Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
Head and neck cancer, Squamous Cell Carcinoma, Phase II, Transoral Surgery, Induction Chemotherapy, Carboplatin, Paclitaxel, Lapatinib
Brief summary
The purpose of this study is to see if a three method risk adapted design using induction chemotherapy, transoral surgery and radiation chemotherapy will lessen toxic effects and make treatment of squamous cell carcinoma of the head and neck (SCCHN) better.
Detailed description
This is a single-arm non-randomized two-stage phase II trial in previously untreated patients with squamous cell carcinoma of the head and neck (SCCHN) arising in the oral cavity, oropharynx, or supraglottic larynx amenable to a transoral surgical approach. Treatment will consist of 3 parts: neoadjuvant induction with weekly carboplatin and paclitaxel in combination with daily lapatinib for 6 weeks (PART 1) prior to transoral surgery (PART 2). Post-operative treatment (PART 3) will vary depending on the risk category assigned to the patient following surgery as follows: no further treatment or treatment limited to involved field radiation (low risk), ipsilateral radiation concurrent with weekly chemotherapy ( medium risk); or cisplatin every 3 weeks and daily lapatinib concurrent with bilateral radiation (high risk).
Interventions
DRUGCarboplatin
Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.
DRUGPaclitaxel
Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.
DRUGLapatinib
Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.
DRUGCisplatin
Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.
RADIATIONIpsilateral Radiation
After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.
RADIATIONBilateral Radiation
After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.
PROCEDURETransoral Surgery
Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.
Sponsors
UNC Lineberger Comprehensive Cancer Center
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously untreated, histologically proven primary squamous cell carcinoma arising in the oral cavity, oropharynx, or supraglottic larynx, and amenable to transoral approach * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix C) * Measurable disease as per Response Evaluation Criteria In Solid Tumors (RECIST1.1) * Age ≥18 years * Adequate bone marrow function as demonstrated by: Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3; Hgb \> 10 g/dL (use of transfusion to reach this threshold prior to study initiation is acceptable); Platelet count ≥ 100,000/mm3 * Adequate hepatic and renal function as demonstrated by: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal (ULN); Total serum bilirubin ≤1.5 mg/dL; Creatinine clearance (CrCL) ≥ 40ml/min as measured via Cockcroft-Gault * Left ventricular ejection fraction (LVEF) must be \> the lower limit of normal (LLN) per institutional standards by either echocardiography or radionuclide-based multiple gated acquisition (MUGA) * Negative serum human chorionic gonadotropin (β-hCG) pregnancy test within 72 hours of day 1 of induction chemotherapy in women of child-bearing potential * All males and females of childbearing potential must agree to use adequate contraception during the study. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy * Signed an institutional review board (IRB)-approved informed consent document for this protocol.
Exclusion criteria
* tumor 1-node 0 (T1N0) disease or tumor 2-node 0 (T2N0) disease * Any metastatic disease * Not considered eligible for any of the chemotherapy agents included in the induction regimen. * Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) * Major surgery within 3 weeks prior to day 1 of study treatment from which the patient has not completely recovered * Current use of a prohibited medication or requires any of these medications during treatment with lapatinib prior to study entry * Receiving any investigational agent currently, or within 2 weeks of Day 1 of treatment on this study * Active, serious infection, medical, or psychiatric condition that would represent an inappropriate risk to the patient or would likely compromise achievement of the primary study objective, including unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction ≤ 6 months prior to study entry * Adequate swallowing function or gastric-tube for drug administration. Of note, lapatinib can be administered via G-tube in a slurry for patients who cannot swallow * Other prior or concomitant malignancies with the exception of: Non-melanoma skin cancer; In-situ malignancy; Low-risk prostate cancer after curative therapy; Other cancer for which the patient has been disease free for ≥ 3 years * Pregnant or lactating women, or adults of reproductive potential who do not agree to use adequate contraception during study treatment (see definition of adequate contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | 11 weeks | Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of 3 Part Therapy | 2 years | Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation. |
| Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy. | 11 weeks | Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen. |
| Overall Survival | up to 7.25 years | Overall survival is measured from the time the patient goes on treatment until death. |
