SRL 172 (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

O'Brien, M. E. R., Anderson, H., Kaukel, E., O'Byrne, Kenneth J., Pawlicki, M., von Pawel, J., & Reck, M. (2004) SRL 172 (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. Annals of Oncology, 15(6), pp. 906-914.

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Background: 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. © 2004 European Society for Medical Oncology.

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ID Code: 65247
Item Type: Journal Article
Refereed: Yes
Additional Information: Articles free to read on journal website after 12 months
Additional URLs:
Keywords: Chemotheraphy, Immunotherapy, NSCLC, SRL172, antineoplastic agent, bacterial vaccine, cisplatin, mitomycin, MVP protocol 2, vinblastine, carboplatin, Mycobacterium vaccine, platinum derivative, srl 172, adult, aged, article, clinical trial, controlled clinical trial, controlled study, female, human, immunology, lung non small cell cancer, lung tumor, male, middle aged, multicenter study, phase 3 clinical trial, quality of life, randomized controlled trial, survival, treatment outcome, advanced cancer, anemia, cancer chemotherapy, cancer survival, deterioration, drug activity, drug safety, health status, leukopenia, major clinical study, Mycobacterium vaccae, priority journal, scoring system, statistical analysis, survival time, suspension, thrombocytopenia, Antineoplastic Combined Chemotherapy Protocols, Bacterial Vaccines, Carcinoma, Non-Small-Cell Lung, Humans, Lung Neoplasms, Mitomycins, Survival Analysis
DOI: 10.1093/annonc/mdh220
ISSN: 0923-7534
Divisions: Current > Schools > School of Biomedical Sciences
Current > QUT Faculties and Divisions > Faculty of Health
Current > Institutes > Institute of Health and Biomedical Innovation
Copyright Owner: © 2004 European Society for Medical Oncology
Deposited On: 10 Dec 2013 01:56
Last Modified: 27 Jan 2015 04:47

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