ESMO Supporter 2018

Browsing Over 3211 Presentations

Proffered paper session - Genitourinary tumours, prostate Proffered Paper session

791O - Updated results of GETUG-12, a phase 3 trial of docetaxel-based chemotherapy in high-risk localized prostate cancer, with a 12-year follow-up.

Presentation Number
791O
Lecture Time
14:00 - 14:15
Speakers
  • Karim Fizazi (Villejuif, FR)
Location
ICM - Room 13, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

GETUG-12 assessed docetaxel-estramustine in patients with high-risk localized prostate cancer: the primary endpoint of relapse-free survival (RFS) was met (adjusted HR: 0.71 [95% CI: 0.54-0.94], p = 0.017) (Lancet Oncol 2015; 16: 787-94). This analysis updates RFS and assesses clinical events for the first time.

Methods

Eligibility included non-pretreated high-risk localized prostate cancer, defined as ≥ 1 of the following: T3-T4, Gleason ≥8, PSA ≥20 ng/mL, pN + (stratification factors). All 413 patients had a staging pelvic lymph node dissection. Patients were randomized to goserelin for 3 years and 4 cycles of docetaxel 70 mg/m2 + estramustine 10 mg/kg/d days 1-5, every 3 weeks (ADT+DE arm) or goserelin alone (ADT arm). Local therapy (radiotherapy: 87%) was administered at 3 months. Outcomes were tested with a pre-specified order (1: RFS, 2: clinical RFS (cRFS), and 3: metastases-free survival (MFS)) by the fixed-sequence method for controlling the family-wise error rate when conducting tests for multiple endpoints. RFS events: biochemical failures, metastases, proven local relapses, use of salvage treatment, and deaths. cRFS events: metastases, proven local relapses, and deaths. MFS events: metastases and deaths.

Results

With a median follow-up of 12 years [95% CI 11.9–12.2], 233 patients (56%) have had an event. RFS was improved in the ADT+DE arm: 12-year RFS rate: 49.4% [42.5%; 56.3%] in the ADT+DE arm vs 36.3% [29.7%; 43.5%] in the ADT arm (adjusted HR: 0.71 [0.55; 0.93], p = 0.01). The median RFS was 11.6 [9.1; NR] and 8.1 [7.3; 9.6] years. cRFS was also significantly improved in the ADT+DE arm (adjusted HR: 0.75 [0.56 ; 1.00]; p = 0.0491); 12-year rates: 58.8% [51.7% ; 65.6%] vs 50.5% [43.4% ; 57.6%]; median cRFS: 13.9 (13.3-14.9) vs 12.5 (9.9-15.3) years. 12-year MFS rates were 62.2% [55.1%; 68.8%] and 55.8% [48.6%; 62.8%] (adjusted HR: 0.81 [0.60; 1.09]. 12-year PC-specific survival rates were 88.2% [82.5%; 92.2%] and 83.9% [77.4%; 88.8%] (adjusted HR: 0.70 [0.40; 1.22]). The 12-year cumulative rates of second cancers (16.4% vs 18.8%) were similar.

Conclusions

Four cycles of docetaxel-based chemotherapy reduces the risk of clinical relapse or death in men with high-risk localized prostate cancer.

Clinical trial identification

NCT00055731.

Legal entity responsible for the study

UNICANCER.

Funding

UNICANCER.

Disclosure

K. Fizazi: Advisory boards, honorarium: Sanofi. F. Joly: Advisory boards: Sanofi. G. Gravis: Travel expense: Sanofi, Janssen, Astellas. L. Mourey: Travel expense, honoraria: Sanofi. All other authors have declared no conflicts of interest.

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Proffered paper session - Genitourinary tumours, prostate Proffered Paper session

792O - A Randomized Phase 2 Study of Cabazitaxel (CAB) vs (ABI) Abiraterone or (ENZ) Enzalutamide in Poor Prognosis Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Presentation Number
792O
Lecture Time
15:00 - 15:15
Speakers
  • Kim N. Chi (Vancouver, CA)
Location
ICM - Room 13, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

The optimal treatment for poor prognosis mCRPC is undefined and includes either taxane chemotherapy or androgen receptor (AR) targeted therapy, emphasizing the need for predictive biomarkers.

Methods

Patients (pts) with poor prognosis (liver metastases, early CRPC (<12 months from ADT start), and/or >3 of 6 poor prognostic criteria (Chi et al, Annals of Oncol, 2016)) were randomized to receive CAB (Arm A) or AR targeted therapy (Arm B, ABI or ENZ by investigator choice) with cross over at progression. No prior ABI or ENZ was permitted, but prior docetaxel allowed. Primary objective was to determine the clinical benefit rate (CBR) (PSA decline ≥50% (PSA50), objective response (OR), or stable disease (SD) ≥ 12 weeks). Other endpoints included time to PSA progression (TTPP), time to progression (TTP), and overall survival (OS). Serial plasma was sampled for circulating tumour DNA (ctDNA).

Results

95 pts were randomized (Arm A: 45, Arm B: 50). Poor prognosis was based on liver mets in 18%, early CRPC in 88%, and 30% by prognostic criteria. Other baseline factors: median age 68 years, elevated LDH in 41%, elevated ALK PHOS in 52%, ECOG PS 0-1 in 94%, 52% had prior docetaxel (half for castration sensitive disease). Median duration of therapy was 5.8 months (m) for Arm A and 4.5 m for Arm B. Treatment discontinuation reasons included disease progression (A vs B: 40% vs 46%) and toxicity (11% vs 4%). Outcomes are summarized in table. In 58 pts with available results, baseline ctDNA fraction >2% correlated with TTP (median 3.4 m vs 10.8 m, p = 0.011) and OS (median 15.5 m vs not reached (NR), p = 0.002). Genomic alterations in AR, RB1, TP53, PI3K pathway, and DNA repair were present in 69%, 36%, 51%, 40%, and 15%.

Arm A (CAB)Arm B (ABI/ENZ)HR (95% CI)P
CBR (%)82860.16
PSA50 (%)56600.68
OR (%)1112>0.90
SD > 12 weeks (%)62460.15
Median TTPP (m)7.44.80.73 (0.42-1.29)0.28
Median TTP (m)5.34.10.86 (.53-1.40)0.56
Median OS (m)NR15.50.56 (0.25-1.22)0.14

Conclusions

Treatment with CAB vs ABI/ENZA resulted in similar outcomes. There was a trend in favour of CAB for survival. Genomic correlations will be presented.

Clinical trial identification

NCT02254785.

Legal entity responsible for the study

Kim N. Chi and BC Cancer.

Funding

Sanofi Genzyme, Prostate Cancer Canada Movember Disxcovery Grant, Canadian Institutes of Health Research Project Grant, Terry Fox Research Institute Program Project Grant.

Disclosure

K.N. Chi: Honorarium, grant support: Sanofi Genzyme. N. Iqbal: Honorarium: Janssen, Astellas. M. Ong: Honorarium: Sanofi Genzyme, Janssen, Astellas. S.J. Hotte: Honorarium, advisory board, grant support: Janssen, Astellas. B. Tran: Consulting, honorarium, research grant support: Sanofi Genzyme, Janssen, Astellas. A. Azad: Honorarium: Sanofi, Janssen, Astellas; Grant: Astellas. S. North: Honorarium: Sanofi Genzyme, Janssen, Astellas. C.V. Pezaro: Honoraria, education support: Janssen, Astellas. S.S. Sridhar: Honorarium, grant support: Sanofi Genzyme, Janssen, Astellas. All other authors have declared no conflicts of interest.

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Proffered paper session - Gynaecological cancers Proffered Paper session

932O - Phase III trial of Lurbinectedin versus PLD or Topotecan in platinum-resistant ovarian cancer patients: Results of CORAIL trial

Presentation Number
932O
Lecture Time
14:00 - 14:15
Speakers
  • Stephanie Gaillard (Baltimore, US)
Location
Hall A1 - Room 15, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

Lurbinectedin (L) is a new anticancer agent that blocks transcriptional transactivation, induces DNA double-strand breaks, and modulates the tumor microenvironment. L showed activity in platinum-resistant ovarian cancer (PROC) patients (pts) in a randomized phase II trial in comparison to topotecan (Ann Oncol 2017; 28:1280).

Methods

Pts with PROC [platinum-free interval [PFI] 1-6 months (mo) after last platinum chemotherapy (CT)] treated with ≤3 prior CT lines and ECOG PS 0-2 were eligible. Enrolled pts were randomly assigned (1:1) to receive L 3.2 mg/m2 q3wk (Arm A), or investigator choice of PLD (P) 50 mg/m2 q4wk or topotecan (T) 1.5 mg/m2/day D1-5 q3wk (Arm B) until progression or discontinuation due to toxicity. Pts were stratified by ECOG PS (0 vs ≥ 1), PFI (1-3 vs > 3-6 mo) and prior CT lines (1-2 vs 3). The primary endpoint was PFS by independent review committee (IRC). Sample size was calculated to demonstrate a 30% reduction in the relative risk of progression or death. The secondary endpoints of ORR, OS, and patient-reported outcomes are also reported.

Results

442 pts were randomized; 221 in each arm. Baseline characteristics were well balanced including median prior CT (n = 2) with the following differences (Arm A/B): median age 63/59 years; serous histology 82/90%; ascites 41/50%; and use of prior bevacizumab 40/46%. Median (95% CI) PFS by IRC was 3.5 mo in arm A vs 3.6 mo in arm B (HR 1.04, 95% CI 0.84-1.29). ORR by IRC was 14.0% (9.7-19.3%) in arm A vs 12.2% (8.2-17.3%) for arm B (p=NS). Interim OS was 11.2 mo in arm A vs 11.1 mo in arm B (HR 0.97, 95% CI 0.77-1.23). Related adverse events (AEs) were reported in 201/219 pts (92%) in Arm A vs 198/213 (93%) in Arm B; grade ≥ 3 AEs in 105 (48%) vs 136 (64%) (p = 0.001), respectively. In arm B, T accounted for a higher percentage of AEs than P. Treatment-related dose reductions, delays and discontinuations were more frequent in Arm B. Global QoL scores were not different between the arms.

Conclusions

Although the primary endpoint (30% of reduction in PFS) was not met, the similar efficacy results between arms and the favorable safety profile indicate a potential role for Lurbinectedin in the difficult-to-treat PROC setting.

Clinical trial identification

NCT02421588.

Legal entity responsible for the study

PharmaMar SA.

Funding

Has not received any funding.

Disclosure

S. Gaillard: Consulting or advisory role: Pfizer, Genentech/Roche, Merck, Tesaro; Patents, royalties, other intellectual property: Sermonix Pharmaceuticals; Honoraria: Merck; Research funding: TetraLogic Pharmaceuticals, PharmaMar, Bristol-Myers Squibb, Gradalis, Merck, Genentech/Roche, Iovance Biotherapeutics. I.L. Ray-Coquard: Consulting or advisory role: Pfizer, Abbvie, Amgen Honoraria: Roche, PharmaMar, AstraZeneca. I.B. Vergote: Consulting or advisory role: AstraZeneca, Amgen, Array Biopharma, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Lilly, GE Healthcare, Genentech, GlaxoSmithKline, Intuitive Surgical, Janssen-Cilag, MedImmune, Menarini, Merck Sharp & Dohme, Morphotek, Nektar, Novo Nordisk, Oasmia Pharmaceutical AB, PharmaMar, Phillips Gilmore Oncology, Roche, Sanofi, Schering-Plough; Travel, accommodations, expenses: GCI Health, Roche, Oasmia Pharmaceutical AB, PharmaMar, AstraZeneca; Research funding: Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Exelixis, Fresenius Biotech, GlaxoSmithKline, Ipsen, Janssen-Cilag, Merck Sharp & Dohme, Merrimack, Morphotek, Nektar, Nerviano Medical, Sciences, Novartis, Pfizer, Quintiles, Roche, Sandoz, Sanofi, Schering-Plough, Vifor Pharma, Wyeth, MedImmune, Genmab, Karyopharm Therapeutics, Tesaro. N. Colombo: Consulting or advisory role: Roche/Genentech, PharmaMar, Amgen, AstraZeneca, Clovis Oncology, Pfizer, MSD Oncology. S.A. Ghamande: Consulting or advisory role: Advaxis; Speakers' bureau: Advaxis; Research funding: Advaxis, GlaxoSmithKline, AstraZeneca, Tesaro, PharmaMar, Teueda, Merck and Co Inc. A. Soto-Matos, C. Kahatt, J. Gomez, A. Nieto: Employee and stock: PharmaMar. C.M. Fernandez, N. Torres: Employee PharmaMar. R.S. Kristeleit: Consulting or advisory role: Clovis Oncology, Roche/Genentech, Sotio, Cerulean Pharma, Basilea; Travel, accommodations, expenses: Clovis Oncology, Basilea, Valirx; Honoraria: Clovis Oncology, Roche/Genentech, AstraZeneca, Tesaro. D.M. O'Malley: Honoraria: Clovis Oncology; Consulting or advisory role: Janssen Oncology, AstraZeneca, Clovis Oncology, Amgen, Tesaro, Novocure, Myriad Genetics, Abbvie; Research funding: Amgen, VentiRx, AstraZeneca, Genentech/Roche, Regeneron, ImmunoGen, Janssen; Research & Development: Clovis Oncology, EMD Serono, Ergomed, Ajinomoto, ImmunoGen, Janssen, Cerulean Pharma, Array BioPharma, Agenus, Tesaro, Tracon Pharma, Stem CentRx, Bristol Myers Squibb, PharmaMar. All other authors have declared no conflicts of interest.

