No abstract

Background:We designed an open-label, noncomparative phase II study to assess the safety and efficacy of first-line treatment with trifluridine/tipiracil plus bevacizumab (TTeB) and capecitabine plus bevacizumab (CeB) in untreated patients with unresectable metastatic colorectal cancer (mCRC) who were not candidates for combination with cytotoxic chemotherapies. Patients and methods: From 29 April 2016 to 29 March 2017, 153 patients were randomly assigned (1:1) to either TTeB (N ¼ 77) or CeB (N ¼ 76). The primary end point was progression-free survival (PFS). The primary PFS analysis was performed after 100 events (radiological progression or death) were observed. Secondary end points included overall survival (OS), quality of life (QoL; QLQ-C30 and QLQ-CR29 questionnaires), and safety. Results: Median (range) duration of treatment was 7.8 (6.0e9.7) months and 6.2 (4.1e9.1) months in the TTeB and CeB groups, respectively. Median (range) PFS was 9.2 (7.6e11.6) and 7.8 (5.5e10.1) months, respectively. Median (range) OS was 18 (15.2 to NA) and 16.2 (12.5 to NA) months, respectively. QoL questionnaires showed no relevant changes over time for either treatment. Therapies were well tolerated. Patients receiving TTeB had more grade !3 neutropenia (47% versus 5% with CeB). Patients receiving CeB had more grade !3 handefoot syndrome (12% versus 0% with TTeB) and grade !3 diarrhea (8% versus 1% with TTeB), consistent with the known safety profiles of these agents. Conclusion: TTeB treatment showed promising clinical activity in untreated patients with unresectable mCRC ineligible for intensive therapy, with an acceptable safety profile and no clinically relevant changes in QoL. Clinical trial information: NCT02743221 (ClinicalTrials.gov)

PET after one cycle of chemotherapy is highly prognostic in HL. No other prognostic tool identifies a group of patients with HL with a more favorable outcome than those patients with a negative PET1. In the absence of precise pretherapeutic predictive markers, PET1 is the best method for response-adapted strategies designed to select patients for less intensive treatment.