bluuebunny/crossref_metadata_2025_split huggingface dataset:
Multicenter, phase II study of bendamustine in refractory or relapsed T-cell lymphoma: The BENTLY trial.
Authors: Gressin Remy , Damaj Gandhi Laurent , Bouabdallah Kamal , Cartron Guillaume , Choufi B , Gyan Emmanuel , Jaccard Arnaud , Park Sophie , Schiano De Colella Jean-Marc , Voillat Laurent , Joly Bertrand , Le Gouill Steven , Saad Alain , Sanhes Laurence , Moles-Moreau Marie-Pierre , Bubenheim Michael , Bene Marie C. , Martin Antoine , Marolleau Jean pierre , Lamy Thierry 
Published: March 2020

8026 Background: T-cell lymphomas have a poor prognosis with few options of effective treatment. This study determined the efficacy and safety of bendamustine as a single agent in the treatment of refractory or relapsed T-cell lymphomas. Methods: Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma (CTCL), who had previously received at least one line of chemotherapy were selected. Bendamustine was administered IV at the dosage of 120 mg/m2 on days 1 and 2 every 3 weeks, for 6 cycles. Treatment response was assessed using the IWC for non-Hodgkin's lymphoma. The primary end point was overall response rate (ORR). Secondary end points were duration of response (DoR), progression-free survival (PFS), and overall survival (OS), NCT00959686. Results: Twenty two female and 38 male were included. The median age was 66 years with more 1/4 of them > 75. Histology was predominantly angio-immunoblastic lymphadenopathy (n=32) and PTCL-nos (n=23). The median previous line of chemotherapy was 1 (1-3). Nearly one half (45%) of the patients was refractory to the last previous chemotherapy and the median duration of the best previous response was 6.6 (1.5-67) months. The disease was disseminated in the majority of case (87%) and the international prognostic index (IPI) was high (3–5) in 68% of the patients. Twenty patients (33%) received less than 3 cycles of bendamustine. The major reason for early discontinuation was disease progression. In the Intent-To-Treat (ITT) population, the best ORR was 50%, including complete response (CR) in 28% and partial response (PR) in 22 %. Bendamustine showed a consistency in the efficacy as a function of major disease characteristics. The median values for DoR, PFS and OS were 3.5, 4 and 6 months respectively. The most frequent grade 3/4 AEs were neutropenia (30%), thrombocytopenia (24%) and infections (20%). Conclusions: Bendamustine is active in high risk refractory and relapsed T-cell lymphoma with manageable toxicity.
Survival with splenectomy in splenic marginal zone lymphoma: Analysis of the Surveillance, Epidemiology and End Results (SEER) database.
Authors: Olszewski Adam J. 
Published: March 2020

8044 Background: The role of splenectomy as the primary therapy for splenic marginal zone lymphoma has been questioned. We studied relative survival in SMZL and the impact of splenectomy on lymphoma-specific survival (LSS). Methods: SMZL cases (diagnosed in 1993-2008) were derived from the SEER database. Age, sex and race-matched actuarial survival data were summarized. Factors predictive of splenectomy were studied using logistic regression with a subsequent propensity score (PS)-weighted survival analysis. Results: 1071 patients were identified with a median age of 69 years (range, 25-96) and a median follow up of 33 months. 53% were women and 92% were white. 70% of the lymphomas were stage III/IV with B symptoms recorded in 22.3%. 54% of patients underwent splenectomy. The significant factors predictive of surgery included younger age (p<10-14), stage I/II (p<10-15), B-symptoms (p=0.003), no prior malignancy (p=0.002), with significantly lower rates in black patients (OR 0.41, 95%CI 0.21-0.80, p=0.008), on the Pacific Coast (OR 0.62, 95%CI 0.47-0.81, p=0.0004) and with decreasing rates over time (p=0.0002). The actuarial 5-year relative survival was 82.8% (95%CI 77.9-86.7%) with no difference by sex (p=0.79), race or stage. 54% of deaths were related to SMZL with the estimated LSS of 80.8% (95%CI 78-84%). Splenectomy was not associated with improved LSS in propensity score-stratified log-rank test (p=0.60) or in the PS-weighted Cox model (HR=0.93, 95%CI 0.62-1.38, p=0.70). Advancing age (HR 1.05, 95%CI 1.03-1.07, p<10-8) and presence of B-symptoms (HR=1.98, 95%CI 1.30-3.01, p=0.002) were significantly predictive of death from SMZL, with no evidence of improvement in LSS over the years (HR=0.97, 95%CI=0.91-1.03, p=0.34). There was also no detectable impact of splenectomy on survival in patients who ultimately died of SMZL (p=0.83). Conclusions: In this cohort, the largest studied to date, splenectomy did not demonstrate a survival benefit in SMZL. Patients continue to have decreased survival despite advances in other indolent B-cell lymphomas. The role of splenectomy versus chemoimmunotherapy remains to be determined.
Radioimmunotherapy efficiency and safety in consolidation and relapse treatment of aggressive B-cell non-Hodgkin lymphoma: An updated analysis of 230 patients of the international RIT-network.
Authors: Hohloch Karin , Lankeit Henrike Katharina , Zinzani Pier Luigi , Lorsbach Michael , Windemuth-Kiesselbach Christiane , Trumper Lorenz H. 
Published: March 2020

