A Randomized Pilot Study of SRL172 (Mycobacterium vaccae) in Patients with Small Cell Lung Cancer (SCLC) Treated with Chemotherapy

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...

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Published in:	Clinical oncology (Royal College of Radiologists (Great Britain)) Vol. 14; no. 1; pp. 23 - 27
Main Authors:	Assersohn, L., Souberbielle, B.E., O'Brien, M.E.R., Archer, C.D., Mendes, R., Bass, R., Bromelow, K.V., Palmer, R.D., Bouilloux, E., Kennard, D.A., Smith, I.E.
Format:	Journal Article
Language:	English
Published:	Amsterdam Elsevier Ltd 01-02-2002 Elsevier
Subjects:	Aged Antineoplastic agents Bacterial Vaccines - therapeutic use Biological and medical sciences Carcinoma, Small Cell - drug therapy Feasibility Studies Female Humans Immunotherapy Lung Neoplasms - drug therapy Male Medical sciences Middle Aged Mycobacterium Pharmacology. Drug treatments Pilot Projects Pneumology Small cell, lung cancer, SRL172, Mycobacterium vaccae, chemotherapy Tumors of the respiratory system and mediastinum Small cell, lung cancer, SRL172, Mycobacterium vaccae, chemotherapy Antineoplastic agent Human Lung disease Mycobacterium vaccae Respiratory disease Toxicity Treatment efficiency Adjuvant treatment Malignant tumor Bronchopulmonary Chemotherapy Mycobacteriales Immunotherapy Phase II trial Mycobacteriaceae Bacteria Bronchus disease Actinomycetes Small cell carcinoma Survival curve
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Summary:	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..
ISSN:	0936-6555 1433-2981
DOI:	10.1053/clon.2001.0030