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Health-related quality of life after maxillectomy: obturator rehabilitation compared with flap reconstruction

British Journal of Oral and Maxillofacial Surgery, In Press, Corrected Proof, Available online 5 June 2016

Abstract

Health-related quality of life (QoL) reported by patients has the potential to improve care after ablative surgery of the midface, as existing treatment algorithms still generally revolve around outcomes assessed traditionally only by clinicians. Decisions in particular relate to reconstruction with a flap compared with rehabilitation with an obturator, the need for adjuvant treatment, and morbidity related to the size of the defect. We prospectively collected health-related QoL assessments for 39 consecutive patients treated by maxillectomy between 01 January 2010 and 31 December 2014 using the University of Washington Quality of Life Questionnaire, and who had a mean (SD) duration of follow-up of 14 (4). We made sub-group analyses using paired t tests and analysis of variance (ANOVA) to compare reconstruction with a flap with rehabilitation with obturators, size of the vertical defect, and whether adjuvant treatment with radiotherapy or chemoradiotherapy adversely affected it. Overall there was a significant decrease in health-related QoL after treatment compared with before (p < 0.001), but there was no significant difference in the effects of any of the paired reconstructive and rehabilitation treatments on it. Obturators remain an important option for rehabilitation in selected patients in addition to reconstruction with a flap. We found that neither increasing the size of the vertical defect (in an attempt to ensure clear margins) nor the use of postoperative radiotherapy seemed to have any adverse effect on QoL. More patients are required before we can conclude that the potential survival benefits of such measures may outweigh any adverse effects.

Keywords: Maxillectomy, Cancer, Quality of Life, Surgery, Complication.

Introduction

The reconstruction and rehabilitation of patients after ablative surgery of the maxilla and midface remains one of the greatest challenges currently faced by head and neck surgeons. Ablative surgery affects physical function, particularly speech, chewing, and swallowing. 1 and 2 Treatment of the maxillectomy defect should aim to minimise the facial deformity, restore oral function, and preserve psychological wellbeing. 2 and 3 The most common options are rehabilitation with a prosthetic obturator, or reconstruction with a flap. Each option has its advantages and disadvantages, and there is a need to tailor treatment to patients individually.

Obturator rehabilitation remains the most common option worldwide, and acceptance has been greatly improved through retention provided by implants.4 and 5 Provision of an obturator is a quick surgical option, with low cost, low morbidity, and the possibility of modification according to the patients’ needs, and it can supply missing teeth and support soft tissues.2 Success is related in part to the extent of resection of the soft and hard palate, 3 with larger obturators causing more problems with appearance, pain, and soreness in the mouth than reconstruction with a flap.1 Retention and stability of an obturator in particular can vary among patients, and have the greatest impact on function and overall acceptability.2

Reconstruction with a flap can potentially overcome the problems associated with prosthetic obturators, particularly nasal leakage and the need to clean and repeatedly refine the prosthesis.1 Various flaps have been advocated, most commonly the temporalis flap; the osteocutaneous scapular, iliac crest, and fibular flaps; and the fasciocutaneous radial forearm and anterolateral thigh flaps. 4 and 5 This potentially overwhelming choice can be aided by classifying the defect into its horizontal and vertical components.4 and 5 There is, however, an appreciable potential morbidity for patients in undertaking free flaps in terms of both the donor site, the potential for failure, and the increased anaesthetic time and duration of hospital stay.

