Prognostic value of radiological extranodal extension detected by computed tomography for predicting outcomes in head and neck squamous cell cancer patients treated with radical chemoradiotherapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6560-6560
Author(s):  
Abhishek Mahajan ◽  
Ankur Chand ◽  
Vijay Maruti Patil ◽  
Vanita Noronha ◽  
Amit Joshi ◽  
...  
Keyword(s):  
Head And Neck ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
Imaging Biomarker ◽  
P Value ◽  
Open Label ◽  
Equal Distribution ◽  
Pre Treatment

6560 Background: As per the AJCC 8th edition ENE/ECS is the most important predictor for N staging of HNSCC and is one of the key predictor of outcomes. Because ENE/ECS is based on pathological findings after surgery and it is difficult to predict outcomes for locally advanced squamous head and neck cancer (LASHNC) treated radically with CCRT. We hypothesized that ENE assessed by CT imaging (rENE) may directly correlate with outcomes in LASHNC treated radically with CCRT. Methods: This open-label, investigator-initiated, phase 3, randomized trial was conducted from 2012 to 2018. Adult patients with LASHNC who were fit for radical chemoradiation were randomized 1:1 to receive either radical radiotherapy (66-70 grays) with concurrent weekly cisplatin (30 mg/m2) (CRT) or the same schedule of CRT with weekly nimotuzumab (200 mg) (NCRT). 536 patients were accrued,182 were excluded due to non-availability DICOM CT scan, 354 patients were analysed for rENE (based on 6 criterion for metastasis and 3 for rENE). Near equal distribution of patients was achieved in CRT arm (170 patients) and NCRT arm (184 patients). There were 181 (51.1%) oropharynx and 173(48.9%) larynx and hypopharynx patients. We evaluated association of radiological ENE and clinical outcomes.The endpoints were disease-free survival (DFS), duration of locoregional control (LRC), and overall survival (OS). Results: There were 244(68.9%) patients with radiologically metastatic nodes, out of which 140(57.3%) had rENE. There was no significant association between rENE and CRT (p value 0.3) or NCRT (p value 0.412). The median follow-up was 33.0 months (95%CI 30.7-35.2 months). Complete response was achieved in 204 (57.6%) cases, PR/SD in 126(35.6%) cases and PD in 24(6.8%) cases. rENE positive patients had poor overall 3-year survival (46.7%), poor DFS (48.8%) and LRC (39.9%) than rENE negative cases (63.6%, 87%, 60.4%). rENE positive cases had 1.71 times increase chances of incomplete response than rENE negative cases. Overall stage, clinical positive node, response, rENE and site were the only significant factors for predicting OS, DFS and LRC. Conclusions: In conclusion, pre-treatment rENE can be regarded as an independent prognostic factor for survival (OS, DFS, LRC) in patients with LASHNC treated radically with CCRT. Pre-treatment rENE is not only associated with CCRT response but is also associated with poor prognosis and hence rENE, as an imaging biomarker, can stratify responder’s vs non-responders. Clinical trial information: CTRI/2014/09/004980 .

Concurrent Paclitaxel and Radiation in the Treatment of Locally Advanced Head and Neck Cancer

2001 ◽  
Vol 19 (3) ◽  
pp. 800-811 ◽  
Author(s):  
John B. Sunwoo ◽  
Laurie L. Herscher ◽  
Glenn S. Kroog ◽  
Giovana R. Thomas ◽  
Frank G. Ondrey ◽  
...  
Keyword(s):  
Head And Neck ◽  
Continuous Infusion ◽  
Locally Advanced ◽  
Plasma Concentrations ◽  
Disease Free Survival ◽  
Complete Response ◽  
Survival Duration ◽  
Advanced Head ◽  
Skin Reactions ◽  
Standard Format

PURPOSE: To determine the feasibility of an organ preservation regimen consisting of infusional paclitaxel administered concurrently with radiotherapy to patients with locally advanced head and neck squamous cell carcinoma (HNSCC). PATIENTS AND METHODS: Thirty-three previously untreated patients with stage III or IV tumors were enrolled onto the study. Paclitaxel was administered as a 120-hour continuous infusion every 3 weeks during the course of radiation therapy. Sixteen patients received a paclitaxel dose of 105 mg/m2, and 17 patients received 120 mg/m2. Radiation was delivered in a standard format at 1.8 Gy/d to a total dose of 70.2 to 72 Gy. RESULTS: Three months after therapy, a 76% complete response (CR) at the primary site and a 70% overall CR was achieved. At 36 months, locoregional control was 55.7%, overall survival was 57.8%, and disease-free survival was 51.1%. The median survival duration for all 33 patients was greater than 50 months at the time of this report. Local toxicities including mucositis, dysphagia, and skin reactions were severe but tolerable. All patients retained functional speech, and all but four patients were swallowing food 3 months after treatment. Steady-state plasma concentrations for paclitaxel were not achieved during a 120-hour infusion, suggesting a nonlinear process. Tumor volume quantified by pretreatment computerized tomography imaging was associated with likelihood of response and survival. CONCLUSION: Paclitaxel administered as a 120-hour continuous infusion in combination with radiotherapy is a feasible and promising treatment for patients with advanced HNSCC.

Cetuximab, paclitaxel, carboplatin and radiation for esophageal and gastric cancer

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 4029-4029 ◽  
Author(s):  
M. Suntharalingam ◽  
T. Dipetrillo ◽  
P. Akerman ◽  
H. Wanebo ◽  
B. Daly ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Esophageal Cancer ◽  
Head And Neck Cancer ◽  
Head And Neck ◽  
Squamous Cell ◽  
Squamous Cell Cancer ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Complete Response ◽  
Grade 3

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]

Nimotuzumab with concurrent chemoradiotherapy in patients with locally advanced head and neck cancer (LASCCHN).

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6084-6084 ◽  
Author(s):  
Naresh Somani ◽  
Karandikar SM ◽  
Kamlesh Bokil ◽  
Kumar Tapash Bhowmik ◽  
Shyam Agarwal
Keyword(s):  
Monoclonal Antibody ◽  
Adverse Event ◽  
Head And Neck ◽  
Squamous Cell ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Neck Region ◽  
Open Label ◽  
Term Survival ◽  
Head And Neck Region

6084 Background: Nimotuzumab is a humanized monoclonal antibody targeting EGFR receptors. Unlike other anti-EGFR monoclonal antibodies, it has demonstrated to be safe and effective when combined with chemotherapy or/and radiotherapy. We evaluated safety and efficacy of concurrently administrating nimotuzumab with chemo-radiotherapy in patients with locally advanced inoperable squamous cell carcinomas of head and neck region in a usual health care setting. Methods: Open-label single-arm study. Patients of age 18 years and above with histologically confirmed squamous cell cancer of head and neck region in an inoperable stage (stage III & IV) having an ECOG ≤ 2 were included in the study. Informed consent was obtained from all the patients. The patient were administered injection cisplatin (30 mg/m2 IV) and nimotuzumab (200 mg IV) weekly for six weeks along with radiotherapy of 6600cGy over 33 fractions. Patients were evaluated based on RECIST criteria 24 weeks after the last cycle of chemotherapy. Results: Fifty seven patients were enrolled in the study. Mean age of the patients was 51yr (29 yr-79 yr). Most common site of cancer was oral cavity 32 (56.14%). Fourty six (80.70%) patients completed 6 cycles of therapy. ORR was 80.7%, 34 with CR (59.6%), 12 with PR (21%), 8 with SD (14%), 3 with PD (5.2%). Most common adverse event seen was mucositis (33%) but there was no grade III or IV adverse event. Conclusions: Addition of anti-EGFR monoclonal antibody (nimotuzumab) is safe and efficacious based on the loco-regional response and confirms the available phase II data. The long-term survival benefits based on this encouraging response rate needs to be further evaluated especially in patients with inoperable LASCCN.

