Abstract
Purpose
The objective of this pilot study was to determine how different treatment modalities (surgery, radiation, and chemotherapy) impact quality of life (QOL) in a population of head and neck cancer (HNC) survivors.
Methods
Fifty-nine newly diagnosed, biopsy-confirmed HNC patients were recruited between 2007-2012. They completed the EORTC Quality of Life Questionnaire and Head & Neck Module at 5 intervals pre- and post-treatment. Participants were grouped into four categories based on modality: surgery only, surgery/radiation, chemoradiation, or surgery/chemoradiation. Repeated measures ANOVA examined effect of treatment modality on QOL over time.
Results
Xerostomia symptoms were significantly associated with chemoradiation (F(2.47, 59.27) = 3.57, p = 0.03), lowest at pretreatment and highest 6 months post-treatment. Time was significantly associated with head and neck pain, F(2.95,67.89) = 3.39, p = 0.02.
Conclusions
HNC survivors exhibit different QOL related symptoms depending on combined treatment modalities, and time post-treatment. It is important to understand QOL differences based upon treatment modalities when developing treatment plans for HNC patients.
1
Introduction
There are approximately 436,000 head and neck cancer survivors in the United States currently , with 5-year survival rates reported at 63.2% for oral cavity and pharynx and 60.6% for larynx . Virtually all head and neck cancer (HNC) patients present with one or more oral or dental complications , which can be mild and include discomfort and pain, or more serious, with morbidities such as dysphagia, mucositis, xerostomia or osteoradionecrosis . Further, these complications impact quality of life (QOL) long after treatment . Increasing survival rates among HNC patients emphasize the importance of long-term management of these issues in order to optimize health and well-being .
Selection of treatment modality and survival among those with HNC are both related to clinical stage at presentation . When patients present with localized tumors (stage I or II), surgery or radiation therapy is usually the treatment of choice, and such single modality treatment usually has a better prognosis and lesser functional and QOL impact . Unfortunately, a majority of patients tend to present with later stages (III and IV) , often requiring a combination of surgery, radiation therapy, and/or chemotherapy . These treatment modalities have a profound effect on QOL; surgical and non-surgical modalities (radiation therapy and chemotherapy) have shown similar survival benefits, yet different complication profiles that impact each patient’s post-treatment QOL . In addition, although survival and/or possible cure are often prioritized over QOL and function by most HNC patients, studies have shown an association between QOL and survival , with better QOL often associated with an increased chance of survival .
While stage is a factor in treatment decisions, there is also a need for the impact of treatment on QOL to be included in the treatment discussion. QOL could be related to stage at presentation, with more advanced disease having greater pre-treatment negative functional and QOL impact, while earlier stage disease which has less associated functional loss at presentation requires less invasive treatment and has a greater likelihood to preserve function .
This exploratory pilot study’s aim was to determine how the different combination of treatment modalities (surgery, radiation therapy, and chemotherapy) impact QOL in this patient population and to determine if particular combinations of treatments produced associated patterns of post treatment QOL.
2
Materials and methods
For this pilot study, 64 patients were recruited from the head and neck oncology clinic between July 2007 and May 2012. On days where study staff members were available, patients with a new, biopsy-confirmed diagnosis of HNC were asked to participate. Potential participants were between the ages of 18–89, had not been previously treated, and had planned treatment at our academic cancer center. Of the 64 who agreed to participate, five did not complete the initial pre-treatment survey packet & were excluded from the study. The QOL survey packet included five QOL based surveys, including the previously validated EORTC Quality of Life Questionnaire (QLQ) and Head and Neck Module (HN-35) , SF-12 general health survey version 1 , Neck Dissection Impairment Index , Hamilton Anxiety Scale , and Oral Health Impact Profile . For the current study, we focused on results from the EORTC-QLQ & HN-35 due to its ability to capture the wide range of symptoms associated with HNC-specific QOL. Participants completed these surveys at five intervals: pre-treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment and 12 months post treatment. Patients were then sorted into 1 of 4 categories based on their final treatment modality: surgery only; surgery with adjuvant radiation therapy; chemoradiation alone; or surgery with adjuvant chemoradiation. This study was approved by the Saint Louis University Institutional Review Board.
