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
Open accessAbstract
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.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Administration of heat-killed M. vaccae to terminal lung cancer patients was shown to improve emotional health and cognitive function, thought to be as a result of enhanced release of neurotransmitters such as serotonin, as part of the immune response to the microbial products.
“Administration of heat-killed M. vaccae to terminal lung cancer patients was shown to improve emotional health and cognitive function, thought to be as a result of the enhanced release of neurotransmitters such as serotonin, as part of the immune response to the microbial products (483).”
From Signalling cognition: The gut microbiota and hypothalamic-pituitary-adrenal axis (2023) · cites this paper as [483]
Cites
Cancer: Principles and Practice of Oncology.
(1991) · Annals of Internal Medicine · doi:10.7326/0003-4819-114-9-819_4 · Cited by 8,524 · see citing works
Comparison of Four Chemotherapy Regimens for Advanced Non–Small-Cell Lung Cancer
Schiller, J. H., Harrington, D., Belani, C. P., Langer, C., Sandler, A., Krook, J., Zhu, J., & Johnson, D. H. (2002) · New England Journal of Medicine · doi:10.1056/nejmoa011954 · Cited by 4,955 · see citing works
Non-small Cell Lung Cancer Collaborative Group (1995) · BMJ · doi:10.1136/bmj.311.7010.899 · Cited by 3,039 · see citing works
Fayers, P. M., Aaronson, N. K., Bjordal, K., Groenvold, M., Curran, D., & Bottomley, A. (2001) · Research at the University of Copenhagen (University of Copenhagen) · Cited by 2,520 · see citing works
Villalba, J. B. (1996) · Lung Cancer · doi:10.1016/0169-5002(96)85918-6 · Cited by 2,510 · see citing works
Cullen, M. H., Billingham, L. J., Woodroffe, C. M., Chetiyawardana, A. D., Gower, N. H., Joshi, R., Ferry, D., Rudd, R., Spiro, S. G., Cook, J. E., et al. (1999) · Journal of Clinical Oncology · doi:10.1200/jco.1999.17.10.3188 · Cited by 445 · see citing works
Human non-small cell lung cancer cells express a type 2 cytokine pattern
Mao, J. T. (1996) · Lung Cancer · doi:10.1016/0169-5002(96)85851-x · Cited by 259 · see citing works
Pellegrini, P., Berghella, A. M., Beato, T. D., Cicia, S., Adorno, D., & Casciani, C. U. (1996) · Cancer Immunology Immunotherapy · doi:10.1007/s002620050244 · Cited by 190 · see citing works
Cohen, E. E. W., & Vokes, E. E. (2003) · Springer eBooks · doi:10.1007/978-3-642-55780-4_28 · Cited by 172 · see citing works
Immunotherapy of advanced prostate cancer: a phase I/II trial using Mycobacterium vaccae (SRL172)
Hrouda, Baban, Dunsmuir, et al. (1998) · British Journal of Urology · doi:10.1046/j.1464-410x.1998.00803.x · Cited by 82 · see citing works
O'Brien, M. E. R., Saini, A., Smith, I. E., et al. (2000) · British Journal of Cancer · doi:10.1054/bjoc.2000.1401 · Cited by 79 · see citing works
Self-citationEconomic issues in lung cancer: a review.
