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  • Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer

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Lung cancer
Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer
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  1. S M Lee1,
  2. L E James2,
  3. W Qian3,
  4. S Spiro1,
  5. T Eisen4,
  6. N H Gower2,
  7. D R Ferry5,
  8. D Gilligan6,
  9. P G Harper7,
  10. J Prendiville7,
  11. M Hocking8,
  12. R M Rudd9
  1. 1
    University College Hospital, London, UK
  2. 2
    Cancer Research UK & University College London Cancer Trials Centre, London, UK
  3. 3
    Medical Research Council Clinical Trials Unit, London, UK
  4. 4
    Royal Marsden Hospital, London, UK
  5. 5
    Birmingham Heartlands NHS Trust, Birmingham, UK
  6. 6
    Addenbrookes NHS Trust, Cambridge, UK
  7. 7
    Guy’s and St Thomas’ NHS Trust, London, UK
  8. 8
    Walsgrave Hospital NHS Trust, Coventry, UK
  9. 9
    St Bartholomew’s Hospital, London, UK
  1. Dr S M Lee, Department of Oncology, University College Hospital, 250 Euston Road, London NW1 2PG, UK; sm.lee{at}uclh.nhs.uk

Abstract

Background: The combination of cisplatin and etoposide (PE) has been a standard treatment for patients with poor-prognosis small cell lung cancer (SCLC). This non-inferiority design trial aimed to determine whether the combination of gemcitabine and carboplatin (GC) results in similar survival but is less toxic with better quality of life.

Methods: Previously untreated patients with SCLC with extensive disease or limited stage with poor prognostic factors were randomly assigned to six 3-weekly cycles of GC or PE.

Results: 241 patients (121 GC, 120 PE) were recruited, of which 216 (90%) had died. There was no difference in overall survival (HR 1.01, 95% CI 0.77 to 1.32). Median survival with GC and PE was 8.0 and 8.1 months, respectively. Median progression-free survival was 5.9 months with GC and 6.3 months with PE. Grade 3 or 4 myelosuppressions were more frequent with GC (anaemia: 14% GC vs 2% PE; leucopenia: 32% GC vs 13% PE; thrombocytopenia: 22% GC vs 4% PE), but these were not associated with increased hospital admissions, infections or fatalities. Grade 2–3 alopecia (68% PE vs 17% GC) and nausea (43% PE vs 26% GC) were more frequent with PE. Patients given GC received more chemotherapy as outpatients (89% GC vs 66% PE of treatment cycles). In QoL questionnaires, more patients receiving PE reported being upset by hair loss (p = 0.004) and impaired cognitive functioning (p = 0.04).

Conclusions: GC is as effective as PE in terms of overall survival and progression-free survival and has a toxicity profile more acceptable to patients.

Trial registration number: ISRCTN 39679215

https://doi.org/10.1136/thx.2007.093872

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    Supplementary materials

    Footnotes

    • ▸ Additional tables and a figure are published online only at http://thorax.bmj.com/content/vol64/issue1

    • Funding: The trial was funded by The London Lung Cancer Group (registered charity no. 1074994) which received an educational grant from Lilly Oncology to support this trial. The trial was supported by the National Cancer Research Institute (NCRI).

    • Competing interests: None.

    • Ethics approval: The trial was approved by all relevant ethics committees and was undertaken according to the Declaration of Helsinki. All patients provided written informed consent.