Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
experienced after chemotherapy start, exposed patients to a higher risk of
anticipatory CINV and of acute/delayed CINV respectively, as confirmed by
the multivariate logistic model at T0 and by GEE overtime. Conclusion: Even
if clinical staff revealed to be aware and sensitive about patients status and
perceptions, CINV still represents a problem among patients undergoing
chemotherapy, with this study further confirming that particular attention
should be given to anxiety due to its key role in CINV development.
Keywords: chemotherapy-induced nausea and vomiting, first-line treatment,
lung cancer
POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
CLINICAL TRIALS –
TUESDAY, DECEMBER 6, 2016
P2.03A-018 A PHASE I/II STUDY OF ALISERTIB, AN ORAL AURORA
KINASE INHIBITOR, IN COMBINATION WITH ERLOTINIB IN
PATIENTS WITH RECURRENT OR METASTATIC NSCLC
James Godwin, Jessica Bauman, Samuel Litwin, Ranee Mehra, Anthony
Olszanski, Hossein Borghaei
Medical Oncology, Fox Chase Cancer Center, Philadelphia/PA/United States of
America
Background: Erlotinib (E) is an oral reversible tyrosine kinase inhibitor targeting
the epidermal growth factor receptor (EGFR), known to have efficacy in
NSCLC. The aurora kinases are necessary for cell cycle regulation and may
have altered function in certain cancers; alisertib (A) is an oral selective aurora
kinase A inhibitor. Preclinical data suggested that the combination of an EGFR
inhibitor and aurora kinase inhibitor may have synergistic effects in wild-type
EGFR NSCLC patients, leading to this phase I/II trial. Methods: Using a 3 + 3
dose escalation design, A was increased over four dose levels from 30 mg - 50
mg twice daily. E was given daily at 100 mg in DL1 and 150 mg in DL2-4. A was
given on days 1-7 of a 21 day cycle along with daily E. Key eligibility criteria: age
> 18, histologically confirmed NSCLC, ECOG PS 0-1, prior appropriate first line
therapy, acceptable organ function. Key exclusion criteria: EGFR mutation, prior
treatment with an EGFR pathway inhibitor or aurora kinase inhibitor. Results:
We report our experience with the phase I portion of this study and plans for
the phase II portion. Eighteen patients were treated on four dose levels. Patient
characteristics: Median age 61, M/F (8/10), 10/18 had received RT in addition to
systemic therapy. 14/18 patients completed at least 2 cycles. Median number
of cycles completed was 4.6. Common drug-related AEs of any grade were
fatigue (89%), anemia (83%), leukopenia (78%), dyspnea (78%), diarrhea and
anorexia (61% respectively). Drug-related Grade 3/4 AE included neutropenia
and leukopenia (33% each), febrile neutropenia, lymphopenia and anemia (11%
each). Two DLT occurred at DL4 (febrile neutropenia, neutropenia delaying a
cycle by > 7 days, both in cycle 1). Disease responses were noted, including one
patient with a PR who completed 10 cycles, and 5 patients who achieved SD.
Conclusion: In patients with recurrent/metastatic NSCLC, the combination
of A and E was tolerable. However, the maximum administered dose (E 150 mg
daily + E 50 mg BID) led to two DLT, thus the MTD was declared at DL3 (E 150 mg
+ A 40 mg BID); anti-tumor activity was noted. Updated preclinical data from
KRAS mutated and WT cell lines indicate activity of this combination in KRAS
mutants whereas either drug alone is ineffective. Based on this data, a protocol
amendment was submitted to allow only patients with KRAS mutations to be
treated in the phase II portion of the study.
Keywords: alisertib, KRAS, NSCLC, Erlotinib
POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
CLINICAL TRIALS –
TUESDAY, DECEMBER 6, 2016
P2.03A-019 A RETROSPECTIVE ANALYSIS OF NANOPARTICLE
ALBUMIN BOUND PACLITAXEL IN CHINESE PATIENTS WITH
RECURRENT ADVANCED NON-SMALL CELL LUNG CANCER IN A
SINGLE CENTER
Yixiang Zhu 1 , Puyuan Xing 1 , Sipeng Chen 2 , Junling Li 1
1 Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy
of Medical Sciences & Peking Union Medical College, Beijing/China, 2 School of
Public Health, Capital Medical University, Beijing, Beijing/China
Background: This is the first report describing the safety and short-term
efficacy of nanoparticle albumin bound paclitaxel (Nab-PTX) as monotherapy
administered weekly in the treatment of Chinese patients with recurrent
advanced non-small cell lung cancer (NSCLC), and analyzing potential factors
that may affect prognosis. Methods: Patients with recurrent advanced NSCLC
who received an weekly nab-paclitaxel regimen (130 mg/m2/week) treatment
were eligible.Toxicity and response according to the RECIST criteria were
summarized in the study. Classification and regression tree (CART) analysis was
performed to estimate the effect of variables (age, gender, performance score,
smoking, clinic stage, pathological type, previous line of therapy, treatment
cycles, EGFR status, EGFR-/ALK-TKIs, SPARC expression) on PFS. The Kaplan–
Meier analysis was used to estimate the effect of terminal tree notes. Results:
A total of 104 patients were included in the study from June 2010 to March 2014
in the Department of Medical Oncology, Cancer Hospital, Chinese Academy of
Medical Sciences,. The median follow-up period was 9.56 months (0.92-34.00
months). The overall response rate was 21.4%, and the disease control rate
was 73.8%. The median PFS was 4.53 months (95% CI: 3.518- 5.542), and the
median OS was 12.53 months (95% CI: 10.502- 14.558). Grade 3 adverse events
were neutropenia (8.8%), peripheral neuropathy (4.8%), myalgia/arthralgia
(4.0%), and fatigue (1.9%), respectively. Grade 4 toxicities rarely occured
except neutropenia (1.0%). CART analysis identified 4 terminal nodes based on
therapy cycles, age and therapy line. In the four subsets, those with < 4 therapy
cycles had the lowest PFS (Median: 1.80 months). Those with ≥ 4 cycles and
age ≥70 years had the longest PFS (Median: 8.83 months). The median PFS was
significantly different between the four subgroups (P =0.000). In addition, PFS
in the ≥ 4 therapy cycles group was better than the without group (Median: 6.23
vs. 1.80 months, P=0.000). No PFS significant differences were observed for
both age (≥70 years vs third-line vs ≤ third-line; Median: 6.37 vs 4.60, P=0.063). A trend of
a benefit in PFS in favor of ≥70 years age and >third-line groups was found in our
treatment. Conclusion: The weekly Nab-PTX regimen was effective and welltolerated
in patients with recurrent advanced NSCLC. Treatment cycles factors
may be used to predict the therapeutic efficacy of Nab-PTX. Nab-PTX was also
found the favourable survival benefit in older population (aged ≥70 years) and
patients with >third-line therapy.
Keywords: nanoparticle albumin bound paclitaxel (Nab-PTX), advanced nonsmall
cell lung cancer, chemotherapy
POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
CLINICAL TRIALS –
TUESDAY, DECEMBER 6, 2016
P2.03A-020 METRONOMIC ORAL VINORELBINE MONOTHERAPY IN
ELDERLY PATIENTS WITH ADVANCED NCSLC
Kostas Tzimopoulos, Emilia Tsaroucha, Erini Bourgani, Charalabos Kerasiotis,
Anastasios Kalianos, Christina Kolokytha, Angeliki Rapti
2nd Pulmonary, Hospital of Chest Diseases of Athens, Athens/Greece
Background: Metronomic chemotherapy involves chronic administration of
low-dose chemotherapy at regular short intervals, with the aim to induce
prolonged cancer control without significant side effects.Aim: was to
evaluate metronomic oral vinorelbine in elderly patients with advanced
NSCLC. Methods: Chemotherapy naïve patients with a mean age of 72.8 yrs
with NSCLC stage IIIB-IV and PS 0-2 were enrolled in this trial. Vinorelbine
was administered orally at a dose of 40mg three times a week, until disease
progression or unacceptable toxicities occurred. Results: Thirty-four patients
were enrolled (19 adenoca -14 squamous -1 NSCLC). Thirty were eligible
for evaluation.10 pts 33.3% had PS 2 and 7 (23.3%) had comorbidities(
COPD and/or Heart failure). A partial response was observed in 6 patients
(20%) and 12 (40%) had stable disease. After a median follow up period of
24.2 months, the median progression-free survival period ( PFS) was 7.00
months ( 95%CI 4.9- 9.1 months). No significant difference was found in in
PFS between patients with adenoca and squamous (5.00 vs 6.39 months
p>0.05) Four patients(13.3%) showed a clinical improvement changing their
PS from 2 to 1. Most adverse events were grade 1- 2 (peripheral neuropathy,
diarrhea and nephrotoxicity) and there was no need for dose reduction or
discontinuation of vinorelbine. Conclusion: Considering the PFS period and
the negligible toxicity metronomic oral vinorelbine seems to be a useful and
safe therapeutic option for elderly patients with adnanced NSCLC.
Keywords: metronomic, vonorelbine, NSCLC
POSTER SESSION 2 – P2.03A: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
CLINICAL TRIALS –
TUESDAY, DECEMBER 6, 2016
P2.03A-021 VINORELBINE/CARBOPLATIN VS GEMCITABINE/
CARBOPLATIN IN ADVANCED SQUAMOUS CELL LUNG CANCER
Assef Dayyoub 1 , Ali Hasan 2 , Ali Mohammad 2
1 Damascus University, Damascus/Syria, 2 Medical Oncology, Damascus University,
Damascus/Syria
S470 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017