Etoposide plus cisplatin followed by concurrent chemo-radiotherapy and irinotecan plus cisplatin for patients with limited-stage small cell lung cancer: A multicenter phase II study.
OBJECTIVE
The combination of irinotecan and cisplatin (IP) has shown at least comparable efficacy to that of etoposide/cisplatin (EP) in patients with extensive-stage small cell lung cancer. We conducted a phase II study to evaluate the efficacy and tolerance of EP regimen followed by thoracic radiotherapy (TRT) and IP consolidation chemotherapy in patients with limited-stage small cell lung cancer.


METHODS
Thirty-three chemotherapy-naive patients with limited-stage small cell lung cancer (LS-SCLC) were treated with etoposide 100mg/m(2) on days 1-3 and cisplatin 80mg/m(2) on day 1. Radiotherapy was given 3 weeks after the first treatment cycle concurrently with weekly cisplatin 20mg/m(2) on day 1 and etoposide 50mg/m(2) on day 4 within 5-6 weeks, followed by three courses of irinotecan 60mg/m(2) on days 1, 8, and 15 and cisplatin 60mg/m(2) on day 1 of a 4-week cycle.


RESULTS
There were no treatment-related deaths. Toxicities during chemo-radiotherapy were mild including grade 3/4 neutropenia (24%) and grade 2 esophagitis (6%). The major toxicity observed during consolidation chemotherapy was grades 3-4 neutropenia which affected 42% of patients. In an intention-to-treat analysis the overall response rate was 66% (CR: 30% and PR: 36%). After a median follow-up period of 35.7 months (range: 9.6-41.2 months), the median survival time was 19 months (95% CI: 14.5-23.5 months), the median time to tumor progression 8.3 months and the 1- and 2-year survival rates 72% and 27.5%, respectively.


CONCLUSIONS
Consolidation chemotherapy with IP following concurrent EP plus TRT is a safe and with acceptable toxicity regimen and deserves further phase III testing in patients with LS-SCLC.
Department of Medical Oncology, University General Hospital of Alexandroupolis, Greece.
N
N
Xenidis
A
A
Kotsakis
A
A
Kalykaki
Ch
Ch
Christophyllakis
S
S
Giassas
N
N
Kentepozidis
A
A
Polyzos
L
L
Chelis
N
N
Vardakis
L
L
Vamvakas
V
V
Georgoulias
S
S
Kakolyris
D000368:Aged; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology; D018714:Radiotherapy, Adjuvant; D055752:Small Cell Lung Carcinoma / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology / Q000532:radiotherapy*
D005047:Etoposide; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin