Nimo were similar with that in C225 (21.5% vs. 26.7%, p = 0.91; 26.1% vs. 26.7%, p = 0.56). No grade ?3 radiation pneumonitis occurred neither Nimo group nor C225 group. Nimo plus CCRT improved DCR and PFS of patients with LA-ESCC and had a tendency of prolonged survival compared to C225 plus CCRT. Our results suggest that the combination of Nimo and CCRT may be a reasonable option in this population.

SUBMITTER: Jing W

PROVIDER: S-EPMC6606014 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Slight advantages of nimotuzumab versus cetuximab plus concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Jing Wang W Yan Weiwei W Liu Yuguo Y Li Ji J Yu Jinming J Zhu Hui H

Cancer biology & therapy 20190414 8

This study aimed to compare the efficacy of nimotuzumab (Nimo) versus cetuximab (C225) plus concurrent chemoradiotherapy (CCRT) in locally advanced esophageal squamous cell carcinoma (LA-ESCC). A total of 95 patients with LA-ESCC were retrospectively reviewed, including 65 in Nimo and 30 in C225. The results showed that the ORR in Nimo (61.0%; CR 22.0%, 13/59; PR 39.0% 23/59) was slightly higher than that in C225 (43.5%; CR 8.7%, 2/23; PR 34.8%, 8/23) but without significant difference (<i>p</i> ...[more]

PMID: 30983494

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Project description:BackgroundThis study aims to investigate the efficacy and safety of postoperative intensity-modulated radiotherapy (IMRT) covering partial regional lymph node areas combined with chemotherapy for locally advanced thoracic esophageal squamous cell carcinoma patients.MethodsThis was a single-center, single-arm phase II clinical trial that began in 2014. Patients who underwent radical transthoracic resection within 3 months and were histologically confirmed esophageal squamous cell carcinoma (pT3-4 or N+, M0 determined according to AJCC Guidelines, Edition 7) were recruited. Postoperative radiotherapy was performed with a total dose of 50.4Gy in 28 fractions using IMRT. Clinical target volumes (CTVs) included tumor bed, anastomosis, bilateral supraclavicular region, and superior mediastinal lymph nodes. Synchronous chemotherapy for 2 cycles (paclitaxel 150mg/m2, day1; Cisplatin 25mg/m2, day1-3; every 4 weeks), followed by 2 cycles of consolidation chemotherapy with the same regimen. The primary endpoint was the 2-year local control rate, and the secondary endpoints were overall survival (OS) and adverse events (AEs).ResultsA total of 75 eligible patients were included from 2014 to 2017. The 2-year LRFS rate, as the primary endpoint, was 73.3%. The 1-year and 3-year OS rates were 88.0% and 68.0%, respectively. Local recurrence occurred in 13/75 (17.4%) patients, of which 2.7% (2/75) were extra-target lymph nodes. Grade 4 adverse events reported in this study included 10 cases (13.3%) of neutropenia, 1 case (1.3%) of anemia, and 2 cases (2.7%) of thrombocytopenia, without toxic-related deaths. Almost all (96%) patients completed the entire postoperative radiotherapy course, and 62 (82.7%) patients completed at least 2 cycles of chemotherapy.ConclusionPostoperative IMRT (clinical target volume including tumor bed, anastomosis, bilateral supraclavicular region, and superior mediastinal lymph nodes) combined with synchronous chemotherapy in patients with locally advanced thoracic esophageal squamous cell carcinoma was well tolerated, with a high local control rate and a low probability of recurrence outside the irradiation field.Clinical trial registrationhttps://clinicaltrials.gov/ChiCTR1900022689.

