Abstract 511P
Background
Nanoparticle albumin-bound paclitaxel (nab-PTX) + carboplatin (Cb) therapy is one of the standard platinum-containing chemotherapy regimens for patients with advanced non-small cell lung cancer (NSCLC). Adding the anti-vascular endothelial growth factor antibody bevacizumab (BEV) to chemotherapy is an effective treatment option for non-squamous NSCLC. Because the efficacy and safety of the Cb + nab-PTX + BEV triplet regimen has not yet been assessed, we conducted a multicenter, open-label, phase I/II trial of Cb + nab-PTX + BEV therapy for patients with NSCLC. The phase II trial was based on the drug dose and schedule determined in the phase I trial.
Methods
In this phase II trial, the required number of patients was calculated to be 49 cases with α = 0.05 (one-sided) and β = 0.1 assuming a threshold response rate of 30% and an expected response rate of 50%. The patients were to receive 4–6 cycles of Cb (area under the curve = 6) + nab-PTX (100 mg/m2 on days 1, 8 and 15) + BEV (15 mg/kg on day 1) followed by a maintenance dose of nab-PTX + BEV every 3 weeks until disease progression. The primary endpoint was the overall response rate (ORR), and the secondary endpoints included overall survival (OS), progression free survival (PFS) time and toxicity.
Results
The trial was terminated early because of slow patient accrual. Finally, 47 cases were registered, and the main analysis was performed in 46 cases, excluding one case who was unqualified. The median age of the patients was 66 years. The transition percentage to maintenance therapy was 58.7%. The ORR based on central judgment was 56.5% (26/46 cases) with a 95% confidence interval (CI) of 42.2–70.8%, and the primary endpoint was met. The median PFS and OS were 7.79 months and 18.9 months, respectively. The main toxicity was myelosuppression, with grade 3–4 neutropenia (72.0%), anemia (28.0%), thrombocytopenia (14.0%) and febrile neutropenia (2.0%). The grade 3–4 sensory and motor neuropathy commonly seen with paclitaxel was 0%. All adverse events were manageable, and there was no treatment-related death.
Conclusions
Cb + nab-PTX + BEV therapy is a favorable and well-tolerated treatment for patients with advanced non-squamous NSCLC.
Clinical trial identification
UMIN000014560.
Editorial acknowledgement
Legal entity responsible for the study
TORG/OLCSG.
Funding
Taiho Pharmaceutical CO., LTD.
Disclosure
T. Kubo: Honoraria (self): Taiho pharmaceutical; Honoraria (self): Chugai pharmaceutical; Honoraria (self): BMS. A. Bessho: Honoraria (self): Taiho pharmaceutical; Honoraria (self): Chugai pharmaceutical. A. Morita: Honoraria (self): Chugai pharmaceutical. T. Yokoyama: Honoraria (self): Taiho pharmaceutical; Honoraria (self): Chugai pharmaceutical. K. Kaira: Honoraria (self): Taiho pharmaceutical; Honoraria (self): BMS. T. Harada: Honoraria (self): Taiho pharmaceutical. T. Shimokawa: Research grant / Funding (institution): Taiho pharmaceutical; Research grant / Funding (institution): Chugai pharmaceutical; Research grant / Funding (institution): BMS. K. Kiura: Research grant / Funding (institution): Chugai pharmaceutical; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Taiho pharmaceutical. H. Okamoto: Research grant / Funding (institution): Taiho pharmaceutical; Research grant / Funding (institution): BMS; Research grant / Funding (institution): Chugai pharmaceutical. All other authors have declared no conflicts of interest.
Resources from the same session
154P - Genetic characteristics of participants in the Australian Pancreatic Screening Study
Presenter: Krithika Murali
Session: Poster display session
Resources:
Abstract
155P - Mean Platelet Volume (MPV) is it a new prognostic marker in resectable carcinoma stomach?
Presenter: Girish M. S
Session: Poster display session
Resources:
Abstract
156P - A positive feedback between IDO1 metabolite and COL12A1 via MAPK pathway to promote gastric cancer metastasis
Presenter: Zhen Xiang
Session: Poster display session
Resources:
Abstract
157P - Lymph node ratio (LNR) a better prognostic factor after D2 gastrectomy
Presenter: Jitin Yadav
Session: Poster display session
Resources:
Abstract
158P - A clinical significance of preoperative C-reactive protein/albumin ratio in patients with extrahepatic bile duct cancer
Presenter: Kim Jinkook
Session: Poster display session
Resources:
Abstract
159P - The relation between obesity and cancer of gastrointestinal tract in Korea: The data from Statistic Korea between 2001 and 2016
Presenter: Hee Man Kim
Session: Poster display session
Resources:
Abstract
160P - Clinical outcomes of second-line chemotherapy after progression on nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic adenocarcinoma
Presenter: Jooyoung Ha
Session: Poster display session
Resources:
Abstract
161P - Chitinase 3-Like 1 gene (T/C) polymorphism and serum YKL-40 in hepatocellular carcinoma
Presenter: Alshimaa Alhanafy
Session: Poster display session
Resources:
Abstract
162P - Hypofractionated radiotherapy for pulmonary metastases from hepatocellular carcinoma: Treatment response and prognostic factors affecting survival
Presenter: In Young Jo
Session: Poster display session
Resources:
Abstract
163P - Excision repair cross-complementation group 1 and 2 (ERCC1/2) Single nucleotide polymorphisms and chemotherapy treatment outcome in Cholangiocarcinoma
Presenter: Thanachai Sanlung
Session: Poster display session
Resources:
Abstract