Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel as Second- or Third-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer

Mie Kotake; Tomohito Kuwako; Hisao Imai; Yoshio Tomizawa; Kyoichi Kaira; Akihiro Yoshii; Mai Ochiai; Yosuke Miura; Takashi Osaki; Reiko Sakurai; Kousuke Takei; Koichi Minato; Ryusei Saito

doi:10.1159/000508715

Phase II Study of Weekly Nanoparticle Albumin-Bound Paclitaxel as Second- or Third-Line Therapy in Patients with Advanced Non-Small Cell Lung Cancer

Chemotherapy. 2020;65(1-2):21-28. doi: 10.1159/000508715. Epub 2020 Jul 16.

Authors

Mie Kotake^{1

2}, Tomohito Kuwako³, Hisao Imai⁴, Yoshio Tomizawa³, Kyoichi Kaira⁵, Akihiro Yoshii³, Mai Ochiai³, Yosuke Miura^{4

6}, Takashi Osaki³, Reiko Sakurai^{3

7}, Kousuke Takei^{3

8}, Koichi Minato⁴, Ryusei Saito³

Affiliations

¹ Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan, m10702012@gunma-u.ac.jp.
² Department of Respiratory Medicine, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan, m10702012@gunma-u.ac.jp.
³ Department of Respiratory Medicine, National Hospital Organization Shibukawa Medical Center, Shibukawa, Japan.
⁴ Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota, Japan.
⁵ Department of Respiratory Medicine, Comprehensive Cancer Center, International Medical Center, Saitama Medical University, Hidaka, Japan.
⁶ Department of Respiratory Medicine, Gunma University Graduate School of Medicine, Maebashi, Japan.
⁷ Oncology Center, Gunma University Hospital, Maebashi, Japan.
⁸ Division of Respiratory Medicine, Japanese Red Cross Maebashi Hospital, Maebashi, Japan.

PMID: 32674095
DOI: 10.1159/000508715

Abstract

Introduction: Treatment outcomes in patients with advanced non-small cell lung cancer (NSCLC) are poor due to limited treatment options.

Objective: We conducted a multicenter, single-arm phase II study to prospectively assess the efficacy and safety of weekly nab-PTX in patients with advanced NSCLC with failed cytotoxic chemotherapy.

Methods: Patients with advanced NSCLC having adequate organ functions with a performance status of 0-1 were enrolled. A 100 mg/m2 dose of nab-paclitaxel was administered on days 1, 8, and 15 of a 28-day cycle. Primary endpoint was the objective response rate (ORR). Secondary endpoints were disease control rate (DCR), toxicity profile, progression-free survival (PFS), and overall survival (OS).

Results: Between September 2013 and May 2016, 35 patients were enrolled. The ORR was 31.4%, and the DCR was 74.3%. The median PFS was 3.6 months, and the median OS was 11.4 months. The most common grade 3 or 4 toxicities included neutropenia (54.3%), leukopenia (42.9%), and anemia (11.4%). Two patients discontinued chemotherapy due to pneumonitis.

Conclusions: Nab-PTX may be a later-line chemotherapeutic option for previously treated advanced NSCLC.

Keywords: Cancer; Drug combinations; Nab-paclitaxel; Non-small cell lung cancer; Prospective study.

Publication types

Clinical Trial, Phase II
Multicenter Study

MeSH terms

Aged
Aged, 80 and over
Albumin-Bound Paclitaxel / adverse effects
Albumin-Bound Paclitaxel / therapeutic use*
Antineoplastic Agents / adverse effects
Antineoplastic Agents / therapeutic use*
Carcinoma, Non-Small-Cell Lung / drug therapy*
Carcinoma, Non-Small-Cell Lung / mortality
Carcinoma, Non-Small-Cell Lung / pathology
Disease-Free Survival
Drug Administration Schedule
Female
Humans
Kaplan-Meier Estimate
Lung Neoplasms / drug therapy*
Lung Neoplasms / mortality
Lung Neoplasms / pathology
Male
Middle Aged
Nanoparticles / chemistry*
Neoplasm Recurrence, Local
Neoplasm Staging
Neutropenia / etiology
Pneumonia / etiology
Treatment Outcome

Substances

Albumin-Bound Paclitaxel
Antineoplastic Agents