Survival results of phase I dose escalation of stereotactic body radiation therapy and concurrent cisplatin for re-irradiation of unresectable, recurrent head and neck squamous cell carcinoma.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18020-e18020
Author(s):  
Michelle Echevarria ◽  
Christine H. Chung ◽  
Kedar Kirtane ◽  
Jameel Muzaffar ◽  
Julie Ann Kish ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Phase I ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Stereotactic Body Radiation Therapy ◽  
Recurrent Head

e18020 Background: Stereotactic body radiation therapy (SBRT) is a standard option for re-irradiation of recurrent or second primary cancers of the head and neck. We conducted performed a phase I clinical trial to establish a maximum tolerated dose of SBRT with concurrent cisplatin. We previously reported our safety data, and now present our secondary disease control endpoints. Methods: Major inclusion criteria were recurrence of previous squamous cell carcinoma of the head and neck in patients who had previously undergone radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to enrollment, and who were medically unfit for surgery, deemed unresectable, or refused surgery. Patients were treated with radiation therapy every other day for five fractions at three dose levels: 30 Gy, 35 Gy, and 40 Gy. Cisplatin was given prior to every SBRT fraction at a dose of 15 mg/m2. Secondary end points reported herein are locoregional control (LRC), freedom from distant metastasis (FFDM), and overall survival (OS). Results: Twenty patients were enrolled and of those 18 patients were evaluable for secondary endpoints. Nine patients had a primary tumor in the oropharynx, four patients in the oral cavity, three in the neck, one in the larynx, and one simultaneously in the larynx and neck. All patients received the planned dose of Cisplatin. Five patients received a radiation dose of 30 Gy, three patients received a dose of 35 Gy, and 9 patients received a dose of 40 Gy. Median gross tumor volume (GTV) was 11.725 cm3. With a median follow up of 9 months the 1-year OS was 38.9%. LRC at 1 year was 45.7% and FFDM at 1 year was 87.8%. There was a trend to improved OS with increasing SBRT dose, 40 Gy vs < 40 Gy (p = 0.08). There was an improved 1-year OS with a GTV ≤11.725 cm3 of 77.8% vs 0% for tumors > 11.725 cm3 (p < 0.001). For patients with a GTV < 11.725 cm3 who received 40 Gy the 1 year OS was 100% compared with 0% for tumors larger than 11.725 cm3. Conclusions: For patients with previously radiated locally or regionally recurrent head and neck cancer, SBRT up to 40 Gy given concurrently with cisplatin provides reasonable locoregional control and overall survival for patients with smaller tumors. Further evaluation in prospective trials is warranted. Clinical trial information: NCT02158234.

Phase I dose escalation of stereotactic body radiation therapy and concurrent cisplatin for re-irradiation of unresectable, recurrent head and neck squamous cell carcinoma.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6543-6543
Author(s):  
Michelle Echevarria ◽  
Christine H. Chung ◽  
Kedar Kirtane ◽  
Jameel Muzaffar ◽  
John Arrington ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Head And Neck Cancer ◽  
Phase I ◽  
Head And Neck ◽  
Dose Level ◽  
Stereotactic Body Radiation Therapy ◽  
Maximum Tolerated Dose ◽  
Recurrent Head

6543 Background: For patients with unresectable, previously radiated, locoregionally recurrent head and neck cancer, stereotactic body radiation therapy (SBRT) has become an attractive option. The use of high daily doses of radiotherapy may overcome the inherent radioresistance of these recurrent cancers. Given the resistant and advanced nature of many of these cancers, the addition of chemotherapy to radiotherapy is typically recommended as a radiosensitizer. We therefore performed a phase I clinical trial in order to establish a maximum tolerated dose of SBRT with concurrent chemotherapy in locoregionally recurrent head and neck cancer. Methods: Major inclusion criteria were recurrence of previous squamous cell carcinoma of the head and neck in patients who had previously undergone radiotherapy to doses ≥ 45 Gy to the area of recurrence, ≥ 6 months prior to enrollment, and who were medically unfit for surgery, deemed unresectable, or refused surgery. Patients were treated with radiation therapy every other day for five fractions at three dose levels; 30 Gy, 35 Gy, and 40 Gy. Cisplatin was given prior to every SBRT fraction at a dose of 15 mg/m2. Patients were monitored for safety and tolerability for any grade 4 or greater toxicity (per CTCAE v4.0) that occurred within 3 months from the start of SBRT. Primary end point was maximum tolerated dose (MTD). Results: Twenty patients were enrolled and of those 17 patients were evaluable for the primary endpoint. Nine patients had a primary tumor in the oropharynx, four patients in the oral cavity, three in the neck, one in the larynx, and one simultaneously in the larynx and neck. Of the three patients that were not evaluable two withdrew consent, and one patient in the 30 Gy dose level died of unknown causes two weeks following completion of treatment. Due to safety concerns the 30 Gy dose level was expanded an additional three patients, and no further dose limiting toxicities (DLTs) were observed. At the 35 Gy and 40 Gy dose level there were no reported grade 4 or 5 adverse events (per CTCAE v4.0). There were 5 (27%) reported grade 3 toxicities and 12 (66%) grade 2 toxicities. Conclusions: This phase I study demonstrates that 40 Gy SBRT with concurrent cisplatin at a dose of 15mg/m2 is feasible, safe, and well tolerated. Patients continue to be followed for secondary outcomes of local control and overall survival. Clinical trial information: NCT02158234 .

