Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer

Joh, Yo Han; Kim, Tae You; Na, Im Il; Oh, Do Youn; Kim, Byung Su; Kim, Jee Hyun; Kim, Do Yeun; Lee, Se Hoon; Yoo, Chul Gyu; Lee, Choon Taek; Kim, Young Whan; Heo, Dae Seog; Bang, Yung Jue; Han, Sung Koo; Shim, Young Soo; Kim, Noe Kyeong

doi:2001.33.5.373

Cancer Research and Treatment > Volume 33(5); 2001 > Article

Original Article

Cancer Research and Treatment 2001;33(5): 373-376. doi: https://doi.org/10.4143/crt.2001.33.5.373

Phase II Trial of Vinorelbine and Cisplatin Chemotherapy in Advanced Non-Small Cell Lung Cancer

Yo Han Joh, 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

Department of Internal Medicine, Seoul National UniversityCollege of Medicine, Seoul, Korea. kimty@snu.ac.kr

Published online: October 31, 2001.

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.

Key words: Non-small cell lung cancer;Combination chemotherapy;Vinorelbine;Cisplatin