Final overall survival (OS) analysis of a multicenter phase II study of concurrent high-dose (72Gy) three-dimensional conformal radiotherapy (3D-RT) without elective nodal irradiation with chemotherapy using cisplatin (CDDP) and vinorelbine (VNR) in patients with stage III non-small cell lung cancer (NSCLC).

Authors

Hidehito Horinouchi

Hidehito Horinouchi

Nantional Cancer Center Hospital, Tokyo, Japan

Hidehito Horinouchi , Ikuo Sekine , Minako Sumi , Toshinori Soejima , Miyako Satouchi , Hisayasu Nagakura , Hiroshi Isobe , Noriaki Nishiyama , Masao Harada , Naoki Ishizuka , Tomohide Tamura , Yuichiro Ohe

Organizations

Nantional Cancer Center Hospital, Tokyo, Japan, Chiba Cancer Center, Chiba, Japan, Natl Cancer Center Hosp, Tokyo, Japan, Department of Radiation Oncology, Hyogo Cancer Center, Akashi, Japan, Hyogo Cancer Center, Akashi, Japan, KKR Sapporo Medical Center, Sapporo, Japan, Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo, Japan, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan, Department of Respiratory Medicine, National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan, Clinical Trial Department, Cancer Institute Hospital, Tokyo, Japan, St Luke's International Hospital, Tokyo, Japan, National Cancer Center Hospital East, Kashiwa, Japan

Research Funding

Other

Background: We previously reported the adverse events and objective responses in a multicenter phase II study of high-dose chemoradiotherapy. This is a final analysis of the pattern of recurrences, progression free survival (PFS) and OS. Methods: Patients with stage III NSCLC were eligible if they met the following key criteria: age between 20 and 74 years, PS 0-1 and V20≤ 30%. Participants received 3-4 cycles of CDDP (80 mg/m2 day 1) and VNR (20 mg/m2days 1 and 8) every 4 weeks. The 3D-RT was administered at a total dose of 72 Gy divided into 36 fractions from day 1 chemotherapy. The primary endpoint was the 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 were enrolled between 2009 and 2011. The median follow-up time (range) was 51.4 (28.8-65.6) months at the point of data cut-off. This trial was terminated early due to the slow accrual and appearance of 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 the 25, 23 had adenocarcinoma and 21 had stage IIIA disease. The median (range) V20value was 20 (9-30). Among the 20 patients showing disease progression, in-field failures were observed in 5 (25%) patients as the first relapse and a further 4 patients (9 [45%] patients in total) during the follow-up period. The 2-, 3-, and 5-year PFS rates (95% CI) were 44.9% (27.1-61.2), 34.6% (18.5-51.2), and 34.6% (18.5-51.2), respectively. The 2-, 3-, and 5-year OS rates (95% CI) were 64.5% (45.2-78.5), 51.2% (32.6-67.1), and 43.8% (25.8-60.5), respectively. The median PFS and median survival time were 17.1 months and 41.2 months, respectively. Conclusions: The higher TRT dose associated both with an unacceptable incidence of pulmonary toxicities and with relatively better long-term survival. Development of a better strategy is warranted to obtain both a better outcome and tolerable pulmonary toxicities. Clinical trial information: UMIN000001743.

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Abstract Details

Meeting

2015 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 33, 2015 (suppl; abstr 7526)

DOI

10.1200/jco.2015.33.15_suppl.7526

Abstract #

7526

Poster Bd #

273

Abstract Disclosures