Ardizzoni, A.

Barni, S.

Bisagni, G.

Bruzzi, P.

Cavazzini, G.

Ceppi, M.

Cognetti, F.

Colantuoni, G.

De Laurentiis, M.

De Placido, S.

Del Mastro, L.

Durando, A.

Gamucci, T.

Gerratana, L.

Montemurro, F.

Puglisi, F.

Turletti, A.

Valle, E.

Annals of Oncology

English

F. Puglisi

M. Ceppi

L. Gerratana

F. Cognetti

S. De Placido

P. Bruzzi

M. De Laurentiis

G. Bisagni

G. Cavazzini

A. Durando

A. Turletti

E. Valle

F. Montemurro

S. Barni

A. Ardizzoni

G. Colantuoni

T. Gamucci

L. Del Mastro

Crossref

Composite index of risk shows that benefit from adjuvant dose dense chemotherapy is not confined to triple negative breast cancer

Open Access Repository

5% to 76% across arms with an average BCS of 57% (95% CI 52%-62%). Significantheterogeneity was observed among the trials (Cochrane Q¼ 787, p< 0.001, I2¼ 97%).In the meta-regression model, BCS rates were not significantly associated with year offirst patient-in (p¼ 0.89), grade (p¼ 0.93), hormone-receptor status (p¼ 0.39).Clinical N-stage (p¼ 0.01) and HER2 status (p¼ 0.03) were significantly associatedwith BCS. pCR rate ranged from 3% to 60% across studies. The average pCR across allstudy arms was 24% (95% CI 19%-29%). No association was observed between pCRrate in a study arm and the resulting BCS rate in a univariate model (p¼ 0.34) nor afteradjusting for HER2 and clinical nodal status (p¼ 0.82). Change in BCS with NT wasfurther derived from the subset of 14 multi-arm trials, where 17 pairwise contrasts weremade between randomized populations: 2 studies showed a significant difference inBCS. The difference in pCR rates between treatment arms ranged from -22% to 24%.However, no significant association is seen with the corresponding difference in BCSrates (p¼ 0.27).Conclusions: This meta-analysis indicates that, despite increasing pCR, there is no con-comitant increase in BCS. Future NT studies should reconsider using BCS as anendpoint.Legal entity responsible for the study: Carmen CriscitielloFunding: NoneDisclosure: All authors have declared no conflicts of interest.171P Composite index of risk shows that benefit from adjuvant dose densechemotherapy is not confined to triple negative breast cancerF. Puglisi1, M. Ceppi2, L. Gerratana1, F. Cognetti3, S. De Placido4, P. Bruzzi2, M. DeLaurentiis5, G. Bisagni6, G. Cavazzini7, A. Durando8, A. Turletti9, E. Valle10,F. Montemurro11, S. Barni12, A. Ardizzoni13, G. Colantuoni14, T. Gamucci15, L. DelMastro161Department of Medicine, University of Udine, School of Medical Oncology, Udine, Italy,2Clinical Epidemiology, IRCCS AOU San Martino - IST-Istituto Nazionale per la Ricercasul Cancro, Genoa, Italy, 3Medical Oncology Unit, IFO Regina Elena, Rome, Italy,4Medical Oncology Unit, Federico II Hospital, Naples, Italy, 5Medical Oncology, IRCCSFondazione Pascale, Naples, Italy, 6Medical Oncology, Azienda Ospedaliera ArcispedaleSanta Maria Nuova - IRCCS, Reggio Emilia, Italy, 7Medical Oncology, AziendaOspedaliera Ospedale Carlo Poma, Mantova, Italy, 8Breast Unit, Azienda OspedalieraUniversitaria Citta della Salute e delle Scienze, Turin, Italy, 9Medical Oncology, AOU S.Giovanni Battista - Molinette, Turin, Italy, 10Medical Oncology, Ospedale Oncologico A.Businco, Cagliari, Italy, 11Medical Oncology, IRCCS Istituto di Candiolo, Candiolo, Italy,12Medical Oncology, Azienda Ospedaliera Treviglio-Caravaggio, Treviglio, Italy,13Medical Oncology Unit, University Hospital Sant’Orsola, Bologna, Italy, 14Breast Unit,A.O.R.N. San Giuseppe Moscati, Avellino, Italy, 15Medical Oncology, Ospedale SS Trinita,Sora, Italy, 16Medical Oncology, IRCCS AOU San Martino - IST-Istituto Nazionale per laRicerca sul Cancro, Genoa, ItalyBackground: Compared with the standard interval adjuvant chemotherapy, dose-dense schedule is proved to increase disease-free survival (DFS) in node-positive earlybreast cancer (EBC) patients (pts). To date, GIM2 is the only trial supporting the roleof dose-dense chemotherapy in pts with hormone receptor-negative (HR-) or hormonereceptor-positive tumours (HRþ) (Del Mastro et al. Lancet 2015). To further refine theevidence of treatment effect in the HRþ subgroup, a composite index of risk was de-veloped including clinico-pathological features.Methods: The randomized phase III GIM2 trial enrolled 2091 pts with node-positiveEBC (primary endpoint: DFS). A continuous, composite measure of treatment benefitwas determined from a Cox model incorporating potential predictive factors (age: 25-40/41-55/56-71; histological grade: 1þ 2/3; HR status: positive/negative; ki-67 levels:20%/>20%). Subpopulation treatment effect pattern plot methodology was used toreveal differential treatment effects on DFS according to composite index. The studyanalyzed the cohort of pts with HER2- (N¼ 1127) disease with a special focus on HRþdisease (N¼ 980).Results: On average, the magnitude of benefit with dose dense chemotherapy versusstandard chemotherapy widely varied according to composite measure of specific fea-tures. In the HER2- subgroup, the highest benefit was observed in pts with G3, HR-,>10 positive nodes, age<40 yrs, ki-67> 20% (hazard ratio for DFS 0.57, 95% CI 0.35-0.94). Notably, among pts with HRþ disease, the following clinic-pathological charac-teristics conferred the highest benefit: G3,4 positive nodes, age56 yrs, ki-67> 20%(hazard ratio for DFS 0.66, 95% CI 0.38-1.15).Conclusions: Composite risk evaluation and corresponding subpopulation treatmenteffect pattern plot methodology suggest that benefit of dose dense adjuvant chemother-apy is not confined to triple negative EBC.Legal entity responsible for the study: Gruppo Italiano MammellaFunding: NoneDisclosure: All authors have declared no conflicts of interest.172P The prognostic impact of chemotherapy induced amenorrhea inwomen treated with early stage breast cancerC. Ordu1, K.N. Pilancı2, F. Elbüken3, G. Alço4, €U._I. Köksal5, S. _Ilgün6, D. Sarsenov7,A.E. Aydın7, A. €Oztürk8, Z._I. Erdogan9, F. Agaçayak10, C. Tecimer5, Y. Eralp11, F. Aktepe12,V. €Ozmen131Medical Oncology, Gayrettepe FNG Hospital, Istanbul, Turkey, 2Medical Oncology,Haseki State Hospital, Istanbul, Turkey, 3Radiology, Gayrettepe FNG Hospital, Istanbul,Turkey, 4Radiation Oncology, Gayrettepe FNG Hospital, Istanbul, Turkey, 5MedicalOncology, Istanbul Bilim University, Istanbul, Turkey, 6Surgical oncology, Taksim statehospital, Istanbul, Turkey, 7Surgical oncology, _Istanbul FNG Hospital, Istanbul, Turkey,8Surgical Oncology, Biruni University, Istanbul, Turkey, 9Physical Therapy Specialist,Istanbul Bilim University, Istanbul, Turkey, 10Radiology, _Istanbul FNG Hospital, Istanbul,Turkey, 11Medical Oncology, Istanbul University, Istanbul, Turkey, 12Pathology,Gayrettepe FNG Hospital, Istanbul, Turkey, 13Surgical Oncology, Istanbul University,Istanbul, TurkeyBackground: In this study; Amenorrhea caused by chemotherapy in early stage breastcancer patients and its effects on survival were investigated.Methods: A total of 389 patients who received adjuvant chemotherapy from 600 pre-menopausal patients who were treated with early stage breast cancer during 2000-2013and followed up were included in the study. Patients who did not undergo medicalovarian ablation (OA); Amenore as developing and non-developing, two groups wereseparated and compared with clinicopathologic features and survival. SPSS 17. versionwas used.Results: Disease-free survival (DFS): median (m) 57 months (4-197 months), overallsurvival (OS): m 60 (10-168 months) and follow up time m 60 months (23-168months). During follow-up, chemotherapy induced amenorrhea (CIA) was observedin 145 (57.5%) of 252 patients who did not have any ovarian ablation (OA. The 5-yearOS rate of patients with CIA was significantly higher than the