A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC).

Ang, K. Kian; Zhang, Q. E.; Rosenthal, David I.; Nguyen-Tân, Phuc Félix; Sherman, Eric J.; Weber, Randal S.; Galvin, James M.; Schwartz, Daniel L.; El-Naggar, A. K.; Gillison, M. L.; Jordan, Robyn; List, Marcy A.; Konski, André; Thorstad, Wade L.; Trotti, A.; Beitler, Jonathan J.; Garden, Adam S.; Spanos, W.; Yom, Sue S.; Axelrod, Rita

doi:10.1200/jco.2011.29.15_suppl.5500

Cited by 143 publications

(89 citation statements)

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“…The concomitant boost platform was chosen by the RTOG for its 0522 trial, which compared CRT versus CRT plus single-agent cetuximab. Preliminary results showed higher rates of mucositis and skin toxicity but no improvements in PFS or OS (29).…”

Section: Discussionmentioning

confidence: 99%

Prospective Trial of Synchronous Bevacizumab, Erlotinib, and Concurrent Chemoradiation in Locally Advanced Head and Neck Cancer

Yoo

Kirkpatrick

Craciunescu

et al. 2012

Clinical Cancer Research

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Purpose: We assessed the safety and efficacy of synchronous VEGF and epidermal growth factor receptor (EGFR) blockade with concurrent chemoradiation (CRT) in locally advanced head and neck cancer (HNC).Experimental Design: Newly diagnosed patients with stage III/IV HNC received a 2-week lead-in of bevacizumab and/or erlotinib, followed by both agents with concurrent cisplatin and twice daily radiotherapy. Safety was assessed using Common Toxicity Criteria version 3.0. The primary efficacy endpoint was clinical complete response (CR) rate after CRT.Results: Twenty-nine patients enrolled on study, with 27 completing therapy. Common grade III toxicities were mucositis (n ¼ 14), dysphagia (n ¼ 8), dehydration (n ¼ 7), osteoradionecrosis (n ¼ 3), and soft tissue necrosis (n ¼ 2). Feeding tube placement was required in 79% but no patient remained dependent at 12-month posttreatment. Clinical CR after CRT was 96% [95% confidence interval (CI), 82%-100%]. Median follow-up was 46 months in survivors, with 3-year locoregional control and distant metastasis-free survival rates of 85% and 93%. Three-year estimated progression-free survival, diseasespecific survival, and overall survival rates were 82%, 89%, and 86%, respectively. Dynamic contrast enhanced MRI (DCE-MRI) analysis showed that patients who had failed had lower baseline pretreatment median K trans values, with subsequent increases after lead-in therapy and 1 week of CRT. Patients who did not fail had higher median K trans values that decreased during therapy.Conclusions: Dual VEGF/EGFR inhibition can be integrated with CRT in locally advanced HNC, with efficacy that compares favorably with historical controls albeit with an increased risk of osteoradionecrosis. Pretreatment and early DCE-MRI may prospectively identify patients at high risk of failure.

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Section: Discussionmentioning

confidence: 99%

Prospective Trial of Synchronous Bevacizumab, Erlotinib, and Concurrent Chemoradiation in Locally Advanced Head and Neck Cancer

Yoo

Kirkpatrick

Craciunescu

et al. 2012

Clinical Cancer Research

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“…Administration of radiation therapy in combination with chemotherapy improves control of locally advanced head and neck malignant tumor and overall survival rates, but increases the toxicity of treatment [12,13]. The most common acute reactions are taste disturbance, pain, dysphagia, xerostomia, mucositis, dermatitis, rashes [14].…”

Section: Discussionmentioning

confidence: 99%

Safety And Toxicity Combining Radiation Therapy With A Biologic Therapy In Locally Advanced Head And Neck Squamous Cell Cancer At The Klaipeda University Hospital Clinical Practice

et al. 2016

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“…Although the toxicities of cetuximab are generally manageable, severe toxicities have been noted with the agent (e.g., hypomagnesemia, rare hypersensitivity reactions, and others including interstitial pneumonitis and cardiovascular toxicities). Given the negative results from the RTOG 0522 trial, cetuximab should not be combined with cisplatin-based chemoradiation regimens [41], and its use in combination with other chemoradiotherapy regimens must be in the context of clinical trials.…”

Section: Discussionmentioning

confidence: 99%

When is chemotherapy in head and neck squamous cell carcinoma not indicated?

Haigentz

Vermorken

Forastiere

et al. 2014

Eur Arch Otorhinolaryngol

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A randomized phase III trial (RTOG 0522) of concurrent accelerated radiation plus cisplatin with or without cetuximab for stage III-IV head and neck squamous cell carcinomas (HNC).

Cited by 143 publications

References 0 publications

Prospective Trial of Synchronous Bevacizumab, Erlotinib, and Concurrent Chemoradiation in Locally Advanced Head and Neck Cancer

Prospective Trial of Synchronous Bevacizumab, Erlotinib, and Concurrent Chemoradiation in Locally Advanced Head and Neck Cancer

Safety And Toxicity Combining Radiation Therapy With A Biologic Therapy In Locally Advanced Head And Neck Squamous Cell Cancer At The Klaipeda University Hospital Clinical Practice

When is chemotherapy in head and neck squamous cell carcinoma not indicated?

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