Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer.
- Author:
Yo Han JOH
1
;
Tae You KIM
;
Im Il NA
;
Do Youn OH
;
Byung Su KIM
;
Jee Hyun KIM
;
Do Yeun KIM
;
Se Hoon LEE
;
Chul Gyu YOO
;
Choon Taek LEE
;
Young Whan KIM
;
Dae Seog HEO
;
Yung Jue BANG
;
Sung Koo HAN
;
Young Soo SHIM
;
Noe Kyeong KIM
Author Information
1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. kimty@snu.ac.kr
- Publication Type:Original Article
- Keywords:
Non-small cell lung cancer;
Combination chemotherapy;
Vinorelbine;
Cisplatin
- MeSH:
Alopecia;
Anemia;
Carcinoma, Non-Small-Cell Lung*;
Cisplatin*;
Drug Therapy*;
Drug Therapy, Combination;
Humans;
Leukopenia
- From:Cancer Research and Treatment
2001;33(5):373-376
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
PURPOSE: Platinum-based chemotherapy has conferred a modest but significant survival benefit and the introduction of newer drugs has led to achieve higher response rate in patients with advanced non-small cell lung cancer (NSCLC). We performed a phase II trial in order to evaluate the efficacy and toxicity of combination chemotherapy with vinorelbine (Navelbine) and cisplatin in advanced NSCLC. MATERIALS AND METHODS: Patients with previously untreated, unresectable stage IIIB or IV NSCLC with measurable lesion (s) were eligible for entry into the study. NP chemotherapy consisted of intravenous vinorelbine 25 mg/m2, on day 1 and 8, and intravenous cisplatin 80 mg/m2 on day 1; this cycle was repeated every three weeks. RESULTS: A total of 33 patients were enrolled in the study between July 1999 and Feb 2000. Of the 30 patients deemed eligible for analysis, thirteen patients achieved a partial response and thirteen showed a stable disease. The overall response rate was 43.3%. The median duration of response was 5.7 months (95% CI: 2.8~8.5 months). The median time to progression was 7.6 months (95% CI: 5.5~9.7 months) and the overall median survival time was 15.1 months (95% CI: 9.8~20.4 months) in the intent-to-treat analysis. Chemotherapy-related grade 3 or 4 toxicities were anemia in 1.5%, leukopenia in 4.5%, nausea/vomiting in 2.3%, alopecia in 13.3%, and neurotoxicity in 3.3%. CONCLUSION: The combination of vinorelbine and cisplatin chemotherapy seems to be active and fairly tolerable in patients with advanced NSCLC.
