Annals of Oncology 15:906-914, 2004
© 2004 European Society for Medical Oncology
Original Paper |
SRL172 (killed Mycobacterium vaccae) in addition to standard chemotherapy improves quality of life without affecting survival, in patients with advanced non-small-cell lung cancer: phase III results
Received 25 November 2003; revised 22 January 2004; accepted 3 February 2004Background:
This open-label, randomised phase III study was designed to further investigate the clinical activity and safety of SRL172 (killed Mycobacterium vaccae suspension) with chemotherapy in the treatment of non-small-cell lung cancer (NSCLC).
Patients and methods:
Patients were randomised to receive platinum-based chemotherapy, consisting of up to six cycles of MVP (mitomycin, vinblastine and cisplatin or carboplatin) with (210 patients) or without (209 patients) monthly SRL172.
Results:
There was no statistical difference between the two groups in overall survival (primary efficacy end point) over the course of the study (median overall survival of 223 days versus 225 days; P = 0.65). However, a higher proportion of patients were alive at the end of the 15-week treatment phase in the chemotherapy plus SRL172 group (90%), than in the chemotherapy alone group (83%) (P = 0.061). At the end of the treatment phase, the response rate was 37% in the combined group and 33% in the chemotherapy alone group. Patients in the chemotherapy alone group had greater deterioration in their Global Health Status score (–14.3) than patients in the chemotherapy plus SRL172 group (–6.6) (P = 0.02).
Conclusion:
In this non-placebo controlled trial, SRL172 when added to standard cancer chemotherapy significantly improved patient quality of life without affecting overall survival times.
1 The Royal Marsden Hospital NHS Trust, Sutton, Surrey; 2 Kent Cancer Centre, Maidstone, Kent; 3 Chest Clinic, Wythenshawe Hospital, Southmoor Road, Wythenshawe, Manchester, UK; 4 Lungenabteilung, Allgemeines Krankenhaus, Hamburg, Germany; 5 University Department of Oncology, Leicester Royal Infirmary, Infirmary Square, Leicester, UK; 6 Klinika Chemioterapii, Centrum Oncologii Oddzial w Krakowie, Kraków, Poland; 7 ASKLEPIOS Fachklinik, Munchen Gauting, Abteilung Onkologie, Robert Koch Allee 2, München-Gauting, Germany; 8 Krankenhaus Großhansdorf, Pneumolog-Onkolog. Ambulanz, Großhansdorf, Germany
Key words: NSCLC, chemotherapy, immunotherapy, SRL172
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