Table 4.

Best overall objective responses (CR and PR) by central review after completion of protocol therapy according to dose level and sites of disease evaluable for response

Dose levelOverall responseMIBG responseCT/MRI responseBone marrow response
1 a 0/40/41/30/3 c
20/40/40/20/2
30/30/30/30/3
4 b 2/63/62/51/1
50/20/20/20/1 d
5a1/64/61/31/6 c
All dose levels3/25 (12%)7/25 (28%)4/18 (22%)2/16 (13%)
  • aFive patients enrolled to dose level 1, but one patient did not have disease evaluation after first course and is therefore inevaluable for response.

  • bSeven patients enrolled to dose level 4, but one patient did not receive MIBG and therefore is inevaluable for response.

  • cDenominator includes one patient with no BM involvement at baseline, but who subsequently had tumor detected in the BM (PD).

  • dPosttreatment BM not assessed in 1 of the 2 patients (and therefore not evaluable for BM response—although PD noted on CT).