References of "Journal of Clinical Oncology"
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See detailPharmacokinetic (PK) effects and safety of olaparib in combination with tamoxifen, anastrozole or letrozole : Phase I study
Plummer, R.; Verheul, H.M.; Langenberg, M. et al

in Journal of Clinical Oncology (2016), 34

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See detailGemtuzumab Ozogamicin Versus Best Supportive Care in Older Patients With Newly Diagnosed Acute Myeloid Leukemia Unsuitable for Intensive Chemotherapy: Results of the Randomized Phase III EORTC-GIMEMA AML-19 Trial
Amadori, Sergio; Suciu, Stefan; Selleslag, Dominik et al

in Journal of Clinical Oncology (2016)

Purpose To compare single-agent gemtuzumab ozogamicin (GO) with best supportive care (BSC) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for ... [more ▼]

Purpose To compare single-agent gemtuzumab ozogamicin (GO) with best supportive care (BSC) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for intensive chemotherapy. Patients and Methods In this trial, patients at least 61 years old were centrally randomized (1:1) to receive either a single induction course of GO (6 mg/m2 on day 1 and 3 mg/m2 on day 8) or BSC. Patients who did not progress after GO induction could receive up to eight monthly infusions of the immunoconjugate at 2 mg/m2. Randomization was stratified by age, WHO performance score, CD33 expression status, and center. The primary end point was overall survival (OS) by intention-to-treat analysis. Results A total of 237 patients were randomly assigned (118 to GO and 119 to BSC). The median OS was 4.9 months (95% CI, 4.2 to 6.8 months) in the GO group and 3.6 months (95% CI, 2.6 to 4.2 months) in the BSC group (hazard ratio, 0.69; 95% CI, 0.53 to 0.90; P = .005); the 1-year OS rate was 24.3% with GO and 9.7% with BSC. The OS benefit with GO was consistent across most subgroups, and was especially apparent in patients with high CD33 expression status, in those with favorable/intermediate cytogenetic risk profile, and in women. Overall, complete remission (CR [complete remission] + CRi [CR with incomplete recovery of peripheral blood counts]) occurred in 30 of 111 (27%) GO recipients. The rates of serious adverse events (AEs) were similar in the two groups, and no excess mortality from AEs was observed with GO. Conclusion First-line monotherapy with low-dose GO, as compared with BSC, significantly improved OS in older patients with acute myeloid leukemia who were ineligible for intensive chemotherapy. No unexpected AEs were identified and toxicity was manageable. [less ▲]

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See detailAvelumab (MSB0010718C ; anti-PD-L1) as a first-line treatment for patients with advanced NSCLC from the JAVELIN Solid Tumor phase 1b trial : safety, clinical activity, and PD-L1 expression
Verschraegen, C.; Chen, F.L.; Spigel, D.R. et al

in Journal of Clinical Oncology (2016), 34

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See detailPrediction of Allogeneic Hematopoietic Stem-Cell Transplantation Mortality 100 Days After Transplantation Using a Machine Learning Algorithm: A European Group for Blood and Marrow Transplantation Acute Leukemia Working Party Retrospective Data Mining Study
SHOUVAL, Roni; LABOPIN, Myriam; BONDI, Ori et al

in Journal of Clinical Oncology (2015), 33(28), 3144-3152

Purpose: Allogeneic hematopoietic stem-cell transplantation (HSCT) is potentiallu curative for acute leukemia (AL), but carries considerable risk. Machine learning algorithms, which are part of the data ... [more ▼]

Purpose: Allogeneic hematopoietic stem-cell transplantation (HSCT) is potentiallu curative for acute leukemia (AL), but carries considerable risk. Machine learning algorithms, which are part of the data mining (DM) approach, may serve for transplantation-related mortality risk prediction. Patients and Methods: This work is a retrospective DM study on a cohort of 28,236 adult HSCT recipients from the AL registry of the European Group for Blood and Marrow Transplantation. The primary objective was prediction of overall mortality (OM) at 100 days after HSCT. Secondary objectives were estimation of nonrelapse mortality, leukemia-free survival, and overall survival at 2 years. Donor, recipient, and procedural characteristics were alalyzed. The alternating decision tree machine learning algorithm was applied for model development on 70 % of the data set and validated on the remaining data. [less ▲]

