scholarly journals ECOG-ACRIN 2399: analysis of patient related outcomes after Chemoradiation for locally advanced head and neck Cancer

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Anthony Cmelak ◽  
Mary S. Dietrich ◽  
Shuli Li ◽  
Sheila Ridner ◽  
Arlene Forastiere ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Locally Advanced ◽  
Surrogate Marker ◽  
Post Treatment ◽  
Self Report ◽  
Barium Swallow ◽  
Functional Communication ◽  
Swallowing Function ◽  
Modified Barium Swallow

Abstract Background We conducted a correlative study for E2399, a function preservation trial for resectable locally advanced oropharynx and larynx cancer, to prospectively assess effects of chemoradiation (CCR) on quality of life (QOL), swallowing and voice. We correlated the results of swallow assessments done via questionnaires and objective assessments by modified barium swallow (MBS). Methods The Functional Assessment of Cancer-HN (FACT-HN), the Performance Status Scale – Head and Neck (PSS-HN), swallow assessments (including modified barium swallow studies), and voice assessments: Voice Handicap Index (VHI), the Voice Disability Assessment (VDA), and American Speech-Language Hearing Association’s Functional Communication Measure (FCM) were conducted at baseline and periodically post-treatment for 2 years. Results Baseline QOL and swallowing function predicted overall survival. Patients experienced a marked decrease in QOL, swallowing, and speech post CCR although the decrease in vocal function was modest. Function and QOL returned towards baseline in the majority of patients by 12 months post treatment. Less than 10% of patients had severe dysphagia and were PEG dependent at 12 months post treatment. There was a high degree of correlation between the FACT-HN and PSS-HN swallow items. Statistically significant correlations were found between subjective and objective measures of swallow function. Conclusions Patients experience marked loss in swallowing function post CCR which returned to baseline in the majority of patients. The correlations between the FCM and self-report swallow items on the PSS and FACT-HN appear to be sufficiently strong to justify their use as a surrogate marker for swallowing disability in large therapeutic trials.

scholarly journals ECOG-ACRIN 2399: Analysis of Patient Related Outcomes After Chemoradiation for Locally Advanced Head and Neck Cancer

2020 ◽  
Author(s):  
Anthony J. Cmelak ◽  
Mary S. Dietrich ◽  
Shuli Li ◽  
Sheila Ridner ◽  
Arlene A Forastiere ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Locally Advanced ◽  
Surrogate Marker ◽  
Post Treatment ◽  
Self Report ◽  
Barium Swallow ◽  
Functional Communication ◽  
Swallowing Function ◽  
Therapeutic Trials

Abstract Background: We conducted a correlative study for E2399, a function preservation trial for resectablelocally advanced oropharynx and larynx cancer, to prospectively assess effects of chemoradiation (CCR) on quality of life (QOL), swallowing and voice. We correlated the results of swallow assessments done via questionnaires and objective assessments.Methods: The Functional Assessment of Cancer-HN (FACT-HN), the Performance Status Scale – Head and Neck (PSS-HN), swallow assessments (including modified barium swallow studies), and voice assessments: Voice Handicap Index (VHI), the Voice Disability Assessment (VDA), and American Speech-Language Hearing Association’s Functional Communication Measure (FCM) were conducted at baseline and periodically post-treatment for 2 years.Results: Baseline QOL and swallowing function predicted overall survival. Patients experienced a marked decrease in QOL, swallowing, and speech post CCR although the decrease in vocal function was modest. Function and QOL returned towards baseline in the majority of patients by 12 months post treatment. Less than 10% of patients had severe dysphagia and were PEG dependent at 12 months post treatment. There was a high degree of correlation between the FACT-HN and PSS-HN swallow items. Statistically significant correlations were found between subjective and objective measures of swallow function.Conclusions: Patients experience marked loss in swallowing function post CCR which returned to baseline in the majority of patients. The correlations between the FCM and self-report swallow items on the PSS and FACT-HN appear to be sufficiently strong to justify their use as a surrogate marker for swallowing disability in large therapeutic trials.

scholarly journals ECOG-ACRIN 2399: Analysis of Patient Related Outcomes after Chemoradiation for Locally Advanced Head and Neck Cancer

2021 ◽  
Author(s):  
Anthony J. Cmelak ◽  
Mary S. Dietrich ◽  
Shuli Li ◽  
Sheila Ridner ◽  
Arlene A Forastiere ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Locally Advanced ◽  
Surrogate Marker ◽  
Post Treatment ◽  
Self Report ◽  
Barium Swallow ◽  
Swallowing Function ◽  
Vocal Function ◽  
Therapeutic Trials

