Table 1.
Examples of key data from Industry-Sponsored Oncology Registries that have impacted clinical practice.
| Registry name | Disease indication | Sponsor | Years active | N | Key data | Impact |
|---|---|---|---|---|---|---|
| BRiTE and ARIES Bevacizumab Registries | First-line bevacizumab-treated mCRC | Genentech, Inc. | BRiTE: 2004-2008 ARIES: 2006-2012 |
BRiTE: 1953 ARIES: 1550 |
Hypothesis-generating data from these registries suggested that improved clinical outcomes are associated with utilizing bevacizumab beyond first disease progression in mCRC | Results from the 2 registries were published prior to the conclusion of the registrational, phase III ML18147 trial,43-46 which provided randomized data and largely confirmed these observational findings. FDA approved this indication in 2013 |
| Connect® MM | Newly diagnosed MM | Bristol Myers Squibb | 2009-ongoing (through Dec 2024) | 3011 | Real-world data from triple-class exposed RRMM patients in North America and Europe were obtained from three types of data sources: clinical sites, the Connect® MM Registry,13 and external research databases. The data were merged into a single data model and compared with the pivotal KarMMa study of ide-cel47 | Data supported ide-cel approval by the FDA |
| National LymphoCare Study | Recently diagnosed FL | Genentech, Inc. | 2004-2014 | 2740 | An analysis of patients with FL with stages II-IV disease showed that there were no differences in OS between watchful waiting and chemoimmunotherapy or rituximab monotherapy12 | Published in NCCN Guidelines®: B-Cell Lymphomas.v2.202348 Informed treatment approach in adults with FL |
| National LymphoCare Study | Recently diagnosed FL | Genentech, Inc. | 2004-2014 | 2740 | Patients with FL who experienced disease progression within 24 months after therapy with R-CHOP had a 5-year OS of only 50% compared with 90% for patients who progressed after 24 months29 | Published in NCCN Guidelines: B-Cell Lymphomas.v2.202348 Demonstrated utility of POD24 as a predictor of survival in FL patients |
| National LymphoCare Study | Recently diagnosed FL | Genentech, Inc. | 2004-2014 | 2740 | Examined OS and PFS by FLIPI risk category. Demonstrated that FLIPI1 scoring criteria, which was developed in the pre-rituximab era, retained its prognostic significance in the chemoimmunotherapy era49 | Published in NCCN Guidelines: B-Cell Lymphomas.v2.202348 Supported continued use of FLIPI1 scoring criteria in the chemoimmunotherapy era |
| PROCEED | Sipuleucel-T treated advanced prostate cancer | Dendreon | 2011-2017 | 1976 | A prospective registry of patients with mCRPC that showed safety and tolerability of sipuleucel-T were consistent with previous findings41 | Published in NCCN Guidelines: Prostate Cancer.v1.202350 Supported approval of sipuleucel-T, a new class of cancer immunotherapeutic agents, for patients with minimally symptomatic or asymptomatic mCRPC |
| LORHAN | Head and neck carcinoma | MedNet Solutions | 2005-2010 | 4243 | Examined treatment patterns among patients with head and neck cancer in the community and academic settings39 | Published in NCCN Guidelines: Head and Neck Cancers.v1.202351 Supported use of intensity-modulated radiation therapy as a replacement for conventional radiation techniques |
| GIDEON | Unresectable hepatocellular carcinoma | Bayer HealthCare Pharmaceuticals | 2008-2015 | 3202 | Subgroup analysis of OS by liver function class demonstrated lower median OS among patients with Child-Pugh Class B liver function25 | Published in NCCN Guidelines: Hepatocellular Carcinoma.v2.202352 Together with other studies, this study formed the basis for excluding patients with poor liver function from clinical trials |
Abbreviations: CLL: chronic lymphocytic leukemia; FDA: Food and Drug Administration; FL: follicular lymphoma; FLIPI: Follicular Lymphoma International Prognostic Index; HER2: human epidermal growth factor receptor 2; ide-cel: idecabtagene vicleucel; mCRC: metastatic colorectal cancer; mCRPC: castration-resistant prostate cancer; MM: multiple myeloma; NCCN: National Comprehensive, Cancer Network; OS: overall survival; PFS: progression-free survival; POD24: progression of disease within 24 months; R-CHOP: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone; RRMM: relapsed/refractory MM.