Abstract
Purpose: Advanced head-and-neck cancer (HNC) remains a difficult disease to cure. Proteasome inhibitors such as bortezomib have the potential to improve survival over chemoradiotherapy alone. This Phase I dose-escalation study examined the potential of bortezomib in combination with cisplatin chemotherapy and concurrent radiation in the treatment of locally advanced and recurrent HNC. Methods and Materials: Eligible patients received cisplatin once weekly at 30 mg/m{sup 2} per week and bortezomib along with concurrent radiation. Bortezomib was given on Days 1, 4, 8, and 11 every 3 weeks, with an initial starting dose of 0.7 mg/m{sup 2} and escalation levels of 1.0 and 1.3 mg/m{sup 2}. Dose escalation was performed only after assessment to rule out any dose-limiting toxicity. Results: We enrolled 27 patients with HNC, including 17 patients with recurrent disease who had received prior irradiation. Patients received bortezomib dose levels of 0.7 mg/m{sup 2} (7 patients), 1.0 mg/m{sup 2} (10 patients), and 1.3 mg/m{sup 2} (10 patients). No Grade 5 toxicities, 3 Grade 4 toxicities (all hematologic and considered dose-limiting toxicities), and 39 Grade 3 toxicities (in 20 patients) were observed. With a median follow-up of 7.4 months, the overall median survival was 24.7 months (48.4 months for advanced HNC
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Kubicek, Gregory J;
[1]
Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)];
Axelrod, Rita S;
[2]
Machtay, Mitchell;
[1]
Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)];
Ahn, Peter H;
Anne, Pramila R;
[1]
Fogh, Shannon;
[1]
Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)];
Cognetti, David;
[3]
Myers, Thomas J;
[4]
Curran, Walter J;
[1]
Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org
[1]
- Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States)
- Department of Medical Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States)
- Department of Otolaryngology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States)
- EMD Serono, Rockland, MA (United States)
Citation Formats
Kubicek, Gregory J, Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)], Axelrod, Rita S, Machtay, Mitchell, Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)], Ahn, Peter H, Anne, Pramila R, Fogh, Shannon, Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)], Cognetti, David, Myers, Thomas J, Curran, Walter J, and Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org.
Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Chemoradiotherapy for Head-and-Neck Malignancies.
United States: N. p.,
2012.
Web.
doi:10.1016/J.IJROBP.2011.09.023.
Kubicek, Gregory J, Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)], Axelrod, Rita S, Machtay, Mitchell, Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)], Ahn, Peter H, Anne, Pramila R, Fogh, Shannon, Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)], Cognetti, David, Myers, Thomas J, Curran, Walter J, & Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org.
Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Chemoradiotherapy for Head-and-Neck Malignancies.
United States.
https://doi.org/10.1016/J.IJROBP.2011.09.023
Kubicek, Gregory J, Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)], Axelrod, Rita S, Machtay, Mitchell, Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)], Ahn, Peter H, Anne, Pramila R, Fogh, Shannon, Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)], Cognetti, David, Myers, Thomas J, Curran, Walter J, and Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org.
2012.
"Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Chemoradiotherapy for Head-and-Neck Malignancies."
United States.
https://doi.org/10.1016/J.IJROBP.2011.09.023.
