TABLE 2.

Cycles, Escalated Dose of Olaparib, and DLT

PatientCycles (n)Reached dose of olaparibDLTOther reason for hampered escalation
Cohort 1
12100 mg BIDProgressive disease after 2 cycles*
24300 mg BID
44200 mg BIDAbdominal pain G1
52100 mg BIDProgressive disease after 2 cycles*
64300 mg BID
7250 mg BIDNoncompliant*
84100 mg BIDFatigue G2, nausea G2, loss of appetite G2
94300 mg BID
104300 mg BID
114300 mg BIDThrombocytopenia G3
124300 mg BID
Cohort 2
134300 mg BIDThrombocytopenia G3
143100 mg BIDThrombocytopenia G2
154300 mg BID
164300 mg BIDThrombocytopenia G2
1710 mgCarcinoid reaction on first 177Lu infusion*
192200 mg BIDProgressive disease after 2 cycles*
204300 mg BIDThrombocytopenia G3
  • * Premature study discontinuation.

  • Not escalated at cycle 1 because of abdominal pain G1, so did not reach 300 mg.

  • Discontinued last cycle of olaparib.

  • G1 = grade 1; G2 = grade 2; G3 = grade 3.

  • Patients 3 and 18 were excluded from the study.