Gemcitabine (G) compared with gemcitabine plus carboplatin (GC) in advanced non-small cell lung cancer (NSCLC): a phase III study by the Swedish Lung Cancer Study Group (SLUSG)

Reviewer: Ryan Smith, MD
The Abramson Cancer Center of the University of Pennsylvania
Ultima Vez Modificado: 18 de mayo del 2002

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Presenter: C. Sederholm
Presenter's Affiliation: University Hospital, Linkoping, Sweden
Type of Session: Scientific

Background

    Chemotherapy is indicated in patients with locally advanced and metastatic lung cancer who have good performance status and minimal weight loss. The use of combined chemotherapeutic regimens (i.e. doublets) have better results than single agent chemotherapy. Although standard chemotherapy has been with platinum based regimens, the use of gemcitabine as a primary agent has shown efficacy recently. This phase III study investigates the use of gemcitabine vs gemcitabine/carboplatin in the treatment of advanced NSCLC.

Materials and Methods

  • 334 patients, stratified by gender, stage, weight loss (>5 or <5%), and PS (0-1 vs. 2), were randomized to either gemcitabine alone (G) or gemcitabine plus carboplatin (GC) chemotherapy
  • G (N=170 pts)-Gemcitabine 1250 mg/m2 d1, 8 q21 days
  • GC (N=164 pts)-Gemcitabine 1250 mg/m2 d1, 8 plus carboplatin AUC 5 on d1 q21 days
  • If and when patients progressed, 2nd line therapy with supportive care, docetaxel, or reinduction was allowed. Cross over to a different platinum containing regimen was not allowed.

Results

  • Median age was 70, with 85% having PS of 0-1. 32% had >5% weight loss. 40% had stage IIIB disease, with 60% with stage IV disease
  • Mean # of cycles per patient was 4.3 and 4.4, with virtually no reduction in dose intensity
  • Hematologic toxicity was worse in the GC arm (anemia 5% vs 18%, leukopenia 6% vs 30%, thrombocytopenia 4% vs. 50%). Although 24% of pts in the GC group had grade 4 thrmobocytopenia toxicity, this was short-lived and no patient had bleeding episodes (though 6% required platelet transfusion)
  • Non-hematologic toxicity was mild, with approximatley 25% having Grade 3 toxicity in both arms (usually GI).
  • Response was significantly better in the GC arm, with CR/PR 30% vs 12% in the G arm.
  • Time to progression was longer in the GC arm (6 mo) compared to the G arm (4 mo)
  • OS was better in the GC arm (1 year 41% vs 32%, 2 year 5% vs 16%)

Author's Conclusions

  • There was moderate nonhematologic toxicity in both arms
  • There was more thrombocytopenia in the GC arm, though this was short-lived and caused no clinical implications
  • The GC group had a better response rate, time to progression, and overall survival than the G arm

Clinical/Scientific Implications

    As mentioned above, combined, platinum based chemotherapy remains a standard treatment of metastatic NSCLC. Although gemcitabine has shown efficacy in treating metastatic NSCLC, its use as a single agent required testing. As per this study, combination chemotherapy, and platinum based chemotherapy should still be considered a standard approach. Efficacy is improved with the addition of carboplatin to gemcytabine in the treatment of non-small cell lung cancer while non-hematologic toxicity is not increased and hematologic toxicity is increased mildly but manageable. Single agent chemotherapy with gemcytabine cannot be recommended at this time. As an interesting side light, with the high median age in this study, this regimen of gemcitabine and carboplatin seems to be a feasible regimen in treating elderly patients with metastatic NSCLC as well.

Oncolink's ASCO Coverage made possible by an unrestricted Educational Grant from Bristol-Myers Squibb Oncology.

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