Mature results of the LCCC1413 phase II trial of de-intensified chemoradiotherapy for HPV-associated oropharyngeal squamous cell carcinoma.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 6022-6022 ◽  
Author(s):  
Bhishamjit S. Chera ◽  
Robert Amdur ◽  
Colette J. Shen ◽  
Gaorav P. Gupta ◽  
Xianming Tan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Neck Dissection ◽  
Phase Ii ◽  
Squamous Cell ◽  
Smoking Status ◽  
Post Treatment ◽  
Free Survival ◽  
Pet Ct

6022 Background: To report the mature results from a prospective phase II clinical trial of highly de-intensified chemoradiotherapy (CRT) for patients with HPV-associated oropharyngeal squamous cell carcinoma (OPSCC). Methods: The major inclusion criteria were: 1) T0-T3, N0-N2, M0, 2) p16 positive, and 3) minimal/remote smoking history. Treatment was limited to 60 Gy intensity modulated radiotherapy with concurrent weekly intravenous cisplatin 30 mg/m2(second choice was cetuximab). Patients with T0-T2 N0-1 disease did not receive chemotherapy. All patients had a 10 to 12-week post-treatment PET/CT to determine need for planned neck dissection. The primary study endpoint was 2 year progression free survival (PFS). Secondary endpoint measures include 2 year local control (LC), regional control (RC), distant metastasis free survival (DMFS), cause specific survival (CSS) and overall survival (OS), and patient reported symptoms (PRO-CTCAE) and quality of life (EORTC QLQ-C30 & H&N35). Results: 114 patients were enrolled (median f/u of 28.8 months, range 2.6 to 51.4) with 84 having a minimum follow-up of 2 years. Smoking status was as follows: 47% never, 33% ≤ 10 pack years, and 19% > 10 pack years. Post-treatment PET/CT complete response rate was 93% at the primary site and 80% in the neck. Eleven patients had planned neck dissection with 4 having pathological residual disease. Two year LC, RC, DMFS, PFS, CSS, and OS were the following: 96%, 99%, 91%, 88%, 97%, and 95%. Neither smoking status nor receipt of cetuximab correlated with recurrence. Four patients with recurrent disease had PIK3CA mutations. Thirty four percent of patients required a feeding tube (none permanent) for a median of 10.5 weeks. Mean pre- and 2-year post-treatment EORTC QOL scores were: Global 79/83 (lower worse), Swallowing 8/9 (higher worse), Dry Mouth 14/45 (higher worse), and Sticky Saliva 9/28 (higher worse). Mean pre- and 2 year post-treatment PRO-CTCAE (0 to 4 scale, higher worse) scores were: Swallowing 0.5/0.7 and Dry mouth 0.4/1.4. There were no ≥ Grade 3 late adverse events. Conclusions: Clinical outcomes with a highly de-intensified CRT regimen of 60 Gy IMRT with concurrent low-dose cisplatin are excellent in patients with HPV-associated OPSCC. Clinical trial information: NCT02281955.

Phase II study of pembrolizumab after chemoradiotherapy (CRT) as adjuvant therapy for locally advanced esophageal squamous cell carcinoma (LA-ESCC) patients at high risk of recurrence following preoperative CRT plus surgery.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS259-TPS259
Author(s):  
Chih-Hung Hsu ◽  
Jhe-Cyuan Guo ◽  
Ta-Chen Huang ◽  
Hung-Yang Kuo ◽  
Chia-Chi Lin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Phase Ii Study ◽  
Free Survival ◽  
Risk Of Recurrence

