title: An evaluation of a preparation of Mycobacterium vaccae (SRL172) as an immunotherapeutic agent in renal cancer.
abstract: Two studies were carried out to evaluate heat-killed Mycobacterium vaccae SRL172 as an immunotherapeutic agent for patients with metastatic, post-nephrectomy, renal cell carcinoma. In the first study, 60 patients in France and the UK received injections of SRL172, and their survival was compared with that of historical controls who had been treated either with biological response modifiers (IL-2, IFN-alpha) or chemotherapy. In the second study, 36 patients were randomised to receive treatment with IL-2 alone or IL-2 plus SRL172. Survival and adverse events related to the treatments were assessed and compared between treatment groups. The first study showed that those treated with SRL172 alone survived equally as long as those receiving IL-2 or IFN-alpha and both treatment groups survived longer than those on chemotherapy (p<0.001), a result supported by Cox's proportional hazards regression analysis. The second study, stopped early due to drug supply issues, showed that the addition of SRL172 to IL-2 made no difference to survival compared to IL-2 alone, in the limited numbers treated. Adverse events occurring in those receiving SRL172 in the first study were mild and in the second study those receiving IL-2 alone had significantly more adverse events than those receiving SRL172 plus IL-2 (p<0.001). It is concluded that SRL172 may have activity in metastatic renal cancer and has very low toxicity, making it worthy of further study.
authors.affiliation: Academic Division of Clinical Oncology, University of Nottingham, Nottingham University Hospitals-City Campus, Nottingham NG51PB, UK. poulam.patel@nottingham.ac.uk
authors.forename: P M
authors.initials: PM
authors.lastname: Patel
authors.forename: S
authors.initials: S
authors.lastname: Sim
authors.forename: D O
authors.initials: DO
authors.lastname: O'Donnell
authors.forename: A
authors.initials: A
authors.lastname: Protheroe
authors.forename: D
authors.initials: D
authors.lastname: Beirne
authors.forename: A
authors.initials: A
authors.lastname: Stanley
authors.forename: J M
authors.initials: JM
authors.lastname: Tourani
authors.forename: D
authors.initials: D
authors.lastname: Khayat
authors.forename: B
authors.initials: B
authors.lastname: Hancock
authors.forename: P
authors.initials: P
authors.lastname: Vasey
authors.forename: A
authors.initials: A
authors.lastname: Dalgleish
authors.forename: C
authors.initials: C
authors.lastname: Johnston
authors.forename: R E
authors.initials: RE
authors.lastname: Banks
authors.forename: P J
authors.initials: PJ
authors.lastname: Selby
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001428:Bacterial Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D019496:Cancer Vaccines / Q000008:administration & dosage / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000628:therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D007376:Interleukin-2 / Q000008:administration & dosage; D007680:Kidney Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D001428:Bacterial Vaccines; D019496:Cancer Vaccines; D007376:Interleukin-2; C451081:SRL172