patients without CIA(p¼ 0.042, 95.9% vs 89.7 vs 158.88 vs 135.33 months, respectively). In the subgroupanalysis, the OS in patients with CIA was significantly higher than in those without CIAin patients had HR (þ) (p¼ 0.036, 97.5% vs 91.5 vs 162.13 vs. 136.20 months, respect-ively). There was no significant difference in the duration of OS between with CIA andwithout CIA of the patients who had not HR (þ) (p¼ 0.736, 90.9% vs 86.8% and126.16 and 133.76 months, respectively). The duration of OS was significantly longer inpatients with CIA in the luminal A molecular subtype than in those luminal B molecu-lar subtype, but the difference was not significant in patients without CIA (p¼ 0.027 vsp¼ 0.074 respectively).Conclusions: The development of amenorrhea due to chemotherapy provides a signifi-cant survival advantage over those patients who do not develop amenorrhea due tochemotherapy. This advantage is more pronounced in hormone receptor positive,lymph node involvement and advanced disease. The development of amenorrhea dueto chemotherapy in patients with HR negative does not affect survival. Amenorrhea de-velopment further prolongs survival compared to luminal B in the luminal A molecularsubtype.Legal entity responsible for the study: Istanbul Bilim University, Florence NightingaleGroup of HospitalsFunding: NoneDisclosure: All authors have declared no conflicts of interest.173P Determinants and outcomes associated with delays in adjuvantchemotherapy among breast cancer patientsM. Chavez Mac Gregor1, X. Lei2, H. Zhao2, S.H. Giordano11Breast Medical Oncology, Health Services Research, The University of Texas MDAnderson Cancer Center, Houston, TX, USA, 2Health Services Research, The University ofTexas MD Anderson Cancer Center, Houston, TX, USABackground: Adverse outcomes have been associated with delays in the administrationof adjuvant chemotherapy among breast cancer patients. We evaluate the determinantsand outcomes associated with delays in time to chemotherapy (TTC) in a large cohortof older breast cancer patients.Methods: We used the NCI-Surveillance Epidemiology and End Results (SEER) andTexas Cancer Registry (TCR)-Medicare linked data bases to identify patients66 yearsold diagnosed with localized or regional breast cancer between 2001-2011. All patientsreceived chemotherapy within 9 months of surgery. Delayed TTC was defined as> 90days. Multivariable logistic regression was used to identify predictors of treatmentdelay. A Cox Proportional Hazards model was fit to determine the association betweentreatment delay, overall survival (OS) and breast cancer specific survival (BCSS).Results: 25,096 patients were included, of them 2,676 (10.7%) had a TTC>90 days. Inmultivariable analysis factors associated with delays in TTC were: recent year of diagno-sis (2011 vs 2001 OR¼ 1.31; 95%CI 1.03-1.67), older age (76-80 vs 66-70 OR¼ 1.51;95%CI 1.33-1.72), black race (OR¼ 1.35; 95%CI 1.14-1.58), having state buy-in (as anindicator of poverty) (OR¼ 1.27; 95%CI 1.1-1.47), comorbidities (Charlson score 1OR¼ 1.23;95%CI 1.09-1.37; score 2 OR¼ 1.57; 95%CI 1.37-1.81), mastectomy(OR¼ 1.49; 95%CI 1.33-1.67), mastectomy with immediate reconstruction(OR¼ 1.85; 95%CI 1.37-2.48), Oncotype DX testing (OR¼ 1.68; 95%CI 1.4-2.02),mastectomy>30 days after the initial surgery (OR¼ 16.91; 95%CI 12.07-23.68),brachytherapy (OR¼ 4.11; 95%CI 3.17-5.34) and whole breast radiation prior toAnnals of Oncology abstractsVolume 28 | Supplement 5 | September 2017 doi:10.1093/annonc/mdx362 | 51Downloaded from https://academic.oup.com/annonc/article-abstract/28/suppl_5/mdx362.021/4108338by gueston 30 July 2018

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Composite index of risk shows that benefit from adjuvant dose dense chemotherapy is not confined to triple negative breast cancer

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