Cetuximab and radiotherapy versus cisplatin and radiotherapy for locally advanced head and neck cancer: A randomized phase II trial

Stefano Maria Magrini, Michela Buglione, Renzo Corvò, Luigi Pirtoli, Fabiola Paiar, Pietro Ponticelli, Alessia Petrucci, Almalina Bacigalupo, Monica Crociani, Luciana Lastrucci, Stefania Vecchio, Pierluigi Bonomo, Nadia Pasinetti, Luca Triggiani, Roberta Cavagnini, Loredana Costa, Sandro Tonoli, Marta Maddalo, Salvatore Grisanti

Research output: Contribution to journalArticle

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Abstract

Purpose: No randomized trials have been conducted to directly compare radiotherapy (RT) with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced squamous cell carcinoma of the head and neck. In this randomized trial, we compared these two treatment regimens in terms of compliance, toxicity, and efficacy. Patients and Methods: Eligible patients were randomly assigned in a 1:1 ratio to receive either CDDP 40 mg/m2 once per week or CTX 400 mg/m2 as loading dose followed by CTX 250 mg/m2 once per week concomitant to radical RT. For primary end points, compliance to treatment was defined as number of days of treatment discontinuation and drug dosage reduction. The acute toxicity rate was defined according to the National Cancer Institute Common Toxicity Criteria. Efficacy end points were local recurrencefree survival, metastasis-free survival, cancer-specific survival, and overall survival. Results: The study was discontinued early because of slow accrual after the enrollment of 70 patients. RT discontinuation formore than 10 days occurred in 13%of patients given CTX and 0%given CDDP (P = .05). Drug dosage reduction occurred in 34% given CTX and 53% given CDDP (difference not significant). Toxicity profiles differed between the two arms, with hematologic, renal, and GI toxicities more frequent in the CDDP arm, and cutaneous toxicity and the need for nutritional support more frequent in the CTX arm. Serious adverse events related to treatment, including four versus one toxic deaths,were higher in the CTX arm(19%v 3%, P = .044). Locoregional control, patterns of failure, and survivals were similar between the treatment arms. Conclusion: CTX concomitant to RT lowered compliance and increased acute toxicity rates. Efficacy outcomes were similar in both arms. These results raise the issue of appropriately selecting patients with head and neck cancer who can benefit from CTX in combination with RT.

Original languageEnglish
Pages (from-to)427-435
Number of pages9
JournalJournal of Clinical Oncology
Volume34
Issue number5
DOIs
Publication statusPublished - Feb 10 2016

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Head and Neck Neoplasms
Cisplatin
Radiotherapy
Survival
Compliance
Therapeutics
Cetuximab
Nutritional Support
National Cancer Institute (U.S.)
Poisons
Pharmaceutical Preparations
Neoplasm Metastasis
Kidney
Skin

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Cetuximab and radiotherapy versus cisplatin and radiotherapy for locally advanced head and neck cancer : A randomized phase II trial. / Magrini, Stefano Maria; Buglione, Michela; Corvò, Renzo; Pirtoli, Luigi; Paiar, Fabiola; Ponticelli, Pietro; Petrucci, Alessia; Bacigalupo, Almalina; Crociani, Monica; Lastrucci, Luciana; Vecchio, Stefania; Bonomo, Pierluigi; Pasinetti, Nadia; Triggiani, Luca; Cavagnini, Roberta; Costa, Loredana; Tonoli, Sandro; Maddalo, Marta; Grisanti, Salvatore.

In: Journal of Clinical Oncology, Vol. 34, No. 5, 10.02.2016, p. 427-435.