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Proffered paper session - Gynaecological cancers Proffered Paper session

933O - Carboplatin/pegylated liposomal Doxorubicin/Bevacizumab (CD-BEV) vs. Carboplatin/Gemcitabine/Bevacizumab (CG-BEV) in patients with recurrent ovarian cancer. A prospective randomized phase III ENGOT/GCIG-Intergroup study (AGO Study Group, AGO-Austria, ANZGOG, GINECO, SGCTG).

Presentation Number
933O
Lecture Time
14:15 - 14:30
Speakers
  • Jacobus Pfisterer (Kiel, DE)
Location
Hall A1 - Room 15, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

In patients with recurrent ovarian cancer (ROC) suitable for platinum-based retreatment (PBT), standard includes CG-BEV and Carboplatin(C)/pegylated-liposomal- Doxorubicin (D). CG-BEV significantly increases progression-free-survival (PFS) over CG alone whilst CD has one of the best therapeutic indices for ROC-PBT. The aim of this trial was to evaluate whether CD is superior to CG when given in combination with BEV with investigator-determined PFS as primary objective (NCT01837251).

Methods

Between 2013/08 and 2015/07 682 pts. with ROC-PBT were randomized to standard CG-BEV (n = 337) or experimental CD-BEV (n = 345). Secondary objectives were overall survival (OS), biological progression-free survival (PFSBIO) by serum CA125, quality of life (QoL) assessed by EORTC-QLQ-C30 and QLQ-OV28, safety and tolerability. The trial was designed to have 80% power (two-sided logrank-test, alpha level 5%) to show a 26.6% change in PFS (Hazard Ratio (HR) 0.79; 564 PFS events).

Results

At data cut-off 571 events occurred. Mean age was 61.1 (SD 10.3) years, 87.4% had serous histology, 83.1% were high grade, 41.5% were pretreated with BEV as part of first-line treatment. CG-BEV was associated with 359 (53,3%) serious adverse events vs. 314 (46,7%) for CD-BEV (p = 0.083). Median PFS in the standard arm CG-BEV was 11.7 months (95% CI 11.1-12.8) vs. 13.3 months (95% CI 11.7-14.3) in the experimental arm CD-BEV (HR 0.80; 95% CI 0.68-0.96, p = 0.0128). In the stratum with previous anti-angiogenic treatment (N = 309) median PFS was 10.1 months (95% CI 8.5-11.2) for CG-BEV vs. 11.3 months (95% CI 10.1-13.8) for CD-BEV (HR 0.73; 95% CI 0.57-0.94, p = 0.0126).

Conclusions

CD-BEV provided a significant PFS improvement compared to CG-BEV in patients with ROC suitable for PBT. A significant PFS improvement was also seen in the subgroup of patients with previous anti-angiogenic treatment. CD-BEV was associated with fewer serious adverse events. Thus CD-BEV might be an important addition to the therapeutic options in these patients.

Legal entity responsible for the study

AGO Research GmbH.

Funding

Hoffmann La Roche.

Disclosure

J. Pfisterer: Consulting or Advisory role: Roche; Research funding: Roche; Travel, Accomodations, Expenses: Roche. A.P. Dean: Honoraria: Baxalta, Astra Zeneca; Consulting or Advisory role: Baxalta, specialized Therapeutics; Speakers' bureau: Baxalta; Travel, Accomodations, Expenses: Amgen. P. Harter: Consulting or Advisory role: AstraZeneca, Roche/Genentech, Tesaro, Clovis, PharmaMar, Lilly, Sotio; Travel, Accommodations, Expenses: Medac. F. Joly: Consulting or Advisory role: Roche, Janssen; Travel, Accomodations, Expenses: Roche, Janssen. J. Sehouli: Honoraria: Roche, AstraZeneca, Tesaro, PharmaMar; Consulting or Advisory role: Clovis, Roche, AstraZeneca, Tesaro, Novartis; Research funding: Amgen, Novartis, Lilly, Bayer. U. Canzler: Honoraria: AstraZeneca, Roche Consulting or Advisory role: Roche. B. Schmalfeldt: Consulting or Advisory role: Roche, AstraZeneca, Tesaro; Travel, Accomodations, Expenses: Roche, AstraZeneca. C. Shannon: Consulting or Advisory role: AstraZeneca, Roche. D.U. Reimer: Consulting or Advisory role: AstraZeneca, PharmaMar; Travel, Accomodations, Expenses: AstraZeneca, Amgen, PharmaMar, Roche Patents, Royalties, other intellectual property: yes. L.C. Hanker: Consulting or Advisory role: Roche, Tesaro; Travel, Accomodations, Expenses: Roche, AstraZeneca. T. Petit: Consulting or Advisory role: Roche, Pfizer; Travel, Accomodations, Expenses: Roche, Pierre Fabre. F. Marme´: Honoraria: Roche, Amgen, AstraZeneca, Eisai, Celgene, Novartis, Pfizer, Genomic Health; Consulting or Advisory Role: roche, AstraZeneca, Novartis; Travel, Accomodations, Expenses: Roche, Amgen, AstraZeneca, Eisai, Celgene, Novartis, Pfizer, PharmaMar. A. El-Balat: Honoraria: Roche, AstraZeneca, Tesaro; Consulting or Advisory role: Roche, AstraZeneca, PharmaMar; Travel, Accomodations, Expenses: PharmaMar, Tesaro, Clovis. R. Glasspool: Consulting or Advisory role: Tesaro, Roche, Clovis Oncology, Clovis; Research Funding: Ignyta, Boehringer Ingelheim, Roche; Travel, Accomodations, Expenses: AstraZeneca, Roche, Tesaro. N. de Gregorio: Consulting or Advisory role: Roche, AstraZeneca, Tesaro; Travel, Accomodations, Expenses: Tesaro. S. Mahner: Honoraria: Roche/Genentech, AstraZeneca, PharmaMar, Medac, Jenapharm, Janssen-Cilag, Teva, GlaxoSmithKline; Consulting or Advisory role: Roche, AstraZeneca, Merck Sharp & Dohme, Janssen-Cilag, Tesaro, Medac; Research funding: Roche, AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Janssen-Cilag, Medac, PharmaMar, Tesaro, Bayer. J-E. Kurtz: Consulting or Advisory role: Tesaro, AstraZeneca; Travel, Accomodations, Expenses: Roche, PharmaMar. All other authors have declared no conflicts of interest.