Making the choice between rehabilitation with a flap or an obturator is still not clear cut, and authors have suggested that it is the surgeon who makes the final decision.4 The choice varies depending on the size and shape of the defect, the extent of disease, the requirement for postoperative radiotherapy, and the patient's preference.6 Comparisons in outcome between flap and obturator after maxillectomy have traditionally focused on measures such as intelligibility of speech and postoperative diet.7 Although the psychological effects and quality of life (QoL) are recognised, much less has been done to quantify this outcome.4

Health-related QoL has become one of the primary determinants of outcome after treatment in head and neck cancer. Unlike the more traditional measures of survival, locoregional disease control and function, QoL is assessed by the patient independently of the clinician.8 A number of papers have looked at it after maxillectomy, 1, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 with a generally agreed reduction in overall scores in nearly all patients.16 In patients who have had a maxillectomy it is influenced by type and stage of tumour, skin loss, extent of resection, postoperative radiotherapy, number and condition of remaining maxillary teeth, and sociodemographic variables.2, 3, 6, 9, 10, 11, 12, and 13 Many different questionnaires have been proposed for ascertaining health-related QoL after maxillectomy,3, 8, 9, 10, 13, 14, 15, 17, 18, and 19 with the most common being the University of Washington Quality of Life (UoW-QoL).2, 8, 11, and 15 Although the Obturator Functioning Scale has been well validated in terms of how well an obturator is tolerated by a patient, 3 and 10 such a tool does not enable comparisons with outcomes after reconstruction. In addition, most of these assessments were either retrospective, 2, 3, 8, 9, 10, 11, 15, 17, 18, and 19 or were not measured preoperatively. 3, 9, 10, 13, 14, 17, and 18 We know of only a single paper to date that has directly compared QoL after maxillectomy between obturators and flaps.1 In addition, the effects of size of defect and the use of postoperative radiotherapy in both groups are not clear.

The aim of this study was to ascertain the effects of differing treatments on QoL in patients after maxillectomy using a standard questionnaire measured both before and after treatment.

Method

Assessments of health-related QoL both before and after treatment were prospectively recorded for 39 consecutive patients treated by maxillectomy at our centralised oncology service, covering three hospitals in the United Kingdom (UK), between 01 January 2010 and 31 December 2014. The University of Washington Quality of Life Questionnaire version 4 (UoW-QOL v4) was prospectively given to patients to complete before they started treatment, and was used as part of follow up until 18 months after treatment. 20 The UoW-QOL v4 questionnaire consists of 12 questions, each of which has between three and six Likert- scaled responses rated from 0 (worst/poor) to 100 (best/excellent).20 Subjects included pain, appearance, activity, recreation, speech, chewing, swallowing, shoulder pain, taste, saliva, mood, and anxiety. Composite QoL functional scores were divided into two subscales (physical compared with social-emotional function) as suggested by Rogers and Lowe.21 These two groups were subdivided by anatomical site and complication rate. Scores for the physical function subscale were computed as the simple mean of the following domain scores: chewing, swallowing, speech, taste, saliva, and appearance. Scores for the social-emotional function subscale were computed as the simple mean of the following domain scores: pain; activity, recreational, shoulder function, mood, and anxiety.

Questions were asked during a private consultation by a clinical nurse specialist, and an interpreter was present if required. Patients were excluded from paired analyses if they did not have assessments after treatment, or if the assessments were incorrectly completed. Postoperative defects were listed using the classification suggested by Brown and Shaw, and Peker et al., into vertical sizes.4 and 15

Statistical analysis

Comparison of the significance of differences between normally-distributed continuous variables using mean composite social-emotional and physical health-related QoL scores before and after treatment was made using a paired t test and analysis of variance (ANOVA). Sub-group analyses were conducted to ascertain the significance of differences in the effects of flap reconstruction compared with obturators, size of vertical defect, and whether adjuvant treatment with radiotherapy or chemoradiotherapy adversely affected QoL. Probabilities of less than 0.05 were accepted as significant. All statistical analyses and tables and figures were generated using GraphPad Prism® version 6.0 (GraphPad Software, Inc., La Jolla, CA, USA).

Results

Forty-three patients were treated by maxillectomy during the study period, four of whom (9%) were excluded as they did not have postoperative questionnaires completed. Thirty-three of the remaining 39 (85%) had preoperative questionnaires, and all 39 had at least one postoperative questionnaire, completed. Twenty-six (67%) had a 6-month follow up, all had a 12-month follow up, and 12 (31%) had an 18-month follow up questionnaire completed. The mean (SD) duration of follow up was 14 (4) months (Table 1).

