bluuebunny/crossref_metadata_2025_split huggingface dataset:
Willingness to be informed during treatment among cancer patients?
Authors: Gravis G. , Protiere C. , Tarpin C. , Viret F. , Aurran T. , Mohty M. , Viens P. 
Published: April 2020

18522 Background: More than ever the question of patient’s information remains a matter of debate. Some consider information as a risk of anxiety, others see it as a way of patient implication in the treatment and allowing a better patient-physician relationship. Does the model of informed, empowered patient valid in European institution? To assess the impact, in term of anxiety, quality of life (QoL) and satisfaction, of a change in usual practice by proposing a specific structured and organized file (SSOF) including all medical information in real time. Methods: To evaluate this practice change, patients (breast or colon cancer and lymphoma) who have accepted to participate have been randomized between an “access” to the SSOF arm and a “non access” arm. The patients after being randomized in the “access” arm have had the choice to hold, or not, the SSOF. To help the patient, SSOF contains a lexical and a designed trained person was available. Anxiety (state-trait anxiety scale), Qol (EORTC QLQ-C30) and satisfaction were assessed at baseline, during and at the end of the treatment. Moreover, impact of this change was also assessed among the patients’ nurse, general practitioner and referent physician in our institution. Results: Among the 277 eligible patients, only 12 (4%) have refused to participate in the study. 134 have been randomized in the “non-access” arm and 131 in the “access” arm. A counter intuitive result was that no one of these 131 patients has refused to hold the SSOF. No statistical difference in baseline scores of QoL and anxiety scores between the two arms was observed at the time of randomization. Conclusions: First observation is that when you give the opportunity to hold an extended information all patients want to benefit from, even in French European institution. No significant financial relationships to disclose.
Fatigue in breast cancer patients during and after radiotherapy
Authors: Rucinska M. , Langkjer S. T. 
Published: April 2020

18537 Background: Fatigue—an unpleasant sensation of tiredness, weakness or lack of energy—is one of the most prevalent and profound symptoms caused by malignancy itself and anti-neoplastic treatment. The aim of the study was to assess the level of fatigue during and after adjuvant postoperative radiotherapy of breast cancer patients. Methods: 125 patients with breast cancer were recruited between May 2004 and September 2005 (85 after breast-conserving surgery and 40 after mastectomy). Subjective feeling of fatigue intensity was measured according to 10-score visual analog scale (VAS) before the start and once a week during radiotherapy, 14 days and 3 months after radiotherapy (48 Gy/24 fractions/5 weeks; 25 patients received boost 10 Gy/5 fractions/1 week with tumor-bed). Results: 46% of patients demonstrated non-fatigue before the start of radiotherapy. Patients after breast-conserving surgery and chemotherapy manifested higher lever of fatigue in comparison with patients after lumpectomy but without chemotherapy and patients after mastectomy with and without chemotherapy (p = 0.01). Fatigue intensity increased gradually during radiotherapy (mean fatigue-VAS before and in the last week of treatment was 1.8, 2.75 after lumpectomy and 1.25, 2.95 after mastectomy, respectively). 14 days after the end of radiotherapy fatigue intensity was still higher than before treatment (p = 0.04), but 3 months later it was lower than the pretreatment level. However, 25% of the patients defined their fatigue as 2 or more in VAS three months after radiotherapy. 15% of patients reported non-fatigue during radiotherapy. Older patients (>60 years) estimated their fatigue in the last week of treatment on lower level than younger patients (2.22 vs 2.90, p = 0.065). Patients with boost manifested only a little higher fatigue level in comparison with other patients (2.97 vs 2.52). Conclusions: Increasing fatigue was found in 85% of breast cancer patients during adjuvant radiotherapy. Three months after the end of therapy fatigue was reduced to lover then the preliminary level. There were no significant differences between patients after breast-conserving surgery and mastectomy. No significant financial relationships to disclose.
Effectiveness,safety and tolerability of codeine in cancer patients
Authors: Moura G. L. , Giublin M. , Albini L. , Pasquini R. , Viana K. , Chicoski F. 
Published: April 2020

