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Adding an antibody-drug conjugate to a gentle outpatient chemotherapy pairing added about seven months of life for people with relapsed aggressive lymphoma who could not have a transplant.
Rituximab with gemcitabine and oxaliplatin is the regimen offered when someone with relapsed diffuse large B-cell lymphoma cannot tolerate transplant-intensity salvage, and its results have always been modest. POLARGO added polatuzumab vedotin, the CD79b antibody-drug conjugate already established in the first line by POLARIX.
After a 15-patient safety run-in, 255 patients with relapsed or refractory disease (not otherwise specified, or transformed from an indolent lymphoma) who were ineligible for autologous transplant were randomised to polatuzumab with rituximab, gemcitabine and oxaliplatin (129) or to the chemotherapy alone (126), for up to eight 21-day cycles. Overall survival was the primary endpoint, which is unusual and makes the result harder to dismiss. At a median follow-up of 24.6 months the hazard ratio for death was 0.6 (95 per cent confidence interval 0.43 to 0.83, p = 0.0017), with median overall survival 19.5 months against 12.5.
The cost is real: peripheral neuropathy in 57 per cent against 29 per cent, mostly grade 1, and fatal adverse events in 12 per cent against 4 per cent, largely infections including COVID-19. The trial recruited through the pandemic, which bears on that figure.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
255 randomised.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Overall survival (median)primary | Polatuzumab with R-GemOx | 129 | 19.5 months | 0.6 (0.43 to 0.83) | 0.0017 | link |
| R-GemOx | 126 | 12.5 months |
Shares POLARIX, CD79b, Polatuzumab vedotin, Older and multimorbid patients are excluded and undertreated and the tag lymphoma-evidence.
Shares Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL, Older and multimorbid patients are excluded and undertreated, CD20, Rituximab and the tag lymphoma-evidence.
Shares POLARIX, CD20, Rituximab, Roche / Genentech and the tag lymphoma-evidence.
Shares POLARIX, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Toxicity and quality of life are undervalued and the tag lymphoma-evidence.
Shares Stem cell transplant in lymphoma: what it is still for, CD20, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.
Shares Stem cell transplant in lymphoma: what it is still for, Older and multimorbid patients are excluded and undertreated, CD20, Rituximab and the tag lymphoma-evidence.
Shares Older and multimorbid patients are excluded and undertreated, CD20, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting and the tag lymphoma-evidence.
Shares Older and multimorbid patients are excluded and undertreated, Rituximab, Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting, Toxicity and quality of life are undervalued and the tag lymphoma-evidence.