Abstract Background We conducted a correlative study for E2399, a function preservation trial for resectable locally advanced oropharynx and larynx cancer, to prospectively assess effects of chemoradiation (CCR) on quality of life (QOL), swallowing and voice. We correlated the results of swallow assessments done via questionnaires and objective assessments. Methods The Functional Assessment of Cancer-HN (FACT-HN), the Performance Status Scale – Head and Neck (PSS-HN), swallow assessments (including modified barium swallow studies), and voice assessments (Voice Handicap Index and the Voice Disability Assessment) were conducted at baseline and periodically post-treatment for 2 years. Results Baseline QOL and swallowing function predicted overall survival. Patients experienced a marked decrease in QOL, swallowing, and speech post CCR although the decrease in vocal function was modest. Function and QOL returned towards baseline in the majority of patients by 12 months post treatment. Less than 10% of patients had severe dysphagia and were PEG dependent at 12 months post treatment. There was a high degree of correlation between the FACT-HN and PSS-HN swallow items. Statistically significant correlations were found between subjective and objective measures of swallow function. Conclusions Patients experience marked loss in swallowing function post CCR which returned to baseline in the majority of patients. The correlations between the FCM and self-report swallow items on the PSS and FACT-HN appear to be sufficiently strong to justify their use as a surrogate marker for swallowing disability in large therapeutic trials.

Swallowing function for patients treated on E2399: A phase II trial of function preservation with induction paclitaxel/carboplatin followed by radiation plus weekly paclitaxel

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5524-5524 ◽  
Author(s):  
B. A. Murphy ◽  
K. Smith ◽  
A. Cmelak ◽  
A. Forastiere
Keyword(s):  
Phase Ii ◽  
Self Report ◽  
Barium Swallow ◽  
Functional Communication ◽  
Swallowing Function ◽  
Outcome Severity ◽  
Functional Measure ◽  
Squamous Cancer ◽  
Concomitant Chemoradiation ◽  
Function Preservation

5524 ECOG 2399 is a phase II organ preservation study using induction chemotherapy followed by concomitant chemoradiation in unresectable patients with squamous cancer of the larynx or oropharynx. A correlative study was undertaken to assess acute and long-term swallowing. Methods: Swallow evaluations were done at baseline, 3, 12 and 24 months posttreatment. Self-report measures consisted of the PSS-HN and FACT-HN. Objective measures include the Modified Barium Swallow (MBS) scored using a physiologic measure, the Dysphagia Outcome Severity Scale (D) and a functional measure, the Functional Communication Measure (F). Both D and F are graded on a 7-point scale (7 = normal through 1 = absent swallow/unable to take p.o). Results: The number of evaluable D and F assessments at each time point: baseline 97/99, 3 months 72/73, 12 months 40/41, 24 months 24/26. The scores presented in the table are expressed in percentages. Conclusions: The majority of patients presented with objective abnormalities on MBS, but swallow function remained largely intact. At 3 months, swallowing was markedly impaired (severe 18 and 24%, moderate 20 and 21%). By 12 months, swallowing had improved for most patients; however, a significant percentage of patients had persistent mild deficits (5–6). Severe swallowing abnormalities were found in less than 10% of patients at 12 and 24 months. Sponsored, in part, by Bristol-Myers-Squibb. [Table: see text] [Table: see text]

scholarly journals Comparison of altered fractionation schedule with concurrent chemo-radiation for squamous cell carcinoma of head and neck

2020 ◽  
Vol 8 (8) ◽  
pp. 2834
Author(s):  
Mathew Varghese K. ◽  
Geeta S. Narayanan ◽  
Bhaskar Vishwanathan ◽  
Shashidhar V. Karpurmath ◽  
Soumya Narayanan
Keyword(s):  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Performance Status ◽  
Locally Advanced ◽  
Complete Response ◽  
Altered Fractionation ◽  
Fractionation Schedule ◽  
Nodal Burden

Background: Aim of the study was to compare the response of altered fractionation schedule with concurrent chemo-radiation in patients with primary and the nodal disease.Methods: Total of 40 patients (20 in each arm) with stage 1- 4 squamous cell carcinoma of the head and neck with a performance status of 0-2 (ECOG) were included in the study. Arm A was altered fractionation schedule where in patients received 6 fractions per week to a total dose of 6600 cGy in 33 fractions. In Arm B, patients received conventional radiotherapy with concurrent chemotherapy three weekly Inj. of cisplatin (100 mg/m2). Patients were evaluated for acute toxicity every week using the Acute Radiation Morbidity Scoring Criteria. The response was assessed after 6 weeks and 12 weeks post treatment using the RECIST criteria. Data was statistically analyzed.Results: Seventeen patients in Arm A and 18 patients in Arm B completed the treatment. At the end of three months, In Arm A, 7 patients had complete response and in Arm B, 9 patients had complete response of the primary (p>0.05).  When the complete nodal response was compared in both the arms, there was no difference (2 vs 4 in Arm A vs Arm B resp.). But there were more partial nodal responders in Arm B (p = 0.016). The acute toxicities were comparable in both the arms.Conclusions: Altered fraction radiotherapy can be used in early lesions with minimal nodal burden but with locally advanced disease or large nodal burden addition of chemotherapy should not be avoided.

