TY - JOUR

T1 - Phase II study of a 3-day schedule with topotecan and cisplatin in patients with previously untreated small cell lung cancer and extensive disease

AU - Sorensen, Morten

AU - Lassen, Ulrik

AU - Jensen, Peter Buhl

AU - Østerlind, Kell

AU - Jeppesen, Nina

AU - Jensen, Britta Bjerregaard

AU - Mellemgaard, Anders

AU - Rytter, Carsten

AU - Langer, Seppo Wang

PY - 2008/8

Y1 - 2008/8

N2 - INTRODUCTION: Treatment with a topoisomerase I inhibitor in combination with a platinum results in superior or equal survival compared with etoposide-based treatment in extensive disease small cell lung cancer (SCLC). Five-day topotecan is inconvenient and therefore shorter schedules of topotecan and cisplatin are needed. The aim of this phase II study was to establish the response rate and response duration in chemo-naive patients with SCLC receiving a 3-day topotecan and cisplatin schedule.METHODS: Simons optimal two-stage design was used. Patients with previously untreated extensive disease SCLC, adequate organ functions and performance status less than 3 were eligible. Topotecan (2.0 mg/m, intravenously) was administered on days 1 to 3 with cisplatin (50 mg/m, intravenously) on day 3 every 3 weeks for a total of six cycles.RESULTS: Forty-three patients received 219 cycles of chemotherapy. Median age was 59 (range 44-74), 79% had performance status 0 or 1. Thirty-one patients completed all six cycles. Grade 3/4 anemia, neutrocytopenia, and thrombocytopenia were recorded in 9.5%, 66.7%, and 21.4% of patients, respectively. Fourteen percent of patients experienced neutropenic fever. No episodes of fatal sepsis occurred. Non-hematologic toxicity was mild and manageable. Overall and complete response rates were 72.1% and 9.3%, respectively. The median overall survival and response duration were 10.3 months (95% confidence interval: 8.6-12.0) and 7.0 months (95% confidence interval: 6.3-7.7), respectively.CONCLUSION: Three-day topotecan with cisplatin on day 3 is active and safe in extensive disease SCLC. An ongoing phase III randomized trial compares this combination to standard treatment.

AB - INTRODUCTION: Treatment with a topoisomerase I inhibitor in combination with a platinum results in superior or equal survival compared with etoposide-based treatment in extensive disease small cell lung cancer (SCLC). Five-day topotecan is inconvenient and therefore shorter schedules of topotecan and cisplatin are needed. The aim of this phase II study was to establish the response rate and response duration in chemo-naive patients with SCLC receiving a 3-day topotecan and cisplatin schedule.METHODS: Simons optimal two-stage design was used. Patients with previously untreated extensive disease SCLC, adequate organ functions and performance status less than 3 were eligible. Topotecan (2.0 mg/m, intravenously) was administered on days 1 to 3 with cisplatin (50 mg/m, intravenously) on day 3 every 3 weeks for a total of six cycles.RESULTS: Forty-three patients received 219 cycles of chemotherapy. Median age was 59 (range 44-74), 79% had performance status 0 or 1. Thirty-one patients completed all six cycles. Grade 3/4 anemia, neutrocytopenia, and thrombocytopenia were recorded in 9.5%, 66.7%, and 21.4% of patients, respectively. Fourteen percent of patients experienced neutropenic fever. No episodes of fatal sepsis occurred. Non-hematologic toxicity was mild and manageable. Overall and complete response rates were 72.1% and 9.3%, respectively. The median overall survival and response duration were 10.3 months (95% confidence interval: 8.6-12.0) and 7.0 months (95% confidence interval: 6.3-7.7), respectively.CONCLUSION: Three-day topotecan with cisplatin on day 3 is active and safe in extensive disease SCLC. An ongoing phase III randomized trial compares this combination to standard treatment.

KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use

KW - Cisplatin/administration & dosage

KW - Female

KW - Humans

KW - Lung Neoplasms/drug therapy

KW - Male

KW - Maximum Tolerated Dose

KW - Middle Aged

KW - Neoplasm Staging

KW - Prognosis

KW - Small Cell Lung Carcinoma/drug therapy

KW - Survival Rate

KW - Topotecan/administration & dosage

U2 - 10.1097/JTO.0b013e31817e0f58

DO - 10.1097/JTO.0b013e31817e0f58

M3 - Journal article

C2 - 18670309

VL - 3

SP - 902

EP - 906

JO - Journal of Thoracic Oncology

JF - Journal of Thoracic Oncology

SN - 1556-0864

IS - 8

ER -