Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 43-51 |
| Number of pages | 9 |
| Journal | Eur. J. Cancer |
| Volume | 136 |
| DOIs | |
| Publication status | Published - 2020 |
Keywords
- Breast cancer
- Dose-dense chemotherapy
- Hormone receptor-positive
- Luminal subtype
- cyclophosphamide
- epirubicin
- fluorouracil
- Ki 67 antigen
- paclitaxel
- pegfilgrastim
- progesterone receptor
- antineoplastic agent
- epidermal growth factor receptor 2
- estrogen receptor
- adjuvant therapy
- adult
- age
- aged
- Article
- cancer adjuvant therapy
- cancer free survival
- cancer grading
- cancer recurrence
- controlled study
- disease free survival
- dosage schedule comparison
- dose densification
- early cancer
- female
- follow up
- human
- human epidermal growth factor receptor 2 negative breast cancer
- human epidermal growth factor receptor 2 positive breast cancer
- immunohistochemistry
- luminal A breast cancer
- luminal B breast cancer
- major clinical study
- multiple cycle treatment
- overall survival
- priority journal
- randomized controlled trial
- recurrence risk
- adjuvant chemotherapy
- breast tumor
- cancer staging
- clinical trial
- cohort analysis
- disease exacerbation
- dose response
- metabolism
- middle aged
- mortality
- multicenter study
- pathology
- phase 3 clinical trial
- phenotype
- prognosis
- survival analysis
- very elderly
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Combined Chemotherapy Protocols
- Breast Neoplasms
- Chemotherapy, Adjuvant
- Cohort Studies
- Disease Progression
- Dose-Response Relationship, Drug
- Female
- Humans
- Immunohistochemistry
- Middle Aged
- Neoplasm Staging
- Phenotype
- Prognosis
- Receptor, ErbB-2
- Receptors, Estrogen
- Receptors, Progesterone
- Survival Analysis
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Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial : European Journal of Cancer. / Conte, B.; Bruzzone, M.; Lambertini, M. et al.
In: Eur. J. Cancer, Vol. 136, 2020, p. 43-51.Research output: Contribution to journal › Article › peer-review
}
TY - JOUR
T1 - Effect of dose-dense adjuvant chemotherapy in hormone receptor positive/HER2-negative early breast cancer patients according to immunohistochemically defined luminal subtype: an exploratory analysis of the GIM2 trial
T2 - European Journal of Cancer
AU - Conte, B.
AU - Bruzzone, M.
AU - Lambertini, M.
AU - Poggio, F.
AU - Bighin, C.
AU - Blondeaux, E.
AU - De Laurentiis, M.
AU - Valle, E.
AU - Cognetti, F.
AU - Nisticò, C.
AU - De Placido, S.
AU - Garrone, O.
AU - Gamucci, T.
AU - Montemurro, F.
AU - Puglisi, F.
AU - Cardinali, B.
AU - Fregatti, P.
AU - Miglietta, L.
AU - Boccardo, F.
AU - Ceppi, M.
AU - Del Mastro, L.