| Progression-Free Survival | Up to 7.25 years | Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR |
| Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI) | Pre-treatment up to 1 year post surgery | The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes. |
| Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL) | Pre-treatment up to 1 year post surgery | The Voice-Related Quality of Life Tool is a 10 item list of possible voice-related problems. The participant answers 1-5 with 1 being none, not a problem to 5, problem is as bad as it can be. An algorithm is used to calculate the scores, so that sum scores range from 0 to 100, where 0 indicates poor V-RQOL and 100 indicates good V-RQOL |
| Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy | 11 weeks | Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (\<pT2) |
| Response Rates at the Primary Site | 11 weeks | Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. |
| Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Adverse events were assessed up to18 weeks, and overall survival was measured up to 7.25 years | The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. |
| the Kinome Response to Induction Chemotherapy | 11 weeks | Describe the kinome response to induction chemotherapy (lapatinib, paclitaxel, and carboplatin) in patients who consent to this optional evaluation via co-enrollment in LCCC0121 |
| Response Rates at the Neck. | 11 weeks | Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for neck lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJared Weiss, MD
University of North Carolina, Chapel Hill
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Induction Chemotherapy Followed by Transoral Surgery All participants will receive induction chemotherapy and transoral surgery. Following surgery, participants will be stratified into a risk category (low, medium, or high). Subjects in the low risk category will receive no further treatment after their transoral surgery. Subjects in the medium risk category will receive ipsilateral radiation concurrent with weekly cisplatin, and subjects in the high risk category will receive cisplatin every three weeks with concurrent bilateral radiation. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | Induction Chemotherapy Followed by Transoral Surgery |
|---|---|
| Age, Continuous | 57.5 years |
| Disease Location Hypopharynx | 1 Participants |
| Disease Location Oral Cavity | 4 Participants |
| Disease Location Oropharynx | 30 Participants |
| Disease Location Supraglottic Larynx | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 30 Participants |
| Stage of disease T1N1 | 1 Participants |
| Stage of disease T1N2a | 4 Participants |
| Stage of disease T1N2b | 6 Participants |
| Stage of disease T2N1 | 4 Participants |
| Stage of disease T2N2a | 5 Participants |
| Stage of disease T2N2b | 12 Participants |
| Stage of disease T2N2c | 2 Participants |
| Stage of disease T3N0 | 3 Participants |
| Stage of disease T3N2c | 1 Participants |
| Stage of disease T4N1 | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 40 |
| other Total, other adverse events | 39 / 40 |
| serious Total, serious adverse events | 7 / 40 |
Outcome results
Primary
Overall Response Rate
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Overall response rate (ORR) is defined as the number of patients who have a partial or complete response to therapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 11 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Overall Response Rate | 37 Participants |
Secondary
Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy
Pathologic complete response (pCR) is the disappearance of all signs of cancer in tissue samples removed during surgery or biopsy (pT0). Also called pathologic complete remission. Pathologic Partial Response (pPR), is the presence of only non-invasive cancer in tissue samples (\<pT2)
Time frame: 11 weeks
Population: All participants received induction chemotherapy and underwent surgery.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy | Pathologic complete response (pCR) | 14 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Estimate the Pathologic Complete Response Rate at the Primary Site and in the Neck Following Induction Chemotherapy | Pathologic Partial Response (pPR) | 25 Participants |
Secondary
Feasibility of 3 Part Therapy
Percentage of patients successfully completing 3 part therapy will be used to assess the feasibility of 3 part therapy consisting of induction chemotherapy, surgery, and risk-adapted use of chemoradiation.
Time frame: 2 years
Population: All participants started to receive study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Feasibility of 3 Part Therapy | completed | 39 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Feasibility of 3 Part Therapy | not-completed | 1 Participants |
Secondary
Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy.
Number of patients who no longer need radiation (have decreases in risk level post induction therapy). Estimations of Risk level pre-induction will be based on physical examination and imaging, post-induction risk level will be determined based on pathologic evaluation or surgical specimen.