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Proffered paper session - Gynaecological cancers Proffered Paper session

934O - Alienor/ENGOT-ov7 randomized trial exploring weekly Paclitaxel (wP) + bevacizumab (bev) vs wP alone for patients with ovarian Sex Cord tumors (SCT) in relapse

Presentation Number
934O
Lecture Time
14:45 - 15:00
Speakers
  • Isabelle L. Ray-Coquard (Lyon, FR)
Location
Hall A1 - Room 15, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

Ovarian SCT tend to respond poorly to chemotherapy (CT). We explored the efficacy of wP with or w/o bev in a randomized 1:1 phase II trial in patients (pts) with relapse who were not candidate to surgery & after > 1 line of platinum based CT.

Methods

Primary endpoint is the PFS rate at 6 months (PFR-6). Pts in the wP arm were allowed to receive bev alone at progression. A Bayesian approach allowed continuous monitoring PFR-6 with sequential analyses planned every 20 pts to allow early stopping for efficacy. wP+Bev will be considered interesting if the probability is > 0.9 to show that the estimated PFR-6 in wP+Bev is higher than in wP arm.

Results

From 02/13 to 10/16, 60 pts with SCT (52 AGCT (Adult Granulosa cell tumor), 2 SLT (Sertoli Leydig tumor), 6 other) were randomized. All pts had recurrent disease and were previously treated with CT (47 pts received ≤2 lines). Baseline characteristics were well balanced between the 2 arms. 17 pts (28%) received prior hormonal therapy. Platinum-free interval (PFI) was ≥ 12 months in 21 pts (66%) and 22 (79%) in the wP and wP +bev group, respectively. The PFR-6 [95% CI] was 71% [55%; 84%] vs 72% [55%; 87%] in wP arm (arm A) and wP+bev (arm B). Median PFS were 14.7 and 14.9 months, in arm A and B respectively. In wP arm 50% of pts received bev alone at cross over, with median PFS of 7.3 months. Median TFST were 28.5, 33.6 and 33.6 months, in arm A + cross over bev, arm A w/o crossover and arm B respectively. Most frequent AE (all grade) were: hypertension in 78% of pts wP vs 93% of pts wP+Bev, fatigue (63% vs 78%), neuropathy (56% vs 74%), proteinuria (13% vs 63%), bleeding (16% vs 59%), alopecia (34% vs 56%), vomiting (16% vs 7%). Grade 3/4 AEs were reported in 10 arm wP vs 12 pts in arm wP+Bev.

ArmsORRSDPD
wP8(25%)17(53%)7(22%)
wP+Bev12(44%)12(44%)3(11%)

Conclusions

A randomized trial is feasible in rare cancer with a strong international collaboration. wP confirmed as active drug in SCT. Bev added to wP tends to increase ORR compared to wP alone but failed to significantly improve PFR-6 nor PFS in relapsed SCT pts.

Clinical trial identification

EudraCT: 2012-002841-39.

Legal entity responsible for the study

Michèle Torres-Macque.

Funding

Roche.

Editorial Acknowledgement

Thanks to all the patients and their families, the investigators, study nurses, pharmacists, pathologists and all study team.

Thanks to Roche laboratory for their financial support.

Disclosure

P. Harter: Honoraria: Roche, Astrazeneca, Tesaro; Consulting: Roche, AstraZeneca, Tesaro, Clovis, Pharmamar. I.B. Vergote: Consulting role: GCI Health, Oncoinvent AS, Rocje NV, Genmab A/S, Advaxis Inc, Morphotec Inc, F. Hoffmann-La Roche Ltd, Cerulean Pharma Inc, Novocure GMBH, AstraZeneca LP, Mateon Therapeutics Inc, Immunogen Inc, Eli Lilly benelux NV, Amgen INc, Theradex Europe Limited, Pfizer Inc, Debiopharma International SA, Vifor Pharma Belgie NV, Novartis Pharma AG, MSD Belgium BVBA, Oxigene Inc, Janssen-Cilag, Nektar Therapeutics, Bayer Pharma AG; Grant: Amgen, Roche; Travel accomodations: Tesaro, Theradex, Elsevier. K. Fujiwara: Honoraria: Chugai, Roche. L. Gladieff: Honoraria: AstraZeneca, Tesaro, Clovis, Roche; Travel accommodations: Roche, Pharmamar. H-J. Lueck: Honoraria: Tesaro, Roche, Amgen, AstraZeneca; Consulting: Tesaro, Roche, Pfizer, Novartis; Speakers' bureau: Roche, Novartis, Pfizer, Amgen; Travel accommodations: AstraZeneca, Tesaro. A. Floquet: Travel accommodations: Roche. A. Schnelzer: Consulting: Roche S. Pignata: Honoraria, Consulting, Travel accommodations: Roche. F. Selle: Consulting: MSD, Roche, AstraZeneca, Tesaro; Travel accommodations: MSD, Roche. J. Sehouli: Honoraria: Roche, AstraZeneca, Tesaro, Pharmamar; Consulting: Novartis, Clovis, Roche, AstraZeneca, Tesaro; Research fundings: Amgen, Novartis, Lilly, Bayer. G. Mangili: Speakers' bureau: Astrazeneca; Research fundings: Ipsen; Travel accommodations: Roche, PharmaMar. P. Pautier: Consulting role: Roche, Tesaro, AstraZeneca, Lilly. U. De Giorgi: Honoraria: BMS, AstraZeneca, Sanofi, Pfizer, Ipsen. P-E. Heudel: Consulting role: AstreZeneca, Pfizer, Novartis; Research fundings: AstrasZeneca; Travel and accommodation: Pfizer, Novartis. All other authors have declared no conflicts of interest.

