Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
had received 2, 3 and > 3 prior lines of therapy, respectively. Response was
evaluable in 204 patients: with a median number of 8 doses (range, 1–24) and
a median follow-up of 5.1 months, the disease control rate was 47%, with 3
patients (1%) in complete response, 30 patients (14%) in partial response and
66 patients (32%) in stable disease. 36 patients (17%) were treated beyond
RECIST-defined progression, with 11 of them achieving disease control. As
of April 2016, median progression-free survival and median overall survival
were respectively 3.8 and 11.2 months. 117/210 patients (55.7%) discontinued
treatment for any reason except toxicity; 11 out of 210 (5.2%) discontinued
due to AEs. Conclusion: These findings showed that nivolumab provided
clinical activity with a manageable safety profile in patients with advanced,
refractory Sq-NSCLC. These data suggest that nivolumab can be a treatment
option for patients failing more than one line of chemotherapy.
Keywords: NSCLC squamous, heavily pre-treated, Nivolumab
POSTER SESSION 3 – P3.02C: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
IT CLINICAL –
WEDNESDAY, DECEMBER 7, 2016
P3.02C-093 A PROSPECTIVE, RANDOMIZED, MULTICENTER,
PHASE III STUDY, COMPARING RHTPO WITH RHIL-11 TREATING CIT
(NCT02344979)
Shun Lu 1 , Xia Song 2 , Fang Du 3 , Li Liu 4 , Yun Xu 1 , Zhi Ma 5 , Qiong Zhao 6 , Yi
Zhang 7 , Hai Liu 8
1 Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong
University, Shanghai/China, 2 Respiratory Medicine, Shanxi Cancer Hospital,
Taiyuan/China, 3 Dongyang People’s Hospital, Zhejiang Dongyang/China, 4 Wuhan
Union Hospital, Hubei Wuhan/China, 5 Henan Cancer Hospital, Henan Zhengzhou/
China, 6 The First Hospital of Zhejiang Province, Zhejiang Hangzhou/China,
7 Zhejiiang Cancer Hospital, Zhejiang Hangzhou/China, 8 Jilin Oil Field General
Hospital, Jilin Songyuan/China
Background: Chemotherapy-induced thrombocytopenia (CIT) is a common
dose limiting toxicity of clinical chemotherapy drugs, which may lead
to reduced dose chemotherapy or delay chemotherapy time, and even
terminate chemotherapy treatment. This is the first randomized, openlabel,
multicenter, phase III study to compare the efficacy and safety
of prophylactic treatment for thrombocytopenia in China. We tried to
investigate the efficacy and safety of preventive application with rhTPO or
rhIL-11 to protect against CIT in advanced non-small-cell lung cancer (NSCLC)
patients. Methods: From June 2009 to July 2016, 108 patients with NSCLC
who were receiving the first-line platinum-based chemotherapy suffered
from severe thrombocytopenia(the nadir of platelet counts0.05). rhTPO
(15000U/d) was injected subcutaneously on the 2 nd , 4 th , 6 th , 9 th Day after the
initiation of chemotherapy, and IL-11(3mg/d) was injected subcutaneously
per day from Day 9 to Day15 after the initiation of chemotherapy. Blood
routines were conducted to test before chemotherapy initiation and the
3 th , 5 th , 7 th , 9 th , 11 th , 13 th , 15 th , 17 th , and 21 th day after chemotherapy. Toxicity
and efficacy were monitored. Results: In the following chemotherapy cycle
there were no statistical difference between rhTPO arm and rhIL-11 arm
on the following indexes: the nadir of platelet counts(62.6±39.4×10 9 /L vs.
52.8±36.8×10 9 /L, P>0.05), the maximum platelet counts (223.5±127.3×10 9 /L
vs. 245.8±158.7×10 9 /L, P>0.05), duration of platelet counts less than
50×10 9 /L[Median (95%CI): 4.0(3.0-5.0) days vs. 4.5(3.0-9.0) days, P>0.05],
time of platelet count recovered to 75×10 9 /L [Median(95%CI): 5(3-7) days vs.
6(4-8) days, P>0.05] and to 100×10 9 /L[median(95%CI): 6(6-8) days vs. 6(5-9)
days, P>0.05]. Drug-related adverse events in rhTPO arm were less than those
of rhIL-11 arm (5 cases (6.49%) in rhTPO arm, 8 cases (25.8%) in rhIL-11 arm,
P