TPS259 Background: LA-ESCC is a potentially curable disease, for which preoperative CRT followed by esophagectomy is a standard-of-care. Previous studies have identified that close/involved margin and lymph node metastasis with extranodal invasion (ENI) in post-CRT surgical specimens are associated with increased risk of recurrence. In CheckMate-577 trial, adjuvant nivolumab significantly improved disease-free survival (DFS) in patients with esophageal cancer treated with preoperative CRT and surgery; in another trial (the “PACIFIC” trial), adjuvant durvalumab has significantly improved overall survival (OS) in stage III non-small cell lung cancer treated with definitive CRT. We hypothesize that adding pembrolizumab to CRT as an adjuvant therapy would improve the outcomes of LA-ESCC patients who are treated with preoperative CRT plus esophagectomy and with high-risk of recurrence. Methods: This single institution single-arm phase II study include patients with histologically confirmed LA-ESCC (AJCC 7th staging system:cT3-4aN0M0 or T1-4aN1-3M0) harboring at least one risk factor (closed/involved margin, ENI, or ypN2-3) in post-CRT surgical specimens. Patients with adenocarcinoma of esophagus or gastroesophageal junction or synchronously diagnosed with a squamous cell carcinoma of aero-digestive way other than ESCC are excluded. Patients enrolled will receive adjuvant weekly cisplatin–CRT (cisplatin, 30mg/m2 for 2 cycles every week; radiotherapy, 180-200 cGy/fraction for 10-13 times) followed by pembrolizumab (200 mg, every 3 weeks, for 18 cycles). The primary endpoint of this study is 1-year relapse-free survival (RFS) rate; and the key secondary endpoints include RFS, 3-year RFS rate, OS, 3-yr OS rate, toxicity and safety. The study, registered with clinical trial ID of NCT03322267, started patient enrollment in Aug 2018. As of Aug of 2020, 11 of 46 planned patients have been enrolled. Clinical trial information: NCT03322267.

scholarly journals Phase II Trial of De-Intensified Chemoradiotherapy for Human Papillomavirus–Associated Oropharyngeal Squamous Cell Carcinoma

2019 ◽  
Vol 37 (29) ◽  
pp. 2661-2669 ◽  
Author(s):  
Bhishamjit S. Chera ◽  
Robert J. Amdur ◽  
Rebecca Green ◽  
Colette Shen ◽  
Gaorav Gupta ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Human Papillomavirus ◽  
Adverse Events ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Patient Reported Outcomes ◽  
Oropharyngeal Squamous Cell Carcinoma ◽  
Post Treatment ◽  
Free Survival ◽  
Patient Reported

PURPOSE To report the results of a phase II clinical trial of de-intensified chemoradiotherapy for patients with human papillomavirus–associated oropharyngeal squamous cell carcinoma. MATERIALS AND METHODS Major inclusion criteria were (1) having American Joint Committee on Cancer (AJCC) 7th edition T0-T3, N0-N2c, M0 (AJCC 8th edition T0-T3, N0-N2, M0), (2) being p16 positive, and (3) reporting minimal or remote smoking history. Treatment was limited to 60 Gy intensity-modulated radiotherapy with concurrent intravenous cisplatin 30 mg/m2 once per week. Patients with T0-T2 N0-1 (AJCC 7th edition) did not receive chemotherapy. All patients had a 10- to 12-week post-treatment positron emission tomography/computed tomography to assess for neck dissection. The primary end point was 2-year progression-free survival. Secondary end points included 2-year local-regional control, distant metastasis-free survival and overall survival, and patient-reported outcomes (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire and the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events). RESULTS One hundred fourteen patients were enrolled (median follow-up of 31.8 months), with 81% having a minimum follow-up of 2 years. Eighty percent of patients had 10 or fewer tobacco pack-years. Two-year local-regional control, distant metastasis-free survival, progression-free survival, and overall survival were as follows: 95%, 91%, 86%, and 95%, respectively. Mean pre- and 2-year post-treatment European Organisation for Research and Treatment of Cancer quality of life scores were as follows: global, 79/84 (lower worse); swallowing, 8/9 (higher worse); and dry mouth, 14/45 (higher worse). Mean pre- and 2-year post-treatment patient-reported outcomes version of the Common Terminology Criteria for Adverse Events scores (0 to 4 scale, higher worse) were as follows: swallowing, 0.5/0.7, and dry mouth, 0.4/1.3. Thirty-four percent of patients required a feeding tube (median, 10.5 weeks; none permanent). There were no grade 3 or higher late adverse events. CONCLUSION Clinical outcomes with a de-intensified chemoradiotherapy regimen of 60 Gy intensity-modulated radiotherapy with concurrent low-dose cisplatin are favorable in patients with human papillomavirus–associated oropharyngeal squamous cell carcinoma. Neither neoadjuvant chemotherapy nor routine surgery is needed to obtain favorable results with de-escalation.

