Meeting
2023 ASCO Annual Meeting
Subgroup analysis of elderly patients (pts) with diffuse large B-cell lymphoma (DLBCL) in the phase 3 POLARIX study.
Authors
Bei Hu
Levine Cancer Institute, Charlotte, NC
Bei Hu , Patrick Michael Reagan , Laurie Helen Sehn , Jeff Porter Sharman , Mark Hertzberg , Huilai Zhang , Austin Injae Kim , Charles Herbaux , Lysiane Molina , Dai Maruyama , Piotr Smolewski , Frank Stenner , Veronica Craine , Rucha Kothari , Jamie H. Hirata , Deniz Sahin , Matthew Dean Sei Sugidono , Calvin Lee , Herve Tilly
Organizations
Levine Cancer Institute, Charlotte, NC, Wilmot Cancer Institute, University of Rochester, Rochester, NY, BC Cancer Centre for Lymphoid Cancer, Vancouver, BC, Canada, Willamette Valley Cancer Institute and Research Center, US Oncology Research, Eugene, OR, Prince of Wales Hospital, Sydney, NSW, Australia, Tianjin Medical University Cancer Hospital, Tianjin, China, Dana-Farber Cancer Institute, Boston, MA, Department of Clinical Hematology, CHU Montpellier, Montpellier, France, Hématologie Clinique, CHU de Grenoble, La Tronche, France, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan, Medical University of Lodz, Lodz, Poland, University Hospital of Basel, Basel, Switzerland, Hoffmann-La Roche Ltd, Mississauga, ON, Canada, Genentech, Inc., South San Francisco, CA, F. Hoffmann-La Roche Ltd, Basel, Switzerland, Centre Henri-Becquerel and University of Rouen, Rouen, France
Research Funding
Pharmaceutical/Biotech Company
The POLARIX study (NCT03274492) was sponsored by F. Hoffmann-La Roche Ltd and Genentech, Inc. Third-party editorial assistance was provided by Leen Al-Mohammad, BSc, of Ashfield MedComms, an Inizio company, and was funded by F. Hoffmann-La Roche Ltd
Background: In the Phase 3 POLARIX study (NCT03274492), polatuzumab vedotin with rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) significantly improved progression-free survival (PFS) compared with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), with a similar safety profile in pts aged 18–80 years with previously untreated DLBCL (Tilly et al. 2022). Combination regimens may be associated with higher rates of toxicity in elderly pts. We report the efficacy and safety of Pola-R-CHP vs R-CHOP in pts aged ≥70 years enrolled in POLARIX. Methods: POLARIX methods were described by Tilly et al. (2022). Pts with previously untreated DLBCL were randomized 1:1 to receive 6 cycles of Pola-R-CHP or R-CHOP, plus 2 cycles of rituximab. This analysis focused on pts aged ≥70 years at enrollment. Results: Overall, 284 pts were analyzed for efficacy (Pola-R-CHP, n=141; R-CHOP, n=143) and 280 pts were analyzed for safety (Pola-R-CHP, n=137; R-CHOP, n=143). Median age was 74 years (range 70–80), and 69.7% had an International Prognostic Index score of 3–5. Most pts in either arm received all 6 doses of polatuzumab vedotin or vincristine (88.3% and 91.6% in the Pola-R-CHP and R-CHOP arms, respectively). At data cutoff (June 28, 2021; median follow-up: 24.2 months), the risk of progression, relapse or death was lower with Pola-R-CHP vs R-CHOP (hazard ratio [HR] 0.64; 95% confidence interval [CI]: 0.41–0.99) (Table). Death by any cause occurred in 14.2% and 19.6% of pts treated with Pola-R-CHP and R-CHOP, respectively. Overall survival (OS) and disease-free survival (DFS) results are presented in the Table. Safety profiles were generally comparable for Pola-R-CHP vs R-CHOP, including rates of Grade 3–5 adverse events (AEs), Grade 5 AEs, serious AEs, peripheral neuropathy (any grade), neutropenia (Grade 3–4), and infection (Grade 3–4) (Table). Conclusions: Pola-R-CHP and R-CHOP demonstrated similar safety profiles in pts aged ≥70 years with previously untreated DLBCL. The risk-benefit profile favored Pola-R-CHP vs R-CHOP. Clinical trial information: NCT03274492.
| Pola-R-CHP (efficacy-evaluable n=141; safety-evaluable n=137) | R-CHOP (efficacy-evaluable n=143; safety-evaluable n=143) | HR (95% CI)* | |
|---|---|---|---|
| 2-year PFS rate, % (95% CI) | 77.1 (69.98–84.19) | 67.0 (59.15–74.79) | 0.64 (0.41–0.99) |
| 2-year OS rate, % (95% CI) | 86.2 (80.47–91.98) | 82.8 (76.51–89.05) | 0.74 (0.41–1.31) |
| 2-year DFS†rate, % (95% CI) | 80.6 (73.37–87.78) | 73.4 (65.11–81.72) | 0.65 (0.38–1.11) |
| Total no. pts with Grade 3–5 AE, n (%) | 101 (73.7) | 100 (69.9) | |
| Total no. pts with Grade 5 AE, n (%) | 5 (3.6) | 7 (4.9) | |
| Total no. pts with serious AE, n (%) | 59 (43.1) | 55 (38.5) | |
| Total no. pts with peripheral neuropathy, any grade, n (%) | 72 (52.6) | 67 (46.9) | |
| Total no. pts with Grade 3–4 neutropenia, n (%) | 42 (30.7) | 50 (35.0) | |
| Total no. pts with Grade 3–4 infection, n (%) | 22 (16.1) | 18 (12.6) |
*Unstratified analysis; †DFS-evaluable population, n=125 (Pola-R-CHP); n=124 (R-CHOP).
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Abstract Details
Session Type
Poster Discussion Session
Session Title
Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia
Track
Hematologic Malignancies
Sub Track
Non-Hodgkin Lymphoma
Clinical Trial Registration Number
NCT03274492
Citation
J Clin Oncol 41, 2023 (suppl 16; abstr 7518)
DOI
10.1200/JCO.2023.41.16_suppl.7518
Abstract #
7518
Poster Bd #
69
Abstract Disclosures
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