Guideline for the clinical application, documentation and analysis of clinical studies for regional deep hyperthermia

Bruggmoser, G.; Bauchowitz, S.; Canters, R.; Crezee, J.; Ehmann, Michael; Gellermann, Johanna; Lamprecht, Ulf; Lomax, N.; Messmer, Marc Benjamin; Ott, Oliver J.; Abdel-Rahman, S.; Schmidt, Manfred; Sauer, Rolf; Thomsen, Andreas; Wessalowski, Ruediger; Rhoon, Gerard C. van

doi:10.1007/s00066-012-0176-2

Cited by 99 publications

(102 citation statements)

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“…Especially at the interface of muscle and fat, local hot spots can occur [69]. Thus, heating methods that allow for local adjustment of the temperature distribution are preferred, such as radiative heating using a phased array of multiple antennas [70]. Radiative heating also allows for HT treatment planning [71][72][73][74], which may yield better temperature distributions and the possibility to avoid hot spots.…”

Section: Thermal Dosimetrymentioning

confidence: 99%

The clinical benefit of hyperthermia in pancreatic cancer: a systematic review

Horst

Versteijne

Besselink

et al. 2017

International Journal of Hyperthermia

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Objective: In pancreatic cancer, which is therapy resistant due to its hypoxic microenvironment, hyperthermia may enhance the effect of radio(chemo)therapy. The aim of this systematic review is to investigate the validity of the hypothesis that hyperthermia added to radiotherapy and/or chemotherapy improves treatment outcome for pancreatic cancer patients. Methods and materials: We searched MEDLINE and Embase, supplemented by handsearching, for clinical studies involving hyperthermia in pancreatic cancer patients. The quality of studies was evaluated using the Oxford Centre for Evidence-Based Medicine levels of evidence. Primary outcome was treatment efficacy; we calculated overall response rate and the weighted estimate of the population median overall survival (m p ) and compared these between hyperthermia and control cohorts. Results: Overall, 14 studies were included, with 395 patients with locally advanced and/or metastatic pancreatic cancer of whom 248 received hyperthermia. Patients were treated with regional (n ¼ 189), intraoperative (n ¼ 39) or whole-body hyperthermia (n ¼ 20), combined with chemotherapy, radiotherapy or both. Quality of the studies was low, with level of evidence 3 (five studies) and 4. The six studies including a control group showed a longer m p in the hyperthermia groups than in the control groups (11.7 vs. 5.6 months). Overall response rate, reported in three studies with a control group, was also better for the hyperthermia groups (43.9% vs. 35.3%). Conclusions: Hyperthermia, when added to chemotherapy and/or radiotherapy, may positively affect treatment outcome for patients with pancreatic cancer. However, the quality of the reviewed studies was limited and future randomised controlled trials are needed to establish efficacy. ARTICLE HISTORY

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Section: Thermal Dosimetrymentioning

confidence: 99%

The clinical benefit of hyperthermia in pancreatic cancer: a systematic review

Horst

Versteijne

Besselink

et al. 2017

International Journal of Hyperthermia

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“…DPPG 2 -TSL (2 mg DOX per kg bodyweight) were injected into the tail vein after a minimum target temperature of 40°C was reached in all temperature probes. After injection, the tumor temperature was kept constant for 60 min in accordance with treatment periods used in clinically applied HT [40]. Tumor temperature was maintained manually ≥40°C by regulating laser power, light power or water bath temperature.…”

Section: Hyperthermia Experimentsmentioning

confidence: 99%

Method of hyperthermia and tumor size influence effectiveness of doxorubicin release from thermosensitive liposomes in experimental tumors

Willerding

Limmer

Hossann

et al. 2016

Journal of Controlled Release

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“…After injection, HT was continued for another 60 min (Phase IV in fig. 1) in accordance with clinically applied chemotherapy/HT [15]. After 60 min, heated tumors were allowed to cool down to physiologic temperatures (Phase V in fig.…”

Section: Experimental Setup and Treatment Protocolmentioning

confidence: 99%

“…The time period for AUC calculation of 60 min HT after injection was chosen according to the typical clinically applied time in chemotherapy/HT [15] and is comparable to earlier studies using DPPG 2 -TSL for drug or CA delivery [10][11][12]. The long time period used for acquisitions as compared to DCE-MRI minimizes the effect of injection variance or other short term variations.…”

Section: Area Under the Curve (Auc)mentioning

confidence: 99%

“…An improved TSL-formulation based on the synthetic phosphatidyldiglycerol (DPPG 2 -TSL) has been successfully developed [8,9] and investigated in animal models [8,[10][11][12]. Key features are improved serum stability when compared to LTSL and a comparably fast release rate at a temperature above 40°C [9,13,14] which is in the typical range (40°C-43°C) used in combined chemotherapy/HT tumor treatment concepts [15]. DPPG 2 -TSL are considered a particularly promising TSL formulation that fulfills all necessary criteria for heat-triggered intravascular drug release [1].…”

Section: Introductionmentioning

confidence: 99%

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