Regular Article

British Journal of Cancer (2000) 83, 447–453. doi:10.1054/bjoc.2000.1307 www.bjcancer.com
Published online 25 July 2000

Gemcitabine plus best supportive care (BSC) vs BSC in inoperable non-small cell lung cancer – a randomized trial with quality of life as the primary outcome

H Anderson1, P Hopwood2, R J Stephens3, N Thatcher4, B Cottier5, M Nicholson6, R Milroy7, T S Maughan8, S J Falk9, M G Bond10, P A Burt11, C K Connolly12, M B McIllmurray13, J Carmichael14 and on behalf of the UK NSCLC Gemcitabine Group

  1. 1Wythenshawe Hospital, Manchester, UK
  2. 2CRC Psychological Medicine Group, Christie Hospital NHS Trust, Manchester, UK
  3. 3Cancer Division, MRC Clinical Trials Unit, London, UK
  4. 4Department of Medical Oncology, Christie CRC Research Centre, Christie Hospital NHS Trust, Manchester, UK
  5. 5Clatterbridge Hospital, Bebbington, Liverpool, UK
  6. 6Aberdeen Royal Infirmary, Aberdeen, UK
  7. 7Stobhill NHS Trust, Glasgow, UK
  8. 8Velindre Hospital, Whitchurch, Cardiff, UK
  9. 9Bristol Oncology Centre, Bristol, UK
  10. 10Cookridge Hospital, Leeds, UK
  11. 11Christie Hospital NHS Trust, Manchester, UK
  12. 12Darlington Memorial Hospital, Darlington, UK
  13. 13Lancaster Royal Infirmary, Lancaster, UK
  14. 14City Hospital, Nottingham, UK

Received 29 November 1999; Revised 23 March 1999; Accepted 13 April 2000.

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Abstract

Three hundred patients with symptomatic, locally advanced or metastatic NSCLC not requiring immediate radiotherapy were enrolled into this randomized multicentre trial comparing gemcitabine + BSC vs BSC alone. Patients allocated gemcitabine received 1000 mg/m2on days 1, 8 and 15 of a 28-day cycle, for a maximum of six cycles. The main aim of this trial was to compare patient assessment of a predefined subset of commonly reported symptoms (SS14) from the EORTC QLQ-C30 and LC13 scales. The primary end-points were defined as (1) the percentage change in mean SS14 score between baseline and 2 months and (2) the proportion of patients with a marked (greater than or equal to 25%) improvement in SS14 score between baseline and 2 months sustained for greater than or equal to4 weeks. The secondary objectives were to compare treatments with respect to overall survival, and multidimensional QL parameters.The treatment groups were balanced with regard to age, gender, Karnofsky performance status (KPS) and disease stage (40% had metastatic disease). The percentage change in mean SS14 score from baseline to 2 months was a 10% decrease (i.e. improvement) for gemcitabine plus BSC and a 1% increase (i.e. deterioration) for BSC alone (P = 0.113, two-sample t -test). A sustained (greater than or equal to 4 weeks) improvement (greater than or equal to25%) on SS14 was recorded in a significantly higher proportion of gemcitabine + BSC patients (22%) than in BSC alone patients (9%) (P = 0.0014, Pearson's chi-squared test). The QLQ-C30 and L13 subscales showed greater improvement in the gemcitabine plus BSC arm (in 11 domains) than in the BSC arm (one symptom item). There was greater deterioration in the BSC alone arm (six domains/items) than in the gemcitabine + BSC arm (three QL domains). Tumour response occurred in 19% (95% CI 13–27) of gemcitabine patients. There was no difference in overall survival: median 5.7 months (95% CI 4.6–7.6) for gemcitabine + BSC patients and 5.9 months (95% CI 5.0–7.9) (log-rank, P = 0.84) for BSC patients, and 1-year survival was 25% for gemcitabine + BSC and 22% for BSC. Overall, 74 (49%) gemcitabine + BSC patients and 119 (79%) BSC patients received palliative radiotherapy. The median time to radiotherapy was 29 weeks for gemcitabine + BSC patients and 3.8 weeks for BSC. Patients treated with gemcitabine + BSC reported better QL and reduced disease-related symptoms compared with those receiving BSC alone. These improvements in patient-assessed QL were significant in magnitude and were sustained. © 2000 Cancer Research Campaign

Keywords:

gemcitabine, BSC, NSCLC, quality of life

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