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Annals of Oncology
phase III study comparing PEM with DOC suggested that PEM was superior to
DOC in the elderly population (≥70) in terms of both efficacy and toxicity.
Patients and methods: This was a single-arm phase II study of PEM in elderly
(≥75) Japanese patients with chemo-naive advanced non-squamous NSCLC.
Patients received four cycles of PEM (500 mg/m 2 ) every 3 weeks. The primary
endpoint was the response rate, and secondary endpoints were safety and
survival.
Results: Twenty-eight patients were enrolled between January 2010 and April 2012.
Patient characteristics were as follows: male/female: 14/14; median age: 77 yr (75-88);
histology, Ad/La: 27/1; disease stage, IIIB/IV: 6/22; PS, 0/1: 7/21. Five patients were
still under protocol treatment, and 23 patients were evaluable for both safety and
efficacy. There were 0 CR, 7 PR, 10 SD, 5 PD, and 1 NE. Response rate and disease
control rate were 30.4% and 73.9%, respectively. Median treatment cycles were four.
Grade 3/4 toxicity rates were 21.7% for leukocytopenia, 26.1% for neutropenia, 4.3%
for anemia, 8.7% for thrombocytopenia, and 8.7% for nausea/vomiting, respectively.
Four patients required G-CSF treatment, but no patients required blood transfusion.
There were no treatment-related deaths.
Conclusions: PEM was safe and effective in elderly (≥75) Japanese patients with nonsquamous
NSCLC. Final results, including survival data, will be presented at the meeting.
Disclosure: All authors have declared no conflicts of interest.
1357 VERY ELDERLY INOPERABLE NSCLC PATIENTS ABOVE 75
YEARS COMPARED TO YOUNGER PATIENTS: EQUAL
ACTIVITY OF PLATINUM-BASED DOUBLET CHEMOTHERAPY
BUT HIGHER TOXICITY
J.N. Jakobsen, S. Wallerek, S.A. Jensen, J.B. Sorensen
Department of Oncology, Rigshospitalet, Copenhagen University Hospital,
Copenhagen, DENMARK
Purpose: Tolerability and activity of platinum-based doublet chemotherapy was
examined in very elderly inoperable NSCLC patients aged >75 years and compared
to younger patients.
Patients and methods: Chemotherapy naïve inoperable NSCLC patients aged > 18
years with no upper age limit received Carboplatin AUC 5 and Vinorelbine (VNB)
25 mg/m2 day 1 and VNB 80 mg/m2 orally day 8 q 3 weeks for maximum 6 courses
without g-csf. They were divided in group A being 70 years, group B 70-75 years,
and group C > 75 years.
Results: A total of 135 patients received 530 treatment courses (group A 70 patients,
group B 40 patients, and group C 25 patients). There were no differences in
pre-treatment characteristics such as gender, histologic subtype, performance status,
weight loss, or stage. The median age (with range), and frequencies of performance
status 2, stage IV, and subsequent 2nd line chemotherapy were in group A 59.8 years
(36-69), 23%, 69%, and 39%, in group B 72.3 years (70-75), 25%, 60%, and 23%, and
in group C 78.0 years (76-84), 20%, 60%, and 12%, respectively. The frequencies of
grade 4 and grade 3 and 4 leucopenia were 32% and 48% in group C and 6% and
23% in group A, respectively (p = 0.001, p = 0.018) and the frequency of febrile
neutropenia in C (20%) and in A (7%) (p = 0.072). There were no toxic deaths.
Response rates for groups A, B, and C were 33%, 34%, and 44% and median
survivals (with range) were 35 weeks (1-336), 42 weeks (0-104+), and 58+ weeks
(7-296), respectively (not significant). Median times to progression were 19, 29, and
16 weeks, respectively.
Conclusions: Very elderly patients aged > 75 years could receive similar number
of treatment courses as younger patients and with similar level of toxicity except
for leucopenia and febrile neutropenia, which were more frequent in the very
elderly compared to the younger groups. The activity of Carboplatin and
Vinorelbine was statistically similar between age groups, though with a
remarkable trend towards higher disease control rate (NC + PR + CR) among the
elderly and very elderly. Platinum-based doublet chemotherapy is feasible and
highly active in very elderly NSCLC patients but require close hematologic
monitoring. The use of bone marrow stimulating treatment may be considered to
diminish toxicity in this population.
Disclosure: All authors have declared no conflicts of interest.
