Matteo Lambertini1, Marcello Ceppi2, Francesco Cognetti3, Giovanna Cavazzini4, Michele De Laurentiis5, Sabino De Placido6, Andrea Michelotti7, Giancarlo Bisagni8, Antonio Durando9, Enrichetta Valle10, Tiziana Scotto11, Andrea De Censi12, Anna Turletti13, Marco Benasso14, Sandro Barni15, Filippo Montemurro16, Fabio Puglisi17, Alessia Levaggi18, Sara Giraudi19, Claudia Bighin20, Paolo Bruzzi21, Lucia Del Mastro22. 1. Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy; Department of Medicine, BrEAST Data Centre, Institut Jules Bordet and l'Université Libre de Bruxelles (U.L.B.), Brussels, Belgium. Electronic address: matteo.lambertini85@gmail.com. 2. Epidemiology Unit, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: marcello.ceppi@hsanmartino.it. 3. Department of Medical Oncology, Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italy. Electronic address: cognetti@ifo.it. 4. Medical Oncology, Azienda Ospedaliera Carlo Poma, Mantova, Italy. Electronic address: mariagiovanna.cavazzini@aopoma.it. 5. Medical Oncology, Istituto Nazionale Tumori-IRCCS Fondazione Pascale, Napoli, Italy. Electronic address: delauren@unina.it. 6. Medical Oncology, Azienda Ospedaliera Universitaria Federico II, Napoli, Italy. Electronic address: deplacid@unina.it. 7. UO Oncologia Medica I, Ospedale S. Chiara, Dipartimento di oncologia, dei trapianti e delle nuove tecnologie, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy. Electronic address: a.michelotti@ao-pisa.toscana.it. 8. Medical Oncology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia, Italy. Electronic address: bisagni.giancarlo@asmn.re.it. 9. Breast Unit, Azienda Ospedaliera Universitaria Città della Salute e delle Scienze, Torino, Italy. Electronic address: andurando63@gmail.com. 10. Medical Oncology, ASL8-Ospedale Oncologico A. Businco, Cagliari, Italy. Electronic address: enrichettavalle@asl8cagliari.it. 11. U.O. Oncologia Medica, Ospedale Civile, Sassari, Italy. Electronic address: scotto.tiziana@libero.it. 12. S.C. Oncologia Medica, Medical Oncology Unit, E.O. Ospedali Galliera, Genova, Italy. Electronic address: andrea.decensi@galliera.it. 13. Medical Oncology, ASLTO1, Torino, Italy. Electronic address: annaturletti@virgilio.it. 14. Medical Oncology, Ospedale San Paolo, Savona, Italy. Electronic address: m.benasso@asl2.liguria.it. 15. Medical Oncology, Azienda Ospedaliera, Caravaggio, Treviglio, Bergamo, Italy. Electronic address: sandro.barni@ospedale.treviglio.bg.it. 16. Investigative Clinical Oncology, Fondazione del Piemonte per l'Oncologia/Candiolo Cancer Center (IRCCS), Candiolo, Torino, Italy. Electronic address: filippo.montemurro@ircc.it. 17. Department of Oncology, Azienda Ospedaliera di Udine, Udine, Italy. Electronic address: fabio.puglisi@uniud.it. 18. Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: alessia.levaggi@hsanmartino.it. 19. Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: sara.giraudi@hsanmartino.it. 20. Department of Medical Oncology, U.O. Oncologia Medica 2, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: claudia.bighin@hsanmartino.it. 21. Epidemiology Unit, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: paolo.bruzzi@hsanmartino.it. 22. Department of Medical Oncology, U.O. Sviluppo Terapie Innovative, IRCCS AOU San Martino - IST, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy. Electronic address: lucia.delmastro@hsanmartino.it.