scholarly journals Cisplatin, Cetuximab, and Radiation in Locally Advanced Head and Neck Squamous Cell Cancer: A Retrospective Review

2015 ◽  
Vol 9 ◽  
pp. CMO.S18682 ◽  
Author(s):  
Prakash Peddi ◽  
Runhua Shi ◽  
Binu Nair ◽  
Fred Ampil ◽  
Glenn M. Mills ◽  
...  
Keyword(s):  
Head And Neck ◽  
Performance Status ◽  
Cell Cancer ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Rank Test ◽  
Advanced Head ◽  
Significant Difference ◽  
Group A ◽  
Group B

Efficacy of cisplatin versus cetuximab with radiation in locally advanced head and neck cancer (LAHNC) was evaluated. A total of 96 patients with newly diagnosed LAHNC treated at our institution between 2006 and 2011 with concurrent radiation and cisplatin (group A, n = 45), cetuximab (group B, n = 24), or started with cisplatin but switched to cetuximab because of toxicity (group C, n = 27) were reviewed. Chi-square test, analysis of variance, and log-rank test were used for analysis. The three groups had similar baseline characteristics, except for median age, T stage, albumin levels, hemoglobin levels, performance status, and comorbidities. A complete response (CR) was seen in 77%, 17%, and 67% of patients ( P < 0.001), respectively. There was no significant difference in median overall survival (OS) between groups A and C. The median OS for groups A and C was not reached (>65 months), even though it was significantly longer than median OS for group B (11.6 months; P ≤ 0.001). The 2-year OS in groups A and C is significantly higher than that in group B (70% for groups A and C, 22% for group B). There is no significant difference in progression-free survival (PFS) between groups A and C. The median PFS for these groups was not reached (>62 months), and is significantly longer than that for group B (4.3 months; P ≤ 0.001). The 2-year PFS of group A (67%) and group C (76%) was significantly longer than that of group B (20%). Cisplatin with radiation appears to be more efficacious even in suboptimal dosing than cetuximab with radiation in LAHNC but the two groups were not well matched.

scholarly journals Validation of Lysyl Oxidase As a Prognostic Marker for Metastasis and Survival in Head and Neck Squamous Cell Carcinoma: Radiation Therapy Oncology Group Trial 90-03

2009 ◽  
Vol 27 (26) ◽  
pp. 4281-4286 ◽  
Author(s):  
Quynh-Thu Le ◽  
Jonathan Harris ◽  
Anthony M. Magliocco ◽  
Christina S. Kong ◽  
Roman Diaz ◽  
...  
Keyword(s):  
Head And Neck ◽  
Lysyl Oxidase ◽  
Performance Status ◽  
Locally Advanced ◽  
Radiation Therapy Oncology Group ◽  
Prospective Trial ◽  
Continuous Variable ◽  
Phase Iii ◽  
And Performance ◽  
Metastatic Risk

Purpose To validate lysyl oxidase (LOX), a hypoxia-related protein, as a marker for metastasis in an independent head and neck cancer (HNC) patient group enrolled onto a prospective trial. Patients and Methods We performed traditional immunohistochemical (IHC) staining and automated quantitative analysis (AQUA) for LOX expression in 66 HNC patients from one institution. We also performed AQUA staining for LOX in 306 of 1,113 patients treated on a phase III trial comparing four radiation fractionation schedules in locally advanced HNC (RTOG 90-03). Pretreatment characteristics and outcome were similar between patients with and without LOX assessment. We correlated AQUA LOX expression with time to metastasis (TTM), time to progression (TTP), and overall survival (OS). Results LOX expression from both staining methods predicted for TTM in the first 66 patients. Multivariate analysis, controlling for significant parameters including nodal stage and performance status, revealed tumor LOX expression, as a continuous variable, was an independent predictor for TTM (hazard ratio [HR], 1.21; 95% CI, 1.10 to 1.33; P = .0001), TTP (HR, 1.06; 95% CI, 1.02 to 1.10; P = .0069), and OS (HR, 1.04; 95% CI, 1.00 to 1.07; P = .0311) in RTOG 90-03 patients. This translates into a 259% increase in metastatic risk for a patient at the 75th percentile of LOX compared with one at the 25th percentile. Conclusion AQUA LOX expression was strongly associated with increased metastasis, progression, and death in RTOG 90-03 patients. This study validates that LOX is a marker for metastasis and survival in HNC.

