[Efficacy and Safety of Trastuzumab Biosimilars in Combination with Pertuzumab].

Although trastuzumab biosimilars have been approved based on clinical studies on their use as monotherapy or in combination with chemotherapy, clinical studies on their combination with pertuzumab are lacking. Data on the efficacy and safety of this combination are scarce. We evaluated the efficacy and safety of trastuzumab biosimilars in combination with pertuzumab. Progression-free survival was 10.5 months(95% confidence interval[CI]: 3.3-16.3)for a reference biological product and 8.7 months(2.1-not applicable)for biosimilars with a hazard ratio of 0.96(95%CI: 0.29-3.13, p=0.94); however, no statistically significant difference was observed. The incidence of adverse events was not significantly different between the reference biological product and biosimilars, and no increase was observed for any adverse events after switching to the biosimilars. The results of this study verify that a combination of trastuzumab biosimilars with pertuzumab is sufficiently effective and safe in clinical practice.

[A Retrospective Investigation of Lacrimation in Patients Treated with S-1].

Lacrimation is among the typical adverse drug reactions associated with S-1 treatment. However, lacrimation frequencies differ between reports, and a clear consensus regarding reaction times, risk factors, and symptomatic treatment for lacrimation is lacking. We retrospectively investigated the reaction times, risk factors, and outcomes of symptomatic treatment for lacrimation in 202 patients treated with S-1. The median estimated creatinine clearance noted upon initiation of cancer treatment was 75.8mL/min. The median of the relative treatment intensity was 87.1%, while the incidence of lacrimation was 26.7%. The median cumulative dose of S-1 before the onset of lacrimation was 23,520 mg in all patients, and 5,050 mg in those who developed lacrimation. Of the patients who developed lacrimation, 40.7% developed this symptom within 2 months after starting S-1 treatment. There were no apparent risk factors. The most frequently employed symptomatic treatment was a physiological saline ophthalmic solution provided as a hospital preparation. After treatment with this ophthalmic solution, 29.4% of the affected patients showed improvement and 70.6% showed no change; none however, experienced worsening of symptoms. These results suggest that clinicians should assess the presence of lacrimation after starting treatment with S-1. Symptomatic treatment with an ophthalmic solution that does not have a tear retention capacity may be useful in patients who have developed lacrimation.