bluuebunny/crossref_metadata_2025_split huggingface dataset:
Interviews with cancer fatigue patients
Authors: Lasch K. E. , Jernigan K. A. , Scott J. A. , Piault-Louis E. 
Published: August 2020

e17577 Background: Approximately 90% of patients diagnosed with cancer experience fatigue associated with the effects of treatment and/or cancer itself. Despite its high prevalence and negative impact on patients’ lives, there is no consensus on a clinical definition of cancer-related fatigue (CF). Extant qualitative research has methodological limitations, small sample sizes, and varying results regarding CF. A multi-disciplinary research consortium is developing a conceptual model of CF based on 120 qualitative interviews with cancer patients varying by cancer type and stage. Exploratory interviews were conducted to test questions and suggest sensitising concepts for an unbiased interview guide. Methods: Five cancer patients with self-reported CF were purposively sampled and interviewed between September 2007 and March 2008 by a trained interviewer to discuss their CF experiences. Verbatim transcripts were coded by two researchers using qualitative data analysis software and reviewed for consistency and reliability. Data were analyzed using a constant comparison method. Results: Patients were diagnosed with cancer on average 3.5 years ago among the following primary sites: breast (n = 2), lung, colorectal, and prostate/liver. Patients provided 14 terms to describe CF: “tired” and “lack of energy” were the most commonly reported. Patients described CF as a general lack of ability to do anything, a child-like regression, and indicated that current “tiredness” differed from pre-diagnosis tiredness. Patients also described CF in terms of frequency (i.e., duration, onset, recurrence) and intensity and identified treatment as a trigger of fatigue. Patients understood the word “fatigue,” but rarely mentioned it spontaneously. Additionally, patients mentioned that CF was not relieved by rest and impacted several areas of their lives, including activities of daily living and cognitive and emotional functioning. Conclusions: Patients’ experience with CF differs from pre-diagnosis tiredness in terms of intensity, duration, onset, and impact. These results helped to refine the interview guide and provide insight for future interventions. Further research with patients with different cancer types and stages is needed to develop a comprehensive conceptualization and measurement of CF. [Table: see text]
JC papovavirus leukencephalopathy in a patient with B-CLL receiving long-term chemotherapy in combination with an anti-CD20-antibody
Authors: Hartmann B. L. , Winder T. , Sandholzer M. , Gasser K. , Jäger I. , Lang A. H. , Längle M. , Hartmann G. , Bartenstein C. , Luger C. 
Published: August 2020

e18007 Background: Progressive multifocal leukencaphalopathy (PML) is a rare demyelinating infection of the central nervous system caused by viruses (CMV, JC, BK). It is almost exclusively described in profound immunocompromised patients developed as a primary infection or by reactivation of the virus after a latent infection. PML is typically observed among patients with severe immunodeficiency like HIV or in the setting of autologous or allogenic transplantation. Methods: Our patient was a 64-year-old woman with B-CLL diagnosed in 2000 in state B of Binet treated with 12 cycles of fludarabin until July 2007 in a B-cell and lymphoma-reducing manner. For the reason of progressive disease 3 cycles of rituximab, fludarabin, mitoxantrone, and cyclophosphamide were added (dose reduced causing hematologic toxicity) until October 2007 continuing rituximab once a month up to Mai 2008. Results: In a CT scan mixed response was observed with progressive disease infradiafragmatic and regression supradiafragmatic. Corticosteroids could stop B-symptoms and leads to a distinct shrinkage of the lymphomas within 2 weeks. Later on she presented with confusion and disorientation. An MRI of the brain showed subcortical and periventricular lesions with increased signal on T2-weighted and fluid attentuated inversion recovery (FLAIR) suggestive of a vascular origin. Her symptoms progressed by aphasia and weakness of the right leg corresponding to increased size and number of cerebral lesions. A lumbar puncture showed no malignant cells and no evidence of inflammation. A PCR analysis was negative for Toxoplasma gondii, HSV, VCV, CMV, EBV, and enterovirus but positive for JC-DNA (215.000 copies/ml). A rapid progression leads to death two months after onset of symptoms. Conclusions: Antibody deficiency syndrome corresponding to CLL under treatment with chemotherapy and rituximab lead to a severe immunosuppression enabling unusual viral infections such as PML. No significant financial relationships to disclose.
MO19390 (SAiL): Incidence of hemorrhage with first-line bevacizumab (Bv)-based therapy in advanced non-small cell lung cancer (NSCLC)
Authors: Thatcher N. , Stroyakovskiy D. , Zhou C. , Bearz A. , Isla D. , Griesinger F. , Pavlakis N. 
Published: August 2020