scholarly journals EP-1065: Post-treatment FDG-PET CT in detecting residual disease in head & neck squamous cell carcinoma

2016 ◽  
Vol 119 ◽  
pp. S513
Author(s):  
J. Price ◽  
A. Pascoe ◽  
C. Weston ◽  
S. Kathirgamakarthigeyan ◽  
M. Griffin ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Fdg Pet ◽  
Residual Disease ◽  
Post Treatment ◽  
Neck Squamous Cell Carcinoma ◽  
Pet Ct ◽  
Fdg Pet Ct ◽  
Head Neck

Phase II randomized study comparing concurrent chemoradiation versus neoadjuvant chemotherapy followed by chemoradiation in locally advanced unresectable squamous cell carcinoma of esophagus.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e15138-e15138
Author(s):  
Pritee Baburao Chaudhari ◽  
Subhash Chander ◽  
B. K. Mohanti ◽  
Atul Sharma ◽  
Jaspreet Kaur ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Neoadjuvant Chemotherapy ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Locally Advanced ◽  
Post Treatment ◽  
Concurrent Chemoradiation ◽  
Weekly Paclitaxel ◽  
Carcinoma Of Esophagus

e15138 Background: A significant number of patients diagnosed with esophageal cancer (EC) presents with locally advanced disease. Nonsurgical curative therapy for unresectable EC has limited outcome. Methods: Phase II randomized control trial to assess early locoregional response (LRR) to neoadjuvant chemotherapy (NACT) followed by concurrent chemoradiation (CRT) versus definitive CRT in surgically unresectable squamous cell carcinoma of esophagus (ESCC). A total of 30 patients were randomly assigned to two arms. Arm 1: 2 cycles NACT regimen of 5-fluorouracil (750mg/m2 D1-4) and cisplatin (80mg D1-2) followed by CRT, radiation of 56Gy/ 28 Fr concurrent with weekly paclitaxel 50mg/m2 and carboplatin AUC2. Arm2: CRT; consisting of radiation 56Gy/28Fr and weekly paclitaxel 50mg/m2 and carboplatin AUC2. All the patients were followed till 6 months post treatment. LRR assessment was done at 1, 3 and 6 months post treatment. Wilcoxon multivariate analysis was carried out and difference of the factors were assessed by chi square test (x2 p<0.05). Results: Mean age in two arms were 52 and 54 years respectively. The study had median follow up of 6.6 months. Conclusions: In unresectable EC, CRT showed higher LRR, treatment completion and lesser toxicity compared to NACT combined with CRT. In this pilot cohort of locally advanced unresectable EC paclitaxel and carboplatin combined with radiotherapy has good tolerance and compliance. [Table: see text]

A phase II study of early FDG-PET evaluation after one-cycle chemotherapy in patients with locally advanced esophageal squamous cell carcinoma treated with neoadjuvant chemoradiotherapy: Final report.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4042-4042
Author(s):  
Ta-Chen Huang ◽  
Chia-Chi Lin ◽  
Kai-Yuan Tzen ◽  
Yun-Chun Wu ◽  
Jason Chia-Hsien Cheng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Squamous Cell Carcinoma ◽  
Esophageal Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Phase Ii ◽  
Squamous Cell ◽  
Fdg Pet ◽  
Locally Advanced ◽  
Neoadjuvant Chemoradiotherapy ◽  
Final Report

