title: Phase II study of camtobell inj. (belotecan) in combination with cisplatin in patients with previously untreated, extensive stage small cell lung cancer.
abstract: The aim of this study was to investigate the efficacy and safety of belotecan in combination with cisplatin in patients with previously non-treated extensive stage small cell lung cancer. A total of 42 patients were enrolled and treated with combination of belotecan 0.5mg/m2 on daily basis throughout day 1-4 and cisplatin 60 mg/m2 on day 1 of a 3-week cycle, up to 6 cycles. Treatment was continued until the completion of 6 cycles of the chemotherapy, disease progression, detection of unacceptable toxicity, withdrawal of the consent, or death of the patient. Response was assessed every 2 cycles of chemotherapy by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Toxicity was assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 3.0. The overall response rate was 73.8% in an intention to treat population and 83.9% in the evaluable patients. With the median follow up of 9.9 months, the median progression free survival was 6.9 months (95% CI, 6.6-7.2 months), and median overall survival was 11.2 months (95% CI, 9.9-12.5 months). The frequently reported grade ≥3 toxicities were neutropenia (90.2%), thrombocytopenia (63.4%), and anemia (34.1%). Febrile neutropenia was reported in 16 patients (39.0%). Although most of non-hematologic toxicities were grade 1 or 2, there were 4 patient deaths caused by pneumonia complicated by septic shock. Belotecan and cisplatin combination chemotherapy demonstrated a promising efficacy in ED SCLC patients. But, the hematologic toxicity of this regimen requires considerable amount of attention.
authors.affiliation: Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea.
authors.forename: Seungtaek
authors.initials: S
authors.lastname: Lim
authors.forename: Byoung Chul
authors.initials: BC
authors.lastname: Cho
authors.forename: Ji Ye
authors.initials: JY
authors.lastname: Jung
authors.forename: Gun Min
authors.initials: GM
authors.lastname: Kim
authors.forename: Se Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Hye Ryun
authors.initials: HR
authors.lastname: Kim
authors.forename: Han Sang
authors.initials: HS
authors.lastname: Kim
authors.forename: Sun Min
authors.initials: SM
authors.lastname: Lim
authors.forename: Ji Soo
authors.initials: JS
authors.lastname: Park
authors.forename: Jun Ho
authors.initials: JH
authors.lastname: Lee
authors.forename: Darae
authors.initials: D
authors.lastname: Kim
authors.forename: Eun Young
authors.initials: EY
authors.lastname: Kim
authors.forename: Moo Suk
authors.initials: MS
authors.lastname: Park
authors.forename: Young Sam
authors.initials: YS
authors.lastname: Kim
authors.forename: Se Kyu
authors.initials: SK
authors.lastname: Kim
authors.forename: Joon
authors.initials: J
authors.lastname: Chang
authors.forename: Joo Hang
authors.initials: JH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D055815:Young Adult
chemical_list: C116963:belotecan; D002945:Cisplatin; D002166:Camptothecin