title: A randomized pilot study of SRL172 (Mycobacterium vaccae) in patients with small cell lung cancer (SCLC) treated with chemotherapy.
abstract: BACKGROUND
  SRL172 is a suspension of heat killed Mycobacterium vaccae, that has been found to be a potent immunological adjuvant when used with autologous cells in animal models. This is a phase II study to test the clinical activity, feasibility and safety of combining SRL172 with chemotherapy to treat patients with small cell lung cancer (SCLC).
  
  
  METHODS
  Patients were randomized to receive chemotherapy with (n=14) or without (n=14) SRL172. The chemotherapy was either platinum-based (MVP, n=10) or anthracycline-based (ACE, n=18). SRL172 was given intradermally on day 0, weeks 4, 8 and then 3-6 monthly.
  
  
  RESULTS
  The treatment arms were well balanced for disease extent (43% with limited stage in each arm). The toxicity of chemotherapy and overall response at 12-15 weeks (57%) was the same for both treatment regimens. Median survival was 8.6 months and 12.9 for patients treated with chemotherapy alone and with the combination respectively (P=0.10). The survival trend was similar for both disease extent and chemotherapy regimen employed in favour of combination chemotherapy with SRL172.
  
  
  CONCLUSIONS
  There is a trend to improved median survival in SCLC with the combination of chemotherapy and SRL172 with no increased toxicity and irrespective of drug regimen. A phase III study examining chemotherapy in combination with SRL172 in SCLC is now underway.
authors.affiliation: Royal Marsden Hospital NHS Trust, Sutton, Surrey, UK.
authors.forename: L
authors.initials: L
authors.lastname: Assersohn
authors.forename: B E
authors.initials: BE
authors.lastname: Souberbielle
authors.forename: M E R
authors.initials: ME
authors.lastname: O'Brien
authors.forename: C D
authors.initials: CD
authors.lastname: Archer
authors.forename: R
authors.initials: R
authors.lastname: Mendes
authors.forename: R
authors.initials: R
authors.lastname: Bass
authors.forename: K V
authors.initials: KV
authors.lastname: Bromelow
authors.forename: R D
authors.initials: RD
authors.lastname: Palmer
authors.forename: E
authors.initials: E
authors.lastname: Bouilloux
authors.forename: D A
authors.initials: DA
authors.lastname: Kennard
authors.forename: I E
authors.initials: IE
authors.lastname: Smith
mesh_terms: D000368:Aged; D001428:Bacterial Vaccines / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009161:Mycobacterium; D010865:Pilot Projects
chemical_list: D001428:Bacterial Vaccines; C451081:SRL172