Simultaneous chemoradiotherapy with irinotecan and cisplatin in limited disease small cell lung cancer: a phase I study.
BACKGROUND
Early radiotherapy concurrent with chemotherapy appears to have prognostic benefits in patients with limited disease SCLC. Irinotecan/cisplatin have been shown to be superior to a standard treatment with etoposide/cisplatin in extensive disease SCLC. The present phase I study aims to assess the feasibility of irinotecan/cisplatin administered concurrently with radiotherapy.


METHODS
Twelve patients were treated concurrently with conventional fractionated radiotherapy (1.8-45 Gy + 9 Gy (RP)) and two cycles of irinotecan (40/50/60 mg/m2, Day 1/8/15, 29/36/43) and cisplatin (20 mg/m2, Days 1-3, 29-31), and four cycles of consolidation chemotherapy (CT). In addition, patients in complete remission (CR) received prophylactic cranial irradiation (PCI). Dose-limiting toxicity (DLT) was defined as any case grade III/IV non-hematological toxicity (esophagitis grade IV), grade IV leukopenia or grades III/IV thrombopenia (CTC) during RCT.


RESULTS
No DLT was observed; an irinotecan dose of 60 mg/m2 is recommended. 3/12 patients developed grade III leukopenia, one grade II pneumonitis. The predominant toxicity was esophagitis, grade II in 7/12 patients, grade III in 5/12. After RCT 7/12 patients were in CR, systemic progression was not observed during RCT.


CONCLUSIONS
Concurrent RCT with irinotecan (60 mg/m2) and cisplatin followed by four cycles of CT can be safely administered.
Klautke
Gunther
G
Department of Radiotherapy, University Hospital, University of Rostock, Südring 75, 18059 Rostock, Germany. gunther.klautke@med.uni-rostock.de
Fähndrich
Sebastian
S
Semrau
Sabine
S
Büscher
Claudia
C
Virchow
Christian
C
Fietkau
Rainer
R
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016371:Cranial Irradiation; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D004941:Esophagitis / Q000139:chemically induced; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D007970:Leukopenia / Q000139:chemically induced; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D011014:Pneumonia / Q000139:chemically induced; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin