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The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901.
Int J Radiat Oncol Biol Phys 2007; 67(3):643-50IJ

Abstract

PURPOSE

Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients.

METHODS AND MATERIALS

Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 microg/m2 or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system.

RESULTS

Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006).

CONCLUSION

This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer.

Authors+Show Affiliations

Department of Radiation Oncology, University of California, Davis Medical Center, Sacramento, CA 95817, USA. janice.ryu@ucdmc.ucdavis.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

17293228

Citation

Ryu, Janice K., et al. "The Impact of Concurrent Granulocyte Macrophage-colony Stimulating Factor On Radiation-induced Mucositis in Head and Neck Cancer Patients: a Double-blind Placebo-controlled Prospective Phase III Study By Radiation Therapy Oncology Group 9901." International Journal of Radiation Oncology, Biology, Physics, vol. 67, no. 3, 2007, pp. 643-50.
Ryu JK, Swann S, LeVeque F, et al. The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. Int J Radiat Oncol Biol Phys. 2007;67(3):643-50.
Ryu, J. K., Swann, S., LeVeque, F., Scarantino, C. W., Johnson, D., Chen, A., ... Ang, K. K. (2007). The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. International Journal of Radiation Oncology, Biology, Physics, 67(3), pp. 643-50.
Ryu JK, et al. The Impact of Concurrent Granulocyte Macrophage-colony Stimulating Factor On Radiation-induced Mucositis in Head and Neck Cancer Patients: a Double-blind Placebo-controlled Prospective Phase III Study By Radiation Therapy Oncology Group 9901. Int J Radiat Oncol Biol Phys. 2007 Mar 1;67(3):643-50. PubMed PMID: 17293228.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The impact of concurrent granulocyte macrophage-colony stimulating factor on radiation-induced mucositis in head and neck cancer patients: a double-blind placebo-controlled prospective phase III study by Radiation Therapy Oncology Group 9901. AU - Ryu,Janice K, AU - Swann,Suzanne, AU - LeVeque,Francis, AU - Scarantino,Charles W, AU - Johnson,Darlene, AU - Chen,Allan, AU - Fortin,Andre, AU - Pollock,JonDavid, AU - Kim,Harold, AU - Ang,Kian K, PY - 2006/06/20/received PY - 2006/09/27/revised PY - 2006/09/28/accepted PY - 2007/2/13/pubmed PY - 2007/4/10/medline PY - 2007/2/13/entrez SP - 643 EP - 50 JF - International journal of radiation oncology, biology, physics JO - Int. J. Radiat. Oncol. Biol. Phys. VL - 67 IS - 3 N2 - PURPOSE: Based on early clinical evidence of potential mucosal protection by granulocyte-macrophage colony stimulating factor (GM-CSF), the Radiation Therapy Oncology Group conducted a double-blind, placebo-controlled, randomized study to test the efficacy and safety of GM-CSF in reducing the severity and duration of mucosal injury and pain (mucositis) associated with curative radiotherapy (RT) in head-and-neck cancer patients. METHODS AND MATERIALS: Eligible patients included those with head-and-neck cancer with radiation ports encompassing >50% of oral cavity and/or oropharynx. Standard RT ports were used to cover the primary tumor and regional lymphatics at risk in standard fractionation to 60-70 Gy. Concurrent cisplatin chemotherapy was allowed. Patients were randomized to receive subcutaneous injection of GM-CSF 250 microg/m2 or placebo 3 times a week. Mucosal reaction was assessed during the course of RT using the National Cancer Institute Common Toxicity Criteria and the protocol-specific scoring system. RESULTS: Between October 2000 and September 2002, 130 patients from 36 institutions were accrued. Nine patients (7%) were excluded from the analysis, 3 as a result of drug unavailability. More than 80% of the patients participated in the quality-of-life endpoint of this study. The GM-CSF did not cause any increase in toxicity compared with placebo. There was no statistically significant difference in the average mean mucositis score in the GM-CSF and placebo arms by a t test (p = 0.4006). CONCLUSION: This placebo-controlled, randomized study demonstrated no significant effect of GM-CSF given concurrently compared with placebo in reducing the severity or duration of RT-induced mucositis in patients undergoing definitive RT for head-and-neck cancer. SN - 0360-3016 UR - https://www.unboundmedicine.com/medline/citation/17293228/The_impact_of_concurrent_granulocyte_macrophage_colony_stimulating_factor_on_radiation_induced_mucositis_in_head_and_neck_cancer_patients:_a_double_blind_placebo_controlled_prospective_phase_III_study_by_Radiation_Therapy_Oncology_Group_9901_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0360-3016(06)03225-1 DB - PRIME DP - Unbound Medicine ER -