Time frame: 11 weeks
Population: One patient withdrew before surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Number of Patients Who Decreased in Risk Level Post Induction Chemotherapy. | 29 Participants |
Secondary
Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0
The NCI Common Terminology Criteria for Adverse Events is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Time frame: 18 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Alanine aminotransferase increased | 2 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Aspartate Aminotransferase increased | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Hyperglycemia | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Chest pain- cardiac | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Diarrhea | 5 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Fatigue | 4 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Febrile neutropenia | 4 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Hyponatremia | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Hypotension | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Lymphocyte count decreased | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Nausea | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Neutrophil count decreased | 22 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Palmar-plantar erythrodysesthesia syndrome | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Peripheral sensory neuropathy | 2 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Rash acneiform | 4 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | Sepsis | 1 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Number of Subjects Who Experience Grade 3/4 Adverse Events According to CTCAE 4.0 | White blood cell decreased | 15 Participants |
Secondary
Overall Survival
Overall survival is measured from the time the patient goes on treatment until death.
Time frame: 15 years
Secondary
Progression-Free Survival
Progression-free survival associated with 3 part therapy consisting of induction chemotherapy, surgery and risk-adapted use of chemoradiation. Defined as per RECIST criteria. Physical examination, imaging of target lesions by CT scan or MRI and chest imaging (CT or Chest x-ray, if clinically indicated) every 3 months (+/- 30 days) for 18 months following end of treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: 15 years
Secondary
Response Rates at the Neck.
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for neck lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: 11 weeks
Population: All participants received induction chemotherapy and radiological tumor response evaluation was completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Neck. | Complete Response | 11 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Neck. | Partial Response | 15 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Neck. | Stable Disease | 3 Participants |
Secondary
Response Rates at the Primary Site
Evaluation of target lesions through tumor imaging (CT scan, MRI, and/or chest x-ray) at 3-5 weeks post induction chemotherapy. Overall response rate will be based on RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: 11 weeks
Population: All participants received induction chemotherapy and radiological tumor response evaluation was completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Primary Site | Stable Disease | 3 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Primary Site | Complete Response | 15 Participants |
| Induction Chemotherapy Followed by Transoral Surgery | Response Rates at the Primary Site | Partial Response | 21 Participants |
Secondary
the Kinome Response to Induction Chemotherapy
Describe the kinome response to induction chemotherapy (lapatinib, paclitaxel, and carboplatin) in patients who consent to this optional evaluation via co-enrollment in LCCC0121
Time frame: 11 weeks
Population: The data were unable to be analyzed because co-enrollment with LCCC0121 could not be implemented.
Secondary
Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI)
The MD Anderson Dysphagia Inventory (MDADI) is a 20 item assessment designed to measure voice and swallowing function. Participants were asked 13 symptom questions and 6 interference items (walking, working) and asked id the 1- strongly agree to 5 strongly disagree. Scores were summed for a range of 20-100. The lower the score the worse the outcomes.
Time frame: Pre-treatment up to 1 year post surgery
Population: Subjects were encouraged to complete the assessments but it was left to their discretion. Participants with data available reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI) | 83.90 units on a scale | Standard Deviation 14.04 |
| Post-Induction | Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI) | 86.26 units on a scale | Standard Deviation 13.24 |
| 1 Year Post Surgery | Voice and Swallowing Function- MD Anderson Dysphagia Inventory (MDADI) | 81.90 units on a scale | Standard Deviation 16.56 |
Secondary
Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL)
The Voice-Related Quality of Life Tool is a 10 item list of possible voice-related problems. The participant answers 1-5 with 1 being none, not a problem to 5, problem is as bad as it can be. An algorithm is used to calculate the scores, so that sum scores range from 0 to 100, where 0 indicates poor V-RQOL and 100 indicates good V-RQOL
Time frame: Pre-treatment up to 1 year post surgery
Population: Patients were encouraged to complete the assessment but at their discretion. Participants with data available reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Induction Chemotherapy Followed by Transoral Surgery | Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL) | 93.42 units on a scale | Standard Deviation 13.2 |
| Post-Induction | Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL) | 92.00 units on a scale | Standard Deviation 20.12 |
| 1 Year Post Surgery | Voice and Swallowing Function - Voice-Related Quality of Life Assessment (VRQOL) | 91.85 units on a scale | Standard Deviation 13.8 |