Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
a: Log-rank test for survival times, chi-square test for AE’s, and Fisher’s exact
test for deaths. The P-values from these tests are unadjusted.
b: Data available on 2,091 patients Conclusion: Elderly pts in CCRT trials had
worse OS, similar PFS, & a higher rate of severe AE’s.
Keywords: Stage 3 non-small cell lung cancer, Chemoradiotherapy, treatment
outcomes and toxicity, Geriatric Oncology
MA06: LOCALLY ADVANCED NSCLC: RISK GROUPS, BIOLOGICAL FACTORS AND
TREATMENT CHOICES
MONDAY, DECEMBER 5, 2016 - 16:00-17:30
MA06.11 PHASE II STUDY OF NIMOTUZUMAB + CONCURRENT
CHEMORADIOTHERAPY (CRT) FOR STAGE III NON-SMALL CELL
LUNG CANCER (NSCLC): 5-YEAR FOLLOW-UP RESULTS
Kazushige Hayakawa 1 , Yasumasa Nishimura 2 , Hideyuki Harada 3 , Toshinori
Soejima 4 , Kayoko Tsujino 4 , Takuyo Kozuka 5 , Masahiro Tanaka 6 , Tomonari
Sasaki 7 , Nobuyuki Yamamoto 8 , Kazuhiko Nakagawa 9
1 Radiology and Radiation Oncology, Kitasato University, Sagamihara/Japan,
2 Radiation Oncology, Kindai University Faculty of Medicine, Osakasayama/Japan,
3 Radiation and Proton Therapy Center, Shizuoka Cancer Center, Suntougunn/Japan,
4 Radiation Oncology, Hyogo Cancer Center, Akashi/Japan, 5 Radiation Oncology, The
Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo/Japan,
6 Osaka City General Hospital, Osaka/Japan, 7 Health Sciences, Kyushu University,
Fukuoka/Japan, 8 Medical Oncology, Wakayama Medical University Hospital,
Wakayama/Japan, 9 Medical Oncology, Kindai University Faculty of Medicine,
Osaka-Sayama/Japan
Background: Nimotuzumab, a humanized IgG 1
monoclonal anti-EGFR
antibody, is approved and widely used in patients (pts) with head and
neck cancer or malignant glioma in combination with radiotherapy (RT) in
several countries. On in-vitro and in-vivo experiments using NSCLC cell lines,
nimotuzumab showed a radio-sensitizing effect. Methods: This phase II study
evaluated the tolerability and efficacy of nimotuzumab in combination with
concurrent CRT in pts with unresectable locally advanced NSCLC. All eligible
pts received concurrent thoracic RT (60 Gy, 2 Gy/day, 6 weeks from day 1) and
4 cycles of chemotherapy (cisplatin 80 mg/m 2 on day 1, vinorelbine 20 mg/
m 2 on days 1 and 8) once every 4 weeks as scheduled. Nimotuzumab (200 mg)
was administrated once a week from cycle 1 to 4. The primary endpoint was
tolerability in combination with concurrent CRT, which was measured by
the percentage of pts who completed 60 Gy of RT within 8 weeks, completed
2 cycles of chemotherapy and received more than 75% of nimotuzumab.
