In oncology trials, patients are often differentiated based on line of therapy (LOT) for their current disease stage. Briefly, patients can be naïve/untreated (First line), treated before or after surgery/radiation (Neoadjuvant and Adjuvant), treated after progressing on a previous line of therapy (Second line or greater) or treated to maintain a positive response (Maintenance/Consolidation). In Trialtrove, these LOT patient segments have been applied to most oncological disease trials for almost a decade.
To address the widespread use of heavily pretreated patients in oncology clinical trials, here we introduce the revision of Second line or greater/Refractory/Relapsed to Second line and addition of Third line and Fourth line or greater. These three LOT patient segments for refractory/relapsed patients have been applied to the relevant trial records in Trialtrove. Their definitions are shown below.
Second line*
Trials accepting patients who were previously treated with at least one drug therapy for their current disease stage at acceptance into the trial. These patients are refractory to, relapsed or progressed after previous first line drug therapy. Surgery/radiation alone (no drug therapy) is NOT considered refractory/relapsed. Also included are trials for relapsed/refractory patients with an unspecified number of prior drug therapies.
Third line*
Trials accepting patients who were previously treated with first and second line drug therapies for their current disease stage at acceptance into the trial. These patients are refractory to, relapsed or progressed after previous first and second line drug therapy. Surgery/radiation alone (no drug therapy) is NOT considered refractory/relapsed.
Fourth line or greater*
Trials accepting patients who were previously treated with first, second and third or greater lines of drug therapy for their current disease stage at acceptance into the trial. These patients are refractory to, relapsed or progressed after previous first, second and third or greater lines of drug therapy. Surgery/radiation alone (no drug therapy) is NOT considered refractory/relapsed.
*Definitions for CNS oncological diseases include surgery and/or radiation as a possible first line therapy.
Additionally, we have compiled some key insights about oncology trials evaluating refractory/relapsed patients along with Dashboard charts, exported from next generation Trialtrove, that feature these trials segmented by phase, status, sponsor type, disease and start date.
- As of June 6, 2018, Trialtrove’s Oncology portfolio includes 26,367 trials that enroll Second line patients, 4,840 trials that enroll Third line patients and 3,370 trials that enroll Fourth line or greater patients. Trials may include multiple LOT patient segments.
- Together, these trials include 57% all oncology trials in Trialtrove’s portfolio.
- The clinical landscape by phase, status and sponsor type is similar for trials with these three LOT patient segments.
- The clinical landscape by disease and start date differs for trials with these three patient segments.
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