TY - JOUR
T1 - Electrochemotherapy as a first line treatment in recurrent squamous cell carcinoma of the oral cavity and oropharynx pdl-1 negative and/or with evident contraindication to immunotherapy
T2 - A randomized multicenter controlled trial
AU - Perri, Francesco
AU - Longo, Francesco
AU - Fusco, Roberta
AU - D’alessio, Valeria
AU - Aversa, Corrado
AU - Pavone, Ettore
AU - Pontone, Monica
AU - Marciano, Maria Luisa
AU - Villano, Salvatore
AU - Franco, Pierluigi
AU - Togo, Giulia
AU - De Fazio, Gianluca Renato
AU - Ordano, Daniele
AU - Maglitto, Fabio
AU - Salzano, Giovanni
AU - Maglione, Maria Grazia
AU - Guida, Agostino
AU - Ionna, Franco
N1 - Funding Information:
The research was founded by PROJECT F/050140/01-03/X32 IGEA/SPES MEDICA/PASCALE INSTITUTE, Fund for Sustainable Growth-Call HORIZON 2020 PON I&C 2014-2020, entitled ?DEEP-cancers:Deployable-expandable Electrode for ElectroPoration of cancer cells?.
Publisher Copyright:
© 2021 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2021/5/1
Y1 - 2021/5/1
N2 - Background: A significant proportion of patients with head and neck squamous cell carcinoma (HNSCC) have advanced-stage disease (stages III to IVB) that do not respond to therapy despite aggressive, site-specific multimodality therapy. A great number of them will develop disease recurrence, with up to 60% risk of local failure and up to 30% risk of distant failure. Therapy can be very demanding for the patient especially when important anatomical structures are in-volved. For these reasons, therapies that preserve organ functionality in combination with effective local tumor control, like electrochemotherapy (ECT), are of great interest. Until few months ago, systemic cetuximab + platinum-based therapy + 5-fluorouracil represented the standard treatment for HNSCC relapses with a median overall survival of 10.1 months and an objective response rate of 36%. Recently the results of KEYNOTE-048 study were published and a new combination of monoclonal antibody named pembrolizumab and chemotherapy emerged as standard first line therapy of recurrent or metastatic tumor that overexpress tissue PDL-1 (Programmed Death 1 lig-and). Nevertheless, a variable percentage from 10 to 15% of patients with recurrent/metastatic disease have a tumor that does not overexpress tissue PDL-1, and therefore, according to the results of the KEYNOTE-048 study, does not benefit from replacement of cetuximab with pembrolizumab. These patients will be treated with the “gold standard”: cetuximab, cisplatin/carboplatin and 5-fluorouracil. Aim: To verify whether electrochemotherapy performed with bleomycin of HNSCC relapses of the oral cavity and oropharynx (single relapse on T) is able to lead to an increase in the objective response rate in comparison with the systemic treatment with cetuximab + platinum-based therapy + 5-fluorouracil in patients with PDL-1 negative tumors. Methods: The phase IIb study involves the enrolment of 96 patients who meet the inclusion criteria (48 in the control arm and 48 in the treatment arm). The control arm involves the treatment of HNSCC with systemic treatment (ce-tuximab + platinum-based therapy + 5-fluorouracil). The treatment arm involves the ECT with ble-omycin. The primary objective is to verify the objective response rate of patients in the control arm compared to the treatment arm.
AB - Background: A significant proportion of patients with head and neck squamous cell carcinoma (HNSCC) have advanced-stage disease (stages III to IVB) that do not respond to therapy despite aggressive, site-specific multimodality therapy. A great number of them will develop disease recurrence, with up to 60% risk of local failure and up to 30% risk of distant failure. Therapy can be very demanding for the patient especially when important anatomical structures are in-volved. For these reasons, therapies that preserve organ functionality in combination with effective local tumor control, like electrochemotherapy (ECT), are of great interest. Until few months ago, systemic cetuximab + platinum-based therapy + 5-fluorouracil represented the standard treatment for HNSCC relapses with a median overall survival of 10.1 months and an objective response rate of 36%. Recently the results of KEYNOTE-048 study were published and a new combination of monoclonal antibody named pembrolizumab and chemotherapy emerged as standard first line therapy of recurrent or metastatic tumor that overexpress tissue PDL-1 (Programmed Death 1 lig-and). Nevertheless, a variable percentage from 10 to 15% of patients with recurrent/metastatic disease have a tumor that does not overexpress tissue PDL-1, and therefore, according to the results of the KEYNOTE-048 study, does not benefit from replacement of cetuximab with pembrolizumab. These patients will be treated with the “gold standard”: cetuximab, cisplatin/carboplatin and 5-fluorouracil. Aim: To verify whether electrochemotherapy performed with bleomycin of HNSCC relapses of the oral cavity and oropharynx (single relapse on T) is able to lead to an increase in the objective response rate in comparison with the systemic treatment with cetuximab + platinum-based therapy + 5-fluorouracil in patients with PDL-1 negative tumors. Methods: The phase IIb study involves the enrolment of 96 patients who meet the inclusion criteria (48 in the control arm and 48 in the treatment arm). The control arm involves the treatment of HNSCC with systemic treatment (ce-tuximab + platinum-based therapy + 5-fluorouracil). The treatment arm involves the ECT with ble-omycin. The primary objective is to verify the objective response rate of patients in the control arm compared to the treatment arm.
KW - Electrochemotherapy
KW - Randomized trial
KW - Recurrent cell squamous carcinoma
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U2 - 10.3390/cancers13092210
DO - 10.3390/cancers13092210
M3 - Article
AN - SCOPUS:85105242772
VL - 13
JO - Cancers
JF - Cancers
SN - 2072-6694
IS - 9
M1 - 2210
ER -