Phase II trial of radiotherapy after hyperbaric oxygenation with chemotherapy for high-grade gliomas

K Ogawa, Y Yoshii, O Inoue, T Toita, A Saito, Y Kakinohana, G Adachi, S Iraha, W Tamaki, K Sugimoto, A Hyodo, S Murayama, K Ogawa, Y Yoshii, O Inoue, T Toita, A Saito, Y Kakinohana, G Adachi, S Iraha, W Tamaki, K Sugimoto, A Hyodo, S Murayama

Abstract

We conducted a phase II trial to evaluate the efficacy and toxicity of radiotherapy immediately after hyperbaric oxygenation (HBO) with chemotherapy in adults with high-grade gliomas. Patients with histologically confirmed high-grade gliomas were administered radiotherapy in daily 2 Gy fractions for 5 consecutive days per week up to a total dose of 60 Gy. Each fraction was administered immediately after HBO with the period of time from completion of decompression to irradiation being less than 15 min. Chemotherapy consisted of procarbazine, nimustine (ACNU) and vincristine and was administered during and after radiotherapy. A total of 41 patients (31 patients with glioblastoma and 10 patients with grade 3 gliomas) were enrolled. All 41 patients were able to complete a total radiotherapy dose of 60 Gy immediately after HBO with one course of concurrent chemotherapy. Of 30 assessable patients, 17 (57%) had an objective response including four CR and 13 PR. The median time to progression and the median survival time in glioblastoma patients were 12.3 months and 17.3 months, respectively. On univariate analysis, histologic grade (P=0.0001) and Karnofsky performance status (P=0.036) had a significant impact on survival, and on multivariate analysis, histologic grade alone was a significant prognostic factor for survival (P=0.001). Although grade 4 leukopenia and grade 4 thrombocytopenia occurred in 10 and 7% of all patients, respectively, these were transient with no patients developing neutropenic fever or intracranial haemorrhage. No serious nonhaematological or late toxicities were seen. These results indicated that radiotherapy delivered immediately after HBO with chemotherapy was safe with virtually no late toxicity in patients with high-grade gliomas. Further studies are required to strictly evaluate the effectiveness of radiotherapy after HBO for these tumours.

