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Exclusion:
T1 primary tumor or with large-volume stage T4
disease
Pretreatment staging
Laryngoscopy
measurement of the tumor
HRCT neck.
CT chest and barium esophagography
or panendoscopy - To rule out
synchronous primary cancers
Imaging was performed as clinically
indicated to rule out metastatic disease.
1st group – IC + RT
Similar to the treatment group in VA trial.
Laryngectomy –
proven persistent or recurrent carcinoma
after the completion of treatment (both
groups).
inadequate response after two courses
of induction chemotherapy (Group 1).
Follow-up
Examination of the head and neck and CT
imaging – 8 weeks.
Direct laryngoscopy under GA if disease
suspected.
Two questionnaires were used to evaluate
QOL:
1. Functional Assessment of Cancer Therapy
— Head and Neck Scale, version 2, 4
2. University of Washington Quality of Life
instrument
Study End Points
Primary end point - preservation of the
larynx.
Other end points
overall survival
disease-free survival
local control
locoregional control
the time to distant metastasis
laryngectomy-free survival.
Toxic effects were graded according to the
National Cancer Institute Common Toxicity
Criteria, version 1.0, during induction
chemotherapy and according to the
Radiation Therapy Oncology Group toxicity
criteria during radiotherapy.
All deaths occurring during treatment or
within 30 days after the completion of
treatment were considered to be possibly
treatment-related.
Statistical analysis
Dunnett’s two-sided test was used to
adjust for multiple comparisons.
The sample size was calculated with the
use of Bristol’s modification.
The sample size was increased by 10
percent to account for patients deemed
ineligible or lost to follow-up.
OS, DFS AND LFS using Kaplan–Meier
method with the log rank test.
Population stats
August 1992 to May 2000
547 patients
21 - ineligible
1 withdrew consent
7 were excluded as outcome information
was not submitted
518 patients were included in the
analysis
Toxic effects
Response to treatment and compliance
Preservation of the larynx
Speech and swallowing
Survival outcomes
Pattern of failure
Distant metastasis
Toxicity profile
IC + RT CCRT RT
Deaths 3% 5% 3%
Response to treatment & compliance
IC + RT n = 173 CCRT n = 172 RT n = 173
Non-responders
Responders (144)
(24)