Feasibility, safety, and efficacy of stereotactic body radiotherapy combined with intradermal heat-killed mycobacterium obuense (IMM-101) vaccination for non-progressive locally advanced pancreatic cancer, after induction chemotherapy with (modified)FOLFIRINOX - The LAPC-2 trial.

Abstract

BACKGROUND AND PURPOSE:

In this phase I/II trial, non-progressive locally advanced pancreatic cancer (LAPC) patients after (modified)FOLFIRINOX therapy were treated with stereotactic body radiotherapy (SBRT) combined with heat-killed mycobacterium (IMM-101) vaccinations. We aimed to assess safety, feasibility, and efficacy of this treatment approach.

MATERIALS AND METHODS:

On five consecutive days, patients received a total of 40 Gray (Gy) of SBRT with a dose of 8 Gy per fraction. Starting two weeks prior to SBRT, they in addition received six bi-weekly intradermal vaccinations with one milligram of IMM-101. The primary outcomes were the number of grade 4 or higher adverse events and the one-year progression free-survival (PFS) rate.

RESULTS:

Thirty-eight patients were included and started study treatment. Median follow-up was 28.4 months (95 %CI 24.3 - 32.6). We observed one grade 5, no grade 4 and thirteen grade 3 adverse events, none related to IMM-101. The one-year PFS rate was 47 %, the median PFS was 11.7 months (95 %CI 11.0 - 12.5) and the median overall survival was 19.0 months (95 %CI 16.2 - 21.9). Eight (21 %) tumors were resected, of which 6 (75 %) were R0 resections. Outcomes were comparable with the outcomes of the patients from the previous LAPC-1 trial, in which LAPC patients were treated with SBRT, without IMM-101.

CONCLUSION:

Combination treatment with IMM-101 and SBRT was safe and feasible for non-progressive locally advanced pancreatic cancer patients after (modified)FOLFIRINOX. No improvement in the progression-free survival could be demonstrated by adding IMM-101 to SBRT.

• Authors: Freek R van 't Land, Diba Latifi, Miranda Moskie, Marjolein Y V Homs, Koop Bosscha, Bert A Bonsing, Sven D Mieog, Erwin van der Harst, Peter-Paul L O Coene, Jan H Wijsman, George P van der Schelling, Bas Groot Koerkamp, Joost J Nuyttens, Casper H J van Eijck, South West Pancreatic Cancer Care SWPCC consortium
• Journal: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology (Radiother Oncol) Vol. 183 Pg. 109541 (06 2023) ISSN: 1879-0887 [Electronic] Ireland
• PMID: 36813171 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2023. Published by Elsevier B.V.

Chemical References

• folfirinox
• IMM-101

Topics

• Humans
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Feasibility Studies
• Hot Temperature
• Induction Chemotherapy
• Nontuberculous Mycobacteria
• Pancreatic Neoplasms
• Radiosurgery (adverse effects)