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Annals of Oncology
Results: Out of the 230 patients, 227 were eligible for analysis. With a median FU of
23 months the median PFS was 15 months (95% CI 12-21 months), and a 2 years
overall survival of 55% (95% CI 48%-64%). At the time of analysis 134 PFS events
had occurred. The primary factors associated with PFS were tumor volume and SCC,
with the pairwise interactions between SCC and both gender and histology also being
potentially important. A full Cox regression model including the interactions and a
reduced model only including only SCC and tumor volume were constructed. In
both models a difference in PFS at 24 months of roughly 40% was observed between
the high-and low risk groups.
Conclusion: A model prognostic for PFS using SCC and tumor volume, was
developed that identified stage II-III patients at high risk for progressive disease after
CCRT. Validation of this model is ongoing.
Disclosure: All authors have declared no conflicts of interest.
1204P PHASE III STUDY COMPARING SECOND- AND
THIRD-GENERATION REGIMENS WITH CONCURRENT
THORACIC RADIOTHERAPY IN UNRESECTABLE STAGE III
NON-SMALL CELL LUNG CANCER: AN ADDITIONAL
ANALYSIS BY THE HISTOLOGICAL TYPE IN THE
WJTOG0105 STUDY
M. Satouchi 1 , Y. Chiba 2 , N. Yamamoto 3 , Y. Nishimura 4 , K. Tsujino 5 , Y. Fujisaka 6 ,
S. Kudoh 7 , T. Hida 8 , S. Atagi 9 , K. Nakagawa 6
1 Thoracic Oncology, Hyogo Cancer Center, Hyogo, JAPAN, 2 Clinical Reserch
Center, Kinki University, Osakasayama, JAPAN, 3 Thoracic Oncology, Shizuoka
Cancer Center, Shizuoka, JAPAN, 4 Radiation Oncology, Kinki University Faculty
of Medicine, Osakasayama, JAPAN, 5 Radiation Oncology, Hyogo Cancer center,
Akashi, JAPAN, 6 Medical Oncology, Kinki University Fuculty of Medicine, Osaka,
JAPAN, 7 Respiratory Medicine, Osaka City University, Osaka, JAPAN, 8 Thoracic
Oncology, Aichi Cancer Center, Nagoya, JAPAN, 9 Thoracic Oncology,
Kinki-chuo Chest Medical Center, Osaka, JAPAN
Background: The WJTOG0105 study was conducted to compare third-generation
regimen (irinotecan/carboplatin [IC], paclitaxel/carboplatin [PC]) and
second-generation regimen (mitomycin/vindesine/cisplatin [MVP]) with concurrent
thoracic radiotherapy (TRT) in patients with unresectable stage III non-small-cell
lung cancer (J Clin Oncol. 2010; 28: 3739-45). We conducted an additional analysis
by the histological type (Squamous [Sq] vs. Non-squamous [Non-sq]) to closely
examine differences of efficacy between more frequent radiosensitizing doses and
systemic doses of chemotherapy.
Materials and methods: Patients received the following treatments: MVP, mitomycin
(8 mg/m2 on day 1, 29), vindesine (3 mg/m2 on day 1, 8, 29, 36), and cisplatin (80
mg/m2 on day 1, 29) with concurrent TRT (60 Gy), followed by 2 courses of MVP;
IC, weekly irinotecan (20 mg/m2)/carboplatin (AUC 2) for 6 weeks with concurrent
TRT (60 Gy), followed by 2 courses of irinotecan (50 mg/m2)/carboplatin (AUC 5);
PC, weekly paclitaxel (40 mg/m2)/carboplatin (AUC 2) for 6 weeks with concurrent
TRT (60 Gy), followed by 2 courses of paclitaxel (200 mg/m2)/carboplatin (AUC 5).
Overall survival (OS), progression free survival (PFS), and patterns of initial failure
were compared by the histological type.
Results: The median OS and PFS were 20.3, 9.0 months in Sq and 20.5, 8.1 months
in Non-sq. The Hazard ratio (HR) for OS and PFS in Non-sq were 0.996 (P = 0.973)
and 1.199 (P = 0.079). Although there was no statistically significant difference
between Sq and Non-sq, the out-field recurrence rate in Non-sq (51.1%) was higher
than Sq (26.1%) and the PFS in Sq tended to be longer than Non-sq. The efficacy of
PC was compared with MVP in each histological type. For Sq, the median OS and
PFS were 22.0, 10.4 months in PC and 19.7, 9.3 months in MVP. The HR for OS
and PFS in PC were 0.957 (P = 0.822) and 0.871 (P = 0.459). For Non-sq, the median
OS and PFS were 21.3, 8.1 months in PC and 21.8, 7.6 months in MVP. The HR for
OS and PFS in PC were 1.083 (P = 0.662) and 0.996 (P = 0.984). Therefore no
statistically significant difference was found between PC and MVP in each
histological type. Furthermore, the patterns of initial failure were similar between PC
and MVP.
Conclusion: Weekly PC with concurrent TRT showed similar efficacy to MVP with
concurrent TRT, with no relation to the histological type.
Disclosure: All authors have declared no conflicts of interest.