Research output: Contribution to journalArticle

Magrini, SM, Buglione, M, Corvò, R, Pirtoli, L, Paiar, F, Ponticelli, P, Petrucci, A, Bacigalupo, A, Crociani, M, Lastrucci, L, Vecchio, S, Bonomo, P, Pasinetti, N, Triggiani, L, Cavagnini, R, Costa, L, Tonoli, S, Maddalo, M & Grisanti, S 2016, 'Cetuximab and radiotherapy versus cisplatin and radiotherapy for locally advanced head and neck cancer: A randomized phase II trial', Journal of Clinical Oncology, vol. 34, no. 5, pp. 427-435. https://doi.org/10.1200/JCO.2015.63.1671
Magrini, Stefano Maria ; Buglione, Michela ; Corvò, Renzo ; Pirtoli, Luigi ; Paiar, Fabiola ; Ponticelli, Pietro ; Petrucci, Alessia ; Bacigalupo, Almalina ; Crociani, Monica ; Lastrucci, Luciana ; Vecchio, Stefania ; Bonomo, Pierluigi ; Pasinetti, Nadia ; Triggiani, Luca ; Cavagnini, Roberta ; Costa, Loredana ; Tonoli, Sandro ; Maddalo, Marta ; Grisanti, Salvatore. / Cetuximab and radiotherapy versus cisplatin and radiotherapy for locally advanced head and neck cancer : A randomized phase II trial. In: Journal of Clinical Oncology. 2016 ; Vol. 34, No. 5. pp. 427-435.
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abstract = "Purpose: No randomized trials have been conducted to directly compare radiotherapy (RT) with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced squamous cell carcinoma of the head and neck. In this randomized trial, we compared these two treatment regimens in terms of compliance, toxicity, and efficacy. Patients and Methods: Eligible patients were randomly assigned in a 1:1 ratio to receive either CDDP 40 mg/m2 once per week or CTX 400 mg/m2 as loading dose followed by CTX 250 mg/m2 once per week concomitant to radical RT. For primary end points, compliance to treatment was defined as number of days of treatment discontinuation and drug dosage reduction. The acute toxicity rate was defined according to the National Cancer Institute Common Toxicity Criteria. Efficacy end points were local recurrencefree survival, metastasis-free survival, cancer-specific survival, and overall survival. Results: The study was discontinued early because of slow accrual after the enrollment of 70 patients. RT discontinuation formore than 10 days occurred in 13{\%}of patients given CTX and 0{\%}given CDDP (P = .05). Drug dosage reduction occurred in 34{\%} given CTX and 53{\%} given CDDP (difference not significant). Toxicity profiles differed between the two arms, with hematologic, renal, and GI toxicities more frequent in the CDDP arm, and cutaneous toxicity and the need for nutritional support more frequent in the CTX arm. Serious adverse events related to treatment, including four versus one toxic deaths,were higher in the CTX arm(19{\%}v 3{\%}, P = .044). Locoregional control, patterns of failure, and survivals were similar between the treatment arms. Conclusion: CTX concomitant to RT lowered compliance and increased acute toxicity rates. Efficacy outcomes were similar in both arms. These results raise the issue of appropriately selecting patients with head and neck cancer who can benefit from CTX in combination with RT.",
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T1 - Cetuximab and radiotherapy versus cisplatin and radiotherapy for locally advanced head and neck cancer

T2 - A randomized phase II trial

AU - Magrini, Stefano Maria

AU - Buglione, Michela

AU - Corvò, Renzo

AU - Pirtoli, Luigi

AU - Paiar, Fabiola

AU - Ponticelli, Pietro

AU - Petrucci, Alessia

AU - Bacigalupo, Almalina

AU - Crociani, Monica

AU - Lastrucci, Luciana

AU - Vecchio, Stefania

AU - Bonomo, Pierluigi

AU - Pasinetti, Nadia

AU - Triggiani, Luca

AU - Cavagnini, Roberta

AU - Costa, Loredana

AU - Tonoli, Sandro

AU - Maddalo, Marta

AU - Grisanti, Salvatore

PY - 2016/2/10

Y1 - 2016/2/10

N2 - Purpose: No randomized trials have been conducted to directly compare radiotherapy (RT) with concomitant cisplatin (CDDP) versus concomitant cetuximab (CTX) as first-line treatment of locally advanced squamous cell carcinoma of the head and neck. In this randomized trial, we compared these two treatment regimens in terms of compliance, toxicity, and efficacy. Patients and Methods: Eligible patients were randomly assigned in a 1:1 ratio to receive either CDDP 40 mg/m2 once per week or CTX 400 mg/m2 as loading dose followed by CTX 250 mg/m2 once per week concomitant to radical RT. For primary end points, compliance to treatment was defined as number of days of treatment discontinuation and drug dosage reduction. The acute toxicity rate was defined according to the National Cancer Institute Common Toxicity Criteria. Efficacy end points were local recurrencefree survival, metastasis-free survival, cancer-specific survival, and overall survival. Results: The study was discontinued early because of slow accrual after the enrollment of 70 patients. RT discontinuation formore than 10 days occurred in 13%of patients given CTX and 0%given CDDP (P = .05). Drug dosage reduction occurred in 34% given CTX and 53% given CDDP (difference not significant). Toxicity profiles differed between the two arms, with hematologic, renal, and GI toxicities more frequent in the CDDP arm, and cutaneous toxicity and the need for nutritional support more frequent in the CTX arm. Serious adverse events related to treatment, including four versus one toxic deaths,were higher in the CTX arm(19%v 3%, P = .044). Locoregional control, patterns of failure, and survivals were similar between the treatment arms. Conclusion: CTX concomitant to RT lowered compliance and increased acute toxicity rates. Efficacy outcomes were similar in both arms. These results raise the issue of appropriately selecting patients with head and neck cancer who can benefit from CTX in combination with RT.

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