Supradose Intra-Arterial Cisplatin and Concurrent Radiation Therapy for the Treatment of Stage IV Head and Neck Squamous Cell Carcinoma Is Feasible and Efficacious in a Multi-Institutional Setting: Results of Radiation Therapy Oncology Group Trial 9615

Robbins, K. Thomas; Kumar, Parvesh; Harris, Jonathan; McCulloch, Timothy M.; Cmelak, Anthony J.; Sofferman, Robert A.; Levine, Paul A.; Weisman, Robert A.; Wilson, William R.; Weymuller, Ernest A.; Fu, Karen K.

doi:10.1200/jco.2005.03.168

Cited by 125 publications

(71 citation statements)

References 21 publications

(8 reference statements)

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“…Details on this treatment modality were published previously. 8,13,14 Briefly, treatment consisted of 4 consecutive weekly, selective, intraarterial infusions of cisplatin (150 mg/m 2 ) followed by intravenous sodium thiosulfate rescue combined with simultaneous radiotherapy according to the RADPLAT protocol 15 (2 gray [Gy] per day, 5 times per week for 7 weeks to a total dose of 70 Gy). Before the start of treatment, all patients signed an informed consent form that was approved by our Institutional Protocol Review Committee.…”

Section: Methodsmentioning

confidence: 99%

Response measurement after intraarterial chemoradiation in advanced head and neck carcinoma

Broek

Rasch

Pameijer

et al. 2006

Cancer

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BACKGROUNDThe objectives of this prospective trial were to evaluate the diagnostic accuracy and predictive value of magnetic resonance imaging (MRI) and to use MRI evaluation under general anesthesia (EGA) 6 to 8 weeks after chemoradiation to determine local control.METHODSEighty‐two consecutive patients with advanced‐stage squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or supraglottic larynx were treated with selective targeted chemoradiation. All patients who completed treatment and survived had a minimum follow‐up of 3 years. MRI and EGA were performed from 6 to 8 weeks after treatment. Posttreatment MRI findings were compared with pretreatment MRI findings and were graded for risk of local recurrence/residual disease on a 4‐point scale. The diagnosis of treatment failure was based on tissue biopsies, which were obtained during EGA or later during follow‐up. The predictive value of MRI was analyzed by using a Cox proportional hazards model.RESULTSOnly 1 patient with MRI Grade 0 or 1 findings (discrete mass < 10 mm; n = 62 patients) had residual disease 6 to 8 weeks after treatment that was detected during EGA. In 5 patients with MRI findings of Grade 2a and 2b (mass > 10 mm; n = 20 patients), residual disease was detected. After 2 years, 23 patients had a local failure (28%). Twelve local failures were found among 62 patients who had MRI findings of Grade 0 and 1. Posttreatment MRI emerged as an independent predictive factor (hazard ratio, 3.0; P = .014) for local control.CONCLUSIONSPosttreatment MRI studies provided predictive information on local control in addition to pretreatment predictors. In patients with focal masses < 10 mm, the combination of response evaluation under general anesthesia and posttreatment MRI from 6 to 8 weeks after chemoradiation hardly provided more information on the local control than posttreatment MRI alone. Cancer 2006. © 2006 American Cancer Society.

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Section: Methodsmentioning

confidence: 99%

Response measurement after intraarterial chemoradiation in advanced head and neck carcinoma

Broek

Rasch

Pameijer

et al. 2006

Cancer

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“…However, phase III randomized controlled trials are required in order to directly compare RADPLAT with i.v. chemoradiation therapy, the current standard of care [46,77]. The first results of such a trial in The Netherlands are expected at the end of this year.…”

Section: Discussionmentioning

confidence: 99%

“…Feasibility, or the ability to deliver the full prescribed dose of both cisplatin and radiotherapy, was examined recently in the multicenter setting in a prospective phase II trial [46]. Eleven institutions participated, eight of whom were inexperienced in the delivery of RADPLAT.…”

Section: Radplat In Other Centersmentioning

confidence: 99%

RADPLAT: An Alternative to Surgery?

2006

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Head and neck cancer frequently presents at a late stage, leading to a poor prognosis despite optimal treatment with surgery and/or radiotherapy. Chemotherapy for advanced disease has shown little benefit as a single-modality treatment, and the use of concurrent chemoradiation is limited by problems with severe toxicity at higher doses. RADPLAT is the acronym used to describe a new technique, combining intra-arterial delivery of cisplatin with systemic neutralization by i.v. sodium thiosulphate, and concurrent radiotherapy. This allows very high cisplatin dose intensities to be used while potentially minimizing adverse systemic effects. Initial results suggest that excellent locoregional control rates are achievable in patients with unresectable disease, with a favorable side-effect profile when compared with conventional chemoradiation protocols. In addition, RADPLAT may potentially be of benefit in selected patients with resectable disease, allowing for preservation of organ function and quality of life without compromising locoregional control or survival. While current phase II data are encouraging, phase III randomized controlled trials are required in order to directly compare RADPLAT with i.v. chemoradiation therapy, the current standard of care. This article reviews the evolution of the RADPLAT concept, from initial clinical trials to its current application in the treatment of patients with advanced head and neck cancer.

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“…Similar to intravenous drug administration, the response to neoadjuvant IA cisplatin may also be predictive of final oncologic outcomes after definitive surgery or radiation therapy [18]. Feasibility and effectiveness of concomitant IA cisplatin and radiation therapy (RADPLAT) were shown in a prospective multi-institutional study [16], with complete responses in greater than 80 % of patients. High-dose IA cisplatin with concomitant hyperfractionated radiation therapy has also been shown to be feasible with complete response rates of greater than 85 % for advanced and unresectable tumors [19,20].…”

Section: Ia Chemotherapy Despite Demonstrated Feasibility and Efficamentioning

confidence: 99%

“…More recently studied, high-dose IA cisplatin can be administered locally, while systemic toxicities are reduced by a simultaneous intravenous infusion of sodium thiosulfate [16]. The bulk of the literature shows that IA administration via a femoral catheter is feasible for squamous cell carcinoma of the oral cavity, oropharynx, larynx, and hypopharynx with acceptable systemic toxicity.…”

Section: Ia Chemotherapy Despite Demonstrated Feasibility and Efficamentioning

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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Supradose Intra-Arterial Cisplatin and Concurrent Radiation Therapy for the Treatment of Stage IV Head and Neck Squamous Cell Carcinoma Is Feasible and Efficacious in a Multi-Institutional Setting: Results of Radiation Therapy Oncology Group Trial 9615

Abstract: This intensive treatment regimen for head and neck cancer is feasible and effective in a multi-institutional setting.

Cited by 125 publications

References 21 publications

Response measurement after intraarterial chemoradiation in advanced head and neck carcinoma

Response measurement after intraarterial chemoradiation in advanced head and neck carcinoma

RADPLAT: An Alternative to Surgery?

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

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