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See detailRucaparib in Men With Metastatic Castration-Resistant Prostate Cancer Harboring a BRCA1 or BRCA2 Gene Alteration
Abida, Wassim; Patnaik, Akash; Campbell, David et al

in Journal of Clinical Oncology (2020), 0(0), 2001035

PURPOSEBRCA1 or BRCA2 (BRCA) alterations are common in men with metastatic castration-resistant prostate cancer (mCRPC) and may confer sensitivity to poly(ADP-ribose) polymerase inhibitors. We present ... [more ▼]

PURPOSEBRCA1 or BRCA2 (BRCA) alterations are common in men with metastatic castration-resistant prostate cancer (mCRPC) and may confer sensitivity to poly(ADP-ribose) polymerase inhibitors. We present results from patients with mCRPC associated with a BRCA alteration treated with rucaparib 600 mg twice daily in the phase II TRITON2 study.METHODSWe enrolled patients who progressed after one to two lines of next-generation androgen receptor–directed therapy and one taxane-based chemotherapy for mCRPC. Efficacy and safety populations included patients with a deleterious BRCA alteration who received ≥ 1 dose of rucaparib. Key efficacy end points were objective response rate (ORR; per RECIST/Prostate Cancer Clinical Trials Working Group 3 in patients with measurable disease as assessed by blinded, independent radiology review and by investigators) and locally assessed prostate-specific antigen (PSA) response (≥ 50 decrease from baseline) rate.RESULTSEfficacy and safety populations included 115 patients with a BRCA alteration with or without measurable disease. Confirmed ORRs per independent radiology review and investigator assessment were 43.5 (95 CI, 31.0 to 56.7\%; 27 of 62 patients) and 50.8 (95 CI, 38.1 to 63.4\%; 33 of 65 patients), respectively. The confirmed PSA response rate was 54.8 (95 CI, 45.2 to 64.1\%; 63 of 115 patients). ORRs were similar for patients with a germline or somatic BRCA alteration and for patients with a BRCA1 or BRCA2 alteration, while a higher PSA response rate was observed in patients with a BRCA2 alteration. The most frequent grade ≥ 3 treatment-emergent adverse event was anemia (25.2\%; 29 of 115 patients).CONCLUSIONRucaparib has antitumor activity in patients with mCRPC and a deleterious BRCA alteration, but with a manageable safety profile consistent with that reported in other solid tumor types. [less ▲]

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See detailPhase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3.
Slamon, Dennis J.; Neven, Patrick; Chia, Stephen et al

in Journal of Clinical Oncology (2018)

Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer who were treatment ... [more ▼]

Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer who were treatment naive or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Results A total of 484 postmenopausal women were randomly assigned to ribociclib plus fulvestrant, and 242 were assigned to placebo plus fulvestrant. Median progression-free survival was significantly improved with ribociclib plus fulvestrant versus placebo plus fulvestrant: 20.5 months (95% CI, 18.5 to 23.5 months) versus 12.8 months (95% CI, 10.9 to 16.3 months), respectively (hazard ratio, 0.593; 95% CI, 0.480 to 0.732; P < .001). Consistent treatment effects were observed in patients who were treatment naive in the advanced setting (hazard ratio, 0.577; 95% CI, 0.415 to 0.802), as well as in patients who had received up to one line of prior endocrine therapy for advanced disease (hazard ratio, 0.565; 95% CI, 0.428 to 0.744). Among patients with measurable disease, the overall response rate was 40.9% for the ribociclib plus fulvestrant arm and 28.7% for placebo plus fulvestrant. Grade 3 adverse events reported in >/= 10% of patients in either arm (ribociclib plus fulvestrant v placebo plus fulvestrant) were neutropenia (46.6% v 0%) and leukopenia (13.5% v 0%); the only grade 4 event reported in >/= 5% of patients was neutropenia (6.8% v 0%). Conclusion Ribociclib plus fulvestrant might represent a new first- or second-line treatment option in hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. [less ▲]

