SRL 172 (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

Annals of Oncology

Volumn 15, Issue 6, 2004, Pages 906-914

  O'Brien, Maryo E R ^a,b,e,i,j   Anderson, H ^c,l   Kaukel, E ^d,x   O'Byrne, K ^e   Pawlicki, M ^f   von Pawel, J ^g   Reck, M ^h   Ellis, P ^k   Hickish, T ^l   Nicolson, M ^m   Woll, P ⁿ   Dunlop, D ^o   Falk, S ^p   Johnson, P ^q   Collinson, M ^r   Hatton, M ^s   Gilligan, D ^t   Middleton, G ^u   Loddenkemper, R ^v   Deperman, K ^w   Aigner, K ^y   Pirker, R ^z   Rothmund, J ^aa   Tujakowski, J ^ab   Krzakowski, M ^ac   Ramlau, R ^ad   Crawford, B ^ae   Massaro, J ^af   Cross, A ^ag   Tuckwell, N ^ah   Kennard, D ^ah   Povey, J ^ah   more..

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

^b Kent Cancer Centre   (United Kingdom)

^c WYTHENSHAWE HOSPITAL   (United Kingdom)

^d Allgemeines Krankenhaus Eilbek   (Germany)

^e LEICESTER ROYAL INFIRMARY   (United Kingdom)

^f Klinika Chemioterapii   (Poland)

^g ASKLEPIOS FACHKLINIKEN MÜNCHEN GAUTING   (Germany)

^h Pneumolog Onkolog   (Germany)

ⁱ ROYAL MARSDEN HOSPITAL   (United Kingdom)

^j MAIDSTONE HOSPITAL   (United Kingdom)

^k ST THOMAS HOSPITAL   (United Kingdom)

^l ROYAL BOURNEMOUTH HOSPITAL   (United Kingdom)

^m ABERDEEN ROYAL INFIRMARY   (United Kingdom)

ⁿ NOTTINGHAM CITY HOSPITAL   (United Kingdom)

^o GLASGOW ROYAL INFIRMARY   (United Kingdom)

^p YEOVIL DISTRICT HOSPITAL   (United Kingdom)

^q SOUTHAMPTON GENERAL HOSPITAL   (United Kingdom)

^r DERRIFORD HOSPITAL   (United Kingdom)

^s WESTON PARK HOSPITAL   (United Kingdom)

^t ADDENBROOKE S HOSPITAL   (United Kingdom)

^u ROYAL SURREY COUNTY HOSPITAL   (United Kingdom)

^v Krakenhaus Zehlendorf   (Germany)

^w Fachkrankenhaus fur Lungenheilkunde   (Germany)

^x Krakenhaus der Elisabethanien ^*  (Germany)

^y Krakenhaus der Elisabethanien   (Austria)

^z MEDICAL UNIVERSITY OF VIENNA   (Austria)

^aa Landeskrankenhaus Feldkirch   (Austria)

^ab Regional Oncology Centre Bydgoszcz   (Poland)

^ac INSTITUTE OF ONCOLOGY   (Poland)

^ad GREATER POLAND CANCER CENTRE   (Poland)

^ae MAPI VALUES   (United States)

^af Boston University   (United States)

^ag GNB Limited   (United Kingdom)

^ah SR Pharma   (United Kingdom)

more..

Author keywords

Chemotheraphy; Immunotherapy; NSCLC; SRL172

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; MYCOBACTERIUM VACCINE; PLATINUM DERIVATIVE; SRL 172; VINBLASTINE; BACTERIAL VACCINE; MITOMYCIN; MVP PROTOCOL 2; SRL172;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DETERIORATION; DRUG ACTIVITY; DRUG SAFETY; FEMALE; HEALTH STATUS; HUMAN; LEUKOPENIA; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; MYCOBACTERIUM VACCAE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SCORING SYSTEM; STATISTICAL ANALYSIS; SURVIVAL TIME; SUSPENSION; THROMBOCYTOPENIA; IMMUNOLOGY; LUNG TUMOR; MIDDLE AGED; MULTICENTER STUDY; SURVIVAL; TREATMENT OUTCOME;

