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Breast cancer, early stage

1900 - Letrozole and palbociclib versus 3rd generation chemotherapy as neoadjuvant treatment of luminal breast cancer. Results of the UNICANCER-NeoPAL study

Date

08 Sep 2017

Session

Breast cancer, early stage

Presenters

paul cottu

Citation

Annals of Oncology (2017) 28 (suppl_5): v605-v649. 10.1093/annonc/mdx440

Authors

P. cottu1, V. D'Hondt2, S. Dureau3, F. Lerebours4, I. Desmoulins5, P. Heudel6, F. Duhoux7, C. Levy8, M. Mouret-Reynier9, F. Dalenc10, J. Frenel11, C. Jouannaud12, L. Venat-Bouvet13, S. Nguyen14, J. Ferrero15, J. Canon16, J. Grenier17, J. Lemonnier18, A. Vincent-Salomon19, S. Delaloge20

Author affiliations

  • 1 Medical Oncology, Institut Curie, 75005 - Paris/FR
  • 2 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34298 - Montpellier/FR
  • 3 Dept Of Medical Oncology, Institut Curie, 75248 cedex5 - Paris/FR
  • 4 Medical Oncology, Institut Curie, 92210 - Saint Cloud/FR
  • 5 Medical Oncology, Centre Georges-François Leclerc (Dijon), 21000 - Dijon/FR
  • 6 Oncology, Centre Léon Bérard, 69373 - Lyon/FR
  • 7 Medical Oncology, Cliniques Universitaires St. Luc, 1200 - Brussels/BE
  • 8 Medical Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 9 Medical Oncology, Centre Jean Perrin, Clermont-Ferrand/FR
  • 10 Medical Oncology, IUCT Oncopole Toulouse, 31052 - Toulouse/FR
  • 11 Medical Oncology, UNICANCER, ICO Institut de Cancerologie de l'Ouest René Gauducheau, 44805 - Saint-Herblain/FR
  • 12 Medical Oncology, Institut Jean Godinot, 51056 - Reims/FR
  • 13 Medical Oncology, Limoges university hospital, 12000 - limoges/FR
  • 14 Medical Oncology, CH Pau, 64000 - Pau/FR
  • 15 Department Of medical Oncology, Centre Antoine Lacassagne, 06100 - Nice/FR
  • 16 Department Of Oncology-hematology, Grand Hopital de Charleroi, Charleroi/BE
  • 17 Medical Oncology, Institut Ste Catherine, 84082 - Avignon/FR
  • 18 R&d, Unicancer, 75654 - Paris/FR
  • 19 Tumor Biology, Institut Curie, 75248 cedex5 - Paris/FR
  • 20 Medical Oncology, Institut de cancérologie Gustave Roussy, Villejuif/FR
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Abstract 1900

Background

Benefit of neoadjuvant chemotherapy in patients (pts) with luminal breast cancer (LBC) is limited. Palbociclib combined with endocrine treatment has shown impressive results in advanced LBC. We conducted a randomized parallel phase II study, assessing letrozole + palbociclib (LP) as neoadjuvant treatment in LBC.

Methods

Postmenopausal women were eligible if they had a stage II-III ER-positive HER2-negative BC, not candidate for breast conserving surgery (BCS), with either a PAM50 luminal B, or a PAM50 luminal A profile with proven lymph node involvement (N+). A parallel 1:1 randomization proposed 6 courses of 3rd generation chemotherapy (FEC100 x 3 - docetaxel 100 x 3), or 19 weeks (wks) of L 2.5 mg/day plus P 125 mg/day, 3 wks/4. Surgery was performed at wk 20. Primary endpoint was locally assessed Residual Cancer Burden (RCB) rate. Main secondary endpoints included safety, response rate, positive and negative predictive values of PAM50 ROR (risk of recurrence)-defined status, centrally reviewed RCB, and BCS rates. The protocol planned that the trial should be stopped for futility if ≤ 5 local RCB 0-I events (16.7%) were observed in the first 30 pts in the LP arm.

Results

Out of 184 screened pts, 106 women with Stage II-IIIA, PAM50-ascertained LBC were randomized. Pts had T1-2 (73%) or T3 (27%); N + (26.5%); luminal B (89%) tumors. Median ROR score was 68 (22-93). At interim analysis, RCB 0-I was observed in 1 pt in the LP arm and inclusions were stopped. At final analysis, local RCB 0/I/II/III was observed in 3.8%/3.8%/52%/40.4% of pts in the LP arm, and in 5.9%/9.8%/37.3%/47.1% in the chemo arm, respectively. Central and local RCB results were identical. ROR score was not predictive of RCB 0/1. Clinical objective response rates were 74.5% and 76%, and BCS rates 69.2% and 68.6%, in the LP and chemo arms, respectively. Ki67 final median value was significantly lower in the LP arm [3% (range 1-40) vs 8% (2-15), p=.017). Of 19 serious adverse events, 2 occurred in the LP arm and 17 in the chemo arm (p 

Conclusions

Neoadjuvant LP led to a slightly lower pCR/RCB 0-I rate than chemo, however clinical response and BCS rates were similar in both arms and LP had a much better safety profile. Extensive analyses are ongoing.

Clinical trial identification

NCT02400567

Legal entity responsible for the study

UNICANCER R&D

Funding

Pfizer - Nanostring

Disclosure

P. Cottu: Consulting Fees (e.g. advisory boards): Pfizer, Roche, Novartis. Travel: Pfizer, Roche, Novartis. F. Duhoux: Consulting Fees (e.g. advisory boards): Pfizer, Roche. Travel: Amgen, Pfizer, Roche, Teva. All other authors have declared no conflicts of interest.

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