Local and Systemic Inflammatory Markers as Prognostic and Predictive Markers In Locally Advanced Triple Negative Breast Cancer

2020 ◽  
Vol 106 (1_suppl) ◽  
pp. 30-30
Author(s):  
Lamiss Mohamed ◽  
Aymn Elsaka ◽  
Yomna Zamzam
Keyword(s):  
Overall Survival ◽  
Neoadjuvant Chemotherapy ◽  
Inflammatory Markers ◽  
Triple Negative ◽  
Statistical Significance ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Complete Response ◽  
P Value ◽  
Neutrophil Lymphocyte Ratio

Local inflammatory markers have been defined as prognostic and predictive markers in triple negative markers as proved by many studies. The prognostic and predictive value of systemic inflammatory markers such as neutrophil lymphocyte ratio (NLR) and lymphocyte monocyte ratio (LMR) remain to be elucidated. Aim of study: To evaluate pathological complete response (PCR) to neoadjuvant chemotherapy in locally advanced cancer breast in relation to tumor infiltrating lymphocytes(TILs), neutrophil lymphocyte ratio and lymphocyte monocyte ratio as well as overall survival and disease free survival. Patients and methods: In Tanta university Hospital, oncology department form January 2012 to December 2013, 67 patients with locally advanced TNBC stage IIB, IIIB 0r IIIC using TNM 8t h edition . All patients received neoadjuvant chemotherapy in the form of dose dense AC followed by paclitaxel (adriamycin & cyclophosphamide 60 mgm/m2 & 600 mgm/m2 respectively the cycle is repeated every 2 weeks for 4 cycles followed by paclitaxel 175mgm/m2 every 2 weeks for 4 cycles). All cycles with G-CSF support. Pre treatment TILs, NLR and LMR were evaluated with PCR and as prognostic factor of survival. Results: Low NLR has been detected in 74.6% of cases and has been associated with high TILs and this was statistically significant (p value=0.03). High LMR was observed in 80.6% of cases and correlated significantly with TILs (p value =0.003). Pathological CR was found to be associated with high TILs, low NLR and high LMR. In our study we evaluated the pre neoadjuvant systemic and local inflammatory markers as prognostic marker we found that in multivariate analysis, the lymphocyte monocyte ratio maintained their statistical significance with overall survival. While tumor infiltrating lymphocyte maintained their statistical significance as prognostic factors with overall survival and disease free survival. Conclusion: Systemic inflammatory markers can be used as marker of pathological complete response in locally advanced triple negative breast6 cancer with neoadjuvant chemotherapy.

LUX-head and neck 2: Randomized, double-blind, placebo-controlled, phase III trial of afatinib as adjuvant therapy after chemoradiation (CRT) in primary unresected, high/intermediate-risk, squamous cell cancer of the head and neck (HNSCC) patients (pts).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6001-6001 ◽  
Author(s):  
Barbara Burtness ◽  
Robert I. Haddad ◽  
José Dinis ◽  
Jose Manuel Trigo Perez ◽  
Tomoya Yokota ◽  
...  
Keyword(s):  
Oral Cavity ◽  
Head And Neck ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Egfr Inhibition ◽  
N2 Disease ◽  
Ecog Ps