Table: 1205P
1205P PHASE II STUDY OF TWO ERIBULIN REGIMENS IN
COMBINATION WITH ERLOTINIB IN PATIENTS (PTS) WITH
PREVIOUSLY TREATED ADVANCED NON-SMALL CELL LUNG
CANCER (NSCLC)
S.L. Geater 1 , N. Ianotti 2 , S. Thongprasert 3 , A. Spira 4 , D. Smith 4 , V. Lee 5 ,
W-T. Lim 6 , P. Gopalakrishna 7 , C. Reynolds 8 , T.S.K. Mok 9
1 Medical Oncology, Songklanagarind Hospital, Hatyai Songkhla, THAILAND,
2 Medical Oncology, Hematology Oncology Associates, Port Saint Lucie, FL,
UNITED STATES OF AMERICA, 3 Department of Medicine, Maharaj Nakorn
Chiang Mai Hospital, Faculty of Medicine, Chiangmai, THAILAND, 4 Medical
Oncology, US Oncology Research, Houston, TX, UNITED STATES OF
AMERICA, 5 Medical Oncology, Queen Mary Hospital, Hong Kong, Hong Kong,
CHINA, 6 Medical Oncology, National Cancer Centre, Singapore, SINGAPORE,
7 Medical Oncology, Eisai Ltd, Hatfield, UNITED KINGDOM, 8 Oncology, Ocala
Oncology Center and US Oncology Research, Houston, TX, UNITED STATES
OF AMERICA, 9 Clinical Oncology, Chinese University of Hong Kong, Hong Kong,
CHINA
Background: Eribulin, a microtubule dynamics inhibitor, is approved for pts with
locally advanced/metastatic breast cancer that progressed after ≥2 chemotherapeutic
regimens for advanced disease. Prior therapy should have included an anthracycline
and taxane unless not suitable. This randomized, multicenter study compared
efficacy and tolerability of two eribulin regimens administered sequentially with
erlotinib in pts with advanced NSCLC to establish an optimal dosing schedule.
Methods: Pts (ECOG ≤2; ≥1 prior anti-cancer therapy for advanced NSCLC
including ≥1 platinum-based therapy) received 2.0 mg/m 2 eribulin mesilate (2-5 min
IV) on Day (D) 1 and 150 mg oral erlotinib on D2-16 (21D cycle), or 1.4 mg/m 2
eribulin mesilate on D1 and D8 and 150 mg erlotinib on D15-28 (28D cycle).
Primary endpoint was objective response rate (ORR); secondary endpoints were
progression-free survival (PFS), overall survival (OS), disease control rate (DCR),
safety, pharmacokinetics and biomarker (BM) assessment.
Results: 123 pts were treated (63 pts 21D cycle, 60 pts 28D cycle). Median age was
63 years (range 35-87), 53.7% male, 75.6% smokers, 65.9% stage IV disease and
91.1% ≥2 prior therapy for advanced NSCLC. ORR was 12.7% (21D) and 16.7%
(28D); other efficacy parameters were also greater with the 28D cycle. Concomitant
administration of erlotinib did not affect eribulin exposure and was well tolerated
with no unexpected toxicities. BM analysis supported overall results.
Conclusions: Both regimens were associated with moderate activity in this heavily
pre-treated population. The 28D regimen appears to have greater activity and less
toxicity than the 21D.
Disclosure: S. Thongprasert: The author declares the following conflicts of interest:
consultant/advisory role (Novartis/Pfizer/Eli Lilly), honoraria (AstraZeneca/Roche),
and research funding (Novartis/Pfizer/Roche). D. Smith: The author declares the
following conflicts of interest: research funding (Eisai). P. Gopalakrishna: The author
declares the following conflicts of interest: employee (Eisai Ltd. C. Reynolds: The
author declares the following conflicts of interest: honoraria/speakers bureau (Eisai).
T.S.K. Mok: Consultant/advisory role (AstraZeneca /Pfizer/Eli Lilly/Roche/Merck
Serono/Eisai/BMS/BeiGene/AVEO/Taiho/BI), honoraria (AstraZeneca/Roche Pfizer/
Eli Lilly/ Merck Serono/Eisai/BMS/BeiGene/AVEO /Taiho/BI), research funding
(AstraZeneca). All other authors have declared no conflicts of interest.
1206P PEMETREXED (PEM) COMBINATION THERAPY WITH
CARBOPLATIN (CB) FOLLOWED BY PEM MAINTENANCE IN
JAPANESE PATIENTS (PTS) WITH NONSQUAMOUS
NON-SMALL CELL LUNG CANCER (NSCLC): SUBGROUP
ANALYSIS OF ELDERLY PTS
N. Nogami 1 , R. Sekiguchi 2 , S. Enatsu 2 , K. Nakagawa 3 , T. Tamura 4
1 Dept of Thoracic Oncology, NHO Shikoku Cancer Center, Matsuyama, JAPAN,
2 Development Center of Excellence, Eli Lilly Japan K.K., Kobe, JAPAN, 3 Medical
Oncology, Kinki University School of Medicine, Osaka, JAPAN, 4 Division of
Internal Medicine and Thoracic Oncology, National Cancer Center Hospital,
Tokyo, JAPAN
Objectives: This subgroup analysis evaluated the efficacy and safety of Pem
combination therapy with Cb followed by Pem maintenance in Japanese elderly
NSCLC pts.
21D 28D
Median no. cycles (range) Pts completing ≥6 cycles, % 3 (1-31) 36.5 4 (1-23) 36.7
ORR a Partial response (PR) b Stable disease (SD) b DCR
(Complete response + PR + SD) a
12.7 (5.6, 23.5) 8 (12.7) 22 (34.9) 47.6 (34.9, 60.6) 16.7(8.3, 28.5 ) 10 (16.7) 28 (46.7) 63.3 (49.9, 75.4)
PFS c OS c
3.5 (1.9, 4.7) 7.6 (6.3,12.1) 3.8 (3.3, 5.5) 8.5 (6.2,13.1)
Adverse events of interest (grade ≥3), % Diarrhea Neutropenia
Peripheral neuropathy Rash
6.3 44.4 3.2 6.3 1.7 38.3 0 1.6
a % (95% CI) b n (%) c median, months (95% CI).
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds408 | ix393