City of Hope National Medical Center, Duarte, CA
Sumanta K. Pal , David F. McDermott , Michael B. Atkins , Bernard Escudier , Brian I. Rini , Robert J. Motzer , Lawrence Fong , Richard Wayne Joseph , Stephane Oudard , Alain Ravaud , Sergio Bracarda , Cristina Suarez Rodriguez , Elaine Tat Lam , Toni K. Choueiri , Beiying Ding , Caroleen Quach , Kenji Hashimoto , Christina Schiff , Elisabeth Piault , Thomas Powles
Background: The phase 2 IMmotion150 study showed improved PFS with atezo + bev vs sun in patients (pts) whose tumors were PD-L1+ and corroborated the activity of atezo monotherapy in previously untreated mRCC. This study offers an opportunity to evaluate PROs with immunotherapy and VEGF-directed therapy alone and in combination. Methods: Pts randomized to atezo 1200 mg IV q3w alone or with bev 15 mg/kg IV q3w, or sun 50 mg po qd for 4 wk on/2 wk off completed the MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) q3w of each 6-wk cycle until progression (RECIST 1.1). Time to deterioration (TTD; first ≥ 2-point score increase over baseline [BL]) and change from BL (effect size [ES] ≥ 0.2 suggests a clinically important difference vs sun) in MDASI symptom severity and interference and BFI fatigue severity and interference scores are reported for all-comers. Results: Completion rates were > 90% at BL and ≥ 80% at most visits across arms. BL PRO scores indicating mild symptoms and interference were similar across arms. Delayed TTD of symptom severity and interference with daily life was seen with atezo vs sun and atezo + bev vs sun and was longest with atezo alone (Table). Pts reported milder symptoms and less interference during the first 6 cycles with atezo vs sun: ES mean (range) was 0.36 (0.07-0.68) for core symptom severity and 0.36 (0.04-0.83) for symptom interference. The 5 worst pt-reported symptoms during tx (dry mouth, fatigue, rash, drowsiness, lack of appetite) were all in the sun arm; all 16 symptoms measured were milder with atezo vs sun. Conclusions: PROs suggest that atezo alone or with bev maintained daily function with minimal symptom interference vs sun. Clinical activity, safety and PRO data for atezo support its investigation in adjuvant tx of high-risk RCC pts (IMmotion010; NCT03024996). Clinical trial information: NCT01984242
Atezo | Atezo + Bev | |
---|---|---|
MDASI core symptom severity | 0.39 (0.22, 0.71) | 0.74 (0.45, 1.20) |
MDASI RCC symptom severity | 0.22 (0.12, 0.41) | 0.60 (0.38, 0.94) |
MDASI symptom interference | 0.36 (0.22, 0.58) | 0.70 (0.47, 1.04) |
BFI fatigue severity | 0.48 (0.33, 0.70) | 0.75 (0.53, 1.06) |
BFI fatigue interference | 0.38 (0.24, 0.60) | 0.67 (0.46, 0.99) |
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Abstract Disclosures
2017 ASCO Annual Meeting
First Author: Michael B. Atkins
2024 ASCO Genitourinary Cancers Symposium
First Author: Oluseyi Abidoye
2023 ASCO Annual Meeting
First Author: Masatoshi Kudo
2018 ASCO Annual Meeting
First Author: Bernard Escudier