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See detailTransfer of communication skills to the workplace: Impact of a 38-hour communication skills training program designed for radiotherapy teams
Merckaert, Isabelle; Delevallez, France; Gibon, Anne-Sophie et al

in Journal of Clinical Oncology (2015), 33(8), 901-909

Purpose This study assessed the efficacy of a 38-hour communication skills training program designed to train a multidisciplinary radiotherapy team. Methods Four radiotherapy teams were randomly assigned ... [more ▼]

Purpose This study assessed the efficacy of a 38-hour communication skills training program designed to train a multidisciplinary radiotherapy team. Methods Four radiotherapy teams were randomly assigned to a training program or a waiting list. Assessments were scheduled at baseline and after training for the training group and at baseline and 4 months later for the waiting list group. Assessments included an audio recording of a radiotherapy planning session to assess team members’ communication skills and expression of concerns of patients with breast cancer (analyzed with content analysis software) and an adapted European Organisation for Research and Treatment of Cancer satisfaction with care questionnaire completed by patients at the end of radiotherapy. Results Two hundred thirty-seven radiotherapy planning sessions were recorded. Compared with members of the untrained teams, members of the trained teams acquired, over time, more assessment skills (P = .003) and more supportive skills (P = .050) and provided more setting information (P = .010). Over time, patients interacting with members of the trained teams asked more open questions (P = .022), expressed more emotional words (P = .025), and exhibited a higher satisfaction level regarding nurses’ interventions (P = .028). Conclusion The 38-hour training program facilitated transfer of team member learned communication skills to the clinical practice and improved patients’ satisfaction with care. [less ▲]

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See detailAvelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic or locally advanced solid tumors : assessment of safety and tolerability in a phase I, open-label expansion study
Kelly, Karen; Patel, Manish R.; Infante, Jeffrey R. et al

in Journal of Clinical Oncology (2015), 33(suppl ; abstr 3044),

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See detailRelationship of germline polymorphisms to docetaxel toxicity in the ROSE/TRIO-012 trial
Damaraju, Sambasivarao; Gorbunova, Vera; Gelmon, Karen A. et al

in Journal of Clinical Oncology (2015), (suppl abstr 540),

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See detailEffect of itraconazole and rifampin on the pharmacokinetics of olaparib table formulation in patients with advanced solid tumors : phase I open-label studies
Plummer, Elizabeth R.; Verheul, Henk M.W.; Rottey, Sylvie et al

in Journal of Clinical Oncology (2015), 33(suppl : abstr 2565),

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See detailPredictive biomarkers of everolimus efficacy in HER2+ advanced breast cancer : combined exploratory analysis from BOLERO-1 and BOLERO-3
Slamon, Dennis; Hurvitz, Sara; Chen, David et al

in Journal of Clinical Oncology (2015), 33(suppl ; abstr 512),

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See detailRole of Imaging in the Staging and Response Assessment of Lymphoma : Consensus of the International Conference on Malignant Lymphomas Imaging Working Group
BARRINGTON, SALLY F.; MIKKHAEEL, N. GEORGE; KOSTAKOGLU, LALE et al

in Journal of Clinical Oncology (2014)

This article comprises the consensus reached to update guidance on the use of PET-CT for staging and response assessment for 18F FDG-avid lymphomas in clinical practice and late-phase trials.

