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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/m(2) once per week or CTX 400 mg/m(2) as loading dose followed by CTX 250 mg/m(2) 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 recurrence-free 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 for more 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. 

Magrini SM1, Buglione M2, Corvò R1, Pirtoli L1, Paiar F1, Ponticelli P1, Petrucci A1, Bacigalupo A1, Crociani M1, Lastrucci L1, Vecchio S1, Bonomo P1, Pasinetti N1, Triggiani L1, Cavagnini R1, Costa L1, Tonoli S1, Maddalo M1, Grisanti S1.

Author information

1Stefano Maria Magrini, Michela Buglione, Nadia Pasinetti, Luca Triggiani, Roberta Cavagnini, Loredana Costa, Sandro Tonoli, and Marta Maddalo, Brescia University, Istituto del Radio O. Alberti, Spedali Civili Hospital; Renzo Corvò, Almalina Bacigalupo, and Stefania Vecchio, Istituto Di Ricovero e Cura a Carattere Scientifico S. Martino, National Cancer Research Institute and University, Genova; Luigi Pirtoli and Monica Crociani, University of Siena, Siena; Fabiola Paiar and Pierluigi Bonomo, Azienda Ospedaliero-Universitaria Careggi, Firenze; Pietro Ponticelli and Luciana Lastrucci, S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo; and Alessia Petrucci, Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia; Salvatore Grisanti, Brescia University, Brescia, Italy.

2Stefano Maria Magrini, Michela Buglione, Nadia Pasinetti, Luca Triggiani, Roberta Cavagnini, Loredana Costa, Sandro Tonoli, and Marta Maddalo, Brescia University, Istituto del Radio O. Alberti, Spedali Civili Hospital; Renzo Corvò, Almalina Bacigalupo, and Stefania Vecchio, Istituto Di Ricovero e Cura a Carattere Scientifico S. Martino, National Cancer Research Institute and University, Genova; Luigi Pirtoli and Monica Crociani, University of Siena, Siena; Fabiola Paiar and Pierluigi Bonomo, Azienda Ospedaliero-Universitaria Careggi, Firenze; Pietro Ponticelli and Luciana Lastrucci, S. Donato Hospital, Azienda Unità Sanitaria Locale No. 8, Arezzo; and Alessia Petrucci, Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia; Salvatore Grisanti, Brescia University, Brescia, Italy. michela.buglione@unibs.it.