Startseite Kongressberichte 2019 Annual Meeting of the American Society of Clinical Oncology 2019 Breast Cancer Breast Cancer News Aufzeichnung Live-Stream

LIVE-Stream Aufzeichnung vom ASCO 2019: Brustkrebs Deutschland Round Table - Moderation: Renate Haidinger, Brustkrebs Deutschland e.V., München, mit:

Christoph Thomssen; Michael Untch; Renate Haidinger; Nadia Harbeck; Christian Jackisch; Wolfgang Janni
 

Im Live Stream besprochene Studien

Erweiterte adjuvante antihormonelle Therapie:

John Bartlett, Dennis Sgroi, Kai Treuner, Yi Zhang, et al.

Trans-aTTom: Breast Cancer Index for prediction of endocrine benefit and late distant recurrence (DR) in patients with HR+ breast cancer treated in the adjuvant tamoxifen—To offer more? (aTTom) trial.

Conclusions: These data provide further validation and establish level 1B evidence for BCI as a predictive biomarker for preferential benefit from EET in HR+ breast cancer.

 

Lucia Del Mastro, Mauro Mansutti, Giancarlo Bisagni, Riccardo Ponzone, et al.

Benefit from letrozole as extended adjuvant therapy after sequential endocrine therapy: A randomized, phase III study of Gruppo Italiano Mammella (GIM).

Conclusions: After 2-3 years of adjuvant tam, extended treatment with 5 years of letrozole resulted in significant improvement in DFS compared to the standard duration of 2-3 years of letrozole. Clinical trial information: NCT01064635

 

Neoadjuvante Therapie:

Sara A. Hurvitz, Miguel Martin, Kyung Hae Jung, Chiun-Sheng Huang, et al.

Neoadjuvant trastuzumab (H), pertuzumab (P), and chemotherapy versus trastuzumab emtansine (T-DM1) and P in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC): Final outcome results from the phase III KRISTINE study.

Conclusions: EFS numerically favors TCHP due to locoregional progression events with T-DM1+P prior to surgery. T-DM1+P was associated with fewer grade ≥3 AEs but increased treatment discontinuation. Clinical trial information: NCT02131064

Conclusions: EFS numerically favors TCHP due to locoregional progression events with T-DM1+P prior to surgery. T-DM1+P was associated with fewer grade ≥3 AEs but increased treatment discontinuation. Clinical trial information: NCT02131064

  TCHP
(n = 221)		 T-DM1+P
(n = 223)
EFS events, n (%) 13 (5.9) 31 (13.9)
Locoregional progression before surgery 0 (0) 15 (6.7)
Invasive disease recurrence 11 (5.0) 11 (4.9)
Non-invasive recurrence (DCIS) 0 (0) 3 (1.3)
Death without prior EFS event 2 (0.9) 2 (0.9)
3-yr IDFS in patients with pCR (95% CI) 97.5%
(94.7–100.0)		 96.7%
(93.0–100.0)
3-yr IDFS in patients without pCR (95% CI) 84.2%
(72.5–96.0)		 89.4%
(83.1–95.6)
Grade ≥3 AEs, n (%) 148 (67.6) 71 (31.8)
AEs leading to any treatment discontinuation, n (%) 24 (11.0) 45 (20.2)

 

Otto Metzger Filho, Giuseppe Viale, Lorenzo Trippa, Tianyu Li, et al.

HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.

Conclusions: ITH-HER2 assessed by routine pathology evaluation is a strong predictor of pCR to a dual-HER2 targeted therapy regimen. If validated, ITH-HER2 may need to be considered in selection of pts for HER2-targeted regimens without chemotherapy in the curative setting. Clinical trial information: NCT02326974

 

Peter A. Fasching, Christian Jackisch, Kerstin Rhiem, Andreas Schneeweiss, et al.

GeparOLA: A randomized phase II trial to assess the efficacy of paclitaxel and olaparib in comparison to paclitaxel/carboplatin followed by epirubicin/cyclophosphamide as neoadjuvant chemotherapy in patients (pts) with HER2-negative early breast cancer (BC) and homologous recombination deficiency (HRD)

 

Conclusions: GeparOla could not exclude a pCR rate of ≤55% in the PwO arm. Subgroup analysis is hypothesis generating and need further confirmation.

  Olaparib+Paclitaxel
pCR rate (90%CI)		 Carboplatin+Paclitaxel
pCR rate (90%CI)
HR+ patients (n = 29) 52.6% (32.0%, 72.6%) 20.0% (3.7%, 50.7%)
HR- patients (n = 77) 56.0% (43.4%, 68.0%) 59.3% (41.7%, 75.2%)
Patients age < 40 (n = 32) 76.2% (56.3%, 90.1%) 45.5% (20.0%, 72.9%)
Patients age ≥ 40 (n = 74) 45.8% (33.4%, 58.6%) 50.0% (32.7%, 67.3%)

Clinical trial information: NCT02789332

 

William M. Sikov, Mei-Yin Polley, Erin Twohy, Charles M. Perou, et al.

Conclusions: As expected, regardless of treatment arm pCR was associated with markedly better LTOs, and pts with any residual disease had significantly worse outcomes. The addition of Cb or Bev to standard NACT for TNBC did not improve LTOs in this trial, although it should be noted that the trial was not powered for this endpoint. Omission of chemotherapy doses may result in poorer outcomes, especially among Cb-treated pts, which may warrant further evaluation. Support: U10CA180821; U10CA180882; Genentech; https://acknowledgments.alliancefound.org; NCT00861705 Clinical trial information: NCT00861705
 
Tessa Gerjanne Steenbruggen, Mette S. Van Ramshorst, Erik van Werkhoven, Vincent O. Dezentjé, et al.

