bluuebunny/crossref_metadata_2025_split huggingface dataset:
Pyridoxine is not effective for the prevention of hand foot syndrome (HFS) associated with capecitabine therapy: Results of a randomized double-blind placebo-controlled study
Authors: Lee S. , Lee S. , Chun Y. , Kim M. , Chang H. , Kim T. , Ryu M. , Lee J. , Lee J. , Kang Y. 
Published: March 2020

9007 Introduction: Although pyridoxine has been used empirically for the prevention of HFS associated with capecitabine, its efficacy has not been proven yet. We performed a prospective randomized double-blind study to determine whether pyridoxine can prevent the development of HFS when given concurrently with capecitabine. Method: Chemotherapy-naive patients (pts) with gastrointestinal tract cancers who were going to have capecitabine-containing chemotherapy were randomized to receive either oral pyridoxine (200 mg/day) or placebo daily during chemotherapy after stratified by chemotherapy regimen: 1) capecitabine alone, 2) capecitabine and cisplatin, or 3) docetaxel, capecitabine, and cisplatin. The patients were observed until grade 2 or 3 HFS (by NCI CTC version 2.0) developed or capecitabine containing chemotherapy ended. When grade 2 or 3 HFS developed in pts in placebo group, the pts were randomized again to receive either pyridoxine or placebo for next cycle of chemotherapy in order to determine whether pyridoxine could improve the HFS. Result: From Jun 2004 to Oct 2005, total 389 pts were entered onto the study. But, 29 pts (15 in placebo group and 14 in pyridoxine group) were excluded from the study because of ineligibility or pts’ refusal. Pts’ characteristics were well balanced between the 2 groups. Grade 2 or 3 HFS developed in 55 of 180 (30.6%) pts in placebo group and in 57 of 180 (31.7%) pts in pyridoxine group. (p=0.788) The median cycles of chemotherapy to grade 2 or 3 HFS was 3 in both groups. The mean cumulative dose of capecitabine until occurrence of grade 2 or 3 HFS was not different statistically between the two groups. (221,157.5 mg/m2 vs. 259,808.5 mg/m2, p=0.788). Total 44 of 55 pts in placebo group who had grade 2 or 3 HFS were randomized to receive either placebo or pyridoxine at next cycle. There was no significant difference between the two groups in the proportion of pts with improvement of HFS (43% vs 48%, p=0.94). Conclusion: These results indicated that pyridoxine is not effective for the prevention of HFS associated with capecitabine therapy. No significant financial relationships to disclose.
Does health-related quality of life (HRQL) improve for patients who respond to chemotherapy? Analysis of patients with advanced pancreas cancer (APC) receiving gemcitabine on Cancer and Leukemia Group B (CALGB) study #80303
Authors: Romanus D. , Archer L. , Wang X. , Goldberg R. , Mulcahy M. , Kindler H. , Schrag D. 
Published: March 2020

9008 Background: Gemcitabine chemotherapy for APC is palliative and confers only modest survival advantage. Therefore HRQL concerns are of paramount importance. Methods: We compared HRQL scores based on response to chemotherapy at the first interval restaging (8 weeks). We evaluated HRQL at baseline on paper, and then q8 weeks by phone using the EQ5D instrument in patients with APC participating in a double-blind, randomized trial comparing overall survival for gemcitabine with bevacizumab (GB) or placebo (GP). The EQ5D is a HRQL measure whose composite (C) and visual analog scale (VAS) scores respectively reflect societal and patient valuations. Results: Among 552 patients starting protocol treatment, characteristics did not differ between 359 who did and 193 who didn’t complete baseline assessments. Patients who didn’t complete 8 week assessments were more likely to have died, progressed or discontinued protocol therapy. Changes in EQ5D scores from baseline to 8 weeks did not differ by treatment arm (p-values=0.84, 0.79 for C and VAS scales, Wilcoxon rank sum test). At 8 weeks, all patients and those with progressive disease had a modest decline in VAS scores (p-values≤0.02, Wilcoxon signed rank test). Comparisons of changes from baseline in C scores at 8 week follow-up revealed no differences within other response group strata (all p-values > 0.05). Conclusions: Based on this preliminary analysis, gemcitabine therapy was not associated with higher HRQL scores, nor was there any strong association between tumor response and HRQL. To increase data representativeness, future APC trials should assess HRQL more often than every 8 weeks. HRQL Scores Based on Gemcitabine Response Strata. Values are Mean (SD) [Table: see text] [Table: see text]
Angiotensin-converting enzyme gene polymorphism (ACEGP) and cancer cachexia (CC): Is there a link?
Authors: Vigano A. A. , Hamel N. , Morais J. , Foulkes W. , Kilgour R. , Bond R. , Trutschnigg B. , Brar S. , Theberge J. , Tremblay M. 
Published: March 2020