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Proffered paper session - Gynaecological cancers Proffered Paper session

940O - OVPSYCH2: A randomised study of psychological support versus standard of care following chemotherapy for ovarian cancer

Presentation Number
940O
Lecture Time
15:00 - 15:15
Speakers
  • Sarah Blagden (Oxford, GB)
Location
Hall A1 - Room 15, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

Ovarian cancer (OC) treatment is associated with psychological morbidity. We prospectively studied the impact of a brief course of psychological support on self-reported depression, fear of progression (FoP) and quality of life (QOL) in patients (pts) following chemotherapy for primary or recurrent OC.

Methods

Pts consented at their first post-chemotherapy appointment and were eligible if they scored from 5-19 on PHQ9 questionnaire. They were randomised 1:1 to Intervention or Control. Intervention comprised 3 standardised 90-minute sessions of psychological support given 6 -12 weeks after chemotherapy. Control was standard of care in which support was provided where indicated; unblinded block randomisation was used for primary or recurrent OC and 3 levels of PHQ9 as stratification factors. Pts completed PHQ9, FoP-Q-SF, EORTC QLQ C30 and OV28 questionnaires up to 2 years. Primary endpoint was change in PHQ9 score at 3 months compared to baseline.

Results

Oct 2015 - Nov 2017: 182 pts were registered; 107 were eligible and randomised; 54 to Intervention and 53 to Control; mean age of 59 yrs; 75 (70%) primary and 32 (30%) relapsed disease; 63 pts completed baseline and 3-month questionnaires and were included in the analysis: 31 control, 32 intervention. At 3 months there was an improvement in the PHQ9 and the Global Health Status/QOL scale for pts in both arms compared to baseline but no significant difference between Intervention and Control. However, there was a significant improvement on FoP-Q-SF scores in the Intervention arm whilst, for pts in the Control arm, FoP-Q-SF scores deteriorated at 3 months (Intervention effect = -5.2, 95%CI (-8.45-1.9) p = 0.003).

Conclusions

Overall, although symptoms of depression improved following completion of chemotherapy for patients in both arms of the study, Fear of Progression did not. This is the first randomised trial of a survivorship intervention in OC and demonstrates that Fear of Progression is a prominent concern for pts but it can be overcome with provision of psychological support immediately after chemotherapy.

Clinical trial identification

UKCRN ID 15363.

Legal entity responsible for the study

Imperial College London.

Funding

Imperial College Healthcare Charity, Maggie's Centres.

Disclosure

S. Blagden: Advisor: Ellipses; Director of RNA Guardian Ltd, Ad boards: Clovis, Novartis; Research funding: Nucana plc. R.M. Glasspool: Advisory boards: Clovis, Tesaro, Roche, AstraZeneca; Institution receives research funding: Ignyta, Boehringer Ingelheim, AstraZeneca, Tesaro. S. Nicum: Advisory boards: Roche, Tesaro, Clovis, AstraZeneca; Research funding: AstraZeneca. All other authors have declared no conflicts of interest.

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Proffered paper session - Sarcoma Proffered Paper session

1601O - Natural history of sarcomas and impact of reference centers in the nationwide NETSARC study on 35,784 patients (pts) from 2010 to 2017.

Presentation Number
1601O
Lecture Time
14:00 - 14:12
Speakers
  • Jean-Yves Blay (Lyon, FR)
Location
Hall B3 - Room 21, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

We report on the characteristics and determinants of outcome of the 35784 pts included in the nationwide NETSARC/RREPS study since its inception.

Methods

NETSARC (netsarc.org) is a network of 26 reference sarcoma centers with specialized multidisciplinary tumor boards (MDTB), funded by the French National Cancer Institute to improve the outcome of sarcoma patients. Since 2010, presentation to an MDTB and second pathological review are mandatory for sarcoma patients. Patients’ characteristics and follow-up are collected in a database regularly monitored. Descriptive, uni and multivariate analysis of prognostic factors were conducted in the incident (n = 29497) pts population as well as on pts diagnosed before 1/1/2010 (n = 6287), presented to an MDTB after 1/1/10.

Results

We first investigated predisposing and associated conditions: among the 35784, previous cancer, previous RT, NF1, Li-Fraumeni, were reported in 12.5%, 3.6%, 0.7%, 0.1% of pts respectively. 71 of the 35784 (0.2%) pts had 2 or 3 different diagnosis of sarcomas: 28%, 7%, 6%, 3% of these pts had an history of previous cancer, NF1, Li-Fraumeni, Ollier disease (p < 0.001). Prognostic factors of pts outcome at initial diagnosis were then analyzed: male gender, age, size, depth, grade 3, NF1, previous RT were all associated with a worse overall (OS) and progression free survival (PFS) in the incident pts population in univariate and multivariate analysis, while GIST, intermediate malignancy histologies, and surgery in a Netsarc center (HR:0,63) were positively correlated with OS and PFS (p < 0.001 for all). Similar results were obtained in the 6287 pts diagnosed before 2010 for OS. In pts in advanced phase, survival was superior to that reported in the literature with a median of 27 months for all sarcomas but GIST. Median OS was not reached for GIST and tumor of intermediate malignancy (58% and 76% at 5 years respectively). NF1, previous RT, and treatment outside a reference center were again associated with a worse OS in multivariate analysis.

