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Predictors of Non-Compliance with Radiotherapy
Among Patients with Squamous Cell Carcinoma of
the Head and Neck Treated at a Veterans Affairs
Hospital A. Knight, M.D., S.P. Lee, M.D.,
Ph.D., G. Juillard, M.D., J. Sayre, Ph.D., J.
Abelson, M.D., B. McGibbon, M.D., A. Sadeghi,
M.D.Department of Radiation Oncology,
University of California, Los Angeles,
Department of Radiation Oncology, West Los
Angeles Veterans Affairs Hospital, Los Angeles
Discussion
Results Patient Characteristics
Results Compliance Rates and Analysis
Purpose
The purpose of this study was to determine the
rate of non-compliance with radiotherapy among
West Los Angeles Veterans Affairs Hospital
(WLAVA) patients treated for squamous cell
carcinoma of the head and neck (SCCHN), as well
as to identify patient and treatment variables
predictive of non-compliance. The secondary
purpose of the study was to examine the
correlation of the same variables with overall
survival.
133 patients who initiated treatment at the WLAVA
for head and neck cancer between January 1, 2000
and December 31, 2005 were identified. Of these,
25 were excluded from the analysis. The
remaining 108 patients were included in the
analysis. Reason for Exclusion
Number of patients
Of the 108 patients included in the analysis, the
median number of missed radiotherapy days was
two. Patient variables of low KPS, advanced
stage, and short distance of the patients
primary address to the hospital were identified
by stepwise multiple logistic regression analysis
as predictive of missing greater than two
treatment days. Performance of this analysis, as
measured by area under the ROC curve, was 0.73
(95 confidence interval 0.64-0.83.) Of the 108
patients, 59 patients had follow-up of at least
two years. These patients were included in the
survival analysis. Of these, 35 were alive at
the time of analysis, for an actuarial two year
overall survival of 59. Patient variables of
smoking cessation, high KPS, and young age were
identified by stepwise multiple logistic
regression analysis as predictive of survival at
two years. Performance, as measured by area
under the ROC curve, was 0.82 (95 confidence
interval 0.72-0.93.)
At WLAVA, patients with SCCHN are at high risk
for factors we hypothesized would impact their
ability to adhere to a demanding and toxic
treatment regimen. For example, they are largely
single, often have a history of alcohol or other
substance abuse, and have a relatively high rate
of psychiatric illness. Additionally, and
possibly as a result of the above factors, they
often present with SCCHN with advanced
stage. Compliance among these patients was
surprisingly high. This finding lends validity
to the comparison of data between trials
performed within the VA system with those
performed in university settings. 57 of
patients missed no more than two treatment days,
and only 27 missing more than five treatment
days. These rates are similar to those observed
in a recent review of several clinical trials of
altered fractionation regimens. Notably,
increasing distance from the patients home
address to WLAVA was found to be a significant
predictor of compliance. While this finding may
seem counterintuitive, such patients are provided
with campus housing. However, such housing is
available to all patients, regardless of their
distance to WLAVA, and lodging on campus alone
did not predict compliance. Several factors
were not found to be predictive of compliance,
which we had hypothesized would be significant.
Among these are psychiatric illness, alcohol or
substance abuse, and single cohabitation status.
Also, markers of treatment intensity, including
concurrent chemotherapy and post-operative
treatment were not significant predictors. Overal
l survival analysis was performed secondarily and
was limited by small sample size. Predictably,
young age and good performance status predicted
survival. Smoking cessation also predicted
improved survival. Compliance with radiotherapy
was noted to be a predictor of survival in
univariate, but not multivariate analysis (data
not shown.)
Background
Patients with SCCHN experience a high level of
disease-related and treatment-related toxicity,
which may lead to prolongation or discontinuation
of therapy. However, treatment interruption is
known to have a detrimental effect on
locoregional control and survival. Therefore,
treatment compliance is especially challenging
and important for these patients. A review by
Khalil et al. of several clinical trials for
SCCHN demonstrated that approximately a quarter
of patients had treatment prolonged more than
five days beyond the planned duration.
Corresponding data for patients treated in the
community setting are limited. A study of SCCHN
patients treated in an inner-city community
hospital found that more than half of patients
either discontinued radiotherapy prematurely or
had overall treatment times extended by 20
beyond planned. WLAVA is a referral center for
radiation oncology within the VA system, with
some patients traveling more than 250 miles for
treatment. Patients are provided with campus
housing during radiotherapy when needed.
However, the feasibility of this treatment model
for this patient population has not been
thoroughly evaluated. We planned to use the
outcomes of this study to better identify
patients at risk for treatment non-compliance,
and thus develop intervention strategies to
optimize therapy.