9011 Background: ACEGP greatly influences functional status and is currently the gene most involved in human fitness. The insertion allele (II) (a 287 bp fragment) rather than the deletion allele (DD) for the angiotensin-converting enzyme (ACE) gene is associated with low ACE levels in tissues and enhanced metabolic efficiency, as demonstrated by an improved response to vigorous training in healthy individuals. In addition, lower tissue ACE activity in mice was associated with decreased insulin resistance, greater glucose uptake in the skeletal muscle, and higher glycogen and fat stores. The aim of the study was to gather preliminary data on the potential association between muscle mass and ACEGP in advanced cancer patients (ACP). Methods: Buffy coat serum and plasma was obtained from 55 patients 18 years or older, newly diagnosed with Stage III (inoperable)-IV non-small cell lung cancer and unresectable/ metastatic gastrointestinal cancers seen within the McGill University Health Center. Muscle surface area (MSA-cm2) was calculated from computerized tomography slices at the L3 vertebrae using TOMOVISION SliceOmatic software version 4.3. Muscularity (M-cm2/m2) and lean body mass (LBM-kg) were calculated by extrapolation of image analysis used to quantify lean tissue. Results: ANOVA confirmed significant difference (p<0.001) among MSA (II: 134.04±35.23; ID: 122.37±29.74; DD: 115.22±27.55), M (47.72±8.67; 41.65±9.26; 41.80±9.26), and LBM (43.00±11.21; 39.29±9.46; 37.01±8.77). In a multiple linear regression model, the II allele was associated with higher M (p=0.042) and a trend for higher MSA and LBM (p=0.059) independent of age, gender, diagnosis, and treatment received. Conclusions: Our data suggest ACEGP influences muscle mass in ACP. Further investigations in a larger sample of ACP are underway to determine whether ACEGP is an important predisposing factor to CC-associated muscle wasting. No significant financial relationships to disclose.
Cytokine gene polymorphisms and cancer-related symptoms in lung cancer patients
Authors: Reyes-Gibby C. C. , Spitz M. , Wu X. , Shete S. 
Published: March 2020

9012 Background: Cytokines, aberrantly produced by cancer cells, have recently been implicated in the severity of cancer-related symptoms. We hypothesize that functional variations in cytokine genes could explain variability in self-reported pain and depressed mood in lung cancer patients of all stages. Methods: Pain, depressed mood, clinical and demographic variables were assessed at presentation, and prior to initiating any cancer treatment in 514 white patients with non-small cell lung cancer (NSCLC). Using the TaqMan method, we genotyped single nucleotide polymorphisms in interleukin (IL) −6 (−174 G>C), IL-8 (−251 T> A), and tumor necrosis factor-alpha (TNF-; −308 G> A), and determined their associations with pain and depressed mood. Results: Sixteen and 7% of respondents reported severe levels of pain (≥ 7, on a 0–10 scale) and depressed mood most/all of the time, respectively. The severity of pain and depressed mood predictably varied by clinical, sociodemographic, and genotype variables in the univariate analyses. Multivariable logistic regression analyses showed that variant allele in IL8 (OR=2.05;95%CI=1.04–4.06), early age of onset (≤ 50 years) (OR=1.80;95%CI=1.02–3.14), and depressed mood (OR=4.55;95%CI=2.105–9.81) were significant predictors for severe pain. For depressed mood, results showed that variant allele in IL6 (OR=0.49;95%CI=0.24–0.49), severe pain (OR= 3.77;95%CI=1.79–7.95) and a history of stroke (OR=3.50;95%CI=1.03–11.82) as significant predictors. Classification and Regression Tree analyses revealed potential higher order gene-gene interaction for pain (IL1 and IL6) and depressed mood (IL8 and IL6). Conclusions: Variations in individual inflammatory responses could partly explain variability in pain and depressed mood in patients with lung cancer. No significant financial relationships to disclose.
Normalization of bone markers and improved survival during zoledronic acid therapy
Authors: Lipton A. , Cook R. , Coleman R. E. , Major P. , Terpos E. , Body J. , Smith M. R. , Brown J. , Garnero P. 
Published: March 2020

