389TiPPRECYCLE: Impact of CANKADO-based eHealth-support on quality of life in metastatic breast cancer patients treated with palbociclib and endocrine therapy
AbstractBackgroundEfficacy and quality of life (QoL) are key factors when selecting therapies for metastatic breast cancer (MBC) patients. The addition of targeted oral agents such as CDK4/6 inhibitors to endocrine therapy is the new standard for HR+ HER2- MBC and substantially prolongs progression-free survival. However more complex oral medication in oncology might require substantial improvement of patient management. Despite several advantages of oral treatments, patients become increasingly self-responsible and physician-patient contact is reduced. Adherence, maintaining patients ’ satisfaction and early detection m...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
388TiPAlpelisib (ALP) + endocrine therapy (ET) by last prior therapy in patients (pts) with PIK3CA-mutated hormone-receptor positive (HR+) human epidermal growth factor receptor-2-Negative (HER2 –) advanced breast cancer (ABC): Additional study cohort in BYLieve
AbstractBackgroundApproximately 40% of pts with HR+, HER2 – ABC have mutations (mut) in PIK3CA, which encodes α-PI3K and leads to PI3K pathway hyperactivation and potentially ET resistance. ALP is a selective inhibitor of α-PI3K that, in combination with fulvestrant (FUL), significantly improved median progression-free survival (PFS) vs placebo + FUL i n pts with PIK3CA-mut, HR+ HER2– ABC in the phase 3 SOLAR-1 trial (11.0 vs 5.7 mo, respectively; HR 0.65; 95% CI, 0.50-0.85; P < 0.001). BYLieve is an ongoing phase 2, multicenter, open-label, noncomparative study assessing ALP + ET (FUL or letrozole [LET]) i...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
387TiPPalbociclib rechallenge in hormone receptor (HR)[+]/HER2[-] advanced breast cancer (ABC). PALMIRA trial
AbstractBackgroundThe combination of a CDK4/6 inhibitor (CDK4/6i) with letrozole (LET) or fulvestrant (FUL) is the most active first –line (1L) treatment for patients (pts) with HR[+]/HER2[-] ABC. Although endocrine sensitivity persists beyond progression, preliminary findings suggest more adaptive resistance mechanisms to endocrine therapy (ET) than to CDK4/6i. At present, there are no data about prolonging CDK4/6 blockade bey ond progression on a CDK4/6i. The aim of this study is to determine whether palbociclib rechallenge combined with second–line ET upon progression to a prior palbociclib–based therapy will impr...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
386TiPRIbociclib plus goserelin with hormonal therapy versus physician choice chemotherapy in premenopausal or perimenopausal patients with HR+, HER2 – inoperable locally advanced or metastatic breast cancer: RIGHT choice study
AbstractBackgroundA high percentage of breast cancer patients in the Asia-Pacific ( ∼42%) and Middle East (∼50%) regions are aged 50 years or younger. Although a high proportion of younger patients with endocrine-responsive metastatic disease are treated initially with cytotoxic chemotherapy (CT) in routine general practice, data from phase III trials have shown higher response rates and longer progression-free survival with endocrine therapy (ET) in combination with CDK4/6 inhibitor versus single agent ET. Due to lack of direct evidence, trials in pre-/perimenopausal advanced breast cancer are thus necessary to assess...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
385TiPRIBOB: A study on the efficacy and safety of ribociclib in combination with letrozole in older women ( ≥70 years) with hormone receptor-positive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior systemic therapy for advanced disease
AbstractBackgroundRibociclib in combination with endocrine therapy (ET) is the current standard of care in first-line for HR+/HER2- aBC. An increasing proportion of patients who are candidates for ribociclib are older ( ≥70 years of age). The number of older patients who have participated thus far in ribocicib trials is, however, small, and little data is available on the tolerability of ribociclib in this population, particularly among frail older patients. Previous trials, moreover, do not usually include older patient-specific methods of evaluation (comprehensive geriatric assessment). RIBOB addresses the issue of eff...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
