scholarly journals A Prospective Study Investigating the Efficacy and Toxicity of Definitive ChemoRadadiation and ImmunOtherapy (CRIO) in Locally and/or Regionally Advanced Cutaneous Squamous Cell Carcinoma.

2020 ◽  
Author(s):  
Charles Lin ◽  
Trishna Ballah ◽  
Michelle Nottage ◽  
Karen Hay ◽  
Benjamin Chua ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Prospective Study ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Cutaneous Squamous Cell Carcinoma ◽  
Significant Activity ◽  
Clinical Trial Registry ◽  
Curative Intent ◽  
Regional Metastases

Abstract Background: Patients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort. Our hypothesis is that >70% of patients with locally-advanced primary disease or regional metastases can be safely treated for cure using ChemoRadiation and ImmunOtherapy (CRIO) compared to the null hypothesis of ≤50%. Methods: Patients with unresectable locally and or regionally advanced pathologically confirmed cSCC deemed suitable for CRIO by consensus of the Head and Neck Multidisciplinary meeting will be eligible. We aim to accrue a total of 15 patients. The co-primary endpoints of CRIO will be the safety of treatment and the complete response rate. Secondary endpoints will include overall survival, progression free survival, and locoregional control. Translational research endpoints including biomarkers will also be explored utilising multiplex immunohistochemistry on tumour biopsy samples obtained prior to commencing treatment and during treatment (week 2). In addition, the utility of CXCR-4 PET scan will be explored.Discussion: CRIO is a novel trial evaluating the combination of curative intent chemoradiotherapy with concurrent durvalumab for patients with inoperable locally advanced cSCC.Trial registration Trial registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618001573246)

scholarly journals A prospective study investigating the efficacy and toxicity of definitive ChemoRadiation and ImmunOtherapy (CRIO) in locally and/or regionally advanced unresectable cutaneous squamous cell carcinoma

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Charles Lin ◽  
Trishna Ballah ◽  
Michelle Nottage ◽  
Karen Hay ◽  
Benjamin Chua ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Prospective Study ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Complete Response ◽  
Cutaneous Squamous Cell Carcinoma ◽  
Stage Iii ◽  
Significant Activity ◽  
Clinical Trial Registry ◽  
Curative Intent

Abstract Background Patients with unresectable advanced cutaneous squamous cell carcinoma (cSCC) are generally treated with palliative intent. Immune checkpoint blockade has significant activity in the palliative setting in patients with recurrent or metastatic cSCC. This single arm phase 2 prospective study aims to investigate the combination of curative intent chemoradiation and durvalumab (anti-PD-L1 checkpoint inhibitor) for this patient cohort. Methods Patients with unresectable locally and or regionally advanced pathologically confirmed cSCC (stage III-IVa) deemed fit for CRIO by consensus of the Multidisciplinary meeting will be eligible. In the first stage of a two-stage minimax design, we aim to recruit a total of 15 patients. If fewer than 7 patients achieved a complete response in the first stage, we will conclude the treatment is not more effective than standard treatment. The co-primary endpoints of CRIO are the safety of treatment (acute and late toxicities) and the rate of complete response. Secondary endpoints would include overall survival, progression free survival, and locoregional control. Translational research endpoints including biomarkers (CD73, CD39, PD-1, PD-L1) will also be explored utilising multiplex immunohistochemistry on tumour biopsy samples obtained prior to commencing treatment and during treatment (week 2). In addition, the utility of CXCR-4 PET/CT scan will be explored. Discussion CRIO is a novel trial evaluating the combination of curative intent chemoradiotherapy with concurrent and adjuvant durvalumab for patients with unresectable stage III-IVa cSCC. Trial registration: Trial registered with the Australian New Zealand Clinical Trial Registry (ACTRN12618001573246)

Cemiplimab in a very frail population of patients with advanced or metastatic cutaneous squamous cell carcinoma: A monocenter real-life experience from Italy.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21524-e21524
Author(s):  
Michele Guida ◽  
Annarita Fanizzi ◽  
Davide Quaresmini ◽  
Annalisa Nardone ◽  
Andrea Armenio ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Antitumor Activity ◽  
Cell Carcinoma ◽  
Clinical Outcomes ◽  
Squamous Cell ◽  
Life Experience ◽  
Locally Advanced ◽  
Real Life ◽  
Cutaneous Squamous Cell Carcinoma ◽  
High Antitumor Activity

e21524 Background: Cutaneous squamous cell carcinoma (CSCC) is the second most common skin cancer. Although representing less than 5% of all CSCCs, advanced stages are difficult to treat. Cemiplimab, an antiPD-1 monoclonal antibody, is the first approved immunotherapy in the US and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) CSCC. Phase I-II studies showed high antitumor activity and good tolerability, but few data are still available regarding cemiplimab in real life experience in non-selected patients. Methods: We recruited 30 consecutive patients with laCSCC (25 pts) and mCSCC (5 pts) treated with cemiplimab from August 2019 to November 2020 at our Institution. Median age was 81 years (range 36-95); 24 males; median ECOG PS 1 (range 0-2). Five patients had an immunosuppressive condition including 3 patients with stable hematologic malignancies and two patients on immunosuppressive therapy for kidney transplantation and Crohn’s disease, respectively. The majority of patients had comorbidities (median 3). Cemiplimab was administered at the flat dose of 350 mg i.v. every 21 days until disease progression or unacceptable toxicity. In all patients we evaluated clinical outcomes, toxicity, and associations between clinical outcomes and peripheral blood parameters. Results: We reported 23 responses (ORR 76.7%) with CR in 5 patients (16.7%). One patient had SD for 5 months. The global DCR was 80%. The median duration of response and PFS was not reached at a median follow-up of 6 months. We observed a higher ORR in head and neck primary tumours (87% vs. 42.9% of others, p = 0.016) and in patients with haemoglobin level > 12 g/dL (87.5% vs. 64.3%). No significative difference in ORR was observed with respect to the median age (81.3% in >81 years vs. 71.4% in < 81 years). Among the 5 patients with immunosuppressive status, a response was obtained in 4 patients (80%), including 1 CR. Nine patients died, 7 for PD and 2 for causes unrelated to the disease. Twenty patients (67.7%) still have an ongoing response. The treatment was well tolerated by the majority of patients. The most common adverse events were fatigue in 7 patients (23.3%) and skin toxicity in 10 patients (33.3%) including pruritus in 6 patients, rash in 3 patients, bullous erythema in 1 patient. Only 3 (10%) patients experienced severe (grade 3/4) toxicity. Three responder patients interrupted treatment (2 for toxicity after 7 and 9 cycles, and one for pre-existing dementia) but maintaining their response. Conclusions: In our real-life experience cemiplimab showed high antitumor activity with acceptable safety profile similar to those in selected patients of trials. Moreover, its antitumor activity resulted not impaired in very elderly patients or in those with immunocompromized status.

Cetuximab‐radiotherapy combination in the management of locally advanced cutaneous squamous cell carcinoma

2018 ◽  
Vol 63 (2) ◽  
pp. 257-263 ◽  
Author(s):  
Kurian Joseph ◽  
Khalifa Alkaabi ◽  
Heather Warkentin ◽  
Sunita Ghosh ◽  
Naresh Jha ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Cutaneous Squamous Cell Carcinoma
Sign in / Sign up

Export Citation Format

Share Document