Three patients developed neurologic toxicity, including transient delirium (1 grade 2, 1 grade 3) and 1 possibly related grade 5 encephalopathy.
Briefly, motesanib treatment was withheld for suspected or related grade 3 toxicity (other than hypertension) not adequately controlled with supportive care, or treatment-related grade 4 toxicity.
A second HD patient discontinued due to a nonserious, possibly related, Grade 3 report of vertigo after receiving two 240-mg doses; this subject was not replaced.
Only one patient required treatment discontinuation for toxicity (possibly related grade 2 abdominal fistula resulting in a DLT in DL0, followed by radiographic progression within 1 month later).
In sandwich group, acute radiotherapy related grade 1 2 gastrointestinal and genitourinary system toxicities were observed in 72.8 and 63.6 % of patients, respectively.
Local injection site reactions related to study drug were reported if occurring within 7 days of study drug administration; related grade 3 reactions consisted of hardness, pain, redness, and swelling.
In addition, the number of patients with combination treatment related grade ≥ 3 toxicity will be analyzed and if this number is 12 or higher, the study will be terminated because of unacceptable toxicity.
Table 4 shows bevacizumab related grade 3/4 adverse events for patients treated within NO16966 and First BEAT, and specific surgical complications that were prospectively collected from patients undergoing curative-intent resections in First BEAT.
Table 3 shows that grade 3/4 pulmonary symptoms were reported for a single patient who had disease related dyspnoea (grade 3), hypoxia (grade 2) and cough (grade 1).
