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Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial

Issels RD, Boeck S, Pelzer U, Mansmann U, Ghadjar P, Lindner LH, Albertsmeier M, Angele MK, Schmidt M, Xu Y, Bahra M, Pratschke J, Schoenberg M, Thasler WE, Salat C, Stoetzer OJ, Knoefel WT, Graf D, Wessalowski R, Keitel-Anselmino V, Koenigsrainer A, Bitzer M, Zips D, Bamberg M, Fietkau R, Ott O, Kawecki M, Wyrwicz L, Rutkowski P, Rentsch M, Ababei J, Reichardt P, Rigamonti M, Weber B, Abdel-Rahman S, Tschoep–Lechner K, Jauch KW, Bruns CJ, Oettle H, von Bergwelt-Baildon M, Heinemann V, Werner J (2023)

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Publication Type: Journal article

Publication year: 2023

Journal

Book Volume: 181

Pages Range: 155-165

DOI: 10.1016/j.ejca.2022.12.009

Abstract

Background: Regional hyperthermia (RHT) with cisplatin added to gemcitabine showed efficacy in gemcitabine-pre-treated patients with advanced pancreatic ductal adenocarcinoma. We conducted a randomised clinical trial to investigate RHT with cisplatin added to gemcitabine (GPH) compared with gemcitabine (G) in the adjuvant setting of resected pancreatic ductal adenocarcinoma. Methods: This randomised, multicentre, open-label trial randomly assigned patients to either GPH (gemcitabine 1000 mg/m² on day 1, 15 and cisplatin 25 mg/m² with RHT on day 2, 3 and 15,16) or to G (gemcitabine 1000 mg/m² on day 1,8,15), four-weekly over six cycles. Disease-free survival (DFS) was the primary end-point. Secondary end-points included overall survival (OS) and safety. Results: A total of 117 eligible patients (median age, 63 years) were randomly allocated to treatment (57 GPH; 60 G). With a follow-up time of 56.6 months, the median DFS was 12.7 compared to 11.2 months for GPH and G, respectively (p = 0.394). Median post-recurrence survival was significantly prolonged in the GPH-group (15.3 versus 9.8 months; p = 0.031). Median OS reached 33.2 versus 25.2 months (p = 0.099) with 5-year survival rates of 28.4% versus 18.7%. Excluding eight patients who received additional capecitabine in the G-arm (investigators choice), median OS favoured GPH (p = 0.052). Adverse events CTCAE (Common Terminology Criteria for Adverse Events) grade ≥3 occurred in 61.5% (GPH) versus 63.6% (G) of patients. Two patients in the G-group died because of treatment-related toxic effects. Conclusions: The randomised controlled Hyperthermia European Adjuvant Trial study failed to demonstrate a significant difference in DFS. However, it suggests a difference in post-recurrence survival and a trend for improved OS. ClinicalTrials: gov, number NCT01077427.

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APA:

Issels, R.D., Boeck, S., Pelzer, U., Mansmann, U., Ghadjar, P., Lindner, L.H.,... Werner, J. (2023). Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial. European Journal of Cancer, 181, 155-165. https://doi.org/10.1016/j.ejca.2022.12.009

MLA:

Issels, Rolf D., et al. "Regional hyperthermia with cisplatin added to gemcitabine versus gemcitabine in patients with resected pancreatic ductal adenocarcinoma: The HEAT randomised clinical trial." European Journal of Cancer 181 (2023): 155-165.

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