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Publikacje naukowe

Hipertermia regionalna głęboka przy zachowawczym leczeniu dzieci i młodzieży z odpornym na leczenie lub nawrotowym złośliwym nowotworem zarodkowym poza-gonadowym: otwarte, nierandomizowane jednoośrodkowe badanie kliniczne 2 fazy

tytuł oryg.: Regional deep hyperthermia for salvage treatment of children and adolescent with refractory or recurrent non-testicular malignant germ-cell tumours: an open-label, non randomised, single-institution, phase 2 study
Wydawnictwo:The Lancet
Autor główny: Rüdiger Wessalowski
Pozostali autorzy: Dominik T Schneider, Oliver Mils, Verena Friemann, Olga Kyrillopoulou, Jörg Schaper, Christiane Matuschek, Karin Rothe, Ivo Leuschner, Reinhart Willers, Stefan Schönberger, Ulrich Göbel, Gabiele Calaminus for MAKEI study Group
Data: 2013-07-01

DOI: 10.1080/02656736.2016.1213430

Język publikacji: angielski

Klasa publikacji: Badanie kliniczne

Rodzaj badania: Nierandomizowane, jednoośrodkowe

Liczba pacjentów: 44

Rodzaj HT: LRHT RF

Rodzaj HT opis: HT miejscowa, głęboka, fale radiowe

Aparatura: BSD-2000

Jednostka chorobowa: Nowotwór zarodkowy poza-gonadowy złośliwy

Symbol Jednostki chorobowej: -

Stage: -

Typ skojarzenia HT stosowany w badaniu: HT+CT

Rodzaj CT: PEI (cisplatin, etoposide, ifosfamide)

Abstract. Background: Although the survival of children and adolescents with malignant germ-cell tumours has improved greatly in recent years, the outcome remains poor for those with refractory or recurrent malignant germ-cell tumours. We aimed to determine whether objective tumour response could be achieved in patients with refractory  or recurrent malignant germ-cell tumours with PEI-regional deep hyperthermia as salvage treatment.
Methods: Patients with refractory or recurrent non-testicular malignant germ-cell tumours after standard cisplatin-based chemotherapy were treated prospectively with PEI chemotherapy (cisplatin 40 mg/m2, delivered intravenously on days 1 and 4; etoposide 100 mg/m2, intravenously on days 1-4; and ifosfamide 1800 mg/m2, intravenously on days 1-4) plus simultaneous 1-h regional deep hyperthermia (41-43C) on days 1 and 4. Patients received three to four treatment courses at 21-day intervals until residual tumour resection was possible; they subsequently received one or two additional courses of PEI-regional deep hyperthermia. Local radiotherapy was given for incompletely resected tumours. Chemotherapy and hyperthermia toxic effects were assessed using WHO grading. The primary endpoint was the proportion of patients who had an objective response as assessed with Response Evaluation Criteria in Solid Tumours version 1.0 guidelines. Secondary endpoints were the event-free survival and overall survival after 5 years. This ongoing PEI-regional deep hyperthermia study (Hyper-PEI protocol) is registered at the German Cancer Society, number 50-2732.
Findings: 44 patients aged 7 months to 21 years (median 2 years 7 months) with refractory or recurrent malignant germ-cell tumours (nine patients with poor response, 23 patients with first relapse, 12 patients with multiple relapses) were included in this study. We identified 34 yolk sac tumours, eight embryonal carcinomas, one choriocarcinoma, and one dysgerminoma by histology analysis. Of the 35 patients who had sufficient clinical and radiographical data available for response assessment, 30 (86%) had an objective response to treatment (16 patients had complete remission and 14 had partial remission). 5-year event-free survival was 62% (95% CI 45-75), and 5-year overall survival was 72% (95% CI 55-83). The median follow-up of surviving patients was 82 months (range 9-195). WHO grade 3-4 neutropenia and thrombocytopenia occurred in all 181 chemotherapy cycles. Granulocytopenic fever, which required intercurrent hospital admission, was noted in 29 (66%) of 44 patients after 53 (29%) of 181 courses. Five patients experienced treatment-related grade-3 acute renal toxic effects.
Interpretation: A multimodal strategy integrating PEI-regional deep hyperthermia and tumour resection with or without radiation can successfully treat children and  adolescents with refractory or recurrent malignant non-testicular germ-cell tumours. The long-term prognosis of patients with poor response or after first relapse was similar to those receiving first-line treatment. This strategy merits further investigation.
Funding: Deutsche Krebshilfe eV, Bonn, Elterninitiative Kinderkrebsklinik Düsseldorf eV, the Barbara and Hubertus-Trettnerstiftung, and Marie Quendt Fund.

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