6001 Background: Locally advanced HNSCC is treated curatively, but recurrence is common. In HNSCC, EGFR is richly expressed and EGFR inhibition is validated treatment (tx); the ErbB family blocker afatinib (A) showed efficacy in recurrent/metastatic disease. This Phase III trial assessed if A after definitive CRT improves disease-free survival (DFS). Methods: Eligible pts had complete response after CRT ≥66 Gy (or equivalent) with concurrent cisplatin or carboplatin but not prior EGFR inhibition, for HNSCC of oral cavity, hypopharynx, larynx, or oropharynx with >10 pack years (pk yrs) tobacco use. Pts were stratified by ECOG PS (0/1) and nodal stage (N0–2a/N2b–3), and randomized 2:1 to A 40 mg/d or placebo (P); tx continued for 18 m if tolerated, or until disease recurrence. The primary endpoint was DFS. Results: Of 669 pts planned, 617 were randomized; A 411, P 206. Median age was 58 yrs; 86% were male; 65% ECOG PS 0; most had smoked (A/P ex-smoker: 66/72%; current: 28/22%). Subsites (A/P) were: oropharynx 53/54%; hypopharynx 21/23%; larynx 18/12%; oral cavity 9/10%. The majority had T3 or 4 (A/P 70/68%) and N2 disease (67/63%). Accrual was halted for futility on independent DMC recommendation: at a pre-planned interim analysis (40% of DFS events), median DFS was A 43.4 m vs P not reached (NR; HR 1.13 [95% CI 0.81–1.57], p=0.48); the Table shows key subgroups. Median treatment duration was A 300.0 d, P 455.5 d. Recurrence was A 23%, P 23%. Dose reduction of A was required in 53% (mostly due to diarrhea, stomatitis). Tx was discontinued due to AEs in A 15%, P 4%. Conclusions: A after CRT did not improve DFS vs P. Subgroup analyses were underpowered to provide definitive conclusions. Harrington and Cohen contributed equally. Clinical trial information: NCT01345669. [Table: see text]

Randomized Phase III Evaluation of Cisplatin Plus Fluorouracil Versus Cisplatin Plus Paclitaxel in Advanced Head and Neck Cancer (E1395): An Intergroup Trial of the Eastern Cooperative Oncology Group

2005 ◽  
Vol 23 (15) ◽  
pp. 3562-3567 ◽  
Author(s):  
Michael K. Gibson ◽  
Yi Li ◽  
Barbara Murphy ◽  
Maha H.A. Hussain ◽  
Ronald C. DeConti ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck ◽  
Response Rate ◽  
Cell Cancer ◽  
Objective Response ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Complete Response ◽  
Phase Iii ◽  
Significant Difference

Purpose To determine the response rate, survival and toxicity of infusional cisplatin plus fluorouracil (CF) versus cisplatin plus paclitaxel (CP) in patients with incurable squamous cell cancer of the head and neck, with the hypothesis that CP is superior. Patients and Methods Two hundred eighteen patients with locally advanced, recurrent, or metastatic disease were randomly assigned to CF (cisplatin 100 mg/m2 day 1 and fluorouracil 1,000 mg/m2/24 hours by continuous intravenous infusion day 1 through 4) or CP (cisplatin 75 mg/m2 day 1 and paclitaxel 175 mg/m2 over 3 hours on day 1). Cycles were repeated every 3 weeks until progression or a minimum of 6 cycles with complete response or stable disease. The primary outcome was overall survival. Secondary outcomes included response rate and toxicity. Results No significant difference in overall survival or response rate was seen. Estimated median survival was 8.7 months in the CF group and 8.1 month in the CP group. Objective response rate (complete response plus partial response) was 27% in the CF group and 26% in the CP group. Toxicity was similar between groups, with the most frequent including myelosuppression, thrombocytopenia, anemia, nausea, vomiting, and stomatitis. A total of 12 deaths occurred (CF, seven; CP, five) during treatment; eight from infection, two from hemorrhage, one from cardiac causes and one from unknown causes. Gastrointestinal and hematologic toxicities were more common in the CF group, whereas neurotoxicity was equivalent between groups. Conclusion This phase III, randomized, multicenter trial showed no difference in survival between patients treated with CF or CP.