Conclusions

In this nationwide registry of sarcoma patients, unreported prognostic characteristics sarcoma pts were identified.Treatment in a reference center reduces the risk of relapse and death.

Legal entity responsible for the study

NETSARC and French Sarcoma Group.

Funding

French NCI ( INCA).

Disclosure

J-Y. Blay: Research support and honoraria: Roche, Novartis, Bayer, GSK, Lilly, MSD, BMS, Ignyta, Deciphera, PharmaMar. All other authors have declared no conflicts of interest.

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Proffered paper session - Sarcoma Proffered Paper session

1602O - Outcome following unplanned excision in soft tissue sarcoma. Results of a multicentre study including 728 patients.

Presentation Number
1602O
Lecture Time
14:12 - 14:24
Speakers
  • Maria A. Smolle (Graz, AT)
Location
Hall B3 - Room 21, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

Misdiagnosis of soft tissue sarcoma (STS) is common, due to their rarity and unclear clinical presentation. As a result, unplanned excisions (UE) may occur, most often necessitating further treatment at specialised tumour centres. Therapy includes re-resection and adjuvant radiotherapy (ARTX), being associated with increased morbidity. Results on UE’s impact on overall survival (OS) are contradictory, though.

Methods

728 STS patients (376 male, 352 female; mean age: 58 years) undergoing primary surgery or re-resection following UE at three tumour centres were retrospectively included. Median follow-up was 5.5 years. Differences between UE- and non-UE-patients were analysed using chi-square and t-tests. Log-rank and Gray’s tests were applied for time-to-event analyses. Based on differences between UE- and non-UE-patients at baseline, a propensity score of being in the UE-group was estimated. Based on the propensity score, an inverse-probability-of-UE-weight (IPUEW) was calculated. This allowed re-calculation of time-to-event analyses following adjustment for imbalances between non-UE- and UE-patients.

Results

UE had been performed in 281 patients (38.6%), with similar incidences at the three tumour centres. Small (p < 0.005) and superficially located STS (p < 0.005) with a long history of symptoms (p < 0.005), male gender (p = 0.05) and young age (p = 0.036) raised the risk of an UE being performed. At re-resection, plastic reconstruction (p < 0.005) and ARTX (p = 0.041) were significantly more common in UE-patients. In the univariate analysis, UE-patients had a significantly better OS (5-/10-year OS: 78.6%/63.3% for UE; 70.6%/57.9% for non-UE; p = 0.028). Due to a strong correlation between positive prognostic factors and a prior UE, survival analyses were re-calculated after weighting for the IPUEW. As a result, the prognostic benefit of UE in terms of OS was lost (p = 0.241).

Conclusions

Morbidity is raised in patients following UE due to increased necessity of plastic reconstruction and ARTX. However, there is no direct impact of UE on OS. Nevertheless, it is arguable whether a more aggressive approach in the UE-group compensates for the inappropriate primary resection. Thus, UE must be avoided by all means.

Legal entity responsible for the study

Medical University of Graz.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.

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Proffered paper session - Sarcoma Proffered Paper session

1603O - Initial Results of Phase 1 Study of DCC-2618, a Broad-spectrum KIT and PDGFRa Inhibitor, in Patients (pts) with Gastrointestinal Stromal Tumor (GIST) by Number of Prior Regimens.

Presentation Number
1603O
Lecture Time
14:51 - 15:03
Speakers
  • Suzanne George (Boston, US)
Location
Hall B3 - Room 21, ICM München, Munich, Germany
Date
19.10.2018
Time
14:00 - 15:30

Abstract

Background

DCC-2618, a kinase switch control inhibitor, broadly inhibits mutations in KIT exons 9, 11, 13, 14, 17 and 18. Based on clinical activity observed in heavily pretreated GIST pts in a Phase 1 study, DCC-2618 is being evaluated in a Phase 3 study, INVICTUS (NCT03353753), in ≥ 4th line pts. Given the breadth of inhibition of KIT mutations and favorable tolerability profile, the Phase 1 study included expansion cohorts to assess clinical benefit in 2nd and 3rd line GIST pts in advance of the expected initiation of a second Phase 3 study in 2nd line GIST pts by the end of 2018.

Methods

The Phase 1 study includes a dose-escalation component testing oral DCC-2618 dosed QD or BID in 28 day cycles and an expansion phase using the RP2D of 150 mg QDin 6 cohorts, including cohorts for GIST pts based on prior regimens (2nd/3rd, 4th/>4th). RECIST response assements based on local assessment of CT scans were performed every 2 cycles.

Results

At the cut off of April 18, 150 GIST pts were enrolled at dose levels of ≥ 100 mg/d with KIT (141 pts) or PDGFRa- (8 pts) -driven GIST. One pt had SDH-deficient GIST. 114 GIST pts were treated at the 150 mg QD dose, including 19, 27, and 68 pts who previously received 1, 2 or ≥ 3 prior lines of therapy, respectively. For the 114 GIST pts, ORR was 14%, 3-month DCR was 70%, mPFS was 24 weeks with 56% of the pts censored. For the 46 evaluable pts in 2nd/3rd line, ORR was 22%, 3-month DCR was 81% and mPFS was 36 weeks with 61% of the pts censored. Updated ORR, DCR and mPFS will be presented. Grade 3/4 adverse effects (regardless of attribution, in > 1 pt) for all 114 pts treated at 150 mg QD included asymptomatic lipase increase 11, anemia 4, hypertension 3, blood bilirubin increased 3, diarrhea 2, abdominal pain 2, back pain 2, hypophosphatemia 2, hyponatremia 2, hyperkalemia 2.

Conclusions

DCC-2618 demonstrated encouraging clinical benefit and a favorable tolerability profile in GIST pts treated in the 2nd line or later. Clinical benefit as measured by ORR, DCR and mPFS was greater in 2nd/3rd line pts compared to more heavily pretreated pts. Preliminary data from the Phase 1 expansion supports further testing in the planned Phase 3 study in 2nd line GIST.

Clinical trial identification

NCT02571036.

Legal entity responsible for the study

Deciphera Pharmaceuticals, Inc.

Funding

Deciphera Pharmaceuticals, Inc.

