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

      This paper is only available as a PDF. To read, Please Download here.


      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).
      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.
      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.
      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..


      To read this article in full you will need to make a payment


      Subscribe to Clinical Oncology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Zochbauer-Muller S
        • Pirker R
        • Huber H
        Treatment of small cell lung cancer patients.
        Ann Oncol. 1999; 10: 83-91
        • Kelly K
        New chemotherapy agents for small cell lung cancer.
        Cancer. 2000; 117: 156S-162S
        • Ardizzoni A
        • Grossi F
        Update on the treatment of small cell lung cancer (SCLC).
        Ann Oncol. 2000; 11: 101-108
        • Mendes R
        • O'Brien M
        • Bromelow K
        A highly active regimen for malignant mesothelioma with new biological data.
        Br J Cancer. 2000; 83: 7.8
        • O'Brien M
        • Saini A
        • Smith I
        A randomized phase II study of SRL172 (Mycobacterium vaccae) combined with chemotherapy in patients with advanced inoperable non-small-cell lung cancer and mesothelioma.
        Br J Cancer. 2000; 83: 853-857
        • Grant SC
        • Kris MG
        • Miller V
        • Yao TJ
        • Houghton AN
        • Chapman PB
        Long survival in 15 patients with small cell lung cancer (SCLC) immunized with BEC2 plus BCG after initial therapy: An update.
        Proc ASCO. 1997; 16: 1630
        • Maraveyas A
        • Baban B
        • Kennard D
        Possible improved survival of patients with stage IVAJCC melanoma receiving SRL172 immunotherapy: correlation with induction of increased levels of intracellular interleukin-2 in peripheral blood lymphocytes.
        Ann Oncol. 1999; 10: 817-824
        • Hrouda D
        • Baban B
        • Dunsmuir W
        • Kirby R
        • Dalgleish A
        Immunotherapy of advanced prostate cancer: a phase I/II trial using Mycobacterium vaccae (SRL172).
        Br J Urol. 1998; 82: 568-573
        • Hickish T
        • Smith I
        • Nicolson M
        A pilot study of MVP (mitomycin-C, vinblastine and cisplatin) chemotherapy in small-cell lung cancer.
        Br J Cancer. 1998; 77: 1966-1970
        • Noda K
        • Nishiwaki Y
        • Kawahara M
        Randomized Phase III study or irinotecan (CPT-11) and cisplatin versus etoposide and cisplatin in extensive disease small cell lung cancer: Japan Clinical Oncology Group study (JCOG9511).
        Proc ASCO. 2000; 19: 1887