Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial
•Nimotuzumab is an anti-EGFR humanized IgG1 monoclonal antibody.•The addition of Nimotuzumab to cisplatin + RT significantly improved PFS, LRC and DFS.•There was no significant difference in the QoL of patients who received N-CRT versus those who received CRT.•Nimotuzumab + CRT improved outcomes wit...
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| Veröffentlicht in: | Oral oncology 2021-11, Vol.122, p.105517-105517, Article 105517 |
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| creator | Menon, Nandini Patil, Vijay Noronha, Vanita Joshi, Amit Bhattacharjee, Atanu Satam, Balajirao J Mathrudev, Vijayalakshmi Ghosh Laskar, Sarbani Prabhash, Kumar |
| description | •Nimotuzumab is an anti-EGFR humanized IgG1 monoclonal antibody.•The addition of Nimotuzumab to cisplatin + RT significantly improved PFS, LRC and DFS.•There was no significant difference in the QoL of patients who received N-CRT versus those who received CRT.•Nimotuzumab + CRT improved outcomes without having any additional negative impact on the QoL.
The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.
In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.
536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.
The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL. |
| doi_str_mv | 10.1016/j.oraloncology.2021.105517 |
| format | Article |
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The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.
In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.
536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.
The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.</description><identifier>ISSN: 1368-8375</identifier><identifier>EISSN: 1879-0593</identifier><identifier>DOI: 10.1016/j.oraloncology.2021.105517</identifier><identifier>PMID: 34560383</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Antibodies, Monoclonal, Humanized - therapeutic use ; Chemoradiation ; Cisplatin - therapeutic use ; Head and neck cancer ; Head and Neck Neoplasms - therapy ; Humans ; Nimotuzumab ; Quality of Life ; Radiotherapy ; Squamous Cell Carcinoma of Head and Neck - therapy</subject><ispartof>Oral oncology, 2021-11, Vol.122, p.105517-105517, Article 105517</ispartof><rights>2021 Elsevier Ltd</rights><rights>Copyright © 2021 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c380t-5e0ae4515a3c9769fdfed6f765878b9ff00e5717345ababe76ce8329677e652d3</citedby><cites>FETCH-LOGICAL-c380t-5e0ae4515a3c9769fdfed6f765878b9ff00e5717345ababe76ce8329677e652d3</cites><orcidid>0000-0002-4214-5799</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.oraloncology.2021.105517$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3549,27923,27924,45994</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/34560383$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Menon, Nandini</creatorcontrib><creatorcontrib>Patil, Vijay</creatorcontrib><creatorcontrib>Noronha, Vanita</creatorcontrib><creatorcontrib>Joshi, Amit</creatorcontrib><creatorcontrib>Bhattacharjee, Atanu</creatorcontrib><creatorcontrib>Satam, Balajirao J</creatorcontrib><creatorcontrib>Mathrudev, Vijayalakshmi</creatorcontrib><creatorcontrib>Ghosh Laskar, Sarbani</creatorcontrib><creatorcontrib>Prabhash, Kumar</creatorcontrib><title>Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial</title><title>Oral oncology</title><addtitle>Oral Oncol</addtitle><description>•Nimotuzumab is an anti-EGFR humanized IgG1 monoclonal antibody.•The addition of Nimotuzumab to cisplatin + RT significantly improved PFS, LRC and DFS.•There was no significant difference in the QoL of patients who received N-CRT versus those who received CRT.•Nimotuzumab + CRT improved outcomes without having any additional negative impact on the QoL.
The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.
In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.
536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.
The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.</description><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Chemoradiation</subject><subject>Cisplatin - therapeutic use</subject><subject>Head and neck cancer</subject><subject>Head and Neck Neoplasms - therapy</subject><subject>Humans</subject><subject>Nimotuzumab</subject><subject>Quality of Life</subject><subject>Radiotherapy</subject><subject>Squamous Cell Carcinoma of Head and Neck - therapy</subject><issn>1368-8375</issn><issn>1879-0593</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkUuOEzEQhlsIxAwDV0AlVmw6uOPY7mY3Gp7SSAgJ1lbFriYO7naw3UFhxR3mWnMKToJDBzRLVn7UX389vqp61rBFwxr5YrsIEX0YTfDhy2GxZMumBIRo1L3qvGlVVzPR8fvlzmVbt1yJs-pRSlvGmGgEe1id8ZWQjLf8vLr9OKF3-QChB-96AjfCDrOjMSf47vIGfDDo_QHQ7nE0ZGFDaAFHCyOZr2COnxFyJMwl-CfFlN6mGIsHmA0NpVvrimcYT2GXdr68x9nFDSFPP6YB17CnmKZ0V1DGJPj18wYurXVHC_RgMSP0MQyAsNtgIuClvkP_uHrQo0_05HReVJ_fvP509a6-_vD2_dXldW14y3ItiCGtyiqQm07Jrrc9WdkrKVrVrru-Z4yEalTZEq5xTUoaavmyk0qRFEvLL6rns-8uhm8TpawHlwx5jyOFKemlUFKKlVC8SF_OUhNDSpF6vYtuwHjQDdNHmnqr79LUR5p6plmSn57qTOuB7L_Uv_iK4NUsoDLt3lHUyRR0hZKLZLK2wf1Pnd_HoL4o</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Menon, Nandini</creator><creator>Patil, Vijay</creator><creator>Noronha, Vanita</creator><creator>Joshi, Amit</creator><creator>Bhattacharjee, Atanu</creator><creator>Satam, Balajirao