Table of Contents
Conference Papers in Medicine
Volume 2013 (2013), Article ID 412186, 31 pages
http://dx.doi.org/10.1155/2013/412186
Conference Paper

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

Galenic Research Institute, Moscow, Russia

Received 20 January 2013; Accepted 18 April 2013

Academic Editors: G. F. Baronzio, M. Jackson, and A. Szasz

This Conference Paper is based on a presentation given by Sergey Roussakow at “Conference of the International Clinical Hyperthermia Society 2012” held from 12 October 2012 to 14 October 2012 in Budapest, Hungary.

Copyright © 2013 Sergey Roussakow. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. F. Westermark, “Uber die behandlung des ulcerierenden Cervixcarcimons mittels konstanter Warme,” Zentralblatt für Gynäkologie, vol. 22, pp. 1335–1337, 1898. View at Google Scholar
  2. M. R. Horsman and J. Overgaard, “Hyperthermia: a potent enhancer of radiotherapy,” Clinical Oncology, vol. 19, no. 6, pp. 418–426, 2007. View at Publisher · View at Google Scholar · View at Scopus
  3. N. B. Hornback, “Is the community radiation oncologist ready for clinical hyperthermia?” Radiographics, vol. 7, no. 1, pp. 139–149, 1987. View at Google Scholar · View at Scopus
  4. R. Scott, B. Gillespie, C. A. Perez et al., “Hyperthermia in combination with definitive radiation therapy: results of a Phase I/II RTOG study,” International Journal of Radiation Oncology Biology Physics, vol. 15, no. 3, pp. 711–716, 1988. View at Google Scholar · View at Scopus
  5. C. A. Perez, T. Pajak, B. Emami, N. B. Hornback, L. Tupchong, and P. Rubin, “Randomized phase III study comparing irradiation and hyperthermia with irradiation alone in superficial measurable tumors: final report by the Radiation Therapy Oncology Group,” American Journal of Clinical Oncology, vol. 14, no. 2, pp. 133–141, 1991. View at Google Scholar · View at Scopus
  6. D. M. Brizel, “Where there's smoke, is there fire?” International Journal of Hyperthermia, vol. 14, no. 6, pp. 593–594, 1998. View at Google Scholar · View at Scopus
  7. D. S. Kapp, I. A. Petersen, R. S. Cox et al., “Two or six hyperthermia treatments as an adjunct to radiation therapy yield similar tumor responses: results of a randomized trial,” International Journal of Radiation Oncology Biology Physics, vol. 19, no. 6, pp. 1481–1495, 1990. View at Google Scholar · View at Scopus
  8. B. Emami, R. J. Myerson, H. Cardenes et al., “Combined hyperthermia and irradiation in the treatment of superficial tumors: results of a prospective randomized trial of hyperthermia fractionation (1/wk vs. 2/wk),” International Journal of Radiation Oncology Biology Physics, vol. 24, no. 1, pp. 145–152, 1992. View at Google Scholar · View at Scopus
  9. K. Engin, L. Tupchong, D. J. Moylan et al., “Randomized trial of one versus two adjuvant hyperthermia treatments per week in patients with superficial tumours,” International Journal of Hyperthermia, vol. 9, no. 3, pp. 327–340, 1993. View at Google Scholar · View at Scopus
  10. C. C. Vernon, J. W. Hand, S. B. Field et al., “Radiotherapy with or without hyperthermia in the treatment of superficial localized breast cancer: results from five randomized controlled trials,” International Journal of Radiation Oncology Biology Physics, vol. 35, no. 4, pp. 731–744, 1996. View at Publisher · View at Google Scholar · View at Scopus
  11. J. Overgaard, D. Gonzalez Gonzalez, M. C. C. H. Hulshof et al., “Hyperthermia as an adjuvant to radiation therapy of recurrent or metastatic malignant melanoma. A multicentre randomized trial by the European Society for Hyperthermic Oncology,” International Journal of Hyperthermia, vol. 12, no. 1, pp. 3–20, 1996. View at Google Scholar · View at Scopus
  12. E. L. Jones, J. R. Oleson, L. R. Prosnitz et al., “Randomized trial of hyperthermia and radiation for superficial tumors,” Journal of Clinical Oncology, vol. 23, no. 13, pp. 3079–3085, 2005. View at Publisher · View at Google Scholar · View at Scopus
  13. J. van der Zee, M. De Bruijne, J. W. M. Mens et al., “Reirradiation combined with hyperthermia in breast cancer recurrences: overview of experience in Erasmus MC,” International Journal of Hyperthermia, vol. 26, no. 7, pp. 638–648, 2010. View at Publisher · View at Google Scholar · View at Scopus
  14. C. A. Perez, P. W. Grigsby, K. S. C. Chao, D. G. Mutch, and M. A. Lockett, “Tumor size, irradiation dose, and long-term outcome of carcinoma of uterine cervix,” International Journal of Radiation Oncology Biology Physics, vol. 41, no. 2, pp. 307–317, 1998. View at Publisher · View at Google Scholar · View at Scopus
  15. A. Vasanthan, M. Mitsumori, J. H. Park et al., “Regional hyperthermia combined with radiotherapy for uterine cervical cancers: a multi-institutional prospective randomized trial of the international atomic energy agency,” International Journal of Radiation Oncology Biology Physics, vol. 61, no. 1, pp. 145–153, 2005. View at Publisher · View at Google Scholar · View at Scopus
  16. E. L. Jones, L. B. Marks, and L. R. Prosnitz, “Point: hyperthermia with radiation for chest wall recurrences,” Journal of the National Comprehensive Cancer Network, vol. 5, no. 3, pp. 339–344, 2007. View at Google Scholar · View at Scopus
  17. B. McCormick, “Counterpoint: hyperthermia with radiation therapy for chest wall recurrences,” Journal of the National Comprehensive Cancer Network, vol. 5, no. 3, pp. 345–348, 2007. View at Google Scholar · View at Scopus
  18. M. De Bruijne, B. V. D. Holt, G. C. van Rhoon, and J. van der Zee, “Evaluation of CEM43° CT90 thermal dose in superficial hyperthermia: a retrospective analysis,” Strahlentherapie und Onkologie, vol. 186, no. 8, pp. 436–443, 2010. View at Publisher · View at Google Scholar · View at Scopus
  19. T. M. Zagar, J. R. Oleson, Z. Vujaskovic et al., “Hyperthermia combined with radiation therapy for superficial breast cancer and chest wall recurrence: a review of the randomised data,” International Journal of Hyperthermia, vol. 26, no. 7, pp. 612–617, 2010. View at Publisher · View at Google Scholar · View at Scopus
  20. B. Emami, C. Scott, C. A. Perez et al., “Phase III study of interstitial thermoradiotherapy compared with interstitial radiotherapy alone in the treatment of recurrent or persistent human tumors: a prospectively controlled randomized study by the radiation therapy oncology group,” International Journal of Radiation Oncology Biology Physics, vol. 34, no. 5, pp. 1097–1104, 1996. View at Publisher · View at Google Scholar · View at Scopus
  21. J. van der Zee, D. González González, G. C. van Rhoon, J. D. P. van Dijk, W. L. J. van Putten, and A. A. M. Hart, “Comparison of radiotherapy alone with radiotherapy plus hyperthermia in locally advanced pelvic tumours: a prospective, randomised, multicentre trial,” The Lancet, vol. 355, no. 9210, pp. 1119–1125, 2000. View at Google Scholar · View at Scopus
  22. M. Mitsumori, Z. Zhi-Fan, P. Oliynychenko et al., “Regional hyperthermia combined with radiotherapy for locally advanced non-small cell lung cancers: a multi-institutional prospective randomized trial of the International Atomic Energy Agency,” International Journal of Clinical Oncology, vol. 12, no. 3, pp. 192–198, 2007. View at Publisher · View at Google Scholar · View at Scopus
  23. R. D. Issels, L. H. Lindner, J. Verweij et al., “Neo-adjuvant chemotherapy alone or with regional hyperthermia for localised high-risk soft-tissue sarcoma: a randomised phase 3 multicentre study,” The Lancet Oncology, vol. 11, no. 6, pp. 561–570, 2010. View at Publisher · View at Google Scholar · View at Scopus
  24. Y. Harima, K. Nagata, K. Harima, V. V. Ostapenko, Y. Tanaka, and S. Sawada, “A randomized clinical trial of radiation therapy versus thermoradiotherapy in stage IIIB cervical carcinoma,” International Journal of Hyperthermia, vol. 17, no. 2, pp. 97–105, 2001. View at Publisher · View at Google Scholar · View at Scopus
  25. J. van der Zee and D. González González, “The Dutch Deep Hyperthermia trial: results in cervical cancer,” International Journal of Hyperthermia, vol. 18, no. 1, pp. 1–12, 2002. View at Publisher · View at Google Scholar · View at Scopus
  26. M. Franckena, L. J. A. Stalpers, P. C. M. Koper et al., “Long-term improvement in treatment outcome after radiotherapy and hyperthermia in locoregionally advanced cervix cancer: an update of the Dutch Deep Hyperthermia Trial,” International Journal of Radiation Oncology Biology Physics, vol. 70, no. 4, pp. 1176–1182, 2008. View at Publisher · View at Google Scholar · View at Scopus
  27. J. van der Zee, P. C. M. Koper, L. C. H. W. Lutgens, and C. W. Burger, “Point-counterpoint: what is the optimal trial design to test hyperthermia for carcinoma of the cervix? Point: addition of hyperthermia or cisplatin to radiotherapy for patients with cervical cancer; Two promising combinations—no definite conclusions,” International Journal of Hyperthermia, vol. 18, no. 1, pp. 19–24, 2002. View at Publisher · View at Google Scholar · View at Scopus
  28. O. Dahl and O. Mella, “Referee: hyperthermia alone or combined with cisplatin in addition to radiotherapy for advanced uterine cervical cancer,” International Journal of Hyperthermia, vol. 18, no. 1, pp. 25–30, 2002. View at Publisher · View at Google Scholar · View at Scopus
  29. L. Prosnitz and E. Jones, “Counterpoint: test the value of hyperthermia in patients with carcinoma of the cervix being treated with concurrent chemotherapy and radiation,” International Journal of Hyperthermia, vol. 18, no. 1, pp. 13–18, 2002. View at Publisher · View at Google Scholar · View at Scopus
  30. H. Ito, S. Kutuki, I. Nishiguchi et al., “Radiotherapy for cervical cancer with high-dose rate brachytherapy correlation between tumor size, dose and failure,” Radiotherapy and Oncology, vol. 31, no. 3, pp. 240–247, 1994. View at Publisher · View at Google Scholar · View at Scopus
  31. C. A. Perez, P. W. Grigsby, H. Castro-Vita, and M. A. Lockett, “Carcinoma of the uterine cervix. I. Impact of prolongation of overall treatment time and timing of brachytherapy on outcome of radiation therapy,” International Journal of Radiation Oncology Biology Physics, vol. 32, no. 5, pp. 1275–1288, 1995. View at Publisher · View at Google Scholar · View at Scopus
  32. I. Barillot, J. C. Horiot, J. Pigneux et al., “Carcinoma of the intact uterine cervix treated with radiotherapy alone: a French cooperative study: Update and multivariate analysis of prognostics factors,” International Journal of Radiation Oncology Biology Physics, vol. 38, no. 5, pp. 969–978, 1997. View at Publisher · View at Google Scholar · View at Scopus
  33. G. H. Fletcher, “Results of radiotherapy of carcinoma of the uterine cervix,” Proceedings of the Royal Society of Medicine, vol. 61, no. 4, pp. 391–394, 1968. View at Google Scholar · View at Scopus
  34. N. R. Datta, A. K. Bose, H. K. Kapoor, and S. Gupta, “Thermoradiotherapy in the management of carcinoma cervix (stage IIIb): a controlled clinical study,” Indian Medical Gazette, vol. 121, pp. 68–71, 1987. View at Google Scholar
  35. S. Sharma, F. D. Patel, A. P. Sandhu, B. D. Gupta, and N. S. Yadav, “A prospective rendomized study of local hyperthermia as a supplement and radiosensitiser in the treatment of carcinoma of the cervix with radiotherapy,” Endocurietherapy/Hyperthermia Oncology, vol. 5, pp. 151–159, 1989. View at Google Scholar
  36. H.-W. Chen, J.-J. Fan, and W. Luo, “A randomized trial of hyperthermo-radiochemotherapy for uterine cervix cancer,” Chinese Journal of Clinical Oncology, vol. 24, no. 4, pp. 249–251, 1997. View at Google Scholar · View at Scopus
  37. D. Fatehi, Technical Quality of Deep Hyperthermia Using the BSD-2000, Uitgeverij Box Press, Oisterwijk, The Netherlands, 2007.
