A GREEK STUDY

Chemotherapy. 2010 Oct 7;56(5):353-358. [Epub ahead of print]

Biweekly Vinorelbine and Gemcitabine as Second-Line Treatment and Beyond in
Non-Small Cell Lung Cancer.

Chelis L, Xenidis N, Amarantidis K, Prassopoulos P, Chamalidou E, Neanidis K,
Mikroulis D, Chatzaki E, Karakitsos P, Kakolyris S.

Department of Medical Oncology, University General Hospital of Alexandroupolis,
Alexandroupolis, Greece.

Background: To evaluate the activity and tolerance of gemcitabine (GEM) in
combination with vinorelbine (VRL) in pretreated patients with advanced non-small
cell lung cancer (NSCLC). Patients and Methods: Fifteen patients with advanced
NSCLC who had disease progression after a cisplatin- or taxane-based front-line
regimen were enrolled into a 2-stage design trial and were treated with VRL 30
mg/m(2) i.v. for 10 min followed by GEM 1,200 mg/m(2) i.v. for 30 min on days 1
and 15 of each 28-day cycle. Chemotherapy was given for 6 cycles unless disease
progression or unacceptable toxicity was seen. The patients' median age was 64
years and the performance status (WHO) was 0 (n = 7), 1 (n = 5), and 2 (n = 3).
The treatment was second line for 10 (67%) and third line or more for 5 (33%)
patients. Results: No complete or partial responses were observed. Stable disease
was seen in 4 (27%) patients and progressive disease in 11 (73%). The median time
to tumor progression was 3 months (range 1-12) and the median survival was 4
months (range 2-31). Severe myelotoxicity was infrequent. Grade 2 neutropenia was
observed in 2 (13%) patients, grade 2 thrombocytopenia in 1 (7%), and grade 2
anemia in 3 (20%). Nonhematologic toxicities were very mild and easily
manageable. Conclusion: The GEM plus VRL combination at the present doses and
schedule is a safe but ineffective regimen; therefore, it is not recommended as
second-line treatment in patients with advanced NSCLC.