Preliminary Results of the Prospective Randomized Phase III Trial on the Induction Chemotherapy in the Concurrent Chemoradiotherapy for the Locally Advanced Non-small Cell Lung Cancer

Journal of Lung Cancer 2004년 3권 2호 p.86 ~ p.93

김수산(Kim Su-Ssan) - 울산대학교 의과대학 서울아산병원 방사선종양학과
최은경(Choi Eun-Kyung) - 울산대학교 의과대학 서울아산병원 방사선종양학과
김종훈(Kim Jong-Hoon) - 울산대학교 의과대학 서울아산병원 방사선종양학과
안승도(Ahn Seung-Do) - 울산대학교 의과대학 서울아산병원 방사선종양학과
이상욱(Lee Sang-Wook) - 울산대학교 의과대학 서울아산병원 방사선종양학과
신성수(Shin Seong-Soo) - 울산대학교 의과대학 서울아산병원 방사선종양학과
김상위(Kim Sang-We) - 울산대학교 의과대학 서울아산병원 내과학교실
서철원(Suh Chul-Won) - 울산대학교 의과대학 서울아산병원 내과학교실
이정신(Lee Jung-Shin) - 울산대학교 의과대학 서울아산병원 내과학교실
심태선(Shim Tae-Sun) - 울산대학교 의과대학 서울아산병원 호흡기내과
이상도(Lee Sang-Do) - 울산대학교 의과대학 서울아산병원 호흡기내과
고윤석(Koh Youn-Suck) - 울산대학교 의과대학 서울아산병원 호흡기내과
김우성(Kim Woo-Sung) - 울산대학교 의과대학 서울아산병원 호흡기내과
김동순(Kim Dong-Soon) - 울산대학교 의과대학 서울아산병원 호흡기내과
김원동(Kim Won-Dong) - 울산대학교 의과대학 서울아산병원 호흡기내과

Abstract

Purpose: To investigate the role of induction chemotherapy in relation to the treatment results and toxicities of concurrent chemoradiotherapy (CCRT) for locally advanced non-small cell lung cancer (NSCLC).

Materials and Methods: Patients with unresectable and pathologically confirmed Stage III NSCLC were eligible. According to the stage and pathological subgroup, the patients were randomized into two arms. Arm A received two cycles of the induction chemotherapy composed of gemcitabine, 1,000 mg/m2 (D1 and D8), and cisplatin, 70 mg/m2 (D1), followed by CCRT with weekly paclitaxel, 50 mg/m2, and cisplatin, 20 mg/m2. Arm B received immediate CCRT without the induction chemotherapy. A daily 2.2 Gy radiation dose was delivered to the isodose line covering the planned target volume, which was defined as the gross tumor volume plus a 1.0 cm margin from the planning CT, using a 3-D conformal radiation therapy technique.

Results: Between May 2003 and 2004, 63 patients were enrolled. Forty four patients (Arm A 23, Arm B 21) were evaluable, with follow-up periods exceeded 1 month after the end of the assigned treatment. The median follow-up periods were 6 and 7 months for Arms A and B, respectively. The patients’ characteristics, including gender, age, weight loss, performance status, pulmonary function and stage, were well balanced between the two arms. The median largest tumor diameters were 4.8 cm (3.0∼15 cm) and 5.0 cm (2.5∼10 cm) for Arms A and B, respectively. The one-year survival rates were 58 and 63% for Arms A and B respectively, which showed no statistical significance (p=0.6667). The compliance of the induction chemotherapy was 96% (22/23 patients), and those of the CCRT were 86% for both arms (18/21 patients). The response rate of the induction chemotherapy was 64% (14/22 patients) and those of the CCRT were 83 (15/18 patients) and 89% (16/18 patients) for Arms A and B, respectively, which showed no statistical significance (p=0.630). In the 23 patients of Arm A, 8 (35%) suffered grade 3∼4 neutropenia during the induction chemotherapy and 1 expired due to sepsis. CCRT caused grade 3∼4 neutropenia in 6 and 1 patients of Arms A (29%) and B (5%), respectively, showing statistical significance (p=0.038). Grade 3∼4 radiation pneumonitis developed in 2 and patients from Arms A (10%) and B (5%), respectively, (p=0.464) and grade 3∼4 acute esophagitis developed in 7 (Arm A) and 5 patients (Arm B) (p=0.495).
Conclusion: Both treatment schemes showed acceptable treatment compliance and toxicities. However, the induction chemotherapy resulted in a higher incidence of severe neutropenia. The treatment outcomes, as yet, have shown no statistical significance. To evaluate the role of induction chemotherapy on the survival prolongation in CCRT for locally advanced NSCLC, more patients and a longer follow-up are mandatory.

키워드

Phase III randomized trial, Locally-advanced non-small cell lung cancer, Induction chemotherapy, Concurrent chemoradiotherapy
원문 및 링크아웃 정보
등재저널 정보
주제코드
주제명(Target field)
연구대상(Population)
연구참여(Sample size)
대상성별(Gender)
질병특성(Condition Category)
연구환경(Setting)
연구설계(Study Design)
연구기간(Period)
중재방법(Intervention Type)
중재명칭(Intervention Name)
키워드(Keyword)
유효성결과(Recomendation)
Both treatments (Induction chemotherapy, Concurrent chemoradiotherapy ) showed acceptable treatment compliance and toxicities; as yet, have shown no statistical significance.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
출판년도(Year)
참여저자수(Authors)
대표저자
DOI
KCD코드
ICD 03
건강보험코드