1138P - Chemotherpay and dendritic cell vaccine in patient with metastatic melanoma: phase II prospective randomized trial

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Cytotoxic agents
Immunotherapy
Skin cancers
Melanoma
Therapy
Biological therapy
Presenter Igor Samoylenko
Authors I. Samoylenko1, T.N. Zabotina2, I.N. Mikhaylova1, G.Z. Chkadua3, O.V. Korotkova2, K. Baryshnikov4, L.V. Demidov1
  • 1Tumor Biotherapy, NN Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 2Laboratory Of Clinical Immunology, NN Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 3Laboratory Of Experimental Diagnostics And Tumor Biotherapy, NN Blokhin Russian Cancer Research Center, 115478 - Moscow/RU
  • 4Department Of Tumor Bioltherapy, NN Blokhin Russian Cancer Research Center, 115478 - Moscow/RU

Abstract

Introduction

We performed a vaccine trial in metastatic melanoma patients with a stable disease course.

Aim

Primary end point was 6-month progression-free survival; secondary end points included overall survival, progression free survival, immunological parameters.

Patients and methods

Inclusion criteria were morphologically proven metastatic melanoma, ECOG status 0-2, LDH level <= 1,5N, RECIST-evaluable lesions. Any adjuvant treatment and one line of the metastatic melanoma treatment were allowed. Patients with brain metastasis were excluded. All patients scheduled to receive 2 cycles of the polychemotherapy with cisplatin 20 mg/m2 day 1-4; vinblastine 2 mg/m2 day 1-4 and DTIC 800 mg/m2 day 1, cycle 28 days. On day 14 of cycle 2 assessment was predefined. Patients who progressed after two cycles of the chemo were excluded from the study. All other patients were randomized to 3-d cycle of the chemo followed by one vaccination cycle or three cycles of the chemo. Vaccination schedule consisted of 5 subcutaneous injections of DC vaccine (2,000,000 cells) with 14 days intervals. Assessments were performed every 5 vaccine injections (10 wks) in DC-group and every 2 cycles (10 wks) in chemo group.

Results

From March 2010 to April 2012 101 patients were included in the study. After 2 cycles of chemo in 34 patients disease progression was detected. Of the 67 patients effects were not assessed in 3 patients. 31 patients were randomized to the DC-group and 33 to the chemo group. 6 pts were switched to chemo immediately after randomization and did not receive the vaccine. The 6-month PFS in per protocol population was 52.6% in the DC group and 15% in the chemo (RR = 0.56; 95% CI 0.34 to 0.97, p = 0.03). Median PFS was 7.38 mo in the DC group and 4.9 mo in the chemo group (95% CI 6.3 to 8.5 and 3.3 to 6.4, respectively, not significant). Median OS was 13.4 mo in the chemo group and was not reached in the DC group. Immunological testing suggested that population CD4 + CD25hiCD127+ (Tregs) did not predict therapy success and did not significantly change during the treatment.

Conclusion

Dendritic cell vaccine immunotherapy may be a less toxic option for maintenance therapy in patients with metastatic melanoma with stable disease course. Additional trials are needed to compare such a vaccine with best supportive care or placebo.

Disclosure

All authors have declared no conflicts of interest.