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A Phase II Study with Gemcitabine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer
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Jae Wan Park, Hwan Yang Park, Yong Bae Park, Jung Won Kang, Sung Hung Kim, Gwi Lae Lee, Bong Seog Kim, Yong Ho Roh
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Cancer Res Treat. 2002;34(1):23-27. Published online February 28, 2002
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DOI: https://doi.org/10.4143/crt.2002.34.1.23
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 Abstract
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- PURPOSE
To evaluate the efficacy and safety of gemcitabine and carboplatin (GC) in the treatment of advanced non-small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between November 1999 and April 2001, 34 patients were enrolled in this study. The median age was 66 (range: 52-74) years old and all were male.
Sixteen patients demonstrated stage IIIB, 15 stage IV, and 3 recurrence of disease after surgery. Twenty-two patients showed a ECOG performance status of 0 or 1 and 12 had 2.
Twenty patients presented with squamous cell carcinoma, 11 adenocarcinoma and 3 unclassified NSCLC. The treatment regimen consisted of intravenous carboplatin AUC of 6 on day 1 and gemcitabine 1,250 mg/m2 on day 1 and 8. The treatment was repeated every 28 days. Toxicities were evaluated according to WHO toxicity criteria.
RESULTS
All thirty-four patients were evaluable. Partia responses were observed in 15 patients. The overall response rate was 44% (95% confidence interval: 27-61%) and the median response duration was 26 (range 8-60 ) weeks. The median survival of all patients was 50 (range 8-70 ) weeks.
During a total of 144 cycles, granulocytopenia greater than WHO grade 2 occurred in 2%, thrombocytopenia in 2%, and anemia in 3%, respectively. Non- hematologic toxicities were minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous gemcitabine and carboplatin has a relatively high activity with acceptable toxicities in patients with advanced NSCLC.
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Citations
Citations to this article as recorded by  - A Phase II Study of Single-Agent Gemcitabine as a Second-Line Treatment in Advanced Non-Small Cell Lung Cancer
Keun-Hyok Cho, Young-Bong Song, Ik-Sung Choi, Eun-Hee Cho, Jae-Won Choi, Young Mi Ahn, Yong Ho Roh, Seung-Hyun Nam, Bong-Seog Kim
Japanese Journal of Clinical Oncology.2006; 36(1): 50. CrossRef - A 21-day Schedule of Gemcitabine and Cisplatin Administration in the Treatment of Advanced Non-Small Cell Lung Carcinoma: a Phase II Study
Jong-Sung Park, Chang-Min Lee, Shin-Ae Lee, Chang-kil Jung, Sung-Hyun Kim, Hyuk-Chan Kwon, Jae-Seok Kim, Hyo-Jin Kim
Cancer Research and Treatment.2004; 36(1): 62. CrossRef
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A Phase II Study with Vinorelbine and Carboplatin in Patients with Advanced Non-small Cell Lung Cancer
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Jong Lyul Kim, Bong Seog Kim, Byoung Ju Na, Mi Jin So, Jin Han Lee, Oh Young Chung, Gwi Lae Lee, Yong Ho Roh
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J Korean Cancer Assoc. 2000;32(4):690-698.
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Abstract
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- PURPOSE
To evaluate the efficacy and safety of vinorelbine and carboplatin in advanced non- small-cell lung cancer (NSCLC).
MATERIALS AND METHODS
Between August 1998 and July 1999, 25 patients were enrolled. The median age was 68 (range, 46~77) years and male:female ratio was 23:2. Two patients had stage IIIa, 15 had stage IIIb and 8 had stage IV. Sixteen patients had ECOG performance status of 0 or 1 and 9 had 2 or 3. Sixteen patients had squamous cell carcinoma, 8 had adenocarcinoma and 1 had undifferentiated NSCLC. Treatment consists of intravenous carboplatin 400 mg/m2 on day 1 and vinorelbine 25 mg/m2 on days 1 and 8. The treatment was repeated every 28 days.
RESULTS
Twenty-three of 25 patients were evaluable. Partial response were observed in 11 patients. The overall response rate was 48% (95% confidence interval: 27~69%) and the median response duration was 19 (range 7 ~44 ) weeks. The median survival of 25 patients was 52 (range 3~53 ) weeks. Toxicities were evaluated by WHO criteria. During a total of 108 cycles, granulocytopenia worse than WHO grade 3 occurred in 2%, thrombocytopenia in 4% and anemia in 10%, respectively. Treatment-related death occurred in 1 patient due to sepsis during cytopenic period. Non-hematologic toxicity was minor and easily controlled.
CONCLUSION
A combination chemotherapy of intravenous vinorelbine and carboplatin has relatively high activity with acceptable toxicities in patients with advanced NSCLC.
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