A journal club presentation comparing and contrasting the EORTC and RTOG trials of concurrent chemoradiation in Head Neck Cancers in the post operative setting.
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Concurrent Chemoradiation in Postoperative Setting In LAHNC. A comparision of the EORTC and RTOG trials.
1. Long-term Follow-up of the RTOG
9501/Intergroup Phase III Trial: Postoperative
Concurrent Radiation Therapy and
Chemotherapy in High-Risk Squamous Cell
Carcinoma of the Head and Neck
2. Introduction
● In the 1990s two randomized clinical trials
were conducted looking at the role of
concurrent chemoradiation after surgery in
LAHNCC
– RTOG 9501 (Blue)
– EORTC 22931 (Yellow)
● Publications discusses results at long term
FU.
3. Inclusion Criteria (RTOG / EORTC)
● High Risk LAHNSCC
– ≥ 2 Involved Nodes
– ECE
– Positive mucosal
margin
* No stage as inclusion /
exclusion criteria
● T3 – T4 with any N (except
T3N0 Larynx)
● T1-2 with N2-3
● T1-2 with N0-1 with high risk
features:
– ECE
– PNI
– LVE
– Positive Margins
– Level IV-V involement in oral
cavity / oropharyngeal cancers
6. Radiotherapy & Chemotherapy
● Time: Within 56 days
● Dose : 60 Gy in 30 #
● Optional Boost : 6 Gy
●
CDDP 100 mg/m2
D1, D22, D43
● Time : ?
● Dose:
– Ph I: 54 Gy in 27 #
– Ph II: 12 Gy in 6 #
(Boost to areas with high
risk of tumor
dissemination / close
margins)
●
CDDP : 100 mg/m2
D1,
D22 and D43
7. Trial Design
● Control Arm : 2 year
LC 38%
● Absolute
Improvement of 15%
● Total No: 438
(assuming 10%
attrition)
● Control Arm : 3 year
PFS 40%
● Absolute
Improvement of 15%
● Total No: 338
8. Study Endpoints
● Locoregional Control
(1º) – LF / RF or
both.
● DFS
● OS
● Adverse Effects
● PFS (1º) – Any type of
progression or death.
● OS
● Local/Regional Failure
● Distant Metastasis
● 2nd Cancers
● Adverse Events
18. Combined EORTC/RTOG Analysis
● Points of difference (RTOG vs EORTC):
– More oropharyngeal cancers
– Less hypopharyngeal cancers
– More number N2-N3 disease
– More number PD tumors
– However only 59% of patients had ECE &/or +ve
margins as compared to 70% in EORTC !!
19. Combined EORTC/RTOG Analysis
Implication : Number of nodes involved and T stage as well as level of node
involved are not important predictive factors that result in benefit from CRT.
20. New RTOG Analysis
● In ECE / +ve Margins RT alone resulted in :
– 10 Year LRR increased from 21% to 31%
– 10 year DFS decreased from 18% to 12%
– 10 year OS decreased from 27% to 19%
● These differences were not seen when ECE &
or +ve margins were absent.
● No significant differences by the number of
nodes involved.
23. Late Toxicity
● Grade 3 – 5 late
toxicity developed in
25% CRT vs 20% RT
patients
● Grade IV toxicity:
7.3% for CRT vs
3.7% for RT
●
24. Conclusions
● Longer term followup has blunted the benefits
that CRT provides above RT
– However benefit in DFS / LRC in ECE/+ve
margins persist
● Late toxicity increased
– However with time increased incidence not seen
● CRT did not appear to benefit in multiple
nodes.