Goodwin, P. J., & Shepherd, F. A. (1998) · Journal of Clinical Oncology · doi:10.1200/jco.1998.16.12.3900 · Cited by 71 · see citing works
Maraveyas, A., Baban, B., Kennard, D., et al. (1999) · Annals of Oncology · doi:10.1023/a:1008307821189 · Cited by 67 · see citing works
Current Treatment of Unresectable Lung Cancer
Jett, J. R. (1993) · Mayo Clinic Proceedings · doi:10.1016/s0025-6196(12)60376-0 · Cited by 49 · see citing works
Assersohn, L., Souberbielle, B. E., O'Brien, M. E. R., et al. (2002) · Clinical Oncology · doi:10.1053/clon.2001.0030 · Cited by 32 · see citing works
Self-citationFischer, J. R., Schindel, M., Bülzebruck, H., et al. (1997) · Annals of Oncology · doi:10.1023/a:1008242000431 · Cited by 30 · see citing works
Mendes, R. L., O'Brien, M. E. R., Mitra, A., et al. (2002) · British Journal of Cancer · doi:10.1038/sj.bjc.6600063 · Cited by 21 · see citing works
Self-citationFrei, E. (1997) · CHEST Journal · doi:10.1378/chest.112.4_supplement.266s · Cited by 18 · see citing works
Butler, T. M. (1876) · The Lancet · doi:10.1016/s0140-6736(02)49512-8 · Cited by 11 · see citing works
Flagged first, then by citations
Cited by
Sorted by citations
Signalling cognition: The gut microbiota and hypothalamic-pituitary-adrenal axis
Rusch, J. A., Layden, B. T., & Dugas, L. R. (2023) · Frontiers in Endocrinology · doi:10.3389/fendo.2023.1130689 · Cited by 415 · see citing works
Lowry, C. A., Hollis, J. H., de Vries, A., Pan, B., Brunet, L. R., Hunt, J. R. F., Paton, J. F. R., van Kampen, E., Knight, D. M., Evans, A. K., et al. (2007) · Neuroscience · doi:10.1016/j.neuroscience.2007.01.067 · Cited by 199 · see citing works
Microbiota-gut-brain axis and cognitive function
Gareau, M. G. (2014) · Advances in Experimental Medicine and Biology · doi:10.1007/978-1-4939-0897-4_16 · Cited by 189 · see citing works
The microbiota, immunoregulation, and mental health: implications for public health
Lowry, C. A., Smith, D. G., Siebler, P. H., Schmidt, D., Stamper, C. E., Hassell, J. E., Yamashita, P. S., Fox, J. H., Reber, S. O., Brenner, L. A., et al. (2016) · Current Environmental Health Reports · doi:10.1007/s40572-016-0100-5 · Cited by 172 · see citing works
Raison, C. L., Lowry, C. A., & Rook, G. A. W. (2010) · Archives of General Psychiatry · doi:10.1001/archgenpsychiatry.2010.161 · Cited by 169 · see citing works
Ingestion of mycobacterium vaccae decreases anxiety-related behavior and improves learning in mice
Matthews, D. M., & Jenks, S. M. (2013) · Behavioural Processes · doi:10.1016/j.beproc.2013.02.007 · Cited by 105 · see citing works
Bested, A. C., Logan, A. C., & Selhub, E. M. (2013) · Gut Pathogens · doi:10.1186/1757-4749-5-4 · Cited by 84 · see citing works
- Authors
- O’Brien, M. E. R., Anderson, H., Kaukel, E., O’Byrne, K., Pawlicki, M., von Pawel, J., & Reck, M.
- Affiliations
- Royal Marsden NHS Foundation Trust (GB)
- Wythenshawe Hospital (GB)
- Corresponding author
- O’Brien, M.E.R.
- Venue
- Annals of Oncology
- Publisher
- Elsevier BV
- Published
- 2004-06
- Volume
- 15
- Issue
- 6
- Pages
- 906-914
- ISSN
- 0923-7534 (ISSN-L)
- OpenAlex
- W2167829195
- Cited by
- 139
- References
- 19
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 4 · 2023: 4 · 2022: 7 · 2021: 7 · 2020: 8 · 2019: 2 · 2018: 7 · 2017: 6 · 2016: 5 · 2015: 14 · 2014: 3 · 2013: 11 · 2012: 10
- FWCI
- 4.42
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Annals of Oncology (publishedVersion)
- PubMed (publishedVersion)
- Faculty of Health; Institute of Health and Biomedical Innovation
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › Lung Cancer Research Studies
- Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
- Keywords
- non-small cell lung cancer, adjuvant immunotherapy, quality of life, overall survival, platinum-based chemotherapy, mitomycin C, vinblastine, cisplatin, carboplatin, global health status
- MeSH terms
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols, Bacterial Vaccines, Carcinoma, Non-Small-Cell Lung, Cisplatin, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mitomycins, Quality of Life, Vinblastine, Survival Analysis, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
