Literature DB >> 22301401

Phase II trial with letrozole to maximum response as primary systemic therapy in postmenopausal patients with ER/PgR[+] operable breast cancer.

Antonio Llombart-Cussac1, Ángel Guerrero, Antonio Galán, Vicente Carañana, Elvira Buch, Álvaro Rodríguez-Lescure, Amparo Ruiz, Carlos Fuster Diana, Vicente Guillem Porta.   

Abstract

PURPOSE: Letrozole is superior to tamoxifen in terms of response and breast preservation rates as primary systemic therapy (PST) in postmenopausal women with ER-positive early breast cancer. However, the optimum duration of endocrine PST remains uncertain.
METHODS: A phase 2 multicentre, open-label trial was conducted to evaluate the efficacy of letrozole over a preoperative period of 4 months to 1 year. Seventy postmenopausal patients (over 65 years) were recruited in four centers. The primary endpoint was to establish the optimal duration of treatment defined as the time required to attain the maximum response by clinical palpation.
RESULTS: The median age of the group was 79 years (66-91) and the median tumour size 35 mm (range 25-100 mm). No severe adverse events were reported. Fifty-six patients were evaluable for the primary objective. A total of 43 patients (76.8%) achieved an objective response; 29 (51.8%) being partial and 14 (25.0%) complete. The median time to objective response was 3.9 months (95% CI, 3.3-4.5) and the median time to maximum response was 4.2 months (95% CI, 4.0-4.5), although 20 (37.1%) patients achieved the maximal response within 6-12 months.
CONCLUSIONS: Letrozole shows a high activity and excellent tolerability as neoadjuvant therapy in elderly patients with endocrine-dependent breast cancer. Four to six months of letrozole as PST is an optimum duration with modest benefits thereafter.

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Year:  2012        PMID: 22301401     DOI: 10.1007/s12094-012-0771-9

Source DB:  PubMed          Journal:  Clin Transl Oncol        ISSN: 1699-048X            Impact factor:   3.405


  24 in total

1.  Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group.

Authors:  H Mouridsen; M Gershanovich; Y Sun; R Pérez-Carrión; C Boni; A Monnier; J Apffelstaedt; R Smith; H P Sleeboom; F Jänicke; A Pluzanska; M Dank; D Becquart; P P Bapsy; E Salminen; R Snyder; M Lassus; J A Verbeek; B Staffler; H A Chaudri-Ross; M Dugan
Journal:  J Clin Oncol       Date:  2001-05-15       Impact factor: 44.544

Review 2.  Surgery versus primary endocrine therapy for operable primary breast cancer in elderly women (70 years plus).

Authors:  D Hind; L Wyld; C B Beverley; M W Reed
Journal:  Cochrane Database Syst Rev       Date:  2006-01-25

3.  Preoperative treatment of postmenopausal breast cancer patients with letrozole: A randomized double-blind multicenter study.

Authors:  W Eiermann; S Paepke; J Appfelstaedt; A Llombart-Cussac; J Eremin; J Vinholes; L Mauriac; M Ellis; M Lassus; H A Chaudri-Ross; M Dugan; M Borgs
Journal:  Ann Oncol       Date:  2001-11       Impact factor: 32.976

4.  Breast cancer in elderly women: a Cancer Research Campaign trial comparing treatment with tamoxifen and optimal surgery with tamoxifen alone. The Elderly Breast Cancer Working Party.

Authors:  T Bates; D L Riley; J Houghton; L Fallowfield; M Baum
Journal:  Br J Surg       Date:  1991-05       Impact factor: 6.939

5.  Impact of preoperative versus postoperative chemotherapy on the extent and number of surgical procedures in patients treated in randomized clinical trials for breast cancer.

Authors:  Judy C Boughey; Florentia Peintinger; Funda Meric-Bernstam; Allison C Perry; Kelly K Hunt; Gildy V Babiera; S E Singletary; Isabelle Bedrosian; Anthony Lucci; Aman U Buzdar; Lajos Pusztai; Henry M Kuerer
Journal:  Ann Surg       Date:  2006-09       Impact factor: 12.969

6.  Letrozole as primary medical therapy for locally advanced and large operable breast cancer.

Authors:  J M Dixon; C D Love; C O Bellamy; D A Cameron; R C Leonard; H Smith; W R Miller
Journal:  Breast Cancer Res Treat       Date:  2001-04       Impact factor: 4.872

7.  Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27.