e19000 Background: MO19390 (SAiL) is an international, multicenter, open-label study evaluating the safety of first-line Bv in combination with a range of chemotherapy regimens in over 2,000 patients (pts). We report interim safety data with a focus on the incidence of serious bleeding events, including pulmonary hemorrhage. Methods: Primary endpoint was safety; secondary endpoints included time to disease progression and overall survival. Eligibility criteria included: non-squamous NSCLC with no prior chemotherapy, no uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or active cardiovascular disease at baseline, ECOG PS 0–2, no history of grade [g])>2 hemoptysis, and no evidence of tumor abutting or invading major blood vessels. Pts received Bv (7.5 or 15mg/kg) with chemotherapy for up to six cycles, then non-progressors proceeded to receive Bv until disease progression. Results: Interim analyses were available for a safety population of 2,008 pts (data cut-off July 2008). Baseline characteristics for pts were (%): male 60.1; Caucasian/Asian/other 80.1/15.6/4.3; stage IIIB/IV 19.5/80.5 (no data for 3 pts); adenocarcinoma/large cell/other 85.8/7.1/7.1; central tumor location yes/no (Y/N) 27.3/72.7; cavitated tumor Y/N 2.6/97.4; smoking history Y/N 70/30; ECOG PS 0/1/2 38.1/56.1/5.8. The median age was 59 years. Serious bleeding events (g≥3) of any cause were reported in 43 pts (2.1%). Bv-related bleeding events (g≥3) were reported in 16 pts (0.8%), including hemoptysis in 5 pts (0.2%) and gastrointestinal hemorrhage in 3 pts (0.1%). Conclusions: In Bv-treated pts, significant bleeding and hemoptysis are rare events. Our results confirm the well established and manageable safety profile of Bv-based therapy in eligible non-squamous NSCLC pts. Updated results will be presented. [Table: see text]
MO19390 (SAiL): Incidence and management of hypertension (HTN) during bevacizumab (Bv)-based first-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC)
Authors: Garrido Lopez P. , Laskin J. , Jiang G. , Barlesi F. , Isla D. , Tsai C. 
Published: August 2020

e19002 Background: SAiL is an ongoing, multicenter, international, open-label trial investigating the safety and efficacy of first-line Bv in combination with a range of standard first-line chemotherapy regimens in >2,000 pts with advanced NSCLC. Methods: Eligible pts had locally advanced, metastatic or recurrent non-squamous NSCLC. Pts received Bv (7.5mg/kg or 15mg/kg q3w) with standard first-line chemotherapy for up to 6 cycles, then Bv monotherapy until disease progression. Pts with uncontrolled HTN (systolic >150mmHg and/or diastolic >100mmHg) or active cardiovascular disease at baseline were excluded. The primary endpoint was the incidence of serious adverse events (SAEs) related to Bv, and AEs of special interest, including hypertension. Bv was interrupted for persistent or symptomatic grade 3 HTN and discontinued if blood pressure remained uncontrolled by medication. Bv was discontinued for grade 4 hypertension. Results: This analysis was based on 2,008 pts who received at least 1 dose of study medication (data cut-off July 2008): median age was 59 and ECOG PS 0/1/2 (%) was 38.1/56.1/5.8. Antihypertensive medications at baseline included ACE inhibitors (11.3%), Angiotensin II receptor blockers (6.2%), beta-blockers (10.9%), calcium channel blockers (7.7%) and diuretics (8%). Pts received a median of 5 Bv cycles and 4 chemotherapy cycles. Overall, 388 patients (19.3%) had a total of 487 incidents of HTN (any grade), occurring equally in patients ≤65 and >65 years of age (18.9% and 20.2%, respectively). Only six pts (0.3%) had grade ≥3 HTN events related to Bv meeting the criteria for SAE. The overall incidence of HTN was consistent across the various types of chemotherapy regimens. Conclusions: The incidence of grade ≥3 HTN was low, and the overall HTN incidence was similar across age groups and chemotherapy regimens. Updated results will be presented, including data on HTN management and evolution of HTN events during administration of antihypertensive medication. [Table: see text]
Phase I/II study of MKC-1 and pemetrexed (PEM) as second-line therapy in patients (pts) with advanced non-small cell lung cancer (NSCLC)
Authors: Hanna N. H. , Estes D. , Arnott J. , Marcotte S. , Hannah A. , Sidor C. F. , West H. , Clamon G. , Hoang T. 
Published: August 2020

