Multicenter phase II study of concurrent high-dose (72Gy) three-dimensional conformal radiotherapy (3D-CRT) without elective nodal irradiation with chemotherapy using cisplatin and vinorelbine for unresectable stage III non-small cell lung cancer (NSCLC).

Authors

Hidehito Horinouchi

Hidehito Horinouchi

Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan

Hidehito Horinouchi , Ikuo Sekine , Minako Sumi , Miyako Satouchi , Hiroshi Isobe , Masao Harada , Seiji Niho , Kiyoshi Mori , Tomohide Tamura

Organizations

Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan, Division of Radiation Oncology, National Cancer Center Hospital, Tokyo, Japan, Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, Hyogo, Japan, KKR Sapporo Medical Center, Sapporo, Japan, Hokkaido Cancer Center, Sapporo, Japan, Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Chiba, Japan, Department of Medical Oncology, Division of Thoracic Oncology, Tochigi Cancer Center, Utsunomiya, Japan

Research Funding

Other
Background: The optimal dose of radiotherapy remains unclear in concurrent chemoradiotherapy for unresectable stage III NSCLC. We previously concluded that the recommended dose for further trial was 72Gy in a phase I study (Sekine et al., Int J Radiat Oncol Biol Phys. 953-959, 2012). Methods: Eligible patients (unresectable stage III NSCLC, age between 20 and 74, PS 0-1, V20 ≤ 30%) received cisplatin (80 mg/m2 day 1) and vinorelbine (20 mg/m2 days 1 and 8) repeated every 4 weeks for 3-4 cycles. The 3D-CRT started at the first day of chemotherapy at a total dose of 72 Gy in 36 fractions. The primary endpoint was a 2-year survival rate and the planned sample size was 60 to reject the rate of 45% under the expectation of 65% with a power of 90% and an alpha error of 5%. Results: Thirty-one patients from 4 institutions were enrolled between May 2009 and March 2010. This trial was terminated early due to slow accrual and grade 5 pulmonary toxicities in 2 patients. There were 25 men and 6 women with a median (range) age of 59 (32-72) years. Of these, 23 had adenocarcinoma and 21 had stage IIIA disease. The median (range) V20 value was 20 (9-30). The full planned dose of radiotherapy could be administered in 30 (97%) patients, and 26 (84%) of the patients received 3-4 cycles of chemotherapy. During the chemoradiotherapy, grade 3-4 febrile neutropenia, infection and esophagitis were noted in 5, 4 and 1 of the 31 patients, respectively. After completion of the planned chemoradiotherapy, 5 patients had grade 3 or higher radiation pneumonitis, and 2 (6%) of these patients died at 6.6 and 7.3 months after the treatment started. The overall response rate was 97% (95% confidence interval: 83.3-99.9). Twenty-four patients are alive and thirteen patients experienced recurrence (2 had loco-regional recurrences, 7 had distant recurrence and 4 had mixed recurrence pattern) at a median follow up of 16.4 months. Conclusions: Concurrent high-dose (72Gy) 3D-CRT with chemotherapy using cisplatin and vinorelbine may have a too excessive incidence of pulmonary toxicities to warrant any further evaluation.

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Abstract Details

Meeting

2012 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

UMIN000001743

Citation

J Clin Oncol 30, 2012 (suppl; abstr 7070)

DOI

10.1200/jco.2012.30.15_suppl.7070

Abstract #

7070

Poster Bd #

38E

Abstract Disclosures