Authors:  Harry D Bear; Stewart Anderson; Roy E Smith; Charles E Geyer; Eleftherios P Mamounas; Bernard Fisher; Ann M Brown; Andre Robidoux; Richard Margolese; Morton S Kahlenberg; Soonmyung Paik; Atilla Soran; D Lawrence Wickerham; Norman Wolmark
Journal:  J Clin Oncol       Date:  2006-04-10       Impact factor: 44.544

8.  Effect of preoperative chemotherapy on the outcome of women with operable breast cancer.

Authors:  B Fisher; J Bryant; N Wolmark; E Mamounas; A Brown; E R Fisher; D L Wickerham; M Begovic; A DeCillis; A Robidoux; R G Margolese; A B Cruz; J L Hoehn; A W Lees; N V Dimitrov; H D Bear
Journal:  J Clin Oncol       Date:  1998-08       Impact factor: 44.544

9.  Breast conservation after neoadjuvant chemotherapy: the MD Anderson cancer center experience.

Authors:  Allen M Chen; Funda Meric-Bernstam; Kelly K Hunt; Howard D Thames; Mary Jane Oswald; Elesyia D Outlaw; Eric A Strom; Marsha D McNeese; Henry M Kuerer; Merrick I Ross; S Eva Singletary; Fredrick C Ames; Barry W Feig; Aysegul A Sahin; George H Perkins; Naomi R Schechter; Gabriel N Hortobagyi; Thomas A Buchholz
Journal:  J Clin Oncol       Date:  2004-06-15       Impact factor: 44.544

10.  Thresholds for therapies: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2009.

Authors:  A Goldhirsch; J N Ingle; R D Gelber; A S Coates; B Thürlimann; H-J Senn
Journal:  Ann Oncol       Date:  2009-06-17       Impact factor: 32.976

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  19 in total

1.  Neoadjuvant endocrine therapy: for whom, for how long?

Authors:  Fatima Cardoso
Journal:  Clin Transl Oncol       Date:  2012-02       Impact factor: 3.405

Review 2.  Current Status of Neoadjuvant Endocrine Therapy in Early Stage Breast Cancer.

Authors:  Tomás Reinert; Rodrigo Gonçalves; Matthew J Ellis
Journal:  Curr Treat Options Oncol       Date:  2018-04-16

Review 3.  Neoadjuvant Trials in ER+ Breast Cancer: A Tool for Acceleration of Drug Development and Discovery.

Authors:  Angel L Guerrero-Zotano; Carlos L Arteaga
Journal:  Cancer Discov       Date:  2017-05-11       Impact factor: 39.397

Review 4.  Age-related Disparity: Breast Cancer in the Elderly.

Authors:  Rahul Gosain; YaoYao Pollock; Dharamvir Jain
Journal:  Curr Oncol Rep       Date:  2016-11       Impact factor: 5.075

5.  A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB).

Authors:  Ingrid A Mayer; Aleix Prat; Daniel Egle; Sibel Blau; J Alejandro Pérez Fidalgo; Michael Gnant; Peter A Fasching; Marco Colleoni; Antonio C Wolff; Eric P Winer; Christian F Singer; Sara Hurvitz; Laura García Estévez; Peter A van Dam; Sherko Kümmel; Christoph Mundhenke; Frankie Holmes; Naveen Babbar; Laure Charbonnier; Ivan Diaz-Padilla; Florian D Vogl; Dalila Sellami; Carlos L Arteaga
Journal:  Clin Cancer Res       Date:  2019-02-05       Impact factor: 12.531

6.  Neoadjuvant endocrine treatment for breast cancer: from bedside to bench and back again?

Authors:  R R Saleh; N Bouganim; J Hilton; A Arnaout; M Clemons
Journal:  Curr Oncol       Date:  2014-02       Impact factor: 3.677

7.  Neoadjuvant treatment of breast cancer.

Authors:  A M Thompson; S L Moulder-Thompson
Journal:  Ann Oncol       Date:  2012-09       Impact factor: 32.976

8.  Neoadjuvant endocrine therapy in breast cancer patients.

Authors:  Raquel Lobo-Cardoso; André Torres Magalhães; José Luís Fougo
Journal:  Porto Biomed J       Date:  2017-05-02

Review 9.  Neoadjuvant Endocrine Therapy for Estrogen Receptor-Positive Breast Cancer: A Systematic Review and Meta-analysis.

Authors:  Laura M Spring; Arjun Gupta; Kerry L Reynolds; Michele A Gadd; Leif W Ellisen; Steven J Isakoff; Beverly Moy; Aditya Bardia
Journal:  JAMA Oncol       Date:  2016-11-01       Impact factor: 31.777

10.  Letrozole in the neoadjuvant setting: the P024 trial.

Authors:  Matthew J Ellis; Cynthia Ma
Journal:  Breast Cancer Res Treat       Date:  2007-10-03       Impact factor: 4.872

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