Results: Of 40 pts enrolled between June 2009 and May 2010, 39 eligible pts
received the study treatment. The pts characteristics were as follows: 62 years
(median); male/female, 34/5; stage IIIA/B, 21/18; PS0/1, 25/14. Thirty-four pts
met the criteria for treatment tolerability, and 38 pts completed 60 Gy of
RT within 8 weeks. Infusion reaction, >grade 3 skin rash, >grade 3 radiation
pneumonitis, or >grade 4 nonhematological toxicity were not observed. The
3-year and 5-year overall survival rates for the 39 pts were 66.4% and 58.4%,
respectively. The median PFS was 16.9 months, and the 5-year PFS rate for
pts with squamous cell carcinoma (Sq; n = 16) was 50%, while that for pts
with non-squamous cell carcinoma (non-Sq; n = 23) was 13.7%. In terms of the
first relapse site, in-field relapse rates were low for both Sq (4/16; 25%) and
non-Sq (4/23; 17%). However, the distant relapse rate was significantly higher
for non-Sq (15/23; 65%) than that for Sq (4/16; 25%). Cytologic or histologic
specimens were examined for the expression of EGFR protein/mutations
using the EGFR IHC/FISH methods in 20 pts. EGFR 2+/3+ expression was
shown more frequently in sq (8/10) than non-sq (4/10). EGFR mutation was
observed in only 2 pts with non-sq. Conclusion: Addition of nimotuzumab to
the concurrent CRT in this setting was well tolerated with clinical benefit to
the patients. The low in field relapse rates may be attributed to the radiosensitizing
effect of nimotuzumab.
Keywords: Chemoradiotherapy, locally advanced non-small cell lung cancer,
nimotuzumab, molecular targeting drug
MINI ORAL ABSTRACT SESSIONS -
TUESDAY, DECEMBER 6, 2016
SESSION MA07: ALK-ROS1 IN ADVANCED NSCLC
TUESDAY, DECEMBER 6, 2016 - 11:00-12:30
MA07.01 UPDATED POOLED ANALYSIS OF CNS ENDPOINTS IN TWO
PHASE II STUDIES OF ALECTINIB IN ALK+ NSCLC
Sai-Hong Ignatius Ou 1 , Leena Gandhi 2 , Alice Shaw 3 , Ramaswamy Govindan 4 ,
Mark Socinski 5 , D. Ross Camidge 6 , Luigi De Petris 7 , Dong-Wan Kim 8 , Alberto
Chiappori 9 , Denis Moro-Sibilot 10 , Michaël Duruisseaux 10 , Lucio Crinò 11 ,
Tommaso De Pas 12 , Eric Dansin 13 , Antje Tessmer 14 , James Chih-Hsin Yang 15 ,
Ji-Youn Han 16 , Walter Bordogna 17 , Sophie Golding 17 , Ali Zeaiter 17 , Shirish
Gadgeel 18
1 University of California, Irvine School of Medicine, Orange County/CA/United
States of America, 2 Dana-Farber Cancer Institute, Boston/MA/United States of
America, 3 Massachusetts General Hospital, Boston/MA/United States of America,
4 Washington University School of Medicine, St. Louis/AL/United States of America,
5 Florida Hospital Cancer Institute, Orlando/FL/United States of America, 6 Medical
Oncology, University of Colorado, Denver/CO/United States of America, 7 Karolinska
University Hospital, Stockholm/Sweden, 8 Seoul National University Hospital,
Seoul/Korea, Republic of, 9 Moffitt Cancer Center, Tampa/FL/United States of
America, 10 Thoracic Oncology Unit, Chest Department, Pôle Thorax Et Vaisseaux,
CHU de Grenoble, Grenoble/France, 11 Medical Oncology, Perugia University Medical
School, Perugia/Italy, 12 Istituto Europeo Di Oncologia (Ieo), Milan/Italy, 13 Centre
Oscar Lambret, Lille/France, 14 Evangelische Lungenklinik Berlin, Berlin/Germany,
15 National Taiwan University Hospital, Taipei/Taiwan, 16 Center for Lung Cancer,
National Cancer Center, Goyang/Korea, Republic of, 17 F. Hoffmann-La Roche, Basel/
Switzerland, 18 Karmanos Cancer Institute/wayne State University, Detroit/MI/
United States of America
Background: Based on two single-arm, multicentre, phase II studies (NP28673
[NCT01801111] and NP28761 [NCT01871805]), the FDA approved the ALK
inhibitor alectinib for use in ALK+ NSCLC patients after prior crizotinib.
