Patients' preferences for subcutaneous trastuzumab versus conventional intravenous infusion for the adjuvant treatment of HER2-positive early breast cancer: final analysis of 488 patients in the international, randomized, two-cohort PrefHer study

BACKGROUND: Patients with HER2-positive early breast cancer (EBC) preferred subcutaneous (SC) trastuzumab, delivered via single-use injection device (SID), over the intravenous (IV) formulation (Cohort 1 of the PrefHer study: NCT01401166). Here we report patient preference, healthcare professional satisfaction, and safety data pooled from Cohort 1 and also Cohort 2, where SC trastuzumab was delivered via hand-held syringe. PATIENTS AND METHODS: Patients were randomized to receive 4 adjuvant cycles of 600 mg fixed-dose SC trastuzumab followed by 4 cycles of standard IV trastuzumab, or vice versa. The primary endpoint was overall preference proportions for SC or IV, assessed by patient interviews in the evaluable ITT population. RESULTS: A total of 245 patients were randomized to receive SC followed by IV and 243 received IV followed by SC (evaluable ITT populations: 235 and 232 patients, respectively). SC was preferred by 415/467 (88.9%; 95% CI, 85.7-91.6; P<.0001; two-sided test against null hypothesis of 65% SC preference); 45/467 preferred IV (9.6%; 7-13); 7/467 indicated no preference (1.5%; 1-3). Clinician-reported adverse events occurred in 292/479 (61.0%) and 245/478 (51.3%) patients during the pooled SC and IV periods, respectively (P<.05; 2x2 chi2); 16 patients (3.3%) in each period experienced grade 3 events; none were grade 4/5. CONCLUSION: PrefHer revealed compelling and consistent patient preferences for SC over IV trastuzumab, regardless of SID or hand-held syringe delivery. SC was well tolerated and safety was consistent with previous reports, including the HannaH study (NCT00950300). No new safety signals were identified compared to the known IV profile in EBC. PrefHer and HannaH confirm that SC trastuzumab is a validated and preferred option over IV for improving patients' care in HER2-positive breast cancer.