Six versus eight cycles of bi-weekly CHOP-14 with or without rituximab in elderly patients with aggressive CD20+ B-cell lymphomas: a randomised controlled trial (RICOVER-60)

摘要: Summary Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) is used to treat patients with non-Hodgkin lymphoma. Interval decrease from 3 weeks of treatment (CHOP-21) 2 (CHOP-14), addition rituximab CHOP-21 (R-CHOP-21) has been shown improve outcome in elderly diffuse large B-cell lymphoma (DLBCL). This randomised trial assessed whether six or eight cycles R-CHOP-14 can these compared CHOP-14. Methods 1222 (aged 61–80 years) were randomly assigned CHOP-14 without rituximab. Radiotherapy was planned sites initial bulky disease extranodal involvement. The primary endpoint event-free survival; secondary endpoints response, progression during treatment, progression-free survival, overall frequency toxic effects. Analyses done by intention treat. registered on National Cancer Institute website, number NCT00052936 as EU-20243. Findings 3-year survival 47·2% after (95% CI 41·2–53·3), 53·0% (47·0–59·1) CHOP-14, 66·5% (60·9–72·0) R-CHOP-14, 63·1% (57·4–68·8) R-CHOP-14. Compared the improvement 5·8% (−2·8–14·4) for 19·3% (11·1–27·5) 15·9% (7·6–24·2) 67·7% (62·0–73·5) 66·0% (60·1–71·9) 78·1% (73·2–83·0) 72·5% (67·1–77·9) improved −1·7% (−10·0–6·6) 10·4% (2·8–18·0) 4·8% (−3·1–12·7) In a multivariate analysis that reference, adjusting known prognostic factors, all three intensified regimens (eight CHOP-14: RR [relative risk] 0·76 [0·60–0·95], p=0·0172; R-CHOP-14: 0·51 [0·40–0·65], p Interpretation Six significantly event-free, progression-free, over treatment. Response-adapted chemotherapy beyond cycles, though widely practiced, not justified. Of four this study, preferred patients, which other approaches should be compared.