LUX head and neck 2: A randomized, double-blind, placebo-controlled, phase III study of afatinib as adjuvant therapy after chemoradiation in primarily unresected, clinically high-risk, head and neck cancer patients.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS5599-TPS5599 ◽  
Author(s):  
Barbara Burtness ◽  
Jean Bourhis ◽  
Jan Baptist Vermorken ◽  
Luyan Dai ◽  
Charlotte Lind ◽  
...  
Keyword(s):  
High Risk ◽  
Head And Neck ◽  
Neck Dissection ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Salivary Gland Cancer ◽  
Primary Tumors ◽  
Egfr Inhibition

TPS5599 Background: Locally advanced squamous cell cancer of the head and neck (SCCHN) is treated with curative intent, but recurrence and death are common. SCCHN frequently over-expresses EGFR (ErbB1). Co-expression of other HER family members such as HER2 (ErbB2) may contribute to resistance to EGFR inhibition, which is the only validated targeted therapy in SCCHN. Methods: The trial investigates if adjuvant afatanib, an irreversible ErbB family blocker, which has shown preclinical activity against all ErbB dimers including EGFR and HER2, reduces the risk of recurrence in high-risk patients who have no evidence of disease following platinum-based chemoradiation with or without neck dissection. Patients are eligible who have received definitive chemoradiation to a minimum of 66 Gy, with concurrent cisplatin (≥200 mg/m2) or carboplatin (≥AUC 9), for SCC of the oral cavity, oropharynx, or hypopharynx or larynx. Patients with base of tongue or tonsil cancer and ≤10 pack years of tobacco use, as well as those with nasopharynx, sinus or salivary gland cancer, are excluded. Adequate bone marrow, liver and kidney function is required. Prior therapy with investigational agents or EGFR inhibitors is not permitted. Randomization must take place within 16 weeks of the completion of chemoradiation with or without subsequent neck dissection. Patients are randomized 2:1 to afatinib 40 mg po qd or placebo, and treatment continues for 18 months in the absence of disease recurrence, second primary tumors, or intolerance to the study medication. Dose escalation to 50 mg qd is undertaken in patients with no side effects, and stepwise dose reduction to 30 or 20 mg po qd for diarrhea, skin toxicity or other adverse events is permitted. The primary endpoint is disease-free survival (DFS). The study is planned to accrue approximately 669 patients worldwide, with a 90% power to detect a hazard ratio of 0.72. Secondary endpoints are DFS at 2 years, overall survival, health-related quality of life, and safety.

624 A PHASE III STUDY ON NEOADJUVANT TORIPALIMAB PLUS CHEMOTHERAPY VERSUS NEOADJUVANT CHEMOTHERAPY FOR LOCALLY RESECTABLE ESOPHAGEAL SQUAMOUS CELL CARCINOMA

2021 ◽  
Vol 34 (Supplement_1) ◽  
Author(s):  
Yan Zheng ◽  
Jiangong Zhang ◽  
Wenqun Xing
Keyword(s):  
Phase Ii ◽  
Checkpoint Inhibitors ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Phase Iii ◽  
R0 Resection ◽  
Phase Iii Trial ◽  
Free Survival

Abstract   In recent years, immune checkpoint inhibitors (ICIs) have shown promising results in the treatment of ESCC. More than 20 phase II clinical trials have been launched to explore combinations of ICIs in the neoadjuvant setting for ESCC. Based on our phase II clinical trial, a two-arm phase III trial was launched in our Hospital. Methods A two-arm phase III trial was launched in April 2020 in our Hospital. Patient recruitment will be completed within 18 months. The primary endpoint is event-free survival (EFS). The secondary endpoints include pathologic complete response (pCR), disease-free survival (DFS) rate, overall response rate (ORR), R0 resection rate, major pathologic response (MPR), adverse events (AEs), complication rate and quality of life (QOL). A biobank of pretreatment, resected tumor tissue and paired blood samples will be built for translational research in the future. Results Until Dec. 2021, one hundred and twenty ESCC patients recruited in the trial. The trial is ongoing. Conclusion This RCT directly compares NAC with neoadjuvant toripalimab plus chemotherapy in terms of EFS for locally advanced ESCC. The results may usher in a new era of resectable ESCC treatment.

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