Tuberc Respir Dis.  2019 Jul;82(3):211-216. 10.4046/trd.2018.0019.

The Clinical Efficacy and Safety of Four-Weekly Docetaxel as First-Line Therapy in Elderly Lung Cancer Patients with Squamous Cell Carcinoma

• Choi JH
• Choi J
• Chung SM
• Oh JY
• Lee YS
• Min KH
• Hur GY
• Shim JJ
• Kang KH
• Lee HK
• Lee SY

• KMID: 2450898
• DOI: http://doi.org/10.4046/trd.2018.0019

Abstract

BACKGROUND
Docetaxel is one of the standard treatments for advanced non-small cell lung cancer. Docetaxel is usually administered in a 3-week schedule, but there is significant toxicity. In this phase II clinical study, we investigated the efficacy and safety of a 4-weekly schedule of docetaxel monotherapy, as first-line chemotherapy for advanced squamous cell carcinoma in elderly lung cancer patients.
METHODS
Patients with stage IIIB/ IV lung squamous-cell carcinoma age 70 or older, that had not undergone cytotoxic chemotherapy were enrolled. Patients received docetaxel 25 mg/m2 on days 1, 8, and 15, every 4 weeks. Primary endpoint was the objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profiles.
RESULTS
A total of 19 patients were enrolled. Among 19 patients, 17 were for evaluated efficacy and safety. In the intent-to-treat population, ORR and disease control rate (DCR) were 11.8% and 47.1%, respectively. In the response evaluable population, ORR was 16.7% and DCR was 66.7%. Median PFS and OS were 3.1 months and 3.3 months, respectively. There were three adverse grade 3/4 events. Grade 1 neutropenia was reported in one patient.
CONCLUSION
Our data failed to demonstrate efficacy of a 4-weekly docetaxel regimen, in elderly patients with a poor performance status. However, incidence of side effects, including neutropenia, was lower than with a 3-week docetaxel regimen, as previously reported.

Keyword

Carcinoma, Non-Small-Cell Lung; Chemotherapy; Docetaxel; Treatment Outcome; Safety; Therapeutics; Aged; Lung Neoplasms; Carcinoma, Squamous Cell

MeSH Terms

Aged*
Appointments and Schedules
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell*
Clinical Study
Disease-Free Survival
Drug Therapy
Epithelial Cells*
Humans
Incidence
Lung Neoplasms*
Lung*
Neutropenia
Treatment Outcome*

Figure

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  Figure 1 Follow-up of the study patients.

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  Figure 2 Survival analyses. (A) Kaplan-Meier progression-free survival (PFS) curve. (B) Kaplan-Meier overall survival (OS) curve. CI: confidence interval.

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  Figure 3 Best change in measurable lesion size from baseline for 12 patients with evaluable indicator lesions: waterfall plot. PD: progressive disease; SD: stable disease; PR: partial remission.

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