384TiPEffectiveness of olaparib plus trastuzumab in HER2[+], BRCA –mutated (BRCAm) or homologous recombination deficient (HRD) advanced breast cancer (ABC) patients (pts). The OPHELIA study
This study will evaluate the efficacy and safety of olaparib plus trastuzumab in HER2[+] gBRCAm or wild–type gBRCA/HRD ABC pts.Trial designThis is a multicenter, single –arm, two–cohort, Simon’s two–stage, phase II trial. The cohort A will recruit N = 20 gBRCAm ABC pts. The cohort B will recruit N = 13 wild–type gBRCA/HRD ABC pts based on HRDetect assay. Pts will receive olaparib (300mg p.o. b.i.d. during 21–day cycles) in combination with trast uzumab (IV/SC at standard dose) until progression or unacceptable toxicity. Main selection criteria: (1) Pre– and post–menopausal women with HER2[+] ABC; ...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
383TiPBintrafusp alfa (M7824) and eribulin mesylate in treating patients with metastatic triple negative breast cancer (TNBC)(NCT03579472)
AbstractBackgroundTNBC is an aggressive subtype of metastatic breast cancer. Eribulin has been shown to have activity in metastatic TNBC and has enhanced efficacy if TGF- β is downregulated. Additionally, down-regulating TGF-β in the tumor microenvironment may decrease tumor growth and increase responsiveness to checkpoint blockade. Bintrafusp alfa* (M7824) is an innovative first-in-class bifunctional fusion protein composed of the extracellular domain of the TGF-β RII receptor (a TGF-β “trap”) fused to a human IgG1 mAb blocking PD-L1. Therefore the combination of eribulin with bintrafusp alfa is being tested in th...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
382TiPCONTESSA TRIO: A multinational, multicenter, phase II study of tesetaxel plus 3 different PD-(L)1 inhibitors in patients with metastatic triple negative breast cancer (TNBC) and tesetaxel monotherapy in elderly patients with her2- metastatic breast cancer (MBC)
AbstractBackgroundChemotherapy (CT) treatments with robust efficacy that preserve quality of life are needed. Tesetaxel (T) is a novel, oral taxane that has potential advantages over currently available taxanes, including: oral administration with a low pill burden and once every 3 week (Q3W) dosing; no observed hypersensitivity reactions; and preclinical evidence of central nervous system (CNS) penetration and improved activity against CT-resistant tumors. More than 600 pts have been treated with T in clinical studies. T had robust monotherapy activity in a phase 2 study in 38 pts with HER2-, HR+ MBC, with a confirmed obj...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
359PReproducibility and concordance of 4 clinically developed programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) assays in triple negative breast cancer (TNBC)
ConclusionsThe results of this first multicentre PD-L1 assay comparison study in TNBC indicate good-to-high reproducibility and concordance of PD-L1 IC expression between the SP142, 22C3 and 28-8 assays, while higher PD-L1 IC expression levels were detected with SP263. Hence, SP142, 22C3 and 28-8 may be considered analytically interchangeable for PD-L1 IC testing.Clinical trial identificationRoche study ID SL41336.Editorial acknowledgementSupport for third-party writing assistance for this abstract, furnished by Katie Wilson, PhD, of Health Interactions, was provided by Roche Pharma AG, Grenzach-Wyhlen, Germany.Legal entit...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
348PPhase I study of liposomal formulation of eribulin (E7389-LF) in patients (pts) with advanced solid tumours: Primary results of dose-escalation part
ConclusionsE7389-LF was well tolerated in Japanese pts with advanced solid tumors with antitumor effects in several tumor types. Plasma AUC of eribulin after administration of E7389-LF suggested a promising exposure profile of the liposomal formulation in humans. The 2.0 mg/m2 Q3W regimen was recommended for further investigation in an expansion cohort of specific tumor types.Clinical trial identificationNCT03207672.Legal entity responsible for the studyEisai Co., Ltd.FundingEisai Co., Ltd.DisclosureN. Yamamoto: Research grant / Funding (institution): Chugai, Taiho, Eisai, Lilly, Quintiles, Astellas, BMS, Novartis, Daii...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