9013 Background: In patients (pts) with bone metastases, elevated N-telopeptide of type I collagen (NTX) levels correlate with increased relative risks (RR) of skeletal-related events (SREs), disease progression, and death (Brown et al. J Natl Cancer Inst. 2005;97:59–69; Coleman et al. J Clin Oncol. 2005;23:4925–4935). Therefore, we conducted an exploratory analysis of 3 large, randomized, controlled trials to investigate whether reductions in NTX levels by treatment with zoledronic acid (ZOL) correspond with decreased risks of SREs and death. Methods: Urinary NTX was measured at baseline and at 3 months in pts with bone metastases from breast (BC; n = 379), prostate (PC; n = 314), or lung cancer and other solid tumors (LC/OST; n = 204) who received ZOL for up to 24 months. Pts were stratified by baseline NTX levels (normal, < 64 nmol/mmol creatinine; elevated, = 64 nmol/mmol creatinine). Results: Approximately 50% of pts had elevated baseline NTX, and NTX normalization occurred within 3 months of ZOL treatment in 81% of pts with BC or LC/OST and in 70% of PC pts. For all tumor types, NTX normalization in response to ZOL correlated with reduced risk of first SRE and death compared with pts whose NTX did not normalize ( Table ). Further analyses using NTX level as a continuous variable revealed that, for all tumor types, any reduction in NTX levels correlated with lower risk of first SRE and death regardless of baseline NTX level. Conclusions: Pts whose NTX normalized on ZOL at 3 months had a lower risk of first SRE and death compared with pts whose elevated baseline NTX did not normalize. Regardless of baseline NTX level, a reduction in NTX over 3 months (absolute and % change) provided a continuum of SRE risk reduction and survival benefit. No significant financial relationships to disclose. [Table: see text]
Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): Experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial
Authors: Hopwood P. , Nankivell M. , Pugh C. , Gilligan D. , Nicolson M. , Stephens R. J. 
Published: March 2020

9020 Aim: To evaluate QL during the first 2 years follow-up in patients randomised to receive 3 cycles of platinum-based chemotherapy (CT-S) prior to surgical resection of NSCLC compared to those receiving surgery alone (S). Methods: A total of 519 patients were entered into the LU22 trial from 70 centres in the UK, The Netherlands, Germany and Belgium. All patients were asked to complete the SF-36 QL questionnaire prior to randomisation and at 6 and 12 months then annually to 5 years. The scores from the SF-36 questionnaire were combined into 8 domains and also summarised as physical component summary (PCS) and mental component summary (MCS). The 6,12 and 24 month PCS and MCS scores were analysed using multivariable regression to identify prognostic factors and investigate the difference between the regimens. Results: 82% patients completed QL at baseline, and compliance at 6, 12 and 24 months was 59%, 60% and 67% respectively. Median age was 63 (range 25 to 79 years) and 72% were male. At 6 months patients in the S group reported somewhat better functioning in all domains except general health and mental health, but no differences were seen at 12 or 24 months. The regression analyses indicated that better physical health outcomes (PCS) were predicted by baseline PCS and MCS at all follow-up points (all p<0.05), whereas longer time since surgery predicted better PCS at 6 months (p<0.05), and younger age predicted better PCS at 24 months (p=0.07). For mental health, better MCS was predicted at all time points by baseline MCS (p<0.05). In addition, female gender (p=0.07), and PCS (p<0.05), were predictors at 6 months, and younger age predicted better MCS at 24 months (p<0.01). Treatment regimen had no effect on QL at any time point. At 1 and 2 years more than 50% patients considered their health comparable to others, and 45% were generally optimistic about their future health. Conclusions: Over 2 years follow-up, QL was not adversely affected by pre-operative chemotherapy and there were no significant differences between the regimens. Many patients saw themselves as fit as their contemporaries. [Table: see text]
Prognostic significance of patient-physician disagreement about performance status in patients with advanced cancer
Authors: Schnadig I. D. , Fromme E. K. , Loprinzi C. L. , Sloan J. A. , Mori M. , Li H. , Beer T. M. , Perrin N. 
Published: March 2020