18577 Background: In 1984 WHO guidelines for cancer pain was proposed. Codeine was selected among several others drugs when pain ladder step II was required. Since then very few comparative studies have been performed. Codein is a weak opioid and its analgesic action is not completely understood. A possible conversion into morphine is postulated. To determine efficacy, safety and tolerability of codein in advanced cancer patient we designed a prospective cohort study. Methods 150 metastatic cancer patients were studied during six months. A standard zero to then table scale for pain rating was used. The malignacies were: prostate 15 (10%), breast 42 (28%), lung 33 (22%), colon 37 (24.6%), other cancer 23 (15.3%). 62 patients were under treatment (41.3%). Results: There were: 83 M (55.3%) 67 F(44,7%) and the mean age was 62 years. Mean initial and final pain score were 7.1 and 1.3 respectively. Codein dose range from 30 mg/day to 270 mg/day (mean dose 180 mg/day). The average time of use was 13,7 months. Severe toxicity was 0% and the most often side effect was constipation (38.7%). Adjuvant drugs were used in 97 patients (64.7%) of patients. Uncontrolled pain ocurred in 17 patients (11.3%). Conclusions: During the last decade a great increase in the range of opioid agents and formulations available have emerged. Codein still represents an excellent drug for patients with long life expectancy. Side effects are manageable and are mainly constipation. Pain control was achieved in the majority of patients. Codein showed a low toxicity profile with a high compliance rate. Economic reasons must be strongly consider in poor countries and codein represents a good alternative option. Future comparative studies addressing also quality of life should be performed. No significant financial relationships to disclose.
Identifying low-risk febrile neutropenic cancer patients in the West of Scotland
Authors: Drew Y. C. , Appleton R. , Jordan R. , White J. , Paul J. 
Published: April 2020

18592 Background: Febrile neutropenia (FN) is a potentially life threatening complication of chemotherapy. In-patient treatment using intravenous antibiotics reduces FN related mortality. However, most patients with FN are at low risk of complication. Identifying them could result in new strategies such as out-patient, oral antibiotic, based treatment resulting in improved quality of life and cost savings. The Multinational Association for Supportive Care in Cancer (MASCC) and the Talcott model were developed to identify such patients. Two randomised controlled trials have shown that oral antibiotics in low risk patients are safe and effective. However are such models appropriate in populations with a high incidence of co-morbidity such as the West of Scotland? This study reviews FN admissions to our cancer centre to determine the proportion of patients that would fall into a low risk group according to the MASCC and/or Talcott models and to identify other factors that might predict for low risk. Methods: Review of FN admissions between June–December 2002. Data included: patient demographics, MASCC score, Talcott group, co-morbidity, haematological and biochemical values, prior use of antibiotics and growth factors (GFs) and whether the fever resolved without serious medical complication (FRWMC). Results: 77 episodes of FN involving 68 patients. Mean age = 51 (range 16–79). 94% involved patients with solid malignancies. Commonest tumour type was breast (29%). Patients were classified as MASCC and Talcott low risk in 52% and 31% of episodes respectively. There was a significant association between low risk MASCC score and low risk Talcott score (χ2 28.665, d.f.3, p < 0.001). Low risk MASCC was associated with FRWMC (χ2 4.193, d.f.1, p < 0.05). Multiple logistic regression of risk factors showed that high bilirubin and low albumin were associated with a worse outcome. FN mortality rate was 7.8%. Conclusions: The use of clinical risk models to identify low risk patients can predict for an uncomplicated recovery in our patients. Bilirubin and albumin values at presentation added predicted value for low risk over and above the MASCC model. Future trials may validate this observation. No significant financial relationships to disclose.
Quality of life (QOL) in patients (Pts) with hormone resistant prostate cancer (HRPC) treated with docetaxel (D) and celecoxib (C)
Authors: Chang V. T. , Sambamoorthi N. , Yan H. , Gonzalez M. , Cogswell J. , Srinivas S. , Zhong F. , Crump B. , Blumenfrucht M. , Kasimis B. S. 
Published: April 2020