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See detailHigh-Dose Cytarabine in Induction Treatment Improves the Outcome of Adult Patients Younger Than Age 46 Years With Acute Myeloid Leukemia: Results of the EORTC-GIMEMA AML-12 Trial
Willemze, Roelof; Suciu, Stefan; Meloni, Giovanna et al

in Journal of Clinical Oncology (2014), 32(3), 219-228

Purpose : Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia (AML). Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m2 for remission ... [more ▼]

Purpose : Cytarabine plays a pivotal role in the treatment of patients with acute myeloid leukemia (AML). Most centers use 7 to 10 days of cytarabine at a daily dose of 100 to 200 mg/m2 for remission induction. Consensus has not been reached on the benefit of higher dosages of cytarabine. Patients and Methods : The European Organisation for Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell’ Adulto (GIMEMA) Leukemia Groups conducted a randomized trial (AML-12; Combination Chemotherapy, Stem Cell Transplant and Interleukin-2 in Treating Patients With Acute Myeloid Leukemia) in 1,942 newly diagnosed patients with AML, age 15 to 60 years, comparing remission induction treatment containing daunorubicin, etoposide, and either standard-dose (SD) cytarabine (100 mg/m2 per day by continuous infusion for 10 days) or high-dose (HD) cytarabine (3,000 mg/m2 every 12 hours by 3-hour infusion on days 1, 3, 5, and 7). Patients in complete remission (CR) received a single consolidation cycle containing daunorubicin and intermediate-dose cytarabine (500 mg/m2 every 12 hours for 6 days). Subsequently, a stem-cell transplantation was planned. The primary end point was survival. Results : At a median follow-up of 6 years, overall survival was 38.7% for patients randomly assigned to SD cytarabine and 42.5% for those randomly assigned to HD cytarabine (log-rank test P = .06; multivariable analysis P = .009). For patients younger than age 46 years, survival was 43.3% and 51.9%, respectively (P = .009; multivariable analysis P = .003), and for patients age 46 to 60 years, survival was 33.9% and 32.9%, respectively (P = .91). CR rates were 72.0% and 78.7%, respectively (P = .001) and were 75.6% and 82.4% for patients younger than age 46 years (P = .01) and 68.3% and 74.8% for patients age 46 years and older (P = .03). Patients of all ages with very-bad-risk cytogenetic abnormalities and/or FLT3-ITD (internal tandem duplication) mutation, or with secondary AML benefitted from HD cytarabine. Conclusion : HD cytarabine produces higher remission and survival rates than SD cytarabine, especially in patients younger than age 46 years. [less ▲]

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See detailRandomized Multicenter Phase II Trial Comparing Two Schedules of Etirinotecan Pegol (NKTR-102) in Women With Recurrent Platinum-Resistant/Refractory Epithelial Ovarian Cancer.
Vergote, Ignace B.; Garcia, Agustin; Micha, John et al

in Journal of Clinical Oncology (2013)

PURPOSE: Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan ... [more ▼]

PURPOSE: Etirinotecan pegol (NKTR-102) is a unique, long-acting topoisomerase-I inhibitor with prolonged systemic exposure to SN38 (7-ethyl-10-hydroxycamptothecin), the active metabolite of irinotecan. This randomized phase II trial investigated two dosing schedules of etirinotecan pegol in patients with platinum-resistant/refractory ovarian carcinoma. PATIENTS AND METHODS: A total of 71 eligible patients were randomly assigned to receive etirinotecan pegol 145 mg/m2 every 14 or 21 days until progression or unacceptable adverse events (AEs). The primary end point was objective response rate (ORR) by RECIST (version 1.0). Secondary end points included response by Gynecologic Cancer Intergroup criteria, duration of ORR, progression-free survival (PFS), and overall survival (OS). RESULTS: The overall confirmed ORR was 20% (95% CI, 10% to 30%): 20% for once every 14 days, and 19% for once every 21 days. Median response duration was 4.1 months for once every 14 days and 4.0 months for once every 21 days. Median PFS for every 14 and every 21 days was 4.1 and 5.3 months, respectively, and median OS was 10.0 and 11.7 months, respectively. Etirinotecan pegol was well tolerated, with the most common grade 3 to 4 AEs being dehydration (24%) and diarrhea (23%). Diarrhea, dehydration, nausea, and neutropenia were less frequent with the schedule of once every 21 days than with that of once every 14 days. CONCLUSION: Both schedules of etirinotecan pegol showed activity in patients with heavily pretreated ovarian cancer, with encouraging ORR and PFS rates. The schedule of once every 21 days was better tolerated and had slightly longer PFS and OS rates. The treatment schedule of etirinotecan pegol 145 mg/m2 once every 21 days was selected for the expanded phase II study and is preferred for future phase III studies. These findings provide support to directly compare etirinotecan pegol versus one of the approved drugs (eg, pegylated liposomal doxorubicin or topotecan) in platinum-resistant ovarian cancer. [less ▲]