Phase I Study of Paclitaxel Given by Seven-Week Continuous Infusion Concurrent With Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

2001 ◽  
Vol 19 (5) ◽  
pp. 1363-1373 ◽  
Author(s):  
David I. Rosenthal ◽  
Jason H. Lee ◽  
Robert Sinard ◽  
Denise A. Yardley ◽  
Mitchell Machtay ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Phase I ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Continuous Infusion ◽  
Squamous Cell ◽  
Survival Data ◽  
Locally Advanced

PURPOSE: Paclitaxel is one of the most active agents for squamous cell carcinoma of the head and neck (SCCHN) and an in vitro radiosensitizer. The dose-response relationship for paclitaxel may depend more on exposure duration than on peak concentration. This National Cancer Institute–sponsored phase I trial was designed to determine the feasibility of combining continuous-infusion (CI) paclitaxel with concurrent radiation therapy (RT). PATIENTS AND METHODS: Patients with previously untreated stage IVA/B SCCHN were eligible. Primary end points were determination of the maximum-tolerated dose, dose-limiting toxicity, and pharmacokinetics for paclitaxel given by CI (24 hours a day, 7 days a week for 7 weeks) during RT (70 Gy/7 weeks). RESULTS: Twenty-seven patients were enrolled and assessable for toxicity. Nineteen of the patients who completed ≥ 70 Gy were assessable for response. Grade 3 skin and mucosal acute reactions occurred at 10.5 mg/m2/d, but uninterrupted treatment was possible in five of six patients. At 17 mg/m2/d, skin toxicity required a 2-week treatment break for all three patients. The mean paclitaxel serum concentration at dose levels ≥ 6.5 mg/m2/d exceeded that reported to achieve in vitro radiosensitization. Initial locoregional control was achieved in 14 (58%) of 24 of patients treated to 70 Gy, and control persisted in nine (38%). CONCLUSION: CI paclitaxel with concurrent RT is a feasible and tolerable regimen for patients with advanced SCCHN and good performance status. Preliminary response and survival data are encouraging and suggest that further study is indicated. The recommended phase II dose of paclitaxel by CI is 10.5 mg/m2/d with RT for SCCHN.

The impact of radiotherapy, in addition to chemotherapy, on overall survival in the initial management of patients with newly diagnosed metastatic head and neck squamous cell carcinoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6035-6035
Author(s):  
Sujith Baliga ◽  
Rafi Kabarriti ◽  
Nitin Ohri ◽  
Chandan Guha ◽  
Shalom Kalnicki ◽  
...  
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Propensity Score ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Propensity Score Matching ◽  
Squamous Cell ◽  
Prolonged Survival ◽  
Newly Diagnosed

6035 Background: The role of radiation therapy (RT) in the upfront management of patients with metastatic head and neck squamous cell carcinoma (HNSCC) is not clearly defined. In this study, we used the National Cancer Database (NCDB) to assess the association between RT use and overall survival (OS) for patients with metastatic HNSCC who received chemotherapy. Methods: We analyzed the NCDB to identify patients with newly diagnosed metastatic HNSCC from 2004-2013 who were treated with upfront chemotherapy. Associations between the use of RT and OS were evaluated using the Kaplan Meier method, univariate and multivariate cox regression, propensity score matching, and sequential landmark analysis. Survival outcomes were also compared for patients receiving a biologically effective dose (BED) ≥72 Gy10 and < 72 Gy10. Results: We identified 3,516 patients diagnosed with metastatic HNSCC who were treated with chemotherapy, of which 2,288 (65%) were also treated with RT. The median follow up was 11.9 months. The addition of RT to chemotherapy was associated with prolonged survival (median 13.6 v 11.3 months, logrank p < 0.001). On multivariate analysis, the use of RT remained associated with prolonged survival (HR = 0.71, 95% CI 0.61-0.82, p < 0.001). After propensity score matching, the addition of RT was associated with improved median survival (13.5 v 11.2 months) and 5-year (17% v 7%) OS compared to chemotherapy alone (log rank, p < 0·001). Landmark analyses limited to patients who survived at least 3, 6, and 12 months after diagnosis continued to demonstrate improved OS with the addition of RT. Among patients treated with RT, the use of RT schedules with a BED exceeding 72 Gy10 was associated with prolonged survival (median 18.0 versus 11.7 months, logrank p < 0.001). Conclusions: For patients with metastatic HNSCC, the addition of RT to chemotherapy was associated with improved OS in this population based study. These results provide rationale for prospective randomized trials to validate these findings and to determine the optimal radiation therapy dose/fractionation and treatment schedule for these patients.

Predicting unreported clinical trial efficacy using an ex-vivo tumor platform: Pembrolizumab+pt+5-FU vs. extreme in recurrent head and neck squamous cell carcinoma.

2018 ◽  
Vol 36 (15_suppl) ◽  
pp. e18042-e18042
Author(s):  
Munisha Smalley ◽  
Saravanan Thiyagarajan ◽  
Biswanath Majumder ◽  
Nandini Pal Basak ◽  
Abhishek Basu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Ex Vivo ◽  
Neck Squamous Cell Carcinoma ◽  
Recurrent Head

scholarly journals Phase I study of vandetanib with radiation therapy with or without cisplatin in locally advanced head and neck squamous cell carcinoma

Head & Neck ◽  
2015 ◽  
Vol 38 (3) ◽  
pp. 439-447 ◽  
Author(s):  
Vasiliki A. Papadimitrakopoulou ◽  
Steven J. Frank ◽  
Ezra W. Cohen ◽  
Fred R. Hirsch ◽  
Jeffrey N. Myers ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Phase I ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Phase I Study ◽  
Locally Advanced ◽  
Neck Squamous Cell Carcinoma ◽  
Advanced Head
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