e19005 Background: MKC-1 is a novel oral cell cycle inhibitor with preclinical activity against NSCLC cell lines including multi-drug resistant lines, and single agent activity in NSCLC pts. Binding targets of MKC-1 include microtubules, members of the importin-β family and AKT-mTOR. This phase 1/2 study evaluated MKC-1 in combination with PEM as second-line therapy in pts with advanced NSCLC. Methods: Eligible pts had NSCLC previously treated with one regimen for metastatic disease or disease progression within one year following adjuvant and neoadjuvant therapy. Phase 1 dose escalation used 3+3 design. Phase 2 pts were treated with MKC-1 at 75 mg/m2 given p.o. BID for 14 days along with PEM at 500 mg/m2 given i.v. on day 1 of each 21 day cycle. Following 4 cycles of combined treatment, single agent MKC-1 was continued as maintenance therapy. An interim analysis after 17 pts in phase 2 would allow accrual to continue provided one response was confirmed. Results: 27 pts were enrolled (8 in phase 1 and 19 in phase 2). Median age/PS for phase 2 is 64/1 and 89% had adenocarcinoma. Total # of treatment cycles to date for phase 2 pts is 95, with a median of 4 cycles. Of the 19 phase 2 pts, 18 were evaluable for tumor response. The best response was confirmed PR, noted in 3 pts. 5 additional pts (4 confirmed) had minor responses (>10% but <30% shrinkage). One additional pt continues on study with stable disease for >18 months. In phase 2 (n=19), all grade toxicities were anorexia (59%), fatigue (63%), nausea (58%), and dyspnea (48%). Grade 3/4 toxicities included fatigue (26%); neutropenia (22%); dyspnea, anorexia, AST and ALT elevation (11% each); nausea and constipation (5% each). 7 pts had at least one dose reduction of both PEM and MKC-1 and 3 additional pts had only MKC-1 reduced. Median PFS was 86 days with two pts continuing on study (treated for 530+ days and 140+ days, respectively). Conclusions: The phase 2 dose of MKC-1 (75 mg/m2 BID) and PEM (500 mg/m2) has been defined. The combination is well tolerated with 17% of patients achieving a confirmed PR thus far. A decision to proceed with additional accrual in this single arm study versus initiating a randomized phase 2 study of this combination is pending. [Table: see text]
Evaluation of erlotinib treatment after gefitinib failure in Japanese recurrent non-small cell lung cancer patients
Authors: Hata A. , Nanjo S. , Kaji R. , Hujita S. , Katakami N. , Nishimura T. , Ishihara K. , Yoshioka H. , Hayashi H. , Ishida T. 
Published: August 2020

e19008 Background: Both gefitinib (G) and erlotinib (E) belong to the family of epidermal growth factor receptor-tyrosine kinase inhibitors that has shown positive results in the treatment of advanced/recurrent non-small-cell lung cancer (NSCLC). Recent studies suggested a distinction in efficacy between G and E. In fact, there is a subgroup of patients who had clinically meaningful benefit with E therapy after G failure, but little is known about the factors that predict disease control or the risk factors that develop toxicity in these patients. Our aim is to evaluate the efficacy and toxicity of E after G failure in the largest scale study to date. Methods: We retrospectively evaluated the efficacy and toxicity of E therapy and analyzed factors that contributed to disease control in patients had experienced G failure. EGFR mutational analysis was performed in evaluable cases. Results: From January 2008 to December 2008, seventy-seven patients were treated with E after G failure in our institutions. Of these 77 patients, 11 had a partial response (PR) and 21 had a stable disease (SD), resulting in a best response rate of 14% and a disease control rate (DCR) of 42%. Thirty of 56 (54%) patients who had benefited from prior G therapy achieved disease control, while only 2 of 20 (10%) patients who had experienced initial progressive disease to G therapy obtained SD (P<0.001) . Twenty-seven of 48 (56%) patients with performance status (PS) 0/1 achieved disease control, but a DCR of PS 2/3/4 patients was only 17% (5 of 29) (P<0.001). EGFR mutation status, smoking history, and gender had little relationship to disease control. In 4 of 11 patients who achieved PR, E was effective for brain metastases. The most common side effects of E therapy were skin rash and diarrhea, as described in previous studies. Notably in approximately 30% of poor PS patients, grade 3 to 4 non-hematological toxicity including severe general malaise and anorexia was observed. Conclusions: E may be effective as a salvage therapy for some Japanese NSCLC patients after G failure, especially in those who had benefited from prior G treatment and/or those who maintain a good PS. Interestingly, E was effective for brain metastases of some patients after G failure. No significant financial relationships to disclose.
Interstitial lung disease associated with amrubicin in the treatment of patients with small cell lung cancer
Authors: Yoh K. , Nishiwaki Y. , Kemmotsu H. , Yamaguchi Y. , Kubota K. , Ohmatsu H. , Goto K. , Niho S. , Saijo N. 
Published: August 2020

