Phase III randomized, double-blind, placebo-controlled trial of donepezil in irradiated brain tumor survivors.

2006 Background: This RCT assessed the effect of 24 weeks of 5-10 mg per day of donepezil, an acetyl cholinesterase inhibitor, on cognitive functioning (primary endpoint) and fatigue, mood and QOL in long-term brain tumor survivors following partial or whole-brain irradiation. Cognitive results are reported herein. Methods: From 2/08-12/11,198 adult primary and metastatic brain tumor survivors > 6 months post radiation treatment (>30 Gray) recruited at 24 sites affiliated with the Wake Forest Community Clinical Oncology Program Research Base, 3 CTSU sites and M.D. Anderson Cancer Center were randomly assigned to receive donepezil (n=99) or placebo (n=99). Cognitive function was assessed at baseline, 12 and 24 weeks with Hopkins Verbal Learning Test-Revised, Rey-Osterreith Complex Figure, Trail Making Test, Digit Span, Controlled Oral Word Association, and Grooved Pegboard. A Cognitive Composite (CC) score was the primary outcome. Results: The sample was 91% White, 54% female, and median age was 55 yrs. 66% had primary tumors, 27% brain metastases and 8% PCI. Median time since diagnosis: 38 mos. 95% had 0-1 ECOG performance status scores. 74% completed the study. CC score improved significantly by 24 weeks in both arms (p < .01); however, there was not a statistically significant difference between groups (p = .57). Donepezil group performed better than placebo on HVLT Recognition (p = .03) and Discrimination (p = .01) and GP-Dominant Hand (p = 0.02). Significant interactions were found between treatment arm and baseline cognitive scores for: CC (p = .01), HVLT Immed. Recall (p = .03), HVLT %Savings (p < .01), Digit Span Forward (p = .01), ROCF Copy (p = .03), TMT-B (p = .05) and GP-Dominant (p < .01). In all cases, the benefit of donepezil, relative to placebo, was greater for those with worse baseline scores. Conclusions: Long-term brain tumor survivors treated with brain irradiation who have cognitive impairment can benefit from 5-10mg of donepezil for 24 weeks. Improvements in verbal memory, working memory, visuo- and psychomotor performance and executive functioning were observed in this group. (Study supported by NIH/NINR grant 5R01NR009675-04, NIH/NCI grant 2 U10 CA 81851-09-13 and Eisai, Inc.) Clinical trial information: NCT00369785.

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Quality of life (QOL) and cognitive status among irradiated brain tumor survivors treated with donepezil or placebo.

Journal of Clinical Oncology ◽

10.1200/jco.2013.31.15_suppl.2051 ◽

2013 ◽

Vol 31 (15_suppl) ◽

pp. 2051-2051

Author(s):

Doug Case ◽

Michelle Joy Naughton ◽

Volker W. Stieber ◽

Gerald K. Bayer ◽

Paul A. Bilodeau ◽

...

Keyword(s):

Brain Tumor ◽

Word Association ◽

Digit Span ◽

Verbal Learning ◽

Cognitive Status ◽

Phase Iii ◽

Cognitive Symptoms ◽

Learning Test ◽

Predominantly Female ◽

The Impact

2051 Background: Cognitive problems after cancer therapy can decrease QOL. This phase III randomized trial tested the effect of donepezil (5-10 mg daily for 24 weeks) on cognition and QOL in brain cancer patients. Methods: Between 2/2008-12/2011, 198 (99 placebo; 99 donepezil) adult primary and metastatic brain tumor survivors > 6 months post radiation (> 30 Gy) were recruited at 24 sites affiliated with the Wake Forest CCOP Research Base, 3 CTSU sites, and M.D. Anderson. Outcomes were assessed at baseline, 12 and 24 weeks. Regression analyses examined the association of demographics, fatigue (FACIT-Fatigue), and a cognitive performance composite score (CC) (comprised of the Controlled Oral Word Association Test, Hopkins Verbal Learning Test-Revised, Digit Span Test, Trail Making Test A&B, Rey-Osterreith Complex Figure-modified, Grooved Pegboard) on QOL, measured by the FACT-Brain (FACT-Br) total score. Results: Participants had a median age of 55, were predominantly female (54%) and non-Hispanic White (91%), with a median time from diagnosis of 38 months. Study completion was 74%. At 12 and 24 weeks, treatment had no significant effect on QOL, unadjusted and adjusted for race/ethnicity, age, sex, fatigue, baseline FACT-Br, and baseline CC. However, for those below the median on the baseline FACT-Br subscale (i.e., greater cognitive symptoms), donepezil was associated with higher (better) post-tx FACT-Br total scores (p =0.004), unadjusted for covariates. After adjustment for covariates, donepezil was borderline significantly associated with higher post-tx QOL (p=0.052). Improvement in QOL was associated with being female (p=0.017) and less baseline fatigue (p=0.005). For participants with baseline FACT-Br subscale scores above the median, only lower baseline FACT-Br total scores (p=0.015) were significantly related to greater improvements in FACT-Br. Donepezil treatment was not significant (p=0.48). Conclusions: The impact of donepezil on QOL was greater in survivors with more cognitive symptoms at baseline, although the results were borderline significant. Fatigue continued to be a major factor in lower QOL. Other interventions to better manage survivors’ symptoms are needed. Clinical trial information: NCT00369785.

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Surgery, Radio- and Chemo- therapy for Multimodal Treatment of Rectal Cancer

Swiss Surgery ◽

10.1024/1023-9332.7.6.256 ◽

2001 ◽

Vol 7 (6) ◽

pp. 256-274 ◽

Cited By ~ 2

Author(s):

Link ◽

Staib ◽

Kornmann ◽

Formentini ◽

Schatz ◽

...

Keyword(s):

Rectal Cancer ◽

Multimodal Treatment ◽

Local Relapse ◽

Phase Iii ◽

Neoadjuvant Radiotherapy ◽

Term Survival ◽

Primary Tumors ◽

Impact On Survival ◽

Relapse Rates

The possibilities and results of multimodal treatment in rectal cancer were reviewed with respect to the results of surgical treatment only. Based on the results of 4 studies, reducing local relapse rates and increasing long term survival rates significantly, postoperative radiochemotherapy (RCT) + chemotherapy (CT) should remain the recommended standard for R0 resected UICC II and III rectal cancers. The addition of RT to adjuvant CT reduces local relapses without significant impact on survival (NSABP R-02). Vice versa, the addition of CT to RT or an improved CT in the RCT-concept prolongs survival. Preoperative neoadjuvant radiotherapy (RT) reduced local relapse rates in 9 studies, and extended survival in one study that evaluated all eligible patients. Preoperative RT reduced local relapse rates in addition to total mesorectal excision (TME) but did not extend survival. The preoperative RCT + CT downstages resectable and nonresectable tumors and induces a higher sphincter preservation rate. Phase III data justifying its routine use in all UICC II + III stages are not yet available. This treatment may be routinely applied in nonresectable primary tumors or local relapses. Preoperative RCT (or RT) may evolve as standard, if the patient selection is improved and postoperative morbidity and long term toxicity reduced. Intraoperative RT could be added to this concept or be used together with preoperative/postoperative RT at the same indications. Postoperative adjuvant RT reduced local relapses significantly in a single trial, and no impact on survival time is reported. Since postoperative RT is inferior to preoperative RT, this treatment cannot be recommended, if RT is chosen as a single treatment modality in adjunction to surgery. The results of local tumor excisions may be improved with pre- or postoperative RCT + CT. In the future, multimodal treatment of rectal cancer might be more effective, if individualized according to prognostic factors.

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Accuracy of prospective memory tests in mild Alzheimer's disease

Arquivos de Neuro-Psiquiatria ◽

10.1590/s0004-282x2012000100005 ◽

2012 ◽

Vol 70 (1) ◽

pp. 17-21 ◽

Cited By ~ 3

Author(s):

Sergilaine Pereira Martins ◽

Benito Pereira Damasceno

Keyword(s):

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Prospective Memory ◽

Digit Span ◽

Verbal Learning ◽

Auditory Verbal Learning ◽

Significant Difference ◽

Behavioral Memory ◽

Animal Tests ◽

Higher Sensitivity

OBJECTIVES: To verify the accuracy of prospective memory (ProM) tests in Alzheimer's disease (AD). METHODS: Twenty mild AD patients (CDR 1), and 20 controls underwent Digit Span (DS), Trail Making (TM) A and B, visual perception, Rey Auditory-Verbal Learning tests, and Cornell Scale for Depression. AD diagnosis was based on DSM-IV and NINCDS-ADRDA criteria. ProM was assessed with the appointment and belonging subtests of Rivermead Behavioral Memory Test (RBMT); and with two new tests (the clock and animal tests). RESULTS: AD patients had a worse performance than controls on the majority of tests, except DS forward and TM-A. There was no correlation between RBMT and the new ProM tests. As for accuracy, the only significant difference concerned the higher sensitivity of our animal test versus the RBMT belonging test. CONCLUSIONS: The clock and the animal tests showed similar specificity, but higher sensitivity than the RBMT subtests.

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A-223 Hopkins Verbal Learning Test-Revised (HVLT-R) and Brief Visuospatial Memory Test-Revised (BVMT-R) Embedded Performance Validity Analyses in a Healthy Non-Clinical Sample

Archives of Clinical Neuropsychology ◽

10.1093/arclin/acaa068.223 ◽

2020 ◽

Vol 35 (6) ◽

pp. 1018-1018

Author(s):

Arzuyan A ◽

Mathew A ◽

Rosenblatt A ◽

Gracian E ◽

Osmon D

Keyword(s):

Cognitive Ability ◽

Digit Span ◽

Verbal Learning ◽

Memory Test ◽

Visuospatial Memory ◽

Performance Validity ◽

Significant Difference ◽

Embedded Measures ◽

Hopkins Verbal Learning Test ◽

Learning Test

Abstract Objective The Hopkins Verbal Learning Test–Revised (HVLT-R) and Brief Visuospatial Memory Test-Revised (BVMT-R) are memory tests with embedded measures of performance validity (Recognition Discrimination [RD] and Discrimination Index [DI], respectively). We evaluated whether cognitive ability and age influenced embedded measures of effort. Methods Participants included 30 young adults (YA) and 29 older adults (dichotomized into unimpaired [OAu] and impaired [OAi]). Participants completed a medication management ability assessment (MMAA), daily memory lapses survey (DM), digit span, and the Transverse Patterning (TP) and Reversal Learning (RL) computerized tests. Two Repeated-Measures MANOVAs were conducted to determine if Passing PVT and Age/Cognitive Ability influenced performance. An ROC analysis was conducted for HVLT-RD and BVMT-DI to determine pass/fail, and false positives/negatives on embedded measures. Results Those in the YA group who failed RDS (YA-fail), performed better than OAi-fail and OAi-pass groups on RT Errors (p < .0001). On TP Errors, the YA group differed from all four OA groups (p < .0001). On MMAA a significant difference was observed between OAi-fail and all other groups (p < .001). On RD, YA groups differed from both OAi groups (p = .0008). On DI, the YA groups differed from the OAi-fail group (p = .002). A logistic regression classified 43/57 participants successfully into the three cognitive groups using the six predictors (χ2 = 55.73, p < .0001, R2 = .468). RT Errors and TP were significant (Likelihood χ2 = 7.25, p = .027). Conclusion HVLT-RD failed to detect validity for OAi, as did BVMT-DI for YA and OAu. Instead, impairment effects are seen on HVLT-RD and BVMT-DI where YA groups differed from some combination of both/one of the OA groups.

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Agomelatine vs fluoxetine: Efficacy and improvement of cognitive functions in patients with MDD

European Psychiatry ◽

10.1016/j.eurpsy.2016.01.1463 ◽

2016 ◽

Vol 33 (S1) ◽

pp. S405-S405

Author(s):

E. Aydın ◽

M. Güleç ◽

E. Oral ◽

A.G. Daloğlu

Keyword(s):

Cognitive Functions ◽

Rating Scale ◽

Word Association ◽

Digit Span ◽

Verbal Learning ◽

Wisconsin Card Sorting Test ◽

Card Sorting ◽

Neurocognitive Functions ◽

Significant Difference ◽

Competing Interest

IntroductionIn major depressive disorder (MDD) neurocognitive functions are impaired. In addition to melatonergic properties of agomelatine, via 5-HT2C antagonism it increases extracellular noradrenaline and dopamine in frontal cortex and may improve the neurocognitive functions of patients with MDD.Aims and objectivesTo investigate the extent of neurocognitive improvement and efficacy of agomelatine and fluoxetine in patients with MDD.Material and methodAgomelatine 25 mg/day (n: 24) and fluoxetine 20 mg/day (n: 24) were administered to drug-naive unipolar, non-psychotic, non-suicidal MDD patients according to DSM-IV. Evaluations were performed just before the treatment and at the sixth week of treatment via administering Hamilton Depression Rating Scale, Rey Auditory Verbal Learning Test, Controlled Oral Word Association Test (COWAT), Digit Span Test (DST), Trail Making Test (TMT-A/B), Stroop Test and Wisconsin Card Sorting Test.ResultsBoth agomelatine and fluoxetine was found to be efficacious for the treatment of MDD (P < 0.05 for both). Further there was no difference between the antidepressant efficacy of two drugs. Both of the drugs improved measured neurocognitive functions (P < 0.05), except scores of DST (P > 0.05) and only fluoxetine improved significantly scores of COWAT (P < 0.05). Only in terms of TMT-B there was significant difference between groups and agomelatine was superior to fluoxetine (P < 0.05).ConclusionAgomelatine and fluoxetine were efficacious in treatment of MDD. Furthermore both of the drugs improved cognitive functions in patients with MDD. Superiority of agomelatine in improvement of executive functioning (TMT-B) is important and therefore it could be an appropriate choice for MDD patients who have pronounced executive disturbances.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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Busulfan Induces Hematologic and Molecular Responses in Polycythemia Vera (PV) Refractory to Multiple Drugs

Blood ◽

10.1182/blood.v120.21.5068.5068 ◽

2012 ◽

Vol 120 (21) ◽

pp. 5068-5068

Author(s):

Emil Tom Kuriakose ◽

Stefani Gjoni ◽

Y. Lynn Wang ◽

Amy Jones ◽

Nicholas C.P. Cross ◽

...

Keyword(s):

Response Time ◽

Polycythemia Vera ◽

Phase Iii ◽

Molecular Response ◽

Low Doses ◽

Molecular Responses ◽

Hematologic Response ◽

Significant Difference ◽

Multiple Drugs

Abstract Abstract 5068 Busulfan, a highly effective and established drug in polycythemia vera (PV), produces lasting clinical and hematologic responses. Its use as a first and second line therapy for PV recently diminished owing to largely unsubstantiated concerns of increased leukemogenicity. However, in a pivotal phase III trial of busulfan vs. P32 conducted by the EORTC in patients with PV, busulfan sustained long term clinical and hematologic responses as well as superior 10 year overall survival (70% vs. 55%). Toxicity was minimal and a low incidence of acute leukemia was reported (1% at 8 years). Accordingly, we treated 5 PV patients with busulfan, 4 of whom were refractory to multiple drugs including hydroxyurea (HU), pegylated interferon alfa-2a (pIFN), imatinib, dasatinib, and anagrelide. Clinical and hematologic response was graded according to PVSG criteria and molecular response according to ELN criteria. JAK2V617F allele burdens were determined by pyrosequencing, which quantifies mutant alleles more than 5%. If negative by pyrosequencing, we used an ARMS-PCR assay with a sensitivity of 0. 1%. Phlebotomy was performed to maintain the hematocrit (Hct) less than 45% for men and 42% for women. Treatment with busulfan was discontinued if patients experienced adverse side effects and/or had platelet counts less than 100, 000/mL while in clinical remission. All 5 patients had complete hematologic responses (CHR) within 3 months of starting busulfan (table 1). Molecular responses (MR) were: 1 complete (CMR) after 6 months, 1 partial (PMR) after 6 months, and 3 with no response (NMR) after 3, 7, and 60 months of treatment respectively. The 2 patients who had MR were homozygous for JAK2V617F, and the 3 who did not were heterozygous. Treatment was discontinued in the patient with CHR and CMR after 7 months due to thrombocytopenia; the patient has since maintained CHR and CMR for 3 years off treatment. The remaining 4 patients have maintained CHR on low doses of busulfan (table 1). No adverse events were observed over a median treatment duration of 15 months (range: 3–60 months). The significant difference in molecular response between patients with homozygous and heterozygous JAK2 mutations receiving similar doses of busulfan is noteworthy. This suggests a susceptibility of homozygous JAK2V617F clones to busulfan, but not to other drugs including HU, IFNa, and anagrelide. In summary, our 5 patients with multidrug refractory PV had rapid and sustained hematologic responses to busulfan at low doses, with favorable short and long term toxicity profiles. Two JAK2V617F homozygous patients had the best MR. Our findings indicate the effectiveness of a safe, relatively inexpensive drug in inducing clinical outcomes not significantly different from that of costly drugs, such as JAK2 inhibitors. In addition, the high rates of MR we observed in patients with homozygous JAK2 mutations warrant further study of busulfan with respect to this parameter. Table 1: Demographics and treatment results of 5 patients treated with busulfan for PV Patient Age (yr)-Sex (M/F) Prior treatments-duration (yr) Busulfan dose Adverse effects Duration of tx (months) Hematologic response/time to response (months) Molecular response/time to response (months) Pre-busulfan JAK2 allele burden 1 75-F HU-2 yr 4mg daily thrombocytopenia 7 CHR/3 CMR/6 100% 2 70-F HU+anagrelide-1yr Imatinib-2yr Dasatinib-3 yr IFNa-1 yr 2mg 3 times a week None 15 CHR/1 PMR/6 85% 3 84-F HU-2 yr Dasatinib- 3yr Imatinib-1yr 2mg 4 times a week None 18 CHR/3 None 27% 4 81-M HU-5 yr 2mg daily None 3 CHR/2 None 23% 5 81-F None 2mg 3 times a week None 60 CHR/3 None 45% Disclosures: No relevant conflicts of interest to declare.

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An Updated Review on Memantine Efficacy in Reducing Cognitive Dysfunction of Whole-brain Irradiation for Adult Patients with Brain metastasis

International Journal of Cancer Management ◽

10.5812/ijcm.111966 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Anya jafari ◽

Zahra Siavashpour ◽

Mohammad Houshyari

Keyword(s):

Brain Metastasis ◽

Verbal Learning ◽

Whole Brain Radiotherapy ◽

Protective Effects ◽

Whole Brain Irradiation ◽

Whole Brain ◽

Brain Irradiation ◽

Brain Radiotherapy ◽

Delayed Recognition

Context: Increased survival of patients with cancer raises the need to pay attention to long-term side effects. Patients with brain metastasis experienced cognition failure after whole-brain radiotherapy. This review aimed at concluding the efficacy of Memantine in preserving cognitive function by reducing the brain toxicity of whole-brain radiotherapy for metastatic brain cancers. Evidence Acquisition: Published studies evaluating memantine protective effects during brain metastasis radiotherapy were searched for in scientific databases (e.g., Embase, PubMed, Cochrane database, Google Scholar, Scopus) using keywords including whole-brain radiotherapy and Memantine. Results: A total of 4 prospective clinical trials were included in the review. Effects of Memantine on cognition tests were evaluated in these trials. A significantly better Hopkins Verbal Learning Test-Revised (HVLT-R) delayed recognition at months 6 was achieved in RTOG 0614 and NRG CC001. Longer time to cognitive decline was found in the memantine arm of the RTOG trial and was statistically significant. Memantine effects were not statistically significant before 2 months. Conclusions: It seems reasonable to consider Memantine during radiation to prevent long-term cognitive failure in patients with brain metastasis due to the current results. Memantine improves cognition function during whole-brain radiotherapy (WBRT) without adding irreparable complications.

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Meta-analysis of gender effect for first-line chronomodulated 5-fluorouracil-leucovorin-oxaliplatin (ChronoFLO) compared with FOLFOX or constant infusion (conventional delivery, CONV) against metastatic colorectal cancer (MCC) in three international controlled phase III randomized trials (RT)

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.4112 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 4112-4112 ◽

Cited By ~ 1

Author(s):

F. Levi ◽

P. Innominato ◽

A. Poncet ◽

T. Moreau ◽

S. Iacobelli ◽

...

Keyword(s):

Liver Metastases ◽

Meta Analysis ◽

Progression Free Survival ◽

Phase Iii ◽

Constant Infusion ◽

Term Outcome ◽

Long Term Outcome ◽

Significant Difference

4112 Background: Gender predicted for the most effective schedule in a RT of ChronoFLO vs CONV against MCC: overall survival (OS) was significantly increased in men on chronoFLO vs FOLFOX, whereas the reverse was found in women (Giacchetti, JCO 2006). Methods: To assess the relevance of gender for patient (pt) outcome, meta-analysis was performed on individual pt data (IPD) from 3 RT in 845 MCC pts treated with chronoFLO vs CONV (346 F, 499 M at 36 centers in 1990–2002)(Lévi, JNCI 1994; Lancet 1997). Data bases were merged and updated at 9 y after inclusion of the 1st pt. Main prognostic factors were comparable in each RT according to gender and treatment arm (median age: 61y; PS=0, 46% pts; liver M, 85% pts; liver involvement >25%, 41% pts; lung M, 37% pts; CEA>10, 56% pts). Results: No significant difference was found according to delivery schedule or gender in the whole population for Response Rate (RR), Progression-Free Survival (PFS) and OS. However, men on chronoFLO had highest RR, longest PFS and OS. PFS and OS were highest in women on CONV ( Table ). The rate of complete macroscopic resections of liver metastases (R0+R1) was 12.5% in men on chronoFLO vs 7.8–8.5% in men on CONV or in women on either schedule. A complete histologic response of liver metastases was documented in 2.1% of the men on chronoFLO vs 0–1.1% in the other groups. The relative risk of an earlier death in men vs women was 0.76 [95% CL, 0.91 to 0.94] on chronoFLO and 1.24 [0.99 to 1.56] on CONV. Conclusions: This IPD meta-analysis of 3 RT in MCC with a minimum follow up of 5 years confirms that men benefit from chronoFLO as compared to CONV delivery, with regard to long term outcome and medico-surgical strategy. ChronoFLO should be preferred to conventional oxaliplatin-5-FU-LV schedules in men with MCC. Support: ARTBC Internationale, P. Brousse Hospital, Villejuif, France. [Table: see text] No significant financial relationships to disclose.

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Impact of p16 status on the QOL effects of chemoradiation for locally advanced oropharynx cancer: Results of TROG 02.02.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.5571 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. 5571-5571 ◽

Cited By ~ 1

Author(s):

Jolie Ringash ◽

Richard Fisher ◽

Lester J. Peters ◽

Brian O'Sullivan ◽

Andy Trotti ◽

...

Keyword(s):

Oropharyngeal Cancer ◽

Locally Advanced ◽

Phase Iii ◽

Phase Iii Trial ◽

Significant Difference ◽

Ecog Ps ◽

The Impact ◽

Subsequent Time Point

5571 Background: We report the impact of p16 status on quality of life (QOL) for patients with stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oropharynx (OPC) treated with concurrent chemoradiotherapy in a large international phase III trial (TROG 02.02/HeadSTART). Methods: The 861 patients accrued received definitive radiotherapy (RT) (70 Gy/7 weeks) concurrently with 3 cycles of either cisplatin (100mg/m2) or cisplatin (75 mg/m2) plus tirapazamine (290 mg/m2/day) by random assignment, as previously described. QOL was measured with the FACT-H&N at baseline, 2,6,12, 23 and 38 months. No significant difference in overall or subscale QOL score change from baseline was observed between arms at any subsequent time point; results for the oropharynx subgroup by p16 status are reported for both treatment arms combined. Results: Of 853 eligible participants, 465 had OPC, for whom p16 status could be determined in 206. Of 179 who received adequate RT (≥ 60 Gy, no major deviations) and completed baseline QOL, 104 were p16+ and 79 were p16-. p16+ patients had better baseline ECOG PS, lower T-category, higher N-category, were younger and were less likely to be current smokers. Baseline mean FACT-H&N score was statistically and clinically significantly better in p16+ patients (111 vs. 102, p=0.001). The drop in QOL from baseline to 2 months was more severe in p16+ cases (-20.4 vs -9.1, p=0.001), resulting in an equalization of 2 month scores (p16+: 90.6, p16-: 93.6, p=0.16). At 6 and 12 months post-treatment, no difference in score changes from baseline by p16 status was seen (6 mo, p16+: -6.2, p16 -:-1.2, p=0.22; 12 mo, p16 +: -0.3, p16 -: +2.0, p=0.82). Conclusions: p16 associated oropharyngeal cancer has been shown to be a distinct entity with different demographic features. In our study, such patients exhibited better baseline QOL and a more severe drop immediately after treatment, but did not differ in long-term QOL response to the effects of aggressive concurrent chemoradiation. Given the favorable prognosis of p16-associated oropharyngeal cancer, efforts to reduce the QOL burden of treatment are warranted.

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