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Development of a Patient-Reported Outcome Measure for Recurrent or Metastatic Head-and-Neck Cancer
Volume 88 Number 2 Supplement 2014 However, a significant percentage of these patients have persistent or recurrent disease and undergo salvage surgery as a secondary curative option. Surgery after radiation or chemoradiation is, however, associated with significantly higher morbidity rates when compared with primary surgical intervention. Hyperbaric oxygen therapy (HBOT) has been widely studied in the area of wound healing with promising results in the prevention of osteoradionecrosis, treatment of diabetic wounds and improved tissue perfusion in previously irradiated tissue. However, the evidence supporting the efficacy of its use for the prevention of post-operative wound complications in the area of salvage surgery remains limited. The primary objective of the study is to assess the efficacy of HBOT in the prevention of post-operative complications within the study population. Materials/Methods: 175 patients who underwent a clean-contaminated head and neck procedure following previous radiation or chemoradiation treatment for head and neck cancer from January 2006 to June 2013 were identified at a large academic tertiary care center. 134 of these patients did not receive post-operative HBOT and were designated for the control cohort. 41 patients received prophylactic post-operative HBOT and were designated for the study cohort. Patient co-morbidities, clinicopathologic data, and morbidity outcomes were analyzed. Results: The control and study cohorts were statistically matched in age, gender, history of previous chemotherapy, and time between completion of radiation therapy and surgical intervention. The overall rates of surgical complications in the control and study cohorts were 43% and 48%, respectively (p Z 0.59). The rates of major surgical complications, which resulted in significant morbidity or increased hospital stay to the patient, were 21% and 22% in the control and study cohorts, respectively (p Z 0.78). Similarly, the length of hospital stay (p Z 0.88), need for additional surgical intervention (p Z 0.13) and hospital re-admission rates (p Z 0.66) were not statistically different between the two groups. The 2-year overall survival in the control cohort was 40% and 36% in the study cohort. Conclusions: Prophylactic HBOT following salvage surgery does not decrease rates of postoperative complications, length of hospital stay or need for additional surgical intervention. Author Disclosure: A. Marcinow: None. T. Teknos: None. A. Agrawal: None. E. Ozer: None. R. Carrau: None. D. Schuller: None. M. Old: None.
153 Development of a Patient-Reported Outcome Measure for Recurrent or Metastatic Head-and-Neck Cancer Management of Recurrent Head-and-Neck Squamous Cell Carcinoma L. Kolnick,1 J. Deng,2 S.H. Ridner,2 M.S. Dietrich,3 and B.A. Murphy1; 1 Department of Medicine, Vanderbilt University, Nashville, TN, 2School of Nursing, Vanderbilt University, Nashville, TN, 3Department of Biostatistics, Schools of Medicine and Nursing, Vanderbilt University, Nashville, TN Purpose/Objective(s): Currently there are no available patient reported outcome measures developed for and tested in patients with recurrentmetastatic head and neck cancer (RMHNC). Furthermore, the symptom burden for this population has been poorly described. Thus, available tools are hypothesized to be inadequate in evaluation of symptoms in this cohort. We describe the development of the Vanderbilt Head and Neck Symptom Survey - Recurrent/Metastatic (VHNSS-RM), which was designed to identify tumor related symptoms in patients with RMHNC. This assessment tool takes into account tumor related symptoms, residual toxicity from prior therapy, and side effects from current treatment. Materials/Methods: One-on-one interviews with 17 RMHNC patients and a focus group of 14 HNC providers were conducted to identify symptom and self-reported functional issues in this unique population. Seventy-one symptoms were identified for further testing. Panel members assessed items for content validity and rated the items importance for inclusion in the questionnaire. The panel approved 46 symptoms and 13 psychosocial items. Subsequently, 20 patients performed a 2-step card sort to identify high-frequency and high-impact symptoms. Items endorsed by 35% of patients or those rated as high-impact were included in the final
Poster Presentations
505
questionnaire. The questionnaire contains 35 physical symptoms- and 12 psychosocial issues scored on a 0 to 10 scale (none to severe). Results: Items in the VHNSS-RM were compared to the currently available tools: VHNSS v 2.0, Functional Assessment of Cancer Therapy -HN v4.0, University of Wisconsin Quality of Life Scale, European Organization for Research and Treatment of Cancer Quality of life QuestionnaireC30 and H&N35, and the MD Anderson Symptom Inventory -HN. Symptoms not addressed by those currently available tools include: change in diet due to swelling in mouth, tongue movement affecting speech and swallowing, swelling of the face/neck, cramping in neck/jaw, bad breath, drooling, wound complications (drainage/pain/odor), nasal congestion/ drainage, eyes watering, numbness of face/tongue/ear/scalp, headaches and confusion. Psychosocial issues including: perception of being a burden to family/friends, lost independence, fear, embarrassment, mood swings, stress and boredom were also novel aspects. Conclusions: Many of the symptoms experienced by patients with RMHNC are different than at initial presentation and during primary treatment. An assessment tool for symptoms and self-reported function deficits secondary to RMHNC could potentially enhance the ability to direct supportive care measures allowing for improved palliation in this cohort. In addition, it could aid in assessment of treatment response and impact on overall symptom burden. Validation studies are ongoing. Author Disclosure: L. Kolnick: E. Research Grant; Bristol-Myers Squibb Corporation (Fellows Grant). J. Deng: None. S.H. Ridner: None. M.S. Dietrich: None. B.A. Murphy: None.
