Randomized phase III trial of radiation treatment ± amifostine in patients with advanced-stage lung cancer

Antonadou, D.; Coliarakis, N.; Synodinou, M.; Athanassiou, H.; Kouveli, A.; Verigos, C.; Georgakopoulos, Grigoris; Panoussaki, Katerina; Karageorgis, P.; Throuvalas, N.

doi:10.1016/s0360-3016(01)01713-8

Cited by 193 publications

(77 citation statements)

References 30 publications

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“…[9][10][11][12][25][26][27][28][29][30][31] With the availability of sophisticated computer-controlled modification systems for clinical radiotherapy dose distribution by modern linear accelerators including intensity-modulated radiation therapy, 1,2,7 many physical barriers to dose optimization in complex tumor volumes have been overcome. Unfortunately, effective high dose delivery to complex tumor volumes in the thoracic cavity, which has been developed for patients with lung cancer, esophagus cancer, and other thoracic malignancies, has necessitated often large lung transit volumes and associated toxicity.…”

Section: Discussionmentioning

confidence: 99%

“…Pharmacologic interventions and biologic response modifiers have recently been focused on pulmonary radiation protection. Intravenous or systemic delivery of compounds such as WR2721 (Amifostine), [9][10][11][26][27][28][29]32 colony stimulating factors, 31 or other antioxidant molecules 30,33,34 has the potential problem of distribution to tumor vasculature within the target volume. 27,29 Simultaneous tumor and normal tissue radiation protection would not alter the therapeutic ratio or shift to a desirable effect of normal tissue radiation protection.…”

Section: Discussionmentioning

confidence: 99%

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Inhalation delivery of manganese superoxide dismutase-plasmid/liposomes protects the murine lung from irradiation damage

et al. 2005

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Intratracheal injection of manganese superoxide dismutaseplasmid/liposome (MnSOD-PL) complexes has been demonstrated to delay the onset and reduce the extent of ionizing irradiation-induced murine pulmonary organizing alveolitis/ fibrosis. To facilitate translation of this modality to clinical fractionated radiotherapy, inhalation delivery of MnSOD-PL was developed using an ultrasonic nebulizer. Transgene product was quantitated by immunohistochemical quantitation and pulmonary tissue levels of MnSOD biochemical activity. C57BL/6NHsd female mice demonstrated a plasmid dose-dependent increased expression of MnSOD transgene product over the range of 250 mg-2.5 mg of MnSOD-PL administered over a constant 5 min interval. Delivery of a constant concentration of 500 mg of MnSOD-PL with varying times of administration ranging from 0.5 to 10 min demonstrated optimal MnSOD expression at 5 min. Mice pretreated by inhalation delivery of MnSOD-PL demonstrated significantly improved survival after 20 Gy single fraction irradiation to both lungs compared to LacZ-PL inhalation-treated or irradiated control mice. Mice receiving 10 fractions of 3.5 cGy demonstrated increased pulmonary MnSOD transgene product activity by a protocol of every Monday-Wednesday or daily inhalation of MnSOD-PL. Thus, inhalation radioprotective gene therapy using MnSOD-PL provides a practical and effective method for delivery of lung-specific radioprotection during fractionated radiotherapy protocols in a mouse model. Gene Therapy (2005) 12, 685-693.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Inhalation delivery of manganese superoxide dismutase-plasmid/liposomes protects the murine lung from irradiation damage

et al. 2005

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“…Therefore, the primary strategy in controlling esophagitis involves the use of effective radioprotective agents. Amifostin has been studied as a radioprotector to decrease radiation induced toxicity in patients treated with RT for NSCLC (Antonadou et al, 2001). However, a larger, multi-institutional study (242 patients) by the Radiation Therapy Oncology Group failed to demonstrate an improvement in the esophageal tolerance (Wermer-Wasik et al, 2003).…”

Section: 53 Oral Glutamine Supplementation For Esophagitis In Lung Cmentioning

confidence: 99%

Oral Glutamine Supplementation Reduces Radiotherapy-induced Esophagitis in Lung Cancer Patients