8052 Background: In aggressive lymphoma, few reliable clinical data about the use of radioimmunotherapy exist. Pts. with DLBCL registered in the international RIT-Network (RIT-NT) were analyzed with regard to Indication, line of therapy and outcome. Methods: The RIT-NT recruited 1111 pts. between Dec. 2006 and 2010. It is a web-based registry that collects observational data from RIT-treated patients with malignant lymphoma. 232 pts. with DLBCL registered in the database were evaluated in the analysis. Results: 232 pts with DLBCL are registered, 17 pts were excluded. Histologic subtypes: 190 DLBCL, 15 primary mediastinal, 9 large cell anaplastic, 1 intravascular. Median age was 62 years (range 17-88), 27% of pts >70 years old. Stage I 16pts, II 54 pts, III 60 pts, IV 68 pts; 6 extranodal involvement, for 11 pts. stage is not documented. 187 pts had 1-3 previous chemotherapies (Ctx), 21 pts 4-6 previous Ctx, 1 pts had 7 previous Ctx, for 6 pts. previous Ctx is not documented. 15 pts. had previous RIT and 24 pts a stem cell transplantation prior to RIT. 6 pts had bone marrow infiltration prior to RIT, 3 with more than 25%. 87 pts had RIT as first line (8 pts. conditioning, 68 pts consolidation, 1 primary therapy, 10 other), and 84 pts received RIT in relapse (2d to 8 th. line therapy) (2 pts. conditioning, 31 pts consolidation, 26 recurrence, 19 therapy refractory, 6 other). Grade IV° hematotoxicity occured for neutrophils and platelets, grade III° for hemoglobin after RIT. Median time to recovery of blood count was 81 days (range 0-600 days). ORR was 63,3 %; CR 54,4%; PR 8,8%, SD 0,9%, PD 23,7%, N.D. 12%. CR rate first line was 76,3 %, for relapse 44,3%. Mean overall survival (OS) in first line was 26,5 months 14,3 months for pts. treated in relapse or refractory disease. Conclusions: Most pts. with DLBCL in the RIT-N received RIT as consolidation after first line therapy with excellent CR rates and OS compared to published data from risk groups . In relapsed DLBCL RIT is a safe and feasible treatment leading to satisfactory response rates with low toxicity. A prospective randomized phase III trial in front line DLBCL is currently planned (ZEST).
Use of the cumulative amount of serum-free light chains (sFLC) at diagnosis and PET2 for the early identification of high risk of treatment failure in Hodgkin lymphoma (cHL).
Authors: De Filippi Rosaria , Morabito Fortunato , Corazzelli Gaetano , Russo Filippo , Calemma Rosa , Iaccarino Giancarla , Crisci Stefania , Frigeri Ferdinando , Capobianco Gaetana , Volzone Francesco , Tripodo Claudio , Pinto Antonio 
Published: March 2020

