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 Anti-Cancer Agents & Biologic Therapy
Cancer Immunology and Immunotherapy
Melanoma and other Skin Tumours
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.