e19018 Background: Amrubicin is a novel anthracycline agent with significant activity against small-cell lung cancer (SCLC). The adverse pulmonary effects of amrubicin are less well known. We investigated the incidence of acute interstitial lung disease (ILD) in SCLC patients receiving amrubicin. Methods: Medical records were used to retrospectively investigate a total of 100 SCLC patients treated with single-agent amrubicin at the National Cancer Center Hospital East between June 2003 and March 2008. The radiographic records and clinical data of these patients were reviewed to find patients who developed acute ILD after being treated with amrubicin. Results: Seven of 100 SCLC patients subsequently developed pulmonary infiltrates without underlying heart disease after receiving amrubicin, and were identified as cases of acute ILD associated with amrubicin. The median time from the start of amrubicin treatment to the development of ILD was 22 days (15–94 days). Among 7 patients who developed ILD, 6 patients received treatment with corticosteroids and ILD improved in 3 patients. However 3 patients died of respiratory failure. The incidence of ILD was 33% (4/12) in patients with preexisting pulmonary fibrosis and 3% (3/88) in patients without preexisting pulmonary fibrosis, and the difference between the two groups was statistically significant (P = 0.0036). Conclusions: Our findings indicate that amrubicin can cause severe ILD, and that the incidence of ILD might be higher in the patients with preexisting pulmonary fibrosis. Physicians need to be alert to the possibility. No significant financial relationships to disclose.
Effect of genetic polymorphisms on toxicity and survival in advanced non-small cell lung cancer (NSCLC) patients (pts) treated with carboplatin (CBDCA) and pemetrexed disodium regimen
Authors: Ludovini V. , Crinò L. , Pistola L. , Floriani I. , Meacci M. , Chiari R. , Garavaglia D. , Tofanetti F. R. , Mare M. , Giuffrida D. , Gori S. 
Published: August 2020

e19028 Background: Identification of genetic polymorphisms which influence chemotherapy outcome may help towards individually optimized therapy. We investigated the influence of ten single nucleotide polymorphisms (SNPs) of 7 genes (P53 Arg72Pro (G/C); XRCC3 Thr241Met (C/T); XPD Lys751Gln (A/C); ERCC1 Asn118Asn (C/T); GARFT C/G, GARFT C/T, DHFR C/G, DHFR A/G, TS 5’UTR, TS 3’UTR involved with metabolism of CBDCA and Alimta regimen in pts with advanced NSCLC. Methods: Genomic DNA was extracted from whole blood samples using the QIAamp DNA estraction kit on Biorobot EZ1 (Qiagen). Polymorphisms were detected with TaqMan-probe based assays using the 7300 Real-Time PCR system (Applied Biosystems, Foster City, CA) or PCR followed by RFLP. The results of SNPs were assessed by Cox model for survival/PFS & logistics regression for response/toxicity. Results: We performed a retrospective analysis in 57 advanced pretreated (2nd or 3th line) NSCLC pts treated with CBDCA(AUC=5) + Alimta (500 mg/m2). Median age was 59 years (range 26–79), M/F:63/37%; Adeno/Squa/other Ca:65/20/15%; ECOG PS:0–1/2–3:96/4%. Overall response rate was 38.6%, stable disease 38.6% and disease progression 21.1%. At median follow-up of 7.9 months, 10 pts (17.5%) died, 47 pts (82.5%) are alive. The median progression free survival (PFS) was 7.4 months, the median survival time not reached. P53 Pro72Pro was significantly associated with shorter survival (HR 5.5, 95%CI 1.01–30.5, p=0.04) when compared to P53 Arg72Arg. None of the analyzed polymorphisms was related to response to therapy. No associations were found between the analyzed polymorphisms and toxicity considered either as the maximum observed grade, or as sum of each toxicity pattern grade, probably due to low number of events observed for toxicity within this data set. Conclusions: P53 Pro72Pro may be associated with shorter survival in pts with advanced NSCLC. Further studies are warranted to validate this finding. Genotype-related differences in common toxicities and in response to therapy were not observed. The small sample size limits interpretation of these data. No significant financial relationships to disclose.
Role of PET/CT scanning in detecting asymptomatic brain metastases in non-small cell lung cancer
Authors: Virani S. , Almubarak M. , Marano G. , Rogers J. S. 
Published: August 2020

