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Phase III Study of Adjuvant Vaccination With Bec2/Bacille Calmette-Guerin in Responding Patients With Limited-Disease Small-Cell Lung Cancer (European Organisation for Research and Treatment of Cancer 08971-08971B; Silva Study)

From the Vrije Universiteit Medical Center, Amsterdam, the Netherlands (on behalf of the EORTC Lung Cancer Group); EORTC Data Center, Brussels, Belgium (C. Coens, on behalf of the EORTC Quality of Life Unit); Vall d'Hebron University Hospital, Barcelona, Spain (on behalf of the Spanish Lung Cancer Group); Memorial Sloan-Kettering Cancer Center, New York, NY; School of Medicine and Pharmacology, Sir Charles Gairdner Hospital, Perth, Australia (on behalf of centers in Australia and New Zealand); Clinique Pneumologique, Rouen University Hospital, France (on behalf of the Groupe Français de Pneumo-Cancérologie); Kantonsspital, St Gallen, Switzerland (on behalf of the Schweizerische Arbeitsgruppe für Klinische Krebsforschung); VA Connecticut Cancer Center, West Haven, CT (on behalf of the Veteran Administration centers in the United States); Charles University, Faculty Hospital Bulovka and Postgraduate Medical School, Prague, Czeck Republic; and Merck Farma y Quimica, S.A., Barcelona

Address reprint requests to Giuseppe Giaccone, MD, PhD, Division of Medical Oncology, Vrije Universiteit Medical Center, 1117 De Boelelaan, Amsterdam, the Netherlands; e-mail: g.giaccone{at}vumc.nl

PURPOSE: Bec2 is an anti-idiotypic antibody that mimics GD3, a ganglioside that is expressed on the surface of tumor cells and is of neuroectodermal origin. We assessed whether Bec2/bacille Calmette-Guerin (BCG) vaccination prolongs survival in patients with limited-disease small-cell lung cancer (SCLC) after a major response to chemotherapy and chest radiation.

PATIENTS AND METHODS: Patients were randomly assigned to receive five vaccinations of Bec2 (2.5 mg)/BCG vaccine or follow-up. Vaccination was given over a 10-week period. The sample size was targeted to detect an increase in median survival of 40% after random assignment, and stratification was by performance status, response, and institution. Quality of life was assessed by using the European Organisation for Research and Treatment of Cancer instrument. Humoral response was assessed in patients who received vaccination.

RESULTS: A total of 515 patients were randomly assigned. The primary toxicities of vaccination were transient skin ulcerations and mild flu-like symptoms. There was no improvement in survival, progression-free survival, or quality of life in the vaccination arm. Median survival from randomization was 16.4 and 14.3 months in the observation and vaccination arms (P = .28), respectively. Among vaccinated patients, a trend toward prolonged survival was observed in those (one third) who developed a humoral response (P = .085). Multivariate analysis showed a positive impact on survival by prior treatment with concomitant chemoradiotherapy, prophylactic cranial irradiation, female sex, low lactate dehydrogenase, and normal platelets.

CONCLUSION: Vaccination with Bec2/BCG has no impact on outcome of patients with limited-disease SCLC responding to combined-modality treatment. Vaccination strategies in SCLC may still be warranted using vaccines that produce a better immunologic response.

The current affiliation for C.D. is European Medicines Agency, London, United Kingdom.

The current affiliation for S.C.G. is Kenyon & Kenyon, New York, NY.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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