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To examine the effectiveness of an initial management strategy of watchful waiting for follicular lymphoma (FL) in clinical practice, we compared outcomes for patients diagnosed 2004-2007 in the United States initially managed with watchful waiting with outcomes following initial rituximab monotherapy and chemoimmunotherapy. In total, 1754 stage II-IV patients in the National LymphoCare Study underwent watchful waiting (n = 386), rituximab monotherapy (n = 296) or rituximab plus chemotherapy (n = 1072) as initial management strategy. Female patients and those who received treatment in the Northeast or in an academic setting more commonly underwent watchful waiting versus initial chemoimmunotherapy; whereas patients with grade 3 histology, anaemia, elevated lactate dehydrogenase, extranodal involvement, B symptoms or performance status ≥1 more commonly received chemoimmunotherapy. Although time to new treatment and progression-free survival following first- and second-line therapy were improved with chemoimmunotherapy, and time to chemotherapy was improved with rituximab monotherapy, there were no differences in overall survival between watchful waiting and chemoimmunotherapy or rituximab monotherapy. With 8-year overall survival estimates of 74%, initial management with watchful waiting in the context of sequential therapy remains a viable option for FL patients in the modern era. This trial was registered at www.clinicaltrials.gov (NCT00097565)., (© 2016 John Wiley & Sons Ltd.)

Data from the National LymphoCare Study (a prospective, multicentre registry that enrolled follicular lymphoma (FL) patients from 2004 to 2007) were used to determine disease characteristics, treatment patterns, outcomes and prognosis for elderly FL (eFL) patients. Of 2650 FL patients, 209 (8%) were aged >80 years; these eFL patients more commonly had grade 3 disease, less frequently received chemoimmunotherapy and anthracyclines, and had lower response rates when compared to younger patients. With a median follow-up of 6.9 years, 5-year overall survival (OS) for eFL patients was 59%; 38% of deaths were lymphoma-related. No treatment produced superior OS among eFL patients. In multivariate Cox models, anaemia, B-symptoms and male sex predicted worse OS (P < 0.01); a prognostic index of these factors (0, 1 or ≥ 2 present) predicted OS [hazard ratio (95% CI): ≥ 2 vs. 0, 4.72 (2.38-9.33); 1 vs. 0, 2.63 (1.39-4.98)], with a higher concordance index (0.63) versus the Follicular Lymphoma International Prognostic Index (0.55). The index was validated in an independent cohort. In the largest prospective US-based eFL cohort, no optimal therapy was identified and nearly 40% of deaths were lymphoma-related, representing baseline outcomes in the modern era., Competing Interests: Conflict-of-interest disclosures: C.N discloses consulting/advisory board roles for Genentech, Janssen, Celgene, Astellas, and Gilead. M.B discloses employment and stock options with Genentech. J.R.C discloses consulting/advisory roles with Genentech. K.D discloses employment and stock options with Genentech. C.R.F discloses consulting/advisory roles with Algeta, OptumRx, Biogen Idec, Genentech BioOncology, Roche, Celgene and research funding from Abbott, Celgene, Millennium/Takeda, Spectrum, Gilead, and Janssen/Pharmacyclics. J.W.F has no relevant conflict of interests to disclose. B.K.L discloses honoraria from Genentech, consulting and advisory roles with Genentech, AbbVie, Gilead, and research funding from Genentech, Millennium, Pharmacyclics, and Janssen. M.J.M has no relevant conflict of interests to disclose. A.R has no relevant conflict of interests to disclose. A.D.Z discloses consulting /advisory roles with Genentech, Celegene, Gilead, Amgen, Hospira, Reddy Laboratories and research funding from Genentech/Roche, Gilead, and BMS. X.Z is employed by RTI-HS, which has a research contract with Genentech., (© 2015 John Wiley & Sons Ltd.)