18598 Background: The impact of chemotherapy on QOL for pts with HRPC is not well described. Thirty patients(30) participated in a trial of D and C(Kasimis et al, submitted ASCO 2006). The objectives for this companion study were to study QOL outcomes with the FACT instrument including the Prostate subscale(FP) and utility from the EQ5D. Methods: In a phase II trial, 30 pts with progressive HRPC were treated with D and C for 4 wks in each cycle. Response evaluation was made by RECIST criteria and PSA reduction by >50% for biochemical response every 2 cycles. Patients completed the FACT and EQ5D instruments at the beginning of every cycle. We analyzed the FACT subscales with different statistical approaches, and compared FACT and utility for responders and non responders. Results: All 30 pts accrued were evaluable for toxicity and response. Thirty (30) pts received a minimum of 2 cycles, median (M) 4.5 (range 2–8). The M age was 74 yr (55–94), ECOG PS 1 (0–2). For 19 pts, the baseline mean score for the FACT P was 29, Standard Deviation 10. The Cronbach’s Coefficient was 0.83. The FACT Physical Well Being (PWB) correlated with the EQ5D utility score 0.76 (p < .0003), as did the Functional Well Being (FWB) 0.67 (p < .003) and FACT P 0.62 (p < .006). The FACT PWB, EWB, FP, Treatment Outcome Index, and EQ5D Utility differed significantly between responders and non responders by radiographic parameters, alpha = 0.1. The results for PSA reduction >50% are similar. Conclusions: The FACT Prostate subscale has good psychometric properties, correlates with EQ5D utility measure, and also with responder status by radiography and PSA. [Table: see text]
Microanatomic characteristics of melanoma metastases in the sentinel node(s) (SN) predict survival and question the need for complete lymph node dissection (cLND)
Authors: Van Akkooi A. C. , De Wilt J. H. , Verhoef C. , Schmitz P. I. , Van Geel A. N. , Kliffen M. , Eggermont A. M. 
Published: April 2020

8005 Introduction: The SN procedure has become a widely used staging procedure for stage I/II melanoma patients. We previously reported on the high SN+ identification rate with the use of the EORTC MG group pathology protocol (van Akkooi et al., Eur J Cancer: 2006, in press). Because only approximately 20% of SN positive patients have additional non-SN lymph node involvement in the cLND specimen, we have proposed to identify a SN+ patient group, which can be spared a cLND. Therefore further microanatomic analyses of the metastatic SNs has been performed to identify patient/tumor or SN factors which predict DFS and OS as well as additional non-SN nodal positivity. Methods: 262 stage I/II pts were included into the SN database between 10/97 and 5/04. 77 were SN+ (29%). 74 pts had SN material for re-evaluation in this study. Microanatomic analysis categorized a.o. the location of tumor cells; subcapsular, parenchymal (or combined), multifocal or extensive; the Starz classification and the measurement of the amount of tumor load (in mm). Tumor load was quantified by size: <0.1mm (single melanoma cells), 0.1 - 1.0mm, >1.0mm. DFS, OS and additional non-SN positivity was calculated for all the microanatomic analyses. Results: Mean/Median Breslow was 3.5/3.0 (0.8 - 12.0) mm, mean/median FU was 35/30 (6 - 81) months. There were no signif. differences in OS or additional non-SN positivity for the different loc. of involvement. The estimated 5yr OS rates were 100%, 63% and 35% for the different groups of tumor load, <0.1mm, 0.1 - 1.0mm, >1.0mm respectively (Figure)(P=0.03). There were no patients with add. non-SN positivity in the group with involvement <0.1mm. On multivariate analysis the tumor load was the most important prognostic factor for DFS (P=0.005) and OS (P=0.03). DFS, OS and add. non-SN positivity of all other analyses will be presented at the meeting. Conclusions: It is questionable whether SN with onlysingle cells involvement (<0.1mm) should be considered positive. Dist. mets are exceedingly rare (1/16 = 6.3%) and was identical to the SN- patient pop., and non-sentinel node involvement was not observed at all. These patients should probably not undergo add. LND and may not be considered stage III patients. No significant financial relationships to disclose.
Preliminary results of a randomized phase II study comparing two schedules of temozolomide in combination with sorafenib in patients with advanced melanoma
Authors: Amaravadi R. K. , Schuchter L. M. , Kramer A. , Barth S. F. , Villanueva J. , Troxel A. B. , Tuveson D. A. , Nathanson K. L. , O’Dwyer P. J. , Flaherty K. T. 
Published: April 2020