J</creator><creator>Mathrudev, Vijayalakshmi</creator><creator>Ghosh Laskar, Sarbani</creator><creator>Prabhash, Kumar</creator><general>Elsevier Ltd</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-4214-5799</orcidid></search><sort><creationdate>202111</creationdate><title>Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial</title><author>Menon, Nandini ; Patil, Vijay ; Noronha, Vanita ; Joshi, Amit ; Bhattacharjee, Atanu ; Satam, Balajirao J ; Mathrudev, Vijayalakshmi ; Ghosh Laskar, Sarbani ; Prabhash, Kumar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c380t-5e0ae4515a3c9769fdfed6f765878b9ff00e5717345ababe76ce8329677e652d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Chemoradiation</topic><topic>Cisplatin - therapeutic use</topic><topic>Head and neck cancer</topic><topic>Head and Neck Neoplasms - therapy</topic><topic>Humans</topic><topic>Nimotuzumab</topic><topic>Quality of Life</topic><topic>Radiotherapy</topic><topic>Squamous Cell Carcinoma of Head and Neck - therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Menon, Nandini</creatorcontrib><creatorcontrib>Patil, Vijay</creatorcontrib><creatorcontrib>Noronha, Vanita</creatorcontrib><creatorcontrib>Joshi, Amit</creatorcontrib><creatorcontrib>Bhattacharjee, Atanu</creatorcontrib><creatorcontrib>Satam, Balajirao J</creatorcontrib><creatorcontrib>Mathrudev, Vijayalakshmi</creatorcontrib><creatorcontrib>Ghosh Laskar, Sarbani</creatorcontrib><creatorcontrib>Prabhash, Kumar</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Oral oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Menon, Nandini</au><au>Patil, Vijay</au><au>Noronha, Vanita</au><au>Joshi, Amit</au><au>Bhattacharjee, Atanu</au><au>Satam, Balajirao J</au><au>Mathrudev, Vijayalakshmi</au><au>Ghosh Laskar, Sarbani</au><au>Prabhash, Kumar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial</atitle><jtitle>Oral oncology</jtitle><addtitle>Oral Oncol</addtitle><date>2021-11</date><risdate>2021</risdate><volume>122</volume><spage>105517</spage><epage>105517</epage><pages>105517-105517</pages><artnum>105517</artnum><issn>1368-8375</issn><eissn>1879-0593</eissn><abstract>•Nimotuzumab is an anti-EGFR humanized IgG1 monoclonal antibody.•The addition of Nimotuzumab to cisplatin + RT significantly improved PFS, LRC and DFS.•There was no significant difference in the QoL of patients who received N-CRT versus those who received CRT.•Nimotuzumab + CRT improved outcomes without having any additional negative impact on the QoL.
The addition of Nimotuzumab to radical chemoradiation (CRT) improved outcomes in patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing radical CRT in a phase 3 randomized trial. The current study focuses on the quality of life (QoL) of patients in this trial.
In this phase III randomized trial, patients with newly diagnosed, nonmetastatic, stage III/IV LAHNSCC of the oral cavity, oropharynx, hypopharynx, or larynx were randomized to receive cisplatin 30 mg/m2 or cisplatin 30 mg/m2 with nimotuzumab once a week with curative radiotherapy. The primary end point of the trial was PFS. The aim of the current study was to compare the QoL between the two arms. QoL was assessed using the EORTC QLQ-C30 (v3.0) and HN-35 (v1.0). The linear mixed-effects model was used for longitudinal analysis of QoL.
536 patients were randomized in this trial (268 in each arm) and 423 patients were included for QoL analysis. There was a significant change in the global health status QoL scores over time (p = 0.0016) with no difference between the two arms (p = 0.396). On longitudinal analysis there was a significant difference in the QoL scores in most of the function & symptom scales over time, but there was no significant difference in these scores between the two arms. QoL scores for most symptom scales worsened during treatment and improved thereafter in both arms.
The addition of nimotuzumab to cisplatin based chemoradiation in LAHNSCC improved PFS, LRC and DFS without negatively impacting QoL.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>34560383</pmid><doi>10.1016/j.oraloncology.2021.105517</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0002-4214-5799</orcidid></addata></record> |
| fulltext | fulltext |
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| ispartof | Oral oncology, 2021-11, Vol.122, p.105517-105517, Article 105517 |
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| language | eng |
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| source | Elsevier ScienceDirect Journals Complete - AutoHoldings; MEDLINE |
| subjects | Antibodies, Monoclonal, Humanized - therapeutic use Chemoradiation Cisplatin - therapeutic use Head and neck cancer Head and Neck Neoplasms - therapy Humans Nimotuzumab Quality of Life Radiotherapy Squamous Cell Carcinoma of Head and Neck - therapy |
| title | Quality of life in patients with locally advanced head and neck cancer treated with concurrent chemoradiation with cisplatin and nimotuzumab versus cisplatin alone – Additional data from a phase 3 trial |
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