Annual Meeting Proceedings Part 1 - American Society of Clinical ...

476s Lung Cancer—Non-small Cell Local-Regional/Small Cell/Other Thoracic Cancers
7100 General Poster Session (Board #42C), Sat, 1:15 PM-5:15 PM
Amrubicin and carboplatin with pegfilgrastim in patients with extensivestage
small-cell lung cancer (ES-SCLC): A phase II study of the Sarah
Cannon Research Institute (SCRI). Presenting Author: Dianna Shipley,
Tennessee Oncology, PLLC/Sarah Cannon Research Institute, Nashville,
TN
Background: Amrubicin is a novel anthracycline associated with high
objective response rates (ORR) in patients (pts) with relapsed SCLC.
Amrubicin improved the ORR and progression-free survival (PFS) in
relapsed SCLC vs. topotecan, but not overall survival (OS) in a phase III
study. Amrubicin with cisplatin/carboplatin for elderly Japanese pts was
safe and active. We conducted a multicenter phase II study evaluating
amrubicin and carboplatin in newly diagnosed ES-SCLC. Methods: Eligible
pts had untreated ES-SCLC, measurable/evaluable disease (RECIST v. 1.1)
and an ECOG PS �2. Pts received 4 cycles of amrubicin 30 mg/m2 on days
1-3 and carboplatin AUC�5 both IV day 1 every 21 days with restaging
every 6 weeks. Pegfilgrastim 6 mg sq was administered on day 4 of each
cycle. The primary endpoint was 1-year OS. Secondary endpoints included
ORR, PFS, OS, and toxicity. Results: 78 pts were enrolled from 3/2010 to
7/2011. Baseline characteristics included: median age 65 yrs (range
45-84); 56% female. 64% completed 4 cycles of treatment. Eleven (14%)
pts showed complete responses and 47 (60%) pts partial responses, for an
ORR of 74% (95% confidence interval 65%-82%). Twelve (15%) pts had
stable disease. Median PFS and OS were 5.3 and 9.5 months, respectively.
The 1-year OS was 36%. Grade 3/4 myelosuppression was the most
common toxicity (thrombocytopenia 44%, neutropenia 34%, febrile neutropenia
12%, anemia 26%), but was manageable. Severe non-hematologic
toxicities (�5%) included hypokalemia 17%, fatigue 13%, dehydration
10%, hyponatremia 10%, pneumonia 9%, and nausea/vomiting 8%. 1 pt
died from sepsis and another from aspiration pneumonia. Conclusions:
First-line ES-SCLC treatment with amrubicin and carboplatin induced
several complete responses and is considered highly active. Myelosuppression
was managed effectively with growth factor support. These results are
comparable to historical data with platinum-doublet chemotherapy. A
larger randomized study would be required to best assess this regimen’s
impact on survival.
7102 General Poster Session (Board #42E), Sat, 1:15 PM-5:15 PM
Incidence of venous thromboembolism in lung cancer and its effect on
survival. Presenting Author: Mohammad Mozayen, McLaren Regional
Medical Center, Michigan State University, Flint, MI
Background: Lung cancer is a major risk factor of venous thromboembolism
(VTE). The incidence of VTE in different histological patterns of lungs
cancer and its impact at the disease outcome is not well studied. We aim to
evaluate the incidence rate of VTE in lung cancer and its effect on survival.
Methods: Patients (pts) with lung cancer diagnosis from cancer database of
community hospital were reviewed. Pts’ medical records were checked for
VTE over 3 years after diagnosis. Pts’ demographics, pathology, TNM stage
and overall survival were studied. Development of VTE was primary
outcome and 3 year overall survival was the secondary outcome. Results: A
total 2,164 pts with lung cancer between 1995 and 2008 were included.
Median age of the study population was 70 years. Males were 53%, African
Americans were 7%. 200 pts (9%) were diagnosed with VTE. Out of 1783
pts with non-small cell lung cancer (NSCLC), 176 pts (9.9%) had VTE
whereas out of 381 pts with small cell lung cancer (SCLC) 24 pts (6.3%)
had VTE (p�0.015). Among NSCLC pts, 13.5% of pts with adenocarcinoma
had VTE, whereas 6.6% of pts with squamous cell carcinoma had
VTE (p�0.05). The incidence of VTE in stages I, II, III, IV of all pts were
(8.4%, 7.3%, 13%, 7.5%) (p�0.007) respectively. In NSCLC, three years
overall survival of pts with and without VTE was 22% and 24% respectively
(p�0.34). In SCLC, three years overall survival of pts with and without VTE
was 21% and 11% respectively (p�0.09). Conclusions: There is a higher
incidence of VTE in non-small cell lung cancer than in small cell lung
cancer. Among the NSCLC, VTE’s incidence was higher in adenocarcinoma
than squamous carcinoma. VTE maybe higher at advanced stages (stage
III) in both NSCLC and SCLC combined. There was no significant difference
in the 3 years overall survival of lung cancer patients with and without VTE.
7101 General Poster Session (Board #42D), Sat, 1:15 PM-5:15 PM
Comparison of treatment patterns, health care utilization, and direct costs
in elderly patients with distant-stage small cell lung cancer (SCLC) versus
non-small cell lung cancer (NSCLC) using the SEER-Medicare database.