8009 Background: Sorafenib (SO) is an oral Raf kinase/VEGFR-2 inhibitor that has anti-melanoma activity when given with carboplatin/paclitaxel. The primary objective of this study is to estimate the duration of progression-free survival (PFS) for patients with metastatic melanoma (MM) taking SO + temozolomide (TEM). Secondary objectives are to determine the optimal dosing of TEM when given with SO, response, and toxicity rates. Correlative studies include BRAF genotyping and assessment of intratumoral Raf inhibition. Methods: Patients with MM and ECOG PS<2 are eligible. Prior therapy is allowed. Accrual is designed for 167 patients in one stage. All patients receive SO 400 mg po bid continuously. After one week of SO alone, patients without brain metastasis and no prior TEM are randomized to receive either extended daily dosing (EDD): TEM 75 mg/m2 po qd for 6 /8 weeks (Arm A), or standard dosing (STD): TEM 150 mg/m2 po qd for days1–5/28 (Arm B). Patients with prior TEM use are treated with EDD (Arm C) and patients with brain metastasis without prior TEM are treated with STD (Arm D). Responses are assessed using RECIST criteria. Results: 65 patients were evaluated for toxicity. Of these, 58 received SO + TEM and were evaluable for response (Table). SO + TEM resulted in a 24% overall response rate (ORR) [95% CI 11–41%] in patients without brain metastasis or prior TEM and 20% ORR [95% CI 3–56%] in patients with brain metastasis and no prior TEM. Observed grade 3 toxicities attributable to study medication were: hand-foot syndrome (12%), rash (8%), nausea (5%), anorexia (8%), and hypertension (3%). Nausea and anorexia were more prevalent with STD. Tumor blocks and 8 paired biopsy samples have been collected for correlative studies. Conclusions: Initial phase II results demonstrate encouraging antitumor activity and safety profile for SO + TEM in MM. Updated PFS data, response and toxicity rates, and correlative results will be presented. [Table: see text] [Table: see text]
Mismatch repair (MMR) and base excision repair (BER) protein expression correlates with clinical response to dacarbazine (DTIC)/temozolomide (TMZ) therapy of patients with metastatic melanoma
Authors: Sobol R. W. , Tawbi H. , Jukic D. M. , Mule K. , Mascari R. , Kirkwood J. M. 
Published: April 2020

8015 Background: The non-classical alkylators DTIC and TMZ exert their cytotoxic effect through methylation of DNA bases. DNA damage is repaired by direct reversal of the O6-MeG lesion by the protein O6-methylguanine-DNA methyltransferase (MGMT/AGT); recognition of alkylation-damage-induced replication errors by the MMR pathway and excision repair of alkylated bases (N7-MeG and N3-MeA) conducted by the BER pathway. We report the results of a study evaluating the correlation between MGMT, MMR and BER protein expression in tumor tissue of patients (pts) with metastatic melanoma and documented clinical response to chemotherapy. Methods: Frozen tumor tissue was obtained from 17 pts with metastatic melanoma treated with DTIC/TMZ. Tumors were classified as sensitive (S) if pts showed stable disease (SD), partial response (PR) or complete response (CR) by RECIST criteria; and resistant (R) if progressive disease (PD) was observed after 2 cycles of treatment with DTIC/TMZ. Immunohistochemical staining for MGMT, MLH1 (MMR), and DNA polymerase-ß (pol-ß, BER) was performed. Levels of expression were assessed by a pathologist blinded to response data. Fisher’s Exact and Wilcoxon Rank Sum statistical tests were used to assess correlations. Results: 9 tumors were considered to be sensitive (S) and 7 resistant (R). Clinical response was found to significantly correlate with functional MMR (increased MLH1 expression): 7 of 9 S tumors had high MLH1 expression as compared to 1 of 7 R (p-value=0.015). Clinical response was also found to be inversely correlated with pol-ß expression: 6 of 9 S tumors expressed low levels of pol-ß as compared to 1 of 7 R tumors (p-value=0.08). MGMT expression did not seem to correlate with response. Conclusions: The presence of a functional MMR pathway is a requirement for the cytotoxic effect of alkylating agents and was significantly correlated with clinical response. Decreased BER potential (pol-ß expression) was correlated with increased sensitivity to alkylator-based chemotherapy. These findings lend additional support to the view that DNA repair status correlates with response to alkylator-based chemotherapy for melanoma. No significant financial relationships to disclose.
Surgical resection for stage IV melanoma: A Southwest Oncology Group trial (S9430)
Authors: Sondak V. K. , Liu P. Y. , Warneke J. , Vetto J. , Tuthill R. , Redman B. , Sosman J. A. 
Published: April 2020

