Patient‐ versus clinician‐reported symptoms in the POLARIX study

Introduction: The safety profiles of novel agents are mainly based on clinician-reported adverse events (AEs) from clinical trials. Patient-reported outcomes (PROs) may better represent the treatment burden experienced by patients (pts) compared with clinician-reported AEs. Using data from POLARIX, a double-blind, placebo-controlled, randomized Phase 3 international study (NCT03274492), we previously presented PRO and clinician-reported data showing similar rates of neuropathy (Trněný et al., 2022). Here, we evaluate the reporting of other common symptoms using PRO and clinician-reported data in POLARIX. Methods: POLARIX methods were previously described (Tilly et al., 2022); this analysis included all pts with PRO data. PRO and clinician-reported data described the incidence and severity of fatigue, constipation, diarrhea, nausea, and vomiting. Clinician-reported severity grading was based on the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0. PROs were collected using the European Organisation Research and Treatment of Cancer Quality of Life-Core 30 questionnaire (EORTC QLQ-C30), which was administered to pts at clinic visits on Day 1 of Cycles 1 (baseline), 2, 3, and 5, and end of treatment (EOT). PRO severity scores included ‘A little’, ‘Quite a bit’, and ‘Very much’. Results: Overall, 825 pts were evaluable. From baseline to EOT, PROs showed a higher incidence of symptoms compared with clinicians for fatigue (98% vs. 27%), constipation (68% vs. 29%), diarrhea (56% vs. 26%), nausea (58% vs. 40%), and vomiting (24% vs. 15%). PRO severity scores of ‘Quite a bit’ or ‘Very much’ were reported in 33% of pts for fatigue, 29% for constipation, 17% for diarrhea, 19% for nausea, and 7% for vomiting (Table). Clinicians reported Grade ≥2 symptoms in 11% of pts for fatigue, 11% for constipation, 11% for diarrhea, 14% for nausea, and 6% for vomiting (Table). Conclusions: In POLARIX, pts reported a higher incidence and severity of symptoms compared with clinicians. Although distinct scales were used, the differences in symptom rates reported by pts and clinicians were clinically meaningful. These data may have implications for symptom management, including physician evaluation and communication of symptom expectations for pts. Reporting of symptoms by PROs should be incorporated into clinical trials as an adjunct to standard AE reporting to better characterize the patient experience. Table: Encore Abstract - previously submitted to ASCO 2023 The research was funded by: The POLARIX study (NCT03274492) was sponsored by F. Hoffmann-La Roche Ltd. and Genentech, Inc. Third-party editorial assistance, under the direction of the authors, was provided by Leen Al-Mohammad, BSc, of Ashfield MedComms, an Inizio company, and was funded by F. Hoffmann-La Roche Ltd. Keywords: Aggressive B-cell non-Hodgkin lymphoma, Combination Therapies Conflicts of interests pertinent to the abstract. N. Mehta-Shah Consultant or advisory role: Kyowa Kirin, Daiichi Sankyo/UCB Japan, Secura Bio, AstraZeneca, F. Hoffmann-La Roche Ltd./Genentech, Inc., Karyopharm Therapeutics, C4 Therapeutics, Ono Pharmaceutical, Kyowa Kirin International Research funding: Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd./Genentech, Inc., Celgene, Verastem, Innate Pharma, Corvus Pharmaceuticals, AstraZeneca, C4 Therapeutics, Daiichi Sankyo, Yingli Pharma, Dizal Pharma C. Flowers Consultant or advisory role: Bayer, Gilead Sciences, Spectrum Pharmaceuticals, AbbVie, Celgene, Denovo Biopharma, BeiGene, Karyopharm Therapeutics, Pharmacyclics/Janssen, F. Hoffmann-La Roche Ltd./Genentech, Inc., Epizyme, Genmab, Seattle