Disclosure

S. George, M. Heinrich, P. Chi, M. von Mehren, M. Gordon, N. Somaiah, F. Janku: Research sponsored: Deciphera Pharmaceuticals, Inc.; Scientific advisory board: Deciphera Pharmaceuticals, Inc. A. Razak, K.N. Ganjoo, J. Wolf, J. Rodon Ahnert: Research sponsored: Deciphera Pharmaceuticals, Inc. J.C. Trent: Scientific advisory board: Deciphera Pharmaceuticals, Inc. R. Ruiz-Soto, O. Rosen: Employee: Deciphera Pharmaceuticals, Inc.

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Proffered paper session - NSCLC, metastatic Proffered Paper session

1377O - Phase 2 study of tepotinib + gefitinib (TEP+GEF) in MET-positive (MET+)/epidermal growth factor receptor (EGFR)-mutant (MT) non-small cell lung cancer (NSCLC)

Presentation Number
1377O
Lecture Time
17:12 - 17:27
Speakers
  • Yi-Long Wu (Guangzhou, CN)
Location
Hall A2 - Room 18, ICM München, Munich, Germany
Date
19.10.2018
Time
16:00 - 17:40

Abstract

Background

NSCLC can acquire resistance to EGFR tyrosine kinase inhibitors (EGFR TKIs) via MET activation; dual MET/EGFR inhibition may have potential in EGFR TKI-resistant NSCLC. TEP is a potent, selective MET TKI. We report randomized phase 2 data from a phase 1b/2 signal detection trial of TEP+GEF vs chemotherapy (pemetrexed + cisplatin/carboplatin) in patients (pts) with MET+/EGFR+T790M- NSCLC (NCT01982955).

Methods

Asian pts with advanced MET + (IHC2+, IHC3+, gene amplification) NSCLC, acquired resistance to 1st-line EGFR TKI and ECOG performance status 0–1 were eligible. Tumors had an EGFR-activating mutation (T790M-). Pts received TEP+GEF 500/250mg once-daily. Primary endpoint: progression-free survival (PFS by investigator). Secondary endpoints: safety, antitumor activity, pharmacokinetics.

Results

Due to low recruitment, enrolment was halted after 55 pts were randomized to TEP+GEF (n = 31) or chemotherapy (n = 24): male n = 23, median age 60.4 (range 42–82) years. There was a numeric trend towards TEP+GEF on PFS in the intent-to-treat analysis set (hazard ratio [HR]: 0.71 [0.36, 1.39]), driven by the IHC3 + (HR: 0.35 [0.17, 0.74]) and gene-amplified (HR: 0.17 [0.05, 0.57]) pts (Table) confirming these as predictive biomarkers as indicated by phase 1b data. All pts had treatment-related (TR) treatment-emergent adverse events (TEAEs). In the TEP+GEF vs chemotherapy arms, respectively, 9.7 vs 4.3% had TEAEs leading to permanent discontinuation, 3.2 vs 0% had TEAEs leading to death (none were TRTEAEs), 16.1 vs 30.4% had serious TRTEAEs, 51.6 vs 52.2% had Grade ≥3 TRTEAEs, 12.9 vs 8.7% had a TRTEAE of special interest (lipase/amylase increase ≥3).

Conclusions

TEP+GEF shows promising antitumor activity in pts with MET protein overexpression (IHC3+) and gene amplification EGFR-MT NSCLC and was generally well-tolerated. This positive signal warrants further exploration in this pt population.

Clinical trial identification

NCT01982955.

Legal entity responsible for the study

Merck KGaA.

Funding

Merck KGaA.

Editorial Acknowledgement

Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Lisa Jolly PhD of Bioscript Science (Macclesfield, UK).

Disclosure

S. Lu: Research support: AstraZeneca; Speaker fees: AstraZeneca, Eli Lilly, Roche, Pfizer; Advisor, consultant role: AstraZeneca, Hutchison MediPharma, Simcere, BMS, Roche, Pfizer. R. Bruns, A. Johne, J. Scheele: Employee: Merck KGaA. Y-L. Wu: Speaker fees: AstraZeneca, Eli Lilly, Pfizer, Roche, Sanofi. All other authors have declared no conflicts of interest.

Investigator assessedMedian PFS [90% CI], monthsObjective response rate, n (%) [90% CI]
Overall intent-to-treat (MET + [IHC 2+/IHC 3+/gene amplification]/EGFR T790M-)
Tepotinib + gefitinib (n = 31)4.86 [3.88, 6.87]14 (45.2) [29.7, 61.3]
Pemetrexed + cisplatin/carboplatin (n = 24)4.37 [4.17, 6.80]8 (33.3) [17.8, 52.1]
Stratified HR [90% CI] or odds ratio (OR) adjusted by randomization strata [90% CI]HR: 0.71 [0.36, 1.39]OR: 1.99 [0.56, 6.87]
IHC3+/EGFR T790M-
Tepotinib + gefitinib (n = 19)8.31 [4.11, 21.16]13 (68.4) [47.0, 85.3]
Pemetrexed + cisplatin/carboplatin (n = 15)4.37 [4.11, 6.80]5 (33.3) [14.2, 57.7]
Unstratified HR [90% CI] or OR [90% CI]0.35 [0.17, 0.74]4.33 [1.03, 18.33]
Gene Amplification (GCN ≥5 or MET/CEP7 ratio ≥2/EGFR T790M-)
Tepotinib + gefitinib (n = 12)21.16 [8.31, 21.16]8 (66.7) [39.1, 87.7]
Pemetrexed + cisplatin/carboplatin (n = 7)4.21 [1.35, 6.97]3 (42.9) [12.9, 77.5]
Unstratified HR [90% CI] or OR [90% CI]0.17 [0.05, 0.57]2.67 [0.37, 19.56]

MET+: Met overexpression by immunohistochemistry (IHC2+ or 3+) and/or MET gene amplification and/or increased gene copy number (GCN ≥5 or MET/CEP7 ratio ≥2) by in-situ hybridisation

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Proffered paper session - Breast cancer, early stage Proffered Paper session

184O - Distant disease-free survival (DDFS) according to response category in neoadjuvant endocrine therapy (NET): 6-Year analysis in phase III NEOS trial

Presentation Number
184O
Lecture Time
16:00 - 16:12
Speakers
  • Hiroji Iwata (Nagoya, JP)
Location
ICM - Room 13, ICM München, Munich, Germany
Date
19.10.2018
Time
16:00 - 17:30

Abstract

Background

NEOS is a randomized phase III study that assessed the long-term prognosis of estrogen receptor positive (ER+) primary breast cancer (PBC) pts who received NET with/without adjuvant chemotherapy (CT). We presented the first report about the relationship between DFS and clinical response to NET at median follow-up 4Y in SABCS 2017. We now present new data corrected according to long follow-up (median 5.9Y).

