Prevention and management of obinutuzumab-associated toxicities: Australian experience.

Patients with chronic lymphocytic leukaemia (CLL) are typically diagnosed at an advanced age and may have multiple co-existing conditions, augmenting the challenges of treating their CLL. Aggressive cytotoxic therapies are often poorly tolerated in this patient population. Obinutuzumab is a glycoengineered type II anti-CD20 monoclonal antibody indicated in combination with chlorambucil for previously untreated CLL. The approval of this drug was based on the pivotal CLL11 trial, which demonstrated longer progression-free survival vs. rituximab/chlorambucil and chlorambucil alone in patients with significant co-existing medical conditions and/or poor renal function. However, a higher risk of infusion-related reactions (IRRs) was demonstrated with obinutuzumab-based therapy. We highlight important nursing care considerations to help prevent and successfully manage IRRs and other important adverse events, to improve the treatment experience of patients receiving obinutuzumab infusions and to enable them to complete their treatment and receive optimal benefit. Premedication, drug handling, dosing, administration, monitoring and documentation are discussed.

Clinical Outcomes of Patients with Rare and Heavily Pretreated Solid Tumors Treated according to the Results of Tumor Molecular Profiling.

Patients with heavily pretreated advanced cancer or with rare tumors are difficult to treat. Molecular profiling (MP) of tumors to identify biomarkers that predict potential outcomes with individual therapies is an emerging strategy to guide treatment decisions. Patients with rare tumors for which standard-of-care therapy was unavailable or more common tumors for which standard-of-care options had been exhausted underwent MP at a single Australian center. Data regarding treating physicians' choice of therapy, MP results and recommendations, and patient outcomes were collected. Seven patients had received prior standard first-line therapy (PST), 16 had rare tumors, and 31 had been heavily pretreated (HPT; ≥2 prior lines). Most treatments suggested by MP (541/594; 91.1%) were common chemotherapy drugs available in generic formulations. MP-guided therapy recommendations differed from physician's recommendations in 48 patients (88.9%). MP-guided therapy produced clinical benefit (improved QOL and/or performance status, symptoms, bodyweight, or RECIST) in 19/31 (61.3%), 11/16 (68.8%), and 3/7 (42.9%) patients with HPTs, rare tumors, and PSTs, respectively, and had a PFS ratio ≥1.3 in 22/37 evaluable patients (59.5%; 95% confidence interval 44-76%). The null hypothesis that ≤15% of these patients would have a PFS ratio ≥1.3 was rejected (one-sided p < 0.0001). In conclusion, using MP to guide therapy selection is feasible in clinical practice and may improve patient outcomes.