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Oral Papers
S001
QUALITY AND PERFORMANCE INDICATORS FOR AN ACADEMIC
HEAD AND NECK SURGICAL ONCOLOGY DEPARTMENT. Randal S
Weber, MD, Scott Eastman, MBA, Ehab Y Hanna, MD, Olubumi Akiwumi,
MS, Amy Hessel, MD, Stephen Y Lai, MD PhD, Leslie Kian, MBA,
Michael Kupferman, MD, Dianna Roberts, PhD; Department of Head
and Neck Surgery, University of Texas MD Anderson Cancer Center,
Houston, Texas.
Introduction: Health care costs are rapidly outstripping a level of
economic sustainability. Delivery of high quality and effective care will
be the underpinnings of cost control. Future payments to health care
providers may be tied to meeting quality and performance benchmarks
that are adjusted for patient acuity. The study objective was to create
the methodology for assessing physician performance and quality of
care delivered in a tertiary surgical oncology practice and to develop
a monitoring tool for the utilization of global and subspecialty-specific
quality and performance indicators that positively impact patient care,
safety, and satisfaction. Methods: Between 2004 and 2008 data was
collected on the following outcome measures for 10 surgeons. These
included length of stay (LOS), return to operating room (OR) within 7
days of surgery, and 30-day: mortality, hospital readmission, transfusion,
and wound infection. Patients were divided into two groups, high
and low acuity, based on the extent of their procedure. High acuity
procedures were: mandibulectomy, pharyngolaryngectomy, and major
glossectomies, all with major reconstruction. Low acuity procedures
were: laryngoscopy, lymphadenectomy, minor glossectomies,
parotidectomy, and thyroidectomies. To assess relative performance by
surgeon, the number of negative indicators developed by each patient
was enumerated and the percent of cases for each physician that
developed one or more negative indicators, for low acuity cases, and
two or more negative indicators, for high acuity cases was determined.
2234 low acuity and 384 high acuity procedures were performed.
Adjustments were made for comorbid conditions that included cardiovascular
disease, COPD, diabetes, liver disease, prior heart failure, and
renal disease. The impact of these factors was examined in two ways:
the presence of any comorbidity and any two or more comorbidities.
The procedure acuity, comorbid conditions and influence of the surgeon
were used to develop a risk estimates. Physicians were ranked on each
positive or negative indicator among cases stratified by procedure acuity.
Results: The methodology allowed for grouping commonly performed
head and neck surgical procedures into two major categories based
upon scope of the procedure. Available comorbidity data permitted an
adjustment of risk thereby removing this as a bias for examining surgical
outcomes by provider. Patients undergoing high acuity procedures had
a significantly higher proportion of 2 or more comorbid conditions than
patients undergoing low acuity procedures (29% vs. 15%) and high
acuity procedures, as expected, were associated with greater LOS
(median of 8 days vs. 1 day), increased blood product usage (41% vs.
3%), and higher rates of all the other negative indicators. The relative risk
estimates for two or more negative quality or performance indicators was
as follows: procedure acuity high vs. low (RR=3.9), operating physician
(RR=3.4) and co-morbid conditions (RR=1.9). Conclusions: The data
demonstrated the feasibility of examining the impact of procedure
type, physician influence and comorbidity on accepted performance
measures and how this methodology can be used to evaluate physician
performance. These data may identify best practices and provide
benchmarks that permit comparison of physician performance.”
S002
TRANSORAL ROBOTIC SURGERY (TORS): A MULTICENTER STUDY
TO ASSESS SAFETY, FEASIBILITY AND EFFICACY. Gregory S
Weinstein MD FACS, Professor and Vice Chairman, J. Scott Magnuson
MD FACS, Associate Professor of Surgery, Eric J Moore MD FACS,
Associate Professor, William R Carrol MD FACS, Professor, Kerry D ,
Olsen MD FACS, Bert O’Malley, Professor and Chairman, F. Christopher
Holsinger, Associate Professor, F. Christopher Holsinger, Associate
Professor; Department of Otorhinolaryngology: Head and Neck Surgery,
The University of Pennsylvania; Department of Otorhinolaryngology,
Mayo Clinic, Minnesota; Department of Head and Neck Surgery, The
University of Texas MD Anderson Cancer Center, Houston.
