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KMID : 0982820040030020086
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Journal of Lung Cancer
2004 Volume.3 No. 2 p.86 ~ p.93
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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
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Kim Su-Ssan
Choi Eun-Kyung
Kim Jong-Hoon
Ahn Seung-Do
Lee Sang-Wook
Shin Seong-Soo
Kim Sang-We
Suh Chul-Won
Lee Jung-Shin
Shim Tae-Sun
Lee Sang-Do
Koh Youn-Suck
Kim Woo-Sung
Kim Dong-Soon
Kim Won-Dong
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Abstract
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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.
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KEYWORD
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Phase III randomized trial, Locally-advanced non-small cell lung cancer, Induction chemotherapy, Concurrent chemoradiotherapy
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