4042 Background: The optimal use of the metabolic tumor response measured by 18fluorodeoxyglucose positron emission tomography (FDG-PET) in the treatment of esophageal cancer is currently unknown. We launched a phase II clinical trial to evaluate the early metabolic response to one-cycle chemotherapy in locally advanced esophageal squamous cell carcinoma (ESCC) patients, who subsequently received neoadjuvant chemoradiation (neo-CRT) followed by surgery. Methods: ESCC patients with stage T3 or N1M0 or M1a (AJCC, 6th edition) were enrolled to receive one-cycle chemotherapy, day 1 and 8 doses of paclitaxel, cisplatin, and 24-hour infusional 5-fluorouracil and leucovorin, followed by paclitaxel/cisplatin- based 40Gy neo-CRT and surgery. FDG-PET was performed at baseline and day 14 of the one-cycle chemotherapy. The primary endpoint is pathological complete response (pCR) to neo-CRT. We hypothesized that early PET responders, defined as > 35% reduction of maximum standardized uptake value (SUVmax) from the baseline, would significantly improve pCR. Results: Between Feb 2008 and Mar 2012, 66 patients (M: F = 61: 5) were enrolled. Their clinical stages were: II or III, 56; IVA, 10. Forty seven received surgery. The pCR rate per surgical population was 34.0%. The median progression-free survival (PFS) and overall survival (OS) for the whole study group was 16 months (95% CI 9-27) and 22 months (95% CI 16-40), respectively. A total of53 patients were evaluable for PET response. The early PET response was not associated with high pCR rate or better survivals. However, in an exploratory analysis, the post-chemotherapy SUVmax was an independent prognostic factor for pCR, PFS and OS. A predictive model for pCR composed of weight loss and the post-chemotherapy SUVmaxwas established with an AUC of 0.84. Conclusions: Our study failed to validate the predictive value of predefined early PET response to one-cycle chemotherapy for pCR to neo-CRT in locally advanced ESCC patients. However, the FDG-PET SUVmax after one-cycle chemotherapy may have prognostic and predictive significance, and may be explored in further studies. Clinical trial information: NCT01034332.

scholarly journals Value of 18F-FDG PET/CT for Assessment of Advanced Lacrimal Sac Non-Keratinizing Squamous Cell Carcinoma Successfully Treated with Concurrent Chemoradiotherapy

Diagnostics ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. 1961
Author(s):  
Ching-Yu Liao ◽  
Li-An Huang ◽  
Yu-Hsuan Lin
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Squamous Cell ◽  
Fdg Pet ◽  
Post Treatment ◽  
Lacrimal Sac ◽  
Pet Ct ◽  
18F Fdg ◽  
Keratinizing Squamous Cell Carcinoma ◽  
Fdg Pet Ct

Non-keratinizing squamous cell carcinoma (NKSCC) of the lacrimal apparatus is extremely rare. It is usually very aggressive in destroying local tissue and has a grave prognosis for relentless recurrence and distant failures. Though the current evidence cannot make confident recommendations regarding the best management, curative surgical excision with adjuvant radiotherapy remains the most commonly used strategy. Here, we report a 71-year-old woman presented with progressive right medial canthal swellings for six months. A transnasal endoscopic biopsy revealed NKSCC of the lacrimal sac. She then underwent a combination of magnetic resonance images (MRI) and 2-deoxy-2-(18F)fluoro-D-glucose positron emission tomography/computed tomography (18F-FDG PET/CT) for staging purposes. Following cisplatin-based concurrent chemo-radiotherapy (CCRT), the post-treatment PET/CT illustrated the absence of an abnormal metabolic accumulation over the suspicious region as observed in post-treatment CT. A further trans-ostia re-biopsy confirmed complete tumor remission. This case demonstrates the remarkable ability of 18F-FDG PET/CT to differentiate between a persistent malignancy and post-treatment changes. Furthermore, a definite CCRT might provide comparable outcomes to traditional surgery.

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