| Added by | pcoopman |
|---|---|
| Group name | EquipePC |
| Item Type | Journal Article |
| Title | Letrozole and palbociclib versus chemotherapy as neoadjuvant therapy of high-risk luminal breast cancer |
| Creator | Cottu et al. |
| Author | P. Cottu |
| Author | V. D'Hondt |
| Author | S. Dureau |
| Author | F. Lerebours |
| Author | I. Desmoulins |
| Author | P.-E. Heudel |
| Author | F. P. Duhoux |
| Author | C. Levy |
| Author | M.-A. Mouret-Reynier |
| Author | F. Dalenc |
| Author | J.-S. Frenel |
| Author | C. Jouannaud |
| Author | L. Venat-Bouvet |
| Author | S. Nguyen |
| Author | J.-M. Ferrero |
| Author | J.-L. Canon |
| Author | J. Grenier |
| Author | C. Callens |
| Author | D. Gentien |
| Author | J. Lemonnier |
| Author | A. Vincent-Salomon |
| Author | S. Delaloge |
| Abstract | Background: Palbociclib is a CDK4/6 inhibitor with demonstrated efficacy and safety in combination with endocrine therapy in advanced luminal breast cancer (LBC). We evaluated the respective efficacy and safety of chemotherapy and letrozole-palbociclib (LETPAL) combination as neoadjuvant treatment in patients with high-risk LBC. Patients and Methods: NeoPAL (UCBG10/4, NCT02400567) is a randomised, parallel, non-comparative phase II study. Patients with ER-positive, HER2-negative, Prosigna®-defined luminal B, or luminal A and node-positive, stage II-III breast cancer, not candidate for breast-conserving surgery, were randomly assigned to either letrozole (2.5?mg daily) and palbociclib (125?mg daily, 3 weeks/4) during 19 weeks, or to FEC100 (5FU 500?mg/m2, epirubicin 100?mg/m2, cyclophosphamide 500?mg/m2) x3 21-day courses followed by docetaxel 100?mg/m2 x3 21-day courses. Primary endpoint was residual cancer burden (RCB 0-1 rate). Secondary endpoints included clinical response, proliferation-based markers, and safety. Results: Overall, 106 patients were randomised (median Prosigna® ROR Score 71 (22-93)). RCB 0-I was observed in four and eight patients in LETPAL [7.7% (95% CI 0.4-14.9)] and chemotherapy [15.7% (95% CI 5.7-25.7)] arms, respectively. pCR rates were 3.8% and 5.9%. Clinical response (75%) and breast-conserving surgery rates (69%) were similar in both arms. Preoperative Endocrine Prognostic Index 0 scores (breast cancer-specific survival) were observed in 17.6% and 8.0% of patients in LETPAL and chemotherapy arms, respectively. Safety profile was as expected, with two versus 17 serious adverse events (including 11 grade 4 serious AEs in the chemotherapy arm). Conclusion: LETPAL combination was associated with poor pathological response but encouraging clinical and biomarker responses in Prosigna®-defined high-risk LBC. Contemporary chemotherapy regimen was associated with poor pathological and biomarker responses, with a much less favourable safety profile. LETPAL combination might represent an alternative to chemotherapy in early high-risk LBC. Clinical Trial Number: NCT02400567. |
| Publication | Annals of Oncology: Official Journal of the European Society for Medical Oncology |
| Date | Oct 11, 2018 |
| Journal Abbr | Ann. Oncol. |
| Language | eng |
| DOI | 10.1093/annonc/mdy448 |
| ISSN | 1569-8041 |
| Library Catalog | PubMed |
| Extra | PMID: 30307466 |
| Tags | clinic |
| Date Added | 2018/11/14 - 12:52:12 |
| Date Modified | 2019/05/16 - 15:20:59 |
| Notes and Attachments | PubMed entry (Attachment) Version acceptée (Attachment) |
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