A prospective study investigating the impact of definitive chemoradiation in locoregionally advanced squamous cell carcinoma of the skin.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8538-8538 ◽  
Author(s):  
Michelle K. Nottage ◽  
Alessandra Bastian Francesconi ◽  
Kathleen Emilie Mary Houston ◽  
Charles Lin ◽  
Lizbeth M. Kenny ◽  
...  

8538 Background: Our state, Queensland, Australia, has the highest rate of cutaneous squamous cell cancer (SCC) in the world. Spread to regional lymph nodes or more distant sites occurs in 5-10%. A proportion of patients can not undergo surgical resection but complete response rates with radiotherapy alone are low. This led to the hypothesis that combined chemoradiation (CRT) may be of benefit. We decided to document the outcomes of concurrent chemoradiation by means of a prospective trial. Methods: This was a single arm, phase II study with planned sample size 30 patients. The primary endpoint was complete response rate (CRR), estimate 60%. Patients with locally/regionally advanced (non-metastatic) cutaneous SCC deemed unresectable or unsuitable for surgery by consensus of the multidisciplinary Head and Neck Cancer Clinic, with measurable disease, aged over 18, performance status 0-2, received definitive radiotherapy (XRT) (70Gy in 35#) and concurrent weekly platinum based chemotherapy (CT) (cisplatin 40mg/m2 or carboplatin AUC 2). Results: 14 patients were enrolled (Feb 2008-June 2011), median age 66 (48-84), 64% ECOG PS 0, 64% stage IV, 57% nodal disease only. Cisplatin/carboplatin was administered in 64%/36% respectively. 42% received all planned CT while 58% had 1 or 2 weeks omitted. 2 patients had dose reductions. XRT was completed as planned in 93%. The CRR was 57% (8/14) at analysis in December 2011 (median follow-up 13.5m). 2 further patients with partial response (PR) achieved CR after undergoing salvage surgery. Six (43%) patients had a PR; 4(29%) did not receive surgery and later progressed. Median overall survival was not reached, with 3 year survival 54%. The most frequent toxicities were dermatitis, mucositis, thrombocytopenia, nausea, anaemia, dysphagia. 28% had grade 3/4 toxicity, mainly cytopenias, infection, dehydration and nausea. Conclusions: This is the only prospective series of CRT for cutaneous squamous cell cancer. A high complete response rate was documented in patients with loco-regionally advanced disease and multiple co-morbidities, with acceptable toxicity, making this a reasonable alternative for patients unable to undergo surgery.

2020 ◽  
Vol 13 (2) ◽  
pp. 835-842
Author(s):  
Aline Houessinon ◽  
Aurélie Moreira ◽  
Jérèmie Bettoni ◽  
Marine Schoonaker ◽  
Chloé Sauzay ◽  
...  

The survival of patients with head and neck squamous cancer with locoregional recurrence is short if salvage surgery or radiation cannot be performed. Systemic chemotherapy based on platinum salts and cetuximab produces only partial and transient responses. Immune checkpoint inhibitors (i.e., nivolumab) lead to a low complete response rate of only about 10%, but in some cases the effects can be long-lasting. Intratumoral chemotherapy (ITC) has been proposed for patients with local recurrence of head and neck squamous cell carcinoma with an objective response rate of 27–50%. However, it often leads to peritumoral tissue necrosis, and the duration of local control is limited. Here, we present 2 patients with head and neck squamous cell cancer whose local recurrences were refractory to intravenous chemotherapy and nivolumab. ITC using nonnecrotizing molecules, associated with nivolumab, led to complete stable local and distant response. ITC seems to trigger tumor resensitization to previously ineffective immunotherapy. This combination deserves an evaluation in the framework of a prospective trial.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yu-Chieh Ho ◽  
Yuan-Chun Lai ◽  
Hsuan-Yu Lin ◽  
Ming-Hui Ko ◽  
Sheng-Hung Wang ◽  
...  

