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Comparison of gemcitabine and carboplatin versus cisplatin and etoposide for patients with poor-prognosis small cell lung cancer
  1. Siow Ming Lee (sm.lee{at}uclh.nhs.uk)
  1. University College London Hospitals, United Kingdom
    1. Lindsay James (lj{at}ctc.ucl.ac.uk)
    1. Cancer Research UK & University College London Cancer Trials Centre, London, United Kingdom
      1. Wendi Qian (wendi.qian{at}ctu.mrc.ac.uk)
      1. Medical Research Council Clinical Trials Unit, London, United Kingdom
        1. Stephen Spiro (stephen.spiro{at}uclh.nhs.uk)
        1. University College London Hospitals, United Kingdom
          1. Tim Eisen (tim.eisen{at}icr.ac.uk)
          1. Royal Marsden Hospital, London, United Kingdom
            1. Nicole Gower (ng{at}ctc.ucl.ac.uk)
            1. Cancer Research UK & University College London Cancer Trials Centre, London, United Kingdom
              1. David Ferry (drf{at}ferryd.freeserve.co.uk)
              1. Birmingham Heartlands NHS Trust, Birmingham, United Kingdom
                1. David Gilligan (david.gilligan{at}addenbrookes.nhs.uk)
                1. Addenbrookes NHS Trust, Cambridge, United Kingdom
                  1. Peter Harper (peter.harper{at}kcl.ac.uk)
                  1. Guy's and St Thomas' NHS Trust, London, United Kingdom
                    1. Joseph Prendiville (joseph.prendiville{at}gstt.nhs.uk)
                    1. Guy's and St Thomas' NHS Trust, London, United Kingdom
                      1. Mark Hocking (mark.hocking{at}uhcw.nhs.uk)
                      1. Walsgrave Hospital NHS Trust, Coventry, United Kingdom
                        1. Robin Rudd (robin{at}robinrudd.com)
                        1. St Bartholomew's Hospital, London, United Kingdom

                          Abstract

                          Background: Cisplatin and etoposide (PE) has been a standard treatment for patients with poor prognosis small cell lung cancer (SCLC). This non-inferiority design trial (registered as ISRCTN 39679215) aimed to determine whether gemcitabine and carboplatin (GC) has a similar survival but is less toxic with better quality of life (QoL).

                          Methods: Previously untreated SCLC patients 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 and 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 was 8.0 months and 8.1 months with GC and PE 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 v 2% PE; leucopenia, 32% GC v 13% PE; thrombocytopenia, 22% GC v 4% PE) but these were not associated with increased hospital admissions, infections, or fatalities. More frequent grade 2-3 alopecia (68% PE v 17% GC) and nausea (43% PE v 26% GC) were seen with PE. GC patients received more chemotherapy as out-patients (89% GC vs 66% PE of treatment cycles). In QoL questionaires, more PE patients reported upset by hair loss (P=.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.

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