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
339TiP - PACIFIC-5: Phase III study of durvalumab after either concurrent or sequential chemoradiotherapy (CRT) in patients with stage III NSCLC
Presenter: Yi-Long Wu
Session: Poster display session
Resources:
Abstract
340TiP - A multicenter, randomized, controlled, phase II trial exploring adjuvant combined therapy of apatinib and SHR-1210 (anti-PD-1), in patients with hepatocellular carcinoma at high risk of recurrence after radical resection
Presenter: Shida Yan
Session: Poster display session
Resources:
Abstract
347P - Relationship between modified surgical margin and prognosis of cutaneous squamous cell carcinoma
Presenter: Yukiko Teramoto
Session: Poster display session
Resources:
Abstract
348P - Malignant melanoma: A study of clinical profiles and treatment outcomes in Indian patients
Presenter: Sorun Shishak
Session: Poster display session
Resources:
Abstract
349P - Flavonoids from ethanol extracts of euphorbia hirta inhibit melanoma growth and metastatic potential
Presenter: Shubhra Mishra
Session: Poster display session
Resources:
Abstract
350P - Low-dose cisplatin and 5-fluorouracil combined concurrent chemoradiotherapy for unresectable cutaneous squamous cell carcinoma: Analysis of 23 cases
Presenter: Azusa Hiura
Session: Poster display session
Resources:
Abstract
353P - A prediction model for the intents regarding life-sustaining treatment decisions in patients with terminal cancer
Presenter: Yoonsun Kim
Session: Poster display session
Resources:
Abstract
354P - Predictive factors and survival outcomes with stereotactic body radiation therapy in treatment of oligometastases in colorectal cancer
Presenter: Vibhay Pareek
Session: Poster display session
Resources:
Abstract
355P - Cost analysis and overview of single versus multiple fraction palliative radiotherapy for painful bone metastasis
Presenter: Vinodhkumar Selvaraj
Session: Poster display session
Resources:
Abstract
356P - Observational study on role of crude cannabis in pain control and quality of life in terminally ill cancer patients: An Indian perspective
Presenter: Vidyasagar Dusi
Session: Poster display session
Resources:
Abstract