AbstractWe aimed to determine the prognostic significance of cardiac dose and hematological immunity parameters in esophageal cancer patients after concurrent chemoradiotherapy (CCRT). During 2010–2015, we identified 101 newly diagnosed esophageal squamous cell cancer patients who had completed definitive CCRT. Patients' clinical, dosimetric, and hematological data, including absolute neutrophil count, absolute lymphocyte count, and neutrophil-to-lymphocyte ratio (NLR), at baseline, during, and post-CCRT were analyzed. Cox proportional hazards were calculated to identify potential risk factors for overall survival (OS). Median OS was 13 months (95% confidence interval [CI]: 10.38–15.63). Univariate analysis revealed that male sex, poor performance status, advanced nodal stage, higher percentage of heart receiving 10 Gy (heart V10), and higher NLR (baseline and follow-up) were significantly associated with worse OS. In multivariate analysis, performance status (ECOG 0 & 1 vs. 2; hazard ratio [HR] 3.12, 95% CI 1.30–7.48), heart V10 (> 84% vs. ≤ 84%; HR 2.24, 95% CI 1.26–3.95), baseline NLR (> 3.56 vs. ≤ 3.56; HR 2.36, 95% CI 1.39–4.00), and follow-up NLR (> 7.4 vs. ≤ 7.4; HR 1.95, 95% CI 1.12–3.41) correlated with worse OS. Volume of low cardiac dose and NLR (baseline and follow-up) were associated with worse patient survival.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4029-4029 ◽  
Author(s):  
M. Suntharalingam ◽  
T. Dipetrillo ◽  
P. Akerman ◽  
H. Wanebo ◽  
B. Daly ◽  
...  

4029 Background: Cetuximab is an IgG1, chimerized, monoclonal antibody that binds specifically to the epidermal growth factor receptor. Cetuximab improves survival when combined with radiation for patients with locally advanced head and neck cancer. We evaluated the safety and efficacy of the addition of cetuximab to concurrent chemoradiation for patients with esophageal and gastric cancer. Methods: Patients with adenocarcinoma or squamous cell cancer of the esophagus or stomach without distant organ metastases were eligible. Patients with locally advanced disease from mediastinal, celiac, portal and gastric lymphadenopathy were eligible. Surgical resection was not required. Clinical complete response was defined as no tumor on postreatment endoscopic biopsy. Patients received cetuximab, 400mg/m2 week #1 then 250 mg/m2/week for 5 weeks, paclitaxel, 50 mg/m2/week, and carboplatin, AUC =2 weekly for 6 weeks, with concurrent 50.4 Gy radiation. Results: Thirty-seven patients have been entered. The median age was 61 (range of 30–87). Thirty-four have esophageal cancer and 3 have gastric cancer. Of the patients with esophageal cancer, twenty-five have adenocarcinoma and nine have squamous cell cancer. Thus far, 30 patients have completed treatment and are evaluable for toxicity. There have been no grade 4 non-hematologic toxicities and 1 pt had grade 4 neutropenia (3%). Six patients (20%) had grade 3 esophagitis. Other grade 3 toxicities included dehydration (n=5), rash (n=9), and paclitaxel/cetuximab hypersensitivity reactions (n=2). Eighteen of 27 patients (67%) have had clinical complete response. Seven pts out of 16 (43%) who have gone to surgery have had a pathologic CR. Conclusions: Cetuximab can be safely administered with chemoradiation for patients with esophageal cancer. Consistent with the data in head and neck cancer, cetuximab increases cutaneous toxicity but does not increase mucositis/esophagitis when combined with chemoradiation. Further evaluation is ongoing. [Table: see text]


2020 ◽  
Author(s):  
Hesan Luo ◽  
Shao-Fu Huang ◽  
Hong-Yao Xu ◽  
Xu-Yuan Li ◽  
Sheng-Xi Wu ◽  
...  

