Session Item

Saturday
August 28
08:00 - 08:40
N103
The role of RTT leadership in advancing multi-disciplinary research
Sophie Perryck, Switzerland
0070
Teaching lecture
RTT
08:45 - 08:53
RT and concomitant CDDP vs cetuximab for head and neck cancer: long term outcomes of a randomized PH. II trial
PH-0038

Abstract

RT and concomitant CDDP vs cetuximab for head and neck cancer: long term outcomes of a randomized PH. II trial
Authors: Tomasini|, Davide(1)*[tomad88@libero.it];Maddalo|, Marta(2);Borghetti|, Paolo(2);Corvò|, Renzo(3);Bonomo|, Pierluigi(4);Petrucci|, Alessia(5);Paiar|, Fabiola(6);Lastrucci|, Luciana(7);Bonù|, Marco Lorenzo(1);Greco|, Diana(2);Costa|, Loredana(2);Pegurri|, Ludovica(2);Triggiani|, Luca(1);Belgioia|, Liliana(3);Desideri|, Isacco(4);Grisanti|, Salvatore(8);Buglione|, Michela(1);Magrini|, Stefano Maria(1);
(1)ASST Spedali Civili and University of Brescia, Radiation Oncology Department, Brescia, Italy;(2)ASST Spedali Civili di Brescia, Radiation Oncology Department, Brescia, Italy;(3)Ospedale Policlinico San Martino and University of Genova, Health Science Department DISSAL and Radiation Oncology, Genova, Italy;(4)Azienda Ospedaliero Universitaria Careggi, Department of Radiation Oncology, Firenze, Italy;(5)Pistoia Hospital, Azienda Unità Sanitaria Locale No. 3, Pistoia, Italy;(6)Azienda Ospedaliera Universitaria Pisana and University of Pisa, Department of Radiation Oncology, Pisa, Italy;(7)Azienda Unità Sanitaria Locale No. 8, S. Donato Hospital, Arezzo, Italy;(8)ASST Spedali Civili di Brescia, Medical Oncology Department, Brescia, Italy;
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Purpose or Objective

Describing long-term survival and toxicity outcomes of a multicenter randomized phase II trial comparing radiotherapy (RT) plus concomitant cisplatin (CDDP) or cetuximab (CTX) as first line treatment in locally advanced squamous cell carcinoma of head and neck (LASCCHN).

Material and Methods

Between January 2011 and August 2014, 70 patients were enrolled and randomized 1:1 to receive RT plus concomitant weekly CDDP (40 mg/m2) or CTX (250 mg/m2 plus a loading dose of 400 mg/m2). This updated series focuses primarily on late toxicities (graded by using CTCAE scale version 4.0) and long-terms outcomes of survival, evaluated in terms of local control (LC), overall survival (OS), cancer-specific survival (CSS) and metastasis free survival (MFS). A supplementary analysis based on HPV status was also performed.

Results

No statistically significant difference was found in terms of late effects (xerostomia, fibrosis, mucosal atrophy, weight loss) in the two treatment arms (table 1). For the whole population, in the CDDP arm and in the CTX arm, respectively, 5-year LC rates were 67% and 48%; 5-year MFS rates 83% and 97%; 5-years OS rates 61% and 52%: 5-year CSS rates 70% and 59%. For patients with HPV+ oropharyngeal carcinoma, all the survival outcomes were even poorer in the CTX arm vs the CDDP arm. None of these differences reached statistical significance.

MeasureRT + CTX (n = 24)RT + CDDP (n = 27)p
Xerostomia ≥ G31 (4)4 (15)ns
Disgeusia, any grade
No
Yes

14 (58)
10 (42)

15 (56)
12 (44)
ns
Fibrosis ≥ G35 (21)5 (19)ns
Mucosal atrophy, any grade
No
Yes

17 (71)
7 (29)

22 (81)
5 (19)
ns
Weight loss > 10%*
No
Yes

18 (82)
4 (18)

18 (82)
4 (18)
ns
Weight loss, any percentage*
No
Yes

7 (32)
15 (68)

6 (27)
16 (73)
ns

Table 1. All data are presented as No (%) unless otherwise indicated. Abbreviations: CDDP, cisplatin; CTX, cetuximab; ns, non significant; RT, radiotherapy.
* Weight loss data were available only in 44 patients, 22 in the RT+CTX arm and 22 in the RT+CDDP arm.

Conclusion

Long-term results of this trial are in line with current literature suggesting that RT + CTX is inferior to CDDP + RT for LASCCHN. However, CTX + RT might still play a role in properly selected LASCCHN (particularly in HPV negative), also according to recent translational studies.