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See detailChanges of microbiome profile during nivolumab treatment in NSCLC patients.
Botticelli, Andrea; Putignani, Lorenza; Zizzari, Ilaria et al

in Journal of Clinical Oncology (2018), 36(suppl), 15020

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See detailPrognostic factors associated with survival and recurrence in resectable gastroesophageal adenocarcinoma: retrospective analysis of 497 patients operated at two Italian centers
Ghidini, Michele; Botticelli, Andrea; Donida, Bianca Maria et al

in Journal of Clinical Oncology (2017), 35

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See detailPresence of bone metastases(BM) at diagnosis is associated with poor prognosis and coagulation disorders (CD) in patients (pts) with advanced gastric cancer (AGC)
Toppo, Laura; Liguigli, Wanda; Senti, Chiara et al

in Journal of Clinical Oncology (2017), 35

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See detailImmunomodulatory effects of tyrosine kinase inhibitors (TKIs) in renal cell carcinoma (RCC) patients
Nuti, Marianna; Zizzari, Ilaria; Napoletano, Chiara et al

in Journal of Clinical Oncology (2017), 35

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See detailMolecular Alterations and Everolimus Efficacy in Human Epidermal Growth Factor Receptor 2-Overexpressing Metastatic Breast Cancers: Combined Exploratory Biomarker Analysis From BOLERO-1 and BOLERO-3.
Andre, Fabrice; Hurvitz, Sara; Fasolo, Angelica et al

in Journal of Clinical Oncology (2016), 34(18), 2115-24

PURPOSE: Two recent phase III trials, BOLERO-1 and BOLERO-3 (Breast Cancer Trials of Oral Everolimus), evaluated the addition of everolimus to trastuzumab and chemotherapy in human epidermal growth factor ... [more ▼]

PURPOSE: Two recent phase III trials, BOLERO-1 and BOLERO-3 (Breast Cancer Trials of Oral Everolimus), evaluated the addition of everolimus to trastuzumab and chemotherapy in human epidermal growth factor receptor 2-overexpressing advanced breast cancer. The current analysis aimed to identify biomarkers to predict the clinical efficacy of everolimus treatment. METHODS: Archival tumor samples from patients in BOLERO-1 and BOLERO-3 were analyzed using next-generation sequencing, immunohistochemistry, and Sanger sequencing. RESULTS: Biomarker data were available for 549 patients. PIK3CA activating mutations and PTEN loss were reported in 30% and 16% of BOLERO-1 samples and in 32% and 12% of BOLERO-3 samples, respectively. PI3K pathway was hyperactive (PIK3CA mutations and/or PTEN loss and/or AKT1 mutation) in 47% of BOLERO-1 and 41% of BOLERO-3 samples. In both studies, differential progression-free survival (PFS) benefits of everolimus were consistently observed in patient subgroups defined by their PI3K pathway status. When analyzing combined data sets of both studies, everolimus was associated with a decreased hazard of progression in patients with PIK3CA mutations (hazard ratio [HR], 0.67; 95% CI, 0.45 to 1.00), PTEN loss (HR, 0.54; 95% CI, 0.31 to 0.96), or hyperactive PI3K pathway (HR, 0.67; 95% CI, 0.48 to 0.93). Patients with wild-type PIK3CA (HR, 1.10; 95% CI, 0.83 to 1.46), normal PTEN (HR, 1.00; 95% CI, 0.80 to 1.26), or normal PI3K pathway activity (HR, 1.19; 95% CI, 0.87 to 1.62) did not derive PFS benefit from everolimus. CONCLUSION: This analysis, although exploratory, suggests that patients with human epidermal growth factor receptor 2-positive advanced breast cancer having tumors with PIK3CA mutations, PTEN loss, or hyperactive PI3K pathway could derive PFS benefit from everolimus. [less ▲]

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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 detailNivolumab safety in patients with advanced melanoma who have progressed on or after Ipilimumab : a single-arm, open-label, multicenter, phase II study (CheckMate 172)
Ascierto P.A.; Demidov, L.; Garbe, C. et al

in Journal of Clinical Oncology (2016), 34

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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 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 detailReply to G. Keramida et al.
Barrington, Sally F.; Mikhaeel, N. George; Kostakoglu, Lale et al

in Journal of Clinical Oncology (2015), 33(34), 4121-2

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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 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 detailReply to B. Bennani-Baiti et al, H.J.A. Adams et al, E. Laffon et al, and E.A. Hawkes et al.
Barrington, Sally F.; Mikhaeel, N. George; Kostakoglu, Lale et al

in Journal of Clinical Oncology (2015), 33(10), 1221-3

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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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