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

被引：5

作者：

Issels, Rolf D. ^{[1
,19
]}

Boeck, Stefan ^{[1
]}

Pelzer, Uwe ^{[2
]}

Mansmann, Ulrich ^{[3
]}

Ghadjar, Pirus ^{[2
]}

Lindner, Lars H. ^{[1
]}

Albertsmeier, Markus ^{[1
]}

Angele, Martin K. ^{[1
]}

Schmidt, Michael ^{[3
]}

Xu, Yujun ^{[3
]}

Bahra, Marcus ^{[4
]}

Pratschke, Johann ^{[2
]}

Schoenberg, Michael ^{[5
]}

Thasler, Wolfgang E. ^{[5
]}

Salat, Christoph ^{[6
]}

Stoetzer, Oliver J. ^{[6
]}

Knoefel, Wolfram T. ^{[7
]}

Graf, Dirk ^{[8
]}

Wessalowski, Rudiger ^{[7
]}

Keitel-Anselmino, Verena ^{[9
]}

Koenigsrainer, Alfred ^{[10
]}

Bitzer, Michael ^{[10
]}

Zips, Daniel ^{[10
]}

Bamberg, Michael ^{[10
]}

Fietkau, Rainer ^{[11
]}

Ott, Oliver ^{[11
]}

Kawecki, Maciej ^{[12
]}

Wyrwicz, Lucian ^{[12
]}

Rutkowski, Piotr ^{[12
]}

Rentsch, Markus ^{[13
]}

Ababei, Juliana ^{[14
]}

Reichardt, Peter ^{[15
]}

Rigamonti, Marco ^{[16
]}

Weber, Bernhard ^{[17
]}

Abdel-Rahman, Sultan ^{[1
]}

Tschoep-Lechner, Katharina ^{[1
]}

Jauch, Karl-Walter ^{[1
]}

Bruns, Christiane J. ^{[18
]}

Oettle, Helmut ^{[2
]}

von Bergwelt-Baildon, Michael ^{[1
]}

Heinemann, Volker ^{[1
]}

Werner, Jens ^{[1
]}

机构：

[1] Ludwig Maximilians Univ Munchen, LMU Univ Hosp Munich, Munich, Germany

[2] Charite, Berlin, Germany

[3] Ludwig Maximilians Univ Munchen, Munich Inst Med Data Proc Biometr & Epidemiol, Munich, Germany

[4] Acad Hosp Waldfriede Charite, Berlin, Germany

[5] Red Cross Hosp Munich, Munich, Germany

[6] Munchen GmbH, Med Ctr Hematol Oncol, Munich, Germany

[7] Univ Hosp Dusseldorf, Dusseldorf, Germany

[8] Grevenbroich St Elizabeth Hosp, Rheinland Hosp Grp, Grevenbroich, Germany

[9] Univ Hosp Magdeburg, Otto Guericke Univ, Magdeburg, Germany

[10] Univ Hosp Tubingen, Tubingen, Germany

[11] Erlangen Univ Hosp, Erlangen, Germany

[12] Maria Sklodowska Curie Mem Canc Ctr, Warsaw, Poland

[13] Hosp Ingolstadt, Ingolstadt, Germany

[14] Hosp Landshut, Landshut, Germany

[15] HELIOS Hosp Berlin Buch, Berlin, Germany

[16] Red Cross Hosp Lindenberg, Lindenberg, Germany

[17] Hosp Bad Trissl, Oberaudorf, Germany

[18] Univ Hosp Cologne, Cologne, Germany

[19] Ludwig Maximilians Univ Munchen, Marchioninistr15, D-81377 Munich, Germany

来源：

EUROPEAN JOURNAL OF CANCER | 2023年 / 181卷

关键词：

Pancreatic cancer; Adjuvant chemotherapy; Randomised clinical trial; Regional hyperthermia; Cisplatin; Gemcitabine; HEAT study; SOFT-TISSUE SARCOMA; PHASE-III TRIAL; NEOADJUVANT CHEMOTHERAPY; ADJUVANT CHEMOTHERAPY; CANCER; MULTICENTER; THERAPY; FUTURE;

D O I：

10.1016/j.ejca.2022.12.009

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: Regional hyperthermia (RHT) with cisplatin added to gemcitabine showed efficacy in gemcitabine-pre-treated patients with advanced pancreatic ductal adeno-carcinoma. 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.(c) 2022 Elsevier Ltd. All rights reserved.

引用

页码：155 / 165

页数：11

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