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Tschöp-Lechner, K.E.* ; Milani, V.* ; Berger, F.* ; Dieterle, N.* ; Abdel-Rahman, S.* ; Salat, C.* ; Issels, R.D.

Gemcitabine and cisplatin combined with regional hyperthermia as second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer.

Int. J. Hyperthermia 29, 8-16 (2013)
DOI PMC
Open Access Gold möglich sobald Verlagsversion bei der ZB eingereicht worden ist.
Purpose: There is no standard second-line therapy for patients with advanced pancreatic cancer (APC) after gemcitabine (G) failure. Cisplatin (Cis)-based chemotherapy has shown activity in APC. It is proven that cytotoxicity of G and Cis is enhanced by heat exposure at 40 degrees +/- to 42 degrees C. Therefore G plus Cis with regional hyperthermia (RHT) might be beneficial for patients with G-refractory APC. Patients and methods: We retrospectively analysed 23 patients with advanced (n = 2) or metastatic (n = 21) pancreatic cancer with relapse after G mono first-line chemotherapy (n = 23). Patients had received G (day 1, 1000 mg/m(2)) and Cis (day 2 and 4, 25 mg/m(2)) in combination with RHT (day 2 and 4, 1 h) biweekly for 4 months. We analysed feasibility, toxicity, time to second progression (TTP2), overall survival (OS) and clinical response. Results: Between October 1999 and August 2008 23 patients were treated. Haematological toxicity was low with no grade 4 event. Hyperthermia-associated toxicity consisted of discomfort because of bolus pressure (3%), power-related pain (7%) or position-related pain (17%). Median TTP1 was 5.9 months (95% confidence interval (CI): 2.6-9.2), median TTP2 was 4.3 months (95%CI: 1.2-7.4) and OS 12.9 months (95%CI: 9.9-15.9). The disease control rate in 16 patients with available CT scans was 50%. Conclusion: We show first clinical data of G plus Cis with RHT being clinically active in G-pretreated APC with low toxicity. A prospective controlled phase II second-line clinical trial (EudraCT:2005-003855-11) and a randomised phase III adjuvant clinical trial offering this treatment (HEAT; EudraCT: 2008-004802-14) are currently open for recruitment.
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Publikationstyp Artikel: Journalartikel
Dokumenttyp Wissenschaftlicher Artikel
Korrespondenzautor
Schlagwörter Hyperthermia ; Pancreatic Cancer ; Gemcitabine ; Cisplatin; Multicenter Phase-ii ; Neoadjuvant Chemotherapy ; Pretreated Patients ; Quality-assurance ; Tumor-cells ; Adenocarcinoma ; 5-fluorouracil ; Oxaliplatin ; Trial ; Cytotoxicity
ISSN (print) / ISBN 0265-6736
e-ISSN 1464-5157
Quellenangaben Band: 29, Heft: 1, Seiten: 8-16 Artikelnummer: , Supplement: ,
Verlag Informa Healthcare
Nichtpatentliteratur Publikationen
Begutachtungsstatus Peer reviewed