  38. J. F. Tierney, “Adjuvant chemotherapy for localised resectable soft-tissue sarcoma of adults: meta-analysis of individual data,” The Lancet, vol. 350, no. 9092, pp. 1647–1654, 1997. View at Publisher · View at Google Scholar · View at Scopus
  39. A. Bakhshandeh, I. Bruns, A. Traynor et al., “Ifosfamide, carboplatin and etoposide combined with 41.8°C whole body hyperthermia for malignant pleural mesothelioma,” Lung Cancer, vol. 39, no. 3, pp. 339–345, 2003. View at Publisher · View at Google Scholar · View at Scopus
  40. A. Bakhshandeh, G. Wiedemann, P. Zabel et al., “Randomized trial with ICE (ifosfamide, carboplatin, etoposide) plus whole body hyperthermia versus ICE chemotherapy for malignant pleural mesothelioma,” Journal of Clinical Oncology, vol. 22, no. 14S, Supplement, p. 7288, 2004, ASCO Annual Meeting Proceedings (Post-Meeting Edition). View at Google Scholar
  41. A. Ioka, H. Tsukuma, W. Ajiki, and A. Oshima, “Influence of age on cervical cancer survival in Japan,” Japanese Journal of Clinical Oncology, vol. 35, no. 8, pp. 464–469, 2005. View at Publisher · View at Google Scholar · View at Scopus
  42. J. J. W. Lagendijk, “A new coaxial TEM radiofrequency/microwave applicator for non-invasive deep-body hyperthermia,” Journal of Microwave Power, vol. 18, no. 4, pp. 367–375, 1983. View at Google Scholar · View at Scopus
  43. S. Gottschalk, “Zur behandlung des ulcerierenden inoperablen Cervixcarcinoms,” Zentralblatt für Gynäkologie, vol. 3, pp. 79–80, 1899. View at Google Scholar
  44. L. H. Lindner and R. D. Issels, “Hyperthermia in soft tissue sarcoma,” Current Treatment Options in Oncology, vol. 12, no. 1, pp. 12–20, 2011. View at Google Scholar
  45. H. L. Kindler, “Malignant pleural mesothelioma,” Current Treatment Options in Oncology, vol. 1, no. 4, pp. 313–326, 2000. View at Google Scholar · View at Scopus
  46. B. Hildebrandt, S. Hegewisch-Becker, T. Kerner et al., “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,” International Journal of Hyperthermia, vol. 21, no. 2, pp. 169–183, 2005. View at Publisher · View at Google Scholar · View at Scopus
  47. A. Bakhshandeh, V. Bath, G. J. Wiedemann et al., “Year 2000 guidelines for clinical practice of whole body hyperthermia combined with cytotoxic drugs from the university of lübeck and the university of wisconsin,” Journal of Oncology Pharmacy Practice, vol. 5, no. 3, pp. 131–134, 1999. View at Publisher · View at Google Scholar · View at Scopus
  48. H. I. Robins and W. Longo, “Whole body hyperthermia: simple complexities,” Intensive Care Medicine, vol. 25, no. 9, pp. 898–900, 1999. View at Publisher · View at Google Scholar · View at Scopus
  49. G. Crile Jr., “The effects of heat and radiation on cancers implanted on the feet of mice,” Cancer Research, vol. 23, pp. 372–380, 1963. View at Google Scholar · View at Scopus
  50. M. Hiraoka, S. Jo, K. Akuta, Y. Nishimura, M. Takahashi, and M. Abe, “Radiofrequency capacitive hyperthermia for deep-seated tumors: I. Studies on thermometry,” Cancer, vol. 60, no. 1, pp. 121–127, 1987. View at Google Scholar · View at Scopus
  51. M. Hiraoka, S. Jo, and K. Akuta, “Radiofrequency capacitive hyperthermia for deep-seated tumors: II. Effects of thermoradiotherapy,” Cancer, vol. 60, no. 1, pp. 128–135, 1987. View at Google Scholar · View at Scopus
  52. S. A. Sapareto and W. C. Dewey, “Thermal dose determination in cancer therapy,” International Journal of Radiation Oncology Biology Physics, vol. 10, no. 6, pp. 787–800, 1984. View at Google Scholar · View at Scopus
  53. M. Franckena, R. De Wit, A. C. Ansink et al., “Weekly systemic cisplatin plus locoregional hyperthermia: an effective treatment for patients with recurrent cervical carcinoma in a previously irradiated area,” International Journal of Hyperthermia, vol. 23, no. 5, pp. 443–450, 2007. View at Publisher · View at Google Scholar · View at Scopus
  54. M. W. Dewhirst, Z. Vujaskovic, E. Jones, and D. Thrall, “Re-setting the biologic rationale for thermal therapy,” International Journal of Hyperthermia, vol. 21, no. 8, pp. 779–790, 2005. View at Publisher · View at Google Scholar · View at Scopus
  55. M. W. Dewhirst, B. L. Viglianti, M. Lora-Michiels, M. Hanson, and P. J. Hoopes, “Basic principles of thermal dosimetry and thermal thresholds for tissue damage from hyperthermia,” International Journal of Hyperthermia, vol. 19, no. 3, pp. 267–294, 2003. View at Publisher · View at Google Scholar · View at Scopus
  56. G. C. van Rhoon and J. van der Zee, “Hyperthermia a treatment for cancer: maturation of its clinical application,” Polish Journal of Environmental Studies, vol. 15, no. 4A, pp. 11–15, 2006. View at Google Scholar