Cetuximab in the Treatment of Locally Advanced Head and Neck Cancer

2011 ◽  
Vol 07 (01) ◽  
pp. 16
Author(s):  
Rainald Knecht ◽  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Head And Neck ◽  
Phase Ii ◽  
Locally Advanced ◽  
Phase Iii ◽  
Significant Advance ◽  
Life Questionnaire ◽  
Large Phase

Locally advanced squamous cell cancer of the head and neck (LA SCCHN) includes various cancers of the oral cavity, pharynx and larynx that have spread from the primary site but have not metastasised. Due to poor public awareness of SCCHN and its symptoms, about 50–70% of cases are diagnosed only when the disease has become locally advanced; prognosis by this time is poorer than during earlier stages. Combinations of chemotherapy with radiotherapy have produced greater efficacy in treating LA SCCHN over radiotherapy alone in various clinical trials, but this approach increases the incidence of toxicities. An alternative therapeutic approach is to use the monoclonal antibody cetuximab (Erbitux®). Cetuximab targets epidermal growth factor receptor (EGFR), which is overexpressed in LA SCCHN, and this overexpression of EGFR is associated with poor prognosis. A number of recent phase II and III clinical trials have demonstrated that cetuximab is an effective and safe treatment for LA SCCHN. One large phase III clinical trial demonstrated that the addition of cetuximab to radiotherapy in patients with LA SCCHN provides substantial efficacy and quality of life benefits, including improvements in overall survival, disease-free survival, response rate and European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 parameters, without markedly affecting safety and tolerability. Other, smaller phase II studies in patient populations having either resectable or non-resectable tumours have demonstrated the benefits of adding cetuximab to other chemotherapy/radiotherapy regimens for LA SCCHN. Cetuximab is currently the only targeted biological therapy approved for use in combination with radiation therapy for LA SCCHN. In conclusion, cetuximab represents a significant advance in the treatment of LA SCCHN. Furthermore, based on the data from the large phase III trial, the most recent European Society for Medical Oncology (ESMO) guidelines recommend the use of cetuximab in combination with radiotherapy in LA SCCHN.

Quality of life in patients with locally advanced head and neck cancer undergoing chemoradiation with once-a-week versus once-every-three-weeks cisplatin.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 12092-12092
Author(s):  
Nandini Sharrel Menon ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
Vijay Maruti Patil ◽  
Atanu Bhattacharjee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Locally Advanced ◽  
Phase Iii ◽  
Locoregional Control ◽  
Advanced Head ◽  
Significant Difference ◽  
Eortc Qlq ◽  
The Impact

12092 Background: This trial was conducted to compare the efficacy of low dose once-a-week cisplatin with once-every-3-weeks cisplatin with radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). The current analysis focuses on the quality of life (QoL) of patients in this trial. Methods: In this phase III randomized trial, patients with stage III or IV non-metastatic LAHNSCC were randomized to receive cisplatin 30 mg/m2 once a week or cisplatin 100 mg/m2 once every 3 weeks concurrently with curative intent radiotherapy. The primary endpoint was locoregional control. QoL was a key secondary endpoint. QoL was assessed using the EORTC QLQ-C30 (v.3) and EORTC QLQ-H&N35 (v.1). QoL data were assessed at baseline and days 22 and 43 during treatment; at the end of chemoradiation and at each follow-up. The linear mixed effects model was used for longitudinal analysis of QoL domains to determine the impact of treatment (arm) and time on QoL scores. Results: Three hundred patients were enrolled, 150 in each arm. QoL data from 283 patients with at least one assessable questionnaire were analyzed. The pretreatment QoL scores were similar in both the arms in all domains. There was no significant difference in the global health status/QoL with respect to the treatment arm ( P =0.608) or time ( P=0.0544 ). There was no significant difference in the longitudinal QoL scores between the two treatment arms in all domains except the physical function ( P= .0074), constipation ( P= .0326), trouble with social contact ( P= .0321) and sexuality ( P= .0004). There was a decline in the QoL scores in all domains in both arms during treatment. After completion of treatment, the QoL scores started improving steadily up to 1 year and plateaued thereafter in both arms. Conclusions: The use of once-every-three weeks cisplatin significantly improved the locoregional control without adversely impacting the quality of life as compared to once-a-week cisplatin in combination with radical radiotherapy in locally advanced HNSCC. Clinical trial information: CTRI/2012/10/ 003062. .

Quality of life assessment in renal cell carcinoma Phase II and III clinical trials published between 2010 and 2020: a systematic review

2021 ◽  
Author(s):  
Alessandro Rizzo ◽  
Veronica Mollica ◽  
Filippo Gustavo Dall’Olio ◽  
Angela Dalia Ricci ◽  
Ilaria Maggio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Renal Cell ◽  
Life Assessment ◽  
Phase Iii ◽  
End Points

Aims: Quality of life (QoL) assessment is frequently not included among the end points of clinical trials (CTs) on renal cell carcinoma. Herein we aimed to describe the assessment and reporting of QoL in Phase II and Phase III CTs published between 2010 and 2020. Methods: A total of 25 CTs were included; 76% of trials included were conducted in metastatic renal cell carcinoma patients, while 20% of studies evaluated adjuvant systemic treatments. Results: In 13/25 publications, QoL was not listed among the end points, with secondary publications dedicated to QoL present in a minority of cases. Conclusions: QoL was not included among the end points of a large percentage of CTs. Implementing the inclusion of QoL represents an urgent need.