Background: Single institution series have demonstrated the potential
for Transoral Robotic Surgery (TORS) for the treatment of head and
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neck cancer. We present here the results of a multicenter study
to assess safety, feasibility and efficacy of this minimally invasive
approach. Objectives: To determine the safety, feasibility and efficacy
of transoral robotic surgery in a multicenter trial. Design and Setting/
Interventions: A review of patients undergoing TORS in multicenter
prospective clinical trial in academic tertiary referral centers. Patients:
192 patients were initially screened but inadequate exposure did
not permit TORS in 13 (6.7%). In two additional patients, TORS was
performed but intraoperatively converted to an “open” procedure. Thus,
our intent-to-treat population had a total of 177 patients (average age:
59 yrs; 81% male). 98.3% had a Charlson comorbidity index of >5.
162 patients had malignant tumors; 15 with benign disease. Patients
had tumors of the oropharynx (77%), larynx (15%), and other sites,
including the hypopharynx and oral cavity, (8%). Average follow-up was
354 days. Results: For all 177 patients undergoing TORS, we found
an average hospital stay post-operatively was 4.2 days. 12.4 % of all
patients (22/177) required tracheostomy in the perioperative period, but
only 2.3% (4/177) had their tracheostomy at last follow-up. Average
estimated blood loss was 82.8 cc and no patient required transfusion.
There was no intraoperative mortality or death in the immediate postoperative
period. However, 30% of patients experienced at least
on adverse event (AE), including 16% with a serious AE. Nine (5%)
patients had post-operative hemorrhage, including 5 who required an
operative procedure to control. Five patients developed post-operative
pneumonia. The rate of temporary dysphagia was 3.4% (6/177). For
162 patients undergoing TORS for malignancy, most patients (87%) had
squamous carcinoma with the following staging: T1 (31.9%); T2 (51.6%);
T3 (13.6%); T4 (4.9%). In this group, the rate of positive margins was
4.3% (7/162). Average operative time, including time for exposure and
robotic docking was 162 minutes. At 12 months following TORS, only
7.4% of patients required gastrostomy for alimentation. Summary:
In this multicenter study, we demonstrate that TORS is an safe,
feasible and effective across institutions and surgeons. There was no
perioperative mortality and few serious adverse events. We document a
low rate of positive surgical margins and excellent functional outcomes.
These findings suggest that TORS should play an important role in the
multidisciplinary management of head and neck cancer.
S003
EVALUATION OF GRADE 3/4 MUCOSITIS AND DYSPHAGIA FOR
THREE DIFFERENT RADIOTHERAPY REGIMENS, WITH AND
WITHOUT CETUXIMAB, IN LOCOREGIONALLY ADVANCED HEAD
AND NECK CANCER. J A Bonner, MD, P M Harari, MD, J Giralt, MD, H
Youssoufian, MD, J Zhu, PhD, K K Ang, MD; The University of Alabama
at Birmingham, Birmingham, AL, USA; University of Wisconsin, Madison,
WI, USA; Vall D’Hebron University Hospital, Barcelona, Spain; ImClone
Systems Corporation, Branchburg, NJ, USA.
Background: Patients with locoregionally advanced head and
neck cancer (LAHNC) benefit form altered fractionated radiotherapy,
compared to once-daily radiotherapy, when radiotherapy alone is the
primary treatment. Altered fractionated radiotherapy may not be as
important when chemotherapy is given in combination with radiotherapy.
The acute toxicities of mucositis and dysphagia can increase with more
aggressive radiotherapy regimens. This analysis compared the rates
of grade 3/4 mucositis and dysphagia for three different radiotherapy
regimens with or without cetuximab. Methods: Patients (n = 424) with
(LAHNC) of the larynx, hypopharynx or oropharynx were entered on a
phase III randomized trial of radiotherapy alone vs. radiotherapy with
weekly cetuximab. As previously reported, the addition of cetuximab
resulted in an improvement in locoregional control and survival (NEJM,
354:567-578). Physicians were allowed to treat patients with one of three
radiotherapy (RT) regimens: 1) Once-daily radiotherapy (ODR) with 70
Gy / 35 fractions, 2) Twice-daily radiotherapy (TDR) with 72 – 76.8 Gy /
60 – 64 fractions or 3) 72 Gy / with 1.8 Gy daily and 1.5 Gy as a second
daily concomitant boost fraction during the last 12 days of treatment
(CBR). Patients who received cetuximab underwent a loading dose of
400 mg/m2 for 6 – 7 weekly treatments during radiotherapy. Toxicities
were assessed by the Radiation Therapy Oncology Group (RTOG) criteria
and comparisons of toxicities rates were made by chi square analyses.
Results: The trial included 424 patients (211 received cetuximab and
radiotherapy and 213 received radiotherapy alone). Mucositis was
reported in 397/424 patients and dysphagia was reported in 270/424
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