This document describes a study comparing the efficacy of induction chemotherapy plus chemoradiation to chemoradiation alone in patients with locally advanced non-small cell lung cancer. 48 patients were randomized to receive either 2 cycles of induction chemotherapy followed by chemoradiation (Arm B) or chemoradiation alone (Arm A). The study found no significant differences between the arms in treatment response rates, acute toxicities, disease-free survival, or progression-free survival. Both treatments had similar outcomes with no clear benefit seen from adding induction chemotherapy.

1. Dr. Rajib Bhattacharjee, PGT, IPGME&R, Kolkata
Dr. Subir Pal, PGT, IPGME&R, Kolkata
Dr. Somnath Roy, SR, IPGME&R, Kolkata
Dr. Siddhartha Basu, Professor & HOD, IPGME&R, Kolkata

2.  Lung cancer is the major cause of cancer
related deaths worldwide.
 About 85% of lung cancers are of non small
cell histology.
 In our OPD we most commonly encounter
stage III NSCLC (locally advanced).
 Locally advanced disease warrants curative
approach in the form of surgery or
radiotherapy

3. • Operable
• Stage III A
Surgery
• Stage III B
• Inoperable stage III A
Conc. CT-RT
• Stage III B
• Inoperable stage III A
Induction
chemo f/b RT

4. Induction chemo with Cisplatin &Vinorelbin f/b RT(60Gy) was compared to RT alone
CT-RT RT alone
Tumor response 56% 43%
Median survival 13.7 mo 9.6 mo
CONCLUSION – Sequential CT-RT improved tumor response and median survival
BUT
80-85% patients still die within 5 years due to loco-regional and distant failure in
both the arms.

5. CONCLUSION – Concurrent chemoradiation showed
survival benefit over sequential therapy.

6. The Jury is still out !!!

7. • To compare efficacy of adding induction chemotherapy to
chemoradiation with chemoradiation alone.
• PRIMARY END POINT
1. Response evaluation as per RECIST guidelines.
2. Comparison of acute toxicities according to RTOG/EORTC
radiation morbidity criteria.
• SECCONDARY END POINT
1. Disease Free Survival (DFS).
2. Progression Free Survival (PFS).

8. Assessed
for
eligibility
n = 56
Randomized
n = 53
Excluded
n = 3
Allocated to
intervention in arm A
n = 27
Did not receive
intervention (n=1)
Allocated to
intervention in arm B
n = 24
Did not receive
intervention (n=1)
Allocation
Lost to
follow up
n = 2
Lost to
follow up
n = 1
Analyzed
n = 25
Analyzed
n = 23
Follow
up
Analysis

9. Concurrent CT-RT with
Paclitaxel(50mg/m2)
iv weekly
Carboplatin(AUC2)
iv weekly
RT dose – 66 Gy in
2 Gy/#
Arm A
n = 25
Induction CT with
Paclitaxel(200mg/
m2) iv 3weekly
Carboplatin(AUC6)
iv 3weekly
2 cycles
Concurrent CT-RT
As Arm A
Arm B
n = 23

10. Baseline characteristics
 Age & sex distribution, performance status,T & N stages and
histology were similar in the two arms (p>0.05).
 Sex distribution – male in Arm A – 88%
Arm B – 95.65% [p = 0.61]
 Smoker – in Arm A – 84%
Arm B – 86.95% [p = 1.00]
Median follow up
 Arm A – 8 months (2 – 14months)
 Arm B – 8 months (2-16 months).

11. Arm
Response
Total
CR PR SD PD
A 5
20%
9
36%
5
20%
6
24%
25
100%
B 6
28.06%
10
43.47%
4
17.39%
3
13.04%
23
100%
Total 11
22.91%
19
39.58%
9
18.74%
9
18.74%
48
100% 0
5
10
15
20
25
30
35
40
45
50
Arm A Arm B
ChartTitle
CR PR SD PD
P = 0.76

12. Arm
Recurrence after CR
Total
No Yes
A 3
60%
2
40%
5
100%
B 5
83.33%
1
16.67%
6
100%
Total 8
72.72%
3
27.27%
11
100%
0
1
2
3
4
5
6
7
Arm A Arm B
CR Disease free RecurrenceP = 0.54

15. Arm Toxicity grade Total
0 1 2 3
A 10
40%
9
36%
5
20%
1
4%
25
100%
B 12
52.17%
9
39.13%
2
8.69%
0
0%
23
100%
Total 22
45.83%
18
37.49%
7
14.58%
1
2.08%
48
100%
0
2
4
6
8
10
12
14
Arm A Arm B
Grade 0 Grade 1
Grade 2 Grade 3P = 0.25

16. Arm
Toxicity grade
Total
0 1 2 3
A 11
44%
9
36%
4
16%
1
4%
25
100%
B 7
30.43%
12
52.17%
4
17.39%
0
0%
23
100%
Total 18
37.49%
21
43.74%
8
16.67%
1
2.08%
48
100%
0
2
4
6
8
10
12
14
Arm A Arm B
Grade 0 Grade 1
Grade 2 Grade 3
P = 1.00

17. Arm
Toxicity grade
Total
0 1 2 3
A 9
36%
12
48%
3
12%
1
4%
25
100%
B 4
17.39%
12
52.17%
5
21.73%
2
8.69%
23
100%
Total 13
27.08%
24
50%
8
16.67%
3
6.25%
48
100%
0
2
4
6
8
10
12
14
Arm A Arm B
Grade 0 Grade 1
Grade 2 Grade 3P = 0.31

18. Arm
Toxicity grade
Total0 1 2
A 19
76%
5
20%
1
4%
25
100%
B 19
82.6%
4
17.39%
0
0%
23
100%
Total 38
79.16%
9
18.74%
1
2.08%
48
100% 0
2
4
6
8
10
12
14
16
18
20
Arm A Arm B
Grade 0 Grade 1 Grade 2
P = 0.73

19. • In our study, 48 patients were finally analyzed
in two arms. Patients in both arms had similar
baseline characteristics.
• Majority of the patients were male smokers.
• The overall response rate with induction
chemotherapy was higher but it did not attain
statistical significance.
• The acute toxicities were similar in both arms.
• DFS & PFS for both the arms were similar.

20. In terms of treatment response, survival
and acute toxicity profiles, there was no
significant difference between induction
chemotherapy followed by
chemoradiotherapy and sole
chemoradiotherapy in our study.