9021 Background: Physician-reported performance status (PS) is an important prognostic factor in advanced malignancies and is a commonly used stratification variable in cancer clinical trials. However, the extent, predictors, and prognostic importance of disagreement in PS assessment between physicians and patients have not been examined. Methods: Using NCCTG clinical trials from 1987–1990 (J Clin Oncol 19(15):3539–3546, 2001), we analyzed the difference and agreement of PS (ECOG and Karnofsky [KPS]) and nutritional status assessments reported by physicians and patients individually. The degree of disagreement was analyzed using paired t-test. Overall mortality was estimated by Kaplan-Meier method. The effect of disagreement on overall survival was analyzed by Cox regression. Independent predictors of disagreement were identified by logistic regression. Results: 1,636 patients with advanced lung and colorectal cancer had a median survival of 9.8 months (95% CI, 9.4 to 10.4). Percent agreement between patients and physicians about KPS, ECOG PS, and appetite/nutritional status was 32.9%, 43.4% and 42.0% respectively. Physicians were more likely to rate patients better than individual patients were to rate themselves: ECOG (Mean 0.91 vs 1.30, p<.0001), KPS (Mean 83.3 vs. 81.7, p<0.0001), appetite/nutritional status (Mean 1.6 vs. 2.1, p<0.0001). Inability to work, depression and less than a high school education were independently associated with disagreement. An increased risk of death was observed for patient and physician disagreement on KPS (HR=1.15, 95% CI, 1.03 to 1.27 p=0.01) and appetite/nutritional status (HR=1.39, 95% CI, 1.26 to 1.54 p<0.0001). Conclusions: Patients and physicians frequently disagree about patient PS, with physicians tending to rate patients higher than patients do themselves. Baseline patient demographic factors that independently predict disagreement have been identified. Disagreement confers an increased risk of death in the setting of advanced malignancies. These findings illustrate limitations of physician-only assessed PS. No significant financial relationships to disclose.
Continuous intravenous lidocaine controls abdominal pain secondary to peritoneal carcinomatosis as a consequence of diffusion into ascites
Authors: Tanaka T. , Tsukui R. , Okano S. , Tsuchiya M. , Obokata K. , Ogawa T. , Abe T. , Ikeya T. , Miyasaki M. 
Published: March 2020

9031 Background: Our team reported at the 42nd ASCO meeting that continuous, low-dose intravenous (IV) lidocaine is an effective method for pain relief in terminal patients with peritoneal carcinomatosis. Our aim was to explore the mechanism by which abdominal pain of terminally-ill patients with peritoneal carcinomatosis was improved by continuous IV lidocaine. Methods: 48 patients with peritoneal carcinomatosis due to GI (46) and GYN (2) malignancies were administered lidocaine at low-doses (0.4 and/or 0.8mg/kg- h) for >24 hours, because opiates, NSAIDs, and other adjuvants were ineffective in relieving their abdominal pain. Pain (faces rating scale; 0-no pain, 5-worst pain), oral intake, side effects, and activities of daily life were quantified. Two days after beginning lidocaine, ascites was sampled to measure ascitic concentration of lidocaine, tumor markers and cytology. Results: Mean age (±SE) was 60±2. The volume of ascites was estimated to be 2,700±400ml by the ultrasound 5 points methodology. Abdominal symptoms improved in 1.5±0.2days after beginning lidocaine, and the pain scale decreased from 1.9±0.2 to 0.5±0.1; p<0.001; 75% of patients had improvement in pain of whom 78% had complete relief of pain. Oral intake increased from 18% to 49% of baseline (p<0.001), and 67% in those with improvement in pain had an increased volume of oral intake. There were no obvious differences in response to 0.4 and 0.8 mg/kg-h in patients receiving both doses. Serum concentrations of lidocaine at 0.4 and 0.8 mg/kg-h were 1.7±0.2 and 3.2±0.2 μg/ml, respectively; lidocaine concentrations in the ascites were 1.2±0.2 and 2.1±0.2 μg/ml. No patient complained of pain at the time of peritoneal puncture. Side effects included bradycardia of <60 beats per minutes (3 patients). The duration of lidocaine administration was 23±3 days; 43% of patients were able to be discharged home for end-of-life care, with parenteral nutrition and continuation of lidocaine administration or oral mexiletine (300–450 mg/day) for adjuvant analgesia. Conclusions: Lidocaine diffuses into ascites and almost equilibrates with serum concentrations acting as a peritoneal anesthesia which, as a result, controls abdominal pain in patients with peritoneal carcinomatosis. No significant financial relationships to disclose.
Aromatase inhibitors (AI) for elderly patients: Efficacy, compliance and safety according to patient age in the BIG 1–98 trial
Authors: Crivellari D. , Sun Z. , Coates A. S. , Price K. N. , Thürlimann B. , Mouridsen H. , Mauriac L. , Forbes J. F. , Castiglione- Gertsch M. , Goldhirsch A. 
Published: March 2020