Project description:PurposeInduction chemotherapy plus concurrent chemoradiotherapy and concurrent chemoradiotherapy alone are both standard treatment regimens for managing locally advanced nasopharyngeal carcinoma. However, the results of comparisons between them in clinical trials vary. Therefore, we designed this meta-analysis to illustrate their advantages and disadvantages in patients with locally advanced nasopharyngeal carcinoma.MethodsWe thoroughly searched the PubMed, EMBASE, and Cochrane Library databases and then merged the effect indicators of hazard ratios and risk ratios using RevMan 5.1.ResultsSeven randomized controlled trials totaling 2,319 patients were included in our research. The synthesized results showed that induction chemotherapy plus concurrent chemoradiotherapy improved overall survival (HR = 0.75, 95% CI: 0.63-0.89, P = 0.001), progression-free survival (HR = 0.69, 95% CI: 0.60-0.80, P < 0.001), distant metastasis-free survival (HR = 0.65, 95% CI: 0.53-0.80, P < 0.001) and locoregional recurrence-free survival (HR = 0.68 95%, CI: 0.54-0.86, P = 0.001) versus concurrent chemoradiotherapy alone. It also increased the risk of anemia, thrombocytopenia, and neutropenia during concurrent chemoradiotherapy. However, the incidence of leukopenia and mucositis was similar in induction chemotherapy and induction chemotherapy plus concurrent chemoradiotherapy. Furthermore, the subgroup analysis showed better survival outcomes with induction chemotherapy plus concurrent chemoradiotherapy than with concurrent chemoradiotherapy alone in the triweekly cisplatin subgroup (all P < 0.01), whereas induction chemotherapy plus concurrent chemoradiotherapy could only improve progression-free survival and locoregional recurrence-free survival in the weekly cisplatin subgroup (HR = 0.78, P = 0.02; and HR = 0.66, P = 0.03, respectively).ConclusionsInduction chemotherapy plus concurrent chemoradiotherapy improved survival outcomes in patients with locally advanced nasopharyngeal carcinoma versus concurrent chemoradiotherapy. For the weekly cisplatin regimen subgroup, it did not improve remote control or overall survival versus concurrent chemoradiotherapy alone, warranting further clarification.

Project description:Objective This study investigated the curative effect of adding nimotuzumab (NTZ) in patients with locally advanced nasopharyngeal carcinoma (NPC) who were treated with concurrent chemoradiotherapy (CCRT) and explored significant prognostic factors of NPC. Materials and methods The clinical data of 307 patients with NPC treated in the First Affiliated Hospital of Soochow University from January 2013 to December 2018 were retrospectively analyzed. The patients were divided into the NTZ-CCRT group and the CCRT group according to whether they were associated with NTZ. We applied propensity score matching to reduce the interference of biases and compared the short-term efficacy and long-term survival rate of the two groups. Moreover, univariate and multivariate analyses were performed for all patients, and subgroup analysis was used to compare the efficacy of therapy combined with NTZ in different subgroups. Results In primary nasopharyngeal tumors, the objective response rates in the NTZ-CCRT group and CCRT group were 95.8% and 85.7%, respectively (P =0.007). In cervical positive lymph nodes, the objective response rates in the NTZ-CCRT group and CCRT group were 98.3% and 87.4%, respectively (P =0.001). Compared with CCRT alone, the addition of NTZ significantly improved the 5-year OS (94.1% vs. 81.8%, P=0.014) and the 5-year DFS (84.2% vs. 75.5%, P=0.031) of NPC patients; however, the addition of NTZ was accompanied by more severe hematologic toxicity and acute oral mucositis. Multivariate analysis demonstrated that the addition of NTZ was an important prognostic factor for OS and DFS (HR 0.367, 95% CI 0.167-0.808, P=0.013 for OS and HR 0.536, 95% CI 0.312-0.919, P=0.023 for DFS) and the level of pretreatment LDH (HR 5.170, 95% CI 2.125-12.580, P<0.001 for OS and HR 2.421, 95% CI 1.027-5.707, P=0.043 for DFS). Moreover, patients with high levels of hsCRP before treatment (HR 0.389, 95% CI 0.177-0.853, P=0.018) may gain more benefits from combined treatment with NTZ. Conclusions For locally advanced NPC patients treated with concurrent chemoradiotherapy, the addition of NTZ can significantly improve their survival outcome. However, it is necessary to guard against the associated increase in hematological toxicity and acute oral mucositis.

Dataset Information

Slight advantages of nimotuzumab versus cetuximab plus concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

Publications

Slight advantages of nimotuzumab versus cetuximab plus concurrent chemoradiotherapy in locally advanced esophageal squamous cell carcinoma.

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