Abstract Purpose: To develop and validate a nomogram model to predict complete response (CR) after concurrent chemoradiotherapy (CCRT) in esophageal squamous cell carcinoma (ESCC) patients using pretreatment CT radiomic features. Methods: Data of patients diagnosed as ESCC and treated with CCRT in Shantou Central Hospital during the period from January 2013 to December 2015 were retrospectively collected. Eligible patients were included in this study and randomize divided into a training set and a validation set after successive screening. The least absolute shrinkage and selection operator (LASSO) with logistic regression to select radiomics features calculating Rad-score in the training set. The logistic regression analysis was performed to identify the predictive clinical factors for developing a nomogram model. The area under the receiver operating characteristic curves (AUC) was used to assess the performance of the predictive nomogram model and decision curve was used to analyze the impact of the nomogram model on clinical treatment decisions. Results: A total of 226 patients were included and randomly divided into two groups, 160 patients in training set and 66 patients in validation set. After LASSO analysis, seven radiomics features were screened out to develop a radiomics signature Rad-score. The AUC of Rad-score was 0.812 (95%CI: 0.742-0.869, p<0.001) in the training set and 0.744 (95%CI: 0.632-0.851, p=0.003) in the validation set. Multivariate analysis showed that Rad-score and clinical staging were independent predictors of CR status, with P values of 0.035 and 0.023, respectively. A nomogram model incorporating Rad-socre and clinical staging was developed and validated, with an AUC of 0.844 (95%CI: 0.779-0.897) in the training set and 0.807 (95%CI: 0.691-0.894) in the validation set.Delong test showed that the nomogram model was significantly superior to the clinical staging, with P<0.001 in the training set and P=0.026 in the validation set. The decision curve showed that the nomogram model was superior to the clinical staging when the risk threshold was greater than 25%. Conclusion: We developed and validated a nomogram model for predicting CR status of ESCC patients after CCRT. The nomogram model was combined radiomics signature Rad-score and clinical staging. This model provided us with an economical and simple method for evaluating the response of chemoradiotherapy for patients with ESCC.


2020 ◽  
Vol 16 (30) ◽  
pp. 2411-2420
Author(s):  
Zhigang Yuan ◽  
Marissa Frazer ◽  
Kamran A Ahmed ◽  
Syeda Mahrukh Hussnain Naqvi ◽  
Michael J Schell ◽  
...  

Aim: Genomic-based risk stratification to personalize radiation dose in rectal cancer. Patients & methods: We modeled genomic-based radiation dose response using the previously validated radiosensitivity index (RSI) and the clinically actionable genomic-adjusted radiation dose. Results: RSI of rectal cancer ranged from 0.19 to 0.81 in a bimodal distribution. A pathologic complete response rate of 21% was achieved in tumors with an RSI <0.31 at a minimal genomic-adjusted radiation dose of 29.76 when modeling RxRSI to the commonly prescribed physical dose of 50 Gy. RxRSI-based dose escalation to 55 Gy in tumors with an RSI of 0.31–0.34 could increase pathologic complete response by 10%. Conclusion: This study provides a theoretical platform for development of an RxRSI-based prospective trial in rectal cancer.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21070-e21070
Author(s):  
Xiaorong Dong ◽  
Lin Wu ◽  
Dingzhi Huang ◽  
Ying Cheng

e21070 Background: Treatment strategies for advanced lung squamous cell cancer (LSCC) of third-line or further-line are limited. We assessed the efficacy and safety of recombinant anti-EGFR monoclonal antibody SCT200 in patients with advanced LSCC in a phase 1b study. Methods: Advanced LSCC Patients previously treated with at least two chemotherapy regimens were randomly assigned to intravenous injection of SCT200 9 or 12 mg/kg every week (QW) for a maximum of 6 cycles, followed by 12 or 15 mg/kg every two weeks (Q2W). The primary endpoint was objective response rate (ORR). The secondary endpoint was progression free survival (PFS), overall survival (OS) and safety. This study was registered at ClinicalTrials.gov (NCT03808701). Results: Between March 19, 2019 and October 19, 2019, a total of 25 patients were enrolled and 23 were included in the final analysis (10 low dose [9mg/kg] and 13 high dose [12mg/kg]). The median age was 57 years old, and 21 (91.3%) patients were males. 22 patients (95.6%) had ECOG performance status of 1, and 17 (74%) were stage IV. The baseline characteristics were similar between the two dose groups. While no patients were evaluated as complete response or partial response, 5 and 6 patients achieved stable disease in the 9mg/kg and 12mg/kg dose groups respectively. However, the mOS was 5.96m (2.14 ̃ NR) and 9.59m (2.86 ̃ NR) in the low and high dose groups respectively. The mPFS was 2.23 (0.23 ̃ 5.26) and 1.38 (1.25 ̃ 3.02) in each group. The most common grade ≥3 treatment-related AEs were hypomagnesemia (13%), rash (13%) and anemia (4.3%). Conclusions: In this trial, a clinical benefit in OS was observed in the high dose group. SCT200 was shown to be safe and well tolerated in all patients. Our study indicated that SCT200 could serve as a potential single treatment or in combination with other therapy for advanced LSCC. Clinical trial information: NCT03808701. [Table: see text]


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