Subgroup analysis of elderly patients (pts) with diffuse large B‐cell lymphoma (DLBCL) in the Phase 3 POLARIX study
Bibliographic record
Abstract
Introduction: 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 versus 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 versus 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 versus 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 versus R-CHOP. 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. B. Hu Consultant or advisory role: ADC Therapeutics, BeiGene, MorphoSys, Janssen Research funding: Genentech, Inc., BeiGene P. M. Reagan Consultant or advisory role: Kite (a Gilead Company) Research funding: F. Hoffmann-La Roche Ltd./Genentech, Inc., Seattle Genetics L. H. Sehn Consultant or advisory role: Celgene, AbbVie, Seattle Genetics, TG Therapeutics, Janssen, Amgen, F. Hoffmann-La Roche Ltd./Genentech, Inc., Gilead Sciences, Lundbeck, Apobiologix, Karyopharm Therapeutics, Kite (a Gilead Company), Merck, Takeda, Teva, AstraZeneca, Acerta Pharma, MorphoSys, Incyte, Debiopharm Group, Sandoz-Novartis, Genmab, Verastem Honoraria: Amgen, Apobiologix, AbbVie, Celgene, Gilead Sciences, Janssen-Ortho, Karyopharm Therapeutics, Kite (a Gilead Company), Lundbeck, Merck, F. Hoffmann-La Roche Ltd./Genentech, Inc., Seattle Genetics, Takeda, Teva, TG Therapeutics, AstraZeneca, Acerta Pharma, MorphoSys, Incyte, Debiopharm Group, Sandoz-Novartis, Verastem, Genmab Research funding: F. Hoffmann-La Roche Ltd./Genentech, Inc., Teva J. Sharman Consultant or advisory role: TG Therapeutics, Genentech, Inc., AbbVie, Acerta Pharma/AstraZeneca, BeiGene, Bristol-Myers Squibb, Merck Research funding: Pharmacyclics, Genentech, Inc., Celgene, Acerta Pharma, Gilead Sciences, Seattle Genetics, TG Therapeutics, Merck, Takeda M. Hertzberg Consultant or advisory role: Janssen, F. Hoffmann-La Roche Ltd., Takeda, Gilead Sciences, BeiGene, Novartis Honoraria: F. Hoffmann-La Roche Ltd./Genentech, Inc., Janssen Educational grants: Takeda C. Herbaux Honoraria: F. Hoffmann-La Roche Ltd., Janssen-Cilag, AbbVie, Gilead Sciences Research funding: Takeda Educational grants: Janssen-Cilag, AbbVie, F. Hoffmann-La Roche Ltd. L. Molina Consultant or advisory role: AbbVie Educational grants: AbbVie, Janssen, Novartis D. Maruyama Honoraria: MSD, Zenyaku Kogyo, Bristol-Myers Squibb Japan, Nippon Shinyaku, Takeda, Janssen, Eisai, Celgene, Kyowa Kirin, Ono Pharmaceutical, Mundipharma, Chugai, Daiichi Sankyo, Asahi Kasei, AstraZeneca, Synmosa Biopharma Research funding: Amgen Astellas BioPharma, Astellas Pharma, Otsuka, Novartis, Kyowa Kirin, Sanofi, Bristol-Myers Squibb, Chugai, Ono Pharmaceutical, Celgene, Janssen, Eisai, Takeda, MSD P. Smolewski Consultant or advisory role: F. Hoffmann-La Roche Ltd. Poland, Takeda Honoraria: F. Hoffmann-La Roche Ltd. Poland, Takeda Educational grants: F. Hoffmann-La Roche Ltd. Poland, Takeda Other remuneration: F. Hoffmann-La Roche Ltd. Poland (Expert Testimony) F. Stenner Consultant or advisory role: Bristol-Myers Squibb, MSD, F. Hoffmann-La Roche Ltd., Novartis, Celgene, Janssen Honoraria: Bristol-Myers Squibb, MSD, F. Hoffmann-La Roche Ltd., Novartis, Celgene, Janssen Research funding: Bristol-Myers Squibb, Takeda Educational grants: Bristol-Myers Squibb, MSD, F. Hoffmann-La Roche Ltd., Novartis, Celgene, Janssen V. Craine Employment or leadership position: F. Hoffmann-La Roche Ltd. R. Kothari Employment or leadership position: F. Hoffmann-La Roche Ltd./Genentech, Inc. Stock ownership: F. Hoffmann-La Roche Ltd./Genentech, Inc. J. Hirata Employment or leadership position: Genentech, Inc. Stock ownership: F. Hoffmann-La Roche Ltd. D. Sahin Employment or leadership position: F. Hoffmann-La Roche Ltd. Stock ownership: F. Hoffmann-La Roche Ltd. M. Sugidono Employment or leadership position: F. Hoffmann-La Roche Ltd./Genentech, Inc. Stock ownership: F. Hoffmann-La Roche Ltd./Genentech, Inc. C. Lee Employment or leadership position: F. Hoffmann-La Roche Ltd. Stock ownership: F. Hoffmann-La Roche Ltd. 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
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.002 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".