e19038 Background: Up to one-third of non-small cell lung cancer (NSCLC) patients are diagnosed with brain metastasis. Our study aims to evaluate the role of whole body and brain FDG-PET/CT in detecting asymptomatic brain metastasis in this population. Methods: We performed a retrospective chart review of 282 consecutive non-small cell lung cancer patients between February of 2005 and June of 2008. 60 patients with brain metastasis were identified. Information regarding tumor histology and presence of neurological symptoms at the time of discovery of brain metastasis was collected. In addition, data was acquired from brain MRI and PET/CT (with IV contrast) reports including: study date, findings and any change in staging secondary to the study. Results: The median age was 63 years (47 % women). 39 (65%) of the patients had neurological symptoms at the time of discovery of brain metastasis. PET/CT scan with IV contrast was performed in 53 patients with brain metastasis. For patients who had a PET/CT scan, the histological types were: adenocarcinoma (58.4%), unclassified (22.6%), squamous (13.2%), large cell (3.8%) and other (1.8%). PET/CT scan had a sensitivity of 97.8% in detecting CNS metastasis seen on brain MRI. 19/53 patients were found to have asymptomatic brain metastasis on PET/CT scan (2 stage I, 1 stage II, 2 stage III and 13 stage IV). Overall, PET/CT scan resulted in upstaging of 5 asymptomatic and 6 symptomatic patients or 11/53 (20.7%). Conclusions: PET/CT scan with IV contrast has a high sensitivity in detecting brain metastasis in patients with NSCLC when compared to brain MRI. It is effective in detecting asymptomatic brain metastasis in this population. Those patients, who initially were thought to have non-metastatic disease, are spared inappropriate aggressive surgery or radiation. No significant financial relationships to disclose.
Can meta-analysis suggest carboplatin/paclitaxel as a reference arm in randomized trials of first-line chemotherapy for advanced non-small cell lung cancer?
Authors: Yamanaka T. , Yamamoto N. , Seto T. , Takahashi T. , Murakami H. , Tsuya A. , Naito T. , Kaira K. , Nakamura Y. , Ichinose Y. 
Published: August 2020

e19039 Background: The validity of adapting carboplatin/paclitaxel (CbP) as a reference arm in randomized trials of first-line chemotherapy for advanced non-small-cell lung cancer has not been fully evaluated. Methods: We performed a meta- analysis on trials identified through a literature search. The analysis included randomized trials comparing CbP with cisplatin-based third- generation (3G) regimens. Results: Of 160 articles screened, seven randomized trials were eligible for the analysis. The pooled hazard ratio (HR) for overall survival showed that CbP was not an inferior regimen to cisplatin-based 3G regimens (HR=1.04; 95% confidence interval, 0.96–1.13; p=0.296). On focusing on 3G agents other than vinorelbine, we observed a marginally significant improvement in survival with cisplatin-based regimens (HR=1.08; 95% confidence interval, 0.99–1.18; p=0.080). CbP generally involved a higher risk of thrombocytopenia and peripheral neuropathy but a lower risk of anemia, nausea, and toxic deaths. Conclusions: There is no evidence that CbP was significantly inferior to cisplatin-based 3G regimens in terms of efficacy. However, since CbP was less inclined to result in better survival, the preferred use of CbP as a reference arm in randomized trials instead of cisplatin-based 3G regimens may depend on the purpose of the trial. No significant financial relationships to disclose.