Phase II study of irinotecan plus cisplatin with concurrent radiotherapy for the patients with limited-disease small-cell lung cancer.

Jeong, Hye Cheol; Lee, Sang Yeub; Lee, Sung Yong; Kim, Je Hyeong; Shin, Chol; Shim, Jae Jeong; In, Kwang Ho; Kang, Kyung Ho; Yoo, Se Hwa
Lung cancer (Amsterdam, Netherlands)
2006Sep ; 53 ( 3 ) :361-6.
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Jeong, Hye Cheol -
Lee, Sang Yeub -
Lee, Sung Yong -
Kim, Je Hyeong -
Shin, Chol -
Shim, Jae Jeong -
In, Kwang Ho -
Kang, Kyung Ho -
Yoo, Se Hwa -
ABSTRACT
BACKGROUND: A recently conducted randomized, phase III study that compared irinotecan plus cisplatin (IP) with etoposide plus cisplatin for the patients with extensive disease SCLC revealed a superior median survival rate and a superior 2-year survival rate for the IP combination therapy. Yet there have been few such reports on the patients suffering with limited disease SCLC (LD-SCLC). We conducted a phase II trial to evaluate the efficacy and toxicity of administering IP with concurrent radiotherapy for the patients with LD-SCLC. PATIENTS AND

METHODS: Twenty chemotherapy-na챦ve patients with LD-SCLC were enrolled in our study. The patients were treated with 40 mg/m(2) irinotecan on days 1, 8 and 15 and with 60 mg/m(2) cisplatin on day 1 every 4 weeks until a maximum of six cycles was delivered. Once-daily radiotherapy included the administration of 50.4 Gy in 28 fractions. After completion of the radiation therapy, the dose of irinotecan was increased to 60 mg/m(2).

RESULTS: The response rate was 85% (CR: 6; partial response, PR: 11). The median survival was 20.0 months (95% CI: 15.6-24.4 months) with 1-year and 2-year overall survival rates of 85 and 35%, respectively. The median progression free survival (PFS) was 12 months (95% CI: 6.2-18.1 months) with a 1-year PFS of 36%. The major hematologic toxicities of this regimen were neutropenia (60%), leukopenia (55%), anemia (20%) and thrombocytopenia (10%). The non-hematologic toxicities were nausea/vomiting (55%), diarrhea (35%) and dysphagia (15%).

CONCLUSIONS: Our data show that IP with concurrent radiotherapy is an effective and tolerable regimen for the treatment of LD-SCLC and these findings warrant further investigation.
Limited stage; Small-cell lung cancer; Irinotecan; Cisplatin; Concurrent chemoradiation therapy
MESH
Adolescent, Adult, Antineoplastic Combined Chemotherapy Protocols/*therapeutic use, Camptothecin/administration & dosage/*analogs & derivatives, Carcinoma, Small Cell/*drug therapy, Cisplatin/*administration & dosage, Combined Modality Therapy/*methods, Disease Progression, Disease-Free Survival, Female, Humans, Lung Neoplasms/*drug therapy, Male, Radiotherapy/*methods, Recurrence, Time Factors, Treatment Outcome
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IP with concurrent radiotherapy is an effective and tolerable regimen for the treatment of LD-SCLC.
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DOI
10.1016/j.lungcan.2006.06.002
KCDÄÚµå
ICD 03
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