Abstract 109P
Background
The majority of breast cancers occur in women over the age of 65, but older breast cancer patients are largely underrepresented in clinical trials. We investigated the effect of adding capecitabine to adjuvant treatment with ibandronate in elderly breast cancer patients.
Methods
The multicenter phase III ICE trial enrolled women ≥65 years with early node-positive/high-risk node-negative breast cancer and a Charlson Comorbidity Index (CCI) ≤2. Patients were randomized to capecitabine 2000 mg/m2 day 1-14 q3w for 6 cycles plus ibandronate (50 mg p.o. daily or alternatively 6 mg i.v. q4w) or ibandronate alone for 2 years. We present here an update on long-term follow-up for the secondary endpoint of overall survival (OS).
Results
1358 (96.4%) from 1409 randomized patients started treatment. 564 (83.4%) completed 6 cycles of capecitabine. 513 (77.7%) and 516 (78.8%) completed ibandronate in the capecitabine/ibandronate and ibandronate arm, respectively. Median age was 71 (range 64-88) years, 1099 (81%) were hormone receptor (HR)-positive, 705 (51.9%) node-negative, 794 (58.5%) had a CCI of 0. HR-positive patients received additional adjuvant endocrine treatment. After an updated median follow-up time of 74 (IQR 56-126) months for OS in the entire cohort, 7-year OS was 83.5% for capecitabine/ibandronate versus 80.9% for ibandronate, and 10-year OS was 73.1% for capecitabine/ibandronate versus 70.8% for ibandronate (P=0.413). Lack of effect was independent from age, nodal and HR status. Addition of capecitabine caused significantly higher skin and gastrointestinal toxicities.
Conclusions
The adjuvant combination of capecitabine and ibandronate did not show significantly better OS than ibandronate alone in elderly breast cancer patients.
Clinical trial identification
Trial Registration: NCT 00196856.
Legal entity responsible for the study
The authors.
Funding
Roche and AstraZeneca.
Disclosure
E. Stickeler: Financial Interests, Institutional, Other, Consulting Fees: AstraZeneca, MSD, Roche, Gilead; Financial Interests, Institutional, Speaker’s Bureau: Roche, MSD, Gilead, Novartis, Seagen, PierreFabre, Onkowissen; Financial Interests, Institutional, Other, Travel support: Novartis, MSD; Financial Interests, Institutional, Advisory Board: iOMEDICO, AstraZeneca. J. Huober: Financial Interests, Institutional, Research Grant: Novartis, Lilly; Financial Interests, Personal, Other, Consulting Fees: Lilly, Novartis, Roche, Pfizer, Hexal, AstraZeneco, MSD, Celgene, AbbVie, Daiichi; Financial Interests, Personal, Other, Cinsulting Fees: Gilead; Financial Interests, Personal, Speaker’s Bureau: Lilly, Novartis, Roche, Pfizer, AstraZeneca, MSD, Celgene, Eisai, AbbVie, Seagen, Gilead, Daiichi; Financial Interests, Personal, Other, Travel support: Roche, Pfizer, Novartis, Celgene, Daiichi, Gilead. C. Jackisch: Financial Interests, Personal, Speaker’s Bureau: Roche, Novartis; Financial Interests, Personal, Other, Travel support: Roche. V. Nekljudova: Financial Interests, Institutional, Research Grant: AbbVie, AstraZeneca, BMS, Daiichi Sankyo, Gilead, Novartis, Pfizer, Roche; Non-Financial Interests, Institutional, Other: Daiichi Sankyo, Gilead, Novartis, Pfizer, Roche, Seagen; Other, Institutional, Other, EP14153692.0: Patent; Other, Institutional, Other, EP21152186.9: Patent; Other, Institutional, Other, EP15702464.7: Patent; Other, Institutional, Other, EP19808852.8: Patent; Other, Institutional, Royalties: VM Scope GmbH; Other, Institutional, Full or part-time Employment: GBG GmbH. S. Loibl: Financial Interests, Institutional, Advisory Board, Member: Amgen, AstraZeneca, BMS, Celgene, EirGenix, GSK, Lilly, Pierre Fabre, Roche, Seagen, AbbVie, Sanofi, Gilead, Merck, Novartis, Relay Therapeutics; Financial Interests, Institutional, Invited Speaker: AstraZeneca, DSI, Novartis, Pfizer, Roche, Gilead, Seagen; Financial Interests, Institutional, Advisory Board: DSI, Pfizer, Olema; Financial Interests, Personal, Invited Speaker: Medscape; Financial Interests, Personal, Full or part-time Employment, CEO: GBG Forschungs GmbH; Financial Interests, Institutional, Invited Speaker, Ki67: VM Scope GmbH; Financial Interests, Institutional, Research Grant: AstraZeneca, Celgene, Novartis, Immunomedics/Gilead, Pfizer, Roche, Daiichi Sankyo; Financial Interests, Institutional, Funding: AbbVie, Molecular Health; Financial Interests, Personal, Other, PIPenelope/Padma: Pfizer; Financial Interests, Personal, Other, SC PALOMA3: Pfizer; Financial Interests, Personal, Other, SC SOLAR1: Novartis; Financial Interests, Personal, Other, SC ASCENT: Immunomedics/Gilead; Financial Interests, Personal, Other, SC HERCLIMB: Seagen; Financial Interests, Personal, Other, SC Katherine: Roche; Financial Interests, Personal, Other, SC Capitello; EC Cambria 1: AstraZeneca; Financial Interests, Personal, Other, SC Inavo: Roche; Financial Interests, Personal, Other, SC Destiny B05; SC Destiny B09: Daiichi Sankyo; Non-Financial Interests, Principal Investigator, After publication of primary endpoint: PI Aphinity; Non-Financial Interests, Advisory Role, Group in Germany responsible for breast cancer guidelines: AGO Kommission Mamma; Non-Financial Interests, Member, German Gynaecological Oncology society: AGO; Non-Financial Interests, Member, German Cancer Society: DKG; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Member, Member guideline committee; past chair in ESMO Breast: ESMO; Other, EP14153692.0No financial interest, Institutional: Patent; Other, EP21152186.9No financial interest, institutional: Patent; Other, EP15702464.7No financial interest, institutional: Patent; Other, EP19808852.8 No financial interest, Institutional: Patent. All other authors have declared no conflicts of interest.