The article by Moore provides an example of much needed research
evaluating clinical outcomes in head and neck oncology. Measuring
the quality of life (QOL) of patients with head and neck cancer
presents some unique challenges. First, head and neck cancer profoundly
influences some of the most fundamental functions of life, including
breathing, eating, and communication. Second, treatment of head
and neck cancer does not always improve these functional deficits,
and in many instances, the treatment itself results in further
deterioration of these functions. Finally, "traditional"
outcome measures (disease-free survival, overall survival, local
and regional control, response rates) do not adequately assess
the global impact of this disease and/or its treatment on patients'
perception of life satisfaction.
Sometimes the treatments used for head and neck cancer, which
include surgery, radiation, or chemotherapy (used as single modalities
or in any combination), can result in disabilities that patients
perceive as being worse than the untreated disease.[1,2] Therefore,
there is a need for the use of validated instruments to quantify
the impact of head and neck cancer and its treatment on patients'
Although interest in the incorporation of QOL outcome measures
in head and neck cancer has recently increased, several questions
remain unanswered: Which instrument should be used? Is a general,
disease-specific, or site-specific instrument most appropriate
in this patient population? Is head and neck cancer a single disease
or a heterogeneous collection of the same disease at different
subsites? Are certain instruments more specific to some treatment
modalities than others? What is the most appropriate frequency
and duration of QOL assessment in head and neck cancer patients?
Who should administer the questionnaires? This discussion will
explore some of the controversy surrounding these issues.
Which QOL Instrument to Use?
General vs Disease Specific--Health-related QOL instruments
can be divided into general and disease-specific instruments.
General measures assess the overall impact of patients' health
status on their QOL. Examples of such instruments include the
Sickness Impact Profile (SIP), the Quality of Well-Being Scale,
and the Medical Outcome Study (MOS). General instruments employ
detailed questionnaires, including numerous items that cover a
broad spectrum of functional, physical, psychological, and social
domains. Their main advantage is that they can be utilized across
a broad range of patients, and allow for comparison of results
across different diseases. The disadvantage of general instruments
is their lack of responsiveness to the peculiar aspects of a particular
disease process, such as cancer.
Disease-specific instruments are designed to evaluate in more
depth the intricate features of a particular disease process.
Examples of cancer-specific instruments include different performance
status measures (Karnofsky, ECOG, AJCC), the Quality
of Life Index, and the Functional Living Index-Cancer, or FLIC).
These instruments are often more responsive to changes in cancer
patients' health status over time than are general measures.
Site-Specific vs Modular Instruments--Although the diagnosis
and treatment of cancer result in certain salient and well-recognized
effects common to all cancer patients, the location of disease
poses specific problems unique to that particular site. The head
and neck region provides a very dramatic example of this concept.
The devastating effects of head and neck cancer and/or its treatment
on voice, speech, mastication, deglutition, sense of taste and/or
smell, and facial appearance are peculiar to this patient population.
Site-specific instruments are designed to be more responsive than
cancer-specific instruments in measuring those difficulties that
are most pronounced at a particular site. Examples of head and
neck-specific instruments include the Performance Status Scale
for Head and Neck Cancer Patients (PSS-HN) used in the Moore
article, the University of Washington Head and Neck Questionnaire
(UW QOL), and the Head and Neck Radiation Therapy Questionnaire
Site-specific instruments may lack some of the broader assessment
of the impact of cancer on patients' QOL. To combine the benefits
of both approaches, some instruments have been designed with a
measurement strategy called the "modular approach."
In this approach, a core disease-specific instrument is used for
all patients with the diagnosis of cancer, supplemented with a
site-specific instrument that varies with the site of origin or
method of treatment. Examples of such instruments are the Functional
Assessment of Cancer Therapy (FACT)[reference 14 and personal
communication, D. F. Cella, md, January 10, 1992] and the European
Organization for Research and Treatment of Cancer (EORTC) Core
Quality of Life Questionnaire, both of which have supplementary
head and neck modules. This modular approach may prove to be ideal
in measuring QOL in patients with head and neck cancer.
Is Head and Neck Cancer a Single Disease?
Patients with head and neck cancer have certain similarities.
Most of these patients give a long-standing history of heavy tobacco
and alcohol consumption. These carcinogenic factors also predispose
patients to common comorbidities, including chronic obstructive
pulmonary disease, pancreatitis, cirrhosis, delirium tremens,
and second malignancies, especially lung cancer. These comorbidities
have a somewhat uniform impact on the QOL of head and neck cancer
patients regardless of the primary site.