Kanyılmaz¹,

Muge²,

A³

et al. 2015

Asian Pacific Journal of Cancer Prevention

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Background: The purpose of this study was to assess the the efficacy of oral glutamine (GLN) in prevention of acute radiation-induced esophagitis in patients with lung cancer and determine the predictive role of clinical and dosimetric parameters. Materials and Methods: Thirty-two patients diagnosed with lung cancer were studied prospectively. Sixteen patients (50%) received prophylactic powdered GLN orally in doses of 10g/8h. Patients were treated 2 Gy per fraction daily, 5 days a week. We evaluated the grading of esophagitis daily at the end of each fraction of each treatment day until a cumulative dose of 50 Gy was reached. The primary end point was radiation-induced esophagitis. Results: All patients tolerated GLN well. Toxicity grade, weight loss, serum cytokine levels and esophageal transit times exhibited statistically significant improvement in the GLN receiving group. GLN suppressed the inflammation related to the disease and treatment and reduced toxicity with statistical significance. Conclusions: This study suggests a benefical role of oral GLN use in prevention and/or delay of radiation-induced esophagitis, in terms of esophageal transit time and serum immunological parameters, as well as weight loss.

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“…Amifostine has been tested predominantly in patients with solid tumors receiving conventional chemotherapy or radiotherapy, [10][11][12][13][14] and in a limited number of patients after high-dose chemotherapy with autologous stem cell rescue. [15][16][17][18] While Chauncey et al 15 found no evidence that amifostine reduced regimen-related mucositis or hepatic dysfunction, two other reports showed that amifostine had a positive impact on glomerular filtration rate, grade III/IV stomatitis, and engraftment in patients who received highdose chemotherapy and autologous transplants.…”

Section: Discussionmentioning

confidence: 99%

“…Several trials have shown that amifostine reduces toxicity induced by cytotoxic agents as diverse as cyclophosphamide (CY), cisplatin, carboplatin, and radiotherapy given in nonmyeloablative doses. [10][11][12][13][14] Reports on the use of amifostine in the transplant setting have so far been restricted to autologous transplants where mixed results were reported. [15][16][17][18] Here, we evaluated whether amifostine offered protection against toxicity from a high-dose myeloablative regimen in patients receiving allogeneic stem cells.…”

mentioning

confidence: 99%

Lack of cytoprotective effect of amifostine following HLA-identical sibling transplantation for advanced myelodysplastic syndrome (MDS): a pilot study

Benesch

McDonald

Schubert

et al. 2003

Bone Marrow Transplant

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Summary:The objective of this prospective study was to determine whether amifostine (Ethyol s ) reduced conditioning-related toxicity following a regimen of busulfan (7 mg/kg) and fractionated total body irradiation (6 Â 200 cGy). In all, 12 patients with advanced myelodysplastic syndrome transplanted from HLA-identical siblings were enrolled. Patients received 340 mg/m 2 amifostine i.v. twice daily during conditioning (days -7 through -1). All patients developed oropharyngeal mucositis. Six patients had evidence of sinusoidal obstruction syndrome of the liver. Six patients experienced pulmonary toxicity of grades II-III. A total of 11 patients died, one with relapse and 10 with infectious complications or regimen-related toxicity. Nonrelapse causes of death included invasive aspergillosis in three, multiorgan failure in three, and idiopathic interstitial pneumonitis in two patients. One patient each died of organizing pneumonia and CMV pneumonia. One patient is alive in complete remission 31 months after transplantation. These results were not superior to those in patients conditioned with busulfan plus fractionated total body irradiation and not given amifostine, and suggest that amifostine, as administered here, has no protective effect against toxicity from this myeloablative regimen.

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Randomized phase III trial of radiation treatment ± amifostine in patients with advanced-stage lung cancer

Cited by 193 publications

References 30 publications

Inhalation delivery of manganese superoxide dismutase-plasmid/liposomes protects the murine lung from irradiation damage

Inhalation delivery of manganese superoxide dismutase-plasmid/liposomes protects the murine lung from irradiation damage

Oral Glutamine Supplementation Reduces Radiotherapy-induced Esophagitis in Lung Cancer Patients

Lack of cytoprotective effect of amifostine following HLA-identical sibling transplantation for advanced myelodysplastic syndrome (MDS): a pilot study

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