References

    1. Al-Waili NS, Butler GJ, Beale J, Hamilton RW, Lee BY, Lucas P (2005) Hyperbaric oxygen and malignancies: a potential role in radiotherapy, chemotherapy, tumor surgery and phototherapy. Med Sci Monit 11: RA279–RA289
    1. Bennett M, Feldmeier J, Smee R, Milross C, Bennett M (2005) Hyperbaric oxygenation for tumour sensitization to radiotherapy. Cochrane Database Syst Rev 19: CD005007
    1. Beppu T, Kamada K, Nakamura R, Oikawa H, Takeda M, Fukuda T, Aradi H, Ogasawara K, Ogawa A (2003) A phase II study of radiotherapy after hyperbaric oxygenation combined with interferon-beta and nimustine hydrochloride to treat supratentorial malignant gliomas. J Neurooncol 61: 161–170
    1. Beppu T, Kamada K, Yoshida Y, Arai H, Ogasawara K, Ogawa A (2002) Changes of oxygen pressure in glioblastoma tissue under various conditions. J Neurooncol 58: 47–52
    1. Buckner JC (2003) Factors influencing survival in high-grade gliomas. Semin Oncol 30(6 Suppl 19): 10–14
    1. Choi IS, Lee SH, Kim TY, Bang JS, Paek SH, Kim S, Kim IH, Heo DS, Bang YJ, Kim DG, Jung HW, Kim NY (2002) Phase II study of chemotherapy with ACNU plus cisplatin followed by cranial irradiation in patients with newlydiagnosed glioblastoma multiforme. J Neurooncol 60: 171–176
    1. Collingridge DR, Piepmeier JM, Rockwell S, Knisely JP (1999) Polarographic measurements of oxygen tension in human glioma and surrounding peritumoral brain tissue. Radiother Oncol 53: 127–131
    1. Cox DR (1972) Regression models and life tables. J R Stat Soc 34: 187–220
    1. Curren Jr WJ, Scott CB, Horton J, Nelson JS, Weinstein AS, Fishbach AJ, Chang CH, Rotman M, Asbell SO, Krisch RE (1993) Recursive partitioning analysis of prognostic factors in three Radiation Therapy Oncology Group malignant glioma trials. J Natl Cancer Inst 85: 704–710
    1. Dische S (1991) What have we learnt from hyperbaric oxygen? Radiother Oncol 20(Suppl 1): 71–74
    1. Dowling S, Fischer JJ, Rockwell S (1992) Fluosol and hyperbaric oxygen as an adjunct to radiation therapy in the treatment of malignant gliomas: a pilot study. Biomater Artif Cells Immobilizat Biotechnol 20: 903–905
    1. Fine HA (1994) The basis for current treatment recommendations for malignant gliomas. J Neurooncol 20: 111–120
    1. Fine HA, Dear KB, Loeffler JS, Black PM, Canellos GP (1993) Meta-analysis of radiation therapy with and without adjuvant chemotherapy for malignant gliomas in adults. Cancer 71: 2585–2597
    1. Gray LH, Conger AD, Ebert M, Hornsey S, Scott OC (1953) The concentration of oxygen dissolved in tissues at the time of irradiation as a factor in radiotherapy. Br J Radiol 26: 638–648
    1. Grossman SA, O'Neill A, Grunnet M, Mehta M, Pearlman JL, Wagner H, Gilbert M, Newton HB, Hellman R (2003) Phase III study comparing three cycles of infusional carmustine and cisplatin followed by radiation therapy with radiation therapy and concurrent carmustine in patients with newly diagnosed supratentorial glioblastoma multiforme: Eastern Cooperative Oncology Group Trial 2394. J Clin Oncol 21: 1485–1491
    1. Hall EJ (1994) Radiobiology for the Radiologist, 4th ed Lippincott: Philadelphia, pp. 408–417
    1. Hartmann KA, van der Kleij AJ, Carl UM, Hulshof MC, Willers R, Sminia P (2001) Effects of hyperbaric oxygen and normobaric carbogenon the radiation response of the rat rhabdomyosarcoma R1 H. Int J Radiat Oncol Biol Phys 51: 1037–1044
    1. Henk JM, Kunkler PB, Smith CW (1977) Radiotherapy and hyperbaric oxygen in head and neck cancer. Final report of first controlled clinical trial. Lancet 2: 101–103
    1. Ito M, Lammertsma AA, Wise RJ, Bernardi S, Frackowiak RS, Heather JD, McKenzie CG, Thomas DG, Jones T (1982) Measurement of regional cerebral blood flow and oxygen utilization in patients with cerebral tumors using 15O and positron emission tomography: analytical techniques and preliminary results. Neuroradiology 23: 63–74
    1. Jain KK (1990) Textbook of Hyperbaric Medicine. Hogrefe & Huber Publishers: Toronto, pp. 408–417
    1. Jamieson D, van den Brenk HAS (1963) Measurement of oxygen tensions in cerebral tissues of rats exposed to high pressures of oxygen. J Appl Physiol 18: 869–876
    1. Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53: 457–481
    1. Kayama T, Yoshimoto T, Fujimoto S, Sakurai Y (1991) Intratumoral oxygen pressure in malignant brain tumor. J Neurosurg 74: 55–59
    1. Kinoshita Y, Kohshi K, Kunugita N, Tosaki T, Yokota A (2000) Preservation of tumour oxygen after hyperbaric oxygenation monitored by magnetic resonance imaging. Br J Cancer 82: 88–92
