Annual Meeting Proceedings Part 1 - American Society of Clinical ...

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594s Patient and Survivor Care 9110 General Poster Session (Board #46H), Sat, 8:00 AM-12:00 PM Efficacy and safety of half-dose pegfilgrastim in cancer patients receiving cytotoxic chemotherapy. Presenting Author: Ryan C. Ramaekers, Saint Francis Cancer Treatment Center, Grand Island, NE Background: Pegfilgrastim reduces neutropenia risk in patients (pts) on cytotoxic chemotherapy. A single 6 mg dose per chemotherapy cycle commonly causes bone pain and leukocytosis. While half-dose pegfilgrastim has been shown to be safe and effective in breast cancer pts, there is no data on half-dose pegfilgrastim in general oncology pts. Methods: We evaluated the efficacy and safety of half-dose pegfilgrastim in general oncology pts on cytotoxic chemotherapy at St Francis Cancer Center. Pts who received at least one dose of 6 mg pegfilgrastim and developed NCI-CTCAE grade 2 or more bone pain and/or leukocytosis (WBC�10,000/ ml) were given 3 mg dose pegfilgrastim on their following chemotherapy cycles. Pt demographics, type/number of chemotherapy regimens, efficacy, side effects and complications were evaluated. McNemar’s test, logistic regression analysis and ANOVA were used for statistical analysis. Results: Twenty-six pts (3 males, 23 females, all Caucasian) with median age 55 (range 34-86) received a total of eighty-three 3 mg doses of pegfilgrastim. Cancers treated were breast (N�16), colorectal (N�7), head and neck (N�1), non-Hodgkin lymphoma (N�1) and non-small cell lung cancer (N�1). Chemotherapy received was anthracycline (N�9), taxane (N�7), 5-FU/oxaliplatin (N�7), 5-FU/cisplatin (N�1), gemcitabine/oxaliplatin (N�1), pemetrexed/carboplatin (N�1). No neutropenia or chemotherapy dose modifications occurred on half-dose pegfilgrastim. In the 26 pts we report, bone pain occurred in 23 pts at 6 mg and 14 pts at 3 mg dose. Leukocytosis occurred in 23 pts at 6 mg and only 2 pts at 3 mg dose (McNemar’s test, P�0.01). While older age and full-dose pegfilgrastim were predictive of bone pain, more than one line of chemotherapy and half-dose pegfilgrastim were predictive of lack of leukocytosis (logistic regression analysis/ANOVA, P�0.01). Conclusions: Half-dose pegfilgrastim in general oncology pts receiving cytotoxic chemotherapy seems to be safe and effective with less bone pain and leukocytosis without resultant neutropenia or need for chemo modification. Larger prospective studies of half-dose pegfilgrastim in this setting are needed to further understand the feasibility of this approach. 9112 General Poster Session (Board #47B), Sat, 8:00 AM-12:00 PM Determinants of fatigue improvement in outpatient oncology according to baseline categories of fatigue severity. Presenting Author: Michael Fisch, University of Texas M. D. Anderson Cancer Center, Houston, TX Background: Understanding the determinants of fatigue response may help distinguish between different fatigue phenotypes and inform trial designs. Methods: Patients with invasive cancer of the breast, prostate, colon/ rectum, or lung were enrolled from multiple sites. At baseline and 4-5 weeks later patients rated their symptoms on a 0-10 numerical rating scale. A 2-point change was considered clinically significant for fatigue change. Logistic regression models and ordinal logistic regression models were used to examine the effects of demographic and clinical factors on fatigue change. Separate models were constructed for fatigue deterioration in patients with mild fatigue at baseline and lack of improvement for those with severe fatigue at baseline or any significant change for those with moderate baseline fatigue. Results: 3,106 pts were enrolled at baseline and 3,032 were analyzable for fatigue change. At baseline, 23% had no fatigue, 35% mild, 25% moderate, and 17% severe. Improvement varied by baseline fatigue score with response in 54% with severe fatigue, 31% with moderate, and 9% with mild. Overall, 13 different parameters were significant in these 3 models of fatigue change, but no single parameter was common to all 3 categories of fatigue. Exposure to anxiolytics and duration of current treatment were significant in models of mild and severe fatigue; antidepressant exposure was significant for mild and moderate fatigue, and baseline fatigue level was a significant parameter in moderate and severe fatigue. In colorectal and lung cancer patients, gender was not significant for fatigue change in patients with mild or moderate fatigue, but gender was the strongest predictor fatigue improvement in patients with severe fatigue with men most likely to significantly improve (OR�2.49, 95% CI 1.15-5.41, p�0.021). Conclusions: Clinically significant improvement in fatigue varies between 9% and 54%. Predictors of fatigue change vary depending on categories of baseline fatigue severity. Gender is the strongest predictor for fatigue improvement among lung and colorectal outpatients with severe baseline fatigue. Future trial designs should account for gender and baseline fatigue severity. 