Belani, Chandra P.

Davies, Angela M.

Gandara, David R.

Longmate, Jeff

Ramalingam, Suresh S.

Vokes, Everett E.

Wright, John

Elsevier - Publisher Connector 

Journal of Thoracic Oncology • Volume 2, Number 8, Supplement 4, August 2007  12th World Conference on Lung Cancer
Copyright © 2007 by the International Association for the Study of Lung CancerS736
P3-133 NSCLC: Molecular Targeted Therapy Posters, Wed, Sept 5 – Thurs, Sept 6 
Bortezomib for advanced Bronchioloalveolar Carcinoma (BAC): 
a California-Pittsburgh Cancer Consortium multicenter phase II 
study
Ramalingam, Suresh S.1 Davies, Angela M.2 Longmate, Jeff3 Vokes, 
Everett E.4 Wright, John5 Gandara, David R.2 Belani, Chandra P.1 
1 University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA 2 
University of California Davis Cancer Center, Sacramento, CA, USA 3 
City of Hope National Medical Center, Duarte, CA, USA 4 University of 
Chicago Cancer Center, Chicago, IL, USA 5 National Cancer Institute, 
Bethesda, MD, USA 
Background: BAC accounts for approximately 3-5% of all cases of 
non-small cell lung cancer (NSCLC). An additional 20% of patients 
with adenocarcinoma have a BAC component. The optimal treat-
ment of advanced BAC is yet to be deﬁned, though inhibitors of the 
epidermal growth factor receptor pathway (EGFR) have demonstrated 
promising efﬁcacy. Bortezomib, a novel proteosome inhibitor, has 
demonstrated single agent activity against NSCLC. We conducted a 
phase II study to evaluate the efﬁcacy of bortezomib for patients with 
advanced BAC or adenocarcinoma with BAC features. A novel weekly 
schedule of bortezomib was utilized for the study.
Methods: Eligibility criteria were: histological conﬁrmation of diag-
nosis, ≤ 1 prior chemotherapy regimen, ECOG PS 0-2, presence of 
measurable disease, adequate bone marrow, hepatic and renal function 
and willingness to sign informed consent. Prior EGFR inhibitor therapy 
was permitted (not considered as a chemotherapy regimen for eligibil-
ity). Bortezomib (1.6 mg/m2) was administered intravenously on days 
1 and 8 of every 3 week cycle. Treatment was continued until disease 
progression or unacceptable toxicity. The primary endpoint was deter-
mination of the response rate. Secondary endpoints included survival 
and toxicity assessment.
Results: Twenty four patients have been enrolled to date: females-12; 
PS 0-9; PS 1-13; never smokers-8; prior therapy-16. Treatment was 
tolerated well and a median of 3 cycles of therapy were administered. 
Nine patients are still on treatment. Salient toxicities (grades 2/3) (N) 
attributable to treatment are: neutropenia-2/0; fatigue-4/2; diarrhea-2/2; 
nausea-1/0; emesis-1/0 and sensory neuropathy-1/0. One patient experi-
enced partial response (4.5%) and 14 had stable disease (64%) out of 
22 evaluable patients (clinical beneﬁt rate - 69%). The median survival 
is 9.4 months. Most patients were censored at a median follow up of 5 
months for the purposes of this analysis. Accrual to the study continues.
Conclusions: The preliminary results of our study demonstrate modest 
anti-cancer activity with bortezomib in patients with advanced BAC, 
including those who had disease progression with an EGFR inhibitor. 
P3-134 NSCLC: Molecular Targeted Therapy Posters, Wed, Sept 5 – Thurs, Sept 6 
Sunitinib in combination with gemcitabine plus cisplatin for 
advanced non-small cell lung cancer (NSCLC): preliminary results 
from a phase I dose escalation study
Reck, Martin1 Frickhofen, Norbert2 Gatzemeier, Ulrich1 Fuhr, Heinz-
Georg2 Lanzalone, Silvana3 Lechuga, Maria J.3 Wang, Erjian4 Chao, 
Richard4 Felip, Enriqueta5 
1 Hospital Grosshansdorf, Grosshansdorf, Germany 2 HSK, Dr. Horst 
Schmidt, Wiesbaden, Germany 3 Pfizer Italia srl, Milan, Italy 4 Pfizer 
Global Research and Development, La Jolla, CA, USA 5 Vall d’Hebron 
University Hospital, Barcelona, Spain 
Background: Sunitinib malate is an oral, multitargeted tyrosine 
kinase inhibitor of VEGFRs, PDGFRs, KIT, RET, and FLT3, approved 
internationally for the treatment of advanced renal cell carcinoma 
and imatinib-resistant or -intolerant gastrointestinal stromal tumor. 
Single-agent sunitinib is also active in advanced NSCLC after failure of 
platinum-based therapy, resulting in an objective response rate of 11% 
(Socinski, ESMO 2006). We report preliminary results from a phase 
I dose-ﬁnding study assessing the safety, tolerability, and pharmaco-
kinetics of sunitinib in combination with gemcitabine and cisplatin as 
ﬁrst-line treatment of advanced NSCLC.
Methods: Patient eligibility criteria included histologically proven, 
stage IIIB or IV NSCLC not amenable to curative treatment; no prior 
chemotherapy except for adjuvant therapy completed more than 6 
months before study start; ECOG performance status 0 or 1; and 
adequate organ function. Planned dose levels include: oral sunitinib 
(37.5 or 50 mg/day for 2 weeks followed by 1 week off treatment [2/1 
schedule], in repeated three-week cycles) plus gemcitabine (1000 or 
1250 mg/m2 iv on days 1 and 8 of a 21-day cycle) and cisplatin (80 
mg/m2 iv on day 1 of each cycle). Sunitinib administered daily on a 
continuous dosing schedule will also be tested. Sunitinib doses are 
escalated in serial patient cohorts to determine the maximum tolerated 
dose for both schedules. Other endpoints include pharmacokinetics and 
antitumor efﬁcacy.
Results: As of October 2006, 13 patients were treated on the 2/1 
schedule, including 9 male and 4 female patients, median age 59 (range 
48-68). Six patients received sunitinib 37.5 mg + gemcitabine 1000 
mg/m2 + cisplatin 80 mg/m2, and 7 patients were treated with sunitinib 
50 mg + gemcitabine 1000 mg/m2 + cisplatin 80 mg/m2. No dose-lim-
iting toxicities were observed with sunitinib 37.5 mg, but 2 patients 
treated with sunitinib 50 mg experienced dose-limiting neutropenia and 
infection, and neutropenia, infection and thrombocytopenia, respec-
tively. Grade 3/4 hematological adverse events included neutropenia 
(n=3 at sunitinib 37.5 mg/day and n=5 at sunitinib 50 mg/day dose 
levels), thrombocytopenia (n=1 and n=5) and anemia (n=2 and n=0). 
Three patients treated at the sunitinib 50 mg/day dose level achieved a 
partial tumor response. There were no apparent drug-drug interactions 
between sunitinib and gemcitabine or cisplatin based on their systemic 
exposures in this study.
Conclusions: The combination of sunitinib (37.5 mg) given on 
schedule 2/1 with gemcitabine (1000 mg/m2) and cisplatin (80 mg/m2) 
appears safe and tolerable in this patient population with advanced 
NSCLC. The trial continues with gemcitabine escalated to 1250 mg/m2 
and with sunitinib administered on a continuous dosing schedule.
P3-135 NSCLC: Molecular Targeted Therapy Posters, Wed, Sept 5 – Thurs, Sept 6 
Results of an open-label, Phase II trial of nanoparticle albumin 
bound paclitaxel (nab-paclitaxel), carboplatin, and bevacizumab 
as first-line therapy in patients with advanced non-squamous non-
small cell lung cancer (NSCLC)
Reynolds, Craig1,7 Barrera, David1,2 Vu, Duy Quoc1,3 Jotte, Robert1,4 
Spira, Alexander I.1,5 Weissman, Charles1,6 Boehm, Kristi A.1 Pritchard, 
Sharon8 Asmar, Lina1 
1 US Oncology Research, Inc., Houston, TX, USA 2 Texas Cancer 
Center, Ft. Worth, TX, USA 3 New York Oncology Hematology, Albany, 
NY, USA 4 Rocky Mountain Cancer Centers, Denver, CO, USA 5 Fairfax 
Northern Virginia Hematology - Oncology, Fairfax, VA, USA 6 New 


P3-133: Bortezomib for advanced Bronchioloalveolar Carcinoma (BAC): a California–Pittsburgh Cancer Consortium multicenter phase II study 

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P3-133: Bortezomib for advanced Bronchioloalveolar Carcinoma (BAC): a California–Pittsburgh Cancer Consortium multicenter phase II study

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