1358 OUTCOMES FOR ELDERLY, ADVANCED–STAGE NON-SMALL
CELL LUNG CANCER (NSCLC) PATIENTS TREATED WITH
AMRUBICIN (AMR) AS THIRD-LINE OR FOURTH-LINE
CHEMOTHERAPY: ANALYSIS OF HOKKAIDO LUNG CANCER
CLINICAL STUDY GROUP TRIAL (HOT) 0901
S. Oizumi 1 , T. Harada 2 , K. Takamura 3 , S. Sugawara 4 , M. Maemondo 5 , Y. Fujita 6 ,
I. Kinoshita 7 , H. Dosaka-Akita 7 , H. Isobe 8 , M. Nishimura 9
1 First Department of Medicine, Hokkaido University School of Medicine,
Sapporo, JAPAN, 2 Center for Respiratory Disease, Hokkaido Social Insurance
Hospital, Sapporo, JAPAN, 3 First Department of Medicine, Obihiro-Kosei
General Hospital, Obihiro, JAPAN, 4 Department of Respiratory Medicine, Sendai
Kousei Hospital, Sendai, JAPAN, 5 Department of Respiratory Medicine, Miyagi
Cancer Center, Natori, JAPAN, 6 Department of Respiratory Medicine, National
Hospital Organization Asahikawa Medical Center, Asahikawa, JAPAN,
7 Department of Medical Oncology, Hokkaido University Graduate School of
Medicine, Sapporo, JAPAN, 8 Department of Medical Oncology and Respiratory
Medicine, KKR Sapporo Medical Center, Sapporo, JAPAN, 9 First Department of
Medicine, Hokkaido university School of Medicine, Sapporo, JAPAN
Background: HOT0901 trial evaluated the efficacy and safety of AMR,
third-generation synthetic anthracycline agent, for NSCLC patients as third-line or
fourth-line chemotherapy. We conducted a subset analysis of HOT0901 to determine
the outcome for elderly patients.
Methods: Eligible patients had a performance status 0 to 2, failure of second-line or
third-line chemotherapy, and adequate organ function. Patients received AMR 35 mg/m 2
intravenously on days 1-3 every 3 weeks. The primary endpoint was disease control rate
(DCR: CR + PR + SD). Secondary endpoints were overall survival (OS), progression-free
survival (PFS), response rate (CR + PR), and toxicity profile. Elderly patients were defined
as those at least 70 years of age at the time of enrollment. The efficacy and safety data for
AMR therapy was compared between the elderly and younger patients (< 70 years).
Results: There were 14 elderly and 27 younger patients in this study. Elderly patients
accounted for 34% of the study cohort. Clinical characteristics such as PS or histologic
subtypes were similar between the groups. The median number of treatment cycles was
3 in elderly and 2 in younger patients. The overall response rate and DCR were 14.3%
and 71.4% in elderly patients and 7.4% and 55.5% in younger patients, respectively (p =
0.42 and 0.26). Median PFS was 3.6 and 2.4 months (p = 0.70), whereas median survival
time was 11.3 and 13.9 months (p = 0.67) in elderly and younger patients. The most
common grade 3/4 toxicity was neutropenia (64.3 vs. 70.4%); overall, there was no major
difference in the incidence of hematological and nonhematological toxicities between the
groups. No treatment-related death was observed in this study.
Conclusion: Third-line or fourth-line AMR yielded the similar efficacy and toxicity
profiles between elderly and younger NSCLC patients. Data from this post-hoc analysis
encourage prospective evaluation of potential benefit of AMR in elderly NSCLC patients.
Disclosure: All authors have declared no conflicts of interest.
1359 MULTI-CENTER OBSERVATIONAL STUDY ON THE DIAGNOSIS
OF NON-SMALL CELL LUNG CANCER BONE METASTASIS
AND THE EFFICACY AND SAFETY OF BISPHOSPHATES
TREATMENT (C-TONG 0801)
Y. Wu 1 ,Z.Li 2 , C. Zhou 3 , L. Shun 4 , Y. Zhang 5 , M. Hou 6 , W. Liu 7 , J. Wang 8 ,
G. Chen 9 , Y. Zhou 10
1 Department of Clinical Oncology, Guangdong General Hospital (GGH) &
Guangdong Academy of Medical Sciences, Guangzhou, CHINA, 2 Oncology, Sun
Yat-Sen University Cancer Center, Guangzhou, CHINA, 3 Lung Cancer Institute,
Shanghai Pulmonary Hospital, Shanghai, CHINA, 4 Shanghai Lung Cancer
Clinical Center, Shanghai Chest Hospital, Shanghai, CHINA, 5 Oncology, Zhejiang
Cancer Hospital, Hangzhou, CHINA, 6 Oncology, West China Hospital, Chengdu,
CHINA, 7 Oncology, Xijing Hospital, Xi’an, CHINA, 8 Oncology, Beijing Cancer
Hospital, Beijing, CHINA, 9 Oncology, Heilongjiang Cancer Hospital, Harbin,
CHINA, 10 Oncology, Henan Provincal Hospital, Zhengzhou, CHINA
Objective: To study the current status of the NSCLC bone metastasis (BM) in China,
including the diagnosis, NTX parameters, and the efficacy and safety of
bisphosphates (BP) treatment.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds409 | ix443