9111 General Poster Session (Board #47A), Sat, 8:00 AM-12:00 PM Continued suppression of bone turnover following a single dose of zoledronic acid: Time to re-think dosing intervals in the management of bone metastases? Presenting Author: Christine E. Simmons, St. Michael’s Hospital, University of Toronto, Toronto, ON, Canada Background: The management of patients (pts) with bone metastases has changed significantly over the past decade, with the advent of newer, more potent anti-osteoclastic agents. However, the dosing interval in which these agents are given has not changed; pts are still dosed at a frequency of monthly or q3weekly injections. It is not known if this is the optimal dosing frequency or due to convention. The purpose of this study was to determine the duration of suppression of bone turnover by Zoledronic Acid (ZA) in a population of bisphosphonate naive metastatic breast cancer (MBC) pts. Methods: This prospective single arm phase II study enrolled 26 pts with MBC to bone who had not received bisphosphonates in the metastatic setting. A single dose of ZA was given at week 0, and biomarkers of bone turnover (serum CTX) were collected every 2 weeks subsequently. Pain scores and quality of life data were collected every 4 weeks. Pts remained on study if their biomarkers remained suppressed, but came off study as soon as escape from suppression was noted, (defined as a rise � 50% of baseline value). Results: At 12 weeks, 73% (95% CI 56%-90%) of pts had continued suppression of bone turnover demonstrated by serum CTX. The pts that escaped suppression did so at a median of 8 weeks after first infusion of ZA (range 8-10 weeks). The magnitude of suppression (proportion decrease from baseline) of serum CTX at week 4 was significantly greater in those who had continued suppression compared to those who escaped suppression before 12 weeks (75% vs 58%, p � 0.02). The absolute baseline value of CTX was significantly lower in pts who maintained suppression (507 vs. 745 ng/L, p � 0.04). Quality of life scores and pain medication use did not change appreciably during this period. Conclusions: This study suggests that ZA may not need to be given at conventional intervals in the majority of pts, and may safely be withheld without increased risk to morbidity or decline in quality of life over a 12 week period. Baseline CTX and the magnitude of suppression of bone turnover at 4 weeks may predict for the optimal dosing frequency. Confirmation in a randomized trial is needed. 9113 General Poster Session (Board #47C), Sat, 8:00 AM-12:00 PM Pain, sleep disturbance, and fatigue symptom cluster in patients suffering from chronic chemotherapy-induced neuropathic pain (CINP). Presenting Author: Jennifer S. Gewandter, University of Rochester Medical Center, Rochester, NY Background: Various symptom cluster combinations of pain, fatigue, sleep disturbance (SD), and depression have been identified in cancer patients. The presence of symptom clusters has not been assessed in patients with persistent CINP. This exploratory analysis aimed to determine which symptoms statistically clustered with pain in cancer survivors with CINP. Methods: The University of Rochester Cancer Center Community Clinical Oncology Program recruited 461 patients with CINP � 4 (on a 0-10 scale) who had completed chemotherapy (median 7 months ago) for a pain intervention trial. At baseline, groups of highly associated symptoms that included pain were identified empirically using factor and cluster analyses of the 11 symptoms in the University of Rochester Symptom Inventory plus the Hospital Anxiety and Depression Scale (HADS) scores. To investigate if associated symptoms track together over time, multiple linear regression (MLR) analysis was performed using changes in symptom severity between baseline and week 6, controlling for gender, age, education, race, and marital status. Results: Subjects were 88% white and 71% female, and on average 61 years old. Mean (standard deviation) baseline pain, fatigue, and SD were 5.7 (2.8), 5.0 (2.7), and 4.2 (3.1), respectively; 26% of subjects had borderline or abnormal HADS scores. Factor analysis identified 3 factors that accounted for 88% of the variance. One factor included pain, fatigue, SD, but not HADS, and accounted for 37% of the variance. Variable clustering also identified pain, SD, and fatigue as 1 symptom cluster. Changes in severity of SD and fatigue (p � 0.0001), but not HADS, were associated with changes in pain (adjusted R2 � 0.168) in MLR analysis. Conclusions: Pain, fatigue, and SD were identified as a symptom cluster by factor and cluster analyses, and were found to track together over time by MLR. Since these data suggest that pain is associated with sleep quality and fatigue in patients with persistent CINP, targeting one of these symptoms may lead to reductions in the others. Future research should investigate interventions that target pain, fatigue, and SD concurrently in cancer survivors suffering from CINP. Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.
