770P - Tolerability and efficacy of trabectedin plus pegylated liposomal doxorubicin (PLD) in elderly patients with ovarian cancer (OC): GEICO 105-O study

Background

Scarce data have been published for elderly patients (pts) (≥70 years) with OC, who are often underrepresented in clinical trials. Trabectedin (T) plus PLD is approved for relapsed platinum-sensitive OC, and there is a need to gain insights into the safety and efficacy of this scheme in the elderly.

Methods

GEICO conducted a retrospective study with 15 Spanish hospitals, including pts ≥70 years at the start of T+PLD, with relapsed platinum-sensitive high-grade OC (platinum-free interval [PFI] ≥6 months). Pts received at least one cycle of T+PLD according to Summary of Product Characteristics between January 2015 and December 2019. Toxicity, efficacy, dosing, and patient characteristics data were extracted from medical charts.

Results

Forty-three pts with a median of 74 years (70-86) were recruited. The most common FIGO stage at diagnosis was IIIC (51.2%). At baseline, the median PFI was 9 months (81.4% 6-12, 18.6% >12), ECOG 0/1/2 (32.6%, 39.5%, 9.3%), 81.4% of pts had measurable disease, and 76.7% had relevant comorbidities (21.4% hypertension). The median of previous lines was 2 (1-5). The initial dose of T was 1.1 mg/m2 in 81.4% of pts and 79.1% received PLD 30 mg/m2 (reduced initial doses were given due to pts fragility). The median number of T+PLD cycles was 5 (1-21) (46.5% received ≥6 cycles) and 51.2% of pts had delayed infusions. Treatment ended due to personal decision (7.0%), medical decision (23.3%), progression (39.5%), toxicity (23.3%), and other (7.0%). There were no toxic deaths. The main G3-4 adverse reactions were neutropenia (18.6%), asthenia (11.6%), thrombocytopenia (7.0%), mucositis (4.7%), transaminitis (4.7%), and anemia (2.3%). The mPFS was 7.7 months (95% CI 4.4-9.4) with a favorable disease control rate of 72.1% (CR 9.3%, PR 32.6%, SD 30.2% RECIST 1.1). Median OS was 19.5 months (95% CI 12.8-27.2). Seven pts had s/gBRCA1/2 (16.2%) and 13 (30.2%) BRCA unknown. For BRCAmut, T+PLD response was CR 28.6%, PR 42.9%, SD 14.3%, PD 14.3%.

Conclusions

T+PLD is well tolerated by OC pts with 70 years or older. The adverse reactions are comparable to those published for younger pts and efficacy remains beneficial. Albeit in a small sample, a high overall response rate was observed for BRCAmut pts.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Grupo Español de Investigación en Cáncer de Ovario (GEICO).

Funding

PharmaMar.

Disclosure

M.J. Rubio Perez: Financial Interests, Personal, Advisory Role: AstraZeneca, MSD, GSK, Clovis, PharmaMar; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, MSD, GSK, Clovis. A. Manzano Fernández: Financial Interests, Invited Speaker: Sanofi, GSK, Clovis, AstraZeneca, PharmaMar, ROVI, Bayer, Leo Pharma; Financial Interests, Speaker, Consultant, Advisor: GSK, AstraZeneca, Grunenthal; Financial Interests, Other, Travel expenses: GSK, Roche, AstraZeneca, Clovis, MSD; Financial Interests, Research Funding: AstraZeneca. P. Estevez Garcia: Financial Interests, Advisory Role: AstraZeneca, MSD, GSK, Clovis, PharmaMar; Financial Interests, Research Funding: GSK; Financial Interests, Speaker, Consultant, Advisor: AstraZeneca, MSD, GSK, Clovis, PharmaMar. M.D.M. Gordon Santiago: Financial Interests, Advisory Role: PharmaMar. E.M. Guerra Alia: Financial Interests, Speaker, Consultant, Advisor: AstraZeneca-MSD, Clovis Oncology, GSK-Tesaro, PharmaMar, Roche; Financial Interests, Speaker’s Bureau: AstraZeneca-MSD, PharmaMar, Roche, GSK-Tesaro, Clovis; Financial Interests, Other, Travel expenses: Roche, GSK-Tesaro, Baxter. I. Romero: Financial Interests, Research Grant: Roche, AstraZeneca, GSK; Financial Interests, Speaker, Consultant, Advisor: PharmaMar, Roche, AZ, GSK, MSD; Financial Interests, Speaker’s Bureau: PharmaMar, Roche, AZ, GSK, MSD. J. Martinez-Garcia: Financial Interests, Speaker, Consultant, Advisor: AstraZeneca-MSD, GSK-Tesaro, PharmaMar; Financial Interests, Speaker’s Bureau: PharmaMar, GSK-Tesaro; Financial Interests, Other, Travel expenses: PharmaMar, GSK-Tesaro, MSD. A. Gonzalez Martin: Financial Interests, Advisory Role: Alkermes, Amgen, AstraZeneca, Clovis, Genmab, GSK, HederaDx, Immunogen, Illumina, Mersana, MSD, Novartis, Novocure, Oncoinvent, PharmaMar, Roche, SOTIO, SUTRO, Seagen, Takeda, Tubulis, Zailab. All other authors have declared no conflicts of interest.