Alectinib was well tolerated in both phase II studies and showed efficacy
against both systemic and central nervous system (CNS) disease, the
latter being a common progression site in ALK+ NSCLC. This analysis uses
pooled data from the latest cut-offs (22 Jan 2016 for NP28761; 1 Feb 2016
for NP28673) to examine the long-term CNS efficacy of alectinib. Methods:
Both studies enrolled crizotinib-refractory patients ≥18 years with ECOG PS
0–2 and locally advanced or metastatic ALK+ NSCLC (confirmed by FDAapproved
test). CNS metastases were permitted if asymptomatic. Patients
received 600mg oral alectinib BID. The primary endpoint in both studies was
objective response rate (ORR) by independent review committee; secondary
CNS endpoints included CNS ORR, CNS duration of response (DoR), and CNS
disease control rate (DCR). CNS response and progression were determined by
RECIST v1.1. All patients had baseline imaging to assess CNS metastases, with
further imaging every 6 or 8 weeks for NP28761 and NP28673, respectively.
Results: The overall pooled analysis population comprised 225 patients (n=87
from NP28761; n=138 from NP28673); median follow-up for this updated
analysis was 18.8 (0.6–29.7) months (>6 months additional follow-up). At
baseline, 50 patients had measurable and 86 had non-measurable CNS
disease; together, these groups comprised 136 patients, 60% of the overall
pooled population. Seventy percent of patients had prior CNS radiotherapy;
58% of these completed radiotherapy >6 months before study entry. Updated
CNS data are shown in the Table and are consistent with systemic results.
Measurable CNS
disease at baseline
(n=50)
Measurable and
non-measurable CNS
disease at baseline
(n=136)
CNS ORR, n (%) [95% CI] 32 (64.0) [49.2–77.1] 60* (44.1) [35.6–52.9]
Complete response (CR), n (%) 11 (22.0) 39* (28.7)
CNS DCR, n (%) [95% CI]
45 (90.0) [78.2–
96.7]
117 (86.0) [79.1–91.4]
Median CNS DoR, months
[95% CI] Patients with event,
n (%)
* N.B. Non-measurable disease
response can only be classified
as CR, non-CR/non-progressive
disease (PD) or PD
11.1 [7.6–NE] 18
(56.3)
13.8 [11.0–21.5] 32
(53.3)
Conclusion: This updated pooled analysis with mature data confirms that
alectinib can provide long-term control of CNS metastases in ALK+ NSCLC,
with a high CR rate.
MA07: ALK-ROS1 IN ADVANCED NSCLC
TUESDAY, DECEMBER 6, 2016 - 11:00-12:30
MA07.02 UPDATED EFFICACY AND SAFETY DATA FROM THE PHASE
2 NP28761 STUDY OF ALECTINIB IN ALK-POSITIVE NON-SMALL-
CELL LUNG CANCER
D. Ross Camidge 1 , Shirish Gadgeel 2 , Sai-Hong Ou 3 , Leena Gandhi 4 , Gregory
Riely 5 , Jeremy Cetnar 6 , Howard West 7 , Mark Socinski 8 , Alberto Chiappori 9 ,
Tarek Mekhail 10 , Bo Chao 11 , Hossein Borghaei 12 , Kathryn Gold 13 , Walter
Bordogna 14 , Bogdana Balas 14 , Johannes Noe 14 , Sophie Golding 14 , Ali Zeaiter 14 ,
Alice Shaw 15
1 University of Colorado, Aurora/CO/United States of America, 2 Karmanos Cancer
Institute/wayne State University, Detroit/MI/United States of America, 3 University
of California Irvine School of Medicine, Orange/CA/United States of America,
4 Dana-Farber Cancer Institute, Boston/MA/United States of America, 5 Memorial
Sloan Kettering Cancer Center, New York/NY/United States of America, 6 Oregon
Health and Sciences University, Portland/OR/United States of America, 7 Swedish
Copyright © 2016 by the International Association for the Study of Lung Cancer
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