Open AccessPhase I Study of Concurrent and Consolidation Cisplatin and Docetaxel Chemotherapy with Thoracic Radiotherapy in Non-Small Cell Lung Cancer
Author(s) -
T W Zhang,
George Rodrigues,
Alexander V. Louie,
David A. Palma,
A. Rashid Dar,
Brian Dingle,
Walter Kocha,
Michael Sanatani,
Brian Yaremko,
Eugene Yu,
Jawaid Younus,
Mark Vincent
Publication year - 2018
Publication title -
current oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.053
H-Index - 51
eISSN - 1718-7729
pISSN - 1198-0052
DOI - 10.3747/co.25.3657
Subject(s) - docetaxel , medicine , neutropenia , nausea , pneumonitis , leukopenia , cisplatin , lung cancer , chemotherapy , chemoradiotherapy , gastroenterology , esophagitis , radiation therapy , phases of clinical research , oncology , lung , disease , reflux
Background: We designed a phase I study of concurrent chemoradiotherapy (CCRT) with docetaxel (D) and cisplatin (C), followed by consolidation DC, for unresectable stage III non-small cell lung cancer (NSCLC). Methods: Patients with histologically proven and unresectable stage III NSCLC were eligible. During CCRT, C was given every 3 weeks (75 mg/m2) and D given weekly. The starting dose of D was 20 mg/m2, escalated in cohorts of 3 to define the maximum tolerated dose (MTD). Radiotherapy was prescribed to a dose of 60 Gy in 30 fractions. This was followed by 2 cycles of consolidation DC, which were dose escalated if CCRT was tolerated. Results: Twenty-six patients were enrolled, with 1 excluded following evidence of metastatic disease. Nineteen patients completed both phases of treatment. There were 7 grade 3 events during CCRT (5 esophagitis, 2 nausea), and 8 grade 3 events during consolidation (2 neutropenia, 2 leukopenia, 1 esophagitis, 2 nausea, and 1 pneumonitis). Three patients had grade 4 neutropenia. No patients died due to toxicities. The MTD of concurrent weekly D was 20 mg/m2. Consolidation D and C were each dose escalated to 75 mg/m2 in 8 patients. The median overall survival (OS) and progression-free survival (pfs) of all patients were 33.6 months and 17.2 months, respectively, with median follow-up of 26.6 months (range 0.43–110.8). Conclusions: The use of docetaxel 20 mg/m2 weekly and cisplatin 75 mg/m2 every 3 weeks concurrent with thoracic radiotherapy, followed by consolidation docetaxel and cisplatin, both given at 75 mg/m2 every 3 weeks, appears to be safe in this phase I trial.