Abstract
BACKGROUND: No evidence exists to recommend a specific chemotherapy regimen in young breast cancer patients. We performed a pooled analysis of two randomised clinical trials to evaluate the efficacy of adjuvant dose-dense chemotherapy in premenopausal breast cancer patients and its impact on the risk of treatment-induced amenorrhoea. PATIENTS AND METHODS: In the MIG1 study, node-positive or high-risk node-negative patients were randomised to 6 cycles of fluorouracil/epirubicin/cyclophosphamide every 2 (dose-dense) or 3 (standard-interval) weeks. In the GIM2 study, node-positive patients were randomised to 4 cycles of dose-dense or standard-interval EC or FEC followed by 4 cycles of dose-dense or standard-interval paclitaxel. Using individual patient data, the hazard ratio (HR) for overall survival by means of a Cox proportional hazards model and the odds ratio for treatment-induced amenorrhoea through a logistic regression model were calculated for each study. A meta-analysis of the two studies was performed using the random effect model to compute the parameter estimates. RESULTS:A total of 1,549 patients were included. Dose-dense chemotherapy was associated with a significant improved overall survival as compared to standard-interval chemotherapy (HR, 0.71; 95% confidence intervals [CI], 0.54-0.95; p = 0.021). The pooled HRs were 0.78 (95% CI, 0.54-1.12) and 0.65 (95% CI, 0.40-1.06) for patients with hormone receptor-positive and -negative tumours, respectively (interaction p = 0.330). No increased risk of treatment-induced amenorrhoea was observed with dose-dense chemotherapy (odds ratio, 1.00; 95% CI, 0.80-1.25; p = 0.989). CONCLUSION:Dose-dense adjuvant chemotherapy may be considered the preferred treatment option in high-risk premenopausal breast cancer patients.
RCT Entities:
BACKGROUND: No evidence exists to recommend a specific chemotherapy regimen in young breast cancerpatients. We performed a pooled analysis of two randomised clinical trials to evaluate the efficacy of adjuvant dose-dense chemotherapy in premenopausal breast cancerpatients and its impact on the risk of treatment-induced amenorrhoea. PATIENTS AND METHODS: In the MIG1 study, node-positive or high-risk node-negative patients were randomised to 6 cycles of fluorouracil/epirubicin/cyclophosphamide every 2 (dose-dense) or 3 (standard-interval) weeks. In the GIM2 study, node-positive patients were randomised to 4 cycles of dose-dense or standard-interval EC or FEC followed by 4 cycles of dose-dense or standard-interval paclitaxel. Using individual patient data, the hazard ratio (HR) for overall survival by means of a Cox proportional hazards model and the odds ratio for treatment-induced amenorrhoea through a logistic regression model were calculated for each study. A meta-analysis of the two studies was performed using the random effect model to compute the parameter estimates. RESULTS: A total of 1,549 patients were included. Dose-dense chemotherapy was associated with a significant improved overall survival as compared to standard-interval chemotherapy (HR, 0.71; 95% confidence intervals [CI], 0.54-0.95; p = 0.021). The pooled HRs were 0.78 (95% CI, 0.54-1.12) and 0.65 (95% CI, 0.40-1.06) for patients with hormone receptor-positive and -negative tumours, respectively (interaction p = 0.330). No increased risk of treatment-induced amenorrhoea was observed with dose-dense chemotherapy (odds ratio, 1.00; 95% CI, 0.80-1.25; p = 0.989). CONCLUSION: Dose-dense adjuvant chemotherapy may be considered the preferred treatment option in high-risk premenopausal breast cancerpatients.
Authors: Tessa G Steenbruggen; Mette S van Ramshorst; Marleen Kok; Sabine C Linn; Carolien H Smorenburg; Gabe S Sonke Journal: Drugs Date: 2017-08 Impact factor: 9.546
Authors: Valentino Martelli; Maria Maddalena Latocca; Tommaso Ruelle; Marta Perachino; Luca Arecco; Kristi Beshiri; Maria Grazia Razeti; Marco Tagliamento; Maurizio Cosso; Piero Fregatti; Matteo Lambertini Journal: Breast Cancer (Dove Med Press) Date: 2021-05-24