Table 1 Details of patients treated by maxillectomy for whom health-related quality of life (QoL) data were available.

Variable Flap (n = 18) Obturator (n = 21) Overall (n = 39)
Age and sex:
 Mean (SD) age (years) at time of operation 65 (9) 64 (5) 64 (7)
 Male 10 12 22 (56)
 Female 8 9 17 (44)
Analysis of scores before and after operation:
 Included 15 18 33 (85)
 Excluded* 3 3 6 (15)
Size and staging of tumour:
 T1N0M0 0 5 5 (13)
 T1N2bM0 0 1 1 (3)
 T2N0M0 5 0 5 (13)
 T3N0M0 1 1 2 (5)
 T4aN0M0 9 12 21 (54)
 T4aN2bM0 1 1 2 (5)
 T4bN0M0 2 1 3 (8)
Histopathological diagnosis:
 Adenocarcinoma 0 2 2 (5)
 Adenoid cystic carcinoma 2 1 3 (8)
 Odontogenic myxoma 0 1 1 (3)
 Squamous cell carcinoma 15 17 32 (82)
 Spindle cell carcinoma 1 0 1 (3)
Site of tumour:
 Hard palate 10 13 23 (59)
 Maxillary alveolus 6 3 9 (23)
 Maxillary sinus 2 4 6 (15)
 Nasal cavity 0 1 1 (3)
Adjuvant treatment:
 Chemoradiotherapy 8 2 10 (26)
 Radiotherapy 5 8 13 (33)
 None 5 11 16 (41)
Recurrence of tumour:
 Yes 5 5 10 (26)
 No 13 16 29 (74)

* Signifies that six patients were excluded from paired analyses because preoperative QoL questionnaires were not available. Data are expressed as number (%).

Treatment

A mixture of obturators, pedicled flaps, and free flaps were used for reconstruction and rehabilitation (Table 2). Of the 39 patients treated by maxillectomy, 16 (41%) had no adjuvant treatment, 13 (33%) had postoperative radiotherapy alone (between 55–60 Gy), and 10 (26%) had postoperative chemoradiotherapy (all with cisplatin and 5FU).

Table 2 Reconstructive and rehabilitative options chosen for ablative defects classified according to defect size.

Defect Obturator Pedicled flap Soft tissue free flap Composite free flap
Temporalis Radial forearm Anterolateral thigh Scapula
1 3 4 1 - -
2 10 5 2 2 -
3 4 1 - - 2
4 4 - 1 - -
Total 21 10 4 2 2

University of Washington Quality of Life Questionnaire (UW-QOL v4)

Overall there was a significant decrease in health-related QoL after treatment compared with preoperatively (p < 0.001). The three subset analyses are given below.

The comparison of QoL with flaps and obturators before and after treatment is shown in Fig. 1. There was no significant difference in QoL after treatment between flaps and obturators, either overall, or when analysed by physical function (mean difference −15.22, p = 0.31) and social-emotional function domains (mean difference −7.93, p = 0.929). Similarly, when stratified by size of vertical defect using dichotomised categories, small (Brown class 1 and 2) and large (Brown class 3 and 4), there was no significant difference in mean QoL (p = 0.827 and p = 0.424 respectively, Fig. 2).4

gr1

Fig. 1 Health-related quality of life scores for each of the University of Washington questionnaire domains comparing flaps with obturators.

gr2

Fig. 2 Last available follow-up composite health-related quality of life scores for patients with flaps compared with obturators, grouped by size of vertical defect. Vert 1 = resection of alveolar bone, but not causing an oronasal fistula; Vert 2 = maxillary resection not involving the orbit; Vert 3 = maxillary resection involving the orbit but preserving the eye; and Vert 4 = orbital enucleation or exenteration.4.

