36MO - Patient-reported outcomes in primary advanced or recurrent endometrial carcinoma treated with atezolizumab or placebo in combination with carboplatin-paclitaxel in the AtTEnd/ENGOT-EN7 trial

Background

The AtTEnd trial showed that adding atezolizumab (atezo) to carboplatin-paclitaxel chemotherapy (CP) improved progression free survival (PFS) in patients (pts) with advanced/recurrent endometrial carcinomas (EC), especially those with mismatch repair deficient tumours. Here we report the patient-reported outcomes (PROs).

Methods

Pts were randomized (2:1) to receive CP plus atezo (N=360) or placebo (N=189), followed by maintenance atezo or placebo until disease progression. EORTC QLQ-C30, QLQ-EN24 and EQ-5D-5L questionnaires were analysed at baseline (BL), cycle 6 (C6) of treatment phase, and cycle 8 (M8) of maintenance phase. Mixed models were used to analyze score trends over time, with individual pts treated as random effects to account for intra-patient variability, and trial treatment and baseline values treated as fixed effects.

Results

PROs completed were evaluable for 89% pts (atezo arm, N=323; placebo arm, N=170). Although no statistically differences were detected, global health status scores decreased at C6 but improved by M8 above BL in atezo arm, remaining lower than BL in placebo arm (Table). At C6, pts reported lower scores in most functional scales except for emotional functioning. By M8, all functional scales showed improvement, with social functioning increased above BL in both arms and role functioning increased above BL in atezo arm only. No differences in symptom scales were reported between two arms, except for back/pelvic pain score where a significant reduction in severity from BL was observed in favour of atezo vs placebo arm (p=0.023). Mean scores on the EQ-5D-5L were similar at all time points in both arms.Table: 36MO

Numbers are mean (SD), *lower scores indicate reduced symptom severity.

Conclusions

Quality of life was maintained over time in both arms, even if an initially reduction could not be excluded. Coupled with the significantly improved PFS, these findings support the use of CP plus atezo in advanced/recurrent EC.

Clinical trial identification

NCT03603184; EudraCT 2018-001072-37.

Legal entity responsible for the study

Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Via Mario Negri 2, Milan.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

Y.C. Lee: Financial Interests, Institutional, Funding: BeiGene. N. Colombo: Financial Interests, Personal, Advisory Board, Various: Roche, AstraZeneca, MSD/Merck, Clovis Oncology, GSK, Immunogen, Mersana; Financial Interests, Personal, Invited Speaker, Congress, Symposia, Lectures: AstraZeneca; Financial Interests, Personal, Advisory Board, Lectures: Eisai; Financial Interests, Personal, Advisory Board, Advisory role: Nuvation Bio, Pieris; Financial Interests, Personal, Advisory Board, Advisory Role: Onxerna; Financial Interests, Personal, Invited Speaker: MSD/MERCK; Financial Interests, Personal, Invited Speaker, Speaker: GSK; Financial Interests, Institutional, Research Grant: AstraZeneca, Roche, GSK; Non-Financial Interests, Personal, Other, Steering Committee, member Clinical Guidelines: ESMO; Non-Financial Interests, Personal, Leadership Role, Chair, Scientific Committee: ACTO (Alleanza contro il tumore ovarico). K. Harano: Financial Interests, Personal, Invited Speaker: AstraZeneca, MSD, Takeda; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, Chugai, Takeda; Financial Interests, Institutional, Research Grant: Merck, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: MSD, Daiichi Sankyo, Takeda; Non-Financial Interests, Personal, Principal Investigator: Merck, Chugai. E. Hudson: Financial Interests, Personal, Advisory Board: GSK, Clovis, Roche. I. Braicu: Financial Interests, Personal, Advisory Board: GSK; Financial Interests, Personal and Institutional, Advisory Board, Insitution, AdBoard: MSD; Financial Interests, Personal and Institutional, Other, Institution, travel, AdBoard, Talks: AstraZeneca; Financial Interests, Institutional, Research Grant: Roche Diagnostic, Incyte, Roche, Bayer, Clovis, Resolve; Financial Interests, Personal, Other, Medical Director NOGGO: North Eastern German Society of Gynecological Oncology (NOGGO). E. Petru: Financial Interests, Personal, Advisory Board, Lecture fees: GSK, Merck, Roche. A. Redondo: Financial Interests, Personal, Invited Speaker: MSD, AstraZeneca, GSK, PharmaMar, Pharma&; Financial Interests, Personal, Advisory Board: MSD, AstraZeneca, GSK, PharmaMar, Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Roche, Eisai, PharmaMar. K. Takehara: Financial Interests, Personal, Speaker’s Bureau: Takeda, AstraZeneca, Chugai Pharma, MSD, Eisai, Mochida Pharma, Nippon Kayaku, Zeria Pharma, Sanofi, Kracie Pharma, Ethicon/ Johnson & Johnson, Terumo, Tsumura & co. Y. Antill: Non-Financial Interests, Personal, Advisory Board, Financially Compensated role: AstraZeneca; Non-Financial Interests, Personal, Advisory Board, Financially compensated role: Eisai; Non-Financial Interests, Personal, Advisory Board, Financially Compensated role: MSD, GSK. G. Tasca: Financial Interests, Personal, Advisory Board: GSK, MSD, Eisai; Financial Interests, Personal, Invited Speaker: GSK, AstraZeneca, GSK; Non-Financial Interests, Personal, Member, Collaborative Group in Gynecologial Oncology: MaNGO; Other, Personal, Other, Travel Grant: PharmaMar. C. Zamagni: Financial Interests, Personal, Advisory Board: Roche, EISAI, Novartis, AstraZeneca, Pfizer, Eli Lilly, Daiichi Sankyo, Exact Sciences, MSD, GSK, Gilead, Seagen; Financial Interests, Institutional, Invited Speaker: Roche, Novartis, AstraZeneca, Pfizer, Seagen, Medivation, AbbVie, Array BioPharma, Morphotek, Synthon, Daiichi Sankyo, MSD, GSK, Gilead; Financial Interests, Personal, Other, Member of an Independent Data Monitoring Committee for an international clinical trial: AstraZeneca; Non-Financial Interests, Personal, Other, member of the Scientific Committee: LOTO Onlus, Susan J Komen Emilia-Romagna, Mamazone Sudtirol; Other, Personal, Other, travel accommodation and participation expenses for scientific congresses: Roche, Novartis, Pfizer, Daiichi Sankyo, MSD, GSK, Gilead, AstraZeneca. M.P. Barretina Ginesta: Financial Interests, Personal, Advisory Board: AstraZeneca, GSK, MSD, Eisai, PharmaMar; Financial Interests, Personal, Invited Speaker: AstraZeneca, GSK, MSD, Eisai, MSD. All other authors have declared no conflicts of interest.