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
357P - Application of multi-modal approach to palliation in end of life head and neck cancer pain
Presenter: Srujana Joga
Session: Poster display session
Resources:
Abstract
358P - Evaluation of continuous low dose versus standard dose capecitabine monotherapy as second/third-line chemotherapy for metastatic malignancies
Presenter: Swaroop Revannasiddaiah
Session: Poster display session
Resources:
Abstract
359P - Factors associated with economic burden among cancer patients with minor children: A cross-sectional web-based survey of an online cancer community
Presenter: Midori Yuki
Session: Poster display session
Resources:
Abstract
360P - Factors influencing treatment decisions among breast cancer patients in the Philippine general hospital cancer institute: Medical oncology outpatient clinic
Presenter: Bobby De Guzman
Session: Poster display session
Resources:
Abstract
361P - The role of volunteers in quality palliative care delivery
Presenter: NABANITA MANDAL
Session: Poster display session
Resources:
Abstract
362P - Survey to assess the efficacy of continuity of care delivered through an out of hours telephonic consultation liaison
Presenter: Rahul D. Arora
Session: Poster display session
Resources:
Abstract
366P - Activity of larotrectinib in TRK fusion cancer patients with primary central nervous system tumours
Presenter: David Ziegler
Session: Poster display session
Resources:
Abstract
367P - Molecular characteristics and efficacy of crizotinib among different subsets of MET Amplification detected by next-generation sequencing in lung cancer
Presenter: Jing Li
Session: Poster display session
Resources:
Abstract
368P - Genomic analysis of malaysian breast cancers unravel molecular differences from Caucasian breast cancers
Presenter: Soo-Hwang Teo
Session: Poster display session
Resources:
Abstract
369P - Institutional-based prospective molecular profiling of advanced solid tumours in Hong Kong: A report of 253 cases
Presenter: Herbert Loong
Session: Poster display session
Resources:
Abstract