    1. Kleinberg L, Grossman SA, Piantadosi S, Zeltzman M, Wharam M (1999) The effects of sequential vs concurrent chemotherapy and radiotherapy on survival and toxicity in patients with newly diagnosed high-grade astrocytoma. Int J Radiat Oncol Biol Phys 44: 535–543
    1. Kohshi K, Kinoshita Y, Imada H, Kunugita N, Abe H, Terashima H, Tokui N, Uemura S (1999) Effects of radiotherapy after hyperbaric oxygenation on malignant gliomas. Br J Cancer 80: 236–241
    1. Kristiansen K, Hagen S, Kollevold T, Torvik A, Holme I, Nesbakken R, Hatlevoll R, Lindgren M, Brun A, Lindgren S, Notter G, Andersen AP, Elgen K (1981) Combined modality therapy of operated astrocytomas grade III and IV. Confirmation of the value of postoperative irradiation and lack of potentiation of bleomycin on survival time: a prospective multicenter trial of the Scandinavian glioblastoma study group. Cancer 47: 649–652
    1. Kunugita N, Kohshi K, Kinoshita Y, Katoh T, Abe H, Tosaki T, Kawamoto K, Norimura T (2001) Radiotherapy after hyperbaric oxygenation improves radioresponse in experimental tumor models. Cancer Lett 164: 149–154
    1. Laperriere N, Zuraw L, Cairncross G (2002) Radiotherapy for newly diagnosed malignant glioma in adults: a systematic review. Radiother Oncol 64: 259–273
    1. Lassen U, Kristjansen PE, Wagner A, Kosteljanetz M, Poulsen HS (1999) Treatment of newly diagnosed glioblastoma multiforme with carmustine, cisplatin and etoposide followed by radiotherapy. A phase II study. J Neurooncol 43: 161–166
    1. Lindegaard JC, Overgaard J, Bentzen SM, Pedersen D (1996) Is there a radiobiologic basis for improving the treatment of advanced stage cervical cancer? J Natl Cancer Inst Monogr 21: 105–112
    1. Macdonald DR, Cascino TL, Schold Jr SC, Cairncross JG. (1990) Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol 21: 3547–3549
    1. Mantel N (1966) Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50: 163–170
    1. Mayer R, Hamilton-Farrell MR, van der Kleij AJ, Schmutz J, Granstrom G, Sicko Z, Melamed Y, Carl UM, Hartmann KA, Jansen EC, Ditri L, Sminia P (2005) Hyperbaric oxygen and radiotherapy. Strahlenther Onkol 181: 113–123
    1. Mineura K, Sasajima T, Kowada M, Ogawa T, Hatazawa J, Shishido F, Uemura K (1994) Perfusion and metabolism in predicting the survival of patients with cerebral gliomas. Cancer 73: 2386–2394
    1. Ogawa K, Yoshii Y, Inoue O, Toita T, Saito A, Kakinohana Y, Adachi G, Ishikawa Y, Kin S, Murayama S (2003) Prospective trial of radiotherapy after hyperbaric oxygenation with chemotherapy for high-grade gliomas. Radiother Oncol 67: 63–67
    1. Overgaard J, Horsman MR (1996) Modification of hypoxia-induced radioresistance in tumors by the use of oxygen and sentitizers. Semin Radiat Oncol 6: 10–21
    1. Rampling R, Cruickshank G, Lewis AD, Fitzsimmons SA, Workman P (1994) Direct measurement of pO2 distribution and bioreductive enzymes in human malignant brain tumors. Int J Radiat Oncol Biol Phys 29: 427–431
    1. Scott CB, Scarantino C, Urtasun R, Movsas B, Jones CU, Simpson JR, Fischbach AJ, Curran Jr WJ (1998) Validation and predictive power of Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis classes for malignant glioma patients: a report using RTOG 90-06. Int J Radiat Oncol Biol Phys 40: 51–55
    1. Stewart LA (2002) Chemotherapy in adult high-grade glioma: a systemic review and meta-analysis of individual patient data from 12 randomized trials. Lancet 359: 1011–1018
    1. Stupp R, Mason W, van der Bent MJ, Weller M, Fisher B, Taphoorn MJB, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curshmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross G, Eisenhauer E, Mirimanoff RO (2005) Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med 352: 987–996
    1. Tyler JL, Diksic M, Villemure JG, Evans AC, Meyer E, Yamanoto YL, Feindel W (1987) Metabolic and hemodynamic evaluation of gliomas using positron emission tomography. J Nucl Med 33: 1123–1133
    1. Walker MD, Alexander Jr E, Hunt WE, MacCarty CS, Mahaley Jr MS, Mealey Jr J, Norrell HA, Owens G, Ransohoff J, Wilson CB, Gehan EA, Strike TA (1978) Evaluation of BCNU and/or radiotherapy in the treatment of anaplastic gliomas: a cooperative clinical trial. J Neurosurg 49: 333–343
    1. Weller M, Muller B, Koch R, Bamberg M, Krauseneck P (2003) Neuro-Oncology Working Group 01 trial of nimustine plus tenitoside vs nimustine plus cytarabine chemotherapy in addition to involved-field radiotherapy in the first line treatment of malignant glioma. J Clin Oncol 21: 3276–3284
    1. Wick W, Hermisson M, Kortmann RD, Kuker WM, Duffner F, Dichgans J, Bamberg M, Weller M (2002) Neoadjuvant gemcitabine/treosulfan chemotherapy for newly diagnosed glioblastoma: a phase II study. J Neurooncol 59: 151–155

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever