Conflict of Interest disclosure slide for representative speakers or investigators

Pattern of care and outcome of nonsmall cell lung cancer patients receiving
gefitinib beyond radiologic progression.

Research fundName oflead presenter‫ڧ‬scientific research fund ‫ڧ‬contract ‫ڧ‬donation‫ڧ‬other 㸦      㸧 ‫ڧ‬N/ASponsor

Hideo Kunitoh, M.D.

Institution orcompany/positionNo

employee of company and/or profit-making
organization
adviser of company and/or profit-making
organization
profit of stock
lecturer fees
manuscript fees
research expenses

Hideo Kunitoh, Yukio Hosomi, Chiharu Tanai, Kiyotaka Yoh, Yasushi Goto,and Yasuo Ohashi
Department of Medical Oncology, Japanese Red Cross Medical Center,Tokyo, Japan; Department of Thoracic Oncology and Respiratory
Medicine, Tokyo Metropolitan Cancer and Infectious Diseases Center
Komagome Hospital, Tokyo, Japan; Division of Respiratory Medicine, NTT
Medical Center, Tokyo, Japan; Division of Thoracic Oncology, National
Cancer Center Hospital East, Kashiwa, Japan; Department of Thoracic
Oncology, National Cancer Center Hospital, Tokyo, Japan; Chuo University,Tokyo, Japan

contributions
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Hideo Kunitoh, M.D.
presents or any payment

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lecturer fees
manuscript fees
research expenses
contributions
fees of testimony, judgment, comment, etc.
representative of organization for clinical study
receiving research expenses from company
presents or any payment

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profit of stock

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BackgroundObjectives• We previously showed (Yamane et al, ESMO2014) that 1/3 of non-small cell lung cancer
patients (NSCLC pts) with activating epidermal
growth factor receptor mutation (EGFRm+)
continued to receive an EGFR-tyrosine kinase
inhibitor after radiological “progressivedisease” (R-PD) was seen, if they remained
clinically stable, until clinical deterioration (CPD).

• To explore for patients subgroups who would
be likely to receive benefit from “continuationof TKI beyond PD” strategy, in gefitinibreceiving cohort.
• Focusing on elderly (>70 y.o.) and female
patients, as compared to non-elderly andmale patients, respectively.

Study subjects (Patients)••

Inclusion criteria– Advanced or post-operational recurrent non-small-cell lung cancer– Diagnosed as having tumor harboring EGFR mutation• Definition of EGFR gene mutation positive (mutation of sensitive gene)– (A)Deletion of Exon19 (irrespective of the subtype)– (B)Exon 21 L858R– (C)
Other rare mutations (Exon 18 G791X, etc.)• EGFR gene mutation excluded from this study:– (A)Exon 20 insertion mutation
– (B)
T790M
– Treatment with Gefitinib or was started from January 1, 2009 until
December 31, 2011 as the initial anti-cancer therapy
Exclusion criteria– Prior treatment with cytotoxic chemotherapy– Concomitant malignancy

Definition of“Clinical PD (disease progression)”• Symptomatic progression• Declining of PS due to progression• Threat to major organ(s)• Unequivocal multi-organ progression

Patient characteristics of those who remained clinically stable on radiological PD (groups B and C)

Patients cohort㻳 㼜㻳㼞㼛㼡㼜㻌㻭㻦㻌䇾㻾㻗㻯䇿㻌㻌㻔㻺㻩㻝㻢㻜㻘㻌㻟㻜㻑㻕㻌㻔㻺㻺㻩㻝㻢㻜㻘㻌㻟㻜㻑㻕㼅㼑㼟㻌㼅㼑㼟㻳㼑㼒㼕㼠㼕㼚㼕㼎㻌㼀㼔㼑㼞㼍㼜㼥㻌㻭㼐㼢㼍㼚㼏㼑㻌㻺㻿㻯㻸㻯㻌㻱㻳㻲㻾㻌㼙㼡㼠㼍㼠㼕㼛㼚㻌㻔㻺㻩㻡㻞㻥㻕㻌㻯㼘㼕㼚㼕㼏㼍㼘㻯㼘㼕㼚㼕㼏㼍㼘㻌㻼㻰㻼㻰㻌㼅㼑㼟㻌㼅㼑㼟㻾 㻿㼀㻾㻱㻯㻵㻿㼀㻌㻼㻼㻰㻌㼅㼑㼟㻌㼅㼑㼟㻺㼛㻌㻺㼛㻱㻳㻲㻾㻌㻱㻳㻲㻾㼀㻷㻵㻌㼀㻷㻵㼟㼠㼛㼜㼜㼑㼐㻌㼟㼠㼛㼜㼜㼑㼐㻺㼛㻺㼛㻌㻱㻳㻲㻾㻌㻱㻳㻲㻾㼀㻷㻵㼀㻷㻵㻌㼟㼠㼛㼜㼜㼑㼐㻌㼅㼑㼟㻌㼅㼑㼟㻺㼛㻌㻳㼞㼛㼡㼜㻌㻮㻦㻌㻳㼞㼛㼡㼜㻌㻮㻦㻌㻌䇾㻾㻌㼍㼚㼐㻌㼟㼠㼛㼜䇿㻌䇾㻾㻌㼍㼚㼐㻌㼟㼠㼛㼜䇿㻌㻌㻔㻺㻩㻝㻢㻣㻘㻌㻟㻞㻑㻕㻌㻔㻺㻺㻩㻝㻢㻣㻘㻌㻟㻞㻑㻕㻳㼞㼛㼡㼜㻌㻯㻦㻌㻳㼞㼛㼡㼜㻌㻯㻦㻌㻌㻳䇾㻾㻌㼍㼚㼐㻌㼏㼛㼚㼠䇿㻌䇾㻾㻌㼍㼚㼐㻌㼏㼛㼚㼠䇿㻌㻌㻺㼛㻌 㻔㻔㻺㻩㻥㻝㻘㻌㻝㻣㻑㻕㻌㻺㼛㻺㻩㻥㻝㻘㻌㻝㻣㻑㻕㻳㼞㼛㼡㼜㻳㻰㻦 䇾㼛㼠㼔㼑㼞䇿㻳㼞㼛㼡㼜㻌㻰㻦㻌㻌䇾㼛㼠㼔㼑㼞䇿㻌㻌㻔㻺㻔㻺㻩㻤㻞㻘㻌㻝㻢㻑㻕㻌㻳㻳㼞㼛㼡㼜㻌㻱㻦㻌䇾㼚㼛㻌㻼㻰䇿㻌㻔㻌㻔㻺㻩㻞㻥㻘㻌㻡㻑㻕㻌
7GroupB (N=167)