Conversely, the biologic behavior, and hence, outcome of head
and neck cancer depend largely on the site of disease (eg, larynx,
oral cavity, nasopharynx, and so on). Also, the disabilities that
result from head and neck cancer or its treatment vary widely
according to the site of involvement. The article by Moore presents
an excellent example of measuring QOL in a specific subsite of
a relatively homogeneous patient population with base of tongue
Treatment-Specific QOL Measures
Some QOL instruments are better suited to measuring the morbidity
of surgical extirpation of head and neck cancer, while others
are more sensitive to the morbidity associated with radiation
and/or chemotherapy. For instance, the UW QOL includes domains
that assess pain, disfigurement, chewing, swallowing, speech,
shoulder disability, activity, recreation, and employment--all
of which are profoundly affected by surgical ablation of head
and neck cancer (eg, laryngectomy, glossectomy, mandibulectomy,
neck dissection). On the other hand, the HNRQ contains items
detailing the assessment of mucositis, skin reactions, xerostomia,
nausea, vomiting, appetite, and energy level, among others. These
items are more profoundly influenced by radiation and/or chemotherapy
than by surgery.
In the article by Moore, the PSS-HN was chosen to assess the QOL
of patients treated primarily with radiation therapy. The three
domains detailed by the PSS-HN (eating in public, understandability
of speech, and normalcy of diet) are more likely to be influenced
by surgical ablation of head and neck cancer than by radiation
therapy. The PSS-HN was initially validated in patients treated
largely with surgery, and its results were highly responsive to
the extent of surgical resection. This instrument does not
specifically assess radiation-induced morbidity. This probably
leads to underestimation of the effects of radiation on the QOL
of these patients. It also makes comparison between the two modalities
of treatment (surgery vs radiation) less meaningful. An instrument
specifically designed to assess radiation-induced morbidity (eg,
the HNRQ or EORTC) would have been more appropriate in
a patient population treated primarily with radiation.
Frequency and Duration of QOL Assessment
Temporal factors greatly influence the results of QOL assessment.
When measuring the acute morbidity of a disease process or its
treatment, one should measure QOL frequently. In the case of radiation
therapy or chemotherapy, QOL measurement probably should be done
before treatment, at weekly or biweekly intervals during treatment,
and for several weeks afterward.
Some therapeutic modalities have delayed effects (months or years)
on QOL, and thus, require delayed measurement. If such a determination
is not performed, the impact of this delayed morbidity may be
missed. An example of this pitfall is the study by Harrison et
al cited in the Moore article. Harrison et al used the PSS-HN
in patients with base of tongue cancer treated with surgery and/or
radiation. The radiation-therapy group had consistently better
scores, and the authors recommended using radiation as a primary
modality of therapy because the radiation-therapy group had survival
rates equal to those of the surgery group but had better QOL.
Several caveats about these conclusions are worth mentioning.
First, the previously mentioned limitation of the PSS-HN being
a more surgery-sensitive than radia-
tion-sensitive instrument applies to the Harrison et al study
as well as to the Moore study. Second, Harrison et al gave no
indication of the extent of surgical resection. Finally, and perhaps
most importantly, the Harrison et al study did not report
long-term QOL scores.
These issues are crucial because before any modality, either surgical
or radiotherapeutic, becomes accepted as the primary treatment
for any particular type of head and neck cancer, its long-term
effect on QOL should be known. For instance, Larson et al
reported on long-term complications in 128 patients who had cancer
of the oral cavity and oropharynx treated with radiation therapy
alone and who were free of disease for at least 5 years. The study
reported a 56.3% overall incidence of soft-tissue ulceration,
osteoradionecrosis, or spontaneous fracture. Osteoradionecrosis
occurred in 44 of 119 patients, and the incidence of this complication
increased over time (42% within 2 years, 56% within 3 years, and
82% within 5 years). Out of these 44 patients, 18 required subsequent
partial mandibulectomy or hemimandibulectomy.
This study illustrates the need for long-term QOL measurement
especially when dealing with a treatment modality that has a relatively
high rate of delayed complications.
Who Should Administer QOL Questionnaires?
Questionnaires on QOL can be self-reported (administered by the
patients themselves) or interviewer-reported (administered by
a physician, nurse, or other professional).
The PSS-HN used in the article by Moore is an example of an interviewer-administered
questionnaire. The main advantage of these instruments is that
they avoid vague or incomplete answers. Their main disadvantage
is that the quality of data is highly interviewer-dependent. Possible
areas of interviewer bias include their training and preconceptions
about patients' demographics (age, sex, race, education, social
class, and so forth), the disease process, or the treatment utilized.
Several studies have demonstrated the poor correlation between
patients' self-ratings and interviewer-generated ratings. Currently,
patient self-reporting is generally the preferred method of obtaining
The article by Moore describes the use of a well-defined QOL instrument
in a homogeneous group of patients with base of tongue cancer
treated with radiotherapy. Future studies in a similar patient
population should perhaps consider an instrument that is more
suited to the assessment of radiation-induced morbidity and its
effect on QOL in such patients. Other factors that may enhance
the ability to assess QOL in head and neck cancer include long-term
reporting, patient-administered questionnaires, and instruments
of the "modular" type that involve a core cancer-specific
questionnaire with a head and neck specific module.
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