Overall there was no significant difference in mean composite QoL scores between vertical defect groupings either before treatment (F(3,29) = 1.33, p = 0.283) or at last available follow-up (F(3,29) = 0.96, p = 0.439). Results of composite follow-up QoL results showed no evidence that larger defects resulted in a worse QoL. While patients with Brown defects 2 and 3 reported significantly lower follow-up QoL scores in both the physical and social-emotional domains, patients with a level 2 defect reported slightly more loss of physical function than social-emotional function (-13.66 compared with -10.78, Table 3, respectively).

Table 3 University of Washington health-related quality of life scores showing the postoperative effects of the size of the vertical defect. Data are expressed as mean (SD) except where otherwise stated.

Domain Treatment Last available follow-up Mean difference 95% CI p value
Physical Function domain:
 Vertical Brown score 1 (n = 5) 98.9 (2.53) 84.8 (13.70) -14.03 (-33.15 to 5.09) 0.111
 Vertical Brown score 2 (n = 18) 92.4 (8.98) 79.0 (16.75) -13.46 -23.35 to -3.57 0.011
 Vertical Brown score 3 (n = 6) 99.1 (2.31) 74.6 (18.05) -24.47 -43.40 to -5.54 0.021
 Vertical Brown score 4 (n = 4) 96.5 (4.66) 80.7 (13.21) -15.83 -35.13 to 3.46 0.080
Social-Emotional Function domain:
 Vertical Brown score 1 (n = 5) 98.0 (2.74) 81.2 (12.94) -12.63 -25.35 to 0.08 0.051
 Vertical Brown score 2 (n = 18) 93.2 (11.84) 82.4 (10.67) -10.78 -17.55 to -4.00 0.004
 Vertical Brown score 3 (n = 6) 98.4 (4.01) 73.7 (14.57) -24.61 -42.25 to -6.97 0.016
 Vertical Brown score 4 (n = 4) 93.0 (9.31) 86.6 (10.67) -6.38 -18.33 to 5.58 0.188

Vertical Brown scores: 1 = resection of alveolar bone but not causing an oronasal fistula; 2 = maxillary resection not involving the orbit; 3 = maxillary resection involving the orbit but preserving the eye; and 4 = orbital enucleation or exenteration.

There was no significant difference in mean composite QoL scores by vertical defect groupings at the last available follow-up between patients given adjuvant treatment compared with no adjuvant treatment (F(6,25) = 0.87, p = 0.534). Composite follow-up scores showed no evidence that the use of postoperative adjuvant radiotherapy or chemoradiotherapy resulted in significantly lower QoL scores in either functional domain (Table 4).

Table 4 University of Washington health-related quality of life scores for operation alone compared with postoperative radiotherapy or chemoradiotherapy.

Domain/adjuvant treatment Before treatment Last available follow-up Mean difference 95% CI p value
Physical function domain:
 Radiotherapy or chemoradiotherapy (n = 17) 96.2 (8.08) 80.0 (15.09) -16.24 -26.06 to -6.41 0.003
 Surgery alone (n = 16) 94.0 (6.83) 78.5 (16.95) -15.42 -24.60 to -6.23 0.003
Social-emotional function domain:
 Radiotherapy or chemoradiotherapy (n = 17) 95.0 (11.45) 80.7 (13.25) -14.32 -22.43 to -6.21 0.002
 Surgery alone (n = 16) 94.7 (7.49) 83.0 (9.69) -11.68 -18.11 to -5.24 0.002

Discussion

Outcomes reported by patients, such as health-related QoL, are becoming increasingly important measures to facilitate patient-centred care, to screen for physical and psychological problems, and to monitor a patient's progress over time.22 QoL is a valuable measurement of outcome that extends beyond the traditional clinician-judged measurements of outcome such as mortality and morbidity for patients with cancer.16 However, it is difficult to measure because it is multidimensional, subjective,and changes with time and circumstances.23 In this study we aimed to use an internationally-recognised and well-validated scale to try to compare different treatments prospectively as well as to judge the effect of the size of themaxillectomy defect on QoL.