549PImpact of concomitant medications on disease free survival (DFS) and overall survival (OS) in patients from the PETACC8 study
ConclusionsComorbidities related to analyzed ATC classes negatively impact OS and DFS in PETACC8 pts, except antidiarrheal agents which positively impact OS and DFS.Clinical trial identificationPETACC8; 2005-003463-23.Legal entity responsible for the studyF édération Francophone de Cancérologie Digestive, Dijon.FundingMerck and Sanofi.DisclosureJ. Taieb: Advisory / Consultancy: Merck; Advisory / Consultancy: Sanofi; Advisory / Consultancy: Roche Genentech; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Amgen. All other authors have declared no conflicts of interest. (Source: Annals of Oncology)
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
1675PDEURO-B.O.S.S.: Outcome in rare non-osteosarcoma bone sarcoma
ConclusionsMultiagent chemotherapy was feasible in this patient population. Outcome seems comparable to high-grade osteosarcoma with a non-significant trend for UPS over leiomyosarcoma. Favorable outcome was associated with extremity site, secondary surgery after neoadjuvant chemotherapy, and good response to primary chemotherapy.Legal entity responsible for the studyThe authors.FundingCOSS, SSG, ISG.DisclosureP. Reichardt: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy: Pfizer; Honoraria (institution), Advisory / Consultanc...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
531PDSequential RAS mutation testing in cfDNA in RAS wild type (wt) metastatic colorectal cancer (mCRC) patients (pt) treated with panitumumab (P) and chemotherapy (CT) in first-line (1L): PERSEIDA study
ConclusionsRAS mutational status assessed in cfDNA before starting 1L or sequentially during P+CT Tx in pt with RASwt SB was not a significant predictor of PFS and ORR in none of the cutoffs considered, although in RASmut pt clinical results tended to increase as MAF decreased. The highest proportion of mutated pt was observed at PD, which may be linked to the emergence of resistance. Mutated cfDNA by itself did not predict a lack of clinical benefit to CT and P in our study.Editorial acknowledgementMarta Mu ñoz-Tudurí (TFS, S.L.).Legal entity responsible for the studyAmgen S.A.FundingAmgen S.A.DisclosureM. Valladares-Ay...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
1191OPhase II study of olaparib (O) and durvalumab (D) (MEDIOLA): Updated results in patients (pts) with germline BRCA-mutated (gBRCAm) metastatic breast cancer (MBC)
ConclusionsThe data suggest that pts with fewer prior lines of chemotherapy (0/1) had higher ORR, longer mDoR, mPFS and mOS than those with 2 prior lines. The chemo-free combination was well-tolerated, with safety consistent with the individual agent profiles. Confirmation of these results in early-line patients is warranted.Clinical trial identificationNCT02734004.Editorial acknowledgementWriting assistance was provided by Martin Goulding, PhD, of Mudskipper Ltd and funded by AstraZeneca.Legal entity responsible for the studyAstraZeneca and the authors.FundingAstraZeneca.DisclosureS. Domchek: Honoraria (self), Research gr...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
511TiPA phase I, open-label study of GSK1795091 administered in combination with immunotherapies in participants with advanced solid tumours (NCT03447314)
AbstractBackgroundToll-like receptor (TLR) activation can enhance a range of antitumor immune responses via production of inflammatory cytokines and modulation of immune cells in the tumor microenvironment. GSK1795091 is a synthetic TLR4 agonist that showed immunomodulatory activity in preclinical cancer models (Gao et al. J Clin Oncol 2018) and successfully completed a safety, pharmacokinetic (PK) and pharmacodynamic (PD) study using IV administration in healthy volunteers. The current study will evaluate GSK1795091 with immunotherapies that have highly complementary mechanisms of action and supporting preclinical data (e...
Source: Annals of Oncology - October 1, 2019 Category: Cancer & Oncology Source Type: research
