Randomized phase II study of the PDGFRα antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer

Table 2 Patient disposition

	No. (%) of Patients
	Olaratumab + Liposomal Doxorubicin	Liposomal Doxorubicin	Total
mITT population	62	61	123
Treated	62 (100.0)	61 (100.0)	123 (100.0)
On treatment^a	1 (1.6)	0	1 (0.8)
Off treatment	61 (98.4)	61 (100.0)	122 (99.2)
Reasons for discontinuation of study therapy
Adverse event	2 (3.2)	7 (11.5)	9 (7.3)
Death	2 (3.2)	0	2 (1.6)
PD per RECIST	42 (67.7)	12 (19.7)	54 (43.9)
PD, symptomatic deterioration	10 (16.1)	8 (13.1)	18 (14.6)
Withdrawal by patient	1 (1.6)	3 (4.9)	4 (3.3)
Lost to follow-up	1 (1.6)	0	1 (0.8)
Other	3 (4.8)	3 (4.9)	6 (4.9)
Reasons for discontinuation for patients electing to receive olaratumab monotherapy after progression on liposomal doxorubicin
PD per RECIST	0	26 (42.6)	26 (21.1)
PD, symptomatic deterioration	0	2 (3.3)	2 (1.6)
On study^a	1 (1.6)	1 (1.6)	2 (1.6)
Off study	61 (98.4)	60 (98.4)	121 (98.4)

mITT, modified intent-to-treat; PD, progressive disease; RECIST, Response Evaluation Criteria in Solid Tumors.^aRefers to those who were still on study therapy or on study evaluations as of cutoff date. For patient who discontinued study therapy for reasons other than PD, radiological scans continued until a documented PD. After PD was documented, patient was considered off study. Patients were followed for survival status. In any study phase, patients could withdraw consent or become lost to follow-up

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