Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial

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Abstract

Background

This trial aimed to investigate the treatment response, survival profiles and treatment-related adverse events (AEs) of apatinib plus docetaxel in advanced non-squamous non-small cell lung cancer (NSCLC) patients with wild-type epidermal growth factor receptor (EGFR).

Methods

Thirty advanced non-squamous NSCLC patients with wild-type EGFR were recruited in this multi-center, phase II trial. All patients received apatinib (orally 500 mg, once daily until disease progression, intolerable toxicity, or death) plus docetaxel (intravenously 60 mg/m ² at day 1 every 3 weeks for 4–6 cycles). The treatment response, progression-free survival (PFS), overall survival (OS) and treatment-related AEs were evaluated.

Results

One patient lacked response and survival assessment due to early lost follow-up, therefore, 29 patients were included in response and survival analysis. There was no (0.0%) patient achieved complete remission, 8 (27.6%) patients achieved partial remission, 20 (69%) patients with stable disease, and 1 (3.4%) patient with progressive disease, resulting in objective response rate and disease control rate of 27.6% and 96.6%, respectively. According to the survival data, median PFS was 5.3 months (95% CI: 3.6–6.9 months) and median OS was 9.6 months (95% CI: 6.33–12.9 months). For safety, totally 30 patients were included in the analysis. Common non-hematologic AEs included hypertension (66.7%), hand-foot syndrome (40.0%), proteinuria (36.7%); common hematologic AEs included leukopenia (26.7%), thrombocytopenia (23.3%), neutropenia (16.7%). Notably, majority of AEs were at grade 1–2, and the overall AEs were tolerable.

Conclusions

Apatinib plus docetaxel is an effective and tolerable treatment option for advanced non-squamous NSCLC with wild-type EGFR.

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Most cited references 20

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Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

Hossein Borghaei, Luis Paz-Ares, Leora Horn … (2015)

Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity.

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Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial.

Martin Reck, Rolf Kaiser, Anders Mellemgaard … (2014)

The phase 3 LUME-Lung 1 study assessed the efficacy and safety of docetaxel plus nintedanib as second-line therapy for non-small-cell lung cancer (NSCLC). Patients from 211 centres in 27 countries with stage IIIB/IV recurrent NSCLC progressing after first-line chemotherapy, stratified by ECOG performance status, previous bevacizumab treatment, histology, and presence of brain metastases, were allocated (by computer-generated sequence through an interactive third-party system, in 1:1 ratio), to receive docetaxel 75 mg/m(2) by intravenous infusion on day 1 plus either nintedanib 200 mg orally twice daily or matching placebo on days 2-21, every 3 weeks until unacceptable adverse events or disease progression. Investigators and patients were masked to assignment. The primary endpoint was progression-free survival (PFS) by independent central review, analysed by intention to treat after 714 events in all patients. The key secondary endpoint was overall survival, analysed by intention to treat after 1121 events had occurred, in a prespecified stepwise order: first in patients with adenocarcinoma who progressed within 9 months after start of first-line therapy, then in all patients with adenocarcinoma, then in all patients. This trial is registered with ClinicalTrials.gov, number NCT00805194. Between Dec 23, 2008, and Feb 9, 2011, 655 patients were randomly assigned to receive docetaxel plus nintedanib and 659 to receive docetaxel plus placebo. The primary analysis was done after a median follow-up of 7·1 months (IQR 3·8-11·0). PFS was significantly improved in the docetaxel plus nintedanib group compared with the docetaxel plus placebo group (median 3·4 months [95% CI 2·9-3·9] vs 2·7 months [2·6-2·8]; hazard ratio [HR] 0·79 [95% CI 0·68-0·92], p=0·0019). After a median follow-up of 31·7 months (IQR 27·8-36·1), overall survival was significantly improved for patients with adenocarcinoma histology who progressed within 9 months after start of first-line treatment in the docetaxel plus nintedanib group (206 patients) compared with those in the docetaxel plus placebo group (199 patients; median 10·9 months [95% CI 8·5-12·6] vs 7·9 months [6·7-9·1]; HR 0·75 [95% CI 0·60-0·92], p=0·0073). Similar results were noted for all patients with adenocarcinoma histology (322 patients in the docetaxel plus nintedanib group and 336 in the docetaxel plus placebo group; median overall survival 12·6 months [95% CI 10·6-15·1] vs 10·3 months [95% CI 8·6-12·2]; HR 0·83 [95% CI 0·70-0·99], p=0·0359), but not in the total study population (median 10·1 months [95% CI 8·8-11·2] vs 9·1 months [8·4-10·4]; HR 0·94, 95% CI 0·83-1·05, p=0·2720). Grade 3 or worse adverse events that were more common in the docetaxel plus nintedanib group than in the docetaxel plus placebo group were diarrhoea (43 [6·6%] of 652 vs 17 [2·6%] of 655), reversible increases in alanine aminotransferase (51 [7·8%] vs six [0·9%]), and reversible increases in aspartate aminotransferase (22 [3·4%] vs three [0·5%]). 35 patients in the docetaxel plus nintedanib group and 25 in the docetaxel plus placebo group died of adverse events possibly unrelated to disease progression; the most common of these events were sepsis (five with docetaxel plus nintedanib vs one with docetaxel plus placebo), pneumonia (two vs seven), respiratory failure (four vs none), and pulmonary embolism (none vs three). Nintedanib in combination with docetaxel is an effective second-line option for patients with advanced NSCLC previously treated with one line of platinum-based therapy, especially for patients with adenocarcinoma. Boehringer Ingelheim. Copyright © 2014 Elsevier Ltd. All rights reserved.