8083 Background: Since early identification of patients (pts) at risk of failure is the mainstay of a risk-adapted therapy, we explored the prognostic impact of the sFLC assay in cHL, whose biology involves ongoing activation of polyclonal B-cells. Methods: Serum samples from 248 untreated cHL pts were tested by the Freelite assay. Median age was 32 yrs (r 15-85), males 47%, stages: I (5%), II (51%), III (17%), IV (27%); B-sympt. 60%, E-disease, 38%; bulky >10 cm, 44%; ESR > 65, 42%; IPS ≥3, 39%. Early unfavorable disease (GHLSG/ EORTC) was respectively found in 33% and 42% of cases. ABVD was given to 89% of pts. Results: Absolute FLC levels were summed into a sFLC(κ+λ) variable and ROC analysis indicated 57.1 mg/mL as the threshold to discriminate outcomes. CR rates were 96% and 67% for pts below and above the cutoff, respectively (p<.0001). Cox univariate analysis disclosed a HR of 16.70 (95% CI, 8.5-32.9) of events for sFLC(κ+λ) ≥ 57.1 mg/mL, by far higher than for PET2 positivity (HR 10.8), PS >1 (HR 4.2), IPS ≥3 (HR 2.8) and all other predictors (HR 0.54-2.4). In a multivariaye model only sFLC(κ+λ) and PET2 remained independent predictors. A dismal 8-yrs EFS characterized pts with sFLC(κ+λ) above threshold (20% vs 89%; Χ2 119, p<.0001). Pts with sFLC(κ+λ) below cutoff and a negative PET2 had an EFS of 93% as compared to 36% of those with sFLC(κ+λ) above cutoff or a positive PET2. Pts with sFLC(κ+λ) above cutoff and positive PET2, had the worse outcome with an EFS <10% and a median survival <12 mo.s (Χ2 65.4; p<.0001). sFLC assay was even more valuable in identifying poor risk pts within the early unfavorable category (5-yrs EFS <25%, Χ2 51 p<.0001). By immunoistochemistry small B cells and plasmacytoid lymphocytes were identified as the main source of sFLC in HL tissues while a strong sFLC uptake by mast cells was documented. Conclusions: A cumulative amount of sFLC ≥57.1 mg/mL, is the strongest independent predictor of failure in cHL. Combining sFLC(κ+λ) and PET2 outcomes can timely discriminate poor risk pts subsets, who may benefit from upfront treatment escalation or early salvage. Our data also support that sFLC might endorse immunobiologic activities relevant to cHL pathobiology.
A prospective study investigating the impact of definitive chemoradiation in locoregionally advanced squamous cell carcinoma of the skin.
Authors: Nottage Michelle K. , Francesconi Alessandra Bastian , Houston Kathleen Emilie Mary , Lin Charles , Kenny Lizbeth M. , Hughes Brett Gordon Maxwell 
Published: March 2020