Presenting Author: Sudeep Karve, RTI Health Solutions, Research Triangle
Park, NC
Background: Limited data exist on real-world treatment patterns, healthcare
utilization, and associated costs of advanced SCLC among elderly patients
in the US, and there are no recent comparisons between patients with
advanced SCLC and advanced NSCLC. Methods: We retrospectively analyzed
administrative claims data for elderly patients (�65 years) from the
linked Surveillance, Epidemiology and End Results (SEER)-Medicare
database for 2000-2008. Patients with a new diagnosis of distant stage
lung cancer receiving cancer-directed therapy (ie, surgery, radiation,
biologics, and/or chemotherapy) were grouped by tumor type (SCLC
[n�5,855] vs NSCLC [n�24,090]). Survival was compared using Kaplan-
Meier Log-rank; categorical measures with Chi-square statistics; and
continuous measures with t-tests. Results: Compared to SCLC patients, a
significantly greater proportion of patients with NSCLC received radiation
therapy (75.6% vs 65.4%; p�0.001) and surgery (13.6% vs 7.8%;
p�0.001). Chemotherapy was received by 85.5% of SCLC patients and
60.3% of NSCLC patients (p�0.001). Significantly higher proportions of
SCLC patients also received red blood cell (20.7% vs 10.9; p�0.001) and
platelet transfusions (5.6% vs 1.8%; p�0.001) as well as growth factor
support (58.9% vs 39.5%; p�0.001). Survival did not differ significantly
between groups (p�0.424), with the mean (10.4 months vs 11.1 months)
and median (7.4 months vs 5.9 months) survival for SCLC and NSCLC
noted accordingly. Total lifetime lung cancer-related costs ($44,167 vs
$37,932; p�0.001) and all-cause costs ($70,548 vs $67,175; p�0.001)
per patient for SCLC exceeded those for NSCLC. The primary drivers of cost
included resource utilization across 3 care settings: hospitalizations, office
visits, and hospital outpatient visits. Conclusions: Overall total lifetime and
disease-related costs per advanced SCLC and NSCLC patient were high,
and costs for SCLC exceeded those for NSCLC. Survival estimates coupled
with per patient costs for both cancers underscores the unmet medical
need for patients with distant stage SCLC and NSCLC.
7103 General Poster Session (Board #42F), Sat, 1:15 PM-5:15 PM
A phase (Ph) I/II study of belinostat (Bel) in combination with cisplatin,
doxorubicin, and cyclophosphamide (PAC) in the first-line treatment of
advanced or recurrent thymic malignancies. Presenting Author: Anish
Thomas, National Cancer Institute, Bethesda, MD
Background: Belinostat is a hydroxamic acid histone deacetylase (HDAC)
pan-inhibitor with single agent activity in thymic malignancies. PAC has
activity against thymic cancers. Synergy between Bel and several chemotherapeutic
agents, including P, A, and C, has been demonstrated in
preclinical models. Methods: Patients with histologically confirmed, treatment
naive advanced thymic malignancies, PS�2, measurable disease,
and adequate renal, hepatic and hematopoietic functions were eligible.
Ph1 evaluated safety and tolerability of the combination using increasing
dose levels (DL) of Bel (1000-2000 mg/m² over 48 h CIVI) and PAC
(50/50/500 mg/m² IV/cycle) (3�3 dose escalation schema), administered
every 21 days for no more than 6 cycles followed by optional maintenance
Bel every 4 weeks. Primary end point of Ph2 is overall response rate (ORR).
Results: From March 2010 to January 2012, 13 patients were enrolled [7
thymoma (T), 6 thymic carcinoma (TC); 8 in Ph1 and 5 in Ph2; median age:
49 years (range, 23-76)]. In Ph1, 6 patients were treated at DL1 (Bel 1000
mg/m2� PAC) and 2 patients at DL2 (Bel 2000 mg/m2� PAC). Dose
Limiting Toxicities were Grade 3 nausea and diarrhea, and Grade 4
neutropenia and thrombocytopenia. Recommended phase II dose (RP2D)
was set at DL1. Most common grade 3/4 treatment-related adverse events
(AE) were lymphocytopenia (100%), leucopenia (85%), neutropenia (77%)
thrombocytopenia (54%), anemia (38%), hypophosphatemia (38%), hypomagnesemia,
hypokalemia, elevated AST, prolonged QTc and infusioncatheter
related thromboembolic complications (23% each). Outcomes
included one complete response (CR; T at DL1), 6 partial responses (PR; 4
T, 2 TC; 4 in Ph1, 2 in Ph2) and 6 stable disease (SD; 2 T, 4 TC; 3 each in
Ph1 and Ph2). Four patients previously deemed unresectable underwent
surgical resection. Conclusions: Belinostat in combination with PAC has
activity in thymic malignancies with a predicable AE profile. ORR was 54%
including 33% PR in the TC subgroup. RP2D of the combination has been
defined. Accrual to Ph2 part and molecular profiling of patient tumors is
ongoing.
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