Quality assurance for clinical studies in 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.; Sauer, Rolf; Schmidt, Manfred; Thomsen, Andreas; Wessalowski, Rüdiger; Rhoon, Gerard C. van

doi:10.1007/s00066-011-1145-x

Cited by 92 publications

(81 citation statements)

References 32 publications

(31 reference statements)

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“…Knowing the actual temperature in the tumour during treatment is critical in HT, to verify that the therapeutically required temperature is obtained [69]. However, in only three studies, temperature was measured intratumorally and in six studies temperature was not measured at all.…”

Section: Thermal Dosimetrymentioning

confidence: 99%

“…bring the temperature below the required temperature, as reported by Yamada et al [54]; although their target temperature was 42.5 C, only in five of the 17 patients the tumour was heated to more than the required 42 C. In this review, only one subcutaneous fatty burn was reported in one patient. 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].…”

Section: Thermal Dosimetrymentioning

confidence: 99%

“…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. With temperature being heterogeneous and not constant in time, reporting is preferably done using a set of thermal dose parameters [69]. Such reporting allows for proper thermal dosimetry and enables (future) linking of thermal dose with outcome.…”

Section: Thermal Dosimetrymentioning

confidence: 99%

“…Reporting should be performed by intention to treat and should include overall survival, response, QoL, and tumour stage and toxicity reporting according to well-established criteria, to enable comparison between studies. Also proper thermometry [69], with accurate registration of the temperature throughout the HT treatment, is essential both for quality assurance of the delivered treatment as well as for linking treatment to clinical outcome.…”

Section: Future Workmentioning

confidence: 99%

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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%

Section: Thermal Dosimetrymentioning

confidence: 99%

Section: Thermal Dosimetrymentioning

confidence: 99%

Section: Future Workmentioning

confidence: 99%

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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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“…Recommendations for hyperthermia treatments, including indication, preparation, treatment, and standardized analysis were presented. (120) The technological challenge of delivery of effective hyperthermia was a primary concern early on. Over the past 35 years, several hundred devices and techniques have been developed for heating tissue.…”

Section: Challenges To Clinical Implementationmentioning

confidence: 99%

Hyperthermia, Radiation and Chemotherapy: The Role of Heat in Multidisciplinary Cancer Care

Hurwitz

Stauffer

2014

Seminars in Oncology

114

104

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Technological Advances, Biologic Rationales, and the Associated Success of Chemotherapy With Hyperthermia in Improved Outcomes in Patients With Sarcoma

Dewhirst

Kirsch

2018

JAMA Oncol

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Soft tissue sarcomas are a heterogeneous group of mesenchymal tumors that account for approximately 12 000 new cancer cases and almost 5000 deaths each year in the United States.For large (>5 cm), high-grade sarcomas of the extremity, surgical resection and radiation therapy can achieve local control in approximately 90% of patients. 1,2 However, these patients are at risk for developing metastases to the lung. Therefore, in some sarcoma centers, patients with high-risk, localized sarcoma also receive chemotherapy. Even with systemic therapy, many patients die. Therefore, the European Organization for Research and Treatment of Cancer (EORTC) initiated a multinational, multi-institutional phase 3 randomized clinical trial (EORTC 62961-ESHO 95) to evaluate whether adding regional hyperthermia to chemotherapy improves outcomes for patients with localized high-risk soft tissue sarcoma.In this issue of JAMA Oncology, Issels et al 3 report the longterm outcomes for patients enrolled on EORTC 62961-ESHO 95, which compared neoadjuvant doxorubicin, ifosfamide, and etoposide chemotherapy alone to neoadjuvant chemotherapy with regional hyperthermia. Just over half of the patients had nonextremity sarcomas, which have a higher risk for local recurrence and death as a consequence of local recurrence. In addition to hyperthermia improving local progression-free survival (hazard ratio, 0.65; 95% CI, 0.49-0.86; P = .002), with a median follow-up of 11.3 years, compared with chemotherapy alone, hyperthermia improved survival from disease or its treatment by 11.4% and 9.9% at 5 and 10 years. This trial 3 demonstrates that regional hyperthermia increases the effectiveness of neoadjuvant chemotherapy in this extremely recalcitrant tumor type.Modern interest in the use of hyperthermia as a cancer treatment emerged from a number of laboratories in the 1970s, although references to its use trace back to Hippocrates. 4 Hyperthermia interacts synergistically with radiotherapy, as well as a number of chemotherapeutic agents. Pleiotropic effects contribute to synergism, as hyperthermia enhances drug uptake by cells, inhibits the ability of cells to repair damage incurred by chemotherapy, and increases intracellular oxidative stress. Anthracyclines, ifosfamide, and etoposide were used in this trial. 3 The first 2 drugs interact synergistically with hyperthermia. 4 A further benefit of hyperthermia is that it reverses anthracycline drug resistance. At the tissue level, hyperthermia increases tumor perfusion and reduces hypoxia. The choice of using hyperthermia in a neoadjuvant setting in soft tissue sarcoma, which is hypoxic, underperfused, and relatively drug resistant, was based on this extensive biologic rationale.

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Quality assurance for clinical studies in regional deep hyperthermia

Abstract: The guideline contains recommendations for hyperthermia treatments, including indication, preparation, treatment, and standardized analysis.

Cited by 92 publications

References 32 publications

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

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

Hyperthermia, Radiation and Chemotherapy: The Role of Heat in Multidisciplinary Cancer Care

Technological Advances, Biologic Rationales, and the Associated Success of Chemotherapy With Hyperthermia in Improved Outcomes in Patients With Sarcoma

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