Irinotecan and vinorelbine in patients with non-small cell lung cancer previously treated with platinum-based chemotherapy. A phase II study of the Hellenic Cooperative Oncology Group.
OBJECTIVE
To evaluate the efficacy and tolerability of irinotecan plus vinorelbine every 2 weeks in patients with advanced non-small cell lung cancer (NSCLC), previously treated with platinum-based chemotherapy.


METHODS
Forty-one patients with advanced NSCLC, refractory or resistant to platinum derivatives, were treated on an out-patient basis with irinotecan 150 mg/m2 intravenous (i.v.) and vinorelbine 25 mg/m2 on days 1 and 15. Chemotherapy was repeated every 4 weeks. The response was evaluated every two cycles.


RESULTS
On an intent-to-treat analysis, 6 patients (14.6%) [95% confidence interval (CI) 5.57% to 29.17%] achieved partial response (PR), 15 (36.6%) stable disease (SD) and 20 (48.8%) progressive disease (PD). The median time to tumor progression (TTP) was 4.9 months (range 0.17-15.5 months), the median survival time was 7.8 months (range 0.9 to 19.6 months) and the 1-year survival rate was 37%. Symptomatic benefit response including improvement of performance status (PS), dyspnea, anorexia and fatigue, cessation of hemoptysis, fever and reduction of cough and pain was seen in 10 to 42% of patients. No patient experienced grade 3/4 anemia. Grade 3/4 thrombocytopenia occurred in 2 (5%) patients. Five patients (12%) developed grade 3/4 neutropenia and 5 (12%) had neutropenic fever that required hospitalization, but was successfully treated with antibiotics and G-CSF support. One patient (2%) developed grade 4 fatigue and was withdrawn. Other grade 3/4 adverse events included diarrhea (n = 3; 2 required hospitalization), alopecia (n = 5) and neurotoxicity (n = 1). Six patients required a dose reduction.


CONCLUSIONS
The combination of irinotecan plus vinorelbine administered every 2 weeks demonstrated rather low activity in advanced NSCLC patients who had previously failed platinum-based chemotherapy, but it was well-tolerated and was associated with increased 1-year survival rate and improvement in cancer related symptoms.
Pectasides
D
D
1st Department of Medical Oncology, Metaxa's Memorial Cancer Hospital, Piraeus, Greece. pectasid@otenet.gr
Fountzilas
G
G
Rigopoulos
A
A
Bountouroglou
N G
NG
Koutras
A
A
Glotsos
J
J
Onyenadum
A
A
Makatsoris
Th
T
Kalofonos
H P
HP
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016190:Carboplatin / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000627:therapeutic use; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
D014747:Vinblastine; D000077146:Irinotecan; D016190:Carboplatin; D002945:Cisplatin; D000077235:Vinorelbine; D002166:Camptothecin