Journal Thoracic Oncology

Abstracts Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017
Christina Baik 1 , Bernardo Goulart 1 , Katherine Nguyen 2 , Sylvia Lee 3 , Keith
Eaton 3 , Laura Chow 1 , Cristina Rodriguez 1 , Rafael Santana-Davila 1 , Rebecca
Wood 1 , Renato Martins 1
1 Division of Medical Oncology, Thoracic, Head, and Neck Program, University of
Washington, Seattle Cancer Care Alliance, Seattle/WA/United States of America,
2 Hematology/Medical Oncology, Group Health, Seattle/WA/United States of
America, 3 Division of Medical Oncology, Thoracic, Head, and Neck Program,
University of Washington, Seattle Cancer Care Alliance, Seattle/United States of
America
Background: Patients with NSCLC harboring a sensitizing EGFR mutation
have effective targeted therapy options initially but most patients eventually
need to receive cytotoxic chemotherapy. We previously reported our
institutional experience with taxane based therapy in this patient population
and this provided the rationale for the currently ongoing phase II study
(NCT01620190). Methods: Patients with EGFR mutation positive NSCLC who
were refractory to tyrosine kinase inhibitor (TKI) therapy and chemotherapy
naive received nab-P at 125mg/m2 on days 1, 8 and 15 in a 28-day cycle. The
primary endpoint was response rate which was assessed using RECIST v1.1.
Results: As of data cut-off of March 14 2016, 22 patients were enrolled and
received therapy (19 evaluable, 2 not yet evaluable, 1 patient excluded due to
not being eligible). Median age was 65 (range 54-77), 75% of patients were
women, 40% did not have a smoking history and majority (65%) of patients
had an ECOG performance status of 1. Tumor histology consisted mostly of
adenocarcinoma (90%); 55% of patients harbored exon 21 L858R and 45%
harbored exon deletion 19 mutations. Confirmed partial response was
documented in 8 of 19 (42%) patients with a median duration of response of
4.3 months (range 3.3-9.5) and stable disease was documented in 4 of 19 (21%)
patients with a disease control rate of 63%. Median progression free survival
was 4.4 months (95% CI 1.8-5.5 months). The most common grade 3 treatmentrelated
adverse events (AE) were peripheral neuropathy (10%), fatigue (10%)
and neutropenia (15%). There were no treatment-related grade 4 AEs.
Conclusion: Single agent nab-P has promising activity in patients with EGFR
mutation positive NSCLC. The AE profile was consistent with previously
reported AEs in the literature. Accrual of patients continues and updated data
will be presented
abemaciclib 150mg (dose identified in preceding dose escalation part of study)
administered every 12 hours on days 1–21. Major eligibility criteria include:
progression after platinum-based chemotherapy regimen and maximum 1
other prior chemotherapy for advanced and/or metastatic disease (prior
treatment with EGFR-TKI and ALK inhibitors was mandatory in patients
whose tumor has EGFR-activating mutations or ALK translocations,
respectively); ECOG PS 0-1; tumor tissue availability for biomarker analysis
and measurable disease. Treatment will continue until disease progression,
unacceptable toxicity, or withdrawal of consent by the patient, or sponsor/
investigator decision. Results: This safety interim includes 16 squamous and
non-squamous patients treated at recommended dose (necitumumab 800mg
+ abemaciclib 150mg) and having completed 2 cycles of study treatment (or
otherwise discontinued study treatment). The most common (>15% patients)
adverse events (AEs) of any grade are shown in the Table. Grade ≥3 AEs were
reported in 6 patients (diarrhea, nausea, vomiting, neutropenia, decreased
appetite, hypophosphotaemia, dyspnoea were each reported in 1 patient and
fatigue in 2 patients); grade ≥3 AEs were judged to be related to study
treatment in 4 patients. No patients have discontinued the study due an AE.
Conclusion: The combination of necitumumab and abemaciclib in advanced
NSCLC is well tolerated when administered according to recommended dosing
schedules.
Keywords: abemaciclib, non-small cell lung cancer, Necitumumab
Keywords: nab-paclitaxel, EGFR, chemo
POSTER SESSION 3 – P3.02B: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
EGFR CLINICAL –
WEDNESDAY, DECEMBER 7, 2016
POSTER SESSION 3 – P3.02B: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/
IMMUNOTHERAPY
EGFR CLINICAL –
WEDNESDAY, DECEMBER 7, 2016
P3.02B-062 SAFETY OF NECITUMUMAB AND ABEMACICLIB
COMBINATION THERAPY IN PATIENTS WITH ADVANCED NON-
SMALL CELL LUNG CANCER (NSCLC)
Benjamin Besse 1 , Johan Vansteenkiste 2 , Patrick-Aldo Renault 3 , Bente
Frimodt-Moller 4 , Grace Chao 5 , Maciej Gil 6 , Fabrice Barlesi 7
1 Department of Cancer Medicine, Gustave Roussy, Villejuif/France, 2 Respiratory
Oncology Unit (Pneumology), University Hospital KU Leuven, Leuven/Belgium,
3 Chr de Pau, Pau/France, 4 Eli Lilly and Company, Copenhagen/Denmark, 5 Eli Lilly
and Company, Bridgewater/NJ/United States of America, 6 Eli Lilly, Warsaw/Poland,
7 Centre Essais Précoces En Cancérologie de Marseille Clip, Marseille/France
Background: Trials of anti-EGFR necitumumab and the CDK4 and CDK6
inhibitor abemaciclib have demonstrated anti-tumor activity of each agent in
patients with NSCLC. In a xenograft model of NSCLC, the addition of
necitumumab to abemaciclib improved the anti-tumor efficacy compared to
either monotherapy. Methods: Single-arm, multicenter Phase 1b study to
investigate the combination of necitumumab and abemaciclib in patients
with stage IV NSCLC (NCT02411591). The safety interim population includes
squamous and non-squamous patients treated with the recommended dose
of necitumumab 800mg IV on days 1 and 8, every 21 days in combination with
P3.02B-063 ANALYSIS OF SURVIVAL IN EGFR-MUTATION-POSITIVE
ADVANCED NON-SMALL-CELL LUNG CANCER PATIENTS WITH
MILIARY PULMONARY METASTASIS
Kageaki Watanabe, Yusuke Okuma, Maki Miwa, Yukio Hosomi, Tatsuru
Okamura
Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and
Infectious Diseases Center Komagome Hospital, Tokyo/Japan
Background: Backgrounds: Miliary pulmonary metastasis of non-small-cell
lung cancer (NSCLC) indicates hematogenous dissemination and is more
frequent in patients harboring EGFR mutations, and dramatic responses are
often observed after treatment with EGFR-tyrosine kinase inhibitors (TKI).
The relevance between miliary pulmonary metastasis and EGFR mutation has
been suggested; therefore, we analyzed the survival in patients with miliary
pulmonary metastasis harboring EGFR mutations treated with EGFR-TKI.
Methods: Methods: We retrospectively analyzed 269 patients diagnosed
with advanced or recurrent NSCLC treated with EGFR-TKI between 2005 and
2015 identified from the electronic database at our hospital. OS and PFS
were estimated using the Kaplan–Meier method. We analyzed the survival
in all eligible patients and performed propensity score matching based
on clinical characteristics. Results: Results: A total of 215 NSCLC patients
harboring EGFR mutations and treated with EGFR-TKIs were included in the
study. Patients had a median age of 61 years (38–88 years). With regard to
EGFR-TKIs, gefitinib was administered in 167 patients (77.7%), erlotinib in
S644 Journal of Thoracic Oncology • Volume 12 Issue S1 January 2017