8538 Background: Our state, Queensland, Australia, has the highest rate of cutaneous squamous cell cancer (SCC) in the world. Spread to regional lymph nodes or more distant sites occurs in 5-10%. A proportion of patients can not undergo surgical resection but complete response rates with radiotherapy alone are low. This led to the hypothesis that combined chemoradiation (CRT) may be of benefit. We decided to document the outcomes of concurrent chemoradiation by means of a prospective trial. Methods: This was a single arm, phase II study with planned sample size 30 patients. The primary endpoint was complete response rate (CRR), estimate 60%. Patients with locally/regionally advanced (non-metastatic) cutaneous SCC deemed unresectable or unsuitable for surgery by consensus of the multidisciplinary Head and Neck Cancer Clinic, with measurable disease, aged over 18, performance status 0-2, received definitive radiotherapy (XRT) (70Gy in 35#) and concurrent weekly platinum based chemotherapy (CT) (cisplatin 40mg/m2 or carboplatin AUC 2). Results: 14 patients were enrolled (Feb 2008-June 2011), median age 66 (48-84), 64% ECOG PS 0, 64% stage IV, 57% nodal disease only. Cisplatin/carboplatin was administered in 64%/36% respectively. 42% received all planned CT while 58% had 1 or 2 weeks omitted. 2 patients had dose reductions. XRT was completed as planned in 93%. The CRR was 57% (8/14) at analysis in December 2011 (median follow-up 13.5m). 2 further patients with partial response (PR) achieved CR after undergoing salvage surgery. Six (43%) patients had a PR; 4(29%) did not receive surgery and later progressed. Median overall survival was not reached, with 3 year survival 54%. The most frequent toxicities were dermatitis, mucositis, thrombocytopenia, nausea, anaemia, dysphagia. 28% had grade 3/4 toxicity, mainly cytopenias, infection, dehydration and nausea. Conclusions: This is the only prospective series of CRT for cutaneous squamous cell cancer. A high complete response rate was documented in patients with loco-regionally advanced disease and multiple co-morbidities, with acceptable toxicity, making this a reasonable alternative for patients unable to undergo surgery.
Vemurafenib (V) in BRAF V600E metastatic melanoma (mM): Analysis of 507 patients (pts) enrolled in the French temporary authorization for use (ATU).
Authors: Lebbe Celeste , Robert Caroline , Dreno Brigitte , Thomas Luc , Grob Jean Jacques , Meyer Nicolas , Regnier-Rosencher Elodie , Saiag Philippe , Mortier Laurent , Hospital Valerie , Duval-Modeste Anne Benedicte , Dalac-Rat Sophie , Lesimple Thierry , Guillot Bernard , Leccia Marie Thérèse , Bitoun Laurence , Bobadilla Luz , Jouary Thomas 
Published: March 2020

8591 Background: V, a selective BRAF inhibitor, significantly improves OS in BRAF mutated mM. ATU is an exceptional measure making available drugs that have not yet been granted a Marketing Authorisation. We provide demographic data of pts treated by V in the ATU. Methods: V 960 mg BID was given to pts with unresectable stage IIIC or IV BRAF V600E mM. Genotyping was done on the national network of molecular genetics platforms funded by the Institut National du Cancer. Data were prospectively collected. Results: From Apr 2011 to Jan 2012, 83 sites enrolled 507 pts. 80% were treated by oncodermatologists. Pts characteristics at baseline are summarized below. Safety and efficacy data are being evaluated. Conclusions: Around 2 out of 3 patients with a BRAF mutated mM were enrolled in France in the ATU highlighting a large access to BRAF genotyping and to V. Demographic data differs from literature and clinical trials for: site of primary melanoma (reverse trunk/extremity ratio) and inclusion of pts with brain metastasis or PS>2 (excluded in CT). A high number of pts had risk factors for NMSC emphasizing the importance of the communication between oncologists and dermatologists for managing V therapy. [Table: see text]
Widespread use of complementary and alternative medicine (CAM) among non-Hodgkin lymphoma (NHL) survivors.
Authors: Leal Alexis D. , Allmer Cristine , Maurer Matthew J. , Cerhan James R. , Nowakowski Grzegorz S. , Inwards David James , Macon William R , Ehlers Shawna L. , Link Brian K. , Habermann Thomas Matthew , Thompson Carrie A. 
Published: March 2020

