Combination chemotherapy with cisplatin, etoposide and irinotecan in patients with extensive small-cell lung cancer: A phase II study of the Hellenic Co-operative Oncology Group.
OBJECTIVE
The purpose of this study was to evaluate the efficacy and toxicity of cisplatin, etoposide and irinotecan as first-line treatment in patients with extensive small-cell lung cancer (E-SCLC).


METHODS
Chemo-naïve adult patients with a performance status (PS) of 0-2 and adequate organ function were eligible. Patients received cisplatin 20mg/m(2) i.v. daily for three consecutive days, etoposide 75mg/m(2) i.v. daily for three consecutive days and irinotecan 120mg/m(2) i.v. on day 2, every 21 days for six to eight cycles. Administration of G-CSF was given in the presence of febrile neutropenia and as a 5-day prophylaxis around the recorded nadir day in patients who developed grades 3-4 neutropenia.


RESULTS
Fifty-six patients were assessable. The median age was 62.2 years; 96.4% had PS 0-1, 33.5% had >3 metastatic sites. The overall response rate was 80.4% with 8 (14.3%) patients achieving a complete response. The median time to tumor progression was 7.8 months [95% confidence interval (CI), 7.1-8.6 months] with a median survival of 15.1 months [95% CI, 9.7-20.5 months] and 1-year survival rate of 56.5%. One patient died from toxicity. Grades 3-4 neutropenia occurred in 37.5% of patients, grades 3-4 thrombocytopenia occurred in 10.9% of patients and 11 (19.6%) patients developed febrile neutropenia. Grades 3-4 non-hematological toxicities were primarily nausea-vomiting 3.6%, diarrhea 7.1% and fatigue 3.6%.


CONCLUSIONS
This study strongly suggests that cisplatin, etoposide and irinotecan combination is very effective for the treatment of E-SCLC with good safety profile. The triplet regimen currently seems a promising regimen and has to be further explored in phase III trials.
Pectasides
D
D
Second Department of Internal Medicine-Propaedeutic, Oncology Section, University General Hospital Attikon, Athens, Greece. hecogoff@otenet.gr
Samantas
E
E
Fountzilas
G
G
Briasoulis
E
E
Kosmidis
P
P
Skarlos
D
D
Dimopoulos
M A
MA
Kalofonos
H P
HP
Economopoulos
T
T
Syrigos
K
K
D000328:Adult; D000368:Aged; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D005047:Etoposide / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015996:Survival Rate
D005047:Etoposide; D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin