Department of Oncology, Soroka University Medical Center, P.O.B. 151 84101 Israel
*Correspondence to: Beer Sheva, E-mail: wilmosh@bgumail.bgu.ac.il
There is no single-standard treatment for locally advanced non-small cell lung cancer (NSCLC), but platinum based chemotherapy with one of the new generation agents is regarded as most effective for patients with good performance status. The purpose of this study is retrospective comparative analysis of response, toxicity and survival of two chemotherapy regimens containing cisplatin, combined with gemcitabine (GP) or vinorelbine (VP) in previously untreated patients with advanced NSCLC.
Between 1998–2001 60 patients (51 males and 9 females) with stage III B-IV NSCLC received chemotherapy. Fifty two patients (86.7%) presented with locally advanced (stage IIIB - 11 patients, 18.3%) or metastatic (stage IV - 41 patients, 68.4%), and 8 patients (13.3%) had metastases after previous radical surgery. The choice of chemotherapy regimen was a matter of distinction of treating physician. 31 patients received chemotherapy GP and 29 patients were treated with VP regimen. The groups were comparable in terms of age, performance state and stage of disease. Chemotherapy regimens consisted of either intravenous (i.v.) gemcitabine 1250 mg/m2 given over 30 minutes on days 1 and 8, and i.v. cisplatin 80 mg/m2 given over 2 hours on day 8, both repeated every 3 weeks, or i.v. vinorelbine 30 mg/m2 given over 10 minutes on days 1, 8 and 15 and i.v. cisplatin 80 mg/m2 given over 2 hours on day 1, both repeated every 4 weeks. Both regimens were planned to 6 cycles. Treatment was terminated in case of disease progression or unacceptable toxicity.
All patients were evaluable for response and toxicity.
A total of 157 cycles of GP and 142 cycle of VP were given. Therapy was well-tolerated without any life threatening event.
Grade III-IV toxicities for GP and VP regimens included vomiting in 0% vs 13.8 %, neutropenia in 29% vs 68% (p=0.007), neutropenic fever 0% vs 10.3%, thrombocytopenia in 9.7% vs 0%, anemia in 3.2% vs 13.7% and peripheral neuropathy 0% vs 6.8% of patients respectively. Thirty one per cent of patients who received VP developed chemical phlebitis, that ultimated insertion of central venous access device.
No complete responses (CR) were documented. Partial response (PR) was achieved in 29% of patients who received GP as compared with 20.7% of those treated with VP, the disease remained stable (SD) in 32.3% and 31% of patients respectively. There were no statistically significant difference in survival between GP and VP groups. The median progression free survival was 7 months vs 4 months, the median survival was 12.5 vs 8.3 months and one-year survival was 53% vs 45% respectively.
To our experience, chemotherapy GP and VP for advanced NSCLC were both well tolerated. Though the rate of neutropenia was significantly higher in VP group, it wasn't life threatening. Response and survival analysis reveals no statistically significant difference between two regimens, that correspond with data reported in the literature. Both GP and VP regimens may be used as a standard of care for advanced NSCLC.