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See detailBolero-6:Phase 2 Study of Everolimus plus Exemestane versus Everolimus or Capecitabine Monotherapy in HR+HER2- Advanced Breast Cancer
Ejlerstsen, Bent; JERUSALEM, Guy ULg; Hurvitz, Sara et al

in Journal of Clinical Oncology (2013), 31

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See detailImpact of Azacitidine before allogeneic stem-cell transplantation for myelodysplastic syndromes : a study b the Société Française de Greffe de Moelle et de Thérapie-Cellulaire and the Groupe Francophone des Myélodysplasies
Damaj, Gandhi; Duhamel, Alain; Robin, Marie et al

in Journal of Clinical Oncology (2012), 30

Purpose : To investigate the impact of prior-to-transplantation azacitidine (AZA) on patient outcome after allogeneic stem-cell transplantation (alloSCT) for myelodysplastic syndrome (MDS). Patients and ... [more ▼]

Purpose : To investigate the impact of prior-to-transplantation azacitidine (AZA) on patient outcome after allogeneic stem-cell transplantation (alloSCT) for myelodysplastic syndrome (MDS). Patients and Methods Of the 265 consecutive patients who underwent alloSCT for MDS between October 2005 and December 2009, 163 had received cytoreductive treatment prior to transplantation, including induction chemotherapy (ICT) alone (ICT group; n 98), AZA alone (AZA group; n 48), or AZA preceded or followed by ICT (AZA-ICT group; n 17). At diagnosis, 126 patients (77%) had an excess of marrow blasts, and 95 patients (58%) had intermediate-2 or high-risk MDS according to the International Prognostic Scoring System (IPSS). Progression to more advanced disease before alloSCT was recorded in 67 patients. Donors were sibling (n 75) or HLA-matched unrelated (10/10; n 88). They received blood (n 142) or marrow (n 21) grafts following either myeloablative (n 33) or reduced intensity (n 130) conditioning. Results : With a median follow-up of 38.7 months, 3-year outcomes in the AZA, ICT, and AZA-ICT groups were 55%, 48%, and 32% (P .07) for overall survival (OS); 42%, 44%, and 29% (P .14) for event-free survival (EFS); 40%, 37%, and 36% (P .86) for relapse; and 19%, 20%, and 35% (P .24) for nonrelapse mortality (NRM), respectively. Multivariate analysis confirmed the absence of statistical differences between the AZA and the ICT groups in terms of OS, EFS, relapse, and NRM. Conclusion : With the goal of downstaging underlying disease before alloSCT, AZA alone led to outcomes similar to those for standard ICT. [less ▲]

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See detailFinal results of NKTR-102, a topoisomerase I inhibitor-polymer conjugate, in patients (Pts) with pretreated metastatic breast cancer (MBC) demonstrating significant antitumor activity
Garcia, A; Awada, A; Chan, S et al

in Journal of Clinical Oncology (2011), 29(supplement 27),

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See detailToo low iron doses and too many dropouts in negative iron trial
Aapro, M.; Beguin, Yves ULg; Birgegard, G. et al

in Journal of Clinical Oncology (2011)

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See detailChlordecone Exposure and Risk of Prostate Cancer
Multigner, Luc; NDong, Jean-Rodrigue; Giusti, Arnaud ULg et al

in Journal of Clinical Oncology (2010)

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