Ifosfamide, carboplatin and etoposide combined with 41.8°C whole body hyperthermia for malignant pleural mesothelioma

Bakhshandeh, A.; Bruns, Ingmar; Traynor, Anne M.; Robins, H. Ian; Eberhardt, K.; Demedts, A; Kaukel, E.; Koschel, G.; Gatzemeier, U.; Kohlmann, T; Dalhoff, K; Ehlers, Eva-Maria; Gruber, Y; Zumschlinge, R.; Hegewisch-Becker, S.; Peters, Stefan O.; Wiedemann, G. J.

doi:10.1016/s0169-5002(02)00536-6

Cited by 23 publications

(28 citation statements)

References 25 publications

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“…Results of multiple phase II WBH trials usually do not justify initiation of III phase trial. Bakhshandeh et al [39] trial is demonstrative in this respect (see Table 14). In this II phase trial, 20% partial remission and 20% 2-year survival in 27 patients with I-II stage malignant pleural mesothelioma was shown after TChT (ICE + WBH); extensive myelosuppression (75% of 3-4 grade) with 3.7% mortality was reported.…”

Section: Whole-body Hyperthermiamentioning

confidence: 80%

“…Meanwhile, it's known that efficacy of majority of chemotherapies is also 15%-20% but on heavier samples, and efficacy of gemcitabine+cisplatin combination had demonstrated 48% partial remission with less toxicity (not more than 30%-40% of 3-4 grade toxicity) [45]. Thus, Bakhshandeh et al [39] phase II study had showed more than dubious clinical efficacy with undisputedly higher toxicity, that is could hardly be considered a basis for further studies. Anyway, authors had considered these results "promising" and initiated III phase trial.…”

Section: Whole-body Hyperthermiamentioning

confidence: 99%

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Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases

Roussakow¹

2013

Conference Papers in Medicine

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Hyperthermia in oncology still remains an experimental treatment with no realistic future in clinical cancer therapy, though declaration of the undisputed efficacy of hyperthermia is a common place in every hyperthermia paper. We have studied the available randomized trials on hyperthermia from the position of "null hypothesis" to confirm or refuse the efficacy and safety of clinical hyperthermia, taking into account also the possible biases. Unfortunately, careful analysis of 14 randomized clinical trials has not confirmed a clinical benefit of hyperthermia independently of its type: superficial, deep or whole-body. We have not found any positive trial not affected with biases. With correction to the distortions, there is no trial with obvious long-term positive effect of hyperthermia. Effect of hyperthermia could be shown in experimentally designed clinical trial or versus inadequate comparator. In clinical setting and provided that study design is correct, hyperthermia is not effective at all or not effective enough to justify its obvious disadvantages: toxicity and labor intensity. Thermal concept of hyperthermia seems to be irrelevant. Nevertheless, multiple publications of positive trials, reviews, and meta-analyses create an impression of hyperthermia renaissance.

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Section: Whole-body Hyperthermiamentioning

confidence: 80%

Section: Whole-body Hyperthermiamentioning

confidence: 99%

Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases

Roussakow¹

2013

Conference Papers in Medicine

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“…In Germany, the WBH 2000 unit and the Heckel HT 3000 with chambers that enclose all but the patient's head are intensively used. As the first Phase III trials [18,23,138,139] in Germany have been published, WBH with adjunctive chemotherapy in patients with metastatic cancer is developing steadily. In the USA, MW radiation units are used instead.…”

Section: Expert Commentarymentioning

confidence: 99%

Current devices for high-performance whole-body hyperthermia therapy

Jia

Liu

2010

Expert Review of Medical Devices

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For late-stage cancer, whole-body hyperthermia (WBH) is highly regarded by physicians as a promising alternative to conventional therapies. Although WBH is still under scrutiny due to potential toxicity, its benefits are incomparable, as diversified devices and very promising treatment protocols in this area are advanced into Phase II and III clinical trials. Following the introduction of the WBH principle, this paper comprehensively reviews the state-of-art high-performance WBH devices based on the heat induction mechanisms - radiation, convection and conduction. Through analyzing each category's physical principle and heat-induction property, the advantages and disadvantages of the devices are evaluated. Technical strategies and critical scientific issues are summarized. For future developments, research directions worth pursuing are presented in this article.

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“…These studies, in which four different WBH-devices have been evaluated, have been published between 2000-2004, five of them already available as full papers at the time of submission of this manuscript [12,[18][19][20][21][22][23][24][25] (Table II).…”

Section: Clinical Trialsmentioning

confidence: 99%

“…continous infusion of up to 0.5 mg kg À1 min À1 noradrenaline). Some investigators also recommend continuous infusions of lignocaine (1-2 mg kg À1 h À1 ), dopamine (2-3 mg kg À1 min À1 ) and 20% sodium chloride (3 g h À1 ) [2,7,18,21,23,24].…”

Section: Induction Of Wbhmentioning

confidence: 99%

Current status of radiant whole-body hyperthermia at temperatures >41.5°C and practical guidelines for the treatment of adults. The German ‘Interdisciplinary Working Group on Hyperthermia’

Hildebrandt

Hegewisch-Becker

Kerner

et al. 2005

International Journal of Hyperthermia

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The term 'extreme' whole-body hyperthermia (WBH) describes the procedure of raising a patients' body-core temperature to 41.5-42.0 degrees C for 60 min. WBH represents the only hyperthermia technique that enables systemic heat treatment in patients with disseminated malignancies and is, therefore, usually combined with systemic chemotherapy. Up to now, several WBH-approaches have proved to be safe and associated with acceptable toxicity rates when radiant heat devices are employed. Until the late 1990s, the use of radiant WBH was restricted to a few specialized treatment centres worldwide. During the last 5 years, a larger number of WBH-devices were put into operation particularly in Germany. As a result, a novel generation on phase II trials on chemotherapy and adjunctive WBH in patients with various malignancies has been completed. Based on the promising results observed herein, first multi-centric phase III-trials on chemotherapy +/- WBH have been initiated, with a considerable number of patients treated at German institutions. The authors are members of the 'Interdisciplinary Working Group for Hyperthermia' ('Interdisziplinäre Arbeitsgruppe Hyperthermie'), a sub-group of the German Cancer Society. They formulated these guidelines in order to standardize the WBH treatment procedure and supportive measures, to provide some uniformity in the selection of patients to be treated and to define criteria of a successful WBH-treatment. These recommendations may be helpful to ensure the quality of WBH performed at different institutions.

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Ifosfamide, carboplatin and etoposide combined with 41.8°C whole body hyperthermia for malignant pleural mesothelioma

Cited by 23 publications

References 25 publications

Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases

Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases

Current devices for high-performance whole-body hyperthermia therapy

Current status of radiant whole-body hyperthermia at temperatures >41.5°C and practical guidelines for the treatment of adults. The German ‘Interdisciplinary Working Group on Hyperthermia’

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