Page 119 - Haematologica August 2018

Coltuximab ravtansine monotherapy in DLBCL
3 patients) were considered related to treatment: hepato- toxicity (n=2), pneumonia, abdominal pain, nausea, and grade 5 febrile neutropenia (n=1).
The most common grade 3-4 hematologic laboratory abnormalities were neutropenia (25%), lymphopenia (21%), and leukopenia (15%) (Table 3). Grade 3-4 non- hematologic laboratory abnormalities were rare, with ele- vated levels of aspartate aminotransferase, alkaline phos- phatase, alanine aminotransferase, and creatinine each occurring in 2 patients. Grade 3-4 febrile neutropenia was also observed in one patient, but this did not require growth factor administration.
Eye disorders occurred in 15 patients (25%); all were grade 1-2 and none required a dose modification. Nineteen extracorneal eye disorders were observed in 13 patients (21.3%), with the first occurrence during cycle 1 (6 patients), cycle 2 (n=2), cycle 3 (n=3), cycle 7 (n=1), and cycle 9 (n=1). Fourteen of these events had resolved at the time of data cut-off, with a median recovery time of 12.5 days (range 1-47). One patient experienced a corneal event (grade 2 keratitis during cycle 4), which resolved within 9 days. A further 2 patients experienced dry eyes, occurring during cycle 1 and resolving after 13 and 17 days, respectively. Neuropathy was observed in
Figure 2. Duration of response for individ- ual patients in the per protocol population. Patients with a duration of response of 0.03 months were censored to the first documentation of the response, in the absence of another evaluable assessment before the cut-off date. CR: complete response; DLBCL: diffuse large B-cell lym- phoma; PR: partial response.
Figure 3. Kaplan–Meier curve of pro- gression-free survival (PFS) (per proto- col population) and overall survival (OS) (safety population).
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