2
Materials/Methods: The QOL of patients with AJCC (2002) stage I/II accrued from our department comparing IMRT versus CRT were assessed with EORTC C30 and H&N 35 modules questionnaire. The questionnaire was administered at the time of diagnosis, the end of radiotherapy, 3 months, 6 months and 12 months after radiotherapy. Each patient’s QOL scores including function and symptoms were calculated as instructed in EORTC C30 and H&N 35 modules scoring manual. 66 Gy/30Fx was prescribed to the GTV for the patients who had received IMRT. 70 Gy/35Fx was prescribed to the isocenter for the CRT group patients. Results: From January 2005 to June 2006 38 patients were available to enter this study (IMRT = 21, CRT = 17). After one year follow up, there was no any treatment failure detected. No significant difference between the baseline QOL scores of the two groups was observed. The changing pattern of QOL scores with time was similar for both groups. The IMRT group showed severe de- terioration of QOL at the end of radiotherapy, even worse than the CRT group. Partial recovery was showed in both groups at 3 months end of the treatment. The better function and symptoms subscale score were found in IMRT group at 6 months and 12 months, especially for dry mouth (p = 0.02). Conclusions: The patients with early stage NPC treated with IMRT had rapider recovery of QOL when compared with patients treated by CRT alone. Author Disclosure: G. Zhu, None; X. Wang, None; Y. Wu, None; C. Hu, None. 2695 Computerized Symptom and Quality of Life Self-Reporting for Radiation Oncology Patients: Identifying Clinically Significant Symptoms Before and During Therapy J. Keam 1 , M. Austin-Seymour 1 , B. Halpenny 2 , N. Bush 3 , J. Fann 1,3 , B. Lober 1,2 , S. Wolpin 1 , D. Berry 3,2 1 University of Washington Medical Center, Seattle, WA, 2 University of Washington School of Nursing, Seattle, WA, 3 Fred Hutchinson Cancer Research Center, Seattle, WA Purpose/Objective(s): For cancer patients, inadequate symptom assessment may profoundly impact quality of life (QOL), com- pliance, and outcomes. Studies suggest that although oncologists are attentive to side effects, communication tends to be clinician- oriented with frequent interruptions and closed-ended questions, which may prevent full symptom reporting. Studies indicate that computerized self-reporting tools can enhance communication. The use of wireless, touchscreen notebook computers by cancer patients to score symptom and QOL measures is being investigated at the University of Washington/Seattle Cancer Care Alliance (UW/SCCA). This study sought to identify clinically significant symptoms and changes in symptom scores reported by radiation therapy (RT) patients at the time of initial consultation (T1) and during therapy (T2), using a web-based, electronic self-report assessment program for cancer (ESRA-C). Materials/Methods: A total of 113 RT patients included in this analysis completed ESRA-C at T1 and T2, from 2005–2007. The computerized surveys were completed in clinic before visits. Technical feasibility, physician usability, and patient acceptability of ESRA-C at UW/SCCA RT clinics amidst a diverse patient demographic have been previously validated. ESRA-C includes demo- graphic questions and validated surveys: Symptom Distress Scale (13-item, cancer specific assessment using 5-point Likert scales), Pain Intensity Numerical Score (PINS, 0–10 scale), Patient Health Questionnaire-9 (PHQ-9, a DSM-IV-based depression screen). Threshold scores for clinical intervention were: SDS $3 (moderate to serious distress), PINS $5, and PHQ-9 $10 (moderate to severe depression). A total of 54 patients triggered and completed the entire PHQ-9 module at T1 and T2. T-tests were used to compare changes in mean scores from T1 to T2. McNemar’s tests were used to assess differences between proportions below or at/above threshold at T1 and T2. Results: Patient characteristics included: median age = 53 years (range 20–89), 43% male, 57% female, 93% Caucasian, 69% with post-secondary education. Most common cancer diagnoses were: head/neck 24%, breast 23%, prostate 10%. Median number of days between T1 and T2 was 48. Frequencies of symptom scores at or above threshold reported at T1 and T2 were, respectively: sexual activity/interest impact (44% vs. 51%), pain frequency (39% vs. 38%), fatigue (34% vs. 45%), insomnia (31% vs. 31%), appetite change (15% vs. 28%), nausea (4% vs. 18%), PINS $5 (10% vs. 13%), depression (23% vs. 35%). When comparing mean scores for these symptoms, there were significant differences between T1 and T2 for nausea (p \0.001), appetite (p = 0.003), and fatigue (p = 0.018). McNemar’s tests showed significant differences in proportions of patients reporting at/above threshold at T1 vs. T2 for nausea (p = 0.001) and appetite (p = 0.021). Conclusions: Computerized self-assessment is a novel way for patients to fully report a comprehensive spectrum of symptoms, subsequently improving clinical care and quality of life. It can identify prevalent conditions that may not be typically addressed, such as depression and sexual dysfunction. It can efficiently identify symptoms that are changing in severity over time, reaching a critical threshold, or being inadequately alleviated. Author Disclosure: J. Keam, None; M. Austin-Seymour, None; B. Halpenny, None; N. Bush, None; J. Fann, None; B. Lober, None; S. Wolpin, None; D. Berry, None. 2696 Lithium-Mediated Neuroprotection During Cranial Irradiation: A Phase I Trial E. S. Yang, B. Lu, D. E. Hallahan Vanderbilt University Medical Center, Nashville, TN Purpose/Objective(s): Cranial irradiation often results in long-term neurocognitive deficiencies, especially in children. These def- icits have been associated with radiation-induced hippocampal damage. GSK3 enzyme inhibition leads to neuroprotection through the inhibition of program cell death. Preclinical studies show that lithium inhibits GSK3 and blocks radiation-induced apoptosis in hippocampal neurons without protecting cancer cells. Lithium also improved neurocognitive function in mice treated with whole brain irradiation. These data suggest the potential use of lithium to attenuate radiation-induced cognitive defects to improve the quality of life in cancer survivors. To determine whether lithium is tolerated in patients treated with whole brain irradiation, we studied patients with brain metastases receiving lithium prior to and during radiation. We present a pilot study to evaluate the feasibility of neoadjuvant and concurrent lithium treatment in patients receiving whole brain radiotherapy. Materials/Methods: Patients with histologically confirmed extracranial primary malignancy and associated brain metastases were given lithium treatment one week prior to as well as during whole brain radiotherapy. Dose of lithium was started at one-half S586 I. J. Radiation Oncology d Biology d Physics Volume 69, Number 3, Supplement, 2007

Lithium-Mediated Neuroprotection During Cranial Irradiation: A Phase I Trial

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Page 1: Lithium-Mediated Neuroprotection During Cranial Irradiation: A Phase I Trial

S586 I. J. Radiation Oncology d Biology d Physics Volume 69, Number 3, Supplement, 2007

Materials/Methods: The QOL of patients with AJCC (2002) stage I/II accrued from our department comparing IMRT versus CRTwere assessed with EORTC C30 and H&N 35 modules questionnaire. The questionnaire was administered at the time of diagnosis,the end of radiotherapy, 3 months, 6 months and 12 months after radiotherapy. Each patient’s QOL scores including function andsymptoms were calculated as instructed in EORTC C30 and H&N 35 modules scoring manual. 66 Gy/30Fx was prescribed to theGTV for the patients who had received IMRT. 70 Gy/35Fx was prescribed to the isocenter for the CRT group patients.

Results: From January 2005 to June 2006 38 patients were available to enter this study (IMRT = 21, CRT = 17). After one yearfollow up, there was no any treatment failure detected. No significant difference between the baseline QOL scores of the two groupswas observed. The changing pattern of QOL scores with time was similar for both groups. The IMRT group showed severe de-terioration of QOL at the end of radiotherapy, even worse than the CRT group. Partial recovery was showed in both groups at3 months end of the treatment. The better function and symptoms subscale score were found in IMRT group at 6 months and12 months, especially for dry mouth (p = 0.02).

Conclusions: The patients with early stage NPC treated with IMRT had rapider recovery of QOL when compared with patientstreated by CRT alone.

Author Disclosure: G. Zhu, None; X. Wang, None; Y. Wu, None; C. Hu, None.

2695 Computerized Symptom and Quality of Life Self-Reporting for Radiation Oncology Patients: Identifying

Clinically Significant Symptoms Before and During Therapy

J. Keam1, M. Austin-Seymour1, B. Halpenny2, N. Bush3, J. Fann1,3, B. Lober1,2, S. Wolpin1, D. Berry3,2

1University of Washington Medical Center, Seattle, WA, 2University of Washington School of Nursing, Seattle, WA,3Fred Hutchinson Cancer Research Center, Seattle, WA

Purpose/Objective(s): For cancer patients, inadequate symptom assessment may profoundly impact quality of life (QOL), com-pliance, and outcomes. Studies suggest that although oncologists are attentive to side effects, communication tends to be clinician-oriented with frequent interruptions and closed-ended questions, which may prevent full symptom reporting. Studies indicate thatcomputerized self-reporting tools can enhance communication. The use of wireless, touchscreen notebook computers by cancerpatients to score symptom and QOL measures is being investigated at the University of Washington/Seattle Cancer Care Alliance(UW/SCCA). This study sought to identify clinically significant symptoms and changes in symptom scores reported by radiationtherapy (RT) patients at the time of initial consultation (T1) and during therapy (T2), using a web-based, electronic self-reportassessment program for cancer (ESRA-C).

Materials/Methods: A total of 113 RT patients included in this analysis completed ESRA-C at T1 and T2, from 2005–2007. Thecomputerized surveys were completed in clinic before visits. Technical feasibility, physician usability, and patient acceptability ofESRA-C at UW/SCCA RT clinics amidst a diverse patient demographic have been previously validated. ESRA-C includes demo-graphic questions and validated surveys: Symptom Distress Scale (13-item, cancer specific assessment using 5-point Likert scales),Pain Intensity Numerical Score (PINS, 0–10 scale), Patient Health Questionnaire-9 (PHQ-9, a DSM-IV-based depression screen).Threshold scores for clinical intervention were: SDS $3 (moderate to serious distress), PINS $5, and PHQ-9 $10 (moderate tosevere depression). A total of 54 patients triggered and completed the entire PHQ-9 module at T1 and T2. T-tests were used tocompare changes in mean scores from T1 to T2. McNemar’s tests were used to assess differences between proportions belowor at/above threshold at T1 and T2.

Results: Patient characteristics included: median age = 53 years (range 20–89), 43% male, 57% female, 93% Caucasian, 69% withpost-secondary education. Most common cancer diagnoses were: head/neck 24%, breast 23%, prostate 10%. Median number ofdays between T1 and T2 was 48. Frequencies of symptom scores at or above threshold reported at T1 and T2 were, respectively:sexual activity/interest impact (44% vs. 51%), pain frequency (39% vs. 38%), fatigue (34% vs. 45%), insomnia (31% vs. 31%),appetite change (15% vs. 28%), nausea (4% vs. 18%), PINS $5 (10% vs. 13%), depression (23% vs. 35%). When comparing meanscores for these symptoms, there were significant differences between T1 and T2 for nausea (p\0.001), appetite (p = 0.003), andfatigue (p = 0.018). McNemar’s tests showed significant differences in proportions of patients reporting at/above threshold at T1vs. T2 for nausea (p = 0.001) and appetite (p = 0.021).

Conclusions: Computerized self-assessment is a novel way for patients to fully report a comprehensive spectrum of symptoms,subsequently improving clinical care and quality of life. It can identify prevalent conditions that may not be typically addressed,such as depression and sexual dysfunction. It can efficiently identify symptoms that are changing in severity over time, reachinga critical threshold, or being inadequately alleviated.

Author Disclosure: J. Keam, None; M. Austin-Seymour, None; B. Halpenny, None; N. Bush, None; J. Fann, None; B. Lober,None; S. Wolpin, None; D. Berry, None.

2696 Lithium-Mediated Neuroprotection During Cranial Irradiation: A Phase I Trial

E. S. Yang, B. Lu, D. E. Hallahan

Vanderbilt University Medical Center, Nashville, TN

Purpose/Objective(s): Cranial irradiation often results in long-term neurocognitive deficiencies, especially in children. These def-icits have been associated with radiation-induced hippocampal damage. GSK3 enzyme inhibition leads to neuroprotection throughthe inhibition of program cell death. Preclinical studies show that lithium inhibits GSK3 and blocks radiation-induced apoptosis inhippocampal neurons without protecting cancer cells. Lithium also improved neurocognitive function in mice treated with wholebrain irradiation. These data suggest the potential use of lithium to attenuate radiation-induced cognitive defects to improve thequality of life in cancer survivors. To determine whether lithium is tolerated in patients treated with whole brain irradiation,we studied patients with brain metastases receiving lithium prior to and during radiation. We present a pilot study to evaluatethe feasibility of neoadjuvant and concurrent lithium treatment in patients receiving whole brain radiotherapy.

Materials/Methods: Patients with histologically confirmed extracranial primary malignancy and associated brain metastases weregiven lithium treatment one week prior to as well as during whole brain radiotherapy. Dose of lithium was started at one-half

Page 2: Lithium-Mediated Neuroprotection During Cranial Irradiation: A Phase I Trial

Proceedings of the 49th Annual ASTRO Meeting S587

(300 mg BID) of maximal dose (300 mg QID) for mood disorders. Weekly serum lithium concentrations were obtained. Wholebrain radiation consisted of a total of 3000 cGy over ten fractions. The feasibility of lithium treatment was measured as a functionof safety and compliance. Safety was assessed by the rate of grade 3 or worse non-hematological toxicities. Compliance wasdefined as the completion of the treatment regimen without interruption of more than two doses of radiotherapy.

Results: Five patients have been enrolled in this study. The median age at treatment was sixty. Two patients had metastatic mel-anoma, two had metastatic non-small cell lung cancer, and one had metastatic rectal cancer. Median ECOG performance status wasone. Median dose of lithium was 300 mg BID. Median lithium serum concentration was 0.6 mEq/L (ref. 0.6–1.2). Compliance was100%. No grade 3 or greater toxicities were seen with neoadjuvant and concurrent lithium treatment with whole brain radiotherapy.All patients had symptomatic improvement at the completion of radiation therapy. Serial neurological testing of patients’ globaland spatial memory revealed no decline in short term memory.

Conclusions: Lithium treatment one week prior to and during whole brain radiotherapy is well tolerated in patients treated withcranial irradiation for brain metastases. Future studies to evaluate the efficacy of lithium in the attenuation of radiation-inducedcognitive deficits are currently underway. Our long-term goal is to improve the quality of life in cancer survivors who haveundergone whole brain radiation. Phase II clinical trials are planned to study functional MRI and neurocognitive function inadult patients receiving prophylactic cranial irradiation, which was followed by studies in children treated for medulloblastoma.Cooperative group participation is encouraged.

Author Disclosure: E.S. Yang, None; B. Lu, None; D.E. Hallahan, None.

2697 Quality of Life (QOL) After Salvage Cryosurgery of the Prostate: Comparison With Outcome After

Primary Radiotherapy

M. Abdelhady1, A. M. McKenna2, A. Elamaadawi1, C. K. Ng3, J. L. Chin1, G. S. Bauman2, G. B. Rodregues2, V. Venkatesan2

1LHSC, London, ON, Canada, 2LRCP, London, ON, Canada, 3Singapore Hospital, Singapore, Singapore

Purpose/Objective(s): Currently, with modern technology and improved patient selection, cryosurgery is being used as one of thesalvage procedures for local failure after radical radiation therapy for prostate cancer with successful long-term salvage in approx-imately 35%. With the earlier concerns about the poor quality of life (QOL) in these patients, we aimed to evaluate the QOL aftercontemporary salvage cryosurgery and assess the most affected domains of a validated questionnaire in comparison to the scores ofpatients who had undergone radical radiotherapy for prostate cancer.

Materials/Methods: EPIC questionnaires were mailed to prostate cancer patients who received primary radiotherapy (n = 996) orsalvage cryosurgery (n = 155) in our center between the years 1998–2004. T test was used for statistical analysis to compare be-tween the means of scores in each group.

Results: The over all response rate was 66% (68% and 64% for cryosurgery and radiotherapy groups respectively). Patients aftersalvage cryosurgery showed statistically significant deterioration of the urinary (p \ 0.0001) and sexual (p = 0.0039) domainswhen compared to the means of radiotherapy group, while the means for the bowel and hormonal domains showed no statisticallysignificant difference (graph 1). On looking at the AUA symptom score for both groups, the cryosurgery group showed higher scorethan the radiotherapy group (11.07 vs. 8.25, p = 0.0005). Finally, there was no difference in the satisfaction mean score for bothgroups (75.27 vs. 79.02, p = 0.21).

Conclusions: Although patients after salvage cryosurgery of the prostate may experience further deterioration of their urinary andsexual function, they are usually satisfied with that modality of salvage treatment. Quality of life scores have improved since theearlier days of salvage cryoablation with improvement in patient selection, cryo-technology and operative techniques. Togetherwith acceptable rate of complications and a reasonable 8-year biochemical disease free rate of 37% in some studies, our data sup-ports the selective use of cryosurgery as a salvage treatment modality after failure of primary radiotherapy for prostate cancer.

Author Disclosure: M. Abdelhady, None; A.M. McKenna, None; A. Elamaadawi, None; C.K. Ng, None; J.L. Chin, None;G.S. Bauman, None; G.B. Rodregues, None; V. Venkatesan, None.

2698 Prospective Study on the Short-Term Adverse Effects From Gamma Knife Radiosurgery

S. T. Chao, V. V. Thakkar, B. Jamison, A. M. Reuther, G. H. Barnett, M. A. Vogelbaum, L. Angelov, S. A. Toms, G. Neyman,J. H. Suh

Cleveland Clinic, Cleveland, OH

Purpose/Objective(s): To determine the types, incidence, and severity of acute complications from Gamma Knife radiosurgery.

Materials/Methods: This prospective Institutional Review Board approved study included patients never before treated withGamma Knife (GK). The questionnaire used applicable questions modified from CTCAE (Common Terminology Criteria for Ad-verse Events) v.3.0. The Brief Pain Questionnaire (Short Form), Brief Fatigue Inventory, and the Tinnitus Handicap Inventory alsowere used to assess patients. A baseline questionnaire was administered prior to GK, and follow-up questionnaires were obtained at1 week, 1 month, and 2 months to assess complications. A total of 76 eligible patients with complete data were used for the analysis.Comparisons of baseline to each of the above time periods were analyzed using the Wilcoxon Signed Rank test. When 3 intervalswere compared, Bonferroni’s correction was implemented, resulting in a p-value \0.0166 as significant.

Results: The median age was 62 years old (range: 18–90). Twenty-six (34%) had brain metastases, 15 (20%) had trigeminal neu-ralgia, 12 (16%) had schwannoma, 10 (13%) had meningioma, 7 (9%) had arteriovenous malformation, 3 (4%) had pituitaryadenoma, and 3 (4%) had other.

One week after GK, 24% of patients reported minimal scalp numbness, not interfering with function and 1% reported mild scalpnumbness, interfering with function, but not activities of daily living (p = 0.0004 baseline compared to 1 week). At one and twomonths, 13% and 2% reported minimal scalp numbness, respectively (p = NS compared to baseline for both intervals).

Thirteen percent developed pin site pain at 1 week with a median intensity level of 2 out of 10. By one month, only 3% had pinsite pain with a median intensity level of 3 out of 10. Four percent developed pin-site infection at 1 week and none at 1 and 2 months.