Methods

Postmenopausal BC pts with ER +/HER2 negative, T1c-2, clinically node negative, and under 76 years old were enrolled at primary registration. Pts were treated by leterozole (LET) in weeks 24-28 after primary enrollment. Pts who experienced progression of disease (PD) during neoadjuvant phase were excluded at randomization and received systemic therapy driven by investigators before or after surgery. Pts who met eligibility criteria were randomized 1:1 to LET for 4.5-5 years after CT or LET alone for 4.5-5 years without CT after surgery. DFS/OS in patients showing CR, PR, SD or PD response to NET are secondary endpoints and DDFS is an exploratory endpoint.

Results

Between May 2008 and June 2013, 904 patients were enrolled at primary registration from 100 institutions in Japan and 21 pts were withdrawn during neoadjuvant phase. The median age was 63 years, T1c: 36%, T2: 64%, and progesterone receptor (PgR) +: 79%. Clinical response rates (CR, PR, SD and PD) were 2% (16pts), 48% (421pts), 46% (403pts) and 5% (43pts), respectively. In each response, 0% (0/16), 10.7% (45/421), 12.7% (51/403), and 44.2% (19/43) experienced DFS events and 0% (0/16), 5.2% (22/421), 7.2% (29/403) and 26% (11/43) experienced DDFS events. DDFS in PD pts to NET were statistically significantly worse than CR, PR, SD pts (p < 0.001, hazard ratio 4.83 (95% CI:2.52-9.29). The predictive markers of PD for NET were PgR status (P < 0.001) and Ki67 status (P = 0.041) in biopsy specimen among factors evaluated by multivariate analysis

Conclusions

The DDFS of PBC pts excluding PD pts to NET is excellent regardless of treatment with/without CT. NET with utilization of PD response as a prognostic marker can be considered as a standard treatment option for these patients.

Clinical trial identification

UMIN000001090.

Legal entity responsible for the study

CSPOR.

Funding

The parent NEOS study was sponsored by CSPOR (Comprehensive Support Project for Oncology Research), part of a Sponsored by CSPOR and Novartis and Chugai Pharmaceuticals provided funding to CSPOR.

Disclosure

H. Iwata: Research: Chugai, Novartis, MSD, Lilly; Honororia: Chugai, AstraZeneca, Daiichi Sankyo; Advisory Board: Daiichi Sankyo, Chugai, Lilly, Kyowa Hakko Kirin, Pfizer, Novartis, AstraZeneca. N. Masuda: Honoraria: Chugai, AstraZeneca, Pfizer, Takeda; Research: Chugai, Novartis, MSD, Eli-Lilly, AstraZeneca, Daiichi Sankyo, Kyowa- Kirin, Pfizer. T. Toyama: Research fund: Eisai, Kyowa Kirin, Takeda, Chugai, Novartis, Nippon Kayaku, Pfizer, Daiichi Sankyo; Advisory board: AstraZeneca. M. Kashiwaba: Honoraria: Chugai, AstraZeneca. Y. Ohashi: Honororia: Chugai, PHRF; Consultant: Chugai; Research fund: Eisai. All other authors have declared no conflicts of interest.

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Proffered paper session - Breast cancer, early stage Proffered Paper session

185O_PR - Serum assessment of non-adherence to adjuvant endocrine therapy (ET) among premenopausal patients in the prospective multicenter CANTO cohort

Presentation Number
185O_PR
Lecture Time
16:12 - 16:24
Speakers
  • Barbara Pistilli (Villejuif, FR)
Location
ICM - Room 13, ICM München, Munich, Germany
Date
19.10.2018
Time
16:00 - 17:30

Abstract

Background

Previous studies demonstrated that younger patients (pts) with breast cancer (BC) are more likely to be non-adherent to adjuvant ET, leading to impaired prognosis.

Methods

The CANTO cohort (NCT01993498) is a French multicenter prospective longitudinal study that will include 12000 pts with recently diagnosed stage I-III BC, to characterize long-term impact of BC treatment toxicities. CANTO COMPLETE, a pre-defined sub study, aims to determine, in premenopausal pts who have been prescribed adjuvant ET, the prevalence and dynamic predictors of non-adherence, at 1 (M12), 3 (M36) and 5 (M60) years, using serum assessment of tamoxifen (TAM) and aromatase-inhibitors (AI) matched with pts’ self-declaration. TAM dosage has been determined by liquid chromatography-tandem mass spectrometry on 200 µL of serum. According to standard definitions, adherence to TAM has been defined as: non-adherent if TAM ≤15 ng/mL (≤40 nM), poorly-adherent if TAM 15-60 ng/mL (40-150 nM) and adherent if > 60 ng/mL (>150 nM).

Results

By December 2017, 11237 pts have been included in CANTO, of whom 1799 (16%) are premenopausal and have been prescribed and agreed to take ET: TAM 1496 (83.2%); TAM + LHRH-analogs (LHRH) 26 (1.4%); AI+LHRH 134 (7.5%); unknown 143 (7.9%).We present here the results of TAM plasma assessment at 1 year on all 1228 pts who reached 1 year of follow-up. Overall, 224 (18.2%) pts appeared not adequately adherent to TAM: 162 (13.2%) non-adherent and 62 (5.0%) poorly-adherent. Matching with pts’ self-declaration and clinical determinants of non-adherence will be presented.

Conclusions

At one year from initiation of TAM, plasma measurements show that a substantial proportion of premenopausal pts are not adequately adherent to this treatment. Poorly-adherent pts could benefit from metabolic and pharmacogenetic investigations. Identification of pts at risk of non-adherence allows early targeted interventions to promote adherence in this unique population.

Clinical trial identification

NCT01993498

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