Two or six hyperthermia treatments as an adjunct to radiation therapy yield similar tumor responses: results of a randomized trial

Kapp, Daniel S.; Petersen, Ivy A.; Cox, Richard S.; Hahn, George M.; Fessenden, Peter; Prionas, Stavros D.; Lee, Eric R.; Meyer, John P.; Samulski, Thaddeus V.; Bagshaw, Malcolm A.

doi:10.1016/0360-3016(90)90361-m

Cited by 87 publications

(37 citation statements)

References 26 publications

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“…Randomized studies have failed to prove that more sessions are better than fewer sessions (26,27), or that a twice weekly schedule is inferior because of possible development of thermal tolerance (9,(28)(29)(30). At present there is no documented schedule of hyperthermia that is clearly superior.…”

Section: Experimental Backgroundmentioning

confidence: 99%

Status of Clinical Hyperthermia

Dahl

Dalene²,

Bc³

et al. 1999

Acta Oncologica

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Section: Experimental Backgroundmentioning

confidence: 99%

Status of Clinical Hyperthermia

Dahl

Dalene²,

Bc³

et al. 1999

Acta Oncologica

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“…This is absolutely incorrect approach. The results of other trials show that with normal/high TD, the effect of thermal modification becomes insignificant or disappears [5,[7][8][9] or even reverses [15]; therefore the extrapolation is incorrect. The strength of RT impact in this trial was much stronger than HT strength: CLR rate was 56% for 27 Gy versus 25% for 24 Gy (Gain 124%, = 0.05), that is, twice stronger than HT effect (Gain 64%).…”

Section: Trialmentioning

confidence: 99%

“…Three clinical trials with similar design were published nearly simultaneously in 1990-1993, comparing efficacy of different TRT protocols: Kapp et al [7] compared effect of 2 and 6 hyperthermia sessions; Emami et al [8] and Engin et al [9] compared effect of 4 and 8 sessions (see Table 1). The difference between "short" and "long" protocols was negligible, and Engin et al even showed lower efficacy of "long" protocol: CLR was 55% in 8 sessions arm and 59% in 4 sessions arm (not significant difference).…”

Section: Superficial Hyperthermia Clinical Trialsmentioning

confidence: 99%

“…Kapp et al [7] Perez et al [5] Emami et al [8] Engin et al [9] Vernon et al [10] Chest the trial were negative for HT, giving only general statistics of the trial. In fact, ICHG had just dissolved the results of 3 "negative" arms in dubious results of another 2 "positive" arms.…”

Section: Trialmentioning

confidence: 99%

“…The counterpoint was sound by McCormick [17] scenario, more research on HT and radiation is needed before this treatment combination can be considered standard care. " Thus, of 7 reviewed randomized clinical trials on superficial hyperthermia, 4 were considered negative by the authors themselves (Perez et al [5], Emami et al [8], Kapp et al [7], and Engin et al [9]). Of the 3 remaining trials which were considered positive by their authors, Jones et al trial was biased and dubious, Vernon et al trial had incorrect design and controversial data, and Overgaard et al trial was not representative, biased and clinically insignificant.…”

Section: Trialmentioning

confidence: 99%

See 2 more Smart Citations

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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Adenoid cystic carcinoma of the salivary glands. Management of recurrent, advanced, or persistent disease with hyperthermia and radiation therapy

Barnett

Kapp

Goffinet

1990

Cancer

Self Cite

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Adenoid cystic carcinomas (ACC) of the salivary glands are aggressive tumors characterized by multiple late local recurrences and distant metastases. Current therapy includes wide local excision and high-dose postoperative radiation therapy (XRT) (5400 to 7000 cGy). Despite early aggressive treatment, local recurrence remains a major problem with limited safe and effective therapeutic options available. The excellent local responses obtained in four patients (six sites) with ACC of the head and neck treated either with additional low-dose irradiation (2160 to 3420 cGy) in conjunction with two to five hyperthermia (HT) treatments or with full dose XRT and HT as part of the overall treatment plan are reported. All HT treatments were for 45 minutes once steady state conditions were obtained. Monitored intratumoral temperatures for all treatments achieved average maximum (Tmax), average mean (Tave), and average minimum (Tmin) temperatures of 44.2"C, 41.2"C, and 38.9"c, respectively. A complete response was obtained for all six fields with no significant long-term complications. Two patients remain alive and free of local disease at 42 and 63 months of follow-up. Two patients died-one with metastases (with persistent local control) and one with a local recurrence at 9 and 30 months, respectively, after XRT and HT. This is the first report of HT and low-dose XRT in the management of previously irradiated ACC and suggests a potential role for the use of this modality in the treatment of ACC. Cancer 65:2648-2656,1990. __ ~ DENOID CYSTIC CARCINOMAS (ACC) of the salivary A glands are aggressive salivary gland cancers. ACC represent 7% to 18% of parotid malignan~ies,'-~ and 33% to 58% of minor salivary gland malignancies.'~~-~ Treatment has included surgery, radiation therapy (XRT), or a combination of the two. Despite aggressive local treatment , the disease is characterized by multiple, often late, local recurrences and distant metastases. Failure may

show abstract

Two or six hyperthermia treatments as an adjunct to radiation therapy yield similar tumor responses: results of a randomized trial

Cited by 87 publications

References 26 publications

Status of Clinical Hyperthermia

Status of Clinical Hyperthermia

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

Adenoid cystic carcinoma of the salivary glands. Management of recurrent, advanced, or persistent disease with hyperthermia and radiation therapy

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