J Lung Cancer.  2004 Dec;3(2):86-93.

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

Affiliations
  • 1Department of Radiation Oncology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea. ekchoi@amc.seoul.kr
  • 2Department of Internal Medicine, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.

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

Keyword

Phase III randomized trial; Locally-advanced non-small cell lung cancer; Induction chemotherapy; Concurrent chemoradiotherapy

MeSH Terms

Arm
Carcinoma, Non-Small-Cell Lung*
Chemoradiotherapy*
Cisplatin
Compliance
Esophagitis
Follow-Up Studies
Humans
Incidence
Induction Chemotherapy*
Neutropenia
Paclitaxel
Prospective Studies*
Radiation Dosage
Radiation Pneumonitis
Sepsis
Survival Rate
Tumor Burden
Weight Loss
Cisplatin
Paclitaxel
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