AU - Investigators, the GIM2
N1 - Cited By :1 Export Date: 17 February 2021 CODEN: EJCAE Correspondence Address: Del Mastro, L.; Department of Medical Oncology, Largo Rosanna Benzi, 10, Italy; email: lucia.delmastro@hsanmartino.it Chemicals/CAS: cyclophosphamide, 50-18-0; epirubicin, 56390-09-1, 56420-45-2; fluorouracil, 51-21-8; paclitaxel, 33069-62-4; pegfilgrastim, 208265-92-3; epidermal growth factor receptor 2, 137632-09-8; Receptor, ErbB-2; Receptors, Estrogen; Receptors, Progesterone Funding details: Novartis Funding details: Pfizer Funding details: Celgene Funding details: Eli Lilly and Company Funding details: Eisai Funding details: Roche Italia Funding details: Takeda Pharmaceutical Company Funding details: Agenzia Italiana del Farmaco, Ministero della Salute, AIFA Funding details: Associazione Italiana per la Ricerca sul Cancro, AIRC Funding text 1: L.D.M. declares honoraria from Roche , Pfizer , Ipsen , Eli Lilly , Eisai , Novartis , Takeda and MSD and Seattle Genetics ; a consulting and advisory role for Roche and Eli Lilly and fees for travel, accommodation and expenses from Roche, Pfizer and Celgene outside the submitted work. M.L. served as a consultant for Teva and received speaker honoraria from Theramex outside the submitted work. O.G. received personal fees from Celgene, Eisai, Pfizer, Amgen , Eli Lilly and Novartis; travel and accommodation expenses from Celgene, Roche and Pfizer and research funding from Eisai outside the submitted work. F.P. received honoraria for advisory boards, activities as a speaker, travel grants, research grants from Agmen, Celgene, Eli Lilly, Ipsen, MSD, Novartis, Pierre-Fabre , Pfizer and Takeda and received research funding from Astrazeneca, Eisai and Roche outside the submitted work. M.D.L. declares consulting fees from Pfizer, Novartis, Eli Lilly, Roche, Eisai and Celgene outside the submitted work. Funding text 2: This work was partially supported by grant from Ministero della Salute 5X1000 2015 (Italy) and Associazione Italiana per la Ricerca sul Cancro (AIRC). 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Cheang, M.C.U., Chia, S.K., Voduc, D., Gao, D., Leung, S., Snider, J., Ki67 Index, HER2 status, and prognosis of patients with luminal B breast cancer (2009) JNCI J Natl Cancer Inst, 101, pp. 736-750; Prat, A., Cheang, M.C.U., Martín, M., Parker, J.S., Carrasco, E., Caballero, R., Prognostic significance of progesterone receptor–positive tumor cells within immunohistochemically defined luminal A breast cancer (2013) J Clin Oncol, 31, pp. 203-209; Goldhirsch, A., Winer, E.P., Coates, A.S., Gelber, R.D., Piccart-Gebhart, M., Thürlimann, B., Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2013 (2013) Ann Oncol, 24, pp. 2206-2223; Coates, A.S., Winer, E.P., Goldhirsch, A., Gelber, R.D., Gnant, M., Piccart-Gebhart, M., Tailoring therapies—improving the management of early breast cancer: St Gallen International Expert Consensus on the primary therapy of early breast cancer 2015 (2015) Ann Oncol, 26, pp. 1533-1546; 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Swain, S.M., Tang, G., Geyer, C.E., Rastogi, P., Atkins, J.N., Donnellan, P.P., Definitive results of a phase III adjuvant trial comparing three chemotherapy regimens in women with operable, node-positive breast cancer: the NSABP B-38 trial (2013) J Clin Oncol, 31, pp. 3197-3204; Sonnenblick, A., Francis, P.A., Azim, H.A., de Azambuja, E., Nordenskjöld, B., Gutiérez, J., Final 10-year results of the Breast International Group 2–98 phase III trial and the role of Ki67 in predicting benefit of adjuvant docetaxel in patients with oestrogen receptor positive breast cancer (2015) Eur J Cancer, 51, pp. 1481-1489; Martín, M., Ruiz Simón, A., Ruiz Borrego, M., Ribelles, N., Rodríguez-Lescure, Á., Muñoz-Mateu, M., Epirubicin plus cyclophosphamide followed by docetaxel versus epirubicin plus docetaxel followed by capecitabine as adjuvant therapy for node-positive early breast cancer: results from the GEICAM/2003-10 study (2015) J Clin Oncol, 33, pp. 3788-3795; Mavroudis, D., Matikas, A., Malamos, N., Papakotoulas, P., Kakolyris, S., Boukovinas, I., Dose-dense FEC followed by docetaxel versus docetaxel plus cyclophosphamide as adjuvant chemotherapy in women with HER2-negative, axillary lymph node-positive early breast cancer: a multicenter randomized study by the Hellenic Oncology Research Group (HORG) (2016) Ann Oncol, 27, pp. 1873-1878; Foukakis, T., von Minckwitz, G., Bengtsson, N.