167 Changes in the Efficacy of Chemotherapy for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (RMSCHN) Reported in Randomized Clinical Trials (RCTs) Over the Past 40 Years Management of Recurrent Head-and-Neck Squamous Cell Carcinoma E. Winquist,1,2 I. Al-Rasheedy,1,2 and L. Stitt1; 1London Health Sciences Centre, London, ON, Canada, 2Western University, London, ON, Canada Purpose/Objective(s): Despite advances with targeted drugs, cytotoxic chemotherapy (Chemo) remains the most commonly used treatment for RMSCHN patients (pts). Recent RCTs (Urba 2012, Tortochaux 2011, Gibson 2005) have reported lower than expected objective response rates (ORRs) with commonly used Chemo regimens. We hypothesized this might be due to increased chemoradiation therapy use over the past two decades. To investigate this we analyzed RCTs reported over the past 40 years. Materials/Methods: We performed a systematic review to identify RCTs of Chemo in RMSCHN using electronic databases and hand searching of meeting abstracts and citation bibliographies up to July 2013. Eligible RCTs enrolled RMSCHN pts, had at least one trial arm consisting of a systemically administered Chemo regimen alone, and reported the ORR. Regimens were defined as the same drug(s) given on similar schedules. Data including pt characteristics, treatment, and ORRs were extracted by eligible trial arm from published reports. As we were interested in time trends, regimens eligible for analysis had at least 6 RCT reports spanning a minimum of 20 years. Analyses were done using weighted linear regression of transformed ORRs. Results: 57 eligible RCTs reporting Chemo results published 1973-2013 were identified. Three regimens met criteria for analyses: 1. low dose weekly methotrexate (MTX) (mode: 40-60 mg/m2 IV weekly) 21 RCTs/34 years (1977-2011, median report date 1987), 2. cisplatin (CDDP) (mode: 100 mg/m2 IV q4weeks) 16 trial arms in 14 RCTs/34 years (1978-2012, median report date 1987), and 3. cisplatin + infusional 5-fluorouracil (PF) (mode: CDDP 100 mg/m2 d1 IV + 5-fluorouracil 1000 mg/m2/24 hrs continuous IV infusion x 4 q3weeks) 12 RCTs/28 years (1985-2013, median report date 1993). Linear trends to increasing trial arm sample size over time were observed for CDDP and PF. Overall ORRs were: MTX 179/908 pts (19.7%; range, 9.1-36.7%), CDDP 160/1079 pts (14.8%; range, 8.0-50.0%), and PF 390/1196 pts (32.6%; range, 20.0-72.2%). There were decreasing ORR trends for all regimens over time: MTX 23.8/ 10.0% (1980 to 2010), CDDP 21.1/ 9.8% (1980 to 2010), and PF 41.4/ 26.7% (1990 to 2010). With outliers removed ORRs were: MTX
153 Development of a Patient-Reported Outcome Measure for Recurrent or Metastatic Head-and-Neck Cancer Management of Recurrent Head-and-Neck Squamous Cell Carcinoma L. Kolnick,1 J. Deng,2 S.H. Ridner,2 M.S. Dietrich,3 and B.A. Murphy1; 1 Department of Medicine, Vanderbilt University, Nashville, TN, 2School of Nursing, Vanderbilt University, Nashville, TN, 3Department of Biostatistics, Schools of Medicine and Nursing, Vanderbilt University, Nashville, TN Purpose/Objective(s): Currently there are no available patient reported outcome measures developed for and tested in patients with recurrentmetastatic head and neck cancer (RMHNC). Furthermore, the symptom burden for this population has been poorly described. Thus, available tools are hypothesized to be inadequate in evaluation of symptoms in this cohort. We describe the development of the Vanderbilt Head and Neck Symptom Survey - Recurrent/Metastatic (VHNSS-RM), which was designed to identify tumor related symptoms in patients with RMHNC. This assessment tool takes into account tumor related symptoms, residual toxicity from prior therapy, and side effects from current treatment. Materials/Methods: One-on-one interviews with 17 RMHNC patients and a focus group of 14 HNC providers were conducted to identify symptom and self-reported functional issues in this unique population. Seventy-one symptoms were identified for further testing. Panel members assessed items for content validity and rated the items importance for inclusion in the questionnaire. The panel approved 46 symptoms and 13 psychosocial items. Subsequently, 20 patients performed a 2-step card sort to identify high-frequency and high-impact symptoms. Items endorsed by 35% of patients or those rated as high-impact were included in the final