Genetics, Foresight Diagnostics, Bristol-Myers Squibb/Celgene, Curio Science, AstraZeneca, MorphoSys Stock ownership: Foresight Diagnostics, N Power Research funding: Acerta Pharma, Janssen Oncology, Gilead Sciences, Celgene, TG Therapeutics, F. Hoffmann-La Roche Ltd./Genentech, Inc., Pharmacyclics, AbbVie, Millennium, Alimera Sciences, Xencor, 4D Pharma, Adaptimmune, Amgen, Bayer, Cellectis, EMD Serono, Guardant Health, Iovance Biotherapeutics, Kite/Gilead, MorphoSys, Nektar, Novartis, Pfizer, Sanofi, Takeda, ZIOPHARM Oncology G. Salles Consultant or advisory role: F. Hoffmann-La Roche Ltd./Genentech, Inc., Janssen, Novartis, MorphoSys, Epizyme, Genmab, Debiopharm Group, Velosbio, Bristol-Myers Squibb, BeiGene, Incyte, Miltenyi Biotec, Ipsen, AbbVie, Kite/Gilead, Loxo/Lilly, Molecular Partners, Nordic Nanovector, RAPT Therapeutics, Takeda, Incyte Stock ownership: Owkin Honoraria: AbbVie, Bayer, Regeneron, Incyte H. Tilly Consultant or advisory role: F. Hoffmann-La Roche Ltd., Incyte, Celgene/Bristol-Myers Squibb Honoraria: Bristol-Myers Squibb, F. Hoffmann-La Roche Ltd. Research funding: F. Hoffmann-La Roche Ltd./Genentech, Inc. Educational grants: F. Hoffmann-La Roche Ltd., Janssen N. Chua Consultant or advisory role: Bayer, Amgen, Merck, F. Hoffmann-La Roche Ltd. Canada, Seattle Genetics, Incyte Honoraria: AbbVie Research funding: F. Hoffmann-La Roche Ltd./Genentech, Inc. R. Casasnovas Consultant or advisory role: F. Hoffmann-La Roche Ltd./Genentech, Inc., Takeda, Gilead Sciences, Bristol-Myers Squibb, Merck, AbbVie, Celgene, Janssen, Incyte, ADC Therapeutics Honoraria: F. Hoffmann-La Roche Ltd./Genentech, Inc., Takeda, Gilead Sciences, Bristol-Myers Squibb, Merck, AbbVie, Celgene, Janssen, Amgen Research funding: F. Hoffmann-La Roche Ltd./Genentech, Inc., Gilead Sciences, Takeda Educational grants: F. Hoffmann-La Roche Ltd./Genentech, Inc., Takeda, Gilead Sciences, Janssen, AbbVie F. Miall Consultant or advisory role: F. Hoffmann-La Roche Ltd., Takeda Honoraria: Takeda Other remuneration: F. Hoffmann-La Roche Ltd., Takeda (Speaker’s Bureau) T. M. Kim Consultant or advisory role: AstraZeneca/MedImmune, Janssen Oncology, Novartis, Takeda, Yuhan, Regeneron, Samsung Bioepis Research funding: AstraZeneca Other remuneration: Takeda, Janssen Research & Development, IMBDx, Inc. (Speakers' Bureau) C. Tsai Consultant or advisory role: Novartis, F. Hoffmann-La Roche Ltd., Astellas Pharma, Pfizer Stock ownership: AbbVie, Amgen, BeiGene Honoraria: Astellas Pharma, Bristol-Myers Squibb, BeiGene, Chugai, Harvester, Janssen, Kirin Pharmaceuticals, Novartis, Pfizer Research funding: Astellas Pharma, Bristol-Myers Squibb Other remuneration: Astellas Pharma, Bristol-Myers Squibb, Harvester, Janssen, Kirin Pharmaceuticals, Novartis, Pfizer, Amgen Astellas BioPharma (Speaker’s Bureau) S. Nasta Consultant or advisory role: Merck, MorphoSys, Incyte Honoraria: Acrotech Biopharma Research funding: Millennium, Incyte, Aileron Therapeutics, Debiopharm Group, F. Hoffmann-La Roche Ltd./Genentech, Inc., Atara Biotherapeutics, Rafael Pharmaceuticals, Forty Seven, Pharmacyclics/Janssen V. Craine Employment or leadership position: F. Hoffmann-La Roche Ltd. A. Campinha-Bacote Employment or leadership position: Genentech, Inc. Stock ownership: Genentech, Inc. J. Hirata Employment or leadership position: Genentech, Inc. Stock ownership: F. Hoffmann-La Roche Ltd. C. Lee Employment or leadership position: F. Hoffmann-La Roche Ltd. Stock ownership: F. Hoffmann-La Roche Ltd. M. Sugidono Employment or leadership position: Genentech, Inc./F. Hoffmann-La Roche Ltd. Stock ownership: Genentech, Inc./F. Hoffmann-La Roche Ltd.

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