9057 Background: The incidence of CAM use among patients with cancer is higher when compared to the general population. However, there are few studies examining CAM use in NHL survivors, and limited data are available regarding beliefs in CAM. This study was conducted to examine the prevalence of CAM use in NHL, define CAM beliefs among NHL survivors, and explore differences between patients with indolent and aggressive lymphoma. Methods: Newly diagnosed lymphoma patients were prospectively enrolled within 9 months of diagnosis in the University of Iowa/Mayo Clinic SPORE Molecular Epidemiology Resource from 2002-2008. NHL patients who completed the 3-year post diagnosis questionnaire, which includes questions regarding CAM use and beliefs, were included in this study. Chi-squared tests and Wilcoxon rank-sum tests were used to assess the association of CAM use with prognostic and demographic factors. Results: 719 patients were included with a median age of 63 years (range 22-92). 53% were male. Overall, 636 (89%) reported ever using CAM. 78% of patients used vitamins and 54% alternative therapies (chiropractic (36%) and massage therapy (24%)). Among CAM users, 141 (22%) believe CAM can assist the body to heal, 123 (19%) believe CAM can relieve cancer symptoms, 115 (18%) believe CAM use gives a feeling of control, 106 (17%) believe CAM can boost immunity, 24 (4%) believe CAM can cure cancer, and 35 (6%) believe CAM can prevent the spread of cancer. Female gender was associated with increased overall CAM use (p<0.0001) as well as use of vitamins (p<0.0001), herbal supplements (p=0.006) and alternative therapy (p=0.0002) specifically for cancer. Older age was also associated with increased vitamin use (p=0.005) and decreased herbal supplements use (p=0.008). There was no significant difference in overall CAM use between those with follicular lymphoma grades I-II (n=195, 91%) and non-relapsed diffuse large B-cell lymphoma (n=151, 87%), although massage therapy was utilized more often by FL survivors (29% versus 18%, p=0.005). Conclusions: CAM modalities are used by the majority of NHL survivors (89%). The assessment of CAM use and education regarding potential harms is imperative for the NHL survivor.
Biomarkers of amenorrhea and ovarian function in breast cancer survivors.
Authors: Ruddy Kathryn Jean , Gelber Shari , Tamimi Rulla M. , Ginsburg Elizabeth S , Schapira Lidia , Come Steven E. , Meyer Meghan E , Winer Eric , Partridge Ann H. 
Published: March 2020

9071 Background: Ovarian function after treatment of early breast cancer may affect fertility, menopausal symptoms, endocrine therapy decision-making, and subsequent health and psychosocial concerns among young survivors. We aim to improve understanding of ovarian reserve in women with a history of breast cancer by comparing anti-mullerian hormone (AMH), estradiol (E2), and follicle-stimulating hormone (FSH) levels in survivors with and without amenorrhea, a surrogate for ovarian dysfunction and menopause. Methods: As part of an ongoing prospective multi-center cohort study, women diagnosed with breast cancer at age <41 have blood and surveys collected one year after diagnosis. Women who reported that they were receiving ovarian suppression or had undergone hysterectomy or bilateral oophorectomy/ovarian ablation were excluded. Amenorrhea was defined as >6 months between blood draw and last menstrual period. AMH, E2, and FSH levels were compared between those with and without amenorrhea using a Wilcoxon rank sum test with 2-sided p-values. Results: The first 199 eligible women with blood and survey data at one year were included in this analysis. Median age was 37 years (range 22-40). Seventy-two(36%) had received chemotherapy alone, 75 (38%) had received chemotherapy followed by tamoxifen (TAM), 25 (13%) had received TAM alone, and 10 (5%) reported TAM use but did not respond to chemotherapy items. Median AMH and E2 were lower and FSH was higher in women with amenorrhea, and these differences remained significant when those on and off TAM were analyzed separately (Table). Conclusions: AMH, E2, and FSH all are promising biomarkers for amenorrhea and residual ovarian function in young breast cancer survivors. Future research will evaluate whether AMH, E2, and FSH at baseline and early in the survivorship period predict ovarian function later. [Table: see text]
Efficacy and safety of half-dose pegfilgrastim in cancer patients receiving cytotoxic chemotherapy.
Authors: Ramaekers Ryan C. , Olsen Jon , Obermiller Angela Mae , Jabbour Melhem Salim , Tharnish Mark , Schriner Megan , Hays Rita , Nelson Deborah , Benzel Heather , Hadenfeldt Rebecca , Fuller Courtney , Copur Mehmet Sitki 
Published: March 2020

9110 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.
Continued suppression of bone turnover following a single dose of zoledronic acid: Time to re-think dosing intervals in the management of bone metastases?
Authors: Simmons Christine E. , Goodwin Pamela Jean , Hogeveen Sophie , Clemons Mark , Haq Rashida , Brezden Christine B. , Ebrahim Jalal , Han Dolly 
Published: March 2020

9111 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.