-O., Brandberg, Y., Wallberg, B., Fornander, T., Effect of tailored dose-dense chemotherapy vs standard 3-weekly adjuvant chemotherapy on recurrence-free survival among women with high-risk early breast cancer: a randomized clinical trial (2016) J Am Med Assoc, 316, p. 1888; Möbus, V., Jackisch, C., Lück, H.J., du Bois, A., Thomssen, C., Kuhn, W., Ten-year results of intense dose-dense chemotherapy show superior survival compared with a conventional schedule in high-risk primary breast cancer: final results of AGO phase III iddEPC trial (2018) Ann Oncol, 29, pp. 178-185; Del Mastro, L., De Placido, S., Bruzzi, P., De Laurentiis, M., Boni, C., Cavazzini, G., Fluorouracil and dose-dense chemotherapy in adjuvant treatment of patients with early-stage breast cancer: an open-label, 2 × 2 factorial, randomised phase 3 trial (2015) Lancet, 385, pp. 1863-1872; Lambertini, M., Bruzzi, P., Poggio, F., Pastorino, S., Gardin, G., Clavarezza, M., Pegfilgrastim administration after 24 or 72 or 96 h to allow dose-dense anthracycline- and taxane-based chemotherapy in breast cancer patients: a single-center experience within the GIM2 randomized phase III trial (2016) Support Care Cancer Off J Multinatl Assoc Support Care Cancer, 24, pp. 1285-1294; Lambertini, M., Poggio, F., Bruzzone, M., Conte, B., Bighin, C., de Azambuja, E., Dose-dense adjuvant chemotherapy in HER2-positive early breast cancer patients before and after the introduction of trastuzumab: exploratory analysis of the GIM2 trial (2019) Int J Cancer; Liu, S., Chapman, J.-A.W., Burnell, M.J., Levine, M.N., Pritchard, K.I., Whelan, T.J., Prognostic and predictive investigation of PAM50 intrinsic subtypes in the NCIC CTG MA.21 phase III chemotherapy trial (2015) Breast Cancer Res Treat, 149, pp. 439-448; Liu, M.C., Pitcher, B.N., Mardis, E.R., Davies, S.R., Friedman, P.N., Snider, J.E., PAM50 gene signatures and breast cancer prognosis with adjuvant anthracycline- and taxane-based chemotherapy: correlative analysis of C9741 (Alliance) (2016) Npj Breast Cancer, 2; Colleoni, M., Sun, Z., Price, K.N., Karlsson, P., Forbes, J.F., Thürlimann, B., Annual hazard rates of recurrence for breast cancer during 24 years of follow-up: results from the International Breast Cancer Study Group Trials I to V (2016) J Clin Oncol Off J Am Soc Clin Oncol, 34, pp. 927-935; Schwentner, L., Wöckel, A., König, J., Janni, W., Blettner, M., Kreienberg, R., Assessing the impact of CMF-like/anthracycline-based/anthracycline-taxane-based/dose-dense chemotherapy in dependency of positive axillary lymph nodes/hormone receptor-status/grading/T-stage on survival – a retrospective multi-centre cohort study of 3677 patients receiving adjuvant chemotherapy (2014) Eur J Cancer, 50, pp. 2905-2915; Polley, M.-Y.C., Leung, S.C.Y., McShane, L.M., Gao, D., Hugh, J.C., Mastropasqua, M.G., An International Ki67 reproducibility study (2013) JNCI J Natl Cancer Inst, 105, pp. 1897-1906
PY - 2020
Y1 - 2020
N2 - Background: Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes. Methods: Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 <20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR <20%. Results: Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4–84.5) and 70.5% (66.5–74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2–94.1) and 85.1% (81.7–87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54–0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40–0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59–1.33]; unadjusted HR for OS 0.83 [95% CI 0.45–1.54]). Conclusions: No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule. © 2020 Elsevier Ltd