Poster Presentations
505
questionnaire. The questionnaire contains 35 physical symptoms- and 12 psychosocial issues scored on a 0 to 10 scale (none to severe). Results: Items in the VHNSS-RM were compared to the currently available tools: VHNSS v 2.0, Functional Assessment of Cancer Therapy -HN v4.0, University of Wisconsin Quality of Life Scale, European Organization for Research and Treatment of Cancer Quality of life QuestionnaireC30 and H&N35, and the MD Anderson Symptom Inventory -HN. Symptoms not addressed by those currently available tools include: change in diet due to swelling in mouth, tongue movement affecting speech and swallowing, swelling of the face/neck, cramping in neck/jaw, bad breath, drooling, wound complications (drainage/pain/odor), nasal congestion/ drainage, eyes watering, numbness of face/tongue/ear/scalp, headaches and confusion. Psychosocial issues including: perception of being a burden to family/friends, lost independence, fear, embarrassment, mood swings, stress and boredom were also novel aspects. Conclusions: Many of the symptoms experienced by patients with RMHNC are different than at initial presentation and during primary treatment. An assessment tool for symptoms and self-reported function deficits secondary to RMHNC could potentially enhance the ability to direct supportive care measures allowing for improved palliation in this cohort. In addition, it could aid in assessment of treatment response and impact on overall symptom burden. Validation studies are ongoing. Author Disclosure: L. Kolnick: E. Research Grant; Bristol-Myers Squibb Corporation (Fellows Grant). J. Deng: None. S.H. Ridner: None. M.S. Dietrich: None. B.A. Murphy: None.
167 Changes in the Efficacy of Chemotherapy for Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (RMSCHN) Reported in Randomized Clinical Trials (RCTs) Over the Past 40 Years Management of Recurrent Head-and-Neck Squamous Cell Carcinoma E. Winquist,1,2 I. Al-Rasheedy,1,2 and L. Stitt1; 1London Health Sciences Centre, London, ON, Canada, 2Western University, London, ON, Canada Purpose/Objective(s): Despite advances with targeted drugs, cytotoxic chemotherapy (Chemo) remains the most commonly used treatment for RMSCHN patients (pts). Recent RCTs (Urba 2012, Tortochaux 2011, Gibson 2005) have reported lower than expected objective response rates (ORRs) with commonly used Chemo regimens. We hypothesized this might be due to increased chemoradiation therapy use over the past two decades. To investigate this we analyzed RCTs reported over the past 40 years. Materials/Methods: We performed a systematic review to identify RCTs of Chemo in RMSCHN using electronic databases and hand searching of meeting abstracts and citation bibliographies up to July 2013. Eligible RCTs enrolled RMSCHN pts, had at least one trial arm consisting of a systemically administered Chemo regimen alone, and reported the ORR. Regimens were defined as the same drug(s) given on similar schedules. Data including pt characteristics, treatment, and ORRs were extracted by eligible trial arm from published reports. As we were interested in time trends, regimens eligible for analysis had at least 6 RCT reports spanning a minimum of 20 years. Analyses were done using weighted linear regression of transformed ORRs. Results: 57 eligible RCTs reporting Chemo results published 1973-2013 were identified. Three regimens met criteria for analyses: 1. low dose weekly methotrexate (MTX) (mode: 40-60 mg/m2 IV weekly) 21 RCTs/34 years (1977-2011, median report date 1987), 2. cisplatin (CDDP) (mode: 100 mg/m2 IV q4weeks) 16 trial arms in 14 RCTs/34 years (1978-2012, median report date 1987), and 3. cisplatin + infusional 5-fluorouracil (PF) (mode: CDDP 100 mg/m2 d1 IV + 5-fluorouracil 1000 mg/m2/24 hrs continuous IV infusion x 4 q3weeks) 12 RCTs/28 years (1985-2013, median report date 1993). Linear trends to increasing trial arm sample size over time were observed for CDDP and PF. Overall ORRs were: MTX 179/908 pts (19.7%; range, 9.1-36.7%), CDDP 160/1079 pts (14.8%; range, 8.0-50.0%), and PF 390/1196 pts (32.6%; range, 20.0-72.2%). There were decreasing ORR trends for all regimens over time: MTX 23.8/ 10.0% (1980 to 2010), CDDP 21.1/ 9.8% (1980 to 2010), and PF 41.4/ 26.7% (1990 to 2010). With outliers removed ORRs were: MTX