2.1
QOL measures
The EORTC-QLQ is a 30 item survey addressing various quality of life issues such as physical, social, and emotional functioning as well as symptoms that impact quality of life such as pain, fatigue, and appetite. The scales have been shown to have good internal consistency reliability, with Cronbach alpha scores ranging from 0.61–0.90 . The EORTC HN-35 is a 35 item survey addressing quality of life issues specific to patients with head and neck cancer, such as swallowing, speech problems, dry mouth, and head and neck pain. The scales have also been shown to have good internal consistency reliability, with Cronbach alpha scores ranging from 0.84–0.93 for all scales with the exception of the “senses” scale, which has a reported Cronbach alpha score of 0.54 .
2.2
Data analysis
Participant characteristics were examined using frequencies and means in univariate analysis. A repeated measures ANOVA was used to examine the effect of treatment modality on QOL over time. In cases where the assumption of sphericity was not met, the Greenhouse-Geisser correction was used. This was done to account for unexpected differences in the variation between groups that would affect the analysis. Analyses were performed using SPSS version 22.0 , statistical significance was set at p < 0.05.
2
Materials and methods
For this pilot study, 64 patients were recruited from the head and neck oncology clinic between July 2007 and May 2012. On days where study staff members were available, patients with a new, biopsy-confirmed diagnosis of HNC were asked to participate. Potential participants were between the ages of 18–89, had not been previously treated, and had planned treatment at our academic cancer center. Of the 64 who agreed to participate, five did not complete the initial pre-treatment survey packet & were excluded from the study. The QOL survey packet included five QOL based surveys, including the previously validated EORTC Quality of Life Questionnaire (QLQ) and Head and Neck Module (HN-35) , SF-12 general health survey version 1 , Neck Dissection Impairment Index , Hamilton Anxiety Scale , and Oral Health Impact Profile . For the current study, we focused on results from the EORTC-QLQ & HN-35 due to its ability to capture the wide range of symptoms associated with HNC-specific QOL. Participants completed these surveys at five intervals: pre-treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment and 12 months post treatment. Patients were then sorted into 1 of 4 categories based on their final treatment modality: surgery only; surgery with adjuvant radiation therapy; chemoradiation alone; or surgery with adjuvant chemoradiation. This study was approved by the Saint Louis University Institutional Review Board.
2.1
QOL measures
The EORTC-QLQ is a 30 item survey addressing various quality of life issues such as physical, social, and emotional functioning as well as symptoms that impact quality of life such as pain, fatigue, and appetite. The scales have been shown to have good internal consistency reliability, with Cronbach alpha scores ranging from 0.61–0.90 . The EORTC HN-35 is a 35 item survey addressing quality of life issues specific to patients with head and neck cancer, such as swallowing, speech problems, dry mouth, and head and neck pain. The scales have also been shown to have good internal consistency reliability, with Cronbach alpha scores ranging from 0.84–0.93 for all scales with the exception of the “senses” scale, which has a reported Cronbach alpha score of 0.54 .
2.2
Data analysis
Participant characteristics were examined using frequencies and means in univariate analysis. A repeated measures ANOVA was used to examine the effect of treatment modality on QOL over time. In cases where the assumption of sphericity was not met, the Greenhouse-Geisser correction was used. This was done to account for unexpected differences in the variation between groups that would affect the analysis. Analyses were performed using SPSS version 22.0 , statistical significance was set at p < 0.05.
3
Results
Participant characteristics are presented in Table 1 . The majority of participants were male (57%) and age at diagnosis ranged from 23 to 86 years (mean = 61.14, SD = 11.28). Pre-treatment surveys were completed within one month of first treatment start date (mean days from initial survey packet to treatment = 10.49, SD = 7.77). The most common treatment type was chemoradiation (47%), followed by surgery only (22%). Over half of the patients (n = 31, 55.3%) presented with late stage (T3 or T4) disease.
| Mean (SD) | n (%) | |
|---|---|---|
| Age | 61.14 (11.28) | |
| Gender | ||
| Male | 34 (57) | |
| Female | 26 (43) | |
| Treatment type | ||
| Surgery only | 13 (22) | |
| Chemotherapy & radiation | 28 (47) | |
| Surgery & radiation | 11 (18) | |
| Surgery, chemotherapy, radiation | 8 (13) | |
| T stage | ||
| T1 | 7 (12.5) | |
| T2 | 18 (32.1) | |
| T3 | 19 (33.9) | |
| T4 | 12 (21.4) |
3.1
Pain
Time was significantly associated with head & neck pain, F (2.95,67.89) = 3.39, p = 0.02, though there was not a significant difference in head & neck pain based on treatment at any time point. The highest pain scores were reported prior to treatment then decreased over time, with the lowest scores being reported at 12 months post-treatment.
