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Gemcitabine plus cisplatin (GCis) versus gemcitabine plus carboplatin (GCarb) in patients with stage IIIB and IV non-small cell lung cancer (NSCLC): final results of Czech Lung Cancer Cooperative Group phase III randomized trial
Reviewer: Ryan Smith, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 18 de mayo del 2002
Presenter: L. Novakova
Presenter's Affiliation: Czech Lung Cancer Cooperative Group
Type of Session: Poster
Advanced non-small cell lung cancer has a poor survival. A majority of the patients fail distantly, with metastatic disease. Gemcitabine has been shown to have significant anti-tumor properties against NSCLC, a disease in which platinum-based chemotherapy has become the standard treatment regimen. This study evaluates gemcitabine in two different platinum based regimens to determine safety and efficacy.
Materials and Methods
- 176 patients with stage IIIB or IV NSCLC
- Arm A: Gemcitabine 1200 mg/m2 d1 and 8 plus cisplatin 80 mg/m2 on d1 in 3 week cycles
- Arm B: Gemcitabine 1200 mg/m2 d1 and 8 plus carboplatin AUC 5 on d1 in 3 week cycles
- Patients were stratified according to stage (IIIB vs. IV), PS (<80 vs >80), gender
- Median followup of approximately 6 months
- Median age was 62, median KPS of 90
- 70 patients had stage IIIB disease, 106 had stage IV disease
- >90% of the patients in both regimens received the anticipated dose of chemotherapy
- Total time to Progression: GCis-5.6 mo vs. GCarb-6.1 mo
- Median Survival was 8.1 months in both groups
- Hematologic Toxicity was mild, with <33% of patients having Grade 3/4 hematologic toxicity in any one facet. The only difference between treatment arms was thrombocytopenia (14% GCis vs. 36% GCarb). This did not translate into a significant incidence of bleeding (3% vs 0%).
- Nonhematologic toxicity was also mild, with <20% experiencing Grade 3/4 toxicity in any one area. The only difference was in nausea/vomiting with a 16% incidence in the GCis group compared to 4% in the GCarb group.
- There was no renal, hepatic, pulmonary, cutaneous, or allergic Grade 3/4 toxicity
- Both regimens are well tolerated, with little difference in the toxcity profile between the two treatment arms
- There is no difference in time to progression or survival between the two arms
- Final toxicity and efficacy data will be available by the end of 2002
Chemotherapy is an important treatment modality for NSCLC both because of radiation sensitizing properties when used in a combined modality treatment plan and the treatment of metastatic disease with chemotherapy alone. This study dealt mainly with the treatment of patients with metastatic disease. These patients have a poor outcome, with overall survival seldom greater than 1 year. This study investigates the use of gemcitabine with two different platinum drugs: cisplatin and carboplatin. As stated by the authors, these regimens were both well tolerated. There was virtually no difference in clinical implications of hematologic toxicities. Notably, the incidence of hematologic toxicity was fairly low in the carboplatin group, historically known for more myelosuppression. In terms of nonhematologic toxicity, the only statistical difference was in the incidence of nausea/vomiting, with carboplatin having significantly less Grade 3/4 n/v. Notably, there was no renal toxicity, historically associated with cisplatin. There was no difference between the two arms in terms of efficacy of treatment. The time to progression and survival times do not seem to be an improvement over historical data, comparing other platinum based treatment regimens (carbotaxol, cisplatin/etoposide, etc). However, because of the mild toxicity profiles, either could be an acceptable regimen in the treatment of metastatic NSCLC.
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