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; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VINBLASTINE;

EID: 3442886281     PISSN: 09237534     EISSN: None     Source Type: Journal    
DOI: 10.1093/annonc/mdh220     Document Type: Article

References (18)

1. Cancer Research Campaign. CRC Cancerstats: Lung Cancer and Smoking - UK 2001.
2. Jett JR. Current treatment of unresectable lung cancer. Mayo Clin Proc 1993;68:603-611.
3. Cancer Survival Trends. Office for National Statistics, HMSO 1999; 95.
4. Ginsberg RJ, Vokes EE, Raben A. Non-small cell lung cancer. In De Vita VT, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology, 5th edition. Philadelphia, PA: Lippincott-Raven 1997; 858-910.
5. Non-small Cell Lung Cancer Collaborative Group. Chemotherapy in non-small cell lung cancer: a meta-analysis using updated data on individual patients from 52 randomised clinical trials. BMJ 1995; 311: 899-909.
6. Schiller JH, Harrington D, Belani CP et al. Comparing regimens for nonsmall-cell lung cancer (ECOG Trial). N Engl J Med 2002; 346: 92-98.
7. Cullen MH, Billingham LJ, Woodroffe CM et al. Mitomycin, ifosfamide, and cisplatin in unresectable non-small-cell lung cancer: effects on survival and quality of life. J Clin Oncol 1999; 17: 3188-3194.
8. Mendes R, O'Brien MER, Mitra A et al. Clinical and immunological assessment of Mycobacterium vaccae (SRL172) with chemotherapy inpatients with malignant mesothelioma. Br J Cancer 2002; 86: 336-341.
9. Pellegrini P, Berghella AM, Del Beato T et al. Dysregulation in Th1 and Th2 subsets of CD4+ T cells in peripheral blood of colorectal cancer patients and involvement in cancer establishment and progression. Cancer Immunol Immunother 1996; 42: 1-8.
10. Huang M, Wang J, Lee P et al. Human non-small cell lung cancer cells express a type 2 cytokine pattern. Cancer Res 1995; 55: 3847-3853.
11. Fischer JR, Schindel M, Bulzebruck H et al. Decrease of interleukin-2 secretion is a new independent prognostic factor associated with poor survival in patients with small-cell lung cancer. Ann Oncol 1997; 8: 457-461.
12. Maraveyas A, Baban B, Kennard D et al. Possible improved survival of patients with stage IV AJCC melanoma receiving SRL172 immunotherapy: correlation with induction of increased levels of intracellular interleukin-2 in peripheral blood lymphocytes. Ann Oncol 1999; 10: 817-824.
13. Hrouda D, Baban B, Dunsmuir WD et al. Immunotherapy of advanced prostate cancer: a phase I/II trial using Mycobacterium vaccae (SRL172). Br J Urology 1998; 82: 568-573.
14. O'Brien MER, Saini A, Souberbielle BE et al. A randomised 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.
15. Assersohn L, Souberbielle BE, O'Brien MER et al. A randomised pilot study of SRL172 (Mycobacterium vaccae) in patients with small cell lung cancer (SCLC) treated with chemotherapy. Clin Oncol 2002; 14: 23-27.
16. Fayers P, Aaronson N, Bjordal K et al. on behalf of EORTC Quality of Life Study Group. EORTC QLQ-C30 Scoring Manual.
17. Goodwin PJ, Shepherd FA. Economic issues in lung cancer: a review. J Clin Oncol 1998; 16: 3900-3912.
18. Patel PM, Johnston C, Bank RE et al. SRL172 (a killed Mycobacterium vaccae suspension) vaccination in the treatment of metastatic renal cell carcinoma. Proc Am Soc Clin Oncol 2003; 22: 409 (Abstr).