@misc{etde_22058962,
title = {Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Chemoradiotherapy for Head-and-Neck Malignancies}
author = {Kubicek, Gregory J, Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)], Axelrod, Rita S, Machtay, Mitchell, Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)], Ahn, Peter H, Anne, Pramila R, Fogh, Shannon, Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)], Cognetti, David, Myers, Thomas J, Curran, Walter J, and Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org}
abstractNote = {Purpose: Advanced head-and-neck cancer (HNC) remains a difficult disease to cure. Proteasome inhibitors such as bortezomib have the potential to improve survival over chemoradiotherapy alone. This Phase I dose-escalation study examined the potential of bortezomib in combination with cisplatin chemotherapy and concurrent radiation in the treatment of locally advanced and recurrent HNC. Methods and Materials: Eligible patients received cisplatin once weekly at 30 mg/m{sup 2} per week and bortezomib along with concurrent radiation. Bortezomib was given on Days 1, 4, 8, and 11 every 3 weeks, with an initial starting dose of 0.7 mg/m{sup 2} and escalation levels of 1.0 and 1.3 mg/m{sup 2}. Dose escalation was performed only after assessment to rule out any dose-limiting toxicity. Results: We enrolled 27 patients with HNC, including 17 patients with recurrent disease who had received prior irradiation. Patients received bortezomib dose levels of 0.7 mg/m{sup 2} (7 patients), 1.0 mg/m{sup 2} (10 patients), and 1.3 mg/m{sup 2} (10 patients). No Grade 5 toxicities, 3 Grade 4 toxicities (all hematologic and considered dose-limiting toxicities), and 39 Grade 3 toxicities (in 20 patients) were observed. With a median follow-up of 7.4 months, the overall median survival was 24.7 months (48.4 months for advanced HNC patients and 15.4 months for recurrent HNC patients). Conclusion: Bortezomib in combination with radiation therapy and cisplatin chemotherapy is safe in the treatment of HNC with a bortezomib maximum tolerated dose of 1.0 mg/m{sup 2} in patients previously treated for HNC and 1.3 mg/m{sup 2} in radiation-naive patients.}
doi = {10.1016/J.IJROBP.2011.09.023}
journal = []
issue = {4}
volume = {83}
journal type = {AC}
place = {United States}
year = {2012}
month = {Jul}
}
title = {Phase I Trial Using the Proteasome Inhibitor Bortezomib and Concurrent Chemoradiotherapy for Head-and-Neck Malignancies}
author = {Kubicek, Gregory J, Department of Radiation Oncology, University of Pittsburgh Medical Center, Pittsburgh, PA (United States)], Axelrod, Rita S, Machtay, Mitchell, Department of Radiation Oncology, Case Western Reserve University, Cleveland, OH (United States)], Ahn, Peter H, Anne, Pramila R, Fogh, Shannon, Department of Radiation Oncology, University of California, San Francisco, San Francisco, CA (United States)], Cognetti, David, Myers, Thomas J, Curran, Walter J, and Dicker, Adam P., E-mail: Adam.dicker@jeffersonhospital.org}
abstractNote = {Purpose: Advanced head-and-neck cancer (HNC) remains a difficult disease to cure. Proteasome inhibitors such as bortezomib have the potential to improve survival over chemoradiotherapy alone. This Phase I dose-escalation study examined the potential of bortezomib in combination with cisplatin chemotherapy and concurrent radiation in the treatment of locally advanced and recurrent HNC. Methods and Materials: Eligible patients received cisplatin once weekly at 30 mg/m{sup 2} per week and bortezomib along with concurrent radiation. Bortezomib was given on Days 1, 4, 8, and 11 every 3 weeks, with an initial starting dose of 0.7 mg/m{sup 2} and escalation levels of 1.0 and 1.3 mg/m{sup 2}. Dose escalation was performed only after assessment to rule out any dose-limiting toxicity. Results: We enrolled 27 patients with HNC, including 17 patients with recurrent disease who had received prior irradiation. Patients received bortezomib dose levels of 0.7 mg/m{sup 2} (7 patients), 1.0 mg/m{sup 2} (10 patients), and 1.3 mg/m{sup 2} (10 patients). No Grade 5 toxicities, 3 Grade 4 toxicities (all hematologic and considered dose-limiting toxicities), and 39 Grade 3 toxicities (in 20 patients) were observed. With a median follow-up of 7.4 months, the overall median survival was 24.7 months (48.4 months for advanced HNC patients and 15.4 months for recurrent HNC patients). Conclusion: Bortezomib in combination with radiation therapy and cisplatin chemotherapy is safe in the treatment of HNC with a bortezomib maximum tolerated dose of 1.0 mg/m{sup 2} in patients previously treated for HNC and 1.3 mg/m{sup 2} in radiation-naive patients.}
doi = {10.1016/J.IJROBP.2011.09.023}
journal = []
issue = {4}
volume = {83}
journal type = {AC}
place = {United States}
year = {2012}
month = {Jul}
}