9114 General Poster Session (Board #47D), Sat, 8:00 AM-12:00 PM Treatment and mortality rates of older cancer patients with a body mass index Grade 3 2 (50) 3 (30) 2 (67) 6 (67) Liver AEs 0 1 (10) 0 2 (22) Renal AEs Thromboembolic events 2 (50) 0 0 3 (33) b 0 1 (10) 0 2 (22) SAEs 1 (25) 2 (20) 1 (33) 5 (56) Deaths, n (%) c 595s 2 (50) 4 (40)� 1 (33) 3 (33) Plts: Cycles 2-6, mean (n) Pre ctx Day 1 309 (4) 443 (9) 314 (3) 442 (9) Pre ctx Day 8 204 (4) 355 (10) 239 (2) 270 (9) Pre ctx Day 15 75 (3) 164 (10) - - Nadir 103 (4) 143 (10) 53 (2) 113 (9) Grade 3/4 thrombocytopenia: Cycle 2-6, n (%) 1 (25) 0 2 (67) 3 (33) a 7/33 randomized pts never received epag/pbo. b None were considered related to epag and all resolved. One event occurred after stopping epag and following disease progression (PD). c All deaths were from PD; three additional patients died prior to receiving epag or pbo. Visit abstract.asco.org and search by abstract for the full list of abstract authors and their disclosure information.
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Volume 30, Issue 15S, Part I of II
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Editor: Michael A. Carducci, MD Man
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Volume 30, Issue 15S Supplement to
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Letter from the Editor The 2012 ASC
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JOURNAL of CLINICAL ONCOLOGY ......
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ASCO Conflict of Interest Policy an
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2s Special Awards also “normalize
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2012 ASCO Annual Meeting Proceeding
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500 Oral Abstract Session, Sun, 8:0
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508 Clinical Science Symposium, Sat
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Author Index Note: Numerals refer t
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Alexanian, Raymond 8093 Alexeev, Bo
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Arkenau, Hendrik-Tobias 2540, 3000,
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Ballen, Karen K. 6606, 6617, 6618,
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Ben-Aharon, Irit 548, 2556, e13080
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Blancas, Isabel e11535, e11545, e21
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Brandes, Johann Christoph 7048, 106
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Cakir, Betul 9567 Calabek, Bernadet
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Ceraulo, Domenica 4017 Cerbone, Lin
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Chinen, Ludmilla T.D. e16046 Chinen
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Come, Steven E. 9071, 9100 Comis, S
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Dahlheimer, Tambra 2546 Dahmane, El
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DeLacure, Mark D. e16052 Delage, Ju
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Domingo, Gelenis 6568, 6575, 6588 D
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El Sherbeiny, Esam e15129 El-Deiry,
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Fayad, Luis 6501, 8067 Fayette, Jer
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Foroni, Chiara e11546 Foroni, Letiz
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Gang, Wu 7091, e14511 Gangaram, Anj
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Gimenez Capitan, Ana 4068, 10596, e
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Granowetter, Linda 9537 Grant, Barb
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Hainsworth, John D. 618, 1018, 1086
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Heerschap, Arend e13111 Heersink, M
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Hong, Seung-Mo 3568 Hong, Sook Hee
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Im, Young-Hyuck 598^, 644, TPS649,
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Ji, Yongling e17527 Jia, Jingquan e
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Kaparelou, Maria 583 Kapaun, Christ
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Kim, Chan Kyu e14688 Kim, Chang Won
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Komatsu, Yoshihiro e14689 Komatsu,
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Laack, Nadia N. 2032, e14507 Laadem
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Lee, Ji-Hyun TPS3114, 6100 Lee, Jih
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Lim, Kian-Huat e14584 Lim, Kiat Hon
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Loupakis, Fotios 3518, 3540, 3546,
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Man, Shan e11061, e15177^ Manaloor,
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Mathieu-Nicot, Florence e19623 Math
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Mergenthaler, Hans-Guenther e15026
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Molero, Xavier e21035 Moles-Moreau,
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Munoz-Sanchez, MM e19590 Munsell, M
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Ng, Daniel e15050 Ng, Dawn Marie e1
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Oguri, Senri 5556 Oh, Do Youn 1003
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Palassini, Elena 10026, 10053, 1006
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Peisker, Uwe 10600 Peker, Deniz e18
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Piwnica-Worms, Helen 3047 Pizzo, Fa
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Rabinowits, Guilherme 5501, 5582, 9
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Reyes-Rivera, Irmarie CRA3503 Reyna
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Rose, Steven C. 3590 Rosell, Rafael
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Sakata, Shinya e18059 Sakata, Yuh 3
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Schenkein, David P. 6606 Schepp, Wo
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Sha, Dan 3564 Sha, Huifang e13528 S
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Silva, Jose D. 5567 Silva, Milton J
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Sousa, Carlos Eduardo Pires 643 Sou
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Su, Xinying 4124 Su, Yu-Chieh e1600
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Tan, Chee Seng 1064, e19523 Tan, Ch
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Tillmanns, Todd D. 5014, e15514 Til
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Uchiyama, Tomotaka e21108 Udovitsa,
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Videtic, Gregory M.M. e14611, e1466
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Wang, Yuan e15124 Wang, Yunfei 547
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Wischnewsky, Manfred 1078 Wischnik,
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Yasuda, Hiromi e14029 Yasuda, Hiroy
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Zhang, Xinmin e16022 Zhang, Xu Dong
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