Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma.

Abstract

OBJECTIVE:

To evaluate patient-reported outcome (PRO) data from the IMmotion150 study. The phase 2 IMmotion150 study showed improved progression-free survival with atezolizumab plus bevacizumab vs sunitinib in patients with programmed death-ligand 1 (PD-L1)+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC).

PATIENTS AND METHODS:

Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (i.v.) every 3 weeks (n = 103), the atezolizumab regimen plus bevacizumab 15 mg/kg i.v. every 3 weeks (n = 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; n = 101). The MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. The TTD was the first ≥2-point score increase over baseline. Absolute effect size ≥0.2 suggested a clinically important difference with checkpoint inhibitor therapy vs sunitinib.

RESULTS:

Completion rates were >90% at baseline and ≥80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference was observed with atezolizumab (both alone and in combination) vs sunitinib. Improved TTD (hazard ratio [HR], 95% confidence interval [CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22-0.71); RCC symptoms, 0.22 (0.12-0.41); and symptom interference, 0.36 (0.22-0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy vs sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions.

CONCLUSION:

PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone vs sunitinib (IMmotion150; ClinicalTrials.gov Identifier: NCT01984242).

• Authors: Sumanta K Pal, David F McDermott, Michael B Atkins, Bernard Escudier, Brian I Rini, Robert J Motzer, Lawrence Fong, Richard W Joseph, Stephane Oudard, Alain Ravaud, Sergio Bracarda, Cristina Suárez, Elaine T Lam, Toni K Choueiri, Beiying Ding, Caroleen Quach, Kenji Hashimoto, Christina Schiff, Elisabeth Piault-Louis, Thomas Powles
• Journal: BJU international (BJU Int) Vol. 126 Issue 1 Pg. 73-82 (07 2020) ISSN: 1464-410X [Electronic] England
• PMID: 32233107 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2020 The Authors BJU International © 2020 BJU International Published by John Wiley & Sons Ltd.

Chemical References

• Antibodies, Monoclonal, Humanized
• Antineoplastic Agents
• B7-H1 Antigen
• Bevacizumab
• atezolizumab
• Sunitinib

Topics

• Adult
• Aged
• Antibodies, Monoclonal, Humanized (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• B7-H1 Antigen
• Bevacizumab (therapeutic use)
• Carcinoma, Renal Cell (diagnosis, drug therapy, secondary)
• Drug Therapy, Combination
• Female
• Follow-Up Studies
• Humans
• Kidney Neoplasms (drug therapy, pathology)
• Male
• Middle Aged
• Patient Reported Outcome Measures
• Progression-Free Survival
• Prospective Studies
• Sunitinib (therapeutic use)