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Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study.

Corey Langer, Shirish Gadgeel, Hossein Borghaei … (2016)

Limited evidence exists to show that adding a third agent to platinum-doublet chemotherapy improves efficacy in the first-line advanced non-small-cell lung cancer (NSCLC) setting. The anti-PD-1 antibody pembrolizumab has shown efficacy as monotherapy in patients with advanced NSCLC and has a non-overlapping toxicity profile with chemotherapy. We assessed whether the addition of pembrolizumab to platinum-doublet chemotherapy improves efficacy in patients with advanced non-squamous NSCLC.

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Author and article information

Journal

Journal ID (nlm-ta): J Thorac Dis

Journal ID (iso-abbrev): J Thorac Dis

Journal ID (publisher-id): JTD

Title: Journal of Thoracic Disease

Publisher: AME Publishing Company

ISSN (Print): 2072-1439

ISSN (Electronic): 2077-6624

Publication date (Print and electronic): May 2020

Publication date (Print): May 2020

Volume: 12

Issue: 5

Pages: 2450-2458

Affiliations

[1 ]Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine , Nanjing 210002, China;

[2 ]Department of Respiratory Medicine, Nanjing Drum Tower Hospital, Nanjing University School of Medicine , Nanjing 210008, China;

[3 ]Department of Oncology, The Second Affiliated Hospital of Nanjing Medical University , Nanjing 210011, China;

[4 ]Department of Medical Oncology, Jiangsu Cancer Hospital, Nanjing Medical University , Nanjing 210009, China

Author notes

Contributions: (I) Conception and design: Y Song; (II) Administrative support: Y Song; (III) Provision of study materials or patients: All authors; (IV) Collection and assembly of data: All authors; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

Correspondence to: Yong Song. Department of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, 305 East Zhongshan Road, Nanjing 210002, China. Email: yong_song6310@ 123456yahoo.com .

Article

Publisher ID: jtd-12-05-2450

DOI: 10.21037/jtd.2020.03.54

PMC ID: 7330342

PubMed ID: 32642151

SO-VID: fcea2b9e-480d-4867-8bf9-0aeb9022b32a

License:

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0.

History

Date received : 19 January 2020

Date accepted : 05 March 2020

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Combination of apatinib and docetaxel in treating advanced non-squamous non-small cell lung cancer patients with wild-type EGFR: a multi-center, phase II trial

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Most cited references 20

Nivolumab versus Docetaxel in Advanced Nonsquamous Non–Small-Cell Lung Cancer

Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small-cell lung cancer (LUME-Lung 1): a phase 3, double-blind, randomised controlled trial.

Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study.

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