Five-year quality of life results of the randomized clinical phase III (RADPLAT) trial, comparing concomitant intra-arterial versus intravenous chemoradiotherapy in locally advanced head and neck cancer

Head & Neck ◽  
2011 ◽  
Vol 34 (7) ◽  
pp. 974-980 ◽  
Author(s):  
Annemieke H. Ackerstaff ◽  
Coen R. N. Rasch ◽  
Alfons J. M. Balm ◽  
Jan Paul de Boer ◽  
Ruud Wiggenraad ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Locally Advanced ◽  
Phase Iii ◽  
Advanced Head ◽  
Clinical Phase

The Head and Neck Radiotherapy Questionnaire: a morbidity/quality-of-life instrument for clinical trials of radiation therapy in locally advanced head and neck cancer.

1993 ◽  
Vol 11 (5) ◽  
pp. 863-872 ◽  
Author(s):  
G P Browman ◽  
M N Levine ◽  
D I Hodson ◽  
J Sathya ◽  
R Russell ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Performance Status ◽  
Locally Advanced ◽  
Skin Toxicity ◽  
Head And Neck Radiotherapy

PURPOSE The purpose of this study was to develop and validate an instrument for clinical trials to measure radiation-related acute morbidity and quality of life from the perspective of patients with head and neck cancer (HNC) treated with radiotherapy. METHODS The Head and Neck Radiotherapy Questionnaire (HNRQ) was developed by a panel of health care workers and patients, was pretested in a pilot study of HNC patients, and was validated in a randomized double-blind trial of concomitant fluorouracil (FUra) infusional therapy (1.2 g/m2 per 24 hours) or saline placebo administered for 72 hours in the first and third weeks of a 6 1/2-week course of radiation therapy. The HNRQ was validated against existing toxicity and performance status indices, all of which were measured weekly for the 6 1/2 weeks of treatment and for 4 weeks posttreatment. RESULTS There were three a priori constructs: (1) that the HNRQ scores would conform to a shallow U-shaped pattern to reflect declining quality of life (increasing morbidity) during radiation and recovery posttreatment; (2) that the HNRQ would correlate with existing toxicity indices (World Health Organization [WHO] stomatitis, Byfield stomatitis, WHO skin toxicity, Eastern Cooperative Oncology Group [ECOG] and Karnofsky performance status); and (3) that the HNRQ would discriminate between FUra and placebo groups. The HNRQ and its domain scores all showed a change from baseline reflecting increased morbidity during radiation (analysis of variance [ANOVA], P < .00001). The HNRQ correlated well with all other indices (r > or = .60), and domain scores correlated best with other indices that assess the same symptom complex (eg, HNRQ skin domain and WHO skin toxicity index, r = .77). There was a significant difference in HNRQ scores between the FUra and placebo groups during radiation (ANOVA, P = .0007), and all HNRQ domains also discriminated between the treatment groups. CONCLUSION The HNRQ is a valid measure of acute morbidity due to radiation therapy in patients with locally advanced HNC, and may be useful as an outcome measure for future clinical trials of radiation treatment strategies.

Preliminary Functional Outcomes and Quality of Life after Tongue Reconstruction with the Vastus Lateralis Myofascial Free Flap

2021 ◽  
Author(s):  
Armando De Virgilio ◽  
Andrea Costantino ◽  
Raul Pellini ◽  
Gerardo Petruzzi ◽  
Giuseppe Mercante ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck ◽  
Free Flap ◽  
Functional Outcomes ◽  
Vastus Lateralis ◽  
Life Questionnaire ◽  
Donor Area ◽  
Tongue Reconstruction ◽  
Eortc Qlq

AbstractThe aim of the present study is to report our preliminary experience with the vastus lateralis myofascial free flap (VLMFF) for tongue reconstruction according to tongue and donor site functional outcomes. Twelve consecutive patients (F: 5; median age: 54.0 years, interquartile range or IQR 42.75–69.0) were included. The validated European Organization for Research and Treatment of Cancer of the Head and Neck 35 Quality of Life Questionnaire (EORTC QLQ-H&N35) and the performance status scale for head and neck cancer (PSS-HN) questionnaires were used to assess the health-related quality of life (HRQOL). The lower extremity functional scale (LEFS) was used to self-report the donor area function. All patients were successfully treated, and no VLMFF failure was detected during a median follow-up period of 10.5 months (IQR: 6.5–33.0). The HRQOL showed a median EORTC QLQ-H&N35 score of 56.0 (IQR: 50.0–72.5). The median PSS-HN score was 80.0 (IQR: 45.0–95.0), 75.0 (IQR: 62.5–100.0), 75.0 (IQR: 62.5–100.0) for “Normalcy of Diet,” “Public Eating,” and “Understandability of Speech,” respectively. The self-reported function of the lower extremities (donor area) showed a median LEFS of 59.0 (IQR: 32.5–74.0). This study reports optimistic data regarding the functional and quality of life outcomes after tongue reconstruction using VLMFF. Prospective controlled studies are needed to demonstrate advantages and disadvantages when compared with other reconstructive techniques.

Mapping the University of Washington Quality of life questionnaire onto EQ‐5D and HUI‐3 indices in patients with head and neck cancer

Head & Neck ◽  
2019 ◽  
Vol 42 (3) ◽  
pp. 513-521 ◽  
Author(s):  
Robert F. Stephens ◽  
Christopher W. Noel ◽  
Jie (Susie) Su ◽  
Wei Xu ◽  
Murray Krahn ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Life Questionnaire ◽  
University Of Washington ◽  
Quality Of Life Questionnaire ◽  
The University
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