C (N=91)

P value

Gender M
Gender F

58 (35%)109 (65%)

20 (22%)71 (78%)0.03

Age median(Range)

69(31~88)

69(27~93)>0.2< 70 y.o.
> 70 y.o.

95 (61%)72 (39%)48 (53%)43 (47%)>0.2< 80 y.o.
> 80 y.o.

147 (88%)
20 (12%)75 (82%)16 (18%)>0.2

PS 0-1
PS 2-4131 (78%)
36 (22%)69 (76%)22 (24%)>0.2

Never smoker
Ever smoker

106 (63%)
61 (37%)71 (78%)20 (22%)0.05

No prior Tx
Prior Tx

123 (74%)
44 (26%)59 (65%)32 (35%)

0.15

Mutation ex19
Mutation ex21
Mutation others81 (49%)77 (46%)9 (5%)

36 (40%)51 (56%)
4 (4%)>0.2

CR/PR
NC/PD/NE

123 (74%)
44 (26%)72 (79%)19 (21%)>0.2

Group C: R-PD to C-PD

Group C: R-PD to C-PD

1

1

1

1

0.9

0.9

0.9

0.9

0.8

0.8

0.8

0.8

0.7

0.7

0.7

0.7

0.6

0.6

0.6

0.6

70ᮍ‶

0.5

80ᮍ‶

0.570௨ୖ

⏨ᛶ

0.5

Ex19

0.4

0.4

0.4

0.4

0.3

0.3

0.30.3

0.2

0.2

0.2

0.2

0.1

0.1

0.1

0.1

0000180360

540

720

900 1080 1260 1440

0180360

540

720

00900 1080 1260 1440

Ex210.5

ዪᛶ

80௨ୖ

180360540

720

9001080 1260 1440

0180360

5401080 1260 1440

< 70 y.o.

> 70 y.o.

All<70>70<80>80Male

FemaleReason

N=91

N=48

N=43

N=85

N=16

N=20

N=71

1

36 (40%)18 (38%)18 (42%)31 (36%)5 (31%)

8 (40%)

28 (39%)226 (29%)

12 (25%)

14 (33%)20 (24%)6 (38%)

6 (30%)

20 (28%)311 (12%)6 (13%)

5 (12%)

10 (12%)

1 ( 6%)

4 (20%)

7 (10%)

441 (45%)

27 (56%)

14 (33%)37 (44%)4 (25%)

7 (35%)

34 (48%)CB

C

B> 80 y.o.

Symptomatic progression
Declining of PS due to progression
Threat to major organ(s)Unequivocal multi-organ progression

900

Survival from R-PD and Age

Reason of C-PD in Group C

1.
2.
3.
4.

720

< 80 y.o.

C
BCB

Survival and genderMale, S from R-PD

Female, S from R-PD

CC
B
B

Male, S from TKI start

Female, S from TKI start

Summary• Female patients were more likely to receivegefitinib continuation on clinically stable,radiological PD (R-PD).
• Age was not significantly associated withgefitinib continuation on R-PD.

CBCB

Summary (cont’d)• Period from R-PD to clinical PD tended to belonger in female patients who received
gefitinib “beyond PD”.
• Survival after R-PD tended to be longer inelderly (but not non-elderly) patients who
received gefitinib “beyond PD” than who didnot.

Conclusions andAcknowledgement• Female and elderly patients could becandidates for the subpopulations who arelikely to receive benefit from the strategy ofgefitinib “beyond PD” continuation.
• More research should be warranted.
• Funding resources: study funding wasprovided to the Comprehensive Support For
Oncology Research from an Investigator
Sponsored Study Programme, AstraZeneca.