The choice between flap reconstruction and provision of an obturator remains controversial and is highly operator-dependent. Moreno et al.7 described what is to our knowledge the largest comparative series to date (73 patients with obturators and 40 reconstructed with flaps) and found that reconstruction provided a better outcome for swallowing and speech, particularly for larger defects in the horizontal or dental component of the maxilla. The results did not differ significantly in the vertical dimension, but questionnaires were not used and aesthetics (more likely to be a problem in this dimension) were not measured. Previous studies also reported no difference in health-related QoL between obturators and reconstruction for Class I and II defects.1, 4, and 5 We found no significant difference between flaps and obturators in terms of QoL at one year. Treatment must always be tailored to an individual patient's needs, but findings such as ours confirm that obturators, particularly if retained with implants, remain an acceptable option for rehabilitation in selected patients.

The three-dimensional visualisation of invasion into the midface, and the complex anatomy, can make obtaining clear margins difficult. There is also an understandable desire to maintain function and form whenever possible, such as by preserving the eye. Invaded margins may necessitate adjuvant postoperative radiotherapy or chemoradiotherapy,24 and not all patients are likely to tolerate this so clinicians have understandable concerns that it may adversely affect their QoL for only a limited benefit in terms of survival. For example, the strongest predictor of adverse effects on QoL after obturator treatment is known to be postoperative radiotherapy.2, 12, 14, 15, 18, and 21 In addition, the size of the defect after maxillectomy, particularly the extent of resection of the hard and soft palate, has been shown to affect the function of the obturator and the QoL, with most studies reporting that the larger the defect the worse the outcome.2, 7, and 10 The limited evidence for patients not treated with an obturator also suggests that larger defects result in worse QoL.1 We found that neither increasing the size of the vertical defect in an attempt to ensure clear margins, nor postoperative radiotherapy, seemed to have an adverse effect on the health-related QoL.

We recognise that our study does have a number of potential limitations. Mean (SD) time of follow up was 14 (4) months, and it may be that significant differences between groups would have developed given more time. However, studies that have evaluated QoL in patients with tumours of the head and neck have shown that the most important changes in QoL happen during the first year after diagnosis.20 and 25 We also gave no detail on formal completeness of oral rehabilitation and made no objective tests, such as measurement of trismus. We also had a sample size that was insufficient to compare particular subgroups, such as the effect of placement of implants in patients with obturators compared with those that did not. We hope that by continued prospective data gathering we will also be able to compare the effects of subtypes of flaps used for different sizes of defects on QoL. A multicentre trial would increase numbers of patients, and such a collaboration is currently being attempted between units in our region.

The three general questions at the end of the UoW health-related QoL questionnaire reflect overall QoL and therefore may include morbidity at donor sites. However, the use of the UoW questionnaire since the inception of this study has enabled the surgeons in our unit to tailor their surgical practice to patients’ concerns. There has been gradual trend away from use of the temporalis local flap because both clinicians and patients dislike it, but there were too few of these flaps to permit individual analysis of this subgroup. There were also no fibular or DCIA flaps during this particular period, which was purely a matter of chance and not the choice of the operator. It is likely that had a larger group of patients been studied then these bone flaps would have been used. Despite these limitations we think that these results will add to the evidence about decision-making in the treatment and rehabilitation of patients after maxillectomy.

Conflict of Interest

We have no conflict of interest.

Ethics statement/confirmation of patients’ permission

Health-related quality of life assessments are incorporated into the management of our centralised head and neck oncology service and used to focus consultations to the patient's needs. All responses have been anonymised and patients’ data kept strictly confidential.

References

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Footnotes

a Department of Oral and Maxillofacial Surgery, New Cross Hospital, Wolverhampton, England WV10 0QP

b Academic Department of Military Surgery and Trauma, Royal Centre for Defence Medicine, Birmingham Research Park, Birmingham B15 2SQ

c Biostatistical Operations, Worldwide Clinical Trials, Isaac Newton Centre, Nottingham Science Park, Nottingham, England NG7 2RH

Corresponding author at: Department of Oral and Maxillofacial Surgery, New Cross Hospital, Wolverhampton, England WV10 0QP.


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