Conclusions: Adjuvant chemotherapy is associated with higher OS and BCSS in small node negative TNBC. Benefit is most evident in grade 3 tumors and tumors > 1cm and not evident in tumors ≤1cm and grade 1-2.

  aHR OS 95% CI aHR BCSS 95% CI
all patients 0.55 0.44-0.69 0.55 0.42-0.73
pT1ab 1.52 0.80-2.90 1.17 0.55-2.49
pT1c 0.53 0.41-0.67 0.57 0.43-0.76
grade 1-2 1.03 0.63-1.67 0.99 0.57-1.71
grade 3 0.50 0.39-0.65 0.54 0.40-0.74

 

Metastasiertes Mammakarzinom: Triple Negativ
 
Peter Schmid, Sylvia Adams, Hope S. Rugo, Andreas Schneeweiss, et al.

Conclusions: The 2nd IMpassion130 interim OS analysis was consistent with the 1st analysis, confirming clinically meaningful OS benefit with atezo + nP in previously untreated PD-L1+ mTNBC. Clinical trial information: NCT02425891

  Atezo + nP Placebo + nP
ITT population, events/pts, n/n (%) 255/451 (57%) 279/451 (62%)
HR (95% CI); log-rank P 0.86 (0.72, 1.02); 0.078a ―
Median OS (95% CI), mo 21.0 (19.0, 22.6) 18.7 (16.9, 20.3)
2-year OS (95% CI), % 42 (37, 47) 39 (34, 44)
Median follow-up duration, mo 18.5 17.5
PD-L1+ population,b events/pts, n/n (%) 94/185 (51%) 110/184 (60%)
HR (95% CI) 0.71 (0.54, 0.93) ―
Median OS (95% CI), mo 25.0 (19.6, 30.7) 18.0 (13.6, 20.1)
2-year OS (95% CI), % 51 (43, 59) 37 (29, 45)

HRs estimated per stratified Cox model. a Not significant. b PD-L1 on IC ≥ 1% (VENTANA SP142 IHC assay).

 

Charles McCrea, Robert Hettle; AstraZeneca, Cambridge, United Kingdom

 

Conclusions: Results of the ITC suggest that olaparib and talazoparib are equally efficacious on PFS, and differ in AE risk profile, with olaparib predicted to have fewer common hematological and alopecia events, but an increased risk of nausea and vomiting versus talazoparib. Observed differences require confirmation in comparative studies. Limitations of the analysis include heterogeneity in study design, reporting of AEs, and mix of chemotherapies used in the control arm of the studies.

Any grade AE OR (95% credible interval)
olaparib vs talazoparib
Anemia 0.37 (0.18, 0.78)
Thrombocytopenia 0.23 (0.06, 0.90)
Neutropenia 0.54 (0.28, 1.06)
Alopecia 0.22 (0.07, 0.66)
Fatigue 1.00 (0.49, 2.06)
Headache 0.82 (0.36, 1.90)
Diarrhea 1.15 (0.53, 2.53)
Nausea 2.39 (1.23, 4.64)
Vomiting 2.13 (0.96, 4.92)

 

Joshua James Gruber, Anosheh Afghahi, Alyssa Hatton, Danika Scott, et al.
Conclusions: In this proof-of-concept phase II study, single agent talazoparib demonstrated activity in HER2-negative advanced breast cancer pts with a HR pathway mutation beyond BRCA1/2. Further evaluation of talazoparib in this population is warranted. Clinical trial information: NCT02401347
 
Metastasiertes Mammakarzinom: HER2-Positiv
 
Sandra M. Swain, David Miles, Sung-Bae Kim, Young-Hyuck Im, et al.
Conclusions: The OS improvement with 1L P + H + D v Pla + H + D for pts with HER2-positive MBC was maintained after an additional 4 years of long-term follow-up, as were the safety and cardiac safety profiles. Clinical trial information: NCT00567190
 
Metastasiertes Mammakarzinom: Hormon Sensitiv
 
Yeon Hee Park, Tae Yong Kim, Gun Min Kim, Kyung Hae Jung, et al.
 
Conclusions: Exemestane plus palbociclib with ovarian suppression showed clinical benefit in terms of PFS compared with capecitabine in patients with premenopausal ER-positive MBC. Clinical trial information: NCT02592746
 

Abstract LBA1008: Phase III MONALEESA- 7 trial of premenopausal patients withHR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy ± ribociclib: Overall survival (OS) results.

Conclusions: RIB + ET demonstrated a clinically and statistically significant longer OS than ET alone in premenopausal pts with HR+/HER2− ABC. This is the first time that a CDK4/6 inhibitor or any targeted agent + ET has demonstrated significantly longer OS vs ET alone as initial endocrine-based therapy. Clinical trial information: NCT02278120

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Joseph A. Sparano, Robert James Gray, Della F. Makower, Tracy G. Lively, et al.

Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx.

Conclusions: Clinical risk stratification provides additional prognostic information to the 21-gene RS, but not prediction of CT benefit in the overall TAILORx population or those > 50y, and facilitates more refined estimates of absolute CT benefit for women ≤50y with a RS 16-25. (Funded by National Cancer Institute, Komen Foundation, Breast Cancer Research Foundation). Clinical trial information: NCT00310180.