Dose-escalation study of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation for stage III non-small cell lung cancer.

Authors

Naruo Yoshimura

Naruo Yoshimura

Department of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan

Naruo Yoshimura , Shigeki Mitsuoka , Tatsuo Kimura , Hidenori Tanaka , Tomohiro Suzumura , Misato Nagata , Kanako Umekawa , Toshiyuki Nakai , Masako Hosono Hosono , Takuhito Tada , Kazuto Hirata , Shinzoh Kudoh

Organizations

Department of Clinical Oncology, Graduate School of Medicine, Osaka City University, Osaka, Japan, Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan, Department of Respiratory Medicine, JR Osaka railway hospital, Osaka, Japan, Department of Medical Oncology, Izumi Municipal Hospital, Osaka, Japan, Department of Radiology, Graduate School of Medicine, Osaka City University, Osaka, Japan, Department of Radiology, Izumi Municipal Hospital, Osaka, Japan

Research Funding

Other

Background: To determine a recommended dose (RD) of chemoradiotherapy with use of involved-field conformal radiotherapy and accelerated hyperfractionation (AHF) for stage III non-small cell lung cancer (NSCLC). Methods: Eligible patients had unresectable stage III NSCLC, age of less than 75 years, PS: 0 or 1, V20 of 35% or less. PET was used for staging. Cisplatin (80mg/m2) was administered on day 1 and vinorelbine (20mg/m2) was administered on days 1 and 8 for two cycle. Twice-daily radiation therapy (1.5 Gy per fraction) without elective nodal irradiation started on day 1. Total doses were 60Gy in 40 fractions and 66Gy in 44 fractions at levels 1 and 2 respectively. After concurrent chemoradiotherapy, consolidation chemotherapy regimen was cisplatin (80mg/m2) on day 1 and vinorelbine (20mg/m2) on days 1 and 8 every 4 week for three cycles. The dose-limiting toxicity (DLT) was defined as grade ≥ 3 esophagitis, grade 3 neutropenic fever, grade ≥ 3 other non-hematologic toxicities and interruption of irradiation for more than 2 weeks. DLT was monitored for 90 days. Results: A total of 12 patients were enrolled (6 patients in Level 1, 6 patients in Levels 2). DLTs were noted in 2 patients at Level 1, which were grade 3 esophagitis and grade 3 febrile neutropenia. Radiation dose was escalated up to 66 Gy in 44 fractions (Level 2), and there was no DLT. In principle, Sixty-six Gy in 44 fractions (Level 2) should be the RD. Major toxicities were leucopenia, neutropenia, and anemia. The response rate, the median progression free survival time, and the median overall survival time was 83.3%, 10.4 months, and 36.3 months for all patients, respectively. Conclusions: The RD was 66 Gy in 44 fractions (Level 2). The toxicity of this chemoradiothrapy regimen was manageable and efficacy is promising. The efficacy and safety of this regimen should be confirmed in a phase II study. Clinical trial information: UMIN000003769.

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Lung Cancer - Non-small Cell Local-regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

UMIN000003769

Citation

J Clin Oncol 31, 2013 (suppl; abstr 7564)

DOI

10.1200/jco.2013.31.15_suppl.7564

Abstract #

7564

Poster Bd #

23B

Abstract Disclosures