373P - Quality-of-life outcomes in patients with HER2-positive, locally advanced or metastatic breast cancer treated with eribulin mesylate in combination with trastuzumab and pertuzumab in the phase III JBCRG-M06/EMERALD study

Background

The randomized open-label phase 3 JBCRG-M06/EMERALD study (NCT03264547) is the first to show non-inferiority of eribulin (E) to taxane (T) when used with trastuzumab (H) + pertuzumab (P) as first-line systemic therapy for locally advanced or metastatic HER2+ breast cancer (BC). Median PFS was 14.0 and 12.9 months (mo) in the study (E) and control (T) groups, respectively (HR, 0.95; 95% CI, 0.76–1.19), confirming non-inferiority (HR margin,1.33) of the study regimen (ASCO2024 abstract 1007). Maintaining quality of life (QoL) is a growing concern and one of the main goals in cancer treatment. Here, we report QoL outcomes in patients (pts) enrolled in JBCRG-M06.

Methods

Pts were randomized to receive E (1.4 mg/m² on days 1 and 8) or T (docetaxel 75 mg/m² on day 1; paclitaxel 80 mg/m² on days 1, 8 and 15), in both cases with H + P, as first-line therapy (study design, doi: 10.1186/s13063-020-04341-y). To evaluate patient-reported outcomes, pts completed EORTC QLQ-C30 at baseline, wks 9, 18, 27, 36, 45, 57, and 69. A 10-point difference in EORTC QLQ-C30 score was deemed the minimally important difference (MID) for clinically meaningful change. Kaplan–Meier method was used to assess time to QoL deterioration, and log rank test for intergroup comparisons.

Results

Of 446 pts randomized, 437 (221 and 216 in the E and T groups, respectively) comprised the full analysis set for QoL evaluation (median age, 56.0 [29–70] years; 54.7% ER+; 65.2% with visceral metastasis). QoL maintenance rate [proportion of pts whose Global Health Status (GHS) score has not deteriorated by ≥10 points] was 62.7% vs 43.8% at 6 mo and 30.3% vs 25.7% at 12 mo in the E and T groups, respectively. Median time to QoL deterioration was 218 days in the E group, and 139 days in the T group (HR, 0.80; 95% CI, 0.66–0.99; p = 0.08). For GHS (and some subscales), changes in adjusted mean QoL score was stable over time for the E group, whereas in T group pts, QOL tended to deteriorate until at least wk 36 (when most were in the chemotherapy period).

Conclusions

Over 69 wks, the E-based regimen delivered stable and clinically meaningful QoL maintenance that tended to last longer than with the T-based regimen.

Clinical trial identification

JBCRG-M06/EMERALD, NCT03264547.

Editorial acknowledgement

Medical Translation Service (Saitama, Japan) has provided editorial assistance.

Legal entity responsible for the study

Norikazu Masuda, Department of Breast Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.

Funding

Japan Breast Cancer Research Group (JBCRG) and Eisai Co., Ltd.

Disclosure

N. Masuda: Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Eli Lilly, AstraZeneca, Pfizer, Daiichi Sankyo; Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, Eli Lilly, AstraZeneca, Pfizer, Daiichi Sankyo, MSD, Eisai, Novartis, Gilead Science, Ono Pharmaceutical; Other, Personal, Member of Board of Directors: Japan Breast Cancer Research Group (JBCRG), Japanese Breast Cancer Society (JBCS), Japan Society of Clinical Oncology (JSCO). S. Saji: Financial Interests, Personal, Invited Speaker: Eli Lilly, Chugai, AstraZeneca, Kyowa Kirin, Daiichi Sankyo, Taiho, Pfizer, MSD, Novartis, Eisai, Ono, Takeda, Exact Sciences; Financial Interests, Personal, Advisory Board: Gilead; Financial Interests, Institutional, Research Grant: Taiho, Chugai, Daiichi Sankyo; Financial Interests, Institutional, Local PI: MSD, Daiichi Sankyo, Chugai, AstraZeneca, Sanofi, Gilead, Eli Lilly; Non-Financial Interests, Member of Board of Directors: Japanese Breast Cancer Society, Japanse Society of Medical Oncology, Japan Breast Cancer Research Group, Breast International Group. T. Iwatani: Financial Interests, Personal, Expert Testimony: Eisai. T. Takano: Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, Daiichi Sankyo, Eli Lilly. K. Koizumi: Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, Pfizer. Y. Sagara: Financial Interests, Personal, Speaker, Consultant, Advisor: Pfizer, Daiichi Sankyo, Eli Lilly, MSD, Kyowa Kirin, Celltrion Healthcare Japan, AstraZeneca, Eisai, Chugai Pharmaceutical, Nippon Kayaku, Sysmex. Y. Naito: Financial Interests, Personal, Invited Speaker, Speakers Bureau: Chugai, Pfizer, Eli Lilly, Eisai, AstraZeneca, PDR pharma, Novartis, Guardant, Ono, Takeda, Taiho, Bayer, Nihon Kayaku, Daiichi Sankyo, Bristol, MSD; Financial Interests, Personal, Funding: Roche; Financial Interests, Personal, Local PI: AbbVie, Boehringer Ingelheim, Ono, Chugai, Taiho, Pfizer, AstraZeneca, Gilead, Takeda, Eisai; Financial Interests, Personal, Steering Committee Member: Daiichi Sankyo; Non-Financial Interests, Principal Investigator, JCOG: Natera; Non-Financial Interests, Principal Investigator: Myriad. A. Yoshimura: Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, AstraZeneca, Eli Lilly, Pfizer, ACTmed. M. Takahashi: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Eli Lilly, MSD, Eisai, Pfizer, Daiichi Sankyo. J. Tsurutani: Financial Interests, Institutional, Funding: Eisai; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Personal, Speaker, Consultant, Advisor: Eisai, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: Eisai, Daiichi Sankyo, Seagen, Gilead. H. Tada: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, Eli Lilly, Daiichi Sankyo, AstraZeneca, Novartis, Eisai, Takeda Pharmaceutical. Y. Kojima: Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, Taiho Pharmaceutical, Pfizer, Kyowa Kirin, Exact Science, Eisai, Daiichi Sankyo, Eli Lilly, MSD. T. Kadoya: Financial Interests, Personal, Speaker, Consultant, Advisor: Eli Lilly. H. Hasegawa: Financial Interests, Personal, Full or part-time Employment: Eisai. Y. Uchida: Financial Interests, Personal, Full or part-time Employment: Eisai. S. Morita: Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, Bristol Myers Squibb, Chugai Pharmaceutical, Eli Lilly, MSD, Ono Pharmaceutical, Sanofi. T. Yamashita: Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical, Taiho Pharmaceutical, Nippon Kayaku, Daiichi Sankyo, Pfizer, AstraZeneca, MSD, Kyowa Kirin, Seagen, Ono Pharmaceutical, Gilead Science; Financial Interests, Personal, Speaker, Consultant, Advisor: Chugai Pharmaceutical, Taiho Pharmaceutical, Nippon Kayaku, Daiichi Sankyo, Pfizer, AstraZeneca, MSD, Kyowa Kirin, Eisai, Novartis. All other authors have declared no conflicts of interest.