9033 Background: Because elderly patients (pts) are under-represented in clinical trials, care should be taken in extending overall results to that patient group. We compared letrozole (L) with tamoxifen (T) with respect to disease-free survival, treatment compliance, and adverse events (AEs) according to age in the continuous therapy arms of the BIG 1–98 trial. Methods: Between March 1998 and May 2003, 8,028 postmenopausal women with hormone receptor-positive breast cancer were enrolled in the BIG 1–98 trial. This report includes the 4,922 pts allocated to continuous therapy with either T or L for 5 years. Subpopulation Treatment Effect Pattern Plots (STEPP) were used to look at the patterns of differences in disease-free survival and incidences of AEs according to age. In addition, three categorical age groups were defined: “younger postmenopausal” < 65, “older” 65–74, and “elderly” = 75. Cox proportional hazards models were used to compare T and L according to time to first AE, adjusting for relevant pre-existing risk factors. The median follow-up was 40.4 months. Results: STEPP analysis showed the L provided consistent benefit compared with T irrespective of age. Pts 75 and older were less likely to complete trial treatment, but similarly in the two treatment groups. Adjusted treatment comparisons of AEs according to age groups are given below. (T,L: significantly more AEs on T,L; NS: no significant difference) Conclusion: Adjuvant treatment with L had superior efficacy compared with T in all age groups. Physicians should base clinical decisions on the individual patient profile with respect to reduction of risk of recurrence from L as well as existing comorbidities. [Table: see text] No significant financial relationships to disclose.
Omission of radiotherapy after breast conserving surgery among elderly women with favorable prognosis tumors
Authors: Swenson W. T. , Hoffman M. , Hoffman A. 
Published: March 2020

9034 Background: Adjuvant radiotherapy after breast-conserving surgery is a standard therapy for invasive breast carcinoma. Controversy exists regarding the benefit of adjuvant radiotherapy for elderly women with favorable prognosis tumors. Methods: Using data from the Surveillance Epidemiology and End Results (SEER) registry, data were analyzed for 28,808 women ages = 65 years, with stage I and II, who underwent breast conservation therapy between 1998 and 2002. Relative survival rates (observed survival/expected survival) were calculated using Kaplan-Meier method for women who underwent radiotherapy and those for whom radiotherapy was omitted. Results: Among women = 65 years with stage I breast cancer who underwent breast conserving surgery (n = 20,400), 71.7% received adjuvant radiotherapy. Among those with stage II breast cancer (n = 8,408), 66.0% received adjuvant radiotherapy. Five-year relative survival rates among stage I patients were 1.000 (95% CI: 0.990, 1.010) for those receiving adjuvant radiotherapy, and 0.959 (95% CI: 0.932, 0.986) for those without adjuvant radiotherapy. Among stage II patients, the 5-year survival rates were 0.998 (95% CI: 0.978, 1.018) for those receiving adjuvant radiotherapy, and 0.832 (95% CI: 0.791, 0.873) for those without adjuvant radiotherapy. Conclusions: Adjuvant radiotherapy following breast conserving surgery may be safely omitted for elderly women with stage I breast carcinoma, especially for women ages 85–94 years. [Table: see text] No significant financial relationships to disclose.