Impact of chemoradiotherapy for locally advanced head and neck cancer on swallowing function

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6054-6054
Author(s):  
E. Burke ◽  
L. Goguen ◽  
R. Tishler ◽  
L. Wirth ◽  
M. Posner ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Locally Advanced ◽  
Advanced Head ◽  
Swallowing Function ◽  
Pharyngeal Residue ◽  
Feeding Tubes ◽  
Post Radiation ◽  
The Impact

6054 Background: We examined the impact of chemoradiotherapy (CRT) on swallowing function in a group of patients treated for locally advanced head and neck cancer in an ongoing randomized phase II study with concurrent CRT, with or without Ethyol. Methods: Chemotherapy consisted of weekly carboplatin AUC 1.5 and paclitaxel at 45 /m2 for 4 weeks. Radiation was delivered using a 3 field technique with a concomitant boost schedule to a total dose of 72 Gy. Patients were randomized to receive or not receive daily subcutaneous Ethyol. Patients had video swallow studies at the start of radiation and 8, 12, 24 and 52 weeks post chemoradiotherapy. Dysphagia and weight loss were monitored. Video swallow study reports were collected and the incidence of penetration, aspiration, pharyngeal residue and upper esophageal narrowing analyzed. Results: Baseline data were available for 31 patients out of 43 enrolled. 29% of the patients penetrated, 6.4% aspirated and 29% had pharyngeal residue. Patients on both arms of the study had a steady decline in swallowing function from onset until 24 weeks post radiation. Penetration, aspiration and pharyngeal residue were consistently noted at all time points and improvements in deglutition were seen on the 52-week post radiation video swallow. Forty percent of the patients (17/43) had narrowing in the upper esophagus. On average, a third of the patients examined required dilations. The remaining patients with esophageal narrowing were able to advance their diet and have their feeding tubes removed without dilations. The average time from the end of the treatment to PEG removal was 219 days. Conclusion: Based on the video swallow studies that were conducted, patients had a gradual decline in swallowing function from initiation of CRT until 24 weeks post. Esophageal narrowing was common, often requiring dilation. Given that it takes 7 months on average for the feeding tubes to come out, we recommend that these patients undergo intensive swallowing therapy and continuous long term follow up and assessment at two and possibly three years post CRT. Study is ongoing. No significant financial relationships to disclose.

Neoadjuvant and adjuvant methotrexate, cisplatin, and fluorouracil in multimodal therapy of head and neck cancer.

1989 ◽  
Vol 7 (7) ◽  
pp. 838-845 ◽  
Author(s):  
E E Vokes ◽  
W J Moran ◽  
R Mick ◽  
R R Weichselbaum ◽  
W R Panje
Keyword(s):  
Head And Neck Cancer ◽  
Adjuvant Chemotherapy ◽  
Neoadjuvant Chemotherapy ◽  
Head And Neck ◽  
Continuous Infusion ◽  
Neck Cancer ◽  
Performance Status ◽  
Locally Advanced ◽  
Local Therapy ◽  
Stage Iv

To increase the complete response (CR) rate of patients with locally advanced head and neck cancer after three cycles of neoadjuvant chemotherapy, we added sequential methotrexate to the combination of cisplatin and continuous infusion fluorouracil (5-FU). We also evaluated the feasibility of administering three additional cycles of the same regimen as adjuvant chemotherapy. Thirty-eight patients were treated; the median age was 53 years and 36 patients had stage IV disease. Chemotherapy consisted of methotrexate 120 mg/m2 followed 24 hours later by cisplatin 100 mg/m2 and a five-day continuous infusion of 5-FU at 1,000 mg/m2/d. Of 34 patients evaluable for response to neoadjuvant chemotherapy, nine had a CR, 21 a partial response (PR), two a minimal response (MR), and one patient each stable disease (SD) and no response (NR). Of 31 patients who received local therapy, 15 were treated with surgery and radiotherapy and 16 with radiotherapy alone. Of 25 patients eligible to receive adjuvant chemotherapy only ten received all three intended cycles, while 15 received less or no adjuvant chemotherapy because of patient refusal, cumulative toxicity, or early disease progression. With a median follow-up time of 39 months, the median survival is estimated to be 20 months. Of eight patients with nasopharyngeal or paranasal sinus cancer, none has had disease recurrence. Patients with good initial performance status and low N-stage also had a significant survival advantage. Chemotherapy-related toxicities consisted mainly of mucositis, requiring 5-FU dose reduction in the majority of patients; similar toxicities were exacerbated in the adjuvant setting. The addition of methotrexate did not increase the CR rate over what has been reported for the combination of cisplatin and 5-FU alone. Certain subsets of patients appear to have a good prognosis when treated in this fashion. The administration of adequate adjuvant chemotherapy in patients with head and neck cancer remains difficult due to toxicity and poor patient compliance.

Sign in / Sign up

Export Citation Format

Share Document