Overall, pain scores were lowest in the chemoradiation group, though this difference was not significant. Further, those in the surgery/radiation therapy group reported the highest initial pain, though by 1 year post-treatment all groups reported similar pain scores ( Table 2 ).
| Pre-treatment | 1 month post-treatment | 3 months post-treatment | 6 months post-treatment | 12 months post-treatment | |
|---|---|---|---|---|---|
| Global health | |||||
| Status/QOL a | |||||
| Surgery only | 70.83 (10.76) | 65.58 (14.23) | 62.50 (20.97) | 70.83 (15.96) | 72.92 (18.48) |
| Chemoradiation | 63.69 (24.81) | 42.86 (23.99) | 57.74 (21.30) | 53.57 (23.28) | 54.17 (21.12) |
| Surgery & chemoradiation | 60.42 (22.95) | 64.58 (14.23) | 75.00 (11.75) | 66.67 (11.78) | 50.00 (15.21) |
| Surgery & radiation | 68.75 (21.92) | 68.75 (10.49) | 77.08 (15.77) | 81.25 (14.23) | 52.08 (37.50) |
| Head & neck | |||||
| Pain b | |||||
| Surgery only | 37.50 (28.46) | 35.42 (38.11) | 18.75 (17.18) | 27.08 (18.48) | 25.00 (18.00) |
| Chemoradiation | 24.48 (18.87) | 33.85 (28.13) | 16.15 (14.74) | 23.44 (20.69) | 20.31 (22.76) |
| Surgery & chemoradiation | 27.78 (26.79) | 27.78 (28.13) | 27.78 (9.62) | 11.11 (12.73) | 11.11 (19.24) |
| Surgery & radiation | 47.92 (38.71) | 39.58 (29.95) | 39.58 (29.95) | 18.75 (18.48) | 20.83 (25.00) |
| Xerostomia b | |||||
| Surgery only | 20.00 (18.26) | 33.33 (40.82) | 20.00 (44.72) | 40.00 (27.89) | 33.33 (40.82) |
| Chemoradiation | 31.25 (30.96) | 72.91 (31.70) | 83.33 (29.81) | 83.33 (27.22) | 68.75 (33.26) |
| Surgery & chemoradiation | 16.67 (23.57) | 33.33 (0.00) | 33.33 (0.00) | 33.33 (0.00) | 50.00 (23.57) |
| Surgery & radiation | 26.67 (43.46) | 46.67 (38.01) | 60.00 (43.46) | 53.33 (29.81) | 33.33 (23.57) |
a Higher scores indicate a better QOL.
3.2
Xerostomia
Xerostomia symptoms were significantly different across time, F (2.47,59.27) = 3.57, p = 0.03, with a significantly higher occurrence of xerostomia at one month post-treatment compared to pre-treatment ( F (1,24) = 4.73, p = 0.04). Treatment also significantly differed on xerostomia symptoms, F (3,24) = 4.51, p = 0.01. Bonferroni post hoc tests revealed that xerostomia was reported more often in the chemoradiation group when compared to the surgery only group (p = 0.02); there were not significant differences among the other treatment types. Further, xerostomia problems were reported to be the lowest at pretreatment, highest at 6 months post-treatment. Patients who had surgery only showed fewer problems with xerostomia at all post treatment intervals. Xerostomia was reported at the highest level in the chemoradiation groups at all post treatment intervals ( Table 2 ). Treatment differences across time can be seen in Fig. 1 .
3.3
Global quality of life
There was no significant difference in overall QOL across time (p = 0.29) or treatment types (p = 0.08). However, there were some trends in the data. Those in the surgery only group had the highest overall QOL at baseline, 6 months, and 12 months after treatment. Generally, post treatment QOL was lowest in the chemoradiation only group, though by 12 months the multi-modality groups had similar QOL scores ( Table 2 ). These differences can be seen in Fig. 2 .