• Patient and treatment characteristics are listed
  in the table below. All patients were male, with
  a median age of 61 years. Notable variables are
  listed below.
• Patient variables 67 were single, only 6 had
  never smoked, only 32 had never been heavy
  drinkers, 32 had a psychiatric diagnosis, and
  only 34 had a KPS of 80 or higher.
• Disease variables 48 had an oropharyngeal
  primary, 58 were stage IV, and 80 were at least
  stage III.
• Treatment variables 63 were treated with
  concurrent chemotherapy, and 22 received
  radiotherapy post-operatively.

Non-compliance (108 patients)
Conclusion
Methods

• A retrospective analysis of SCCHN patients
  treated with radiotherapy at WLAVA demonstrated
  compliance rates with radiotherapy treatment that
  are comparable to those observed in clinical
  trials.
• Patients living at a great distance from WLAVA
  had compliance rates superior to the overall
  group, indicating that our referral-based system
  does not compromise patients ability to complete
  their radiotherapy treatment.
• Patients with advanced stage disease and low
  performance status were found to be at risk for
  non-compliance with radiotherapy.
• Young age, good performance status, and
  smoking cessation predicted improved overall
  survival.

SCCHN patients who initiated radiotherapy
treatment at WLAVA between January 1, 2000 and
December 31, 2005 were retrospectively
identified. Patients were excluded from analysis
if their treatment was palliative or if they died
during treatment. For the included patients,
demographic, medical, and treatment-related
information were collected from the departmental
chart and VA electronic medical record. This data
included the number of missed treatment days, the
reason for missed treatments, and whether the
patient discontinued treatment prematurely.
Additionally, survival and follow-up duration
were recorded, measured in months after the
completion of radiotherapy. Non-compliance was
measured in number of days of radiotherapy missed
due to patient-related issues (machine
malfunction and departmental closure days were
not included.) Patient and treatment variables
were examined by stepwise multiple logistic
regression analysis for prediction of
non-compliance. The predictive accuracy of the
significant variables was examined by creation of
a receiver operating characteristic (ROC) curve.
SPSS version 14.0 (Chicago, IL) was used for
statistical analysis. Survival analysis was
performed only for patients treated at least two
years prior to the time of data collection, thus
assuring adequate follow up.
Survival (59 patients)
Selected References

• Cathcart CS, et al., Patterns of delivery of
  radiation therapy in a inner-city population of
  head and neck cancer patients an analysis of
  compliance and end results, Journal of Medicine,
  199728(5-6)275-84.
• Franciosi V, et al., Compliance and outcomes in
  locally-advanced head and neck cancer patients
  treated with alternating chemoradiotherapy in
  clinical practice, Tumori, 200389(1)20-25.
• Garden AS, et al., Preliminary results of
  radiation therapy oncology group 97-03 a
  randomized phase II trial of concurrent radiation
  and chemotherapy for advanced squamous cell
  carcinomas of the head and neck, Journal of
  Clinical Oncology, 2004(22)14 2856-2864.
• Khalil A, et al., Compliance to the prescribed
  dose and overall treatment time in five
  randomized clinical trials of altered
  fractionation in radiotherapy for head and neck
  carcinomas, Int J Rad Oncol Biol Phys,
  200355(3)568-575.
• Konski, A., et al., Disadvantage of men living
  alone participating in radiation therapy oncology
  group head and neck trials, Journal of Clinical
  Oncology, 200624(25)4177-4183.
• Pajak TF, et al., Elapsed treatment days a
  critical item for radiotherapy quality control
  review in head and neck trials RTOG report, Int
  J Radiat Oncol Biol Phys, 199120(1)13-20.
• Vercelli M, et al., and the ELDCARE Working
  Group, Cancer survival in the elderly Effects
  of socio-economic factors and health care system
  features (ELDCARE project), European Journal of
  Cancer, 200642(2)234-242.

ROC Curve Survival
ROC Curve Compliance
For Further Information
Andrew Knight, M.D. aknight_at_mednet.ucla.edu,
[phone]