8019 Background: Surgery is the treatment of choice for isolated distant metastases of melanoma. Based on a number of retrospective reports, patients (pts) who have undergone complete resection of metastatic disease can have an excellent survival. Methods: In SWOG, we prospectively evaluated surgical resection for stage IV melanoma. Pts enrolled prior to surgery; treatment following resection was at the discretion of the treating physician. Resected specimens were collected, whenever possible, for future molecular analyses. Results: Over a 9 year period from 1996 to 2005, 77 pts were enrolled from 18 centers, with 7 centers accruing ≥4 pts. Of 77 pts, 10 were incompletely resected and 5 had no evidence of stage IV disease. Therefore, 62 pts (81%) felt to have resectable stage IV actually did, and were included in the analysis. Pts characteristics were: median age 54 yrs (range 23–81); M:F 69%:31%; PS 0–1 100%; prior adjuvant IFN 45%. Resected sites included skin/soft tissue 40%; distant LN 21%; lung 13%; liver 8%; CNS 5%; bone 2%; other visceral sites 27%. Post-surgical complications included 1 grade IV pulmonary embolus and 1 grade III liver toxicity. Following surgery but prior to any further recurrence, 18 pts received adjuvant treatment including 8 with IFN and 7 with radiotherapy. After surgery, median progression-free survival (PFS) was 6 mos (95% CI 3–7 mos) with 9 patients (15%) remaining progression-free. Median overall survival (OS) was 21 mos (95% CI 15–28 mos); 3- and 4-yr OS was 33% and 29%, respectively. Conclusions: These results provide an estimate of prognosis for resected stage IV disease from a diverse patient base. They illustrate the potential for prolonged OS even with a short PFS. In some cases, pts can be repeatedly resected for long-term control of their disease. Pts with resectable stage IV melanoma are appropriate candidates for inclusion in adjuvant therapy trials. No significant financial relationships to disclose.
Phase I/II trial of a PrimeBoost therapeutic vaccine in stage III/IV metastatic melanoma
Authors: Hawkins R. E. , Dangoor A. , Keilholz U. , Schadendorf D. , Harris A. , Ottensmeier C. , Smyth J. , Hoffmnan K. , Anderson R. , Pearce G. 
Published: April 2020

8030 Background: This trialevaluated the safety, immunogenicity and tumour response of increasing doses of DNA plasmid (DNA.Mel3) and MVA viral vector (MVA.Mel3), containing 7 melanoma epitopes. Methods: 41 HLA-A2 positive stage III/IV melanoma patients with unresectable measurable disease were enrolled. Immunisations were administered three weeks apart with continued MVA.Mel3 boosting in patients with tumour control. Epitope-specific CD8+ T cell responses were evaluated using ex vivo tetramer staining and interferon gamma (IFN-γ) ELISPOT assay. Results: DNA.Mel3 was well tolerated at all doses. Dose-related grade 3 local skin reactions and systemic immune-associated reactions were observed following MVA.Mel3, no reactions led to early study discontinuation. Melan-A tetramer responses were observed in 23/36 (64%) evaluable patients, of which 9/36 showed an IFNγ response to at least one epitope in ELISPOT assay. Seven patients (17%) showed tumour control (PR, MR, or SD >6 months), of which 3/7 patients had associated immune responses, including one with PR > 21 months who underwent extended MVA.Mel3 boosting. Overall median progression free survival was 9 weeks (16 weeks for immune responders). Median overall survival for the intention-to-treat population is 11.7 months with follow up of 16 patients continuing. Conclusions: High dose heterologous PrimeBoost immunisation was safe and stimulated immune responses in >50% of late stage metastatic melanoma patients treated. Tumour control was observed with some evidence of association with immune response. [Table: see text] [Table: see text]