AB - Background: Luminal A-like and luminal B-like subtypes have different sensitivity to (neo)adjuvant chemotherapy, but their role in predicting dose-dense (DD) efficacy in the high-risk setting is unknown. In this exploratory analysis of the Gruppo Italiano Mammella 2 (GIM2) trial, we investigated DD efficacy according to luminal-like subtypes. Methods: Patients with node-positive early breast cancer were randomised to receive either DD or standard-interval (SI) anthracycline-based chemotherapy followed by paclitaxel. In our analysis, luminal A-like cohort was identified as having a Ki67 <20% and a progesterone receptor (PgR) ≥ 20%; luminal B-like cohort as having a Ki67 ≥ 20% and/or a PgR <20%. Results: Out of 2003 patients enrolled in the GIM2 trial, 412 had luminal A-like and 638 luminal B-like breast cancer. After a median follow-up of 7.9 years, disease-free survival (DFS) was 80.8% (95% confidence interval [CI] 76.4–84.5) and 70.5% (66.5–74.2) in luminal A-like and luminal B-like cohorts; overall survival (OS) was 91.6% (88.2–94.1) and 85.1% (81.7–87.9), respectively. We found no significant interaction between treatment and luminal subtype (interaction p = 0.603 and 0.535 for DFS and OS, respectively). When DD efficacy was investigated separately in each cohort, luminal-B like cohort appeared to benefit more from the DD schedule both in terms of DFS (unadjusted hazard ratio [HR] 0.72 [95% CI 0.54–0.96]) and OS (unadjusted HR 0.61 [95% CI 0.40–0.94]), compared with the luminal A-like cohort (unadjusted HR for DFS 0.89 [95% CI 0.59–1.33]; unadjusted HR for OS 0.83 [95% CI 0.45–1.54]). Conclusions: No significant interaction between luminal-like subtype and treatment was observed. Patients in the luminal B-like cohort seemed to benefit more from DD schedule. © 2020 Elsevier Ltd
KW - Breast cancer
KW - Dose-dense chemotherapy
KW - Hormone receptor-positive
KW - Luminal subtype
KW - cyclophosphamide
KW - epirubicin
KW - fluorouracil
KW - Ki 67 antigen
KW - paclitaxel
KW - pegfilgrastim
KW - progesterone receptor
KW - antineoplastic agent
KW - epidermal growth factor receptor 2
KW - estrogen receptor
KW - adjuvant therapy
KW - adult
KW - age
KW - aged
KW - Article
KW - cancer adjuvant therapy
KW - cancer free survival
KW - cancer grading
KW - cancer recurrence
KW - controlled study
KW - disease free survival
KW - dosage schedule comparison
KW - dose densification
KW - early cancer
KW - female
KW - follow up
KW - human
KW - human epidermal growth factor receptor 2 negative breast cancer
KW - human epidermal growth factor receptor 2 positive breast cancer
KW - immunohistochemistry
KW - luminal A breast cancer
KW - luminal B breast cancer
KW - major clinical study
KW - multiple cycle treatment
KW - overall survival
KW - priority journal
KW - randomized controlled trial
KW - recurrence risk
KW - adjuvant chemotherapy
KW - breast tumor
KW - cancer staging
KW - clinical trial
KW - cohort analysis
KW - disease exacerbation
KW - dose response
KW - metabolism
KW - middle aged
KW - mortality
KW - multicenter study
KW - pathology
KW - phase 3 clinical trial
KW - phenotype
KW - prognosis
KW - survival analysis
KW - very elderly
KW - Adult
KW - Aged
KW - Aged, 80 and over
KW - Antineoplastic Combined Chemotherapy Protocols
KW - Breast Neoplasms
KW - Chemotherapy, Adjuvant
KW - Cohort Studies
KW - Disease Progression
KW - Dose-Response Relationship, Drug
KW - Female
KW - Humans
KW - Immunohistochemistry
KW - Middle Aged
KW - Neoplasm Staging
KW - Phenotype
KW - Prognosis
KW - Receptor, ErbB-2
KW - Receptors, Estrogen
KW - Receptors, Progesterone
KW - Survival Analysis
U2 - 10.1016/j.ejca.2020.05.007
DO - 10.1016/j.ejca.2020.05.007
M3 - Article
VL - 136
SP - 43
EP - 51
JO - Eur. J. Cancer
JF - Eur. J. Cancer
SN - 0959-8049
ER -